Versavo Dosage/Direction for Use

General: Substitution by any other biological medicinal product requires the consent of the prescribing physician.
Bevacizumab should be prepared by a healthcare professional using aseptic technique (see Special Instructions for Use, Handling and Disposal under Cautions for Usage).
The initial Bevacizumab 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.
Dose reduction of Bevacizumab for adverse events is not recommended. If indicated, Bevacizumab should either be permanently discontinued or temporarily suspended as described in Precautions (see Precautions).
Bevacizumab is not formulated for intravitreal use. (See Precautions.)
Metastatic colon and rectal cancer (rectum or anus): The recommended dose of Bevacizumab for intravenous infusion are: First-line treatment: 5 mg/kg of body weight given once every 2 weeks or 7.5 mg/kg of body weight given once every 3 weeks.
Second-line treatment: 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 Bevacizumab treatment be continued until progression of the underlying disease. Patients previously treated with Bevacizumab can continue with Bevacizumab treatment following first progression. (See Pharmacology: Pharmacodynamics: Clinical/Efficacy Studies: Study ML18147 under Actions.)
Locally recurrent or metastatic Breast Cancer (mBC): The recommended dose of Bevacizumab 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 Bevacizumab treatment be continued until progression of the underlying disease.
Advanced, metastatic, or recurrent Non-Small Cell Lung Cancer (NSCLC): First-line treatment of NSCLC in combination with platinum-based chemotherapy: Bevacizumab is administered in addition to platinum-based for chemotherapy for up to 6 cycles of treatment followed by Bevacizumab as a single agent until disease progression.
The recommended dose of bevacizumab when used in addition to cisplatin-based chemotherapy is 7.5 mg/kg of body weight given once every 3 weeks as an intravenous infusion.
The recommended dose of bevacizumab when used in addition to carboplatin-based chemotherapy is 15 mg/kg of body weight given once every 3 weeks as an intravenous infusion.
First-line treatment of NSCLC with EGFR activating mutations in combination with Erlotinib: The recommended dose of bevacizumab 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 Bevacizumab in addition to Erlotinib is continued until disease progression.
Refer to the full prescribing information for Erlotinib for patient selection and posology.
Advanced and/or metastatic Renal Cell Cancer (mRCC): The recommended dose of bevacizumab is 10 mg/kg of body weight given once every 2 weeks as an intravenous infusion.
It is recommended that Bevacizumab treatment be continued until progression of the underlying disease.
Malignant Glioma (WHO Grade IV) - Glioblastoma: The recommended dose of Bevacizumab for intravenous infusion are: Newly diagnosed glioblastoma: Bevacizumab (10 mg/kg of body weight given once every 2 weeks) is administered in combination with Temozolomide and radiotherapy for 6 weeks.
Following a 4-week treatment break, Bevacizumab (10 mg/kg of body weight given once every 2 weeks) is re-initiated in combination with Temozolomide every 4 weeks, for up to 6 cycles of 4-week duration.
After administration of up to 6 cycles of combined bevacizumab and Temozolomide, Bevacizumab (15 mg/kg of body weight given once every 3 weeks) is continued as a single agent until disease progression.
Treatment of recurrent disease: 10 mg/kg of body weight given once every 2 weeks, or 15 mg/kg of body weight given once every 3 weeks. It is recommended that Bevacizumab treatment be continued until progression of the underlying disease.
Epithelial Ovarian, Fallopian Tube and Primary Peritoneal Cancer: The recommended dose of Bevacizumab for intravenous infusion are: Front-line treatment: 15 mg/kg of body weight given once every 3 weeks when administered in addition to carboplatin and paclitaxel for up to 6 cycles of treatment followed by continued use of bevacizumab as single agent for 15 months or until disease progression, whichever occur earlier.
Treatment of recurrent disease: Platinum sensitive: 15 mg/kg of body weight given once every 3 weeks when administrated in combination with carboplatin and paclitaxel for 6 cycles and up to 8 cycles followed by continued use of bevacizumab as a single agent until disease progression.
Alternately, 15 mg/kg every 3 weeks when administrated in combination with carboplatin and gemcitabine for 6 cycles and up to 10 cycles followed by continued use of Bevacizumab as single agent until disease progression.
Platinum resistant: 10 mg/kg of body weight given once every 2 weeks when administrated in combination with one of the following agents - Paclitaxel, Topotecan (given weekly) or pegylated liposomal doxorubicin (for chemotherapy regimens, see Pharmacology: Pharmacodynamics: Clinical/Efficacy Studies: Study MO22224 under Actions).
Alternatively, 15 mg/kg every 3 weeks when administered in combination with Topotecan given on days 1-5, every 3 weeks (for chemotherapy regimen, see Pharmacology: Pharmacodynamics: Clinical/Efficacy Studies: Study MO22224 under Actions).
It is recommended that treatment be continued until disease progression.
Cervical Cancer: Bevacizumab is administered in combination with one of the following chemotherapy regimens: paclitaxel and cisplatin or paclitaxel and topotecan (for further details on the chemotherapy regimens, see Pharmacology: Pharmacodynamics: Clinical/Efficacy Studies: Study GOG-0240 under Actions).
The recommended dose of bevacizumab is 15 mg/kg of body weight given once every 3 weeks as an intravenous infusion.
It is recommended that Bevacizumab treatment be continued until progression of the underlying disease.
SPECIAL DOSAGE INSTRUCTION: Pediatric use: The safety and efficacy of bevacizumab in children and adolescents (<18 years) has not yet been established (see Use in Children under Precautions).
Geriatric use: No dose adjustment is required in patients ≥ 65 years of age.
Renal impairment: The safety and efficacy of bevacizumab have not been studied in patients with renal impairment.
Hepatic impairment: The safety and efficacy of bevacizumab have not been studied in patients with hepatic impairment.