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HYRIMOZ 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 Hyrimoz® and the reference biologic drug Humira®. Hyrimoz (adalimumab injection) treatment should be initiated and supervised by specialist physicians experienced in the diagnosis and treatment of rheumatoid arthritis (RA), polyarticular juvenile…
Verbatim from this product's HC label. Tap a section to expand.
If an alternate dose is required, other adalimumab products offering such an option should be used. 1 Dosing Considerations To help ensure the traceability of biologic products, including biosimilars, health professionals should recognise the importance of recording both the brand name and the non -proprietary (active ingredient) name as well as other product-specific identifiers such as the Drug Identification Number (DIN) and the batch/lot number of the product supplied.
Pediatrics Polyarticular Juvenile Idiopathic Arthritis See DOSAGE AND ADMINISTRATION, Recommended Dosage and Dosage Adjustment, Pediatrics, Polyarticular 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.
Pediatric Crohn’s Disease. See DOSAGE AND ADMINISTRATION, Recommended Dosage and Dosage Adjustment, Pediatrics, Pediatric Crohn’s Disease. HYRIMOZ Product Monograph Page 9 of 180 The majority (102/192) of pediatric patients with Crohn’s disease studied were 13 to 17 years of age weighing ≥ 40 kg.
Adolescent Hidradenitis Suppurativa See DOSAGE AND ADMINISTRATION, Recommended Dosage and Dosage Adjustment, Pediatrics, Adolescent Hidradenitis Suppurativa. There are no clinical trials with adalimumab in adolescent patients with hidradenitis suppurativa (HS).
The dosage of adalimumab in these patients has been determined based on pharmacokinetic/pharmacodynamic modeling and simulation. Pediatric Uveitis See DOSAGE AND ADMINISTRATION, Recommended Dosage 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. Pediatric Ulcerative Colitis See DOSAGE AND ADMINISTRATION, 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. 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 is needed for this population. A brief discussion can be found under WARNINGS AND PRECAUTIONS, Special Populations, Geriatrics (>65 years of age). Gender No gender-related pharmacokinetic differences were observed after correction for a patient’s body weight.
The adverse drug reaction profiles reported in clinical studies that compared Hyrimoz (adalimumab injection) to the reference biologic drug were comparable. The description of adverse reactions in this section is based on clinical experience with the reference biologic drug.
1 Adverse Reaction Overview The most serious adverse reactions were (see WARNINGS AND PRECAUTIONS): • serious infections • neurologic events • malignancies HYRIMOZ Product Monograph Page 28 of 180 The most common adverse reaction in rheumatoid arthritis patients treated with adalimumab was injection site reactions.
In controlled trials for rheumatoid arthritis, polyarticular JIA, psoriatic arthritis, ankylosing spondylitis, adult and pediatric Crohn’s disease, adult and pediatric ulcerative colitis, adult hidradenitis suppurativa, psoriasis, and adult uveitis, 13% of patients treated with adalimumab developed injection site reactions (erythema and/or itching, hemorrhage, pain or swelling), compared to 7% of patients receiving control treatment.
Most injection site reactions were described as mild and generally did not necessitate drug discontinuation. 0% for placebo-treated patients. 3%). 14%) placebo-treated patients. 37) in the placebo group. In Study DE019, 553 patients were exposed to at least one dose of adalimumab and 202 patients completed 10 years of study.
A total of 24 patients died during the 10 -year exposure period to adalimumab (4 during the double-blind phase, 14 during the open-label extension phase and an additional 6 after study drug termination). Among the treatment -emergent deaths, the most common reasons were: 4 sepsis, 3 cancers and 3 respiratory system events.
However, the total number of deaths was not higher than that calculated according to age - adjusted Standardized Mortality Rates. 0% discontinued due to an adverse event. The most common adverse events associated with discontinuation of study drug were pneumonia and breast cancer (n = 5 each).
Please see the SERIOUS WARNINGS AND PRECAUTIONS BOX at the beginning of PART I:
HEALTH PROFESSIONAL INFORMATION. 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 Hyrimoz (adalimumab injection) and anakinra is not recommended.
See DRUG INTERACTIONS, Drug-Drug Interactions. , anakinra and abatacept) or other TNF antagonists is not recommended based upon the increased risk for HYRIMOZ Product Monograph Page 19 of 180 infections and other potential pharmacological interactions.
See DRUG INTERACTIONS, 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 Hyrimoz should be closely monitored for infections, and appropriate actions should be taken.
There is limited safety experience in patients undergoing arthroplasty while receiving adalimumab. 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. See NON-CLINICAL TOXICOLOGY, TOXICOLOGY, Mutagenicity and Carcinogenicity, In vitro Genotoxicity.
• Patients with known hypersensitivity to Hyrimoz (adalimumab injection) or any of its components. For a complete listing, see DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING. • Patients with severe infections such as sepsis, tuberculosis and opportunistic infections.
See SERIOUS WARNINGS AND PRECAUTIONS BOX, Infections. • Patients with moderate to severe heart failure (NYHA class III/IV). See WARNINGS AND PRECAUTIONS, Cardiovascular, Patients with Congestive Heart Failure.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Healthy volunteers and patients with rheumatoid arthritis displayed similar adalimumab pharmacokinetics. HYRIMOZ Product Monograph Page 10 of 180 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. See ACTION AND CLINICAL PHARMACOLOGY, Pharmacokinetics, Special Populations and Conditions, Disease States.
