DOSAGE AND ADMINISTRATION
Do not initiate AVASTIN until at least 28 days following major surgery. The surgical incision should be fully healed prior to initiation of AVASTIN.
Metastatic Carcinoma of the Colon or Rectum
AVASTIN, used in combination with intravenous 5‑FU‑based chemotherapy, is administered as an intravenous infusion (5 mg/kg or 10 mg/kg) every 14 days.
The recommended dose of AVASTIN, when used in combination with bolus‑IFL, is 5 mg/kg.
The recommended dose of AVASTIN, when used in combination with FOLFOX4, is 10 mg/kg.
Non‑Squamous, Non‑Small Cell Lung Cancer
The recommended dose of AVASTIN is 15 mg/kg, as an IV infusion every 3 weeks.
There are no recommended dose reductions for the use of AVASTIN. If needed, AVASTIN should be either discontinued or temporarily suspended as described below.
AVASTIN should be permanently discontinued in patients who develop gastrointestinal perforation, (gastrointestinal perforation, fistula formation in the gastrointestinal tract, intra‑abdominal abscess), fistula formation involving an internal organ, wound dehiscence requiring medical intervention, serious bleeding, a severe arterial thromboembolic event, nephrotic syndrome, hypertensive crisis or hypertensive encephalopathy. In patients developing RPLS, discontinue AVASTIN and initiate treatment of hypertension, if present. (See WARNINGS: Reversible Posterior Leukoencephalopathy Syndrome.)
Temporary suspension of AVASTIN is recommended in patients with evidence of moderate to severe proteinuria pending further evaluation and in patients with severe hypertension that is not controlled with medical management. The risk of continuation or temporary suspension of AVASTIN in patients with moderate to severe proteinuria is unknown.
AVASTIN should be suspended at least several weeks prior to elective surgery. (See WARNINGS: Gastrointestinal Perforation and Wound Healing Complications and PRECAUTIONS: Surgery). AVASTIN should not be resumed until the surgical incision is fully healed.
Preparation for Administration
AVASTIN should be diluted for infusion by a healthcare professional 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. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration.
Diluted AVASTIN solutions for infusion may be stored at 2°C–8°C (36°F–46°F) for up to 8 hours. No incompatibilities between AVASTIN and polyvinylchloride or polyolefin bags have been observed.
AVASTIN infusions should not be administered or mixed with dextrose solutions.
DO NOT ADMINISTER AS AN IV PUSH OR BOLUS. The initial AVASTIN dose should be delivered over 90 minutes as an IV infusion following chemotherapy. 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.
Stability and Storage
AVASTIN vials must be refrigerated at 2–8°C (36–46°F). AVASTIN vials should be protected from light. Store in the original carton until time of use. DO NOT FREEZE. DO NOT SHAKE.