Duvelisib (Copiktra®)

How to Take Duvelisib (Copiktra®)

This medication comes in capsule form and is to be taken twice a day. Your dose will depend on the seriousness of any side effects you may have from the medication and also depends on the other medications you are taken. The capsule should be swallowed whole and can be taken with or without food. If you are having trouble swallowing the capsule you should notify your provider or pharmacist. If you miss a dose and it is less than 6 hours before your next dose, take your medication right away. If it is less than 6 hours until your next scheduled dose then skip the missed dose and take your next scheduled dose at the regular time.

It is important to make sure you are taking the correct amount of medication every time. Before every dose, check that what you are taking matches what you have been prescribed.

The blood levels of this medication can be affected by certain foods and medications, so they should be avoided. These include: grapefruit, grapefruit juice, verapamil, ketoconazole, rifampin, phenytoin, St. John’s wort, and modafinil, among others. Be sure to tell your healthcare provider about all medications and supplements you take. You may be given medications to prevent fungal and viral infections while you are taking this medication.

Storage and Handling

Store your medication in the original, labeled container at room temperature and in a dry location (unless otherwise directed by your healthcare provider or pharmacist). This medication should not be stored in a pillbox. Keep containers out of reach of children and pets.

If a caregiver prepares your dose for you, they should consider wearing gloves or pour the pills directly from their container into the cap, a small cup, or directly into your hand. They should avoid touching the pills. They should always wash their hands before and after giving you the medication. Pregnant or nursing women should not prepare the dose for you. Ask your oncology team where to return any unused medication for disposal. Do not flush down the toilet or throw in the trash.

Where do I get this medication?

Duvelisib is available through select specialty pharmacies. Your oncology team will work with your prescription drug plan to identify an in-network specialty pharmacy for distribution of this medication and shipment directly to your home.

Insurance Information

This medication may be covered under your prescription drug plan. Patient assistance may be available to qualifying individuals depending upon prescription drug coverage. Co-pay cards, which reduce the patient co-pay responsibility for eligible commercially (non-government sponsored) insured patients, may also be available. Your care team can help you find these resources, if they are available.

Possible Side Effects

There are a number of things you can do to manage the side effects of duvelisib. Talk to your care team about these recommendations. They can help you decide what will work best for you. These are some of the most common or important side effects:

Infection

This medication can cause life-threatening infections, with or without a decrease in white blood cell counts. You should let your doctor or nurse know right away if you have a fever (temperature greater than 100.4°F/38°C), sore throat or cold, shortness of breath, cough, burning with urination, or a sore that doesn't heal. Any sign of infection should promptly be discussed with your provider. Your provider may prescribe medications to prevent infections while you are taking this medication.

Diarrhea and Colitis

Diarrhea can be a serious side effect of this medication. Diarrhea means different things to different people. Any increase in your normal bowel patterns can be defined as diarrhea and should be reported to your healthcare team right away. Other symptoms to look for are abdominal (belly) pain, cramping, mucus or blood in the stool, dark or tar-like stools, and fever. If you have new or worsening diarrhea you should call your provider right away.

Rash and Skin Reactions

You should notify your care provider of any new or worsening rash as this could be a serious skin reaction. If you have painful sore or ulcers on your skin, lips, or in your mouth, have blisters or peeling skin or have a rash with itching or a fever you should contact your care team right away. You may be given a medication to treat the rash or skin reaction.

Pneumonitis

Pneumonitis is inflammation of the lungs which can lead to a new or worsening cough or difficulty breathing. Although an uncommon side effect with this drug, if you have any changes in how you are breathing you should contact your care provider right away.

Low White Blood Cell Count (Leukopenia or Neutropenia)

This medication can cause life threatening infections, with or without a decrease in white blood cell counts.

White blood cells (WBC) are important for fighting infection. While receiving treatment, your WBC count can drop, putting you at a higher risk of getting an infection. You should let your doctor or nurse know right away if you have a fever (temperature greater than 100.4°F/38°C), sore throat or cold, shortness of breath, cough, burning with urination, or a sore that doesn't heal.

Tips to preventing infection:

• Washing hands, both yours and your visitors, is the best way to prevent the spread of infection.
• Avoid large crowds and people who are sick (i.e.: those who have a cold, fever or cough or live with someone with these symptoms).
• When working in your yard, wear protective clothing including long pants and gloves.
• Do not handle pet waste.
• Keep all cuts or scratches clean.
• Shower or bathe daily and perform frequent mouth care.
• Do not cut cuticles or ingrown nails. You may wear nail polish, but not fake nails.
• Ask your oncology care team before scheduling dental appointments or procedures.
• Ask your oncology care team before you, or someone you live with has any vaccinations.

Muscle or Joint Pain/Aches

Your healthcare provider can recommend medications and other strategies to help relieve pain.

Low Red Blood Cell Count (Anemia)

Your red blood cells are responsible for carrying oxygen to the tissues in your body. When the red cell count is low, you may feel tired or weak. You should let your oncology care team know if you experience any shortness of breath, difficulty breathing or pain in your chest. If the count gets too low, you may receive a blood transfusion.

Nausea and/or Vomiting

Talk to your oncology care team so they can prescribe medications to help you manage nausea and vomiting. In addition, dietary changes may help. Avoid things that may worsen the symptoms, such as heavy or greasy/fatty, spicy or acidic foods (lemons, tomatoes, oranges). Try saltines, or ginger ale to lessen symptoms.

Call your oncology care team if you are unable to keep fluids down for more than 12 hours or if you feel lightheaded or dizzy at any time.

Fatigue

Fatigue is very common during cancer treatment and is an overwhelming feeling of exhaustion that is not usually relieved by rest. While on cancer treatment, and for a period after, you may need to adjust your schedule to manage fatigue. Plan times to rest during the day and conserve energy for more important activities. Exercise can help combat fatigue; a simple daily walk with a friend can help. Talk to your healthcare team for helpful tips on dealing with this side effect.

Electrolyte Abnormalities

This medication can affect the normal levels of electrolytes (potassium, phosphorus, sodium, calcium, etc.) in your body. Your levels will be monitored using blood tests. If your levels become too low, your care team may prescribe specific electrolytes to be given by IV or taken by mouth. Do not take any supplements without first consulting with your care team.

Less common, but important side effects can include:

• Liver Toxicity: This medication can cause liver toxicity, which your oncology care team may monitor for using blood tests called liver function tests. Notify your healthcare provider if you notice yellowing of the skin or eyes, your urine appears dark or brown, or you have pain in your abdomen, as these can be signs of liver toxicity.

Reproductive Concerns

Exposure of an unborn child to this medication could cause birth defects, so you should not become pregnant or father a child while on this medication. You will be asked to take a pregnancy test prior to starting treatment. Effective birth control is necessary during treatment and for at least 1 month after treatment. Even if your menstrual cycle stops or you believe you are not producing sperm, you could still be fertile and conceive. You should not breastfeed while taking this medication or for one month after your last dose.