imraldi 40 mg Injection reviews | Uses, Dosage, Side Effects & Precautions

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imraldi 40 mg Injection reviews >> Generic drug of the Therapeutic class: Immunology Medicines

Active ingredients: Adalimumab

what is IMRALDI ?

Pharmaceutical form: Solution for injection
Route of administration: Sc
ATC code: L04AB04
Pharmacotherapeutic group: Adalimumab
Prescribing and dispensing conditions: Medicinal product subject to medical prescription (List I).
Medicines on list I (red box on the box) can only be dispensed for the duration of treatment mentioned on the prescription.
Initial hospital prescription. Prescription and renewal reserved for specialists in rheumatology, pediatrics, internal medicine, gastroenterology and hepatology, dermatology or ophthalmology. Exceptional drug.
Reimbursement according to the indication (OJ of 17/10/2018): The only therapeutic indications giving rise to the right to additional reimbursement by health insurance are, for the specialty referred to below: In adults: – treatment of severe chronic plaque psoriasis in adults, defined by: – failure (insufficient response, contraindication or intolerance) to at least two treatments among non-biological systemic treatments and phototherapy; – and an extended form and / or a significant psychosocial impact; – in combination with methotrexate, treatment of moderately to severely active rheumatoid arthritis in adults when the response to DMARDs, including methotrexate, is inadequate; IMRALDI can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate.
IMRALDI slows the progression of structural joint damage measured by radiography and improves functional abilities when it is given in combination with methotrexate.
treatment of severe and active ankylosing spondylitis in adults who have had an inadequate response to conventional treatment; – treatment of severe axial spondyloarthritis without radiographic signs of AS, but with objective signs of inflammation on MRI and / or a high level of CRP in adults who have had an inadequate response or intolerance to nonsteroidal anti-inflammatory drugs ; – treatment of active, moderate to severe Crohn’s disease in adult patients who have not responded despite an appropriate and well-conducted treatment with a corticosteroid and / or an immunosuppressant, or in whom this treatment is contraindicated or poorly tolerated; – treatment of active and progressive psoriatic arthritis in adults when the response to previous disease-modifying treatment has been inadequate; IMRALDI slows the progression of peripheral joint structural damage, as measured by radiography, in patients with symmetrical polyarticular forms of the disease and improves functional ability. – treatment of active, moderate to severe ulcerative colitis in adult patients who have not responded adequately to conventional treatment, including corticosteroids and azathioprine or 6-mercaptopurine, or in whom this treatment is poorly tolerated or contraindicated. In children: – treatment of severe chronic plaque psoriasis in children from 4 years of age and adolescents defined by: – failure (insufficient response, contraindication or intolerance) to at least two treatments among non-biological systemic treatments and phototherapy; – and an extended form and / or a significant psychosocial impact; – treatment of active, severe Crohn’s disease in children and adolescents from 6 years of age who have not responded to conventional treatment including a corticosteroid, an immunomodulator and first-line nutritional treatment, or in which these treatments are poorly tolerated or contraindicated; – In combination with methotrexate, treatment of progressive polyarticular juvenile idiopathic arthritis in children and adolescents from 2 years of age in the event of an insufficient response to one or more DMARDs. IMRALDI can be administered as monotherapy in cases of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate.
ADALIMUMAB has not been studied in children under 2 years of age.
Specialty Identifier Code (CIS): 61192750
Actual benefit (SMR): Important, Important, Moderate
Laboratory holder AMM: Samsung bioepis nl bv ( 08/24/2017 )
Operating laboratory: Biogen france

This medicine does not belong to any generic group.

Sources:

Summary of Product Characteristics (SPC) of French and European marketing authorizations (AMM)
Drug interactions booklet from the National Agency for the Safety of Medicines and Health Products (ANSM)
ANSM generic directory
Reference documents of the Haute Autorité de Santé (HAS): transparency sheets, good use sheets, SAM documents (Decision Support System by Medicines)
Prices and reimbursements from the Economic Committee for Health Products (CEPS)
Information from laboratories holding Marketing Authorization (see above in the “Other information” tab of this page)
Information wholesalers distributors
Health insurance (CNAMTS): guide to long-term assignments (ALD)
Technical Agency for Information on Hospitalization (ATIH): CIM10 classification
World Health Organization (WHO): ATC classification
European Pharmacopoeia: Standard Terms and EPhMRA Classification
Ministry of Health: doping substances

what is IMRALDI medication used for and indication?

Rheumatoid arthritis

Imraldi in combination with methotrexate is indicated for:

the treatment of moderately to severely active rheumatoid arthritis in adults when the response to DMARDs, including methotrexate, is inadequate.
the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with methotrexate.
Imraldi can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate.
It has been demonstrated that adalimumab slows the progression of damage structural joint measured radiographically and improves function, when given in combination with methotrexate.

Juvenile idiopathic arthritis

Polyarticular juvenile idiopathic arthritis

Imraldi in combination with methotrexate is indicated for the treatment of progressive polyarticular juvenile idiopathic arthritis in patients from 2 years of age in case of insufficient response to one or more DMARDs. Imraldi can be administered as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is unsuitable (for efficacy as monotherapy, see section Pharmacodynamic properties). Adalimumab has not been studied in patients less than 2 years of age.

Enthesitis-related arthritis

Imraldi is indicated for the treatment of active arthritis associated with enthesitis in patients from 6 years of age with insufficient response or intolerance to conventional therapy (see section 5.1).

Axial spondyloarthritis

Ankylosing spondylitis (AS)

Imraldi is indicated for the treatment of severe and active ankylosing spondylitis in adults who have had an inadequate response to conventional therapy .

Axial spondyloarthritis without radiographic evidence of AS

Imraldi is indicated for the treatment of severe axial spondyloarthritis without radiographic evidence of AS, but with objective evidence of inflammation on MRI and / or elevated CRP in adults who have had an inadequate response or intolerance to anti -nonsteroidal inflammatory drugs.

Psoriatic arthritis

Imraldi is indicated for the treatment of active and progressive psoriatic arthritis in adults when the response to previous disease-modifying therapy has been inadequate.
It has been demonstrated that adalimumab slows the progression of damage peripheral joint as measured by X-ray in patients with polyarticular forms symmetrical disease (see section Pharmacodynamic properties) and improves functional capacity.

Psoriasis

Imraldi is indicated for the treatment of chronic, moderate to severe plaque psoriasis in adult patients who require systemic therapy.

Plaque psoriasis in children and adolescents

Imraldi is indicated for the treatment of severe chronic plaque psoriasis in children from 4 years of age and in adolescents with insufficient response to topical treatment and light therapy or when these treatments are inappropriate.

Hidradenitis suppurativa (HS)

Imraldi is indicated for the treatment of active, moderate to severe hidradenitis suppurativa ( Verneuil’s disease ) in adults and adolescents from 12 years of age in the event of an insufficient response to conventional systemic therapy for HS (see section Properties). Pharmacodynamics and Pharmacokinetic Properties).

Crohn’s disease

Imraldi is indicated for the treatment of moderate tosevere active Crohn’s disease in adult patients who have not responded despite appropriate and well-administered treatment with a corticosteroid and / or immunosuppressant; or in whom this treatment is contraindicated or poorly tolerated.

Crohn’s disease in children and adolescents

Imraldi is indicated for the treatment of moderate to severe active Crohn’s disease in children and adolescents from 6 years of age who have failed to respond to conventional therapy including first-line nutritional therapy and a corticosteroid and / or an immunomodulator, or in which these treatments are poorly tolerated or contraindicated.

