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Overview: Copiktra is used to treat certain types of blood cancers. It is a kinase inhibitor that helps stop cancer cells from growing. Common side effects include tiredness, fever, cough, nausea, and muscle or bone pain. Copiktra may also cause serious side effects that may lead to death, including infections, skin reactions, severe diarrhea, or lung inflammation. Tell your health care provider right away if you get a rash, fever, new or worsening diarrhea, or a cough or trouble breathing. Keep all appointments for blood tests while you are taking Copiktra.

Uses

What is Copiktra used for?

Copiktra (duvelisib) is commonly used to treat certain people with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), which are types of blood cancer.

Copiktra may also be used for other conditions as determined by your health care provider.

How does Copiktra work (mechanism of action)?

Copiktra is a type of medicine called a kinase inhibitor. Kinases are proteins in the body that send and receive signals to help cells grow and work properly. Copiktra blocks a kinase called phosphatidylinositol 3-kinase (PI3K). PI3K is overactive in some blood cancers and sends signals to help cancer cells grow and multiply. By blocking PI3K, Copiktra helps stop cancer cells from growing and multiplying and may kill them.

How is Copiktra supplied (dosage forms)?

Brands and other names

  • Copiktra

Dosage forms and strengths

  • 15 mg oral capsules
  • 25 mg oral capsules

How should I store Copiktra?

Copiktra should be stored at room temperature, between 68 F and 77 F (20 C and 25 C). It can be exposed to temperatures between 59 F and 86 F (15 C and 30 C) for shorter periods of time, such as when transporting it. Store in a cool, dry place. Keep the medicine in its blister pack until you are ready to take each dose.

Side Effects

What are the most common side effects of Copiktra?

The most common side effects of Copiktra are listed below. Tell your health care provider if you have any of these side effects that bother you.

  • Diarrhea (see below) or inflammation of the large intestine 
  • Low neutrophil levels (see below)
  • Rash
  • Tiredness
  • Fever
  • Cough
  • Nausea
  • Infections (see below), including infection in the nose or throat, sore throat, common cold symptoms, or pneumonia 
  • Muscle or bone pain
  • Anemia

There may be other side effects of Copiktra that are not listed here. Contact your health care provider if you think you are having a side effect of a medicine. In the U.S., you can report side effects to the FDA at www.fda.gov/medwatch or by calling 800-FDA-1088 (800-332-1088). In Canada, you can report side effects to Health Canada at www.health.gc.ca/medeffect or by calling 866-234-2345.

What are the serious side effects of Copiktra?

While less common, the most serious side effects of Copiktra are described below, along with what to do if they happen.

Severe Allergic Reactions. Copiktra may cause allergic reactions, including a specific type of allergic reaction called DRESS. DRESS stands for drug reaction with eosinophilia and systemic symptoms. It is also sometimes called multi-organ hypersensitivity. This is a reaction that can affect multiple parts of the body, including your liver, kidneys, and heart. Stop taking the medicine and get help right away if you have any of the following symptoms of a serious allergic reaction.

  • Breathing problems or wheezing
  • Racing heart
  • Itching or skin rash
  • Bumps on the skin called hives that can be red, pink, white, or brown depending on your skin tone
  • Fever or general ill feeling
  • Swollen lymph nodes
  • Swelling of the face, lips, mouth, tongue, or throat
  • Shortness of breath, trouble swallowing, or throat tightness
  • Swelling in your feet, ankles, or legs
  • Nausea or vomiting
  • Dizziness, feeling lightheaded, or fainting
  • Stomach cramps
  • Joint pain
  • Dark-colored pee
  • Your skin or the whites of your eyes turning yellowish in color (also called jaundice)

Life-Threatening Side Effects. Copiktra can cause severe side effects that may lead to death. These serious side effects are discussed in more detail below. Talk with your health care provider about the benefits and risks of taking Copiktra and about any questions you may have.

Infections. Copiktra can increase your risk of infections, including serious or life-threatening infections. Call your health care provider right away if you have an infection or any of the following symptoms.

  • Fever, sweats, chills, or muscle aches
  • Burning or stinging when you pee 
  • Coughing, or coughing up blood
  • Shortness of breath
  • Diarrhea or stomach pain
  • Weight loss

Diarrhea. While Diarrhea is a common side effect of Copiktra, it can sometimes be severe or life-threatening. Copiktra may also increase the risk of inflammation of your large intestine (colitis). If you are given medicine to prevent or treat diarrhea, take it exactly as your health care provider tells you. Call your health care provider right away if you have any of the following symptoms.

  • New or worsening diarrhea
  • Diarrhea or stool (poop) with mucus or blood 
  • Severe stomach pain
  • Diarrhea with weakness, dizziness, or fever

Severe Skin Reactions. Copiktra can commonly cause a rash, but it can also cause severe skin reactions, including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), that can lead to death if not treated. If you get a rash, call your health care provider right away. Get emergency help if you have any of the following symptoms of SJS or TEN.

  • Painful skin that looks burned and peels off
  • Flat rash or blisters on your skin, mouth, nose, and genitals
  • Red, painful, watery eyes
  • Flu-like symptoms, including fever, chills, and muscle aches

Lung Inflammation. Copiktra can cause inflammation in your lungs, also called interstitial lung disease or pneumonitis. This can be serious or even life-threatening. Call your health care provider right away if you have a new or worsening cough or trouble breathing.

