Adalimumab-bwwddrug info

0.4 ML adalimumab-bwwd 100 MG/ML Prefilled Syringe [Hadlima]

What it is used for

HADLIMA is a tumor necrosis factor (TNF) blocker indicated for

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.

Juvenile Idiopathic Arthritis (JIA): reducing signs and symptoms of moderately to severely active polyarticular JIA in patients 2 years of age and older.

Psoriatic Arthritis (PsA): reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active PsA.

Ankylosing Spondylitis (AS): reducing signs and symptoms in adult patients with active AS.

Crohn’s Disease (CD): treatment of moderately to severely active Crohn’s disease in adults and pediatric patients 6 years of age and older.

Ulcerative Colitis (UC): treatment of moderately to severely active ulcerative colitis in adult patients. Limitations of Use: Effectiveness has not been established in patients who have lost response to or were intolerant to TNF blockers.

Plaque Psoriasis (Ps): 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.

Hidradenitis Suppurativa (HS): treatment of moderate to severe hidradenitis suppurativa in adult patients.

Uveitis (UV): treatment of non-infectious intermediate, posterior, and panuveitis in adult patients.

1.1 Rheumatoid

Arthritis HADLIMA is indicated for 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 rheumatoid arthritis. HADLIMA can be used alone or in combination with methotrexate or other non-biologic disease-modifying anti-rheumatic drugs (DMARDs).

1.2 Juvenile

Idiopathic Arthritis HADLIMA is indicated for reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older. HADLIMA can be used alone or in combination with methotrexate.

1.3 Psoriatic

Arthritis HADLIMA is indicated for reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis. HADLIMA can be used alone or in combination with non-biologic DMARDs.

1.4 Ankylosing

Spondylitis HADLIMA is indicated for reducing signs and symptoms in adult patients with active ankylosing spondylitis.

1.5 Crohn’s

Disease HADLIMA is indicated for the treatment of moderately to severely active Crohn’s disease in adults and pediatric patients 6 years of age and older.

1.6 Ulcerative

Colitis HADLIMA is indicated for the treatment of moderately to severely active ulcerative colitis in adult patients. Limitations of Use The effectiveness of adalimumab products has not been established in patients who have lost response to or were intolerant to TNF blockers. 1.7 Plaque Psoriasis HADLIMA is indicated for 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. HADLIMA should only be administered to patients who will be closely monitored and have regular follow-up visits with a physician.

1.8 Hidradenitis

Suppurativa HADLIMA is indicated for the treatment of moderate to severe hidradenitis suppurativa in adult patients. 1.9 Uveitis HADLIMA is indicated for the treatment of non-infectious intermediate, posterior, and panuveitis in adult patients.

Text above is quoted in full from the FDA-approved drug label published by openFDA, effective October 23, 2023. Matched to this product by ingredient name rather than by code, so it may describe a different manufacturer’s version of the same drug. Cross-references to other sections of the full prescribing information have been removed, since they point to a document not shown here. Nothing else is changed: no sentence is shortened, reworded or summarised.

Description

Adalimumab-bwwd is a tumor necrosis factor blocker. Adalimumab-bwwd is a recombinant human IgG1 monoclonal antibody with human derived heavy and light chain variable regions and human IgG1:k constant regions. Adalimumab-bwwd is produced by recombinant DNA technology in a mammalian cell (Chinese Hamster Ovary (CHO)) expression system and is purified by a process that includes specific viral inactivation and removal steps. It consists of 1330 amino acids and has a molecular weight of approximately 148 kilodaltons. HADLIMA (adalimumab-bwwd) injection is supplied as a sterile, preservative-free solution for subcutaneous administration. The drug product is supplied as either a single-dose, prefilled autoinjector (HADLIMA PushTouch) or as a single-dose, 1 mL prefilled glass syringe or as a single-dose institutional use vial. Enclosed within the autoinjector is a single-dose, 1 mL prefilled glass syringe. The solution of HADLIMA is clear to opalescent, and colorless to pale brown, with a pH of about 5.2. Each 40 mg/0.8 mL prefilled syringe, autoinjector, or single-dose institutional use vial delivers 0.8 mL (40 mg) of drug product. Each 0.8 mL of HADLIMA contains adalimumab-bwwd (40 mg), citric acid monohydrate (0.544 mg), L‑histidine (0.96 mg), L‑histidine hydrochloride monohydrate (8.64 mg), polysorbate 20 (0.64 mg), sodium citrate dihydrate (1.6 mg), sorbitol (20 mg), and Water for Injection, USP. Each 40 mg/0.4 mL prefilled syringe or autoinjector delivers 0.4 mL (40 mg) of drug product. Each 0.4 mL of HADLIMA contains adalimumab-bwwd (40 mg), L‑histidine (0.376 mg), L‑histidine hydrochloride monohydrate (4.436 mg), mannitol (12.00 mg), polysorbate 20 (0.32 mg), sodium phosphate dibasic heptahydrate (0.008 mg), sodium phosphate monobasic monohydrate (0.14 mg), sodium succinate dibasic (0.196 mg), succinic acid (0.096 mg), and Water for Injection, USP.

This page reproduces regulatory text for reference. It is not medical advice, and KenyRx is not a pharmacy or a prescriber. Talk to a doctor or pharmacist about whether a medicine is right for you.

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