Bevacizumab


Thông tin thuốc gốc
Chỉ định và Liều dùng
Intravenous
Advanced renal cell carcinoma, Metastatic renal cell carcinoma
Adult: In combination with interferon alfa-2a: 10 mg/kg once every 2 weeks. Administer the 1st infusion over 90 minutes; if tolerated, administer the 2nd infusion over 60 minutes, and if this is well-tolerated then subsequent doses may be given over 30 minutes. Dosing interruption or discontinuation may be required according to individual safety or tolerability. Treatment and dosing recommendations may vary among individual products and between countries. Refer to detailed product or local treatment guidelines.

Intravenous
Non-squamous non-small cell lung cancer
Adult: As 1st-line treatment in patients with unresectable advanced, metastatic or recurrent non-squamous non-small cell lung cancer: 7.5 mg/kg or 15 mg/kg once every 3 weeks (in addition to platinum-based chemotherapy) for up to 6 cycles followed by bevacizumab as a single agent until disease progression. Administer the 1st infusion over 90 minutes; if tolerated, administer the 2nd infusion over 60 minutes, and if this is well-tolerated then subsequent doses may be given over 30 minutes. Dosing interruption or discontinuation may be required according to individual safety or tolerability. Treatment and dosing recommendations may vary among individual products and between countries. Refer to detailed product or local treatment guidelines.

Intravenous
Cervical cancer
Adult: In patients with persistent, recurrent, or metastatic cervical cancer; in combination with paclitaxel and cisplatin or paclitaxel and topotecan: 15 mg/kg once every 3 weeks. Administer the 1st infusion over 90 minutes; if tolerated, administer the 2nd infusion over 60 minutes, and if this is well-tolerated then subsequent doses may be given over 30 minutes. Dosing interruption or discontinuation may be required according to individual safety or tolerability. Treatment and dosing recommendations may vary among individual products and between countries. Refer to detailed product or local treatment guidelines.

Intravenous
Metastatic colorectal cancer
Adult: As 1st- or 2nd-line treatment in combination with fluorouracil-based chemotherapy: 5 mg/kg or 10 mg/kg once every 2 weeks; doses depend on the combination of drugs used in the regimen. As 2nd-line treatment in combination with fluoropyrimidine-irinotecan- or fluoropyrimidine-oxaliplatin-based chemotherapy after progression on a 1st-line treatment containing bevacizumab: 5 mg/kg once every 2 weeks or 7.5 mg/kg once every 3 weeks; doses depend on the combination of drugs used in the regimen. Administer the 1st infusion over 90 minutes; if tolerated, administer the 2nd infusion over 60 minutes, and if this is well-tolerated then subsequent doses may be given over 30 minutes. Dosing interruption or discontinuation may be required according to individual safety or tolerability. Treatment and dosing recommendations may vary among individual products and between countries. Refer to detailed product or local treatment guidelines.

Intravenous
Recurrent glioblastoma multiforme
Adult: 10 mg/kg once every 2 weeks. Administer the 1st infusion over 90 minutes; if tolerated, administer the 2nd infusion over 60 minutes, and if this is well-tolerated then subsequent doses may be given over 30 minutes. Dosing interruption or discontinuation may be required according to individual safety or tolerability. Treatment and dosing recommendations may vary among individual products and between countries. Refer to detailed product or local treatment guidelines.

Intravenous
Metastatic hepatocellular carcinoma, Unresectable hepatocellular carcinoma
Adult: In combination with atezolizumab in patients who have not received prior systemic therapy: 15 mg/kg once every 3 weeks. Administer the 1st infusion over 90 minutes; if tolerated, administer the 2nd infusion over 60 minutes, and if this is well-tolerated then subsequent doses may be given over 30 minutes. Continue therapy until disease progression or unacceptable toxicity occurs. Dosing interruption or discontinuation may be required according to individual safety or tolerability. Treatment and dosing recommendations may vary among individual products and between countries. Refer to detailed product or local treatment guidelines.

