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Gavreto Side Effects

Generic name: pralsetinib

Medically reviewed by Drugs.com. Last updated on Sep 25, 2021.

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

For the Consumer

Applies to pralsetinib: oral capsule

Side effects requiring immediate medical attention

Along with its needed effects, pralsetinib (the active ingredient contained in Gavreto) 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

  • Bleeding gums
  • blurred vision
  • chest pain
  • chills
  • cough
  • coughing up blood
  • dark urine
  • decrease or change in the amount of urine
  • difficulty in breathing or swallowing
  • dizziness
  • fainting
  • fast or slow heartbeat
  • fever
  • general feeling of discomfort or illness
  • headache
  • increased menstrual flow or vaginal bleeding
  • irregular pulse
  • joint pain, stiffness, or swelling
  • loss of appetite
  • lower back, side, or stomach pain
  • nausea
  • nervousness
  • nosebleeds
  • paralysis
  • pounding in the ears
  • prolonged bleeding from cuts
  • rapid weight gain
  • red or black, tarry stools
  • red or dark brown urine
  • slow or fast heartbeat
  • stomach pain, severe
  • swelling around the eye
  • swelling of the eyelids
  • swelling of the feet or lower legs
  • swelling or puffiness of the face
  • thickening of bronchial secretions
  • unusual tiredness or weakness
  • vomiting
  • yellow eyes or skin

Less common

  • Black, tarry stools
  • bladder pain
  • bloody or cloudy urine
  • chest pain or tightness
  • confusion
  • difficult, burning, or painful urination
  • frequent urge to urinate
  • lightheadedness
  • lower back or side pain
  • pale skin
  • sneezing
  • sore throat
  • sores, ulcers, or white spots on the lips or in the mouth
  • swollen glands
  • unusual bleeding or bruising

Side effects not requiring immediate medical attention

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

  • Bone pain
  • burning, numbness, tingling, or painful sensations
  • change in taste
  • constipation
  • decreased appetite
  • difficulty in moving
  • dry mouth
  • joint pain
  • lack or loss of strength
  • loss of taste
  • muscle aching or cramping
  • muscle pains or stiffness
  • neck pain
  • pain, swelling, or redness in the joints
  • swelling or inflammation of the mouth
  • tenderness
  • unsteadiness or awkwardness
  • watery or bloody diarrhea
  • weakness in the arms, hands, legs, or feet

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.