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Generic Name
Adalimumab
Brand Names
Adalimumab-aacf, Humira
FDA approval date: December 31, 2002
Form: Kit
What is Adalimumab-aacf (Adalimumab)?
Adalimumab-aacf is a tumor necrosis factor blocker indicated for: Rheumatoid Arthritis .
Approved To Treat
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Brand Information
Adalimumab-aacf (adalimumab)
1DOSAGE FORMS AND STRENGTHS
Adalimumab-aacf is a clear and colorless to pale yellow solution available as:
- Pen (Adalimumab-aacf Pen)
Injection: 40 mg/0.8 mL in a single-dose pen. - Prefilled SyringeInjection: 40 mg/0.8 mL in a single-dose prefilled glass syringe.
- Single-Dose Institutional Use Vial KitInjection: 40 mg/0.8 mL in a single-dose, glass vial kit for institutional use only.
2CONTRAINDICATIONS
None.
3ADVERSE REACTIONS
The following clinically significant adverse reactions are described elsewhere in the labeling:
- Serious Infections
- Malignancies
- Hypersensitivity Reactions
- Hepatitis B Virus Reactivation
- Neurologic Reactions
- Hematological Reactions
- Heart Failure
- Autoimmunity
3.1Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The most common adverse reaction with adalimumab was injection site reactions. In placebo- controlled trials, 20% of patients treated with adalimumab developed injection site reactions (erythema and/or itching, hemorrhage, pain or swelling), compared to 14% of patients receiving placebo. Most injection site reactions were described as mild and generally did not necessitate drug discontinuation.
The proportion of patients who discontinued treatment due to adverse reactions during the double-blind, placebo-controlled portion of studies in patients with RA (i.e., Studies RA-I, RA- II, RA-III and RA-IV) was 7% for patients taking adalimumab and 4% for placebo-treated patients. The most common adverse reactions leading to discontinuation of adalimumab in these RA studies were clinical flare reaction (0.7%), rash (0.3%) and pneumonia (0.3%).
3.2Immunogenicity
The observed incidence of anti-drug antibodies is highly dependent on the sensitivity and specificity of the assay. Differences in assay methods preclude meaningful comparisons of the incidence of anti-drug antibodies in the studies described below with the incidence of anti-drugantibodies in other studies, including those of adalimumab or of other adalimumab products.
There are two assays that have been used to measure anti-adalimumab antibodies. With the ELISA, antibodies to adalimumab could be detected only when serum adalimumab concentrations were < 2 mcg/mL. The ECL assay can detect anti-adalimumab antibody titers independent of adalimumab concentrations in the serum samples. The incidence of anti-adalimumab antibody (AAA) development in patients treated with adalimumab are presented in
3.3Postmarketing Experience
The following adverse reactions have been identified during post-approval use of adalimumab products. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to adalimumab products exposure.
Gastrointestinal disorders: Diverticulitis, large bowel perforations including perforations associated with diverticulitis and appendiceal perforations associated with appendicitis, pancreatitis
General disorders and administration site conditions: Pyrexia
Hepato-biliary disorders: Liver failure, hepatitis
Immune system disorders: Sarcoidosis
Neoplasms benign, malignant and unspecified (including cysts and polyps): Merkel Cell Carcinoma (neuroendocrine carcinoma of the skin)
Nervous system disorders: Demyelinating disorders (e.g., optic neuritis, Guillain-Barré syndrome), cerebrovascular accident
Respiratory disorders: Interstitial lung disease, including pulmonary fibrosis, pulmonary embolism
Skin reactions: Stevens Johnson Syndrome, cutaneous vasculitis, erythema multiforme, new or worsening psoriasis (all sub-types including pustular and palmoplantar), alopecia, lichenoid skin reaction
Vascular disorders: Systemic vasculitis, deep vein thrombosis
4OVERDOSAGE
Doses up to 10 mg/kg have been administered to patients in clinical trials without evidence of dose-limiting toxicities. In case of overdosage, it is recommended that the patient be monitored for any signs or symptoms of adverse reactions or effects and appropriate symptomatic treatment instituted immediately.
5DESCRIPTION
Adalimumab-aacf is a tumor necrosis factor blocker. Adalimumab-aacf is a recombinant human IgG1 monoclonal antibody 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-aacf 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.
