Obinutuzumab


Thông tin thuốc gốc
Chỉ định và Liều dùng
Intravenous
Follicular lymphoma
Adult: Induction for patients with previously untreated advanced cases, in combination with chemotherapy in either 6 28-day cycles with bendamustine, 6 21-day cycles with cyclophosphamide, doxorubicin, vincristine and prednisolone (CHOP), or 8 21-day cycles with cyclophosphamide, vincristine and prednisone/prednisolone/methylprednisolone (CVP): 1,000 mg on Days 1, 8 and 15 of Cycle 1 and on Day 1 of Cycles 2-6 or 2-8. Maintenance for patients who achieve a complete or partial response to induction treatment: 1,000 mg once every 2 months as monotherapy for up to 2 years or until disease progression. Doses are infused at 50 or 100 mg/hour, may increase rate by 50 or 100 mg/hour increments every 30 minutes to a max rate of 400 mg/hour. Infusion rates may vary according to the incidence of IRRs in the previous infusion. Pre-medicate with IV corticosteroid, oral analgesic/antipyretics and antihistamine before infusion. Dosing interruption or discontinuation may be required if IRRs occur (refer to detailed product guidelines).

Intravenous
Chronic lymphocytic leukaemia
Adult: In combination with chlorambucil for patients with previously untreated cases: Cycle 1: Day 1: 100 mg infused at 25 mg/hour over 4 hours; Day 2 (or Day 1 continued): 900 mg given at 25 or 50 mg/hour, may increase rate in increments of 50 mg/hour every 30 minutes to a max rate of 400 mg/hour; Days 8 and 15: 1,000 mg administered at 50 or 100 mg/hour, may escalate rate in increments of 50 or 100 mg/hour every 30 minutes at a max rate of 400 mg/hour. Cycles 2-6: Day 1: 1,000 mg infused at 50 or 100 mg/hour, may increase rate by 50 or 100 mg/hour increments every 30 minutes at a max rate of 400 mg/hour. Therapy duration: 6 28-day treatment cycles. Infusion rates may vary according to the incidence of infusion-related reactions (IRRs) in the previous infusion. Pre-medicate with IV corticosteroid, oral analgesic/antipyretics and antihistamine before infusion. Dosing interruption or discontinuation may be required if IRRs occur (refer to detailed product guidelines).

