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Duvelisib (Oral)

doo-ve-LIS-ib

Oral route(Capsule)

Warning: Fatal and Serious Toxicities: Infections, Diarrhea, or Colitis, Cutaneous Reactions, and PneumonitisFatal and/or serious infections occurred in 31% of duvelisib-treated patients. Monitor for signs and symptoms of infection. Withhold duvelisib if infection is suspected. Fatal and/or serious diarrhea or colitis occurred in 18% of duvelisib-treated patients. Monitor for the development of severe diarrhea or colitis. Withhold duvelisib. Fatal and/or serious cutaneous reactions occurred in 5% of duvelisib-treated patients. Withhold duvelisib. Fatal and/or serious pneumonitis occurred in 5% of duvelisib-treated patients. Monitor for pulmonary symptoms and interstitial infiltrates. Withhold duvelisib .

Medically reviewed by Drugs.com. Last updated on Sep 17, 2019.

Commonly used brand name(s)

In the U.S.

  • Copiktra

Available Dosage Forms:

  • Capsule

Therapeutic Class: Antineoplastic Agent

Uses for duvelisib

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.

Duvelisib is available only with your doctor's prescription.

Before using duvelisib

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 duvelisib, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to duvelisib 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.

Interactions with medicines

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 duvelisib, 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 duvelisib 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 duvelisib 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

Interactions with food/tobacco/alcohol

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 duvelisib. 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 of duvelisib

Take duvelisib 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.

Duvelisib 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 duvelisib with or without food.

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

Dosing

The dose of duvelisib 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 duvelisib. 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 duvelisib, 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 while using duvelisib

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

Using duvelisib 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 duvelisib and for at least 1 month after the last dose. Male patients who have female partners should use effective birth control during treatment with duvelisib and for at least 1 month after the last dose. If you think you have become pregnant while using duvelisib, 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.

Duvelisib 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 duvelisib. 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 duvelisib.

Tell your doctor right away if you have a cough, trouble breathing, chest tightness, or any type of breathing problem with duvelisib. 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.

Duvelisib 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

  • Black, tarry stools
  • bleeding gums
  • blistering, peeling, or loosening of the skin
  • blood in the urine or stools
  • body aches or pain
  • chest pain
  • chills
  • cough
  • cracked lips
  • decreased urine
  • difficulty in swallowing
  • dry mouth
  • ear congestion
  • fever
  • headache
  • increased thirst
  • irregular heartbeat
  • itching
  • joint or muscle pain
  • loss of appetite
  • loss of voice
  • lower back or side pain
  • mood changes
  • muscle pain or cramps
  • nasal congestion
  • nausea
  • numbness or tingling in the hands, feet, or lips
  • painful or difficult urination
  • pale skin
  • pinpoint red spots on the skin
  • red skin lesions, often with a purple center
  • red, irritated eyes
  • runny nose
  • seizures
  • sneezing
  • sore throat
  • sores, ulcers, or white spots on the lips, tongue, or inside the mouth
  • stomach cramps or pain
  • swelling
  • tenderness
  • tightness in the chest
  • troubled breathing
  • troubled breathing with exertion
  • unusual bleeding or bruising
  • unusual tiredness or weakness
  • 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

  • Bone pain
  • constipation
  • decreased appetite
  • difficulty in moving
  • muscle stiffness
  • 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.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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