Concomitant Medications Methotrexate, glucocorticoids, salicylates, nonsteroidal anti-inflammatory drugs (NSAIDs), analgesics or other DMARDs may be continued during treatment with Hyrimoz. When treated with Hyrimoz as monotherapy, some rheumatoid arthritis patients who experience a decrease in their response to Hyrimoz 40 mg every other week may benefit from an increase in dose intensity to Hyrimoz 40 mg every week.
2 Recommended Dose and Dosage Adjustment Note: See Table 4 at end of section for available presentations of Hyrimoz for each indication in pediatrics and adults. Pediatrics Polyarticular Juvenile Idiopathic Arthritis The recommended dose of Hyrimoz for patients with polyarticular JIA from 2 years of age is based on body weight (Table 1).
Hyrimoz is administered every other week via subcutaneous injection. Hyrimoz can be used in combination with methotrexate or as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is not appropriate.
Table 1. Hyrimoz Dose for Patients with Polyarticular JIA 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. HYRIMOZ Product Monograph Page 11 of 180 Patient Weight Dosing Regimen 10 kg to < 30 kg* 20 mg every other week ≥ 30 kg 40 mg every other week *A dose of 10 mg every other week can be considered for patients weighing 10 to <15 kg.
A dif f erent adalimumab product should be considered as there are no available presentations of Hyrimoz capable of delivering 10 mg. 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 Hyrimoz 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, followed by 80 mg at Week 2 administered by subcutaneous injection.
The first dose of 160 mg can be given in one day (four 40 mg injections or two 80 mg injections) or split over two consecutive days (two 40 mg injections or one 80 mg injection each day). The second dose of 80 mg at Week 2 is given as two 40 mg injections or one 80 mg injection in one day.
The recommended Hyrimoz maintenance dose regimen is 20 mg every other week beginning at Week 4. For pediatric patients who […]
Fatigue, pneumonia, cellulitis, and histoplasmosis (n = 3 each) were the most common treatment-related adverse events leading to discontinuation of study drug. 7% were considered at least possibly related to study drug. 8%); of these, only pneumonia was considered to be at least possibly related to study drug.
8%). Adverse events of special interest among the 553 patients included 35 patients with malignancies other than non-melanoma skin cancer (including 5 cases of lymphoma); and 3 patients with tuberculosis. Serious adverse events of special interest included 5 patients each with pulmonary embolism and diverticulitis; 2 patients with multiple sclerosis; and 1 patient with hypersensitivity reaction.
HYRIMOZ Product Monograph Page 29 of 180 Adalimumab has also been studied in 542 patients with early rheumatoid arthritis (disease duration less than three years) who were methotrexate naïve (Study DE013). No new safety signals were seen in this patient population compared to the safety profile seen in adalimumab Studies DE009, DE011, DE019 and DE031.
39%) methotrexate-treated patients. 23) in the methotrexate group. Adalimumab has also been studied in 395 patients with psoriatic arthritis in two placebo - controlled studies and in an open-label extension study, in 393 patients with ankylosing spondylitis in two placebo-controlled studies and in over 1,500 patients with Crohn’s disease in five placebo-controlled and two open-label extension studies.
The safety profile for patients with psoriatic arthritis treated with adalimumab 40 mg every other week was similar to the safety profile seen in patients with rheumatoid arthritis, adalimumab Studies DE009, DE011, DE019, DE031 and DE013.
During the controlled period of the psoriatic arthritis studies, no deaths occurred in the adalimumab-treated or placebo-treated patients. 7 patient-years of exposure. 43). 6 patient-years of exposure. Adalimumab has also been studied in 1,010 adult patients with ulcerative colitis (UC) in two randomized, double-blind, placebo-controlled studies (M06-826, 8 weeks and M06-827, 52 weeks) and an open-label extension study.
No new safety signals were seen in the adult […]
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 Hyrimoz in patients who have heart failure and monitor them carefully. Hyrimoz is contraindicated in moderate to severe heart failure (see 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. , thrombocytopenia, leukopenia) have been infrequently reported with adalimumab.
The causal relationship of these reports to adalimumab remains unclear. , persistent fever, bruising, bleeding, pallor) while on Hyrimoz. Discontinuation of Hyrimoz therapy should be considered in patients with confirmed significant hematologic abnormalities.
, 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. See ADVERSE REACTIONS. 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 Hyrimoz 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 Hyrimoz, treatment should be discontinued. See ADVERSE REACTIONS, Adverse Drug Reaction Overview, Autoantibodies. Immunosuppression The possibility exists for TNF-blocking agents, including adalimumab, 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 WARNINGS AND PRECAUTIONS, Infections and Malignancies and ADVERSE REACTIONS, 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 the adalimumab group compared to 82% in the placebo group.
A total of 37% of adalimumab-treated patients and 40% of placebo-treated patients achieved at least a 2-fold increase in antibody titer to at least three out of five pneumococcal antigens. In the same study, 98% of patients in […]