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HUMIRA 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: 04/2021 1 INDICATIONS, 1.1 Pediatrics (< 18 years of age) 04/2021 4 DOSAGE AND ADMINISTRATION, 4.1 Dosing Considerations 04/2021 4 DOSAGE AND ADMINISTRATION, 4.2 Recommended Dose and Dosage Adjustment 04/2021 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed.…
Verbatim from this product's HC label. Tap a section to expand.
2 Recommended Dose and Dosage Adjustment 04/2021 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. TABLE OF CONTENTS .............................................................................................................
2 PART I: HEALTH PROFESSIONAL INFORMATION ..................................................................... 5 1 INDICATIONS ..............................................................................................................
1 Pediatrics................................................................................................................... 2 Geriatrics ...................................................................................................................
7 2 CONTRAINDICATIONS ................................................................................................. 7 3 SERIOUS WARNINGS AND PRECAUTIONS BOX ............................................................ 8 4 DOSAGE AND ADMINISTRATION.................................................................................
1 Dosing Considerations .............................................................................................. 2 Recommended Dose and Dosage Adjustment ....................................................... 3 Reconstitution .........................................................................................................
4 Administration ........................................................................................................ 5 Missed Dose ............................................................................................................
17 5 OVERDOSAGE........................................................................................................... 17
Reports of serious allergic reactions, including anaphylaxis, have been received following Humira administration. If an anaphylactic reaction or other serious allergic reactions occur, administration of Humira should be discontinued immediately and appropriate therapy initiated.
The Humira Pen and the pre-filled syringe are available with a 29 gauge ½ inch needle and a black needle cover that does not contain latex. See 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING. Immune Autoimmunity Treatment with Humira 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 Humira, treatment should be discontinued. 1 Adverse Reaction Overview, Autoantibodies. Immunosuppression The possibility exists for TNF-blocking agents, including Humira, to affect host defenses 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 Humira, 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 Humira 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. HUMIRA (adalimumab injection) Page 21 of 176 Immunizations In a randomized, double-blind, placebo-controlled study in 226 adult rheumatoid arthritis patients treated with Humira, 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 Humira group compared to 82% in the placebo group. A total of 37% of Humira-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.
, Cardiovascular, Patients with Congestive Heart Failure. HUMIRA (adalimumab injection) Page 8 of 176 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 Humira.
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 Humira should be carefully considered.
The causal association of HSTCL with Humira is not clear. Infections Serious infections due to bacterial, mycobacterial, invasive fungal (disseminated or extrapulmonary histoplasmosis, aspergillosis, coccidioidomycosis), 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 Humira. 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 Humira 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 Humira should be considered prior to initiating therapy.
● Patients with known hypersensitivity to Humira or any of its components. For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING. ● Patients with severe infections such as sepsis, tuberculosis and opportunistic infections.
See
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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In the same study, 98% of patients in the Humira group and 95% in the placebo group achieved protective antibody levels to the influenza antigens. A total of 52% of Humira- 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 Humira therapy. Patients on Humira may receive concurrent vaccinations, except for live vaccines.
No data are available on the secondary transmission of infection by live vaccines in patients receiving Humira. Administration of live vaccines to infants exposed to adalimumab in utero is not recommended for five months following the mother’s last Humira injection during pregnancy.
1 Pregnant Women. Infections Tuberculosis Tuberculosis, including reactivation and new onset of tuberculosis, has been reported in patients receiving Humira. , disseminated) tuberculosis. Before initiation, during and after treatment with Humira, 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 Humira. 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, Humira 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 Humira.
Use of anti-tuberculosis prophylactic treatment should also be considered before the initiation of Humira 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.
HUMIRA (adalimumab injection) Page 22 of 176 Despite prophylactic treatment for tuberculosis, cases of reactivated tuberculosis have occurred in patients receiving Humira. Also, active tuberculosis has developed in patients receiving Humira 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 Humira 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.
, persistent cough, wasting/weight […]
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 Humira. Patients who develop a new infection while undergoing treatment with Humira should be monitored closely and undergo a complete diagnostic evaluation.
Administration of Humira 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 Humira 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 Overview, Infections. The benefits and risks of treatment with Humira 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 Humira.
See 7 WARNINGS AND PRECAUTIONS, Malignancies, Malignancies in Pediatric Patients and Young Adults. 1 Dosing Considerations Pediatrics Polyarticular Juvenile Idiopathic Arthritis See 4 DOSAGE AND ADMINISTRATION, 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. Pediatric Crohn’s Disease See 4 DOSAGE AND ADMINISTRATION, 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. Adolescent Hidradenitis Suppurativa See 4 DOSAGE AND ADMINISTRATION, Recommended Dose and Dosage Adjustment, Pediatrics, Adolescent Hidradenitis Suppurativa.
There are no clinical trials with Humira in adolescent patients with hidradenitis suppurativa (HS). The dosage of Humira in these patients has been determined based on pharmacokinetic/pharmacodynamic modeling and simulation. Pediatric Uveitis See 4 DOSAGE AND ADMINISTRATION, 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. Pediatric Ulcerative Colitis See 4 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. HUMIRA (adalimumab injection) Page 10 of 176 Geriatrics Evidence from clinical studies and experience suggests that use of Humira 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 7 WARNINGS AND PRECAUTIONS, Special Populations, 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 […]