hyrimoz injections Uses, Dosage, Side Effects, Precautions & Warnings
hyrimoz (adalimumab) injections >>> Generic drug of the Therapeutic class: Immunology Medicines
Active ingredients: Adalimumab
what is HYRIMOZ medication used for and indication?
Rheumatoid arthritis
Hyrimoz 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.
- Hyrimoz can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate.
- Adalimumab has been shown to slow the progression of structural damage to joints measured by radiography and to improve functional capacity when given in combination with methotrexate.
Juvenile idiopathic arthritis
Polyarticular juvenile idiopathic arthritis
- Hyrimoz 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. Hyrimoz 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
- Hyrimoz 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.
Axial spondyloarthritis
Ankylosing spondylitis (AS)
- Hyrimoz 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
- Hyrimoz 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
- Hyrimoz is indicated for the treatment of active and progressive psoriatic arthritis in adults when the response to previous disease-modifying therapy has been inadequate.
- Adalimumab has been shown to slow the progression of peripheral joint structural damage as measured by radiography in patients with symmetrical polyarticular forms of the disease (see section 5.1) and to improve functional capacity.
Psoriasis
Hyrimoz is indicated for the treatment of moderate to severe plaque psoriasis in adult patients who require systemic therapy.
- Plaque psoriasis in children and adolescents
- Hyrimoz 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)
- Hyrimoz 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 case of insufficient response to conventional systemic treatment of HS (see section Properties). Pharmacodynamics and Pharmacokinetic Properties).
Crohn’s disease
- Hyrimoz is indicated for the treatment of moderate to severe active Crohn’s disease in adult patients who have not responded despite appropriate and well-managed treatment with a corticosteroid and / or immunosuppressant; or in whom this treatment is contraindicated or poorly tolerated.
Crohn’s disease in children and adolescents
- Hyrimoz 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 comprising first-line nutritional therapy and a corticosteroid and / or an immunomodulator, or in which these treatments are poorly tolerated or contraindicated.
Ulcerative colitis
- Hyrimoz 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
- Hyrimoz 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
- Hyrimoz 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.
hyrimoz dosage
The treatment Hyrimoz should be initiated and supervised by a physician qualified specialist in the diagnosis and treatment of pathologies in which Hyrimoz indicated. It is recommended that ophthalmologists consult an appropriate specialist before initiating treatment with Hyrimoz . Patients treated with Hyrimoz will be given a Patient Alert Card.
After proper training in the injection technique, patients can self-inject Hyrimoz, if their doctor considers it possible, under the guise of appropriate medical supervision.
During treatment with Hyrimoz, other concomitant treatments (such as corticosteroids and / or immunomodulators) should be optimized.
hyrimoz dose
Rheumatoid arthritis
- In adult patients with rheumatoid arthritis, the recommended dose of Hyrimoz is a single dose of 40 mg adalimumab given every two weeks, subcutaneously.
- The administration of methotrexate should be continued during treatment with Hyrimoz.
- The glucocorticoids, salicylates, nonsteroidal anti-inflammatory drugs or analgesics may be continued during treatment with Hyrimoz. Regarding the combination with other anti-rheumatic drugs other than methotrexate, see sections Warnings and precautions for use and Pharmacodynamic properties.
- As monotherapy, some patients with decreased response to Hyrimoz 40 mg every other week may benefit from an increase in dosage to 40 mg adalimumab every week or 80 mg every other week. .
- The available data suggest that the 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.
- Hyrimoz is only available in a 40 mg pre-filled syringe and 40 mg pre-filled pen . Therefore, Hyrimoz cannot be administered to patients requiring a dose lower than the full dose of 40 mg.
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 treatment.
Ankylosing spondylitis, axial spondyloarthritis without radiographic evidence of AS, and psoriatic arthritis
- The recommended dosage of Hyrimoz for patients with ankylosing spondylitis, axial spondyloarthritis without radiographic evidence of AS and for patients with psoriatic arthritis is 40 mg adalimumab as a single dose every two weeks, by subcutaneous injection. .
