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Avastin (Bevacizumab) - Indications and Dosage

 
 



INDICATIONS AND USAGE

AVASTIN®, in combination with intravenous 5‑fluorouracil‑based chemotherapy, is indicated for first- or second‑line treatment of patients with metastatic carcinoma of the colon or rectum.

AVASTIN®, in combination with carboplatin and paclitaxel, is indicated for first‑line treatment of patients with unresectable, locally advanced, recurrent or metastatic non-squamous, non-small cell lung cancer.

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.

Dose Modifications

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.

Administration

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.

HOW SUPPLIED

AVASTIN is supplied as 4 mL and 16 mL of a sterile solution in single‑use glass vials to deliver 100 and 400 mg of Bevacizumab per vial, respectively.

Single unit 100 mg carton: Contains one 4 mL vial of AVASTIN
(25 mg/mL). NDC 50242‑060‑01

Single unit 400 mg carton: Contains one 16 mL vial of AVASTIN
(25 mg/mL). NDC 50242‑061‑01

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