Humira

Trade name: HUMIRA®

Generic names: adalimumab injection for subcutaneous use

Indication and Usage: HUMIRA is a tumor necrosis factor (TNF) blocker indicated for:

• Rheumatoid Arthritis (RA) (1.1): 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) (1.2): reducing signs and symptoms of
  moderately to severely active polyarticular JIA in patients 2 years of age
  and older.
• Psoriatic Arthritis (PsA) (1.3): reducing signs and symptoms, inhibiting
  the progression of structural damage, and improving physical function in
  adult patients with active PsA.
• Ankylosing Spondylitis (AS) (1.4): reducing signs and symptoms in adult
  patients with active AS.
• Crohn’s Disease (CD) (1.5): treatment of moderately to severely active
  Crohn’s disease in adults and pediatric patients 6 years of age and older.
• Ulcerative Colitis (UC) (1.6): treatment of moderately to severely active
  ulcerative colitis in adults and pediatric patients 5 years of age and older.
  Limitations of Use: Effectiveness has not been established in patients who
  have lost response to or were intolerant to TNF blockers.
• Plaque Psoriasis (Ps) (1.7): 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) (1.8): treatment of moderate to severe
  hidradenitis suppurativa in patients 12 years of age and older.
• Uveitis (UV) (1.9): treatment of non-infectious intermediate, posterior,

Ingredients: Adalimumab 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.

• Each 80 mg/0.8 mL prefilled syringe or prefilled pen delivers 0.8 mL (80 mg) of drug product. Each 0.8 mL of HUMIRA contains adalimumab (80 mg), mannitol (33.6 mg), polysorbate 80 (0.8 mg), and Water for Injection, USP.
• Each 40 mg/0.4 mL prefilled syringe or prefilled pen delivers 0.4 mL (40 mg) of drug product. Each 0.4 mL of HUMIRA contains adalimumab (40 mg), mannitol (16.8 mg), polysorbate 80 (0.4 mg), and Water for Injection, USP.
• Each 40 mg/0.8 mL prefilled syringe, prefilled pen, or single-dose 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.
• Each 20 mg/0.2 mL prefilled syringe delivers 0.2 mL (20 mg) of drug product. Each 0.2 mL of HUMIRA contains adalimumab (20 mg), mannitol (8.4 mg), polysorbate 80 (0.2 mg), and Water for Injection, USP.
• Each 20 mg/0.4 mL prefilled syringe delivers 0.4 mL (20 mg) of drug product. Each 0.4 mL of HUMIRA contains adalimumab (20 mg), citric acid monohydrate (0.52 mg), dibasic sodium phosphate dihydrate (0.61 mg), mannitol (4.8 mg), monobasic sodium phosphate dihydrate (0.34 mg), polysorbate 80 (0.4 mg), sodium chloride (2.47 mg), sodium citrate (0.12 mg) and Water for Injection, USP. Sodium hydroxide is added as necessary to adjust pH.
• Each 10 mg/0.1 mL prefilled syringe delivers 0.1 mL (10 mg) of drug product. Each 0.1 mL of HUMIRA contains adalimumab (10 mg), mannitol (4.2 mg), polysorbate 80 (0.1 mg), and Water for Injection, USP.
• Each 10 mg/0.2 mL prefilled syringe delivers 0.2 mL (10 mg) of drug product. Each 0.2 mL of HUMIRA contains adalimumab (10 mg), citric acid monohydrate (0.26 mg), dibasic sodium phosphate dihydrate (0.31 mg), mannitol (2.4 mg), monobasic sodium phosphate dihydrate (0.17 mg), polysorbate 80 (0.2 mg), sodium chloride (1.23 mg), sodium citrate (0.06 mg) and Water for Injection, USP. Sodium hydroxide is added as necessary to adjust pH.

Manufacturer-listed adverse reactions | Humira can cause: Patients treated with HUMIRA are at increased risk for developing serious infections involving various organ systems and sites that may lead to hospitalization or death. Cases of reactivation of tuberculosis and new onset tuberculosis infections including patients who have previously received treatment for latent or active tuberculosis. Reports included cases of pulmonary and extrapulmonary (i.e., disseminated) tuberculosis. Anaphylaxis/angioneurotic (blood vessels and nerves) edema, Rash, Fixed drug reaction/non-specified drug reaction, Urticaria (hives), and Risk of reactivation of hepatitis B virus (HBV). New onset/exacerbation of clinical symptoms and/or radiographic evidence of central nervous system demyelinating disease, including multiple sclerosis (MS) and optic neuritis, and peripheral demyelinating disease, including Guillain-Barré syndrome. Pancytopenia including aplastic anemia, Worsening congestive heart failure (CHF) and new onset CHF, Formation of autoantibodies and, rarely, in the development of a lupus-like syndrome, Diverticulitis, Large bowel perforations including perforations associated with diverticulitis and appendiceal perforations associated with appendicitis, Pancreatitis, Pyrexia (fever), Liver failure, Hepatitis, Sarcoidosis (abnormal collections of inflammatory cells that form lumps known as granulomata), Merkel Cell Carcinoma (neuroendocrine carcinoma of the skin), Demyelinating disorders (e.g., optic neuritis, Guillain-Barré syndrome), Cerebrovascular (blood vessels of the brain) accident, Interstitial lung disease, including pulmonary fibrosis, Pulmonary embolism, Stevens Johnson Syndrome, Cutaneous vasculitis, Erythema multiforme, New or worsening psoriasis (all sub-types including pustular and palmoplantar), Alopecia (baldness), Lichenoid skin reaction, Systemic vasculitis, Deep vein thrombosis, Upper respiratory infection, Sinusitis, Flu syndrome, Nausea, Abdominal pain, Headache, Back pain, Urinary tract infection, Hypertension, Pelvic pain, Thorax (chest) pain, Arrhythmia, Atrial fibrillation, Coronary artery disorder, Heart arrest, Hypertensive encephalopathy, Myocardial infarct, Palpitation, Pericardial effusion, Pericarditis, Syncope (fainting), Tachycardia (increased heart rate), Cholecystitis, Cholelithiasis, Esophagitis, Gastroenteritis, Gastrointestinal hemorrhage, Hepatic necrosis, Vomiting, Parathyroid disorder, Agranulocytosis, Polycythemia, Dehydration, Healing abnormal, Ketosis, Paraproteinemia, Peripheral edema, Arthritis, Bone disorder, Bone necrosis, Joint disorder, Muscle cramps, Myasthenia, Pyogenic arthritis, Synovitis, Tendon disorder, Confusion, Paresthesia, Subdural hematoma, Tremor, Asthma, Bronchospasm, Dyspnea, Adenoma (benign tumor of epithelial tissue with glandular origin), Bone fracture (not spontaneous), Lung function decreased, Pleural effusion, Cataract, Thrombosis leg, Cystitis, Kidney calculus, and Menstrual disorder.

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Disclaimer: This guide is for informational purposes only. By providing the information contained herein we are not diagnosing, treating, curing, mitigating, or preventing any type of disease or medical condition. Before beginning any type of natural, integrative or conventional treatment regimen, it is advisable to seek the advice of a licensed healthcare professional. May contain affiliate links. Product photos/descriptions provided by company websites. This is not medical advice.

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