- The available data suggest that the 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 Hyrimoz 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 Hyrimoz 40 mg every two weeks, patients may benefit from an increase in dosage to 40 mg every week or 80 mg every two weeks. The benefits and risks of continued treatment with 40 mg weekly or 80 mg every other week should be carefully reconsidered in a patient with insufficient response after increasing the dose (see section 5.1). If sufficient response is obtained with 40 mg every week or 80 mg every other week, the dosage may then be reduced to 40 mg every 2 weeks.
- Hyrimoz is only available in a 40 mg pre-filled syringe and 40 mg pre-filled pen . Therefore, Hyrimoz cannot be administered to patients requiring a dose lower than the full dose of 40 mg.
Hidradenitis suppurativa
- The recommended dosage regimen of Hyrimoz 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 in 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 Hyrimoz. During treatment with Hyrimoz, the patient is recommended to 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, Hyrimoz 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 .
- Hyrimoz is only available in a 40 mg pre-filled syringe and 40 mg pre-filled pen . Therefore, Hyrimoz cannot be administered to patients requiring a dose lower than the full dose of 40 mg.
Crohn’s disease
- In adult patients with moderate to severe active Crohn’s disease , the recommended induction regimen of Hyrimoz is 80 mg at week 0, followed by 40 mg at week 2. If it is necessary to obtain 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 consecutive days ), 80 mg at week 2 (given in the form of 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 Hyrimoz and signs and symptoms of the disease return, Hyrimoz 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 Hyrimoz 40 mg every two weeks is observed may benefit from an increase in the dosage to Hyrimoz 40 mg every week or 80 mg every two weeks.
- 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.
- Hyrimoz is only available in a 40 mg pre-filled syringe and 40 mg pre-filled pen . Therefore, Hyrimoz cannot be administered to patients requiring a dose lower than the full dose of 40 mg.
Ulcerative colitis
- In adult patients with moderate to severe ulcerative colitis , the recommended induction regimen of Hyrimoz is 160 mg at week 0 (given as 4 injections of 40 mg per day or 2 injections of 40 mg per 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 Hyrimoz 40 mg every two weeks is observed may benefit from an increase in the dosage to Hyrimoz 40 mg every week or 80 mg every two weeks.
- The available data suggest thatthe clinical response is usually achieved within 2 to 8 weeks of treatment. Treatment with Hyrimoz should not be continued in patients who have not responded within this time frame .
- Hyrimoz is only available in a 40 mg pre-filled syringe and 40 mg pre-filled pen . Therefore, Hyrimoz cannot be administered to patients requiring a dose lower than the full dose of 40 mg.
Uveitis
- In adult patients with uveitis, the recommended dose of Hyrimoz is an initial dose of 80 mg followed by a dose of 40 mg every two weeks starting one week after the first dose. There is limited experience with initiating treatment with adalimumab as monotherapy. Treatment with Hyrimoz 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 Hyrimoz.
- An annual reassessment of the benefits and risks associated with long-term continuous therapy is recommended .
- Hyrimoz is only available in a 40 mg pre-filled syringe and 40 mg pre-filled pen . Therefore, Hyrimoz cannot be administered to patients requiring a dose lower than the full dose of 40 mg.
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
- Hyrimoz is only available in a 40 mg pre-filled syringe / pre-filled pen. Therefore, Hyrimoz cannot be administered to pediatric patients requiring a dose lower than the full dose of 40 mg. If another dose is required, other formulations of adalimumab offering such a possibility should be used.
Juvenile idiopathic arthritis
Polyarticular juvenile idiopathic arthritis from 2 years old
- The recommended dosage of Hyrimoz for patients with polyarticular juvenile idiopathic arthritis from the age of 2 years depends on body weight (Table 1). Hyrimoz is given every two weeks as a subcutaneous injection.
- The available data suggest that 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.
- Hyrimoz is only available in a 40 mg pre-filled syringe and 40 mg pre-filled pen . Therefore, Hyrimoz cannot be administered to patients requiring a dose lower than the full dose of 40 mg.
Enthesitis-related arthritis
- The recommended dosage of Hyrimoz for patients with enthesitis-related arthritis from the age of 6 years depends on body weight (Table 2). Hyrimoz is given every two weeks as a subcutaneous injection.
