Description and Brand Names

Drug information provided by: IBM Micromedex

US Brand Name

  1. Copiktra

Descriptions


Duvelisib is used to treat chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), or follicular lymphoma (FL) that has come back or after 2 or more types of treatment did not work well.

This medicine is available only with your doctor's prescription.

This product is available in the following dosage forms:

  • Capsule

Before Using

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of duvelisib in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of duvelisib in the elderly.

Breastfeeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Drug Interactions

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

  • Lomitapide

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Acalabrutinib
  • Alfentanil
  • Aprepitant
  • Avanafil
  • Boceprevir
  • Bosutinib
  • Budesonide
  • Buspirone
  • Carbamazepine
  • Clarithromycin
  • Cobicistat
  • Cobimetinib
  • Conivaptan
  • Darifenacin
  • Darunavir
  • Eletriptan
  • Enzalutamide
  • Eplerenone
  • Everolimus
  • Felodipine
  • Fluticasone
  • Fosaprepitant
  • Fosphenytoin
  • Ibrutinib
  • Idelalisib
  • Indinavir
  • Itraconazole
  • Ivacaftor
  • Ketoconazole
  • Lopinavir
  • Lovastatin
  • Lumacaftor
  • Lurasidone
  • Maraviroc
  • Midazolam
  • Mitotane
  • Naloxegol
  • Nefazodone
  • Nelfinavir
  • Phenytoin
  • Posaconazole
  • Quetiapine
  • Rifampin
  • Ritonavir
  • Saquinavir
  • Sildenafil
  • Simvastatin
  • Sirolimus
  • St John's Wort
  • Telaprevir
  • Telithromycin
  • Temsirolimus
  • Ticagrelor
  • Tipranavir
  • Tolvaptan
  • Triazolam
  • Vardenafil
  • Venetoclax
  • Voriconazole

Other Interactions

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

  • Bowel problems or
  • Liver disease or
  • Lung disease or breathing problems (eg, pneumonitis)—Use with caution. May make these conditions worse.
  • Infection—May decrease your body's ability to fight an infection.

Proper Use

Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

This medicine comes with a Medication Guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.

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

You may take this medicine with or without food.

Your doctor may give you other medicines (eg, antivirals) to prevent infections and other unwanted effects.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

  • For oral dosage form (capsules):
    • For chronic lymphocytic leukemia, small lymphocytic lymphoma, or follicular lymphoma:
      • Adults—25 milligrams (mg) two times a day for 28 days. Your doctor may adjust your dose as needed.
      • Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

If you miss a dose and it is less than 6 hours from your usual dose, take the missed dose and go back to your regular schedule. If you miss a dose and it is more than 6 hours from your usual dose, skip the missed dose and go back to your regular dosing schedule.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly and to check for unwanted effects.

Using this medicine while you are pregnant can harm your unborn baby. It may also cause birth defects if the father is using it when his sexual partner becomes pregnant. Female patients should use effective birth control during treatment with this medicine and for at least 1 month after the last dose. Male patients who have female partners should use effective birth control during treatment with this medicine and for at least 1 month after the last dose. If you think you have become pregnant while using this medicine, tell your doctor right away.

Call your doctor right away if you start to have a cough that won't go away, weight loss, night sweats, fever, chills, flu-like symptoms (such as a runny or stuffy nose, headache, blurred vision, or feeling generally ill), painful or difficult urination, sores, ulcers, or white spots in the mouth or on the lips. These may be signs that you have an infection.

This medicine may cause diarrhea, and in some cases it can be severe. Do not take any medicine to treat diarrhea without first checking with your doctor. Diarrhea medicines may make the diarrhea worse or make it last longer. If you have any questions about this or if mild diarrhea continues, or gets worse, check with your doctor.

Serious skin reactions can occur with this medicine. Check with your doctor right away if you have blistering, peeling, or loosening of the skin, red skin lesions, severe acne or skin rash, sores or ulcers on the skin, or fever or chills with this medicine.

Tell your doctor right away if you have a cough, trouble breathing, chest tightness, or any type of breathing problem with this medicine. These could be symptoms of a serious lung problem.

Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, vomiting, or yellow eyes or skin. These could be symptoms of a serious liver problem.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

  1. Black, tarry stools
  2. bleeding gums
  3. blistering, peeling, or loosening of the skin
  4. blood in the urine or stools
  5. body aches or pain
  6. chest pain
  7. chills
  8. cough
  9. cracked lips
  10. decreased urine
  11. difficulty in swallowing
  12. dry mouth
  13. ear congestion
  14. fever
  15. headache
  16. increased thirst
  17. irregular heartbeat
  18. itching
  19. joint or muscle pain
  20. loss of appetite
  21. loss of voice
  22. lower back or side pain
  23. mood changes
  24. muscle pain or cramps
  25. nasal congestion
  26. nausea
  27. numbness or tingling in the hands, feet, or lips
  28. painful or difficult urination
  29. pale skin
  30. pinpoint red spots on the skin
  31. red skin lesions, often with a purple center
  32. red, irritated eyes
  33. runny nose
  34. seizures
  35. sneezing
  36. sore throat
  37. sores, ulcers, or white spots on the lips, tongue, or inside the mouth
  38. stomach cramps or pain
  39. swelling
  40. tenderness
  41. tightness in the chest
  42. troubled breathing
  43. troubled breathing with exertion
  44. unusual bleeding or bruising
  45. unusual tiredness or weakness
  46. watery or bloody diarrhea

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

  1. Bone pain
  2. constipation
  3. decreased appetite
  4. difficulty in moving
  5. muscle stiffness
  6. vomiting

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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