Humira (adalimumab)

HUMIRA (adalimumab) – a monoclonal antibody that binds specifically to TNF-alpha and blocks its interaction with the p55 and p75 cell surface TNF receptors. Adalimumab also lyses surface TNF expressing cells in vitro in the presence of complement. TNF is a naturally occurring cytokine that is involved in normal inflammatory and immune responses. Elevated levels of TNF are found in the synovial fluid of patients with RA, JIA, PsA, and AS and play an important role in both the pathologic inflammation and the joint destruction that are hallmarks of these diseases.

FDA approved uses:

1. Rheumatoid arthritis (RA) – Reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active RA.

2. Juvenile idiopathic arthritis (JIA) – Reducing signs and symptoms of moderately to severely active polyarticular JIA in pediatric patients 4 years of age and older.

3. Psoriatic arthritis (PsA) – Reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active PsA.

4. Ankylosing spondylitis (AS) – Reducing signs and symptoms in adult patients with active AS.

5. Chron’s disease (CD) – Reducing signs and symptoms and inducing and maintaining clinical remission in adult patients with moderately to severely active Crohn’s disease who have had an inadequate response to conventional therapy. Reducing signs and symptoms and inducing clinical remission in these patients if they have also lost response to or are intolerant to infliximab.

6. Ulcerative colitis (UC) – Inducing and sustaining clinical remission in adult patients with moderately to severely active ulcerative colitis who have had an inadequate response to immunosuppressants such as corticosteroids, azathioprine or 6-mercaptopurine (6-MP). The effectiveness of HUMIRA has not been established in patients who have lost response to or were intolerant to TNF blockers.

7. Plaque psoriasis (PS) – The treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate.

Available dosage forms: Injection: 40 mg/0.8 mL in a single-use prefilled pen (HUMIRA Pen). Injection: 40 mg/0.8 mL in a single-use prefilled glass syringe. Injection: 20 mg/0.4 mL in a single-use prefilled glass syringe.

Usual dosage: Adalimumab is administered by subcutaneous injection. Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis: 40 mg every other week. Some patients with RA not receiving methotrexate may benefit from increasing the frequency to 40 mg every week. Juvenile Idiopathic Arthritis: 15 kg (33 lbs) to < 30 kg (66 lbs): 20 mg every other week • ≥ 30 kg (66 lbs): 40 mg every other week. Crohn’s Disease and Ulcerative Colitis: Initial dose (Day 1): 160 mg (four 40 mg injections in one day or two 40 mg injections per day for two consecutive days). Second dose two weeks later (Day 15): 80 mg. Two weeks later (Day 29): Begin a maintenance dose of 40 mg every other week. For patients with Ulcerative Colitis only: Only continue HUMIRA in patients who have shown evidence of clinical remission by eight weeks (Day 57) of therapy. Plaque Psoriasis (2.5): 80 mg initial dose, followed by 40 mg every other week starting one week after initial dose.

Contraindications: According to the manufacturer, there are no contraindications to Humira.

Special Warnings: SERIOUS INFECTIONS: Increased risk of serious infections leading to hospitalization or death, including tuberculosis (TB), bacterial sepsis, invasive fungal infections (such as histoplasmosis), and infections due to other opportunistic pathogens. Discontinue HUMIRA if a patient develops a serious infection or sepsis during treatment. Perform test for latent TB; if positive, start treatment for TB prior to starting HUMIRA. Monitor all patients for active TB during treatment, even if initial latent TB test is negative. MALIGNANCY: Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers including HUMIRA. Post-marketing cases of hepatosplenic T-cell lymphoma (HSTCL), a rare type of T-cell lymphoma, have occurred in adolescent and young adults with inflammatory bowel disease treated with TNF blockers including HUMIRA.

Adverse reactions (side effects) of these medications: The most common side effects of Humira include infections (e.g. upper respiratory, sinusitis), injection site reactions, headache and rash. Other adverse reactions reported in clinical trial data include urinary tract infection, back pain, hypertensio, nausea, abdominal pain, arrthymias, atrial fibrillation, chest pain, syncope, cholecystitis, cholelithiasis, esophagitis, gastroenteritis, gastrointestinal hemorrhage, hepatic necrosis, vomiting and parathyroid disease.

Common drug interactions: Abatacept and anakinra increase the likelihood of serious infections when used with adalimumab. Live vaccines should not be given to patients taking adalimumab. Close monitoring is required when initiating or discontinuing adalimumab in patients taking cytochrome P450 substrates with a narrow therapeutic index (like warfarin, cyclosporine or theophylline).

Special instructions for patients: Use exactly as directed by physician. Do not try to inject HUMIRA yourself until you have been shown the right way to give the injections. If your doctor decides that you or a caregiver may be able to give your injections of HUMIRA at home, you should receive training on the right way to prepare and inject HUMIRA. Do not use Humira if it has been frozen, even if it has thawed. The HUMIRA Pen contains glass. Do not drop or crush the Pen because the glass inside may break.

Full prescribing information may be found at the manufacturer‘s official website Humira.com or at the U.S. Food and Drug Administration’s website at Drugs@FDA Humira Info

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