- Adalimumab has not been studied in patients less than 6 years of age with arthritis related to enthesitis.
- Hyrimoz is only available in a 40 mg pre-filled syringe and 40 mg pre-filled pen . Therefore, Hyrimoz cannot be administered to patients requiring a dose lower than the full dose of 40 mg.
Plaque psoriasis in children and adolescents
- The recommended dosage of Hyrimoz for patients with plaque psoriasis aged 4 to 17 years depends on body weight (Table 3). Hyrimoz is administered as a subcutaneous injection.
- The continuing treatment beyond 16 weeks should be carefully reconsidered in a patient not responding within this time.
- If retreatment with adalimumab 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.
- Hyrimoz is only available in a 40 mg pre-filled syringe and 40 mg pre-filled pen . Therefore, Hyrimoz cannot be administered to patients requiring a dose lower than the full dose of 40 mg.
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 Hyrimoz is 80 mg at week 0 followed by 40 mg every two weeks from week 1 by subcutaneous injection.
- In adolescents with an insufficient response to Hyrimoz 40 mg every two weeks, an increase in dosage to 40 mg every week or 80 mg every other week may be considered.
- If necessary, antibiotics can be continued during treatment with Hyrimoz. During treatment with Hyrimoz, the patient is recommended to 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, Hyrimoz 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.
- Hyrimoz is only available in a 40 mg pre-filled syringe and 40 mg pre-filled pen . Therefore, Hyrimoz cannot be administered to patients requiring a dose lower than the full dose of 40
mg.
Crohn’s disease in children and adolescents
- The recommended dosage of Hyrimoz for patients with Crohn’s disease aged 6 to 17 years depends on body weight (Table 4). Hyrimoz is administered as a subcutaneous injection.
-
- 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
* Note: Hyrimoz is currently available in a 40 mg pre-filled syringe and 40 mg pre-filled pen.
The patients with an inadequate response to treatment is observed may benefit from increasing the dosage:
≥ 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.
- Hyrimoz is only available in a 40 mg pre-filled syringe and 40 mg pre-filled pen . Therefore, Hyrimoz cannot be administered to patients requiring a dose lower than the full dose of 40 mg.
Uveitis in children and adolescents
- The recommended dosage of Hyrimoz for children and adolescents with uveitis from the age of 2 years depends on body weight (Table 5). Hyrimoz is administered as a subcutaneous injection.
- In uveitis in children and adolescents, no experience is available on treatment with adalimumab without concomitant treatment with methotrexate.
When initiating treatment with Hyrimoz, a loading dose of 40 mg for patients
- <30 kg or 80 mg for patients ≥ 30 kg can be administered one week before the start of maintenance treatment. 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 Hyrimoz in children aged less than 2 years in this indication.
- An annual reassessment of the benefits and risks associated with long-term continuous therapy is recommended.
- Hyrimoz is only available in a 40 mg pre-filled syringe and 40 mg pre-filled pen . Therefore, Hyrimoz cannot be administered to patients requiring a dose lower than the full dose of 40 mg.
Pediatric ulcerative colitis
- The safety and efficacy of adalimumab in children 4 to 17 years old have not been established. No data is available.
- There is no relevant use of adalimumab in children aged less than 4 years in this indication.
Psoriatic arthritis and axial spondyloarthritis including ankylosing spondylitis
- There is no relevant use of Humira in population pediatric indications in ankylosing spondylitis and psoriatic arthritis.
Administration mode
- Hyrimoz is administered as a subcutaneous injection.
- The complete instructions are provided in the manual.
- Other strengths and presentations of adalimumab are available.
HYRIMOZ Contraindications
- Hypersensitivity adalimumab
- Hamster protein hypersensitivity
- Active tuberculosis
- Severe infection
- Stage III or IV heart failure
- Pregnancy
- Lack of effective female contraception
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).
hyrimoz injection side effects
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 in the group control.
- 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 also 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 adverse reactions is based on clinical studies and post-marketing experience and is presented by system organ class (SOC) 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 column ” System organ class” indicates that more information is available under the sections Contraindications, Warnings and precautions for use and Adverse reactions.
