Source: European Medicines Agency (EU) Revision Year: 2020 Publisher: Gilead Sciences Ireland UC, Carrigtohill, County Cork, T45 DP77, Ireland
Zydelig is indicated in combination with rituximab for the treatment of adult patients with chronic lymphocytic leukaemia (CLL):
Zydelig is indicated as monotherapy for the treatment of adult patients with follicular lymphoma (FL) that is refractory to two prior lines of treatment (see section 4.4).
Treatment with Zydelig should be conducted by a physician experienced in the use of anti-cancer therapies.
The recommended dose is 150 mg idelalisib twice daily. 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.
Treatment with Zydelig must be withheld in the event of a Grade 3 or 4 aminotransferase elevation (alanine aminotransferase [ALT]/aspartate aminotransferase [AST] >5 x upper limit of normal [ULN]). Once values have returned to Grade 1 or below (ALT/AST ≤ 3 x ULN), treatment can be resumed at 100 mg twice daily.
If the event does not recur, the dose can be re-escalated to 150 mg twice daily at the discretion of the treating physician.
If the event recurs, treatment with Zydelig must be withheld until the values return to Grade 1 or less, after which re-initiation at 100 mg twice daily may be considered at the discretion of the physician (see sections 4.4 and 4.8).
Treatment with Zydelig must be withheld in the event of Grade 3 or 4 diarrhoea/colitis. Once diarrhoea/colitis has returned to Grade 1 or below, treatment can be resumed at 100 mg twice daily. If diarrhoea/colitis does not recur, the dose can be re-escalated to 150 mg twice daily at the discretion of the treating physician (see section 4.8).
Treatment with Zydelig must be withheld in the event of suspected pneumonitis. Once pneumonitis has resolved and if re-treatment is appropriate, resumption of treatment at 100 mg twice daily can be considered. Treatment with Zydelig must be permanently discontinued in the event of moderate or severe symptomatic pneumonitis or organising pneumonia (see sections 4.4 and 4.8).
Treatment with Zydelig must be withheld in the event of Grade 3 or 4 rash. Once rash has returned to Grade 1 or below, treatment can be resumed at 100 mg twice daily. If rash does not recur, the dose can be re-escalated to 150 mg twice daily at the discretion of the treating physician (see section 4.8).
Treatment with Zydelig should be withheld in patients while absolute neutrophil count (ANC) is below 500 per mm³. ANC should be monitored at least weekly until ANC is ≥500 per mm³ when treatment can be resumed at 100 mg twice daily (see section 4.4).
| ANC 1,000 to <1,500/mm³ | ANC 500 to <1,000/mm³ | ANC <500/mm³ |
|---|---|---|
| Maintain Zydelig dosing. | Maintain Zydelig dosing. Monitor ANC at least weekly. | |
| Interrupt Zydelig dosing. Monitor ANC at least weekly until ANC ≥500/mm³, then may resume Zydelig dosing at 100 mg twice daily. |
No specific dose adjustment is required for elderly patients (aged ≥65 years) (see section 5.2).
No dose adjustment is required for patients with mild, moderate, or severe renal impairment (see section 5.2).
No dose adjustment is required when initiating treatment with Zydelig in patients with mild or moderate hepatic impairment, but an intensified monitoring of adverse reactions is recommended (see sections 4.4 and 5.2).
There is insufficient data to make dose recommendations for patients with severe hepatic impairment. Therefore, caution is recommended when administering Zydelig in this population and an intensified monitoring of adverse reactions is recommended (see sections 4.4 and 5.2).
The safety and efficacy of Zydelig in children under the age of 18 years have not been established. No data are available.
Zydelig is for oral use. 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 (see section 5.2).
If overdose occurs the patient must be monitored for evidence of toxicity (see section 4.8). Treatment of overdose with Zydelig consists of general supportive measures including monitoring of vital signs as well as observation of the clinical status of the patient.
Shelf life: 5 years.
This medicinal product does not require any special storage conditions.
High density polyethylene (HDPE) bottle, capped with a polypropylene child-resistant closure, containing 60 film-coated tablets and a polyester coil.
Each carton contains 1 bottle.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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