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AMGEVITA is a brand name for Adalimumab, supplied as a solution. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Indications have been granted on the basis of similarity between AMGEVITA and the reference biologic drug Humira®. AMGEVITA is indicated for: Rheumatoid Arthritis • reducing the signs and symptoms, inducing major clinical response and clinical remission, inhibiting the progression of structural damage and improving…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations The AMGEVITA prefilled syringe and prefilled autoinjector are not made with natural rubber latex. 2 Recommended Dose and Dosage Adjustment, Pediatrics, Pediatric Juvenile Idiopathic Arthritis. Safety and effectiveness in pediatric patients with polyarticular JIA less than 2 years of age or in patients with a weight below 10 kg have not been established.
2 Recommended Dose and Dosage Adjustment, Pediatrics, Pediatric Crohn’s Disease. The majority (102/192) of pediatric patients with Crohn’s disease studied were 13 to 17 years of age weighing ≥ 40 kg in a clinical trial with adalimumab.
2 Recommended Dose and Dosage Adjustment, Pediatrics, Adolescent Hidradenitis Suppurativa. There are no clinical trials with adalimumab in adolescent patients with hidradenitis suppurativa. The dosage of adalimumab in these patients has been determined based on pharmacokinetic/ pharmacodynamic modeling and simulation.
2 Recommended Dose and Dosage Adjustment, Pediatrics, Pediatric Uveitis. Safety and effectiveness in pediatric patients with uveitis less than 2 years of age have not been established. Very limited data are available for pediatric patients with uveitis between 2 and < 3 years of age.
2 Recommended Dosage and Dosage Adjustment, Pediatrics, Pediatric Ulcerative Colitis. Safety and effectiveness in pediatric patients with ulcerative colitis less than 5 years of age have not been established. AMGEVITA® (adalimumab) Product Monograph Page 10 of 165 Geriatrics Evidence from clinical studies and experience suggests that use of adalimumab in the geriatric population is not associated with differences in effectiveness.
No dose adjustment of AMGEVITA is needed for this population. 4 Geriatrics. Gender No gender-related pharmacokinetic differences were observed after correction for a patient’s body weight. Healthy volunteers and patients with rheumatoid arthritis displayed similar adalimumab pharmacokinetics.
Race No differences in immunoglobulin clearance would be expected among races. From limited data in non-Caucasians, no important kinetic differences were observed for adalimumab. Dosage adjustment is not required. Hepatic Insufficiency No pharmacokinetic data are available in patients with hepatic impairment.
No dose recommendation can be made. Renal Insufficiency No pharmacokinetic data are available in patients with renal impairment. No dose recommendation can be made. Disease States Healthy volunteers and patients with rheumatoid arthritis displayed similar adalimumab pharmacokinetics.
Reports of serious allergic reactions, including anaphylaxis, have been received following adalimumab administration. If an anaphylactic reaction or other serious allergic reactions occur, administration of AMGEVITA should be discontinued immediately and appropriate therapy initiated.
Immune Autoimmunity Treatment with adalimumab may result in the formation of autoantibodies and rarely, in the development of a lupus-like syndrome. If a patient develops symptoms suggestive of a lupus- like syndrome following treatment with AMGEVITA, treatment should be discontinued.
1 Adverse Drug Reaction Overview, Autoantibodies. AMGEVITA® (adalimumab) Product Monograph Page 18 of 165 Immunosuppression The possibility exists for TNF-blocking agents, including AMGEVITA, to affect host defences against infections and malignancies since TNF mediates inflammation and modulates cellular immune responses.
In a study of 64 patients with rheumatoid arthritis who were treated with adalimumab, there was no evidence of depression of delayed-type hypersensitivity, depression of immunoglobulin levels, or change in enumeration of effector T- and B-cells and NK-cells, monocyte/macrophages, and neutrophils.
The impact of treatment with adalimumab on the development and course of malignancies, as well as active and/or chronic infections, is not fully understood. See 7 Warnings and Precautions, Infections and Malignancies and Adverse Drug Reaction Overview, Infections and Malignancies.
Immunizations In a randomized, double-blind, placebo-controlled study in 226 adult rheumatoid arthritis patients treated with adalimumab, antibody responses to concomitant pneumococcal and influenza vaccines were assessed. Protective antibody levels to the pneumococcal antigens were achieved by 86% of patients in adalimumab group compared to 82% in the placebo group.
Please see 3 Serious Warnings and Precautions Box. General Concurrent Administration of Biologic DMARDs or TNF-Antagonists Serious infections were seen in clinical studies with concurrent use of anakinra (an interleukin-1 antagonist) and another TNF-blocking agent, etanercept, with no added benefit compared to etanercept alone.
Because of the nature of the adverse events seen with the combination of etanercept and anakinra, similar toxicities may also result from the combination of anakinra and other TNF-blocking agents. Therefore, the combination of AMGEVITA and anakinra is not recommended.
