Copiktra
Copiktra (duvelisib) is a targeted therapy used to treat certain types of blood cancer such as chronic lymphocytic leukemia (CLL) and small lymphocytic leukemia (SLL) that have previously been treated with other therapies. It’s convenient because it’s a tablet that you take by mouth. Copiktra (duvelisib) can cause side effects such as diarrhea, low white blood cells, and rash.
What is Copiktra (duvelisib)?
What is Copiktra (duvelisib) used for?
Relapsed or refractory chronic lymphocytic leukemia (CLL) in adults, after at least two previous treatments
Relapsed or refractory small lymphocytic leukemia (SLL) in adults, after at least two previous treatments
How Copiktra (duvelisib) works
There’s a protein called phosphoinositide 3-kinase (PI3K) inside our cells that helps pass on signals that tell cells to grow. In certain cancers, such as CLL and SLL, this protein is overactive and sends too many signals. This means the cancer cells can grow and spread faster.
Copiktra (duvelisib) is a PI3 kinase inhibitor. It targets and blocks PI3K so that it can’t send signals anymore. So, when Copiktra (duvelisib) blocks PI3K, leukemia cells can’t grow or spread as well.
Drug Facts
What are the side effects of Copiktra (duvelisib)?
Common Side Effects
- Low white blood cells (up to 63%)
- Diarrhea, including colitis (up to 57%)
- Low red blood cells (up to 45%)
- High liver enzymes (up to 40%)
- Low platelet levels (39%)
- Rash (31%)
- Electrolyte changes in blood (up to 31%)
- Tiredness (up to 29%)
- Fever (up to 29%)
- Respiratory infections (up to 28%)
- Cough (25%)
Other Side Effects
- Constipation
- Nausea or vomiting
- Headache
- Muscle pain
- Joint pain
- Trouble catching your breath
- Mouth sores
Serious Side Effects
- Serious lung problems: cough, trouble breathing, fever, chest pain
- Infection: fever, body aches, severe tiredness, trouble breathing, cough
- Serious skin reactions: painful blisters, skin wounds, peeling skin, fever, sore throat, body aches
- Severe diarrhea: more than 6 stools over what’s normal for you, fever, severe stomach pain, blood in stool
Source: DailyMed
The following side effects have also been reported
Side effects that you should report to your care team as soon as possible:
- Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
- Dry cough, shortness of breath or trouble breathing
- Infection—fever, chills, cough, sore throat, wounds that don't heal, pain or trouble when passing urine, general feeling of discomfort or being unwell
- Liver injury—right upper belly pain, loss of appetite, nausea, light-colored stool, dark yellow or brown urine, yellowing skin or eyes, unusual weakness or fatigue
- Low red blood cell level—unusual weakness or fatigue, dizziness, headache, trouble breathing
- Rash, fever, and swollen lymph nodes
- Redness, blistering, peeling, or loosening of the skin, including inside the mouth
- Severe or prolonged diarrhea
- Sudden or severe stomach pain, bloody diarrhea, fever, nausea, vomiting
- Unusual bruising or bleeding
Side effects that usually do not require medical attention (report these to your care team if they continue or are bothersome):
- Bone, joint, or muscle pain
- Fatigue
- Headache
- Nausea
- Pain, redness, or swelling with sores inside the mouth or throat
Pharmacist tips for Copiktra (duvelisib)
You can take Copiktra (duvelisib) with or without food. If you miss a dose but it’s within 6 hours of when you should have taken it, go ahead and take it. But if it’s more than 6 hours after you should have taken it, skip it and start with the next planned dose.
We don’t know if Copiktra (duvelisib) passes into human milk. But, because of the risks to a breastfeeding infant, you should avoid breastfeeding while taking Copiktra (duvelisib) and for 1 month after the last dose.
Ask your oncologist about the best way to handle and throw away Copiktra (duvelisib) safely. Anticancer medications can be harmful to people who handle or come in contact with them. You should store the medication up and away, so children and pets won’t be able to reach it.
It’s important not to forget to take your Copiktra (duvelisib). Since you take it twice a day every day, you might consider an app on your phone to help you keep track and remember to take each dose.
Check your temperature regularly, such as once a day, and call your provider immediately if your temperature is 100.4ºF or higher, because this means you have a fever. Taking Copiktra (duvelisib) raises your risk for getting sick. Sometimes, a fever might be the only sign that you’re sick.
If you’re a male, Copiktra (duvelisib) might affect your fertility, or ability to have children, in the future. Talk with your healthcare professional about fertility preservation options such as sperm banking.
Frequently asked questions about Copiktra (duvelisib)
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What are the risks and warnings for Copiktra (duvelisib)?
Copiktra (duvelisib) can cause some serious health issues. This risk may be even higher for certain groups. If this worries you, talk to your doctor or pharmacist about other options.
Higher risk of death
A study suggests that Copiktra (duvelisib) might raise the risk of death in people treated for relapsed or refractory CLL or SLL. The most common cause of death in this study was related to infections. Because of this risk, Copiktra (duvelisib) isn’t a first-choice option for CLL or SLL. Instead, it’s only prescribed for people who’ve already tried at least 2 other prior anticancer treatments.
Infection
People taking Copiktra (duvelisib) can develop serious and life-threatening infections, including pneumonia, sepsis, and lower respiratory infections. Many people develop an infection within the first 6 months after starting treatment. Before you start Copiktra (duvelisib), your oncology team will check to see if you have any active infections, and provide treatment as needed. They might also prescribe you antiviral and antibiotics to take during treatment to prevent infections. If you develop a serious infection, your care team will ask you to pause taking Copiktra (duvelisib). Once you recover, they might restart treatment at a lower dose. If you have any symptoms of being sick, such as a fever, muscle aches, severe tiredness, or trouble breathing, contact your healthcare team right away.
