Duvelisib

What is Duvelisib?

• Duvelisib (Copiktra) is a kinase inhibitor used to treat chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), and follicular lymphoma.

What are the uses of this medicine?

This medicine is 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.

How does this medicine work?

• Duvelisib is an inhibitor of PI3K with inhibitory activity predominantly against PI3K-δ and PI3K-γ isoforms expressed in normal and malignant B-cells.
• Duvelisib induced growth inhibition and reduced viability in cell lines derived from malignant B-cells and in primary CLL tumor cells.
• Duvelisib inhibits several key cell-signaling pathways, including B-cell receptor signaling and CXCR12-mediated chemotaxis of malignant B-cells. Additionally, duvelisib inhibits CXCL12-induced T cell migration and M-CSF and IL-4 driven M2 polarization of macrophages.

Who Should Not Use this medicine ?

• This medicine have no usage limitations.

What drug interactions can this medicine cause?

• Avoid co-administration of Copiktra with strong CYP3A4 inducers.
• Monitor for Copiktra toxicities when co-administered with strong or moderate CYP3A inhibitors. Reduce Copiktra dose to 15 mg twice daily when co-administered with strong CYP3A4 inhibitors.
• Monitor for signs of toxicities when co-administering Copiktra with sensitive CYP3A substrates.

Is this medicine FDA approved?

• It was approved for use in the United States in 2018.

How should this medicine be used?

Recommended Dosage

• 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.
• Provide prophylaxis for Pneumocystis jirovecii (PJP) during treatment with Copiktra.
• Consider prophylactic antivirals during Copiktra treatment to prevent cytomegalovirus (CMV) infection including CMV reactivation.

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)

Administration

• Take Copiktra exactly the way your healthcare provider tells you.
• Your healthcare provider may change your dose of Copiktra or tell you to stop taking Copiktra. Do not change your dose or stop taking Copiktra without talking to your healthcare provider first.
• Swallow Copiktra capsules whole.
• Do not open, break, or chew Copiktra capsules.
• You may take Copiktra with or without food.
• Do not miss a dose of Copiktra. If you miss a dose of Copiktra by less than 6 hours, take the missed dose right away, and then take the next dose at your usual time. If you miss a dose by more than 6 hours, wait and take the next dose at your usual time.
• If you take too much Copiktra, call your healthcare provider right away or go to the nearest hospital emergency room.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form: As Capsules: 25 mg, 15 mg.

This medicine is available in fallowing brand namesː

• Copiktra

What side effects can this medication cause?

The most common side effects of this medicine include:

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

Copiktra can cause serious side effects, including:

• Infections
• Diarrhea or inflammation of your intestine
• Skin reactions
• Inflammation of the lungs

What special precautions should I follow?

• Advise patients that Copiktra can cause serious infections that may be fatal. Advise patients to immediately report symptoms of infection (e.g. fever, chills) .
• Advise patients that Copiktra can cause serious diarrhea or colitis (inflammation of the gut) that may be fatal, and to notify their healthcare provider immediately about any new or worsening diarrhea, stool with mucus or blood, or abdominal pain.
• Advise patients that Copiktra can cause a serious skin rash that may be fatal, and to notify their healthcare provider immediately if they develop a new or worsening skin rash.
• Advise patients that Copiktra may cause pneumonitis (inflammation of the lungs) that may be fatal, and to report any new or worsening respiratory symptoms including cough or difficulty breathing.
• This medicine may cause hepatotoxicity. Monitor hepatic function.
• This medicine may cause neutropenia. Monitor blood counts.
• Copiktra can cause fetal harm. Advise patients of potential risk to a fetus and to use effective contraception.

What to do in case of emergency/overdose?

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.

Can this medicine be used in pregnancy?

• 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 available data in pregnant women to inform the drug-associated risk.

Can this medicine be used in children?

• Safety and effectiveness of Copiktra have not been established in pediatric patients.
• Pediatric studies have not been conducted.

What are the active and inactive ingredients in this medicine?

• Active ingredient: duvelisib
• Inactive ingredients: Colloidal silicon dioxide, crospovidone, magnesium stearate, and microcrystalline cellulose.
• Capsule shells contain gelatin, titanium dioxide, black ink, and red iron oxide.

Who manufactures and distributes this medicine?

• Manufactured for: Verastem Inc, Needham, MA 02494

What should I know about storage and disposal of this medication?

• Store Copiktra at room temperature between 68°F to 77°F (20°C to 25°C).
• Keep Copiktra in its original container until you are ready to take your dose.
• Keep Copiktra and all medicines out of the reach of children.

• Dailymed label info on Duvelisib
• FDA Duvelisib