Company: Roche Products (Ireland) Ltd.
Legal category: Prescription. Hospital only. Sport permitted.
Active ingredient: Obinutuzumab 1000mg.
Description: Concentrate for solution for infusion.
Presentation: 40ml vial-1. Price on request.
Indications: In combination with chlorambucil for treatment of adult patients with previously untreated chronic lymphocytic leukaemia and with comorbidities making them unsuitable for full-dose fludarabine based therapy.
Pharmacology: Obinutuzumab is a recombinant monoclonal humanised and glycoengineered Type II anti-CD20 antibody of the IgG1 isotype. It specifically targets the extracellular loop of the CD20 transmembrane antigen on the surface of non-malignant and malignant pre-B and mature B-lymphocytes. It induces direct cell death and mediates antibody dependent cellular cytotoxicity and antibody dependent cellular phagocytosis through recruitment of FcγRIII positive immune effector cells and it mediates a low degree of complement dependent cytotoxicity. It mediates potent B-cell depletion and antitumour efficacy.
Dosage: Adult: Prophylaxis and premedication for tumour lysis syndrome (TLS) or infusion related reactions (IRRs): See SPC. Six 28 day treatment cycles. Cycle 1: Day 1, 100mg; day 2 (or day 1 continued), 900mg; day 8, 1000mg; day 15, 1000mg. Cycles 2-6: Day 1, 1000mg. Infusion rate: See SPC. Elderly: As per adults. Children: Under 18 years, not recommended.
Contraindications: Hypersensitivity to the active substance or to any of the excipients. Pregnancy (assess risk/benefit), lactation. Women must use effective contraception and not breastfeed during and for 18 months after treatment.
Special precautions: Intravenous use only; do not administer as an intravenous push or bolus. Correct infections before initiation. Closely monitor for thrombocytopenia (especially during first cycle). Caution: Hepatitis B carriers (screen before initiation in all patients, hepatitis B virus reactivation with fatal results can occur, do not use in patients with active hepatitis B disease), pre-existing cardiac/ pulmonary conditions, history of recurring/ chronic infections (fatal infections reported), history of cardiac disease. May occur: IRRs (permanently discontinue if life-threatening or second occurrence of severe IRR occurs), hypersensitivity reactions (permanently discontinue if suspected), tumour lysis syndrome, neutropenia (closely monitor if occurs), progressive multifocal leukoencephalopathy (permanently discontinue if confirmed). Cytokine release syndrome cases reported. Hepatic impairment, severe renal impairment; safety and efficacy not established. Driving/using machines (if IRRs present).
Drug interactions: Live vaccines (not recommended). Concomitant platelet inhibitors and anticoagulants can worsen thrombocytopenia.
Adverse drug reactions: Urinary tract infection, nasopharyngitis, oral herpes, rhinitis, pharyngitis, squamous cell carcinoma of skin, neutropenia, thrombocytopenia, anaemia, leukopenia, TLS, hyperuricaemia, atrial fibrillation, hypertension, cough, gastrointestinal upset, alopecia, arthralgia, back pain, musculoskeletal chest pain, pyrexia, decreased white blood cell count, decreased neutrophil count, increased weight, IRRs.
Full prescribing information and references available from Roche Products (Ireland) Ltd. Telephone: (01) 4690700.