Ulcerative colitis

Imraldi is indicated for the treatment of active, moderate to severe ulcerative colitis in adult patients who have had an inadequate response to conventional therapy, including corticosteroids and 6-mercaptopurine (6-MP) or azathioprine (AZA), or in whom this treatment is contraindicated or poorly tolerated.

Uveitis

Imraldi is indicated for the treatment of non-infectious, intermediate, posterior uveitis and panuveitis in adult patients who have had an insufficient response to corticosteroid therapy, in patients requiring corticosteroid sparing, or in whom corticosteroid therapy is inappropriate.

Uveitis in children and adolescents

Imraldi is indicated for the treatment of chronic non- infectious anterior uveitis in children and adolescents from 2 years of age with insufficient response or intolerance to conventional treatment or for whom conventional treatment is inappropriate.

IMRALDI Dosage

The treatment Imraldi should be initiated and supervised by a physician qualified specialist in the diagnosis and treatment of pathologies in which Imraldi indicated.
It is recommended that ophthalmologists consult an appropriate specialist before initiating treatment with Imraldi.
Patients treated with Imraldi will receive a Patient Alert Card.
After proper training in the injection technique, patients can self-inject Imraldi, if their doctor considers it possible, under the guise of appropriate medical supervision.
During treatment with Imraldi, other concomitant treatments (such as corticosteroids and / or immunomodulators) should be optimized.

Dosage

Rheumatoid arthritis

In adult patients with rheumatoid arthritis, the recommended dose of Imraldi is a single dose of 40 mg adalimumab given every two weeks, subcutaneously. The administration of methotrexate should be continued during treatment with Imraldi.
The glucocorticoids, salicylates, nonsteroidal anti-inflammatory drugs or analgesics may be continued during treatment with Imraldi. Regarding the combination with anti-rheumatic drugs other than methotrexate, see sections Warnings and precautions for use and Pharmacodynamic properties.
As monotherapy, some patients who experience a decrease in their response to Imraldi 40 mg every other week may benefit from an increase in the dosage to adalimumab 40 mg every week or 80 mg every other week.
Available data suggest that clinical response is usually achieved within 12 weeks of treatment. Continuation of treatment should be reconsidered in a patient who has not responded within these time limits.

Interruption of treatment

It may be necessary to stop treatment, eg before surgery or in patients with severe infection.
The available data suggest that re-introduction of adalimumab after stopping 70 days or more results in a clinical response of the same magnitude and a similar safety profile to that observed before stopping.

Ankylosing spondylitis, axial spondyloarthritis without radiographic evidence of AS, and psoriatic arthritis

The recommended dose of Imraldi for patients with ankylosing spondylitis, axial spondyloarthritis without radiographic evidence of AS, and for patients withpsoriatic arthritis is 40 mg adalimumab as a single dose every two weeks, by subcutaneous injection. .
Available data suggest that clinical response is usually achieved within 12 weeks of treatment. Continuation of treatment should be reconsidered in a patient who has not responded within these time limits.

Psoriasis

The recommended dose of Imraldi to start treatment in adults is 80 mg subcutaneously. The dosage will continue one week later with 40 mg subcutaneously every other week.
The continuing treatment beyond 16 weeks should be carefully reconsidered in a patient not responding within this time.
Beyond 16 weeks, in case of insufficient response to Imraldi 40 mg every two weeks, patients may benefit from an increase in the administration dose to 40 mg every week or 80 mg every two weeks. The benefits and risks of continuous treatment of 40 mg every week or 80 mg every other week should be carefully reconsidered in a patient with insufficient response after increasing the dosage.
If sufficient response is obtained with 40 mg every week or 80 mg every two weeks, the dosage may then be reduced to 40 mg every 2 weeks.

Hidradenitis suppurativa

The recommended dosage regimen of Imraldi in adult patients with hidradenitis suppurativa (HS) is an initial dose of 160 mg on day 1 (given as 4 injections of 40 mg in one day or 2 injections of 40 mg mg per day for two consecutive days ), followed by an 80 mg dose two weeks later, on day 15 (given as two 40 mg injections over one day).
Two weeks later (day 29), continue with a dose of 40 mg every week or 80 mg every two weeks (given as two 40 mg injections per day). If necessary, antibiotics can be continued during treatment with Imraldi. During treatment with Imraldi, it is recommended that the patient cleanse his lesions daily with a topical antiseptic.
The continuing treatment beyond 12 weeks should be carefully reconsidered in patients showing no improvement during this period.
If treatment is interrupted, Imraldi 40 mg every week or 80 mg every other week may be reintroduced .
The benefit and risk of continued long-term treatment should be assessed regularly.

Crohn’s disease

In adult patients with moderate to severe active Crohn’s disease , the recommended induction regimen of Imraldi is 80 mg at week 0, followed by 40 mg at week 2. If needed. achieve a faster response to treatment, schedule 160 mg at week 0 (given as 4 injections of 40 mg per day or 2 injections of 40 mg per day for two
injections of 40 mg per day), can be used knowing that the risk of adverse events is then higher during this
induction phase .
Following induction therapy, the recommended dose is 40 mg administered every two weeks by subcutaneous injection. If a patient has stopped treatment with Imraldi and the signs and symptoms of the disease return, Imraldi may be re-administered. Experience with re-administration of treatment beyond 8 weeks after the previous dose is limited.
During maintenance treatment, corticosteroids may be gradually reduced in accordance with clinical practice recommendations .
Some patients in whom a decreased response to treatment with Imraldi 40 mg every two weeks is observed may benefit from an increase in the dose to Imraldi 40 mg every week or 80 mg every other week.
Some patients who have not responded to treatment at week 4 may continue maintenance therapy until week 12. Continuation of treatment should be carefully reconsidered in a patient who has not responded within this time.

Ulcerative colitis

In adult patients with moderate to severe ulcerative colitis , the recommended induction regimen of Imraldi is 160 mg at week 0 (given as 4 injections of 40 mg per day or 2 injections of 40 mg per day. day for two consecutive days ) and 80 mg at week 2 (given as two 40 mg injections per day). After induction therapy, the recommended dose is 40 mg administered every two weeks by subcutaneous injection.
During maintenance treatment, corticosteroids may be gradually reduced in accordance with clinical practice recommendations .
Some patients in whom a decreased response to treatment with Imraldi 40 mg every two weeks is observed may benefit from an increase in the dose to Imraldi 40 mg every week or 80 mg every other week.
The available data suggest that the clinical response is usually achieved within 2 to 8 weeks of treatment. Treatment with Imraldi should not be continued in patients who have not responded within this time frame .

Uveitis

In adult patients with uveitis, the recommended dose of Imraldi is an initial dose of 80 mg followed by a dose of 40 mg every two weeks starting one week after the administration of the first dose. There
is limited experience with initiating treatment with Imraldi as monotherapy. Treatment with Imraldi can be started in combination with corticosteroid therapy and / or with other non-biological immunomodulatory treatments.
The combined corticosteroid dose may be gradually reduced in accordance with clinical practice, starting two weeks after initiation of treatment with Imraldi.
An annual reassessment of the benefits and risks associated with long-term continuous therapy is recommended .

Special populations

Older subjects

No dosage adjustment is necessary.

Renal and / or hepatic impairment

Adalimumab has not been studied in these patient populations. It is not possible to recommend dosages.

