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Control angiogenesis
Extend survival
Now with the confidence of experience
Avastin is proven to increase overall survival
in over half a million patients worldwide.
1
in first-line and second-line mCRC.
2–4
PRESCRIBING INFORMATION Syndrome (RPLS); should RPLS develop, confirm by imaging, treat symptoms and
Refer to Avastin Summary of Product Characteristics (SPC) for full prescribing discontinue Avastin. RPLS signs include: seizures, headache, altered mental status,
information. AVASTIN
®
(bevacizumab) 25 mg/ml concentrate for solution visual disturbance or cortical blindness with/without associated hypertension.
for infusion. Indications: In combination with fluoropyrimidine-based Proteinuria; test prior to and monitor during treatment. Permanently discontinue if
chemotherapy for treatment of metastatic carcinoma of the colon or rectum. In Grade 4 proteinuria (nephrotic syndrome) develops. Arterial thromboembolism including
combination with paclitaxel or docetaxel for first-line treatment of metastatic breast cerebrovascular accidents, transient ischaemic attacks and myocardial infarctions,
cancer. In addition to platinum-based chemotherapy for first-line treatment of especially if prior history or elderly: permanently discontinue if arterial thromboembolic
unresectable advanced, metastatic or recurrent non-small cell lung cancer other than events develop. Venous thromboembolism including pulmonary embolism; discontinue
predominantly squamous cell histology. In combination with interferon alfa-2a for in Grade 4 pulmonary embolism and monitor where <Grade 3. Haemorrhage,
first-line treatment of advanced and/or metastatic renal cell cancer. Dosage and especially tumour-associated haemorrhage; discontinue permanently if Grade 3/4.
Administration: Single use vials (25mg/ml bevacizumab) as 100 mg/4ml or 400 Patients with CNS metastases; monitor and discontinue treatment if intracranial
mg/16ml. Physicians experienced in antineoplastic medicines should supervise Avastin bleeding occurs. Caution in patients with congenital bleeding diathesis, acquired
administration. Recommended dose: Continue until progression of underlying disease. coagulopathy or during anticoagulant therapy. Serious/fatal pulmonary haemorrhage/
Colorectal cancer: either 5 mg/kg or 10 mg/kg every 2 weeks or 7.5 mg/kg or 15 mg/kg haemoptysis in non-small cell lung cancer; do not use where recent significant associated hypertension). Hypertensive encephalopathy. Serious reactions (frequency
every 3 weeks. Breast cancer: 10 mg/kg every 2 weeks or 15 mg/kg every 3 weeks. pulmonary haemorrhage/haemoptysis (>2.5 ml of red blood). Congestive Heart not known): pulmonary hypertension, nasal septum perforation, renal thrombotic
Lung cancer: 7.5 mg/kg or15 mg/kg every 3 weeks in addition to platinum-based Failure (CHF); caution in patients with clinically significant cardiovascular disease or microangiopathy clinically manifested as proteinuria. Other, very common: Wound
chemotherapy for up to 6 cycles, then as monotherapy. Renal cell cancer: 10 mg/kg pre-existing CHF. Neutropenia; fatal infection with severe neutropenia in combination healing delay. Anorexia. Dysgeusia. Eye disorder. Hypertension. Epistaxis, dyspnoea,
every 2 weeks. Administration times; initial dose: 90 minute IV infusion; second dose: with myelotoxic chemotherapy. Drug Interactions: Risk of microangiopathic rhinitis. Rectal haemorrhage, constipation. Exfoliative dermatitis, dry skin, skin
60 minute IV infusion if initial dose well tolerated; subsequent doses: 30 minute IV haemolytic anaemia (MAHA) when combined with sunitinib malate (50 mg daily). discolouration. Arthralgia. Pyrexia, asthenia, pain. Any of the above may become
infusion if second dose well tolerated. Do not administer as IV push or bolus or mix Reversible on discontinuation of both agents. Safety and efficacy with concomitant serious. Elderly; increased risk of severe leucopenia and thrombocytopenia; neutropenia,
with glucose. Dose reduction for adverse events not recommended. If indicated, radiotherapy not established. Pregnancy and Lactation: Contraindicated. No data nausea, headache, diarrhoea, fatigue, or arterial thromboembolic events. Laboratory
discontinue or temporarily suspend therapy. Not recommended in children or on use in pregnancy; may inhibit foetal angiogenesis. Women of childbearing potential abnormalities – refer to SPC. Legal Category: POM Presentation and Basic
adolescents. No dose adjustment in the elderly. Contraindications: Hypersensitivity must use effective contraception during treatment and for 6 months after last dose. NHS Cost: Pack of one 100mg vial: £242.66. Pack of one 400mg vial: £924.40.
to bevacizumab, Chinese hamster ovary cell products, recombinant human or Discontinue breast-feeding during treatment and for 6 months after last dose. Side- Excluding VAT Marketing Authorisation Numbers: 100mg/4ml: EU/1/04/300/001;
humanised antibodies or any excipients. Pregnancy. Lactation. Precautions: effects and Adverse Reactions: For full listings please refer to the Avastin SPC. 400mg/16ml: EU/1/04/300/002 Marketing Authorisation Holder: Roche
Gastrointestinal (GI) perforation; intra-abdominal inflammatory process may cause Serious reactions, very common: Leucopenia, thrombocytopenia, neutropenia and Registration Limited, 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United
increased risk in metastatic colorectal cancer patients; permanently discontinue in febrile neutropenia. Peripheral sensory neuropathy. Diarrhoea, nausea, vomiting. Kingdom. Registered in England No. 3028626 Avastin is a registered trade mark
patients developing GI perforation. Fistulae; permanently discontinue in tracheo- Venous thromboembolic events. Fatigue. Serious reactions, common: Anaemia. Sepsis, Date of Preparation: July 2009 MEDI00082.
esophageal fistula or any Grade 4 fistula, consider discontinuation in non-GI fistula. abscess, infection. Dehydration. Cerebrovascular accident, syncope, somnolence,
Wound healing; do not initiate for at least 28 days following major surgery or until headache. Supraventricular tachycardia, CHF. Arterial thromboembolism, deep vein
Adverse events should be reported. Reporting forms and information can be
surgical wound has healed; withhold for elective surgery. Hypertension; control pre- thrombosis, haemorrhage, including pulmonary haemorrhage. Pulmonary embolism,
found at www.yellowcard.gov.uk. Adverse events should also be reported to
existing hypertension prior to initiation. Diuretics not recommended for hypertension dyspnoea, hypoxia, epistaxis. Ileus, intestinal perforation and obstruction, abdominal
Roche Products Ltd. Please contact Roche Drug Safety Centre on: 01707 367554
control with cisplatin. Monitor blood pressure during therapy and treat as per SPC: pain, GI disorder, stomatitis. Palmar-plantar erythrodysaesthesia syndrome. Muscular References: 1. Summary Bridging Report to EMEA, April 2009. 2. Avastin Summary
permanently discontinue if medically significant hypertension remains uncontrolled weakness, myalgia. Proteinuria, urinary tract infection. Lethargy, mucosal inflammation. of Product Characteristics. 3. Hurwitz H et al. N Engl J Med. 2004;350:2335–2342.
or for hypertensive crisis/encephalopathy. Reversible Posterior Leukoencephalopathy Dysphonia. Serious reactions, uncommon/rare/very rare: Fistulae. RPLS (with or without 4. Giantonio B et al. J Clin Oncol. 2007;25(12):1539–1544.
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