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June 29, 2016


Company: Bristol-Myers Squibb Pharmaceuticals.
Legal category: Prescription. Hospital. Sport permitted.
Active ingredient: Ipilimumab 5mg/ml.
Description: Concentrate for solution for infusion.
Presentation: 10ml, 40ml vials. Price available on request.
Indication: Treatment of advanced (unresectable or metastatic) melanoma in adults who have received prior therapy.
Pharmacology: Ipilimumab is a T-cell potentiator that specifically blocks the inhibitory signal of cytotoxic T-lymphocyte antigen-4 resulting in T-cell activation, proliferation and lymphocyte infiltration into tumours, leading to tumour cell death. The mechanism of action of ipilimumab is indirect, through enhancing T-cell mediated immune response.
Dosage: Adult: Induction, administer 3mg/kg intravenously over 90 minute period every 3 weeks for a total of 4 doses. Elderly: As per adults. Children: Under 18 years, safety and efficacy not established.
Contraindications: Hypersensitivity to the active substance or to any of the excipients. Pregnancy, lactation.
Special precautions: Evaluate liver and thyroid function tests at baseline and before each dose. Immune-related adverse reactions may be severe or life-threatening (may involve gastrointestinal, liver, skin, nervous, endocrine, or other organ systems); may require omission of a dose or permanent discontinuation. Caution: Hepatic impairment (ALT or AST ≥5 x ULN or bilirubin levels >3 x ULN at baseline), history of autoimmune disease. Severe active autoimmune disease (avoid). Ocular melanoma, primary CNS melanoma and active brain metastases (not studied). Driving/using machines. Contains sodium.
Drug interactions: Caution: Anticoagulants. Avoid: Systemic corticosteroids (before treatment only).
Adverse drug reactions: Tumour pain, anaemia, lymphopenia, hypopituitarism (including hypophysitis), hypothyroidism, decreased appetite, dehydration, hypokalaemia, confusional state, peripheral sensory neuropathy, dizziness, headache, lethargy, blurred vision, eye pain, hypotension, flushing, hot flush, dyspnoea, cough, GI disorders, abnormal hepatic function, skin disorders, arthralgia, myalgia, musculoskeletal pain, muscle spasms, fatigue, injection site reaction, chills, asthenia, oedema, pain, increased ALT, increased AST, increased blood bilirubin, decreased weight.
Full prescribing information and references available from Bristol-Myers Squibb Pharmaceuticals. Telephone: 1800 749749.