4 Drug-Drug Interactions. Concomitant administration of AMGEVITA with other biologic DMARDs (eg, anakinra and abatacept) or other TNF antagonists is not recommended based upon the increased risk for infections and other potential pharmacological interactions.
4 Drug-Drug Interactions). Switching Between Biological DMARDs When switching from one biologic to another, patients should continue to be monitored for signs of infection. Surgery There is limited safety experience of surgical procedures in patients treated with adalimumab.
The long half-life of adalimumab should be taken into consideration if a surgical procedure is planned. A patient who requires surgery while on AMGEVITA should be closely monitored for infections, and appropriate actions should be taken.
There is limited safety experience in patients undergoing arthroplasty while receiving adalimumab. AMGEVITA® (adalimumab) Product Monograph Page 17 of 165 Carcinogenesis and Mutagenesis Long-term animal studies of adalimumab have not been conducted to evaluate the carcinogenic potential or its effect on fertility.
No clastogenic or mutagenic effects of adalimumab were observed in the in vivo mouse micronucleus test or the Salmonella-Escherichia coli (Ames) assay, respectively. 2 Non-Clinical Toxicology – Reference Biologic Drug Genotoxicity, In vitro Genotoxicity.
• Patients with known hypersensitivity to AMGEVITA (adalimumab) or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container. For a complete listing, see 6 Dosage Forms, Strengths, Composition and Packaging.
• Patients with severe infections such as sepsis, tuberculosis and opportunistic infections. See 3 Serious Warnings and Precautions Box. • Patients with moderate to severe heart failure (NYHA class III/IV). See 7 Warnings and Precautions, Cardiovascular, Patients with Congestive Heart Failure.
AMGEVITA® (adalimumab) Product Monograph Page 8 of 165
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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3 Pharmacokinetics, Special Populations and Conditions, Disease States. Concomitant Medications MTX, glucocorticoids, salicylates, nonsteroidal anti-inflammatory drugs (NSAIDs), analgesics or other DMARDs may be continued during treatment with AMGEVITA.
When treated with adalimumab as monotherapy, some rheumatoid arthritis patients who experience a decrease in their response to adalimumab 40 mg every other week may benefit from an increase in dose intensity to adalimumab 40 mg every week.
2 Recommended Dose and Dosage Adjustment Pediatrics AMGEVITA is available as a 20 mg and 40 mg prefilled syringe and a 40 mg prefilled SureClick® autoinjector to administer a full 20 mg or 40 mg dose. Polyarticular Juvenile Idiopathic Arthritis The recommended dose of AMGEVITA for patients with polyarticular JIA from 2 years of age is based on body weight (Table 1).
AMGEVITA is administered every other week via subcutaneous injection. AMGEVITA can be used in combination with MTX or as monotherapy in case of intolerance to MTX or when continued treatment with MTX is not appropriate. AMGEVITA® (adalimumab) Product Monograph Page 11 of 165 Table 1 AMGEVITA Dose for Patients with Polyarticular Juvenile Idiopathic Arthritis Patient Weight Dosing Regimen 10 kg to < 30 kga 20 mg every other week ≥ 30 kg 40 mg every other week a A dose of 10 mg every other week can be considered for patients weighing 10 to < 15 kg.
Available data suggest that clinical response is usually achieved within 12 weeks of treatment. Efficacy and safety in patients who do not respond by Week 16 have not been established. There is no relevant use of adalimumab in children aged < 2 years in this indication.
Pediatric Crohn’s Disease The recommended AMGEVITA induction dose regimen for pediatric patients with severely active Crohn’s disease and moderately active Crohn’s disease with no response to conventional therapy is 160 mg at Week 0 (dose can be administered as four injections in one day or as two injections per day for two consecutive days), followed by 80 mg at Week 2 (given as two 40 mg injections in one day).
The recommended AMGEVITA maintenance dose regimen is 20 mg every other week beginning at Week 4. 4 Clinical Trials – Reference Biologic Drug, Pediatric Crohn’s Disease). The use of adalimumab in pediatric patients with Crohn’s disease ages 13 to 17 has been evaluated up to one year in clinical studies.
If a patient has not responded by Week 12, continued therapy should be carefully reconsidered. Adolescent Hidradenitis Suppurativa The recommended AMGEVITA dose regimen for adolescent patients with hidradenitis suppurativa (12 to 17 years of age weighing ≥ 30 kg) is 80 mg at Week 0 followed by 40 mg every other week starting at Week 1 via subcutaneous injection.
In adolescent patients with inadequate response to AMGEVITA 40 mg every other week, an increase in dosing frequency to 40 mg every week may be considered. 4 Clinical Trials – Reference Biologic Drug, Adolescent Hidradenitis Suppurativa.
Antibiotics may be continued during treatment with […]
A total of 37% of adalimumab-treated patients and 40% of placebo-treated patients achieved at least a 2-fold increase in antibody titre to at least three out of five pneumococcal antigens. In the same study, 98% of patients in the adalimumab group and 95% in the placebo group achieved protective antibody levels to the influenza antigens.