Liver Problems. Copiktra may cause changes in liver function tests, which can sometimes be a sign of liver damage (hepatotoxicity). Keep all appointments for blood tests. Call your health care provider right away if you have any of the following symptoms of liver damage.

  • Nausea or vomiting
  • Stomach or belly pain
  • Fever
  • Weakness or unusual tiredness
  • Itching
  • Loss of appetite
  • Light-colored poop
  • Dark-colored urine (pee)
  • Your skin or the whites of your eyes turning yellowish in color (also called jaundice)
  • Easy bruising or bleeding

Low Neutrophil Levels (Neutropenia). Copiktra may cause low levels of a type of white blood cell (called neutrophils), which is known as neutropenia. Neutrophils help prevent infection. Having a low level of neutrophils may increase your risk of infection. Keep all appointments for blood tests. Tell your health care provider right away if you have any of the following symptoms of low neutrophil levels.

  • Fever, chills, or sweats
  • Tiredness
  • Sore throat, cough, or shortness of breath
  • Mouth or throat sores
  • Swollen lymph nodes

Warnings & Precautions

Who should not use Copiktra?

Allergies to Ingredients. People who are allergic to any of the following should not take Copiktra.

  • Copiktra
  • Duvelisib
  • Any of the ingredients in the specific product dispensed

Your pharmacist can tell you all of the ingredients in Copiktra.

What should I know about Copiktra before using it?

Do not take Copiktra unless it has been prescribed to you by a health care provider. Take it as prescribed.

Do not share Copiktra with other people, even if they have the same condition as you. It may harm them.

Keep Copiktra out of the reach of children.

Do not open, break, chew, cut, or crush Copiktra. Swallow the capsules whole.

Keep all appointments, including for blood tests, with your health care provider. This will help them make sure it is safe for you to keep taking this medicine.

Your health care provider may tell you to take other medicines while you are taking Copiktra. Take these medicines exactly as your health care provider recommends. Follow any instructions from your health care provider about how to manage side effects from Copiktra.

If you can get your partner pregnant, you should use effective birth control while taking Copiktra and for at least one month after your last dose. See the Pregnancy section for more details.

What should I tell my health care provider before using Copiktra?

Tell your health care provider about all of your health conditions and any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. This will help them know if Copiktra is right for you.

In particular, make sure that you discuss any of the following.

Current and Past Health Conditions. Tell your health care provider if you have any of the following.

  • An infection
  • Stomach or intestinal problems
  • Breathing or lung problems

Other Medicines and Supplements. Copiktra may interact with other medicines and supplements. Before taking Copiktra, tell your health care provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. See the Interactions section for more details.

Pregnancy. Copiktra may cause harm to a fetus. Your health care provider may do a test to make sure you are not pregnant before starting Copiktra. If you can get pregnant, you should use effective birth control while you are taking Copiktra and for at least one month after your last dose. Tell your health care provider right away if you are pregnant, think you might be pregnant, or plan to become pregnant.

Breastfeeding. Do not breastfeed while you are taking Copiktra and for at least one month after your last dose. It is not known if Copiktra passes into breast milk. Tell your health care provider if you are breastfeeding or plan to breastfeed.

How can I get more information about Copiktra?

For more information about Copiktra, you can visit the drugmaker’s website at www.copiktra.com or call them at 844-973-2872.

Interactions

Does Copiktra interact with foods or drinks?

Grapefruit or grapefruit juice may increase the levels of Copiktra in the body, which could increase your risk of side effects. Talk with your health care provider before eating or drinking grapefruit or grapefruit juice while you are taking Copiktra.

It is unknown if drinking alcohol will affect Copiktra, but heavy drinking can slow your immune response and make it harder for your body to fight cancer.

Does Copiktra interact with other medicines (drug interactions)?

Always tell your health care provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using.

In particular, make sure that you discuss if you are using any of the following before taking Copiktra.

  • Itraconazole (Sporanox, Tolsura), ketoconazole, posaconazole (Noxafil), or voriconazole (Vfend), which are medicines used for fungal infections
  • Rifampin (Rifadin) or rifapentine (Priftin), which are medicines commonly used to treat an infection called tuberculosis
  • A medicine for HIV or AIDS
  • St. John’s wort, which is a supplement that may be used for depression
  • Any medicine for seizures, such as carbamazepine, phenobarbital, or phenytoin

Many other medicines may alter the blood levels of Copiktra, and vice versa. Tell your health care provider about all medicines that you take or have recently taken.

This may not be a complete list of medicines that can interact with Copiktra. Always check with your health care provider.

Does interact with other drugs you are taking?

Enter your medication into the WebMD interaction checker

Overdose/Missed Dose

What should I do if I accidentally use too much Copiktra?

If you or someone else has used too much Copiktra, get medical help right away, call 911, or contact a Poison Control center at 800-222-1222.

What should I do if I miss a dose of Copiktra?

If you miss a dose by less than six hours, take it as soon as you remember. Then take your next dose at the regularly scheduled time. If you miss a dose by more than six hours, skip the missed dose and only take the next dose. Do not take double or extra doses.

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