COPIKTRA Hard capsule Ref.[28036] Active ingredients:

Treatment with Copiktra should be conducted by a physician experienced in the use of anti-cancer therapies.

Posology

The recommended dose is 25 mg duvelisib twice daily. A cycle consists of 28 days. Treatment should be continued until disease progression or unacceptable toxicity.

Delayed or missed doses

Patients should be advised that if a dose is missed by less than 6 hours, the missed dose should be taken right away and the next dose should be taken as usual. If a dose is missed by more than 6 hours, patients should be advised to wait and to take the next dose at the usual time.

Dose modification for concomitant use with CYP3A4 inhibitors

The dose of Copiktra should be reduced to 15 mg twice daily when co-administered with strong CYP3A4 inhibitors (e.g. ketoconazole) [see section 4.5]. No dose adjustment is necessary when coadministered with moderate CYP3A4 inhibitors (e.g. fluconazole) but potential adverse reactions of duvelisib should be closely monitored.

Dose modifications for adverse reactions

Toxicities should be managed as per Table 1 with dose reduction, treatment hold, or discontinuation of Copiktra.

Table 1. Copiktra dose modifications and toxicity management:

Special populations

Elderly

No specific dose adjustment is required for elderly patients (aged ≥ 65 years) (see section 5.2).

Renal impairment

No dose adjustment is required for patients with mild and moderate renal impairment. No data are available for severe and end-stage renal impairment with or without dialysis, (see sections 5.2).

Hepatic impairment

No dose adjustment of the starting dose is required for patients with hepatic impairment Child Pugh Class A, B, and C (see sections 4.4 and 5.2).

Paediatric population

The safety and efficacy of duvelisib in children aged 0 to 18 years has not been established. No data are available. There is no relevant use of duvelisib in the paediatric population for the indication of CLL and FL.

Method of administration

Copiktra is for oral use and can be taken with or without food. The capsules should be swallowed whole. Patients should be advised not to open, break, or chew the capsules.

If overdose occurs the patient must be monitored for evidence of toxicity (see section 4.8). In case of overdose, general supportive measures and treatment should be provided. The patient should be monitored for signs and symptoms, laboratory parameters, and vital signs.

Copiktra 15 mg hard capsules: 4 years.

Copiktra 25 mg hard capsules: 5 years.

Store below 30°C.

Store in the original package in order to protect from light.

Copiktra 15 mg hard capsules: Child-resistant PVC-PE-PCTFE / Aluminium blisters.

Pack size: 28 days carton containing 56 capsules (2 blisters with 28 capsules each).

Copiktra 25 mg hard capsules: Child-resistant PVC-PE-PCTFE / Aluminium blisters.

Pack size: 28 days carton containing 56 capsules (2 blisters with 28 capsules each).

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.