Genentech is excited to share the news of the new FDA approved indication TECENTRIQ®
Genentech is excited to share the news of the new FDA approved indication.
TECENTRIQ® (atezolizumab), in combination with bevacizumab, is indicated for the first-line (1L) treatment of unresectable or metastatic hepatocellular carcinoma (HCC) treatment.
Please see attached for additional information, as well as the TECENTRIQ and the Avastin full Prescribing Information, and Important Safety Information for TECENTRIQ below. Please forward to relevant stakeholders or departments in your organization.
As with all other TECENTRIQ regimens, Genentech Oncology Access Solutions offers a range of access and reimbursement support to help patients begin treatment as soon as possible. We can help your patients by providing:
- Benefits investigations (BIs)
- Prior authorization (PA) resources
- Information about authorized specialty pharmacies (SPs) and specialty distributors
- Sample billing and coding information
- Resources for denials and appeals
- Patient assistance options
For more information about Genentech Oncology Access Solutions, please contact me directly, visit https://www.genentech-access.com/hcp/brands/tecentriq.html, or call (888) 249-4918.
IMPORTANT SAFETY INFORMATION
Serious Adverse Reactions
Please refer to the full Prescribing Information for important dose management information specific to adverse reactions.
Immune-mediated pneumonitis. Immune-mediated pneumonitis or interstitial lung disease, including fatal cases, have occurred. Permanently discontinue TECENTRIQ for Grade 3 or 4 pneumonitis
Immune-mediated hepatitis. Immune-mediated hepatitis and liver test abnormalities, including fatal cases, have occurred. Permanently discontinue TECENTRIQ for AST or ALT elevations more than 8 times the upper limit of normal or total bilirubin more than 3 times the upper limit of normal
Immune-mediated colitis. Immune-mediated diarrhea or colitis have occurred. Permanently discontinue TECENTRIQ for Grade 4 diarrhea or colitis
Immune-mediated endocrinopathies. Thyroid disorders, adrenal insufficiency, type 1 diabetes mellitus, including diabetic ketoacidosis, and hypophysitis/hypopituitarism have occurred
Other immune-mediated adverse reactions. TECENTRIQ can cause severe and fatal immune-mediated adverse reactions. These immune-mediated reactions may involve any organ system. Permanently discontinue TECENTRIQ for Grade 4 immune-mediated adverse reactions involving a major organ
Infections. Severe infections, including fatal cases, have occurred
Infusion-related reactions. Severe or life-threatening infusion-related reactions have occurred. Permanently discontinue TECENTRIQ in patients with Grade 3 or 4 infusion-related reactions
Embryo-fetal toxicity. TECENTRIQ can cause fetal harm in pregnant women. Verify pregnancy status prior to initiating TECENTRIQ. Advise females of reproductive potential of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with TECENTRIQ and for at least 5 months after the last dose. Advise female patients not to breastfeed while taking TECENTRIQ and for at least 5 months after the last dose
Most Common Adverse Reactions
The most common adverse reactions (rate ≥20%) in patients who received TECENTRIQ in combination with bevacizumab for HCC were hypertension (30%), fatigue/asthenia (26%), and proteinuria (20%).
You may report side effects to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. You may also report side effects to Genentech at 1-888-835-2555.
Please see accompanying full Prescribing Information for additional Important Safety Information.
