IMBRUVICA® is a kinase inhibitor indicated for the treatment of patients with Mantle Cell Lymphoma (MCL) who have received at least one prior therapy. This indication is based on overall response rate. An improvement in survival or disease-related symptoms has not been established

INN:

Subtype:

Mantle Cell Lymphoma (MCL)

License:

FDA

Class:

BTK inhibitor

Newly Diagnosed

PI: https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/205552lbl.pdf

1. Approve Labelling

Imbruvica is a kinase inhibitor indicated for the treatment of patients with Mantle Cell Lymphoma (MCL) who have received at least one prior therapy. This indication is based on overall response rate. An improvement in survival or disease-related symptoms has not been established.

2. Treatment Regimen

560 mg taken orally once daily (four 140 mg capsules once daily). Capsules should be taken orally with a glass of water. Do not open, break, or chew the capsules.

3. AE/Warnings

Please see section 5 of the PI.

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