Pronunciation:

doo-ve-LIS-ib

Brand Names:

• Copiktra

Dosage Forms:

• Capsule

Warnings:

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 .

Classifications:

Therapeutic—

Antineoplastic Agent

Uses of This Medicine:

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

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

Before Using This Medicine:

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.

Children—

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.

Older adults—

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

Breast-feeding—

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.

Other 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 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.

• Abametapir
• Acalabrutinib
• Alfentanil
• Apalutamide
• Aprepitant
• Avanafil
• Avapritinib
• Boceprevir
• Bosentan
• Bosutinib
• Budesonide
• Buprenorphine
• Buspirone
• Carbamazepine
• Cenobamate
• Clarithromycin
• Cobicistat
• Cobimetinib
• Colchicine
• Conivaptan
• Darifenacin
• Darunavir
• Dasatinib
• Dronedarone
• Efavirenz
• Eletriptan
• Elexacaftor
• Entrectinib
• Enzalutamide
• Eplerenone
• Etravirine
• Everolimus
• Fedratinib
• Felodipine
• Fexinidazole
• Finerenone
• Fluticasone
• Fosaprepitant
• Fosphenytoin
• Gepirone
• Ibrexafungerp
• Ibrutinib
• Idelalisib
• Indinavir
• Itraconazole
• Ivabradine
• Ivacaftor
• Ketoconazole
• Lopinavir
• Lorlatinib
• Lovastatin
• Lumacaftor
• Lurasidone
• Lurbinectedin
• Maraviroc
• Mavacamten
• Midazolam
• Mitotane
• Modafinil
• Nafcillin
• Naloxegol
• Nefazodone
• Nelfinavir
• Omaveloxolone
• Palovarotene
• Phenobarbital
• Phenytoin
• Posaconazole
• Pralsetinib
• Primidone
• Quetiapine
• Rifabutin
• Rifampin
• Ritonavir
• Saquinavir
• Sildenafil
• Simvastatin
• Sirolimus
• St John's Wort
• Telaprevir
• Telithromycin
• Temsirolimus
• Tezacaftor
• Ticagrelor
• Tipranavir
• Tolvaptan
• Triazolam
• Ubrogepant
• Venetoclax
• Voclosporin
• Voriconazole
• Zolpidem

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 of This Medicine:

Medicines used to treat cancer are very strong and can have many side effects. Before using this medicine, make sure you understand all the risks and benefits. It is important for you to work closely with your doctor during your treatment.

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 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 or small lymphocytic lymphoma:
    • Adults—25 milligrams (mg) 2 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 While Using This Medicine:

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood tests may be needed 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. If you are a woman who can get pregnant, your doctor may do tests to make sure you are not pregnant before starting treatment. 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.

Duvelisib may lower the number of some types of blood cells in your body. Because of this, you may bleed or get infections more easily. To help with these problems, avoid being near people who are sick or have infections. Wash your hands often. Stay away from rough sports or other situations where you could be bruised, cut, or injured. Brush and floss your teeth gently. Be careful when using sharp objects, including razors and fingernail clippers.

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, including drug reaction with eosinophilia and systemic symptoms (DRESS) and toxic epidermal necrolysis can occur with this medicine. Check with your doctor right away if you have black, tarry stools, blistering, peeling, loosening of skin, chest pain, chills, cough, fever, joint or muscle pain, painful or difficult urination, red irritated eyes, red skin lesions, often with a purple center, sore throat, sores, ulcers, or white spots on the lips or in the mouth, swollen glands, trouble breathing, unusual bleeding, bruising, tiredness, or weakness 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 called pneumonitis.

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 of This Medicine:

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 or tightness

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

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 or stuffy nose

seizures

sneezing

sore throat

sores, ulcers, or white spots on the lips, tongue, or inside the mouth

stomach cramps or pain

swelling

swollen glands

tenderness

trouble breathing

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.