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, rhino pharyngitis 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 meningitis |
| System class
organs |
Frequency | Side effects |
| viral).
Opportunistic infections and tuberculosis (including coccidioidomycosis, histoplasmosis, and Mycobacterium avium complex infections). Bacterial infections. Eye infections. Diverticulitis 1) . |
||
| Benign tumors,
malignant and unspecified (incl cysts and polyps) * |
Frequent | Skin cancer excluding melanoma
(including basal cell carcinoma and squamous cell carcinoma). Benign tumor. |
| Rare | Lymphoma **.
Tumors of solid organs (including breast, lung and thyroid cancer). Melanoma**. |
|
| Rare | Leukemia 1) . | |
| Frequency
indeterminate |
Hepatosplenic T-cell lymphoma 1) .
Merkel cell carcinoma (cutaneous neuroendocrine carcinoma) 1) |
|
| Ailments
hematology and lymphatic system * |
Very common | Leukopenia (including neutropenia and
agranulocytosis). Anemia. |
| Frequent | Leukocytosis. Thrombocytopenia. | |
| Rare | Idiopathic thrombocytopenic purpura. | |
| Rare | Pancytopenia. | |
| System disorders
immune* |
Frequent | Hypersensitivity.
Allergies (including seasonal allergy). |
| Rare | Sarcoidosis 1) .
Vasculitis. |
|
| Rare | Anaphylaxis 1) . | |
| Metabolism disorders
and nutrition |
Very common | Increased lipid level. |
| Frequent | Hypokalaemia.
Increased uric acid. Abnormal sodium level in the blood. Hypocalcemia. Hyperglycemia. Hypophosphatemia. Dehydration. |
|
| Psychiatric disorders | Frequent | Mood disorders (including depression).
Anxiety. |
| System class
organs |
Frequency | Side effects |
| Insomnia. | ||
| Nervous system disorders * | Very common | Headache. |
| Frequent | Paresthesia (including hypoaesthesia). Migraine.
Compression of nerve roots. |
|
| Rare | Cerebrovascular accident 1) .
Tremors. Neuropathy. |
|
| Rare | Multiple sclerosis.
Demyelinating disorders (eg optic neuritis, Guillain-Barré syndrome) 1) . |
|
| Eye disorders | Frequent | Visual defects.
Conjunctivitis. Blepharitis. Swelling of the eyes. |
| Rare | Diplopia. | |
| Ear disorders and
labyrinth |
Frequent | Dizziness. |
| Rare | Deafness.
Tinnitus. |
|
| Cardiac disorders * | Frequent | Tachycardia. |
| Rare | Myocardial infarction 1) .
Arrhythmias. Congestive heart failure. |
|
| Rare | Cardiac arrest. | |
| Vascular disorders | Frequent | Hypertension.
Hot flashes. Hematomas. |
| Rare | Aneurysm of the aorta.
Vascular occlusion. Thrombophlebitis. |
|
| Respiratory disorders,
thoracic and mediastinal * |
Frequent | Asthma.
Dyspnea. Cough. |
| Rare | Pulmonary embolism 1) .
Interstitial lung disease. Chronic obstructive pulmonary disease. Pneumopathy. Pleural effusion 1) . |
| System class
organs |
Frequency | Side effects |
| Rare | Pulmonary fibrosis 1) . | |
| 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 perforation 1) . | |
| Ailments
hepatobiliary * |
Very common | Elevated liver enzymes. |
| Rare | Cholecystitis and gallstones.
Fatty liver. Hyperbilirubinemia. |
|
| Rare | Hepatitis.
Reactivation of hepatitis B 1) . Autoimmune hepatitis 1) . |
|
| Frequency not known | Hepatic failure 1) . | |
| Skin disorders and
subcutaneous tissue |
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 multiforme 1) .
Stevens-Johnson syndrome 1) . Angioedema 1) . Cutaneous vasculitis 1) . Skin lichenoid reaction 1) . |
|
| Frequency not known | Worsening of symptoms of dermatomyositis 1) |
| System class
organs |
Frequency | Side effects |
| Musculoskeletal and connective tissue disorders | Very common | Musculoskeletal pain. |
| Frequent | Muscle contractures (including increased serum creatine phosphokinase). | |
| Rare | Rhabdomyolysis.
