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General: Avastin Roche must be administered under the supervision of a physician experienced in the use of antineoplastic medicinal products.
Metastatic Carcinoma of the Colon or Rectum (mCRC): The recommended dose of Avastin Roche, administered as an intravenous infusion, is either 5 mg/kg or 10 mg/kg of body weight given once every 2 weeks or 7.5 mg/kg or 15 mg/kg of body weight given once every 3 weeks.
It is recommended that treatment be continued until progression of the underlying disease or until unacceptable toxicity.
Metastatic Breast Cancer (mBC): The recommended dose of Avastin Roche is 10 mg/kg of body weight given once every 2 weeks or 15 mg/kg of body weight given once every 3 weeks as an intravenous infusion.
It is recommended that treatment be continued until progression of the underlying disease or until unacceptable toxicity.
Non-Small Cell Lung Cancer (NSCLC): First-line treatment of non-squamous NSCLC in combination with platinum-based chemotherapy: Avastin Roche is administered in addition to platinum-based chemotherapy for up to 6 cycles of treatment followed by Avastin Roche as a single agent until disease progression.
The recommended dose of Avastin Roche is 7.5 mg/kg or 15 mg/kg of body weight given once every 3 weeks as an intravenous infusion.
Clinical benefit in NSCLC patients has been demonstrated with both 7.5 mg/kg and 15 mg/kg doses (see Pharmacology: Pharmacodynamics: Clinical Efficacy: Non-Small Cell Lung Cancer under Actions).
It is recommended that treatment be continued until progression of the underlying disease or until unacceptable toxicity.
First-line treatment of non-squamous NSCLC with EGFR activating mutations in combination with erlotinib: EGFR mutation testing should be performed prior to initiation of treatment with the combination of Avastin Roche and erlotinib. It is important that a well-validated and robust methodology is chosen to avoid false negative or false positive determinations.
The recommended dose of Avastin Roche when used in addition to erlotinib is 15 mg/kg of body weight given once every 3 weeks as an intravenous infusion.
It is recommended that the treatment with Avastin Roche in addition to erlotinib is continued until disease progression.
For the posology and method of administration of erlotinib, please refer to the full erlotinib prescribing information.
Advanced and/or metastatic Renal Cell Cancer (mRCC): The recommended dose of Avastin Roche is 10 mg/kg of body weight given once every 2 weeks as an intravenous infusion.
It is recommended that treatment be continued until progression of the underlying disease or until unacceptable toxicity.
Glioblastoma: The recommended dose of Avastin Roche is 10 mg/kg of body weight given once every 2 weeks as an intravenous infusion.
Epithelial Ovarian, Fallopian Tube and Primary Peritoneal Cancer: Front-line treatment: Avastin Roche is administered in addition to carboplatin and paclitaxel for up to 6 cycles of treatment followed by continued use of Avastin Roche as single agent until disease progression or for a maximum of 15 months or until unacceptable toxicity, whichever occurs earlier.
The recommended dose of Avastin Roche is 15 mg/kg of body weight given once every 3 weeks as an intravenous infusion.
Treatment of platinum-sensitive recurrent disease: Avastin Roche is administered in combination with carboplatin and gemcitabine for 6 cycles and up to 10 cycles followed by continued use of Avastin Roche as single agent until disease progression.The recommended dose of Avastin Roche is 15 mg/kg of body weight given once every 3 weeks as an intravenous infusion.
Treatment of platinum-resistant recurrent disease: Avastin Roche is administered in combination with one of the following agents - paclitaxel, topotecan (given weekly) or pegylated liposomal doxorubicin. The recommended dose of Avastin Roche is 10 mg/kg of body weight given once every 2 weeks as an intravenous infusion. When Avastin Roche is administered in combination with topotecan (given on days 1-5, every 3 weeks), the recommended dose of Avastin Roche is 15 mg/kg of body weight given once every 3 weeks as an intravenous infusion. It is recommended that treatment be continued until disease progression or unacceptable toxicity (see Pharmacology: Pharmacodynamics: Clinical Efficacy under Actions, study MO22224).
Cervical Cancer: Avastin Roche is administered in combination with one of the following chemotherapy regimens: paclitaxel and cisplatin or paclitaxel and topotecan.
The recommended dose of Avastin Roche is 15 mg/kg of body weight given once every 3 weeks as an intravenous infusion.
It is recommended that treatment be continued until progression of the underlying disease or until unacceptable toxicity (see Pharmacology: Pharmacodynamics: Clinical Efficacy under Actions).
Special Dosage Instructions: Elderly patients: No dose adjustment is required in the elderly.
Patients with renal impairment: The safety and efficacy have not been studied in patients with renal impairment (see Pharmacology: Pharmacokinetics under Actions).
Patients with hepatic impairment: The safety and efficacy have not been studied in patients with hepatic impairment (see Pharmacology: Pharmacokinetics under Actions).
Paediatric population: The safety and efficacy of bevacizumab in children and adolescents have not been established. Avastin Roche is not approved for use in patients under the age of 18 years. There is no relevant use of bevacizumab in the paediatric population in the granted indications. Currently available data are described in Clinical Trials under Adverse Reactions; Pharmacology: Pharmacodynamics: Clinical Efficacy: Paediatric Population, Pharmacokinetics: Pharmacokinetics on Special Populations, and Toxicology: Preclinical Safety data under Actions but no recommendation on a posology can be made.
Avastin Roche should not be used in children aged 3 years to less than 18 years with recurrent or progressive high-grade glioma because of efficacy concerns (see Pharmacology: Pharmacodynamics: Clinical Efficacy under Actions for results of paediatric trials).
Dose reduction for adverse reactions is not recommended. If indicated, therapy should either be permanently discontinued or temporarily suspended as described in Precautions, General.
Method of Administration: The initial dose should be delivered over 90 minutes as an intravenous infusion. If the first infusion is well tolerated, the second infusion may be administered over 60 minutes. If the 60-minute infusion is well tolerated, all subsequent infusions may be administered over 30 minutes.
It should not be administered as an intravenous push or bolus.
Precautions to be taken before handling or administering the medicinal product: For instructions on dilution of the medicinal product before administration, see Special Instructions for Use, Handling and Disposal under Cautions for Usage. Avastin Roche infusions should not be administered or mixed with glucose solutions. This medicinal product must not be mixed with other medicinal products except those mentioned in Special Instructions for Use, Handling and Disposal under Cautions for Usage.
