Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. Adverse events should also be reported to Roche Products Ltd. Please contact Roche Drug Safety Centre by emailing firstname.lastname@example.org or calling +44 (0)1707 367554.
How to use TECENTRIQ + Avastin for the first-line systemic treatment of adult patients with advanced or unresectable HCC1,2
- Oesophageal varices should be screened for and subsequently treated as per clinical practice
- Pre-existing hypertension should be adequately controlled
- Carefully consider the risk of aneurysms and/or artery dissections in patients with risk factors such as hypertension or history of aneurysm
- AST, ALT, bilirubin, thyroid function, proteinuria by dipstick urinalysis, blood glucose and renal function should be monitored
- Consider appropriate management of patients with abnormal thyroid function tests at baseline
- The use of systemic corticosteroids or immunosuppressants before starting treatment should be avoided because of their potential interference with the pharmacodynamic activity and efficacy of TECENTRIQ
- Avastin should not be initiated for at least 28 days following major surgery or until the surgical wound is fully healed
- Fertility preservation strategies should be discussed with women of child-bearing potential because Avastin may impair female fertility
- Consider a dental examination and appropriate preventive dentistry because invasive dental procedures are a risk factor for osteonecrosis of the jaw in patients on Avastin
- Refer to the TECENTRIQ and Avastin SmPCs for details of contraindications, warnings and precautions
Other dosing schedules are available, for more information please see the smpc
- Treatment should continue until loss of clinical benefit or unmanageable toxicity
- Dose reduction for adverse reactions is not recommended. If indicated, therapy should either be permanently discontinued or temporarily suspended
Most immune-related AEs occurring during TECENTRIQ treatment are reversible with appropriate management
- Most immune-related AEs were reversible with interruptions of TECENTRIQ and initiation of corticosteroids and/or supportive care
- For suspected immune-related AEs, thorough evaluation to confirm aetiology or exclude other causes should be performed
- Based on the severity of the AE, TECENTRIQ should be withheld and corticosteroids administered
- Once improved to grade ≤1, corticosteroids should be tapered over ≥1 month*
- TECENTRIQ must be permanently discontinued for any grade 3 immune-related AE that recurs and for any grade 4 immune-related AE, except for endocrinopathies that are controlled with replacement hormones
*Based on limited data from clinical studies in patients whose immune-related adverse reactions could not be controlled with systemic corticosteroid use, other systemic immunosuppressants may be considered.
Management guidance for Avastin-related AEs
- You must discuss the risks of TECENTRIQ therapy with your patients
- Patients must be provided with the Tecentriq patient alert card, which forms part of the Risk Management Plan
- Please contact Medical Information for risk management support regarding Avastin
AE, adverse event; AST, aspartate aminotransferase; ALT, alanine aminotransferase; CNS, central nervous system; GI, gastrointestinal; HCC, hepatocellular carcinoma; IV, intravenous; PRES, posterior reversible encephalopathy syndrome; SmPC, summary of product characteristics; ULN, upper limit of normal.
- Tecentriq Summary of Product Characteristics - Great Britain, Tecentriq Summary of Product Characteristics - Northern Ireland
- Avastin Summary of Product Characteristics - Great Britain, Avastin Summary of Product Characteristics - Northern Ireland
- Finn RS et al. N Engl J Med 2020;382:1894–1905.
Date of preparation: December 2021.