Intravenous
Metastatic breast cancer
Adult: As 1st-line treatment in combination with paclitaxel: 10 mg/kg once every 2 weeks or 15 mg/kg once every 3 weeks. Administer the 1st infusion over 90 minutes; if tolerated, administer the 2nd infusion over 60 minutes, and if this is well-tolerated then subsequent doses may be given over 30 minutes. Continue therapy until disease progression or unacceptable toxicity occurs. Dosing interruption or discontinuation may be required according to individual safety or tolerability. Treatment and dosing recommendations may vary among individual products and between countries. Refer to detailed product or local treatment guidelines.

Intravenous
Epithelial ovarian carcinoma, Fallopian tube carcinoma, Primary peritoneal carcinoma
Adult: In patients with stage III or IV epithelial ovarian, fallopian tube, or primary peritoneal cancer following initial surgical resection: 15 mg/kg once every 3 weeks (in combination with carboplatin and paclitaxel) for up to 6 cycles, followed by bevacizumab 15 mg/kg once every 3 weeks as a single agent for 15 months or until disease progression, whichever occurs earlier. In patients with platinum-resistant recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer who received no more than 2 prior chemotherapy regimens: 10 mg/kg once every 2 weeks (in combination with paclitaxel, pegylated liposomal doxorubicin, or topotecan) or 15 mg/kg every 3 weeks (in combination with topotecan). Continue therapy until disease progression. In patients with platinum-sensitive recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer: 15 mg/kg once every 3 weeks (in combination with carboplatin and paclitaxel) for 6-8 cycles, followed by bevacizumab 15 mg/kg once every 3 weeks as a single agent until disease progression. Alternatively, 15 mg/kg every 3 weeks (in combination with carboplatin and gemcitabine) for 6-10 cycles, followed by bevacizumab 15 mg/kg every 3 weeks as a single agent until disease progression. All doses are administered via IV infusion initially over 90 minutes; if tolerated, administer the 2nd infusion over 60 minutes, and if this is well-tolerated then subsequent doses may be given over 30 minutes. Dosing interruption or discontinuation may be required according to individual safety or tolerability. Treatment and dosing recommendations may vary among individual products and between countries. Refer to detailed product or local treatment guidelines.
Hướng dẫn pha thuốc
Dilute with appropriate amount of NaCl 0.9% solution to prepare the desired concentration. Do not shake. Instructions for reconstitution may vary among individual products and between countries (refer to specific product guidelines).
Tương kỵ
Incompatible with dextrose-containing solutions.
Chống chỉ định
Pregnancy and lactation.
Thận trọng
Patient with CV disease (e.g. pre-existing coronary artery disease or CHF), hypertension, diabetes, history of aneurysm, history of arterial thromboembolism, history of prior pelvic radiation. Withhold therapy for at least 28 days prior to elective surgery. Therapy should not be started for at least 28 days after major surgery or until the surgical wound is fully healed. Avoid therapy in patients with ovarian cancer who have evidence of recto-sigmoid involvement (by pelvic examination) or bowel involvement (on computed tomography [CT] scan) or clinical symptoms of bowel obstruction. Renal impairment. Elderly.
Tác dụng không mong muốn
Significant: Hypertension; CHF; venous thromboembolic reactions (e.g. pulmonary embolism); serious fistulae (including trachea-oesophageal, bronchopleural, biliary, vaginal, renal and bladder sites); proteinuria, nephrotic syndrome; infusion or hypersensitivity reactions; increased risk of ovarian failure and may impair fertility; osteonecrosis of the jaw (ONJ); posterior reversible encephalopathy syndrome (PRES).
Blood and lymphatic system disorders: Leucopenia, thrombocytopenia, lymphopenia.
Cardiac disorders: Supraventricular tachycardia.
Ear and labyrinth disorders: Deafness, tinnitus.
Eye disorders: Increased lacrimation, blurred vision.
Gastrointestinal disorders: Diarrhoea, dysgeusia, constipation, nausea, vomiting, abdominal pain, stomatitis.
General disorders and administration site conditions: Asthenia, fatigue, pyrexia, lethargy, mucosal inflammation.