Pediatric population

Juvenile idiopathic arthritis

Polyarticular juvenile idiopathic arthritis from 2 years old

The recommended dose of Imraldi for patients with polyarticular juvenile idiopathic arthritis from the age of 2 years depends on body weight (Table 1). Imraldi is given every two weeks as a subcutaneous injection.

Table 1. Dosage of Imraldi in patients with polyarticular juvenile idiopathic arthritis

Patient weight Dosing regimen

10 kg to <30 kg 20 mg every 2 weeks
≥ 30 kg 40 mg every 2 weeks

The clinical response is usually achieved within 12 weeks of treatment. Continuation of treatment should be carefully reconsidered in a patient who has not responded within this time frame.

There is no relevant use of adalimumab in patients under 2 years of age in this indication.

Enthesitis-related arthritis

The recommended dose of Imraldi for patients with enthesitis-related arthritis from the age of 6 years depends on body weight (Table 2). Imraldi is administered every two weeks as a subcutaneous injection.

Table 2. Dosage of Imraldi in patients with enthesitis-related arthritis

Patient weight Dosing regimen

15 kg to <30 kg 20 mg every 2 weeks
≥ 30 kg 40 mg every 2 weeks
Adalimumab has not been studied in patients less than 6 years of age with arthritis related to enthesitis.

Plaque psoriasis in children and adolescents

The recommended dose of Imraldi for patients with plaque psoriasis aged 4 to 17 years depends on body weight (Table 3). Imraldi is administered as a subcutaneous injection.

Table 3. Dosage of Imraldi in Children and Adolescents with Plaque Psoriasis Patient Weight Dosing Regimen

15 kg to <30 kg Initial dose of 20 mg then 20 mg every two weeks starting one week after the initial dose.
≥ 30 kg Initial dose of 40 mg then 40 mg every two weeks starting one week after administration of the initial dose.

The continuing treatment beyond 16 weeks should be carefully reconsidered in a patient not responding within this time.

If retreatment with Imraldi is indicated, the above recommendations for dosage and duration of treatment should be followed.

The safety of adalimumab in children and adolescents with plaque psoriasis has been evaluated over a mean duration of 13 months.

There is no relevant use of adalimumab in children aged less than 4 years in this indication.

Adolescent hidradenitis suppurativa (from 12 years of age, weighing at least 30 kg)

There is no clinical trial conducted with adalimumab in adolescents with HS. The dosage of adalimumab in these patients was determined from pharmacokinetic modeling and simulation .
The recommended dose of Imraldi is 80 mg at week 0 followed by 40 mg every two weeks from week 1 by subcutaneous injectio.
In adolescents with an insufficient response to Imraldi 40 mg every two weeks, an increase in dosage to 40 mg every week or 80 mg both may be considered.
If necessary, antibiotics can be continued during treatment with Imraldi. During treatment with Imraldi, the patient is recommended to cleanse their lesions daily with a topical antiseptic.
The continuing treatment beyond 12 weeks should be carefully reconsidered in patients showing no improvement during this period.
If treatment is interrupted, Imraldi could be reintroduced if necessary.
The benefit and risk of continued long-term treatment should be assessed regularly (see data in adults under Pharmacodynamic properties).
There is no relevant use of adalimumab in children aged less than 12 years in this indication.

Crohn’s disease in children and adolescents

The recommended dose of Imraldi for patients with Crohn’s disease aged 6 to 17 years depends on body weight (Table 4). Imraldi is administered as a subcutaneous injection.

Table 4. Dosage of Imraldi in children and adolescents with Crohn’s disease

Patient weight	Induction dose	Maintenance dose from week 4
<40 kg	If a faster response to treatment is required, bearing in mind that the risk of adverse events associated with a higher induction dose may be greater, the following dosage may be used:	20 mg every 2 weeks
≥ 40 kg	If a faster response to treatment is required, bearing in mind that the risk of adverse events associated with a higher induction dose may be greater, the following dosage may be used:	40 mg every 2 weeks

40 mg in week 0 and 20 mg in week 2
80 mg in week 0 and 40 mg in week 2
80 mg in week 0 and 40 mg in week 2
160 mg in week 0 and 80 mg in week 2

Patients in whom an insufficient response to treatment is observed may benefit from an increase in the dosage:

<40 kg: 20 mg every week
≥ 40 kg: 40 mg every week or 80 mg every two weeks

Continuation of treatment should be carefully reconsidered in a patient who has not responded by week 12.

There is no relevant use of adalimumab in children aged less than 6 years in this indication.

Pediatric ulcerative colitis

The safety and efficacy of adalimumab in children 4 to 17 years old have not yet been established. No data is available. There is no relevant use of Imraldi in children aged less than 4 years in this indication.

Psoriatic arthritis and axial spondyloarthritis including ankylosing spondylitis

There is no relevant use of adalimumab in the population pediatric indications in ankylosing spondylitis and psoriatic arthritis.

Pediatric uveitis

The recommended dose of Imraldi for children and adolescents with uveitis from the age of 2 years depends on body weight (Table 5). Imraldi is administered as a subcutaneous injection.
In uveitis in children and adolescents, no clinical trials have been conducted with adalimumab without concomitant treatment with methotrexate.

Table 5. Dosage of Imraldi in Children and Adolescents with Uveitis Patient Weight Dosing Regimen

<30 kg 20 mg every two weeks in combination with methotrexate
≥ 30 kg 40 mg every two weeks in combination with methotrexate

When initiating treatment with Imraldi, a loading dose of 40 mg for patients <30 kg or 80 mg for patients ≥ 30 kg may be administered one week before the start of maintenance therapy . No clinical data are available from the use of a loading dose of adalimumab in children less than 6 years of age.

There is no relevant use of adalimumab in children under 2 years of age in this indication.

An annual reassessment of the benefits and risks associated with long-term continuous therapy is recommended .

Administration mode

Imraldi is administered as a subcutaneous injection. Full instructions for use are provided in the package leaflet.
A 40 mg pre-filled syringe and pre-filled pen are also available for patients to administer a full 40 mg dose .

IMRALDI Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in the Composition section.
Active tuberculosis or other severe infections such as sepsis and opportunistic infections .
Moderate to severe heart failure (NYHA classes III / IV) .

What are the side effects of Imraldi?

Summary of the safety profile

Adalimumab
has been studied in 9,506 patients in pivotal,
open- label, controlled trials of 60 months and longer duration. These trials included
patients with recent or old rheumatoid arthritis,
juvenile idiopathic arthritis (
polyarticular juvenile idiopathic arthritis and enthesitis-related arthritis) or patients
with axial spondyloarthritis (ankylosing spondylitis and
axial spondyloarthritis without radiographic evidence of AS ),
psoriatic arthritis, Crohn’s disease, ulcerative
colitis, psoriasis, hidradenitis suppurativa and uveitis. The
pivotal controlled studies involved 6,089 patients who received
adalimumab and 3,801 patients who received placebo or an
active comparator during the controlled phase.
The
percentage of patients who discontinued treatment due
to adverse reactions during the double-blind, controlled phase
of the pivotal studies was 5.9% in patients treated with
adalimumab and 5.4% in patients of the control group.
The
most frequently reported side effects are infections
(such as nasopharyngitis, upper
respiratory tract infections and sinusitis),
injection site reactions (erythema, itching, bleeding, pain or
swelling), headache and musculoskeletal pain.
Some
serious side effects have been reported with adalimumab. The
TNF antagonists, such as adalimumab affect the system
immune and their use may affect the
body’s defenses against infection and cancer.
Life-
threatening and fatal
infections (including sepsis, opportunistic infections and tuberculosis),
hepatitis B reactivations and various cancers (including leukemia, lymphoma and
hepatosplenic T-cell lymphoma) have also been reported
with use of adalimumab.
Severe
haematological, neurological and autoimmune effects have been
reported. This includes rare cases of pancytopenia,
bone marrow anemia , cases of central and peripheral demyelination, and
cases of lupus, lupus-related events, and
Stevens-Johnson syndrome .