Diarrhea and colitis
If you have mild-to-moderate diarrhea (less than 6 loose stools per day) or if you have gut inflammation without noticeable symptoms, your oncologist will likely ask you to continue taking Copiktra (duvelisib) and prescribe anti-diarrhea medications to help.They’ll continue to monitor you at least weekly until you recover from the side effects.
But if you have more severe symptoms, such as more than 6 loose stools per day or mucus or blood in your stool, your oncologist might ask you to pause taking Copiktra (duvelisib). They’ll likely prescribe steroids to ease inflammation in the gut. Once you recover, your oncologist might restart treatment at a lower dose. But if you continue to have diarrhea and gut inflammation, they’ll talk with you about other treatment options.
Serious skin problems
Though uncommon, Copiktra (duvelisib) can cause serious or life-threatening skin reactions, such as toxic epidermal necrolysis (TEN) or Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS). Few people reported these reactions as early as a day after starting treatment. But in general, they tend to appear 3 months after the start of treatment and symptoms can last 1-2 months.
Tell your oncologist right away if you have a skin reaction, including rash or redness on the skin, painful blisters, skin wounds, peeling skin, or fever. If your symptoms are mild, your healthcare team will likely ask you to continue Copiktra (duvelisib), but give you antihistamines or steroids to ease your symptoms. But if your symptoms are severe, they’ll ask you to stop taking the medication until you recover or stop treatment permanently.
Serious lung problems
Though not common, people taking Copiktra (duvelisib) experienced a serious lung problem called pneumonitis. Typically, symptoms appear about 4 months after the start of treatment. If you have symptoms such as a cough, trouble breathing, or fever, contact your oncology team right away. They might recommend a scan such as a chest X-ray or CT scan to look at your lungs. Typically they’ll also recommend you pause Copiktra (duvelisib) while they look into it. If you do develop pneumonitis, you might need to take a lower dose of Copiktra (duvelisib) or permanently stop treatment, depending on how serious your condition is.
Serious liver problems
Some people taking Copiktra (duvelisib) have high liver enzymes, which suggests liver irritation, usually within the first few months of treatment. Because people who have liver irritation typically don’t experience symptoms, your healthcare team will order labs regularly to check your liver enzyme level. If the levels are high, they will ask you to pause or permanently stop treatment, depending on how severe your condition is. Contact your care team right away if you have symptoms of liver problems, including yellowing of the skin or whites of the eyes, stomach pain, or a swollen belly.
Low white blood cells
Copiktra (duvelisib) can cause low white blood cell (WBC) counts, which can raise your risk of a serious infection. This is more likely to occur within the first few months of treatment.Your oncologist will monitor your WBC levels with blood tests every 2 weeks the first 2 months after you start Copiktra (duvelisib), and less frequently after that.If your WBC level is too low, they’ll ask you to pause treatment until you recover. After that, your oncologist will likely restart your medication, but at a lower dose.
Harm to unborn baby
Copiktra (duvelisib) hasn’t been studied in human pregnancy. But based on animal studies and the way the medication works, it might cause harm to an unborn baby.
If you’re a female who is able to have babies, your oncologist might require a negative pregnancy test before you start taking Copiktra (duvelisib). You should also use effective birth control while you’re taking Copiktra (duvelisib) Copiktra (duvelisib) hasn’t been studied in human pregnancy, but based on animal studies and the way the medication works, it might cause harm to an unborn baby. If you’re a female who is able to have babies, your oncologist might require a negative pregnancy test before you start taking Copiktra (duvelisib). You should also use effective birth control while you’re taking Copiktra (duvelisib) and for 1 month after the last dose.
If you’re a male who is sexually active, you should use birth control such as condoms while taking Copiktra (duvelisib) and for 1 month after the last dose.
Copiktra (duvelisib) dosage forms
Typical dosing for Copiktra (duvelisib)
The typical dose is 25 mg by mouth twice a day.
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References
Best studies we foundAmerican Cancer Society. (n.d.). Chemotherapy.
American Cancer Society. (2019). Chemotherapy safety.
American Cancer Society. (2021). How targeted therapies are used to treat cancer.
American Cancer Society. (2024). Fevers.
American Cancer Society. (2024). What is chronic lymphocytic leukemia?
Azer, S. A., et al. (2023). Colitis. StatPearls.
Eunice Kennedy Shriver National Institute of Child Health and Human Development. (2017). What is fertility preservation?
Labib, A., et al. (2023). Toxic epidermal necrolysis. StatPearls.
Liu, P., et al. (2009). Targeting the phosphoinositide 3-kinase (PI3K) pathway in cancer. Nature Reviews Drug Discovery.
Lymphoma Research Foundation. (n.d.). Chronic lymphocytic leukemia/small lymphocytic lymphoma.
Melendez Rivera, J. G., et al. (2023). Pneumocystis jirovecii prophylaxis (archived).
National Cancer Institute. (n.d.). Pneumonitis.
National Comprehensive Cancer Network. (2021). Anemia and neutropenia: Low red and white blood cell counts.
Punnapuzha, S., et al. (2023). Febrile neutropenia.
Rodrigues, D. A., et al. (2019). Duvelisib: A 2018 novel FDA-approved small molecule inhibiting phosphoinositide 3-kinases. Pharmaceuticals.
Secura Bio, Inc. (2024). Copiktra- duvelisib capsule [package insert]. DailyMed.
Tigner, A., et al. (2022). Histology, white blood cell. StatPearls.
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