Systemic lupus erythematosus. |
|
| Rare | Lupus-like syndrome 1) . | |
| Kidney and
urinary tract |
Frequent | Renal failure.
Haematuria. |
| Rare | Nocturia. | |
| Disorders of the organs of
reproduction and breast |
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. Fever 1) . |
|
| Rare | Inflammation. | |
| Investigations * | Frequent | Coagulation disorders and disorders
haemorrhagic (including prolongation of activated partial thromboplastin time). Positivity to autoantibodies (including anti-double-stranded DNA antibodies). Increase in blood lactate dehydrogenase level. |
| Injury, poisoning and complications related to
procedures |
Frequent | Delayed 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 adalimumab weekly 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 open-label, controlled 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 extra-pulmonary 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 afte 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 exposure of 655.6 patient-years in studies with adalimumab in patients with juvenile idiopathic arthritis (juvenile arthritis idiopathic polyarticular arthritis and enthesitis-related). In addition, no cases of cancer were observed in 192 pediatric patients
representing 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 pediatric chronic plaque psoriasis . 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, hidradenitis suppurativa, Crohn’s disease, ulcerative colitis and uveitis, a rate (95% confidence interval) of cancers other than lymphomas or non-melanoma skin cancers, of 6.8 (4.4 to 10.5) was observed for 1000 patient years among the 5 291 patients treated with adalimumab 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 1,000 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 1000 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 lymphomas was 0.7 (0.2 – 2.7) per 1,000 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 lymphomas is approximately 1.3 per 1,000 patient-years.
- In post-marketing period 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 reported rates for non-melanoma skin cancer and lymphoma are approximately 0.2 and 0.3 per 1000 patient-years of treatment, respectively.
- 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 3,441 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.
Hepatobiliary 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 x ULN occurred in 3.7% of patients treated by 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 x ULN 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 x ULN 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, elevations of ALT
≥ 3 x ULN 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 induction therapy weight-adjusted
up to 52 weeks of treatment, elevations of ALT ≥ 3 x ULN
occurred in 2.6% of patients (5/192), of whom 4 were
treated in combination with immunosuppressants at the start of 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 x ULN occurred in 1.8% of patients
treated with adalimumab and in 1.8% of patients in the control group. - It has not been observed ALT elevations ≥ 3 x ULN in the study
phase III 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 x ULN 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 for patients treated with adalimumab and patients in the control group, respectively, elevations of ALT ≥ 3 x ULN occurred in 2.4% of patients. 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 l. ‘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.
HYRIMOZ 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 adalimumab and anakinra is not recommended (see section Warnings and precautions for use “Simultaneous administration of biological DMARDs and anti-TNFs”).
- The combination of adalimumab 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 compatibility studies, this medicinal product must not be mixed with other medicinal products.
Drive and use machines
Hyrimoz may have minor influence on the ability to drive and use machines. Dizziness and visual disturbances may occur after administration of Hyrimoz ( see Undesirable effects ).
Warnings and Precautions
In order to improve the traceability of biological medicinal products, the name of the medicinal product and the batch number of the administered product must 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 monitored closely for infections (including tuberculosis) before, during and after treatment with Hyrimoz. As the duration of elimination of adalimumab may be up to four months, monitoring should be continued throughout this period.
- The treatment Hyrimoz 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 Hyrimoz should be considered before initiation. treatment (see Other opportunistic infections).
- The Patients who develop a new infection during treatment with Hyrimoz must be monitored carefully and complete diagnostic workup should be practiced. If a serious new infection or sepsis occurs, administration of Hyrimoz should be discontinued and appropriate antimicrobial or antifungal therapy should be started until the infection is controlled. Caution should be exercised by the physician before using Hyrimoz 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 initiating treatment with Hyrimoz, all patients should be screened for active and inactive (“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 record the performance and results of these tests in the patient monitoring card. 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 Hyrimoz should not be initiated .
- 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 Hyrimoz.