Intravenous
Refractory follicular lymphoma, Relapsed follicular lymphoma
Adult: For patients whose disease did not respond or who progressed during or up to 6 months after therapy with rituximab or a rituximab-containing regimen: Induction, in combination with bendamustine in 6 28-day cycles: 1,000 mg on Days 1, 8 and 15 of Cycle 1 and on Day 1 of Cycles 2-6. Maintenance for patients who achieved a complete or partial response to induction treatment or have stable disease: 1,000 mg once every 2 months as monotherapy for up to 2 years or until disease progression. Doses are infused at 50 or 100 mg/hour, may escalate rate by 50 or 100 mg/hour increments every 30 minutes to a max rate of 400 mg/hour. Infusion rates may vary according to the incidence of IRRs in the previous infusion. Pre-medicate with IV corticosteroid, oral analgesic/antipyretics and antihistamine before infusion. Dosing interruption or discontinuation may be required if IRRs occur (refer to detailed product guidelines).
Hướng dẫn pha thuốc
Dilute 4 mL (100 mg) in 100 mL, 36 mL (900 mg) in 250 mL, and 40 mL (1,000 mg) in 250 mL 0.9% NaCl solution for inj in a polyvinyl chloride (PVC) or non-PVC polyolefin infusion bags. Invert gently to mix. Do not shake.
Chống chỉ định
Hypersensitivity or serum sickness with prior obinutuzumab use. Active infections. Lactation. Concurrent administration with live or attenuated viral vaccines.
Thận trọng
Patient with hepatitis B virus (HBV) infection, history of recurrent or chronic infections, high tumour burden and/or a high circulating lymphocyte count (>25,000/mm3), history of cardiac or pulmonary disease. Give prophylactic hydration and anti-hyperuricaemic agents to patients at high risk of tumour lysis syndrome (TLS) prior to therapy initiation. Renal impairment (CrCl <70 mL/min). Pregnancy.
Tác dụng không mong muốn
Significant: Hypersensitivity reactions (e.g. anaphylaxis, serum sickness), hypotension; exacerbation of pre-existing cardiac disease (e.g. arrhythmias, angina pectoris, acute coronary syndrome, MI, heart failure).
Blood and lymphatic system disorders: Anaemia, leucopenia, lymphopenia.
Cardiac disorders: Atrial fibrillation, chest pain.
Gastrointestinal disorders: Constipation, diarrhoea, dyspepsia.
General disorders and administration site conditions: Asthenia, fatigue, pyrexia.
Infections and infestations: Herpes zoster infection.
Investigations: Decreased WBC and neutrophil count; increased weight, AST, ALT and alkaline phosphatase.
Metabolism and nutrition disorders: Hyperuricaemia, hypokalaemia, hyperkalaemia, hypocalcaemia, hyponatraemia, hypernatraemia, hypophosphataemia, hypoalbuminaemia.
Musculoskeletal and connective tissue disorders: Arthralgia, back or bone pain, pain in extremities, musculoskeletal pain.
Neoplasms benign, malignant and unspecified: Squamous cell carcinoma of skin, basal cell carcinoma.
Nervous system disorders: Headache.
Psychiatric disorders: Anxiety, depression, insomnia.
Renal and urinary disorders: Dysuria, urinary incontinence, UTI.
Respiratory, thoracic and mediastinal disorders: Upper respiratory tract infection, sinusitis, pneumonia, rhinitis, nasopharyngitis, influenza, cough, nasal congestion, rhinorrhoea, oropharyngeal pain.
Skin and subcutaneous tissue disorders: Alopecia, eczema, pruritus.
Vascular disorders: Hypertension, haemorrhoids.
Potentially Fatal: HBV reactivation that may lead to fulminant hepatitis and hepatic failure; progressive multifocal leukoencephalopathy (PML), severe neutropenia (including febrile neutropenia), severe thrombocytopenia (including acute thrombocytopenia), haemorrhagic events, severe infusion-related reactions (e.g. bronchospasm, dyspnoea, tachycardia), TLS; serious bacterial, fungal, and new or reactivated viral infections.
Chỉ số theo dõi
Perform HBV screening by measuring hepatitis B surface antigen (HBsAg) and hepatitis B core antibody (anti-HBc) prior to initiation of treatment. Obtain CBC with differential at regular intervals, fluid status, renal function, electrolytes, and uric acid (in patients at risk of TLS). Monitor for signs of active hepatitis B infection (during and for up to 12 months following treatment completion), infusion-related reaction, infection, and PML.
Tương tác
Increased risk of hypotension with antihypertensive agents.
Potentially Fatal: May enhance the toxic effects of live or attenuated viral vaccines.
Tác dụng
Description: Obinutuzumab is a type II humanised anti-CD20 monoclonal antibody. It binds specifically to the class II epitope of antigen CD20 expressed on the surface of non-malignant and malignant pre-B and mature B-lymphocytes. Following binding to CD20, it activates complement-dependent cytotoxicity, antibody-dependent cellular cytotoxicity and antibody-dependent cellular phagocytosis, resulting in the lysis of B-cells and cell death.
Pharmacokinetics:
Distribution: Distributed mainly in plasma and interstitial fluid. Volume of distribution: Approx 4.1-4.3 L.
Excretion: Elimination half-life: 25.5-35.3 days.
Bảo quản
Store between 2-8°C. Do not freeze. Protect from light. Diluted solutions are stable for up to 24 hours between 2-8°C.
Phân loại MIMS
Liệu pháp nhắm trúng đích
Phân loại ATC
L01FA03 - obinutuzumab ; Belongs to the class of CD20 (Clusters of Differentiation 20) inhibitors. Used in the treatment of cancer.
Tài liệu tham khảo
Anon. Obinutuzumab. AHFS Clinical Drug Information [online]. Bethesda, MD. American Society of Health-System Pharmacists, Inc. https://www.ahfscdi.com. Accessed 13/12/2021.

Anon. Obinutuzumab. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 13/12/2021.

Buckingham R (ed). Obinutuzumab. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 13/12/2021.

Gazyva (Roche [Malaysia] Sdn Bhd). MIMS Malaysia. http://www.mims.com/malaysia. Accessed 13/12/2021.

Gazyva Injection, Solution, Concentrate (Genentech, Inc.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 13/12/2021.

Gazyvaro 1,000 mg Concentrate for Solution for Infusion (Roche Pharma AG). European Medicines Agency [online]. Accessed 13/12/2021.

Joint Formulary Committee. Obinutuzumab. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 13/12/2021.

Roche Products New Zealand Limited. Gazyva 1000 mg in 40 mL Concentrate Solution for Infusion data sheet 03 February 2021. Medsafe. http://www.medsafe.govt.nz. Accessed 13/12/2021.

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