Pediatric population

In
general, the frequency and type of adverse events seen
in children and adolescents were comparable to those seen in
adult patients.

List of side effects

The
list of undesirable effects is based on clinical studies and
post-marketing experience and is presented by
system organ and frequency in Table 6 below: very
common ( ≥ 1/10); common ( ≥ 1/100, <1/10); uncommon ( ≥ 1 / 1,000, <1/100); rare ( ≥
1 / 10,000, <1 / 1,000) and not known (cannot be estimated
from the available data). Within each frequency
grouping, undesirable effects are presented in order of decreasing
seriousness. The highest frequency observed in the various
indications was included. The presence of an asterisk (*) in the
“System organ class” column indicates that more
information is available under the sections Contraindications, Warnings and precautions for use and Undesirable effects.

Table 6 Adverse reactions

System organ class	Frequency	Side effects
Infections and infestations *	Very common	Infections of the respiratory tract (including respiratory infection bass and upper respiratory tract infection, pneumonia, sinusitis, pharyngitis, nasopharyngitis and pneumonia herpes).
	Frequent	Systemic infections (including sepsis, candidiasis and influenza). Intestinal infections (including viral gastroenteritis). Skin and soft tissue infections (including superficial periungual whitlow, cellulitis, impetigo, necrotizing fasciitis and shingles). Ear infections. Oral infections (including herpes, oral herpes and dental infections ). Infections of the reproductive organs (including vulvovaginal yeast infection ).
		Urinary tract infections (including pyelonephritis).
		Fungal infections.
		Joint infections.
	Rare	Neurological infections (including viral meningitis). Opportunistic infections and tuberculosis (including coccidioidomycosis, histoplasmosis and Mycobacterium avium complex infections ). Bacterial infections. Eye infections . Diverticulitis1).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) *	Frequent	Skin cancer excluding melanoma (including basal cell carcinoma and squamous cell carcinoma).

System organ class	Frequency	Side effects
		Benign tumor.
	Rare	Lymphoma . Tumors of solid organs (including breast, lung and thyroid cancer). Melanoma.
	Rare	Leukemia1)
	Frequency not known	T1 lymphocyte hepatosplenic lymphoma). Merkel cell carcinoma (cutaneous neuroendocrine carcinoma) 1)
Blood and lymphatic system disorders *	Very common	Leukopenia (including neutropenia and agranulocytosis). Anemia.
	Frequent	Leukocytosis. Thrombocytopenia.
	Rare	Idiopathic thrombocytopenic purpura.
	Rare	Pancytopenia.
Immune system disorders *	Frequent	Hypersensitivity. Allergies (including seasonal allergy).
	Rare	Sarcoidosis1). Vasculitis.
	Rare	Anaphylaxis1).
Metabolism and nutrition disorders	Very common	Increased lipid level.
Metabolism and nutrition disorders	Frequent	Hypokalaemia. Increased uric acid. Abnormal sodium level in the blood. Hypocalcemia. Hyperglycemia. Hypophosphatemia. Dehydration.
Psychiatric disorders	Frequent	Mood disorders (including depression). Anxiety. Insomnia.
Nervous system disorders *	Very common	Headache.
	Frequent	Paresthesia (including hypoaesthesia). Migraine. Compression of nerve roots.
	Rare	Stroke1). Tremors. Neuropathy.
	Rare	Multiple sclerosis. Demyelinating disorders (eg optic neuritis, Guillain-Barré syndrome) 1).
Eye disorders	Frequent	Visual disturbances. Conjunctivitis. Blepharitis. Swelling of the eyes.
Eye disorders	Rare	Diplopia.
Ear and labyrinth disorders	Frequent	Dizziness.
Ear and labyrinth disorders	Rare	Deafness. Tinnitus.
Cardiac disorders *	Frequent	Tachycardia.
Cardiac disorders *	Rare	Myocardial infarction1). Arrhythmias.

System organ class	Frequency	Side effects
		Congestive heart failure.
	Rare	Cardiac arrest.
Vascular disorders	Frequent	Hypertension. Hot flashes. Hematomas.
Vascular disorders	Rare	Aortic aneurysm. Vascular occlusion. Thrombophlebitis.
Respiratory, thoracic and mediastinal disorders *	Frequent	Asthma. Dyspnea. Cough.
	Rare	Pulmonary embolism1) . Interstitial lung disease. Chronic obstructive pulmonary disease. Pneumopathy. Pleural effusion1).
	Rare	Pulmonary fibrosis1) .
Gastrointestinal disorders	Very common	Abdominal pain. Nausea and vomiting.
	Frequent	Gastrointestinal bleeding. Dyspepsia. Gastroesophageal reflux. Gougerot-Sjögren syndrome.
	Rare	Pancreatitis. Dysphagia. Facial edema.
	Rare	Intestinal perforation1).
Hepatobiliary disorders *	Very common	Elevation of liver enzymes.
	Rare	Cholecystitis and gallstones. Fatty liver. Hyperbilirubinemia.
	Rare	Hepatitis. Reactivation of hepatitis B1). Autoimmune hepatitis1).
	Frequency not known	Hepatic failure1)
Skin and subcutaneous tissue disorders	Very common	Rash (including exfoliative rash).
	Frequent	Worsening or onset of psoriasis (including palmoplantar pustular psoriasis ) 1). Urticaria. Bruises (including purpura). Dermatitis (including eczema). Onychoclasia. Hyperhidrosis. Alopecia 1). Pruritus.
	Rare	Night sweats. Scar.
	Rare	Erythema multiforme1). Stevens-Johnson syndrome1). Angioedema1) Cutaneous vasculitis1)

System organ class	Frequency	Side effects
		Skin lichenoid reaction 1).
	Frequency not known	Worsening of symptoms of dermatomyositis1)
Musculoskeletal and connective tissue disorders	Very common	Musculoskeletal pain.
	Frequent	Muscle spasms (including increased serum creatine phosphokinase).
	Rare	Rhabdomyolysis. Systemic lupus erythematosus.
	Rare	Lupus-like syndrome1).
Kidney and urinary tract disorders	Frequent	Renal failure. Haematuria.
Kidney and urinary tract disorders	Rare	Nocturia.
Reproductive system and breast disorders	Rare	Erectile function disorders.
General disorders and administration site conditions *	Very common	Reaction at the injection site (including erythema at the injection site).
	Frequent	Chest pain. Edema. Fever1).
	Rare	Inflammation.
Investigations *	Frequent	Disorders of coagulation and bleeding disorders (including a lengthening of activated partial thromboplastin time). Positivity to autoantibodies (including anti-double-stranded DNA antibodies). Increase in blood lactate dehydrogenase level.
Injury, poisoning and procedural complications	Frequent	Poor healing.

* Further information is available under the sections Contraindications, Warnings and precautions for use and Adverse reactions.

** including open label extension studies.

1) including data from spontaneous notifications

Hidradenitis suppurativa (HS)

The
safety profile in patients with HS treated with
weekly adalimumab is consistent with the
known safety profile of adalimumab.

