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• • Efficacy in MCRC
  • Dose and Duration in MCRC
  • MCRC Resources
  • Safety Information
  • Prescribing Information

Avastin dosing and administration in first- and second-line MCRC

Avastin is approved in combination with IV 5-FU–containing chemotherapy.

Evidence-based dosing

In clinical trials in first- and second-line MCRC, Avastin has demonstrated significant clinical benefits at the following doses¹:

Established doses in pivotal Phase III MCRC trials¹

• *5 mg/kg IV q2w dose evaluated in first-line MCRC in combination with IFL.
• ^†10 mg/kg IV q2w dose evaluated in second-line MCRC in combination with FOLFOX4.

Important treatment considerations—Women of childbearing potential

Avastin may impair fertility. Prior to initiation of therapy, advise patients of the potential risk of Avastin to the developing fetus. Counsel patients who become pregnant about the possible risks, including hazard to the fetus and/or loss of pregnancy, of both continued treatment and prolonged exposure following discontinuation, keeping in mind the approximate half-life of Avastin (20 days; range 11–50 days). Patients should also be counseled to continue adequate contraception for at least 6 months following the last dose of Avastin. Nursing mothers should be advised to discontinue nursing or Avastin, taking into account the half-life of the product and the importance of Avastin to the mother.

Duration of Avastin treatment^1-3‡

MCRC

• ^‡In first- and second-line MCRC, Avastin is indicated in combination with IV 5-FU–containing chemotherapy.

 

Important treatment considerations—Dose modifications

There are no recommended dose reductions. Discontinue Avastin in patients with gastrointestinal (GI) perforations (GI perforations, fistula formation in the GI tract, intra-abdominal abscess), fistula formation involving an internal organ, wound dehiscence and wound healing complications requiring medical intervention, serious hemorrhage (ie, requiring medical intervention), severe arterial thromboembolic event (ATE), hypertensive crisis or hypertensive encephalopathy, reversible posterior leukoencephalopathy syndrome (RPLS) (symptoms usually resolve or improve within days, although some patients have experienced ongoing neurologic sequelae), and nephrotic syndrome. Temporarily suspend Avastin for at least 4 weeks prior to elective surgery, severe hypertension not controlled with medical management, moderate to severe proteinuria pending further evaluation, and severe infusion reactions. The safety of resumption of Avastin therapy in patients that experienced RPLS, ATE, and moderate to severe proteinuria is unknown.

Preparation for administration¹

• Avastin should be diluted for infusion using aseptic technique

• Withdraw the necessary amount of Avastin to obtain the required dose and dilute in a total volume of 100 mL of 0.9% Sodium Chloride Injection, USP

• Discard any unused portion left in a vial, as the product contains no preservatives. Inspect visually for particulate matter and discoloration prior to administration

• Diluted Avastin solutions for infusion may be stored at 2²C–8°C (36°F–46°F) for up to 8 hours

• Avastin infusions should not be administered or mixed with dextrose solutions

• DO NOT ADMINISTER AS AN IV PUSH OR BOLUS

• DO NOT INITIATE AVASTIN UNTIL AT LEAST 28 DAYS FOLLOWING SURGERY AND UNTIL THE SURGICAL WOUND IS FULLY HEALED

Infusion times¹

• In clinical trials, infusion reactions with the first dose of Avastin were uncommon (<3%), and severe reactions occurred in 0.2% of patients

• Infusion reactions in clinical trials and in postmarketing experience include hypertension, hypertensive crises associated with neurologic signs and symptoms, wheezing, oxygen desaturation, NCI-CTC grade 3 hypersensitivity, chest pain, headaches, rigors, and diaphoresis

• Stop infusion if a severe adverse reaction occurs and administer appropriate medical therapy

Stability and storage¹

Avastin vials must be refrigerated at 2°C–8°C (36°F–46°F). Avastin vials should be protected from light. Store in the original carton until time of use. DO NOT FREEZE. DO NOT SHAKE.

Next: MCRC Resouces