Hepatobiliary disorders: Gallbladder perforation.
Infections and infestations: Sepsis, abscess.
Investigations: Decreased weight, increased serum creatinine.
Metabolism and nutrition disorders: Anorexia, hypomagnesaemia, hyponatraemia, dehydration.
Musculoskeletal and connective tissue disorders: Arthralgia, myalgia, back pain, muscle weakness.
Nervous system disorders: Headache, dysarthria, somnolence, peripheral sensory neuropathy.
Psychiatric disorders: Anxiety.
Renal and urinary disorders: UTI.
Reproductive system and breast disorders: Pelvic pain.
Respiratory, thoracic and mediastinal disorders: Dyspnoea, rhinitis, cough, hypoxia, dysphonia.
Skin and subcutaneous tissue disorders: Cellulitis, palmar-plantar erythrodysaesthesia syndrome, exfoliative dermatitis, dry skin, skin discolouration.
Vascular disorders: DVT, syncope.
Potentially Fatal: Serious gastrointestinal perforation; serious haemorrhage (including haemoptysis, gastrointestinal bleeding, haematemesis, epistaxis, CNS haemorrhage, vaginal bleeding), serious pulmonary haemorrhage; arterial thromboembolic events (e.g. CVA, MI, TIA); serious wound healing complications (including anastomotic complications), necrotising fasciitis; severe or febrile neutropenia, or infection with or without severe neutropenia.
Thông tin tư vấn bệnh nhân
Women of childbearing potential must use proven birth control methods during therapy and for 6 months after stopping the treatment.
Chỉ số theo dõi
Confirm pregnancy status in females of reproductive potential before starting treatment. Perform dental examination prior to treatment initiation. Monitor blood pressure regularly during and after treatment. Obtain baseline echocardiography and may consider repeating frequently during treatment. Assess for signs and symptoms of proteinuria or nephrotic syndrome, infusion reactions, gastrointestinal perforation or fistula, heart failure, bleeding, PRES, thromboembolism and wound healing complications.
Tương tác
Increased risk of osteonecrosis of the jaw with IV bisphosphonates. Increased risk of microangiopathic haemolytic anaemia (MAHA) with sunitinib. Increased risk of severe or febrile neutropenia, or infection with or without severe neutropenia with platinum- or taxane-based therapies.
Tác dụng
Description:
Mechanism of Action: Bevacizumab is a recombinant humanised monoclonal antibody. It binds to vascular endothelial growth factor (VEGF), the key driver of vasculogenesis and angiogenesis, thereby preventing its association with endothelial receptors, Flt-1 (VEGFR-1) and kinase insert domain (KDR or VEGFR-2). Furthermore, neutralising the biological activity of VEGF reduces tumour angiogenesis and inhibits tumour growth.
Pharmacokinetics:
Excretion: Elimination half-life: Approx 20 days (range: 11-50 days).
Bảo quản
Store between 2-8°C. Do not freeze. Protect from light. Follow applicable procedures for receiving, handling, administration, and disposal.
Phân loại MIMS
Liệu pháp nhắm trúng đích
Phân loại ATC
L01FG01 - bevacizumab ; Belongs to the class of VEGF/VEGFR (Vascular Endothelial Growth Factor) inhibitors. Used in the treatment of cancer.
Tài liệu tham khảo
Anon. Bevacizumab. AHFS Clinical Drug Information [online]. Bethesda, MD. American Society of Health-System Pharmacists, Inc. https://www.ahfscdi.com. Accessed 25/07/2023.

Anon. Bevacizumab. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 25/07/2023.

Avastin Concentrate for Solution for Infusion (Roche [Malaysia] Sdn. Bhd.).  National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia.  https://www.npra.gov.my. Accessed 25/07/2023.

Avastin Injection, Solution (Genentech, Inc.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 25/07/2023.

Buckingham R (ed). Bevacizumab. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 25/07/2023.

Joint Formulary Committee. Bevacizumab. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 25/07/2023.

Roche Products (New Zealand) Limited. Avastin 25 mg/mL Concentrate for Solution for Infusion data sheet 30 March 2023. Medsafe. http://www.medsafe.govt.nz. Accessed 25/07/2023.

Zirabev 25 mg/mL Concentrate for Solution for Infusion (Pfizer Limited). MHRA. https://products.mhra.gov.uk. Accessed 25/07/2023.

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