Uveitis

The
safety profile in patients with uveitis treated with
adalimumab every two weeks is consistent with the
known safety profile of adalimumab.

Description of selected adverse reactions

Injection site reactions

In
pivotal controlled trials in adults and children, 12.9% of
patients treated with adalimumab experienced
injection site reactions (erythema and / or pruritus, bleeding, pain or swelling)
versus 7 , 2% of patients receiving placebo or active comparator.
Injection site reactions generally did not require
stopping the drug.

Infections

In
the pivotal controlled trials in adults and children, the
frequency of infections was 1.51 per patient-year in the
adalimumab group and 1.46 per patient-year in the placebo group and the
control group. . The infections mainly consisted of
nasopharyngitis, upper respiratory tract infections and
sinusitis. Most patients continued with adalimumab after
the infection cleared.
The incidence
of serious infections was 0.04 per patient-year in the
adalimumab group and 0.03 per patient-year in the placebo group and the
control group.
In
controlled and open-label studies with adalimumab in
adults and in the pediatric population, serious infections (
including fatal infections, which have rarely occurred)
have been reported including reports of tuberculosis. (including
miliary and extrapulmonary localizations) and
invasive opportunistic infections (eg disseminated
histoplasmosis or extrapulmonary histoplasmosis, blastomycosis, coccidioidomycosis,
pneumocystosis, candidiasis, aspergillosis and listeriosis). Most
cases of tuberculosis have occurred within the first eight months after
starting treatment and may reflect reactivation of
latent disease.

Malignant tumors and lymphoproliferative disorders

No
cases of cancer were observed in 249 pediatric patients
representing an exposure of 655.6 patient-years in studies of
adalimumab in patients with juvenile
idiopathic arthritis (polyarticular juvenile idiopathic
arthritis and arthritis related to enthesitis). In addition, no cases of cancer were
observed in 192 pediatric patients representing an exposure of
498.1 patient years in studies with adalimumab in
pediatric Crohn’s disease. No cases of cancer were observed in 77
pediatric patients corresponding to an exposure of 80
patient-years in a study with adalimumab in psoriasis in
chronic pediatric plaques. No cases of cancer were observed in
60 pediatric patients representing an exposure of 58.4
patient-years in a study with adalimumab in
pediatric uveitis .
During
the controlled periods of pivotal adult clinical trials with
adalimumab lasting at least 12 weeks in patients
with moderately to severely active rheumatoid arthritis,
ankylosing spondylitis, axial spondyloarthritis without
radiographic evidence of AS , psoriatic arthritis, psoriasis,
Crohn’s disease, ulcerative colitis and uveitis, a rate
(95% confidence interval) of cancers other than lymphoma or
non-melanoma skin cancer, of 6.8 ( 4.4 – 10.5) per 1,000
patient-years among the 5,291 patients treated with adalimumab, was
observed versus a rate of 6.3 (3.4 – 11.8) per 1,000
patient-years among the 3,444 patients in the control group (the
mean duration of treatment was 4.0 months for patients treated with
adalimumab and 3.8 months for patients in the control group). The
rate (95% confidence interval) of
non-melanoma skin cancer was 8.8 (6.0 – 13.0) per 1000 patient-years for
patients treated with adalimumab and 3. 2 (1.3 – 7.6) per 1000
patient years among patients in the control group. In these
skin cancers , squamous cell carcinomas occurred at rates
of 2.7 (1.4 – 5.4) per 1,000 patient years in patients treated
with adalimumab and 0.6 (0 , 1 – 4.5) per 1,000 patient years in
patients in the control group (95% confidence interval). The rate
(95% confidence interval) of lymphoma was 0.7 (0.2 – 2.7)
per 1000 patient years in patients treated with adalimumab and
0.6 (0.1 – 4, 5) per 1000 patient-years in patients in the control group.
By
combining controlled portions of these tests and the tests
Expansion open ended or current with a mean duration
of around 3.3 years including 6427 patients and more than 26,439 patient-
years of treatment, the observed rate of cancers, other than lymphomas
and non-melanoma skin cancers is approximately 8.5 per 1,000
patient-years. The observed rate of non-melanoma skin cancer
is approximately 9.6 per 1,000 patient-years and the
observed rate of lymphoma is approximately 1.3 per 1,000 patient-years.
In
post-marketing from January 2003 to December 2010, primarily in
patients with rheumatoid arthritis, the reported rate of
cancer is approximately 2.7 per 1,000 patient-years of
treatment. The rates reported for
non-melanoma skin cancer and lymphoma are approximately 0.2 and 0.3
per 1000 patient-years of treatment, respectively (see section 4.4).
In
post-marketing surveillance, rare cases of
hepatosplenic T-cell lymphoma have been reported in patients
treated with adalimumab.

Autoantibodies

Repeated
autoantibody tests were performed on
serum samples from patients in the IV trials in rheumatoid
arthritis. In these trials,
initially negative antinuclear antibody titers were positive at week 24 in 11.9% of
patients treated with adalimumab and 8.1% of patients on placebo and
comparator. Two of the 3441 patients treated with adalimumab in
all rheumatoid arthritis and
psoriatic arthritis studies presented clinical signs suggestive of a
new onset lupus-like syndrome . The condition of the patients
improved after stopping treatment. No patient presented
lupus nephritis or central nervous symptoms.

Hepato-biliary events

In
phase III controlled clinical trials of adalimumab in
rheumatoid arthritis and psoriatic arthritis with a
control period of 4 to 104 weeks, elevations of ALT ≥ 3 × N occurred in 3.7% of patients treated. with adalimumab and in 1.6% of patients in the control group.
In
phase III controlled clinical trials of adalimumab in
patients with polyarticular juvenile idiopathic arthritis aged
4 to 17 years and patients with enthesitis-related arthritis
aged 6 to 17 years, elevations of ALT ≥ 3 × N occurred in
6.1% of patients treated with adalimumab and in 1.3% of patients
in the control group. Most of the elevations in ALT have occurred
with concomitant use of methotrexate. No
elevation of ALT ≥ 3 × N occurred in the phase
III trial of adalimumab in patients with
polyarticular juvenile idiopathic arthritis aged 2 to <4 years.
In
phase III controlled clinical trials of adalimumab in
patients with Crohn’s disease and ulcerative colitis
with a control period of 4 to 52 weeks, ALT elevations
≥ 3 × N occurred in 0.9 % of patients treated with adalimumab and in 0.9% of patients in the control group.
In
the phase III clinical trial of adalimumab in children and
adolescents with Crohn’s disease which evaluated the efficacy
and safety profile of two
weight-based maintenance regimens following treatment with weight-adjusted induction
up to 52 weeks of treatment, elevations of ALT ≥ 3 × N
occurred in 2.6% of patients (5/192), of whom 4
were treated in combination with immunosuppressants at the start of
the treatment. ‘study.
In
phase III controlled clinical trials of adalimumab in
plaque psoriasis with a control period of 12 to 24 weeks,
elevations of ALT ≥ 3 × N occurred in 1.8% of patients
treated with adalimumab and in 1.8% of patients in the control group.
Elevations of ALT ≥ 3 × N were not observed in the phase III study of adalimumab in pediatric patients with plaque psoriasis .
In
controlled clinical trials of adalimumab (starting doses of 160
mg at week 0 and 80 mg at week 2 followed by 40 mg each
week from week 4), in patients with
HS with severe 12-16
week control period , elevations of ALT ≥ 3 × N occurred in 0.3% of patients treated with adalimumab and 0.6% of patients in the control group.
In
controlled clinical trials of adalimumab (starting dose 80 mg
at week 0 followed by 40 mg every two weeks from
week 1) in adult patients with uveitis for
up to 80 mg weeks, with a median duration of exposure of
166.5 days and 105.0 days respectively for patients treated with
adalimumab and patients in the control group, elevations of ALT
≥ 3 × N occurred in 2.4 % of patients treated with adalimumab
and 2.4% of patients in the control group.
In
clinical trials across all indications, patients with
elevated ALT were asymptomatic and in most cases the
elevations were transient and reversible upon continued
treatment. However, during post-marketing surveillance,
hepatic insufficiency as well as less
severe hepatic disorders , which may precede hepatic insufficiency, such as
hepatitis including autoimmune hepatitis, have been reported in
patients receiving Hepatitis. ‘adalimumab.

