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General: MVASI should be prepared by a healthcare professional using aseptic technique (see Special Instructions for Use, Handling and Disposal under Cautions for Usage).
The initial MVASI 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 MVASI for adverse events is not recommended. If indicated, MVASI should either be permanently discontinued or temporarily suspended as described in General under Precautions.
MVASI is not formulated for intravitreal use (see General under Precautions).
Metastatic Colorectal Cancer (mCRC): The recommended dose of MVASI, 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 MVASI 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 MVASI treatment be continued until progression of the underlying disease.
Advanced, metastatic or recurrent Non Small Cell Lung Cancer (NSCLC): MVASI is administered in addition to platinum-based chemotherapy for up to 6 cycles of treatment followed by MVASI as a single agent until disease progression.
The recommended dose of MVASI 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 MVASI 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 MVASI is 10 mg/kg of body weight given once every 2 weeks as an intravenous infusion.
It is recommended that MVASI treatment be continued until progression of the underlying disease.
Glioblastoma: The recommended dose of MVASI, 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 MVASI 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 MVASI 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 MVASI 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 MVASI 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/Efficacy Studies: study MO22224 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/Efficacy Studies: study MO22224 under Actions for chemotherapy regimen).
It is recommended that treatment be continued until disease progression.
Cervical Cancer: MVASI is administered in combination with one of the following chemotherapy regimens: paclitaxel and cisplatin or paclitaxel and topotecan (see Pharmacology: Pharmacodynamics: Clinical/Efficacy Studies: Cervical Cancer: study GOG-0240 under Actions for further details on the chemotherapy regimens).
The recommended dose of MVASI is 15 mg/kg of body weight given once every 3 weeks as an intravenous infusion.
It is recommended that MVASI treatment be continued until progression of the underlying disease.
Special Dosage Instructions: Pediatric use: The safety and efficacy of MVASI in children and adolescents (<18 years) has 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 MVASI have not been studied in patients with renal impairment.
Hepatic impairment: The safety and efficacy of MVASI have not been studied in patients with hepatic impairment.
Route of Administration: MVASI is not formulated for intravitreal use (See General under Precautions).
