Metastatic carcinoma of the colon or rectum (mCRC)

The recommended dose of Avastin, 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.

Metastatic breast cancer (mBC)

The recommended dose of Avastin 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.

Non-small cell lung cancer (NSCLC)

Avastin is administered in addition to platinum-based chemotherapy for up to 6 cycles of treatment followed by Avastin as a single agent until disease progression.

The recommended dose of Avastin 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. For details refer to section 5.1 Pharmacodynamic Properties, Non-small cell lung cancer (NSCLC).

Advanced and/or metastatic Renal Cell Cancer (mRCC)

The recommended dose of Avastin is 10 mg/kg of body weight given once every 2 weeks as an intravenous infusion.

Special populations

Elderly: No dose adjustment is required in the elderly.

Renal impairment: The safety and efficacy have not been studied in patients with renal impairment.

Hepatic impairment: The safety and efficacy have not been studied in patients with hepatic impairment.

Paediatric population

The safety and efficacy of bevacizumab in children and adolescents have not been established. There is no relevant use of bevacizumab in the paediatric population in the granted indications. Currently available data are described in section 5.2 and section 5.3 but no recommendation on a posology can be made.

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.

Do not administer 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 section 6.6. Avastin 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 section 6.6.

4.3 Contraindications

 • Hypersensitivity to the active substance or to any of the excipients.

• Hypersensitivity to Chinese hamster ovary (CHO) cell products or other recombinant human or humanised antibodies.

• Pregnancy (see section 4.6).
4.4 Special warnings and precautions for use

 Gastrointestinal perforations (see section 4.8)

Patients may be at an increased risk for the development of gastrointestinal perforation when treated with Avastin. Intra-abdominal inflammatory process may be a risk factor for gastrointestinal perforations in patients with metastatic carcinoma of the colon or rectum, therefore, caution should be exercised when treating these patients. Therapy should be permanently discontinued in patients who develop gastrointestinal perforatio