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Avastin® (bevacizumab) in Colorectal Cancer (mCRC)

Start and continue with Avastin in MCRC for proven OS

In the first-line Study 2107: Median OS of 20.3 vs 15.6 months with Avastin plus IFL vs IFL alone (HR=0.66 [95% CI, 0.54–0.81], P<0.001).[1,3]
In the first- through second-line TML study*: Median OS of 11.2 vs 9.8 months with Avastin plus fluoropyrimidine-based chemotherapy vs fluoropyrimidine-based chemotherapy alone (HR=0.81 [95% CI, 0.69–0.94], P=0.0057).[1]

MCRC=metastatic colorectal cancer; OS=overall survival; IFL=5-fluorouracil/leucovorin/irinotecan; HR=hazard ratio; CI=confidence interval.
*TML=Treatment through Multiple Lines (first and second line).
Chemotherapy combinations included either an irinotecan- or oxaliplatin-containing regimen.[1]

Avastin® (bevacizumab) dosing

Dosing in Approved Cancer Types

See all of the Avastin dosing and duration information in approved cancer types, based on the pivotal trial protocols.

Coverage insights

The Majority of Eligible Patients Maintain Coverage for Avastin 3,51-53‡§

Request comprehensive coverage insights for your practice or region today

Out-of-Pocket support

Out-of-Pocket Support

up to $25,000 per calendar year

Learn more about the Genentech Oncology Co-pay Assistance Program and other financial support options.

Insurer/payer policies are subject to change. The completion and submission of coverage or reimbursement-related documentation are the responsibility of the patient and the healthcare provider. Genentech makes no guarantee concerning coverage or reimbursement for any service or item.
§As of 3/31/2023, national coverage for Avastin is >60%. Coverage percentage is calculated with a weighted average based on national patients treated for Avastin.
Eligibility criteria and annual limits apply. Not valid for patients using federal or state government programs to pay for their medications. Patients must be taking AVASTIN for an FDA-approved indication. See full TERMS AND CONDITIONS.

Important Safety Information & Indication

Indication

Metastatic colorectal 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 bevacizumab product-containing regimen.

Limitation of Use: Avastin is not indicated for adjuvant treatment of colon cancer.

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 0.4% 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
  • An evaluation for the presence of varices is recommended within 6 months of initiation of Avastin in patients with HCC

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
    • Hemorrhage
    • Lacrimation disorder
    • Back pain
    • Exfoliative dermatitis

  • Across all studies, Avastin was discontinued in 8% to 22% of patients because of adverse reactions

Indication-specific adverse reactions

  • In first-line MCRC, the most common Grade 3–4 reactions in Study 2107, which occurred at a ≥2% higher incidence in the Avastin plus IFL vs IFL groups, were asthenia (10% vs 7%), abdominal pain (8% vs 5%), pain (8% vs 5%), hypertension (12% vs 2%), deep vein thrombosis (9% vs 5%), intra-abdominal thrombosis (3% vs 1%), syncope (3% vs 1%), diarrhea (34% vs 25%), constipation (4% vs 2%), leukopenia (37% vs 31%), and neutropenia (21% vs 14%)
  • In second-line MCRC, the most common Grade 3–5 (nonhematologic) and 4–5 (hematologic) reactions in Study E3200, which occurred at a higher incidence (≥2%) in the Avastin plus FOLFOX4 vs FOLFOX4 groups, were fatigue (19% vs 13%), diarrhea (18% vs 13%), sensory neuropathy (17% vs 9%), nausea (12% vs 5%), vomiting (11% vs 4%), dehydration (10% vs 5%), hypertension (9% vs 2%), abdominal pain (8% vs 5%), hemorrhage (5% vs 1%), other neurological (5% vs 3%), ileus (4% vs 1%), and headache (3% vs 0%). These data are likely to underestimate the true adverse event rates due to the reporting mechanisms used in this study
  • When continued beyond first progression in MCRC, no new safety signals were observed in the TML study (ML18147) when Avastin was administered in second-line MCRC patients who progressed on an Avastin containing regimen in first-line MCRC. The safety data was consistent with the known safety profile established in first- and second-line MCRC

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 for additional important safety information.

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