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Copiktra (Duvelisib)

Copiktra (Duvelisib)

Copiktra is used to treat adults with chronic lymphocytic leukemia or small lymphocytic leukemia. Copiktra is also used to treat follicular lymphoma.

Copiktra is given after at least two other cancer treatments did not work or have stopped working.

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

HOW COPIKTRA IS GIVEN

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

You may take Copiktra with or without food.

Swallow the capsule whole and do not crush, chew, break, or open it.

Copiktra can cause severe diarrhea, which can be life-threatening. You may need to take medication to prevent or quickly treat diarrhea.

You may be given other medications to help prevent serious side effects. Keep using these medicines for as long as your doctor has prescribed.

Your doctor will need to check your progress regularly, and you will need frequent medical tests. Your cancer treatments may be delayed based on the results.

Store capsules in the blister pack at room temperature, away from moisture and heat.

SIDE EFFECTS

Get emergency medical help if you have signs of an allergic reaction (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

Call your doctor at once if you have:

  • severe diarrhea (more than 6 bowel movements in 1 day);
  • severe stomach pain, new or worsening diarrhea with blood or mucus;
  • liver problems- stomach pain (upper right side), dark urine, jaundice(yellowing of the skin or eyes); or
  • low blood cell counts- fever, chills, tiredness, mouth sores, skin sores, easy bruising, unusual bleeding, pale skin, cold hands and feet, feeling light-headed or short of breath.

Your cancer treatments may be delayed or permanently discontinued if you have certain side effects.

Common side effects may include:

  • diarrhea, nausea;
  • low blood cell counts;
  • bone pain, muscle pain;
  • fever, cough, tiredness; or
  • cold symptoms such as stuffy nose, sneezing, sore throat.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

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. 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. 

BEFORE TAKING COPIKTRA

Tell your doctor if you have ever had:

  • an intestinal disorder such as ulcerative colitis;
  • lung disease; or
  • liver disease.

Both men and women using Copiktra should use effective birth control to prevent pregnancy. Copiktra can harm an unborn baby or cause birth defects if the mother or father is using this medicine.

Keep using birth control for at least 1 month after your last dose. Tell your doctor right away if a pregnancy occurs while either the mother or the father is using Copiktra.

It is not safe to breast-feed a baby while you are using this medicine. Also do not breast-feed for at least 1 month after your last dose.

WARNINGS

Copiktra can cause serious or fatal side effects, including serious infections, severe diarrhea, or a life-threatening skin rash.

Call your doctor right away if you have symptoms such as:-

  • fever, chills, cough, breathing problems;
  • severe stomach pain, diarrhea with blood or mucus; 
  • painful mouth sores, or a skin rash with blistering or peeling.

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