Adalimumab-aacf injection is supplied as a sterile, preservative-free solution for subcutaneous administration. The drug product is supplied as either a single-dose, prefilled pen (Adalimumab-aacf Pen), as a single-dose, 1 mL or prefilled glass syringe or as a single dose institutional use vial kit. Enclosed within the pen is a single-dose, 1 mL prefilled glass syringe. The solution of Adalimumab-aacf is clear and colorless to pale yellow, with a pH of about 5.2.
Each 40 mg/0.8 mL prefilled syringe or prefilled pen, or institutional use vial kit delivers 0.8 mL (40 mg) of drug product. Each 0.8 mL of Adalimumab-aacf contains adalimumab-aacf (40 mg) and glacial acetic acid (0.5 mg), trehalose (54.8 mg), polysorbate 80 (0.8 mg), sodium chloride (2.3 mg), and Water for Injection. Sodium hydroxide is added to adjust pH.
6REFERENCES
- National Cancer Institute. Surveillance, Epidemiology, and End Results Database (SEER) Program. SEER Incidence Crude Rates, 17 Registries, 2000-2007.
7HOW SUPPLIED/STORAGE AND HANDLING
Adalimumab-aacf injection is supplied as a preservative-free, sterile, clear and colorless to pale yellow solution for subcutaneous administration. The following packaging configurations are available.
- Adalimumab-aacf Pen Carton - 40 mg/0.8 mL (2 count)
Adalimumab-aacf is supplied in a carton containing 2 alcohol preps and one tray. The tray contains two single-dose pens, each containing a 1 mL prefilled glass syringe with a 29 gauge staked ½ inch needle, providing 40 mg/0.8 mL of Adalimumab-aacf. The syringe plunger stopper and needle cover are not made with natural rubber latex. The NDC number is 65219-612-99.
- Adalimumab-aacf Pen 40 mg/0.8 mL - Starter Package for Plaque Psoriasis or Uveitis (4 Count)
Adalimumab-aacf is supplied in a carton containing 4 alcohol preps and 2 trays (Starter Package for Plaque Psoriasis or Uveitis). Each tray contains two single-dose pens, each pen containing a 1 mL prefilled glass syringe with a 29 gauge staked ½ inch needle, providing 40 mg/0.8 mL of Adalimumab-aacf. The syringe plunger stopper and needle cover are not made with natural rubber latex. The NDC number is 65219-612-69.
- Adalimumab-aacf Pen 40 mg/0.8 mL - Starter Package for Crohn's Disease, Ulcerative Colitis, or Hidradenitis Suppurativa (6 Count)
Adalimumab-aacf is supplied in a carton containing 6 alcohol preps and 3 trays (Starter Package for Crohn's Disease, Ulcerative Colitis, or Hidradenitis Suppurativa). Each tray contains two single-dose pens, each pen containing a 1 mL prefilled glass syringe with a 29 gauge staked ½ inch needle, providing 40 mg/0.8 mL of Adalimumab-aacf. The syringe plunger stopper and needle cover are not made with natural rubber latex.
The NDC number is 65219-612-89.
- Adalimumab-aacf Prefilled Syringe Carton - 40 mg/0.8 mL (2 count)
Adalimumab-aacf is supplied in a carton containing 2 alcohol preps and one tray. The tray contains two single-dose, 1 mL prefilled glass syringes with a 29 gauge staked ½ inch needle, each syringe providing 40 mg/0.8 mL of Adalimumab-aacf. The syringe plunger stopper and needle cover are not made with natural rubber latex.
The NDC number is 65219-620-20.
- Adalimumab-aacf Single-Dose Institutional Use Vial Kit - 40 mg/0.8 mL.
Adalimumab-aacf is supplied in a carton containing 1 sterile single-use syringe, 1 sterile needle, 1 vial adapter, 2 alcohol preps and 1 glass vial providing 40 mg/0.8 mL of Adalimumab-aacf. The vial stopper is not made with natural rubber latex. The NDC number is 65219-628-89.
8PATIENT COUNSELING INFORMATION
Advise the patient or caregiver to read the FDA-approved patient labeling (