Copiktra

Copiktra is a prescription medication used to treat relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma and relapsed or refractory follicular lymphoma.

Copiktra belongs to a group of drugs called kinase inhibitors. A kinase is an enzyme that promotes cell growth. There are many types of kinases, which control different phases of cell growth. By blocking a particular enzyme from working, this medication can slow the growth of cancer cells.  

This medication comes in capsule form and is taken twice daily, swallowed whole, with or without food.

Common side effects include tiredness, fever, cough, and nausea.

Copiktra is a prescription medicine used to treat adults with:

• Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL) who have received at least 2 prior therapies and they did not work or are no longer working.
• Follicular Lymphoma (FL) who have received at least 2 prior therapies and they did not work or are no longer working. It is not known if Copiktra is safe and effective in children less than 18 years of age.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with Copiktra. See the “Copiktra Precautions” section.

Common side effects of Copiktra include the following:

• Tiredness
• Fever
• Cough
• Nausea
• Upper respiratory infection
• Bone and muscle pain
• Low red blood cell count

This is not a complete list of Copiktra side effects. Ask your doctor or pharmacist for more information. Tell your doctor if you have any side effect that bothers you or that does not go away. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• Medications that inhibit the enzyme CYP3A4 such as amiodarone, clarithromycin, cyclosporine, darunavir, diltiazem, erythromycin, ritonavir, verapamil and others.

• Medications that induce the enzyme CYP3A4 such as carbamazepine, phenobarbitol, phenytoin, rifabutin, rifampin, verapamil, and St. John's wort and others.

This is not a complete list of Copiktra drug interactions. For more information, ask your doctor or pharmacist.

Serious side effects have been reported with Copiktra including the following:

• Infections. Infections are common during Copiktra treatment, and can be serious and can lead to death. Tell your healthcare provider right away if you have a fever, chills, or other signs of an infection during treatment with Copiktra.
• Diarrhea or inflammation of your intestine. Diarrhea or inflammation of your intestine (colitis) is common during Copiktra treatment, and can be serious and can lead to death. Your healthcare provider may prescribe an anti-diarrhea medicine for your diarrhea. Tell your healthcare provider right away if you have any new or worsening diarrhea, stool with mucus or blood, or if you have severe stomach-area (abdominal) pain. Your healthcare provider should prescribe medicine to help your diarrhea and check you at least weekly. If your diarrhea is severe or anti-diarrhea medicines did not work, you may need treatment with a steroid medicine.
• Skin reactions. Rashes are common with Copiktra treatment. Copiktra can cause rashes and other skin reactions that can be serious and can lead to death. Tell your healthcare provider right away if you get a new or worsening skin rash, or other skin reactions during treatment with Copiktra, including: 
  • painful sores or ulcers on your skin, lips, or in your mouth
  • severe rash with blisters or peeling skin
  • rash with itching
  • rash with fever

Your healthcare provider may need to prescribe medicines, including a steroid medicine, to help treat your skin rash or other skin reactions.

• Inflammation of the lungs. Copiktra can cause inflammation of your lungs which can be serious and can lead to death. Tell your healthcare provider right away if you get new or worsening cough or difficulty breathing. Your healthcare provider may do tests to check your lungs if you have breathing problems during treatment with Copiktra. Your healthcare provider may treat you with a steroid medicine if you develop inflammation of the lungs that is not due to an infection.

If you have any of the above serious side effects during treatment with Copiktra, your healthcare provider may stop your treatment for a period of time, change your dose of Copiktra, or completely stop your treatment with Copiktra.

Grapefruit and grapefruit juice may interact with Copiktra and lead to potentially dangerous effects. Discuss the use of grapefruit products with your doctor.

Before taking Copiktra, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• have intestinal problems
• have lung or breathing problems
• have an infection
• are pregnant or plan to become pregnant. Copiktra can harm your unborn baby. 
• are breastfeeding or plan to breastfeed

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Copiktra and certain other medicines may affect each other.

Tell your doctor if you are pregnant or plan to become pregnant.

In animal studies, pregnant animals were given this medication and had some babies born with problems. No well-controlled studies have been done in humans. 

• Your healthcare provider should do a pregnancy test to see if you are pregnant before you start treatment with Copiktra.
• Females who are able to become pregnant should use effective birth control (contraception) during treatment with Copiktra and for at least 1 month after the last dose of Copiktra. Talk to your healthcare provider about birth control methods that may be right for you. Tell your healthcare provider right away if you become pregnant or think you are pregnant during treatment with Copiktra.
• Males with female partners who are able to become pregnant should use effective birth control (contraception) during treatment with Copiktra and for at least 1 month after the last dose of Copiktra.

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known if Copiktra passes into breast milk. Do not breastfeed during treatment and for at least 1 month after the last dose of Copiktra.

• Take Copiktra exactly the way your healthcare provider tells you.
• Your healthcare provider may change your dose of Copiktra or tell you to stop taking Copiktra. Do not change your dose or stop taking Copiktra without talking to your healthcare provider first.
• Swallow Copiktra capsules whole.
• Do not open, break, or chew Copiktra capsules.
• You may take Copiktra with or without food.
• Do not miss a dose of Copiktra. If you miss a dose of Copiktra by less than 6 hours, take the missed dose right away, and then take the next dose at your usual time. If you miss a dose by more than 6 hours, wait and take the next dose at your usual time.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The recommended dose of Copiktra is 25 mg twice daily for the treatment of relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma and relapsed or refractory follicular lymphoma.

If you take too much Copiktra, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

• Store Copiktra at room temperature between 68°F to 77°F (20°C to 25°C).
• Keep Copiktra in its original container until you are ready to take your dose.

Keep Copiktra and all medicines out of the reach of children.

This page was written by Meghan Ha, PharmD Candidate 2020 | UT Austin College of Pharmacy

WARNING: FATAL AND SERIOUS TOXICITIES: INFECTIONS, DIARRHEA OR COLITIS, CUTANEOUS REACTIONS, and PNEUMONITIS.

• Fatal and/or serious infections occurred in 31% of Copiktra-treated patients. Monitor for signs and symptoms of infection. Withhold Copiktra if infection is suspected.

• Fatal and/or serious diarrhea or colitis occurred in 18% of Copiktra-treated patients. Monitor for the development of severe diarrhea or colitis. Withhold Copiktra.

• Fatal and/or serious cutaneous reactions occurred in 5% of Copiktra-treated patients. Withhold Copiktra.

• Fatal and/or serious pneumonitis occurred in 5% of Copiktra-treated patients. Monitor for pulmonary symptoms and interstitial infiltrates. Withhold Copiktra.