IMBRUVICA® as a single agent or in combination with bendamustine and rituximab (BR) is indicated for the treatment of adult patients with Chronic Lymphocytic Leukemia who have received at least one prior therapy

INN:

Subtype:

Chronic Lymphocytic Leukemia/Small Lymphocytic Leukemia (CLL/SLL)

License:

EMA

Class:

BTK inhibitor

R/R

SmPChttp://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/003791/WC500177775.pdf 

1. Approved Labelling 

IMBRUVICA® as a single agent or in combination with bendamustine and rituximab (BR) is indicated for the treatment of adult patients with Chronic Lymphocytic Leukemia (CLL) who have received at least one prior therapy.

2. Treatment Regimen 

Treatment with Imbruvica should be initiated and supervised by a physician experienced in the use of anticancer medicinal products.

The recommended dose for the treatment of CLL, either as a single agent or in combination, is 420 mg (three capsules) once daily. Treatment should continue until disease progression or no longer tolerated by the patient.

Moderate and strong CYP3A4 inhibitors increase the exposure of ibrutinib. The IMBRUVICA dose should be lowered to 140 mg once daily (one capsule) when used concomitantly with moderate CYP3A4 inhibitors.

IMBRUVICA® dose should be reduced to 140 mg once daily (one capsule) or withheld for up to 7 days when it is used concomitantly with strong CYP3A4 inhibitors. IMBRUVICA® therapy should be withheld for any new onset or worsening grade ≥ 3 non-haematological toxicity, grade 3 or greater neutropenia with infection or fever, or grade 4 haematological toxicities. Once the symptoms of the toxicity have resolved to grade 1 or baseline (recovery), IMBRUVICA® therapy may be reinitiated at the starting dose. If the toxicity reoccurs, the once daily dose should be reduced by one capsule (140 mg). A second reduction of dose by 140 mg may be considered as needed. If these toxicities persist or recur following two dose reductions, discontinue the medicinal product. Recommended dose modifications are described below:

Toxicity Occurrence CLL dose modification after recovery 
First  restart at 420 mg daily
Second  restart at 280 mg daily
Third restart at 140 mg daily
Fourth  discontinue IMBRUVICA

If a dose is not taken at the scheduled time, it can be taken as soon as possible on the same day with a return to the normal schedule the following day. The patient should not take extra capsules to make up the missed dose.

IMBRUVICA® should be administered orally once daily with a glass of water approximately at the same time each day. The capsules should be swallowed whole with water and should not be opened, broken, or chewed. IMBRUVICA® must not be taken with grapefruit juice or Seville oranges.

3. AE/Warnings

Please see section 4.4 of the SmPC.

 

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