Abevmy Dosage/Direction for Use

General: A healthcare professional should prepare bevacizumab infusion solution using aseptic technique (see Instructions for Use/Handling under Cautions for Usage). Prepare bevacizumab infusion solution using normal saline only. Do not administer or prepare in dextrose solution. Bevacizumab must be administered under the supervision of a physician experienced in the use of antineoplastic medicinal products.
Deliver the initial bevacizumab dose as an intravenous infusion, over 90 minutes. The second infusion can be administered over 60 minutes, if the first is well tolerated; and subsequent infusions can be administered over 30 minutes, if infusion over 60 minutes is tolerated.
Bevacizumab must not be administered as an intravenous push or bolus; but only as an intravenous (IV) infusion. Bevacizumab must not be initiated until at least 28 days after major surgery; and must be administered after the surgical incision has fully healed.
Dose reduction for adverse reactions is not recommended for bevacizumab. Bevacizumab should either be permanently discontinued or temporarily suspended, if indicated, as described as follows.
Bevacizumab should be permanently discontinued for gastrointestinal perforations (see Warnings); wound dehiscence and wound healing complications requiring medical intervention (see Precautions); serious haemorrhage (i.e., requiring medical intervention) (see Warnings); severe arterial thromboembolic events (see Precautions); life-threatening (Grade 4) venous thromboembolic events, including pulmonary embolism (see Precautions); hypertensive crisis or hypertensive encephalopathy (see Precautions); Posterior Reversible Encephalopathy Syndrome (PRES) (see Precautions); nephrotic syndrome (see Precautions).
Bevacizumab should be temporarily suspended for (1) at least 4 weeks before elective surgery (see Precautions); (2) severe hypertension not controlled with medical management (see Precautions); (3) moderate to severe proteinuria (see Precautions); (4) severe infusion reactions (see Precautions). Bevacizumab is not for intravitreal use (see Precautions).
Metastatic Colorectal Cancer (mCRC): Following are the dose recommendations for bevacizumab, administered as an intravenous infusion: The recommended dose of bevacizumab, 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 to continue bevacizumab treatment until progression of the underlying disease or unacceptable toxicity. If a patient has been previously treated with bevacizumab, bevacizumab treatment can be continued after the first progression.
Non-small cell lung cancer (NSCLC): First-line treatment of non-squamous NSCLC in combination with platinum-based chemotherapy: The recommended dose of bevacizumab is 7.5 mg/kg or 15 mg/kg of body weight given once every 3 weeks as an intravenous infusion, in addition to platinum-based chemotherapy for up to 6 cycles of treatment, followed by bevacizumab as a single agent until disease progression of the underlying disease, or until unacceptable toxicity.
Advanced and/or Metastatic Renal Cell Carcinoma (mRCC): A dose of 10 mg/kg of body weight is recommended, given as an intravenous infusion once every 2 weeks, in combination with interferon alpha.
Continue bevacizumab treatment until progression of the underlying disease or unacceptable toxicity.
Malignant Glioma (WHO Grade IV)-Glioblastoma: A dose of 10 mg/kg of body weight given once every 2 weeks is recommended, given as an intravenous infusion; or a dose of 15 mg/kg of body weight given once every 3 weeks as an intravenous infusion.
Continue bevacizumab treatment until progression of the underlying disease or unacceptable toxicity.
Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer: Following are the dose recommendations for bevacizumab, to be given as an intravenous infusion: For front-line treatment, 15 mg/kg of body weight once every 3 weeks is recommended, when given in addition to carboplatin and paclitaxel for up to six cycles of treatment; thereafter continue bevacizumab as a single agent for 15 months or until disease progression, whichever occurs earlier.
Cervical Cancer: Administer bevacizumab in combination with paclitaxel and cisplatin, or paclitaxel and topotecan. 15 mg/kg of body weight of bevacizumab is recommended, given as an intravenous infusion once every 3 weeks.
Continue bevacizumab treatment until progression of the underlying disease or unacceptable toxicity.
Special Dosage Instructions: Bevacizumab is not approved for use in patients under the age of 18 years. No trials have been conducted to investigate the pharmacokinetics of bevacizumab in patients with hepatic impairment, since the liver is not a major organ for bevacizumab metabolism or excretion.
Children and adolescents: The safety and efficacy of bevacizumab has not been studied in children and adolescents.
Elderly: Elderly patients do not require any dose adjustment.
Renal impairment: The safety and efficacy of bevacizumab in patients with renal impairment has not been studied.
Hepatic impairment: The safety and efficacy of bevacizumab have not been studied in patients with hepatic impairment.