Copiktra Side Effects
Generic name: duvelisib
Medically reviewed by Drugs.com. Last updated on Aug 25, 2024.
Note: This document provides detailed information about Copiktra Side Effects associated with duvelisib. Some dosage forms listed on this page may not apply specifically to the brand name Copiktra.
Applies to duvelisib: oral capsule.
Important warnings
This medicine can cause some serious health issues
Oral route (capsule)
Warning: Fatal and Serious Toxicities: Infections, Diarrhea, or Colitis, Cutaneous Reactions, and Pneumonitis. Fatal 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.
Precautions
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.
Serious side effects of Copiktra
Along with its needed effects, duvelisib (the active ingredient contained in Copiktra) 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 while taking duvelisib:
More common side effects
- 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
Other side effects of Copiktra
Some side effects of duvelisib 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 side effects
- bone pain
- constipation
- decreased appetite
- difficulty in moving
- muscle stiffness
- vomiting
For healthcare professionals
Applies to duvelisib: oral capsule.
General adverse events
The most common adverse reactions (reported in 20% or more of patients) were diarrhea or colitis, neutropenia, rash, fatigue, pyrexia, cough, nausea, upper respiratory infection, pneumonia, musculoskeletal pain, and anemia.[Ref]
Immunologic
- Very common (10% or more): Infection/sepsis (31%)[Ref]
Musculoskeletal
- Very common (10% or more): Musculoskeletal pain (20%), arthralgia (10%)[Ref]
Metabolic
- Very common (10% or more): Lipase increased (36%), hypophosphatemia (31%), ALP increased (29%), serum amylase increased (28), hyponatremia (27%), hyperkalemia (J26%), hypoalbuminemia (25%), creatinine increased (24%), hypocalcemia (23%), decreased appetite (14%), edema (14%), hypokalemia (10%)[Ref]
Hepatic
aminotransferase increased, aspartate aminotransferase increased, transaminases increased, hypertransaminasemia, hepatocellular injury, hepatotoxicity) (15%)[Ref]
Respiratory
- Very common (10% or more): Cough (25%), dyspnea (12%)
- Common (1% to 10%): Pneumocystis jirovecii pneumonia (PJP), cytomegalovirus (CMV) reactivation/infection[Ref]
Other
- Very common (10% or more): Fatigue (29%), pyrexia (26%)[Ref]
Hematologic
- Very common (10% or more): Neutropenia (63%), thrombocytopenia (39%), anemia (45%), lymphocytosis (30%), leukopenia (29%), lymphopenia (21%)[Ref]
Nervous system
- Very common (10% or more): Headache (12%)[Ref]
Renal
- Very common (10% or more): Upper respiratory tract infection (21%), pneumonia (21%), lower respiratory tract infection (10%)[Ref]
Dermatologic
- Very common (10% or more): Rash (e.g., dermatitis [including allergic, exfoliative, perivascular], erythema [including multiforme], rash [including exfoliative, erythematous, follicular, generalized, macular/papular, pruritic, pustular], toxic epidermal necrolysis, toxic skin eruption, drug reaction with eosinophilia and systemic symptoms, drug eruption, Stevens-Johnson syndrome)
- Common (1% to 10%): Cutaneous reactions
- Frequency not reported: Drug reaction with eosinophilia and systemic symptoms (DRESS), toxic epidermal necrolysis (TEN)[Ref]
Gastrointestinal
- Very common (10% or more): Diarrhea/colitis (includes colitis, enterocolitis, colitis microscopic, colitis ulcerative, diarrhea, diarrhea hemorrhagic) (50%), nausea (24%), abdominal pain (18%), vomiting (16%), mucositis (14%), constipation (13%)[Ref]
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References
1. (2018) "Product Information. Copiktra (duvelisib)." Verastem, Inc.
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Copiktra side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.