- A TB prophylaxis should also be considered before introducing Hyrimoz 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 Hyrimoz.
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 Hyrimoz 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 Hyrimoz. For patients who test positive for hepatitis B, it is recommended to consult a doctor specializing in the treatment of hepatitis B.
- In HBV carriers who require treatment with Hyrimoz, 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 on the treatment of patients with HBV treated with antiviral and
TNF antagonist to prevent HBV reactivation. In patients who develop HBV reactivation, Hyrimoz should be discontinued and effective antiviral therapy as well as appropriate additional therapy should be 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 patients with pre-existing or recently-occurring central or peripheral nervous system demyelinating disease with Hyrimoz ; Discontinuation of treatment should be considered if any of these disorders develop. The association between uveitis intermediate and demyelinating diseases of the central nervous system is known. Neurologic assessment should be performed in patients with non-infectious intermediate uveitis before initiating therapy with Hyrimoz, and repeated regularly during therapy to check for pre-existing or active 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 severe allergic reaction occurs, administration of Hyrimoz 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 neutrophil 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 Hyrimoz should be carefully considered. A risk of developing Hepatosplenic T-cell lymphoma in patients treated with Hyrimoz 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 Hyrimoz .
- All patients, especially those with a history of intense immunosuppressive therapy or with psoriasis and a history of puvatherapy, should be examined for skin cancer other than melanoma before and during treatment with Hyrimoz. 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 beenreported with TNF antagonists. Adverse effects of the blood system including medically significant cytopenias (eg , thrombocytopenia, leukopenia) have been observed with adalimumab. Itshould 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 Hyrimoz. Discontinuation of treatment with Hyrimoz
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 immunizations be up to date according to current immunization recommendations before initiating treatment with Hyrimoz.
- The patients Hyrimoz may receive concurrent vaccinations, 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. Hyrimoz should be used with caution in patients with mild heart failure (NYHA classes I / II). Hyrimoz is contraindicated in moderate to severe heart failure..Treatment with Hyrimoz should be stopped in patients with new or worsening symptoms. congestive heart failure.
Autoimmune processes
- The treatment Hyrimoz 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 symptoms of a lupus-like syndrome following treatment with Hyrimoz and exhibits a positive anti- double-stranded DNA reaction , treatment with Hyrimoz 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 Hyrimoz 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. A special attention regarding the risk of infection should be given when treating elderly patients.
Pediatric population
- See Vaccinations above.
Sodium content
- This medicine contains less than 1 mmol (23 mg) sodium per 0.8 ml dose , that is to say essentially ‘sodium-free’.
PREGNANCY & BREAST-FEEDING & FERTILITY
Women of childbearing age
- Women of childbearing potential should consider using effective contraception during treatment with Hyrimoz and continue for at least five months after the last administration of Hyrimoz.
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. Giving live vaccines (for example, 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 breast milk at very low concentrations, with adalimumab being present in breast 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, Hyrimoz 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 HYRIMOZ ?
What is Forms and Composition ?
| SHAPES and PRESENTATIONS |
- Solution for injection (SC injection) (clear to slightly opalescent, colorless to slightly yellowish) 40 mg:
0.8 ml single-dose pre-filled syringe, single use, with rubber stopper, needle with automatic needle shield with collar, cap rubber needle and plunger, box of 2, in a blister pack. - SensoReady 0.8 mL single-dose pre-filled pen, disposable, triangular in shape, with transparent viewing window and label, containing single-use pre-filled syringe, with needle, rubber inner needle cap and rubber stopper, box of 2.
| COMPOSITION |
| p syringe or pen | |
| Adalimumab * | 40 mg |
- * Adalimumab is a recombinant human monoclonal antibody produced in Chinese hamster ovary cells.
- Excipients: adipic acid, citric acid monohydrate, sodium chloride, mannitol, polysorbate 80, hydrochloric acid (for pH adjustment), sodium hydroxide (for pH adjustment), water for injections.
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Special warnings:
- For pregnant and breastfeeding women, the elderly, boys and drivers, and use before surgery.
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- It treats possible side effects and drug interactions that require attention and its effect on continuous use.
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