Krabeva Dosage/Direction for Use

General: Substitution by any other biological medicinal product requires the consent of the prescribing physician.
The safety and efficacy of alternating or switching between Bevacizumab and products that are biosimilar but not deemed interchangeable have not been established.
Therefore, the benefit-risk of alternating or switching need to be carefully considered.
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 for specific adverse reactions as described in Precautions.
Bevacizumab is not formulated for intravitreal use (see Precautions).
Metastatic Colorectal Cancer (mCRC): The recommended dose of Bevacizumab, administered as an 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 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): Bevacizumab is administered in addition to platinum-based 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.
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.
Glioblastoma: The recommended dose of Bevacizumab, administered as an infusion is 10 mg/kg of body weight given once every 2 weeks.
Epithelial Ovarian, Fallopian Tube and Primary Peritoneal Cancer: The recommended dose of Bevacizumab administered as an intravenous infusion is as follows.
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 six cycles of treatment followed by continued use of Bevacizumab as single agent for 15 months or until disease progression, whichever occurs earlier.
Treatment of recurrent disease: Platinum sensitive: 15 mg/kg of body weight given once every 3 weeks when administered 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.
Alternatively, 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 body weight given once every 2 weeks when administered in combination with one of the following agents - paclitaxel, topotecan (given weekly) or pegylated liposomal doxorubicin (see Pharmacology: Pharmacodynamics: Clinical Studies: MO22224 (AURELIA) under Actions for chemotherapy regimens).
Alternatively, 15 mg/kg every 3 weeks when administered in combination with topotecan given on days 1-5, every 3 weeks (see Pharmacology: Pharmacodynamics: Clinical Studies: MO22224 AURELIA) under Actions for chemotherapy regimens).
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 (see Pharmacology: Pharmacodynamics: Clinical Studies: GOG-0240 under Actions for further details on the chemotherapy regimens).
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 Instructions: Pediatric use: The safety and efficacy of Bevacizumab in children and adolescents (<18 years) have not 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.