A total of 52% of adalimumab-treated patients and 63% of placebo-treated patients achieved at least a 4-fold increase in antibody titer to at least two out of three influenza antigens. It is recommended that pediatric patients, if possible, be brought up to date with all immunizations in agreement with current immunization guidelines prior to initiating AMGEVITA therapy.
Patients on AMGEVITA may receive concurrent vaccinations, except for live vaccines. No data are available on the secondary transmission of infection by live vaccines in patients receiving adalimumab. Administration of live vaccines to infants exposed to AMGEVITA in utero is not recommended for five months following the mother’s last AMGEVITA injection during pregnancy.
1 Pregnant Women. Infections Tuberculosis Tuberculosis, including reactivation and new onset of tuberculosis, has been reported in patients receiving adalimumab. e, disseminated) tuberculosis. Before initiation, during and after treatment with AMGEVITA, patients should be evaluated for active and inactive (“latent”) tuberculosis infection with a tuberculin skin test.
Treatment of latent tuberculosis infections should be initiated prior to therapy with AMGEVITA. When tuberculin skin testing is performed for latent tuberculosis infection, an induration size of 5 mm or greater should be considered positive, even if vaccinated previously with Bacille Calmette-Guérin (BCG).
If active tuberculosis is diagnosed, AMGEVITA therapy must not be initiated. The possibility of undetected latent tuberculosis should be considered, especially in patients who have immigrated from or traveled to countries with a high prevalence of tuberculosis or who had close contact with a person with active tuberculosis.
If latent infection is diagnosed, appropriate treatment must be started with anti-tuberculosis prophylactic treatment, in accordance with the Canadian Tuberculosis Standards and Centers for Disease Control and AMGEVITA® (adalimumab) Product Monograph Page 19 of 165 Prevention guidelines, before the initiation of AMGEVITA.
Use of anti-tuberculosis prophylactic treatment should also be considered before the initiation of AMGEVITA in patients with several or significant risk factors for tuberculosis despite a negative test for tuberculosis and in patients with a past history of latent or active tuberculosis in whom an adequate course of treatment cannot be confirmed.
The decision to initiate anti-tuberculosis therapy in these patients should only be made after taking into account both the risk for latent tuberculosis infection and the risks of anti-tuberculosis therapy. If necessary, consultation should occur with a physician with expertise in the treatment of tuberculosis.
Despite prophylactic treatment for tuberculosis, cases of reactivated tuberculosis have occurred in patients receiving adalimumab. Also, active tuberculosis has developed in patients receiving adalimumab whose screening for latent tuberculosis infection was negative, and some patients who have been successfully treated for active tuberculosis have redeveloped active tuberculosis while being treated with TNF-blocking agents.
Patients receiving AMGEVITA should be monitored for signs and symptoms of active tuberculosis, particularly because tests for latent tuberculosis infection may be falsely negative. The risk of false negative tuberculin skin test results should be considered, especially in patients who are severely ill or immunocompromised.
Patients should be instructed to seek medical advice if signs/symptoms suggestive of a tuberculosis infection (eg, persistent cough, wasting/weight loss, low grade fever, listlessness) occur during or after therapy with AMGEVITA, and physicians should […]
Cardiovascular Patients with Congestive Heart Failure Cases of worsening congestive heart failure (CHF) and new onset CHF have been reported with TNF-blockers. Cases of worsening CHF have also been observed with adalimumab. Adalimumab has not been formally studied in patients with CHF; however, in clinical trials of another TNF-blocker, a higher rate of serious CHF-related adverse events was observed.
Physicians should exercise caution when using AMGEVITA in patients who have heart failure and monitor them carefully. AMGEVITA is contraindicated in moderate to severe heart failure (see 2 Contraindications). Gastrointestinal Small Bowel Obstruction Failure to respond to treatment for Crohn’s disease may indicate the presence of fixed fibrotic stricture that may require surgical treatment.
Available data suggest that adalimumab does not worsen or cause strictures. Hematologic Events Rare reports of pancytopenia, including aplastic anemia, have been reported with TNF-blocking agents. Adverse events of the hematologic system, including medically significant cytopenia (eg, thrombocytopenia, leukopenia) have been infrequently reported with adalimumab.
The causal relationship of these reports to adalimumab remains unclear. All patients should be advised to seek immediate medical attention if they develop signs and symptoms suggestive of blood dyscrasias (eg, persistent fever, bruising, bleeding, pallor) while on AMGEVITA.
Discontinuation of AMGEVITA therapy should be considered in patients with confirmed significant hematologic abnormalities. Hypersensitivity Reactions Allergic reactions (eg, allergic rash, anaphylactoid reaction, fixed drug reaction, non-specified drug reaction, urticaria) have been observed in approximately 1% of patients receiving adalimumab in clinical trials.
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