Concomitant administration of azathioprine / 6-mercaptopurine

In
studies in Crohn’s disease in adults, a
higher incidence of tumors and serious infections was observed with
the combination of adalimumab and azathioprine / 6-mercaptopurine
compared to adalimumab used alone.

IMRALDI Interactions

Adalimumab has been studied in patients with rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, and psoriatic arthritis taking adalimumab as monotherapy and in those taking methotrexate concomitantly. Antibody formation was lower when adalimumab was co-administered with methotrexate compared to its use as monotherapy. Administration of adalimumab without methotrexate resulted in increased antibody formation, increased clearance and reduced efficacy of adalimumab.
The combination of Imraldi and anakinra is not recommended (see section Warnings and precautions for use “Simultaneous administration of biological DMARDs and anti-TNF drugs”).
The combination of Imraldi and abatacept is not recommended (see section Warnings and precautions for use “Simultaneous administration of biological DMARDs and anti-TNF drugs”).

In the absence of a compatibility study, this medicinal product must not be mixed with other medicinal products.

Drive and use machines

Imraldi may have minor influence on the ability to drive and use machines. Dizziness and visual disturbances may occur after administration of Imraldi ( see Undesirable effects ).

Warnings and Precautions

Traceability

In order
to improve the traceability of biological medicinal products, the name and
batch number of the administered product should be clearly recorded.

Infections

The
patients receiving TNF-antagonists are more susceptible to
serious infections. Impaired lung function can increase the
risk of developing infections. Patients should therefore be
closely monitored for infections (including
tuberculosis) before, during and after treatment with Imraldi. As the
duration of elimination of adalimumab may be up to four months,
monitoring should be continued throughout this period.
The
treatment Imraldi should not be initiated in patients with
active infections, including chronic infections or
localized, are not controlled. In patients who have been exposed
to tuberculosis or who have traveled to areas at high risk for
tuberculosis or endemic mycoses, for example histoplasmosis,
coccidioidomycosis or blastomycosis, the risks and benefits of
treatment with Imraldi should be considered before
initiation. treatment (see Opportunistic infections).
The
Patients who develop a new infection during
treatment with Imraldi must be monitored
carefully and complete diagnostic workup should be practiced. If
a serious new infection or sepsis
develops , the administration of Imraldi should be discontinued and
appropriate antimicrobial or antifungal therapy should be started until
the infection is controlled. The physician should exercise
caution before using Imraldi in patients with a
history of recurrent infection or with
underlying conditions that may predispose them to infections, including
concomitant treatment with immunosuppressive drugs.

Serious infections

Of
serious infections, including sepsis due to infections
bacterial, mycobacterial, invasive fungal, parasitic,
viral, or other opportunistic infections such as listeriosis,
legionellosis and pneumocystis have been reported in patients
treated with adalimumab.
The
other serious infections seen in clinical trials include
pneumonia, pyelonephritis, septic arthritis and septicemia. There have been reports of infections requiring hospitalization or with fatal outcome.

Tuberculosis

Of
TB cases, including cases of TB reactivation
and primary infection tuberculosis have been reported for patients
receiving adalimumab. Cases of pulmonary and
extra-pulmonary (i.e. disseminated) tuberculosis have been reported.
Before
starting treatment with Imraldi, all patients should
be tested for active or non-active (“
latent”) tuberculosis infection . This assessment should include a detailed medical evaluation
in patients with a history of tuberculosis or
possible previous exposure to patients with active tuberculosis and / or
current or past immunosuppressive therapy. Appropriate
screening tests (eg tuberculin skin test and
chest x-ray) should be performed in all patients
(according to local recommendations). It is advisable to note
the performance and the results of these tests in the
patient monitoring. Prescribers are reminded that
the tuberculin skin test can give false negatives, especially in
seriously ill or immunosuppressed patients.
If active tuberculosis is diagnosed, treatment with Imraldi should not be initiated (see section 4.3).
In
all of the situations described below,
the benefit / risk ratio of the treatment should be assessed very carefully.
In
case of suspicion of latent tuberculosis, consulting a
specialist, qualified in the treatment of tuberculosis
should be considered.
In
case of diagnosis of latent tuberculosis, prophylactic
tuberculosis appropriate and in accordance with local recommendations
must be implemented before the start of treatment with Imraldi.
A
TB prophylaxis should also be considered before
introducing Imraldi in patients with risk factors
or multiple TB significant despite testing
of negative tuberculosis and in patients with a history of
latent or active tuberculosis in that the administration of an
appropriate anti-tuberculosis treatment cannot be confirmed.
The
case of reactivation of tuberculosis despite treatment
prophylactic occurred in patients treated with
adalimumab. Some patients who had been successfully treated
for active tuberculosis developed the disease again during
treatment with adalimumab.
The
patients should be advised that they will need their doctor
in case of occurrence of symptoms suggestive signs or infection
tuberculosis (eg persistent cough, wasting / loss of
weight, low grade fever, listlessness), during or after treatment Imraldi.

Other opportunistic infections

Of
opportunistic infections, including invasive fungal infections,
have been observed in patients treated with adalimumab. These
infections were not always detected in patients receiving
TNF antagonists, resulting in delayed initiation of
appropriate therapy, sometimes with fatal outcome.
In
patients who present with signs and symptoms such as fever,
malaise, weight loss, sweating, cough, dyspnea and / or
pulmonary infiltrates or other serious systemic disease with or without
concomitant shock , an invasive fungal infection should be suspected; in
this case, the administration of Imraldi should be stopped immediately.
Diagnosis and initiation of
empiric antifungal therapy in these patients should be made in consultation with a
physician experienced in the management of patients with
invasive fungal infections.

Reactivation of hepatitis B

A
reactivation of hepatitis B occurred in patients who received
a TNF antagonist including adalimumab and who were carriers
chronic of this virus (that is to say surface antigen positive – Ag
positive HBs) . Some cases have had a fatal outcome. Patients
should be screened for HBV infection before
initiating treatment with Imraldi. For patients who
test positive for hepatitis B, it is
recommended to consult a doctor specializing in the treatment of
hepatitis B.
In
carriers of HBV who require treatment with Imraldi,
careful monitoring of signs and symptoms of active
HBV infection should be observed throughout treatment and for several months after
discontinuation. There are insufficient data available regarding
the treatment of patients with HBV treated with antiviral drugs to
prevent HBV reactivation and treated with a TNF antagonist.
In patients who develop HBV reactivation, Imraldi should
be discontinued and effective antiviral therapy as well as
appropriate complementary therapy initiated.

