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Avastin in rGBM Avastin efficacy and safety
demonstrated in the
EORTC 26101 study

Scroll for important safety information, including Boxed WARNINGS

Avastin is indicated for the treatment of recurrent glioblastoma in adults.

Gastrointestinal (GI) perforation
- Serious and sometimes fatal GI perforation occurs at a higher incidence in Avastin-treated patients compared to patients treated with chemotherapy
- The incidence of GI perforation ranged from 0.3% to 3% across clinical studies
- Discontinue Avastin in patients with GI perforation
Surgery and wound healing complications
- The incidence of wound healing and surgical complications, including serious and fatal complications, is increased in Avastin-treated patients
- Withhold Avastin for at least 28 days prior to elective surgery. Do not administer Avastin for at least 28 days after surgery and until the wound is fully healed
- Discontinue in patients with wound healing complications requiring medical intervention
Hemorrhage
- Severe or fatal hemorrhage, including hemoptysis, GI bleeding, hematemesis, central nervous system hemorrhage, epistaxis, and vaginal bleeding, occurred up to 5-fold more frequently in patients receiving Avastin. In clinical studies, the incidence of grade ≥3 hemorrhagic events among patients receiving Avastin ranged from 0.4% to 7%
- Do not administer Avastin to patients with serious hemorrhage or a recent history of hemoptysis (≥1/2 tsp of red blood)
- Discontinue Avastin in patients who develop grade 3-4 hemorrhage

Additional serious and sometimes fatal adverse events with increased incidence in the Avastin-treated arm vs chemotherapy arm included:
- Non-GI fistulae (<1% to 1.8%, highest in patients with cervical cancer)
- Arterial thromboembolic events (grade ≥3, 5%, highest in patients with GBM)
- Renal injury and proteinuria
- - Grade 3–4 proteinuria ranged from 0.7% to 7% in clinical studies
  - Nephrotic syndrome (<1%)
Additional serious adverse events 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) (1%)
Infusion reactions with the first dose of Avastin occurred in <3% of patients, and severe reactions occurred in 0.2% of patients
Inform females of reproductive potential of the risk of ovarian failure prior to starting treatment with Avastin

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 that breastfeeding is not recommended during treatment with Avastin and for 6 months following their last dose of treatment
Avastin may impair fertility

Across studies, the most common adverse reactions observed in Avastin patients at a rate >10% were:
- Epistaxis
- Proteinuria
- Lacrimation disorder
- Headache
- Taste alteration
- Back pain
- Hypertension
- Dry skin
- Exfoliative dermatitis
- Rhinitis
- Rectal hemorrhage
Across all studies, Avastin was discontinued in 8% to 22% of patients because of adverse reactions

In rGBM Study EORTC 26101, 22% of patients discontinued treatment in the Avastin with lomustine arm due to adverse reactions compared with 10% of patients in the lomustine arm. In patients receiving Avastin with lomustine, the adverse reaction profile was similar to that observed in other approved indications

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 full Prescribing Information, including Boxed WARNINGS, for additional important safety information.

rGBM=recurrent glioblastoma.

Reference: 1. Avastin Prescribing Information. Genentech, Inc. 2018.