Guidelines for Use
Our guideline named ZANUBRUTINIB (Brukinsa) requires the following rule(s) be met for approval:
- You have ONE of the following diagnoses:
- Mantle cell lymphoma (type of white blood cell cancer)
- Waldenström's macroglobulinemia
- Relapsed or refractory marginal zone lymphoma (MZL: a type of blood cancer)
- You are 18 years of age or older
- If you have a diagnosis of mantle cell lymphoma, approval also requires:
- You have previously received at least ONE prior therapy for mantle cell lymphoma
- If you have a diagnosis of relapsed or refractory marginal zone lymphoma (MZL), approval also requires:
- You have received at least ONE anti-CD20-based regimen (a type of blood cancer treatment plan)
Rationale
To promote appropriate utilization of Brukinsa based on FDA approved indication and dosage.
Indications for Use
Brukinsa is a kinase inhibitor indicated for the treatment of adult patients with:
- Mantle cell lymphoma (MCL) who have received at least one prior therapy
- Waldenström's macroglobulinemia
- Relapsed or refractory marginal zone lymphoma (MZL) who have received at least one anti-CD20-based regimen
Dosage and Administration
The recommended dose of Brukinsa is 160 mg taken orally twice daily or 320 mg taken orally once daily until disease progression or unacceptable toxicity.
References
Brukinsa [Prescribing Information]. San Mateo, CA: BeiGene USA, Inc.; September 2021.