Neurological events

The
TNF blockers, including adalimumab, have been associated in rare
circumstances the onset or exacerbation of symptoms
clinical and / or radiographic evidence of demyelinating disease of the
central nervous system including multiple sclerosis,
Optic neuritis and peripheral demyelinating disease, including
Guillain-Barré syndrome. Prescribers are advised with caution before
treating with Imraldi patients with
pre-existing
or recently-occurring central or peripheral nervous system demyelinating disease ; Stopping treatment with Imraldi should be
considered if any of these conditions develop .
The association
between intermediate uveitis and demyelinating diseases of the
central nervous system is known. Neurologic assessment should be
performed in patients with non-
infectious intermediate uveitis before initiating treatment with Imraldi, and repeated
regularly during treatment to check for any pre-existing or progressive central nervous system demyelinating disease.

Allergic reactions

In
clinical trials, serious allergic reactions associated
with adalimumab were rarely reported and
non-serious allergic reactions associated with adalimumab were uncommon. Cases of
severe allergic reactions, including anaphylactic reactions
have been reported after administration of adalimumab. If
an anaphylactic reaction or other
serious allergic reaction occurs, the administration of Imraldi should be
stopped immediately and appropriate treatment initiated.

Immunosuppression

In
a study of 64 patients with rheumatoid
arthritis treated with adalimumab, there was no evidence
of delayed-type hypersensitivity depression,
decreased immunoglobulin levels. or a change in the
count of effector T and B lymphocytes, NK lymphocytes,
monocytes / macrophages and neutrophilic granulocytes.

Malignant tumors and lymphoproliferative disorders

In
the controlled part of clinical trials with anti-TNFs,
more cases of cancer including lymphomas were observed in
patients treated with an anti-TNF than in patients in the
control group . However, the incidence has been rare. During
post-marketing surveillance, cases of leukemia have been reported in
patients treated with anti-TNF. In addition, there is a background of
increased risk of lymphoma and leukemia in patients with
old, inflammatory and highly
active rheumatoid arthritis , which complicates the estimation of risk. In the current state of
knowledge, the possibility of a risk of developing lymphomas,
leukemia or other malignant diseases in patients treated
with anti-TNF cannot be excluded.
Of
malignancies, some fatal, have been reported
postmarketing in children, adolescents and
young adults (up to age 22 years) treated with TNF antagonists
(initiation of therapy before age 18), including
adalimumab. About half of these cases were lymphomas. The
other cases corresponded to other types of malignant tumors among
which rare cancers generally associated with a context
of immunosuppression. The risk of developing malignant tumors can
not be excluded in children and adolescents treated with anti-TNF.
In the
course of the post-marketing surveillance, rare cases of lymphoma
hepatosplenic T-cell lymphoma have been identified in patients
treated with adalimumab. This rare form of T-cell lymphoma
has a very aggressive course and is often fatal. Some of these
hepatosplenic T-cell lymphomas seen with adalimumab
have occurred in young adults who were concomitantly treated
with azathioprine or 6-mercaptopurine used in
inflammatory bowel disease. The potential risk of combining
azathioprine or 6 mercaptopurine with adalimumab should be
carefully considered. A risk of developing
hepatosplenic T-cell lymphoma in patients treated with
Imraldi cannot be excluded .
There
are no studies in patients with a history of
malignancies or in whom treatment with adalimumab is continued
after the development of cancer. Therefore, increased caution
should be observed when considering treatment of these patients
with adalimumab.
All
patients, especially those with a history of
intense immunosuppressive therapy or with psoriasis and with a
history of puvatherapy, should be examined for
skin cancer other than melanoma before and during treatment with
Imraldi. Cases of melanoma and Merkel cell carcinoma have
also been reported in patients treated with anti-TNF inhibitors
including adalimumab.
In
a prospective clinical study evaluating the use of another
anti-TNF agent , infliximab, in patients with
moderate to severe chronic obstructive pulmonary disease (COPD),
more cancers, especially of the lung, were reported. head and neck,
among patients treated with infliximab compared to patients
in the control group. All patients had a history of
heavy smoking. For this reason, care should be
taken in the use of an anti-TNF in patients with
COPD, and also in patients at risk for cancer due to
heavy smoking.
Based
on current data, it is not known whether treatment with
adalimumab influences the risk of developing dysplasia or
colon cancer. All patients with ulcerative colitis
who are at high risk of dysplasia or colon cancer (for
example, patients with old ulcerative colitis or
primary sclerosing cholangitis) or who have a history of
dysplasia or colon cancer should do
regularly screened for dysplasia before treatment and
throughout the course of their disease. This assessment should include
colonoscopy and biopsies according to local recommendations.

Haematological reactions

From
Rare reports of pancytopenia including aplastic anemia have been
reported with TNF antagonists. Adverse blood system effects
including medically significant cytopenias (eg
, thrombocytopenia, leukopenia) have been observed with adalimumab. It
should be recommended for all patients seek immediate
medical advice if they have signs or symptoms suggestive of
blood disorders (eg. Persistent fever, bruising,
bleeding, pallor) while Imraldi. Discontinuation of treatment with Imraldi
should be considered for patients in whom
significant blood abnormalities are confirmed.

Vaccinations

Similar
antibody responses to the
standard 23-valence pneumococcal vaccine and to the trivalent influenza vaccine were
observed in a study in 226 adults with rheumatoid
arthritis treated with adalimumab or placebo. There are no
data available on the secondary transmission of infection from
live vaccines in patients receiving adalimumab.
In
children and adolescents, it is recommended, if possible, that
all vaccinations be up to date according to current
vaccination recommendations before initiating treatment with
adalimumab.
The
adalimumab in patients may receive multiple vaccines
simultaneously, except in respect of live vaccines.
Administration of live vaccines (eg, BCG vaccine) to
infants who have been exposed to adalimumab in utero is not
recommended for 5 months after
the mother’s last injection of adalimumab during pregnancy.

Congestive heart failure

In
a clinical trial with another TNF antagonist,
worsening congestive heart failure and
increased mortality from congestive heart failure were observed . Of
cases of congestive heart failure worsening were also
reported in adalimumab patients. Imraldi should be used
with caution in patients with
mild heart failure (NYHA classes I / II). Imraldi is contraindicated in
moderate to severe heart failure (see section 4.3).
Treatment with Imraldi should be stopped in patients who experience
new or worsening symptoms.
congestive heart failure.

Autoimmune processes

The
treatment Imraldi may cause antibody formation
autoimmune. The impact of long-term treatment with adalimumab on
the development of autoimmune diseases is unknown. If a patient
develops lupus-like symptoms following
treatment with Imraldi and exhibits a positive anti-
double-stranded DNA reaction , treatment with Imraldi should not be continued.

Simultaneous administration of biological DMARDs or anti-TNF

Some
serious infections were seen in clinical studies in
the concurrent use of anakinra and another TNF antagonist,
etanercept, with no added clinical benefit compared to
etanercept alone. Due to the nature of the side effects
seen with treatment with etanercept and anakinra,
similar side effects may also result from the combination
of anakinra and other TNF blockers. Therefore the combination
of adalimumab and anakinra is not recommended (see section Interactions with other medicinal products and other forms of interactions).
Concomitant administration of adalimumab with other biologic
DMARDs (eg anakinra and abatacept) or with other TNF blockers is not
recommended due to the possible increased risk
of infections, including serious infections, and other
potential pharmacological interactions (see section Interactions with other medicinal products and other forms of interactions).

