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Pralsetinib Side Effects

Medically reviewed by Drugs.com. Last updated on Nov 2, 2023.

Applies to pralsetinib: oral capsule.

Serious side effects of Pralsetinib

Along with its needed effects, pralsetinib 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 pralsetinib:

More common

Less common

Other side effects of Pralsetinib

Some side effects of pralsetinib 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 pralsetinib: oral capsule.

General

The most common adverse reactions (25% or greater) were fatigue, constipation, diarrhea, musculoskeletal pain, anemia, and hypertension. The most common Grade 3 or 4 laboratory abnormalities (2% or greater) were decreased lymphocytes, decreased neutrophils, decreased phosphate, decreased hemoglobin, decreased sodium, increased aspartate aminotransferase (AST), decreased platelets, increased alkaline phosphatase, decreased calcium (corrected), and increased alanine aminotransferase (ALT). The most common serious adverse reactions were pneumonia, pneumonitis, and anemia.[Ref]

Respiratory

Tuberculosis mostly extrapulmonary, such as lymph node tuberculosis, peritoneal tuberculosis, or renal tuberculosis have been reported.[Ref]

Very common (10% or more): Cough (up to 27%, includes cough, productive cough, upper-airway cough syndrome), dyspnea (22%), pneumonia (17%, includes pneumonia, atypical pneumonia, lung infection, pneumocystis Jirovecii pneumonia, bacterial pneumonia, cytomegaloviral pneumonia, haemophilus pneumonia, pneumonia influenza, streptococcal pneumonia)

Common (1% to 10%): Cough (Grade 3 or 4), pneumonia (Grade 3 or 4)

Uncommon (0.1% to 1%): Tuberculosis

Frequency not reported: Interstitial lung disease, pneumonitis[Ref]

Cardiovascular

Very common (10% or more): Hypertension all Grades (up to 40%), hypertension Grade 3 or 4 (up to 21%), Hemorrhage (19%)[Ref]

Hepatic

Very common (10% or more): Increased AST (69%), increased ALT (46%), increased bilirubin (24%)

Frequency not reported: Hepatotoxicity[Ref]

Hematologic

Very common (10% or more): Decreased neutrophils (61%), decreased lymphocytes (56%), decreased platelets (27%), decreased hemoglobin (58%), grade 3 or 4 decreased neutrophils (16%), grade 3 or 4 decreased lymphocytes (19%), decreased albumin (up to 36%), increased potassium (up to 26%), thrombocytopenia (up to 19%)

Common (1% to 10%): Decreased hemoglobin (Grade 3 or 4), decreased platelets (Grade 3 or 4), hemorrhage[Ref]

Oncologic

Clinically relevant tumor lysis syndrome occurred in less than 15% of patients.[Ref]

Frequency not reported: Tumor lysis syndrome[Ref]

Gastrointestinal

Very common (10% or more): Constipation (up to 41%), diarrhea (up to 34%), dry mouth (16%), abdominal pain (includes abdominal discomfort, abdominal pain, abdominal pain upper, abdominal tenderness, epigastric discomfort) (17%), stomatitis (includes mucosal inflammation, stomatitis, tongue ulceration) (up to 17%), nausea (17%), vomiting (12%)

Common (1% to 10%): Diarrhea, colitis, enteritis (Grade 2 or 4), constipation (Grade 3 or 4)[Ref]

Other

Very common (10% or more): Fatigue/asthenia (up to 38%), pyrexia (up to 25%) edema (up to 29%, includes edema peripheral, face edema, periorbital edema, eyelid edema, edema generalized, swelling)

Common (1% to 10%): Fatigue/asthenia (Grade 3 or 4)

Frequency not reported: Impaired wound healing, embryo-fetal toxicity[Ref]

Musculoskeletal

Very common (10% or more): Musculoskeletal pain (includes back pain, myalgia, arthralgia, pain in extremity, musculoskeletal pain, neck pain, non-cardiac chest pain, musculoskeletal chest pain, bone pain, musculoskeletal stiffness, arthritis, pain in extremity, spinal pain) (up to 42%)

Frequency not reported: Increased creatine phosphokinase[Ref]

Clinically relevant increases in creatine phosphokinase occurred in less than 15% of patients.[Ref]

Metabolic

Very common (10% or more): Increased alkaline phosphatase (40%), decreased calcium (corrected) (29%), decreased sodium (27%), decreased phosphate (27%), increased phosphate (10%), decreased appetite (15%)[Ref]

Renal

Very common (10% or more): Increased creatinine (42%)[Ref]

Nervous system

Common (1% to 10%): Headache (24%) (includes migraine, tension headache), dizziness (19%) (includes dizziness, dizziness postural, vertigo), peripheral neuropathy (up to 20%, includes dysesthesia, hyperesthesia, hypoesthesia, neuralgia, neuropathy peripheral, paresthesia, peripheral sensory neuropathy, polyneuropathy), dysgeusia/ageusia (17%), taste disorder (16%)[Ref]

Dermatologic

Very common (10% or more): Rash (13%) (includes dermatitis, dermatitis acneiform, eczema, palmar-plantar, erythrodysesthesia syndrome, rash, rash erythematous, rash macular, rash maculo-papular, rash papular, rash pustular)[Ref]

Genitourinary

Common (1% to 10%): Urinary tract infection[Ref]

References

1. Product Information. Gavreto (pralsetinib). Blueprint Medicines Corporation. 2020.

2. Product Information. Gavreto (pralsetinib). Roche Products Pty Ltd. 2023;GAVRETO 20230406.

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.