Alert
FDA Alerts Health Care Professionals of Infection Risk from Repackaged Avastin Intravitreal Injections: Learn more
Important information regarding counterfeit drug labeled as Altuzan (bevacizumab): Learn more
Information regarding distribution change for hospitals for Avastin: Learn more
Side Effect Reporting
You may report side effects to the FDA at (800) FDA-1088 or www.fda.gov/medwatch.
You may also report side effects to Genentech at (888) 835-2555.
Support & Resources
Indication
Indications
[OC]
Avastin, in combination with carboplatin and paclitaxel, followed by Avastin as a single agent, is indicated for the treatment of patients with stage III or IV epithelial ovarian, fallopian tube, or primary peritoneal cancer following initial surgical resection.
Avastin, in combination with paclitaxel, pegylated liposomal doxorubicin, or topotecan, is indicated for the treatment of patients with platinum-resistant recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer who received no more than 2 prior chemotherapy regimens.
Avastin, in combination with carboplatin and paclitaxel, or with carboplatin and gemcitabine, followed by Avastin as a single agent, is indicated for the treatment of patients with platinum-sensitive recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer.
[CC]
Avastin, in combination with paclitaxel and cisplatin or paclitaxel and topotecan, is indicated for the treatment of patients with persistent, recurrent, or metastatic cervical cancer.
[mRCC]
Avastin, in combination with interferon alfa, is indicated for the treatment of metastatic renal cell carcinoma.
[rGBM]
Avastin is indicated for the treatment of recurrent glioblastoma in adults.
[NSCLC]
Avastin, in combination with carboplatin and paclitaxel, is indicated for the first‑line treatment of patients with unresectable, locally advanced, recurrent or metastatic non–squamous non–small cell lung cancer.
[MCRC]
Avastin, in combination with intravenous fluorouracil-based chemotherapy, is indicated for the first‑ or second‑line treatment of patients with metastatic colorectal cancer.
Avastin, in combination with fluoropyrimidine-irinotecan- or fluoropyrimidine-oxaliplatin-based chemotherapy, is indicated for the second‑line treatment of patients with metastatic colorectal cancer who have progressed on a first-line Avastin-containing regimen.
Limitation of Use: Avastin is not indicated for adjuvant treatment of colon cancer.
Important Safety Information
Serious adverse reactions (Warnings and Precautions)
- Serious and sometimes fatal adverse reactions with increased incidence in the Avastin-treated arm vs chemotherapy arm included:
- Gastrointestinal (GI) perforation ranged from 0.3% to 3% of patients across clinical studies
- Non-GI fistulae (<1% to 1.8%, highest in patients with cervical cancer)
- Arterial thromboembolic events (Grade ≥3, 5%, highest in patients with GBM)
- The incidence of wound healing and surgical complications, including serious and fatal complications, is increased in Avastin-treated patients
- Hemorrhage (Grade 3–5) ranged from 0.4% to 7% of patients across clinical studies
- Renal injury and proteinuria
- Grade 3–4 proteinuria ranged from 0.7% to 7% in clinical studies
- Nephrotic syndrome (<1%)
- Additional serious adverse reactions with increased incidence in the Avastin-treated arm vs chemotherapy arm included:
- Venous thromboembolism (Grade ≥3, 11% seen in GOG-0240)
- Hypertension (Grade 3–4, 5%–18%)
- Posterior reversible encephalopathy syndrome (PRES) (<0.5%)
- Congestive heart failure (CHF): Grade >3 left ventricular dysfunction (1%)
- Infusion-related reactions with the first dose of Avastin occurred in <3% of patients, and severe reactions occurred in 0.2% of patients
- Avoid use in patients with ovarian cancer who have evidence of recto-sigmoid involvement by pelvic examination or bowel involvement on CT scan or clinical symptoms of bowel obstruction
- Inform females of reproductive potential of the risk of ovarian failure prior to initiating treatment with Avastin
Pregnancy warning
- Based on the mechanism of action and animal studies, Avastin may cause fetal harm
- Advise female patients that Avastin may cause fetal harm, and to inform their healthcare provider of a known or suspected pregnancy
- Advise females of reproductive potential to use effective contraception during treatment with Avastin and for 6 months after the last dose of Avastin
- Advise nursing women not to breastfeed during treatment with Avastin and for 6 months following their last dose of treatment
- Avastin may impair fertility
Most common adverse reactions
- Across studies, the most common adverse reactions observed in Avastin patients at a rate >10% were:
- Epistaxis
- Headache
- Hypertension
- Rhinitis
- Proteinuria
- Taste alteration
- Dry skin
- Rectal hemorrhage
- Lacrimation disorder
- Back pain
- Exfoliative dermatitis
- Across all studies, Avastin was discontinued in 8% to 22% of patients because of adverse reactions
You may report side effects to the FDA at (800) FDA-1088 or www.fda.gov/medwatch.
You may also report side effects to Genentech at (888) 835-2555.
Please see accompanying full Prescribing Information, including Boxed WARNINGS, for additional important safety information.
