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Copiktra Side Effects

Generic Name: duvelisib

Medically reviewed by Drugs.com. Last updated on July 15, 2020.

Note: This document contains side effect information about duvelisib. Some of the dosage forms listed on this page may not apply to the brand name Copiktra.

For the Consumer

Applies to duvelisib: oral capsule

Warning

Oral route (Capsule)

Warning: Fatal and Serious Toxicities: Infections, Diarrhea, or Colitis, Cutaneous Reactions, and PneumonitisFatal 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.

Side effects requiring immediate medical attention

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

  • Black, tarry stools
  • bleeding gums
  • blistering, peeling, or loosening of the skin
  • blood in the urine or stools
  • body aches or pain
  • chest pain
  • 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
  • nasal congestion
  • 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 nose
  • seizures
  • sneezing
  • sore throat
  • sores, ulcers, or white spots on the lips, tongue, or inside the mouth
  • stomach cramps or pain
  • swelling
  • tenderness
  • tightness in the chest
  • troubled breathing
  • troubled breathing with exertion
  • unusual bleeding or bruising
  • unusual tiredness or weakness
  • watery or bloody diarrhea

Side effects not requiring immediate medical attention

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

For Healthcare Professionals

Applies to duvelisib: oral capsule

Hematologic

Very common (10% or more): Neutropenia (63%), thrombocytopenia (39%), anemia (45%), lymphocytosis (30%), leukopenia (29%), lymphopenia (21%)[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]

General

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]

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]

References

1. "Product Information. Copiktra (duvelisib)." Verastem, Inc., Needham, MA.

Frequently asked questions

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.