Copiktra (duvelisib)

Generic drug: duvelisib

Brand name: Copiktra

Copiktra (duvelisib) is a prescription medicine used to treat adults with:

• Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL) who have received at least 2 prior therapies and they did not work or are no longer working.
• Follicular Lymphoma (FL) who have received at least 2 prior therapies and they did not work or are no longer working.

It is not known if Copiktra is safe and effective in children less than 18 years of age.

Copiktra may cause serious side effects, including:

• Elevated liver enzymes. Copiktra may cause abnormalities in liver blood tests. Your healthcare provider should do blood tests during your treatment with Copiktra to check for liver problems. Tell your healthcare provider right away if you get any symptoms of liver problems, including yellowing of your skin or the white part of your eyes (jaundice), pain in the abdominal region, bruising or bleeding more easily than normal.
• Low white blood cell count (neutropenia). Neutropenia is common with Copiktra treatment and can sometimes be serious. Your healthcare provider should check your blood counts regularly during treatment with Copiktra. Tell your healthcare provider right away if you have a fever or any signs of infection during treatment with Copiktra.

Common side effects of Copiktra include:

• tiredness
• fever
• cough
• nausea
• upper respiratory infection
• bone and muscle pain
• low red blood cell count

These are not all the possible side effects of Copiktra.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Dosing

• The recommended dose of Copiktra is 25 mg administered as oral capsules twice daily (BID) with or without food. A cycle consists of 28 days. The capsules should be swallowed whole. Advise patients not to open, break, or chew the capsules.
• Advise patients that if a dose is missed by fewer than 6 hours, to take the missed dose right away and take the next dose as usual. If a dose is missed by more than 6 hours, advise patients to wait and take the next dose at the usual time.

Recommended Prophylaxis

• Provide prophylaxis for Pneumocystis jirovecii (PJP) during treatment with Copiktra. Following completion of Copiktra treatment, continue PJP prophylaxis until the absolute CD4+ T cell count is greater than 200 cells/μL.
• Withhold Copiktra in patients with suspected PJP of any grade, and discontinue if PJP is confirmed.
• Consider prophylactic antivirals during Copiktra treatment to prevent cytomegalovirus (CMV) infection including CMV reactivation.

Dose Modifications For Adverse Reactions

Manage toxicities per Table 1 with dose reduction, treatment hold, or discontinuation of Copiktra.

Table 1: Copiktra Dose Modifications and Toxicity Management

Recommended dose modification levels for Copiktra are presented in Table 2.

Table 2: Dose Modification Levels

Dose Modification For Concomitant Use With CYP3A4 Inhibitors

• Reduce Copiktra dose to 15 mg twice daily when co-administered with strong CYP3A4 inhibitors (e.g. ketoconazole).

Effects Of Other Drugs On Copiktra

CYP3A Inducers

• Co-administration with a strong CYP3A inducer decreases duvelisib area under the curve (AUC), which may reduce Copiktra efficacy.
• Avoid co-administration of Copiktra with strong CYP3A4 inducers.

CYP3A Inhibitors

• Co-administration with a strong CYP3A inhibitor increases duvelisib AUC, which may increase the risk of Copiktra toxicities.
• Reduce Copiktra dose to 15 mg BID when co-administered with a strong CYP3A4 inhibitor.

Effects Of Copiktra On Other Drugs

CYP3A Substrates

• Co-administration with Copiktra increases AUC of a sensitive CYP3A4 substrate which may increase the risk of toxicities of these drugs.
• Consider reducing the dose of the sensitive CYP3A4 substrate and monitor for signs of toxicities of the co-administered sensitive CYP3A substrate.

• Based on findings from animal studies and the mechanism of action, Copiktra can cause fetal harm when administered to a pregnant woman.
• There are no data on the presence of duvelisib and/or its metabolites in human milk, the effects on the breastfed child, or on milk production.
• Because of the potential for serious adverse reactions from duvelisib in a breastfed child, lactating women should not breastfeed while taking Copiktra and for at least 1 month after the last dose.