Surgery

There is limited experience
with safety during surgical procedures in
patients treated with adalimumab. The long half-life of
adalimumab should be taken into account if surgery
is planned. A patient treated with Imraldi requiring
surgery should be carefully monitored for
infections and appropriate actions should be taken.
There is limited experience with the safety of adalimumab in patients operated on for arthroplasty.

Hail Occlusion

In
Crohn’s disease, treatment failure may indicate the presence of
fixed fibrous strictures that may require surgical treatment.
The available data suggest that adalimumab does not worsen or
cause strictures.

Older subjects

The
frequency of serious infections in subjects treated with
adalimumab over 65 years of age (3.7%) is higher than in
patients under 65 years of age (1.5%). Some cases have had a
fatal outcome . Particular attention
should be paid to the risk of infection when treating the elderly.

Pediatric population

See Vaccinations above.

Excipients with known effect

This medicine
contains 20 mg sorbitol per pre-filled syringe / pre-filled pen. The
patients with rare hereditary fructose intolerance
should not take this medicine.
In
addition, this medicine contains less than 1 mmol sodium (23 mg) per
0.8 ml dose , which means that it is practically “sodium-free”.

PREGNANCY & BREAST-FEEDING & FERTILITY

Women of childbearing age

Women of childbearing potential should consider using an effective method of contraception during treatment with Imraldi and continue it for at least five months after the last administration of Imraldi.

Pregnancy

A large number (approximately 2,100) of pregnancies exposed to adalimumab for which data were collected prospectively, resulting in a live birth with a known term outcome, including more than 1,500 pregnancies exposed to adalimumab during the first trimester, does not reveal any increase in the rate of malformations in the newborn.
In a prospective cohort study, 257 women with rheumatoid arthritis (RA) or Crohn’s disease (CD) treated with adalimumab at least during the first trimester and 120 women with untreated RA or CD by adalimumab were included. The prevalence at birth of major congenital anomalies was the primary endpoint. The rate of pregnancies resulting in at least one living newborn with a major birth defect was 6/69 (8.7%) in women treated with adalimumab with RA and 5/74 (6.8 %) in untreated women with RA (unadjusted OR 1.31, 95% CI 0.38-4.52), and 16/152 (10.5%) in women treated with adalimumab with CD and 3/32 (9, 4%) in untreated women with CD (unadjusted OR 1.14, 95% CI 0.31-4.16). The adjusted OR (considering baseline differences) was 1.10 (95% CI 0.45-2.73) for RA and CD combined. No notable difference was reported between women treated with adalimumab and women not treated with adalimumab for secondary endpoints of spontaneous abortion, minor congenital anomalies, preterm delivery, height. at birth and serious or opportunistic infections, and stillbirth or malignancy. Interpretation of the data may be affected due to methodological limitations of the study, including the small sample size and the non-randomized study design. Adjusted OR (considering baseline differences) was 1.10 (95% CI 0.45-2.73) for RA and CD combined. No notable difference was reported between women treated with adalimumab and women not treated with adalimumab for secondary endpoints of spontaneous abortion, minor congenital anomalies, preterm delivery, height. at birth and serious or opportunistic infections, and stillbirth or malignancy. Interpretation of the data may be affected due to methodological limitations of the study, including the small sample size and the non-randomized study design. Adjusted OR (considering baseline differences) was 1.10 (95% CI 0.45-2.73) for RA and CD combined. No notable difference was reported between women treated with adalimumab and women not treated with adalimumab for secondary endpoints of spontaneous abortion, minor congenital anomalies, preterm delivery, height. at birth and serious or opportunistic infections, and stillbirth or malignancy. Interpretation of the data may be affected due to methodological limitations of the study, including the small sample size and the non-randomized study design. has been reported between women treated with adalimumab and women not treated with adalimumab for secondary endpoints of spontaneous abortion, minor congenital anomalies, preterm delivery, size at birth and severe or opportunistic infections, and stillbirth or malignancy. Interpretation of the data may be affected due to methodological limitations of the study, including the small sample size and the non-randomized study design. has been reported between women treated with adalimumab and women not treated with adalimumab for secondary endpoints of spontaneous abortion, minor congenital anomalies, preterm delivery, size at birth and severe or opportunistic infections, and stillbirth or malignancy. Interpretation of the data may be affected due to methodological limitations of the study, including the small sample size and the non-randomized study design. and stillbirth or malignancy. Interpretation of the data may be affected due to methodological limitations of the study, including the small sample size and the non-randomized study design. and stillbirth or malignancy. Interpretation of the data may be affected due to methodological limitations of the study, including the small sample size and the non-randomized study design.
In a developmental toxicity study performed in monkeys, there were no signs of possible maternal toxicity, embryotoxicity or teratogenic potential. There are no preclinical data on the postnatal toxicity of adalimumab ( see Preclinical Safety ).
Due to its inhibitory effect on TNFα, adalimumab administered during pregnancy may affect the normal immune responses of the newborn. Adalimumab should be used during pregnancy only if needed.
In women treated with adalimumab during pregnancy, adalimumab can cross the placenta and pass into the blood of their child. As a result, these children may have an increased risk of infections. The administration of live vaccines (eg BCG vaccine) to children who have been exposed to adalimumab in utero is not recommended for 5 months after the mother’s last injection during pregnancy.

Feeding with milk

Limited data from the published literature indicate that adalimumab is excreted in human milk at very low concentrations, with adalimumab being present in human milk at concentrations equivalent to 0.1% – 1% of maternal serum levels. . When administered orally, immunoglobulin G proteins undergo intestinal proteolysis and exhibit low bioavailability. No effects on breastfed newborns / infants are expected. Therefore, adalimumab can be used during breast-feeding.

Fertility

Preclinical data on the effects of adalimumab on fertility are not available.

What happens if I overdose from IMRALDI?

No dose related toxicity was observed in clinical trials. The highest dose evaluated consisted of repeated doses of 10 mg / kg IV, which is approximately 15 times the recommended dose.

What is Forms and Composition ?

SHAPES and PRESENTATIONS

40 mg solution for injection (SC) (clear, colorless): 0.8 ml single-dose pre-filled syringe, single use, with needle, rigid needle shield, rubber plunger (bromobutyl), plunger rod, syringe with safety guard and collar for patient use, packs of 1 and 2, with 2 alcohol swabs.
0.8 ml single-dose pre-filled pen, single use, containing one pre-filled syringe, with needle, rigid needle shield and rubber plunger (bromobutyl), packs of 1 and 2, with 2 alcohol swabs.

COMPOSITION

	p ser or pen
Adalimumab ^*	40 mg

^* Adalimumab is a recombinant human monoclonal antibody produced in Chinese hamster ovary cells.
Excipients: sodium citrate, citric acid monohydrate, histidine, histidine hydrochloride monohydrate, sorbitol, polysorbate 20, water for injections.
Excipients with known effect: sorbitol (20.0 mg).

NOT’s

Edrug-online contains comprehensive and detailed information about drugs available in the medical field, and is divided into four sections:

general information:

Includes a general description of the drug, its use, brand names, FAQs, and relevant news and articles

Additional information:

General explanation about dealing with the medicine: how to take the medicine, the doses and times of it, the start and duration of its effectiveness, the recommended diet during the period of taking the medicine, the method of storage and storage, recommendations in cases for forgetting the dose and instructions to stop taking the drug and take additional doses.

Special warnings:

For pregnant and breastfeeding women, the elderly, boys and drivers, and use before surgery.

Side effects:

It treats possible side effects and drug interactions that require attention and its effect on continuous use.
The information contained in this medicine is based on medical literature, but it is not a substitute for consulting a doctor.

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