What Is Adimab 40 mg/0.8 ml Indications and Uses?

Adimab 40 mg/0.8 ml (Adalimumab) injection is a tumor necrosis factor (TNF) blocker indicated for treatment of: 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 ... Read more Adimab 40 mg/0.8 ml (Adalimumab) injection is a tumor necrosis factor (TNF) blocker indicated for treatment of: 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 Adult Crohn’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 Pediatric Crohn’s Disease : Reducing signs and symptoms and inducing and maintaining clinical remission in patients 6 years of age and older with moderately to severely active Crohn’s disease who have had an inadequate response to corticosteroids or immunomodulators such as azathioprine, 6-mercaptopurine, or methotrexate 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 Adimab has not been established in patients who have lost response to or were intolerant to TNF blockers 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 Hidradenitis Suppurative (HS) : The treatment of moderate to severe hidradenitis suppurativa

Pharmacology (Source, Chemical and Physical Composition) Of Adimab 40 mg/0.8 ml

Adimab 40 mg/0.8 ml (Adalimumab) is a recombinant human IgG1 monoclonal antibody specific for human tumor necrosis factor (TNF). Adalimumab 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 Rheumatoid Arthritis, Juvenile Idiopathic Arthritis, Psoriatic Arthritis, and Ankylosing Spondylitis and play an important role in both the pathologic inflammation and the joint destruction that are hallmarks of these diseases. Increased levels of TNF are also found in psoriasis plaques. In Plaque Psoriasis, treatment with Adalimumab may reduce the epidermal thickness and infiltration of inflammatory cells.

Drug Interactions of Adimab 40 mg/0.8 ml

Abatacept: Increased risk of serious infection Anakinra: Increased risk of serious infection Live vaccines: Adimab 40 mg/0.8 ml (Adalimumab) use should be avoided

Side Effects of Adimab 40 mg/0.8 ml

The most common adverse reaction with Adimab 40 mg/0.8 ml (Adalimumab) was injection site reactions (erythema and/or itching, hemorrhage, pain or swelling). The most common adverse reactions leading to discontinuation of Adimab in rheumatoid arthritis were clinical flare reaction, rash and pneumonia. Other adverse reactions of Adimab includes- 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. Vascular disorders: Systemic vasculitis, deep vein thrombosis.

Precautions And Warnings for Adimab 40 mg/0.8 ml

Serious infections : Adimab 40 mg/0.8 ml (Adalimumab) should not be started during an active infection. If an infection develops, should be carefully monitored and if infection becomes serious Adimab should be stopped. Invasive fungal infections : For patients who develop a systemic illness on Adimab, empiric antifungal therapy should be considered for those who reside or travel to regions where mycoses are endemic Malignancies : Incidence of malignancies was greater in Adimab-treated patients than in controls Anaphylaxis or serious allergic reactions may occur Hepatitis B virus reactivation: HBV carriers should be monitored during and several months after therapy. If reactivation occurs, Adimab should be stopped and antiviral therapy should be started Demyelinating disease : Exacerbation or new onset, may occur Cytopenias, pancytopenia: Patients should be advised to seek immediate medical attention if symptoms develop, and should be considered stopping Adimab Heart failure : Worsening or new onset, may occur Lupus-like syndrome : Adimab should be stopped if syndrome develops

Use During Pregnancy and Lactation

Pregnancy Category B. Adequate and well controlled studies with Adimab 40 mg/0.8 ml (Adalimumab) have not been conducted in pregnant women. Adalimumab is an IgG1 monoclonal antibody and IgG1 is actively transferred across the placenta during the third trimester of pregnancy. Limited data from published literature indicate that Adalimumab is present in low levels in human milk and is not likely to be absorbed by a breastfed infant. However, no data is available on the absorption of Adalimumab from breast milk in newborn or preterm infants. Caution should be exercised when Adalimumab is administered to a nursing woman.

Therapeutic Class

Disease-modifying antirheumatic drugs (DMARDs), Immunosuppressant

Storage Conditions of It

Do not use beyond the expiration date on the container. Adimab must be refrigerated at 2-8° C. Do not freeze. Protect the pre-filled syringe from exposure to light. Store in original carton until time of administration. Thanks for using MedEx! How would you rate your experience so far?