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YUFLYMA 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 YuflymaTM and the reference biologic drug Humira®. YuflymaTM (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.
2 Recommended Dose 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.
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. 2 Recommended Dose and Dosage Adjustment, Pediatrics, Adolescent Hidradenitis Suppurativa.
There are no clinical trials with adalimumab injection in adolescent patients with hidradenitis suppurativa (HS). The dosage of adalimumab injection 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 Dose 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. ` YUFLYMATM Page 9 of 188 Geriatrics Evidence from clinical studies and experience suggests that use of adalimumab injection in the geriatric population is not associated with differences in effectiveness.
No dose adjustment is needed for this population. 4 Geriatrics (> 65 years of age). 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 injection administration. If an anaphylactic reaction or other serious allergic reactions occur, administration of YuflymaTM should be discontinued immediately and appropriate therapy initiated.
The YuflymaTM pre-filled syringe and the auto-injector are available with a 29 gauge ½ inch needle. All contents of the pre-filled syringe carton or auto-injector carton (including syringe or auto-injector accessories and packaging) are not made with natural rubber latex.
See 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING. Immune Autoimmunity Treatment with adalimumab injection 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 YuflymaTM, treatment should be discontinued.
1 Adverse Reaction Overview, Autoantibodies. Immunosuppression The possibility exists for TNF-blocking agents, including adalimumab injection, 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 injection, 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 injection on the development and course of malignancies, as well as active and/or chronic infections, is not fully understood. 1 Adverse Reaction Overview, Infections and Malignancies. Immunizations In a randomized, double-blind, placebo-controlled study in 226 adult rheumatoid arthritis patients treated with adalimumab injection, antibody responses to concomitant pneumococcal and influenza vaccines were assessed.
, Cardiovascular, Patients with Congestive Heart Failure. 3 SERIOUS WARNINGS AND PRECAUTIONS BOX Serious Warnings and Precautions • Hepatosplenic T-Cell Lymphoma Very rare post-marketing reports of hepatosplenic T-cell lymphoma (HSTCL), a rare aggressive lymphoma that is often fatal, have been identified in patients treated with adalimumab injection.
Most of the patients had prior infliximab therapy as well as concomitant azathioprine or 6- mercaptopurine use for Crohn’s disease. The potential risk with the combination of azathioprine or 6-mercaptopurine and adalimumab injection should be carefully considered.
The causal association of HSTCL with adalimumab injection is not clear. • Infections Serious infections due to bacterial, mycobacterial, invasive fungal (disseminated or extrapulmonary histoplasmosis, aspergillosis, coccidiodomycosis), viral, parasitic, or other opportunistic infections have been reported in patients receiving tumor necrosis factor (TNF)- blocking agents.
Sepsis, rare cases of tuberculosis, candidiasis, listeriosis, legionellosis and pneumocystis have also been reported with the use of TNF-blocking agents, including adalimumab injection. Other serious infections seen in clinical trials include pneumonia, pyelonephritis, septic arthritis and septicemia.
Hospitalization or fatal outcomes associated with infections have been reported. Many of the serious infections have occurred in patients on concomitant immunosuppressive therapy that, in addition to their underlying disease, could predispose them to infections.
Treatment with YuflymaTM should not be initiated in patients with active infections, including chronic or localized infections, until infections are controlled. In patients who have been exposed to tuberculosis, and patients who have travelled in areas of high risk of tuberculosis or endemic mycoses, such as histoplasmosis, coccidioidomycosis, or blastomycosis, the risk and benefits of treatment with YuflymaTM should be considered prior to initiating therapy.
• Patients with known hypersensitivity to YuflymaTM (adalimumab) or any of its components. For a complete listing, see the 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING. ` YUFLYMATM Page 7 of 188 • Patients with severe infections such as sepsis, tuberculosis and opportunistic infections.
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3 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 adalimumab injection.
When treated with adalimumab injection as monotherapy, some rheumatoid arthritis patients who experience a decrease in their response to adalimumab injection 40 mg every other week may benefit from an increase in dose intensity to adalimumab injection 40 mg every week.
