What is Humira Pen 40mg
Humira Pen 40mg is a medicine called a Tumor Necrosis Factor (TNF) blocker. Humira pen is used to reduce the signs and symptoms of:
- moderate to severe rheumatoid arthritis (RA) in adults. HUMIRA can be used alone, with methotrexate, or with certain other medicines.
- moderate to severe polyarticular juvenile idiopathic arthritis (JIA) in children 2 years and older. HUMIRA can be used alone, with methotrexate, or with certain other medicines.
- psoriatic arthritis (PsA) in adults. HUMIRA can be used alone or with certain other medicines.
ankylosing spondylitis (AS) in adults.
- moderate to severe Crohnic disease (CD) in adults when other treatments have not worked well enough.
- moderate to severe Crohnic disease (CD) in children 6 years and older when other treatments have not worked well enough.
- moderate to severe hidradenitis suppurativa (HS) in people 12 years and older.
- In adults, to help get moderate to severe ulcerative colitis (UC) under control (induce remission) and keep it under control (sustain remission) when certain other medicines have not worked well enough. It is not known if HUMIRA is effective in people who stopped responding to or could not tolerate TNF-blocker medicines.
- To treat moderate to severe chronic (lasting a long time) plaque psoriasis (Ps) in adults who have the condition in many areas of their body and who may benefit from taking injections or pills (systemic therapy) or phototherapy (treatment using ultraviolet light alone or with pills).
- To treat non-infectious intermediate, posterior, and panuveitis in adults and children 2 years of age and older.
What are the possible side effects of HUMIRA PEN?
Humira pen can cause serious side effects, including:
See “What is the most important information I should know about HUMIRA PEN?”
- Serious Infections.
- Your doctor will examine you for TB and perform a test to see if you have TB. If your doctor feels that you are at risk for TB, you may be treated with medicine for TB before you begin treatment with HUMIRA PEN and during treatment with HUMIRA. Even if your TB test is negative your doctor should carefully monitor you for TB infections while you are taking HUMIRA. People who had a negative TB skin test before receiving HUMIRA have developed active TB. Tell your doctor if you have any of the following symptoms while taking or after taking HUMIRA PEN 40mg/0.8ml:
cough that does not go away
- low grade fever
- weight loss
- loss of body fat and muscle (wasting)
HUMIRA PEN DESCRIPTION
Humira pen (adalimumab) is a recombinant human IgG1 monoclonal antibody specific for human tumor necrosis factor (TNF). Humira was created using phage display technology resulting in an antibody with human derived heavy and light chain variable regions and human IgG1:k constant regions. Adalimumab is produced by recombinant DNA technology in a mammalian cell 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.
Humira Pen 40mg is supplied as a sterile, preservative-free solution of adalimumab for subcutaneous administration. The drug product is supplied as either a single-use, prefilled pen (HUMIRA Pen), as a single-use, 1 mL prefilled glass syringe, or as a single-use institutional use vial. Enclosed within the pen is a single-use, 1 mL prefilled glass syringe. The solution of Humira pen is clear and colorless, with a pH of about 5.2.
Each Humira Pen 40 mg prefilled syringe, prefilled pen, or single-use institutional use vial delivers 0.8 mL (40 mg) of drug product. Each 0.8 mL of HUMIRA contains adalimumab (40 mg), citric acid monohydrate (1.04 mg), dibasic sodium phosphate dihydrate (1.22 mg), mannitol (9.6 mg), monobasic sodium phosphate dihydrate (0.69 mg), polysorbate 80 (0.8 mg), sodium chloride (4.93 mg), sodium citrate (0.24 mg) and Water for Injection, USP. Sodium hydroxide is added as necessary to adjust pH.
DOSAGE AND ADMINISTRATION OF HUMIRA PEN 40mg
Rheumatoid Arthritis, Psoriatic Arthritis, And Ankylosing Spondylitis
The recommended subcutaneous dosage of Humira Pen 40mg for adult patients with rheumatoid arthritis (RA), psoriatic arthritis (PsA), or ankylosing spondylitis (AS) is 40 mg administered every other week. Methotrexate (MTX), other non-biologic DMARDS, glucocorticoids, nonsteroidal antiinflammatory drugs (NSAIDs), and/or analgesics may be continued during treatment with HUMIRA. In the treatment of RA, some patients not taking concomitant MTX may derive additional benefit from increasing the dosage of HUMIRA to 40 mg every week or 80 mg every other week.
Juvenile Idiopathic Arthritis Or Pediatric Uveitis
The recommended subcutaneous dosage of HUMIRA PEN for patients 2 years of age and older with polyarticular juvenile idiopathic arthritis (JIA) or pediatric uveitis is based on weight as shown below. MTX, glucocorticoids, NSAIDs, and/or analgesics may be continued during treatment with HUMIRA.
HUMIRA is a clear and colorless solution available as:
- Pen (HUMIRA Pen)
Injection: 40 mg/0.8 ml in a single-dose pen.
- Prefilled Syringe
Injection: 40 mg/0.8 ml in a single-dose prefilled glass syringe.
- Single-Dose Institutional Use Vial
Injection: 40 mg/0.8 ml in a single-dose, glass vial for institutional use only.
Storage And Handling
HUMIRA PEN adalimumab is supplied as a preservative-free, sterile, clear and colorless solution for subcutaneous administration. The following packaging configurations are available.
HUMIRA Pen 40 mg/0.8 ml-Carton
Humira Pen 40mg is supplied in a carton containing two alcohol preps and two dose trays. Each dose tray consists of a single-dose pen, containing a 1 mL prefilled glass syringe with a fixed ½ inch needle, providing 40 mg/0.8 ml of HUMIRA. The needle cover may contain natural rubber latex. The NDC number is 0074-4339-02.