2 Information about venetoclax with rituximab

Marketing authorisation indication

2.1 Venetoclax (Venclyxto, AbbVie) plus rituximab is indicated 'for the treatment of adult patients with chronic lymphocytic leukaemia who have received at least 1 prior therapy.'

Dosage in the marketing authorisation

2.2 Venetoclax should be administered:

  • in the titration phase, 20 mg orally once daily for 7 days, increasing by gradual weekly increments over 5 weeks to 400 mg once daily

  • in the post-titration phase, 400 mg orally once daily.

    Rituximab should be administered after the patient has completed the dose‑titration schedule and has had the recommended daily dose of 400 mg venetoclax for 7 days. Rituximab 375 mg/m2 is given intravenously on day 1 of cycle 1 (a cycle is 28 days), followed by 500 mg/m2 on day 1 of cycles 2 to 6. Rituximab is stopped after cycle 6.

    Venetoclax can be taken for a maximum of 2 years from day 1 of cycle 1 of rituximab, or until disease progression or unacceptable toxicity (see the summary of product characteristics).


2.3 A 112-pack of 100-mg tablets costs £4,789.47 (excluding VAT; British national formulary online, accessed September 2018). The company has a commercial arrangement. This makes venetoclax with rituximab available to the NHS with a discount. The size of the discount is commercial in confidence. It is the company's responsibility to let relevant NHS organisations know details of the discount.

  • National Institute for Health and Care Excellence (NICE)