2 Recommended Dose and Dosage Adjustment Note: See Table 4 at the end of section for available presentations of YuflymaTM for each indication in pediatrics and adults. Pediatrics Polyarticular Juvenile Idiopathic Arthritis The recommended dose of YuflymaTM for patients with polyarticular JIA is based on body weight (Table 1).
YuflymaTM is administered every other week via subcutaneous injection. YuflymaTM 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.
` YUFLYMATM Page 10 of 188 Table 1 YuflymaTM Dose for Patients with Polyarticular JIA Patient Weight Dosing Regimen 10 kg to < 30 kg 20 mg every other week ≥ 30 kg 40 mg every other week 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 YuflymaTM in children aged <2 years in this indication. Pediatric Crohn's disease The recommended YuflymaTM 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 YuflymaTM maintenance dose regimen is 20 mg every other week beginning at Week 4. 5 Clinical Trials – Reference Biologic Drug, Pediatric, Pediatric Crohn’s Disease, Study Results). The use of YuflymaTM 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 YuflymaTM dose regimen for adolescent patients with HS (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.
5 Clinical Trials – Reference Biologic Drug, Pediatric, Adolescent Hidradenitis Suppurativa (HS)). Antibiotics may be continued during treatment with YuflymaTM if necessary. Continued therapy beyond 12 weeks […]
Protective antibody levels to the pneumococcal antigens were achieved by 86% of patients in the adalimumab injection group compared to 82% in the placebo group. A total of 37% of adalimumab injection-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 the adalimumab injection group and 95% in the placebo group achieved protective antibody levels to the influenza antigens. A total of 52% of adalimumab injection-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 YuflymaTM therapy. Patients on YuflymaTM 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 injection. ` YUFLYMATM Page 20 of 188 Administration of live vaccines to infants exposed to adalimumab in utero is not recommended for five months following the mother’s last YuflymaTM injection during pregnancy.
1 Pregnant Women. Infections Tuberculosis Tuberculosis, including reactivation and new onset of tuberculosis, has been reported in patients receiving adalimumab injection. , disseminated) tuberculosis. Before initiation, during and after treatment with adalimumab injection, 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 YuflymaTM. 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, YuflymaTM 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 Prevention guidelines, before the initiation of YuflymaTM.
Use of anti-tuberculosis prophylactic treatment should also be considered before the initiation of YuflymaTM 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 injection. Also, active tuberculosis has developed in patients receiving adalimumab injection 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 YuflymaTM should be monitored for signs and symptoms of active tuberculosis, particularly because tests for latent tuberculosis infection may be […]
See 7 WARNINGS AND PRECAUTIONS, Infections, Other Opportunistic Infections. As with other TNF-blockers, patients should be monitored closely for infections (including tuberculosis) before, during and after treatment with YuflymaTM. Patients who develop a new infection while undergoing treatment with YuflymaTM should be monitored closely and undergo a complete diagnostic evaluation.
Administration of YuflymaTM should be discontinued if a patient develops a serious infection or sepsis, and appropriate antimicrobial or antifungal therapy should be initiated. Physicians should exercise caution when considering the use of YuflymaTM in patients with a history of recurrent infection or with underlying conditions which may predispose them to infections, or patients who have resided in regions where tuberculosis and histoplasmosis are endemic.
1 Adverse Reaction ` YUFLYMATM Page 8 of 188 Overview, Infections. The benefits and risks of treatment with YuflymaTM should be carefully considered before initiating therapy. • Pediatric Malignancy Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF-blockers, including adalimumab injection.
See 7 WARNINGS AND PRECAUTIONS, Malignancies, Malignancies in Pediatric Patients and Young Adults. 2 Recommended Dose 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.
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. 2 Recommended Dose and Dosage Adjustment, Pediatrics, Adolescent Hidradenitis Suppurativa.
There are no clinical trials with adalimumab injection in adolescent patients with hidradenitis suppurativa (HS). The dosage of adalimumab injection 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 Dose 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. ` YUFLYMATM Page 9 of 188 Geriatrics Evidence from clinical studies and experience suggests that use of adalimumab injection in the geriatric population is not associated with differences in effectiveness.
No dose adjustment is needed for this population. 4 Geriatrics (> 65 years of age). 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 […]