Zydelig is indicated in combination with an anti-CD20 monoclonal antibody (rituximab or ofatumumab) for the treatment of adult patients with Chronic Lymphocytic Leukemia (CLL) who have received at least one prior therapy

INN:

Subtype:

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

License:

EMA

Class:

PI3K inhibitors

R/R

SmPC: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/003843/WC500175377.pdf 

1. Approved Labelling

Zydelig is indicated in combination with an anti-CD20 monoclonal antibody (rituximab or ofatumumab) for the treatment of adult patients with Chronic Lymphocytic Leukemia (CLL) who have received at least one prior therapy. 

2. Treatment Regimen

Treatment with Zydelig should be conducted by a physician experienced in the use of anticancer therapies.

The recommended dose of Zydelig is 150 mg, taken orally, twice daily. Patients should be instructed to swallow the tablet whole. The film-coated tablet should not be chewed or crushed. The film-coated tablet can be taken with or without food.

Treatment should be continued until disease progression or unacceptable toxicity.

If the patient misses a dose of Zydelig within 6 hours of the time it is usually taken, the patient should take the missed dose as soon as possible and resume the normal dosing schedule. If a patient misses a dose by more than 6 hours, the patient should not take the missed dose and simply resume the usual dosing schedule.

3. AE/Warnings

Please see section 4.4 of the SmPC

 

 

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