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.
Serious side effects of Duvelisib
Along with its needed effects, duvelisib 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 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 Duvelisib
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
- Bone pain
- constipation
- decreased appetite
- difficulty in moving
- muscle stiffness
- vomiting
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]
