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Pralsetinib Side Effects

For the Consumer

Applies to pralsetinib: oral capsule

Warning

Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • fever, chills;

  • new or worsening cough, shortness of breath, or chest pain;

  • severe headache, dizziness, confusion, trouble speaking;

  • any wound that will not heal;

  • unusual bleeding--bruising, nosebleeds, bleeding gums, abnormal vaginal bleeding, any bleeding that will not stop;

  • signs of bleeding inside your body--weakness, drowsiness, pink or brown urine, bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds;

  • low blood cell counts--fever, tiredness, sore throat, mouth sores, skin sores, pale skin, cold hands and feet, feeling light-headed or short of breath; or

  • liver problems--nausea, vomiting, loss of appetite, stomach pain (upper right side), tiredness, dark urine, jaundice (yellowing of the skin or eyes).

Your cancer treatments may be delayed or permanently discontinued if you have certain side effects.

Common side effects may include:

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For Healthcare Professionals

Applies to pralsetinib: oral capsule

Hematologic

lymphocytes (52%), decreased neutrophils (52%), decreased platelets (26%)

Common (1% to 10%): Grade 3 or greater hemorrhagic events[Ref]

Musculoskeletal

Very common (10% or more): Musculoskeletal pain (e.g., back pain, myalgia, arthralgia, pain in extremity, musculoskeletal pain, neck pain, musculoskeletal chest pain, bone pain, musculoskeletal stiffness, arthritis, spinal pain) (32%)[Ref]

Metabolic

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

Hepatic

Very common (10% or more): Increased AST (69%), increased ALT (46%)[Ref]

Respiratory

Very common (10% or more): Cough (e.g., cough, productive cough, upper-airway cough syndrome) (23%), pneumonia (e.g., pneumonia, atypical pneumonia, lung infection, pneumocystis jirovecii pneumonia, pneumonia bacterial, pneumonia cytomegaloviral, pneumonia haemophilus, pneumonia influenza, pneumonia streptococcal) 17%)

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

Other

Very common (10% or more): Fatigue/asthenia (35%), pyrexia (20%) edema e.g., edema peripheral, face edema, periorbital edema, eyelid edema, edema generalized, swelling) (20%)

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

General

The most common adverse reactions (25% or greater) were fatigue, constipation, musculoskeletal pain, 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, decreased calcium (corrected), and increased alanine aminotransferase (ALT).[Ref]

Renal

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

Cardiovascular

Very common (10% or more): Hypertension all Grades (29%), hypertension Grade 3 or 4 (14%)[Ref]

Gastrointestinal

Very common (10% or more): Constipation (35%), diarrhea (e.g., diarrhea, colitis, enteritis) (24%), dry mouth (16%)

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

References

1. "Product Information. Gavreto (pralsetinib)." Blueprint Medicines Corporation, Cambridge, MA.

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.