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

Applies to pralsetinib: oral capsule.

Serious side effects of Gavreto

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

Other side effects of Gavreto

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.

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).

Respiratory

Very common (10% or more): Cough (up to 27%; e.g., cough, productive cough, upper-airway cough syndrome), dyspnea (22%), pneumonia (17%; e.g., pneumonia, atypical pneumonia, lung infection, pneumocystis jirovecii pneumonia, pneumonia bacterial, pneumonia cytomegaloviral, pneumonia Haemophilus, pneumonia influenza, pneumonia streptococcal)

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

Cardiovascular

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

Hepatic

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

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%)

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

Oncologic

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

Frequency not reported: Tumor lysis syndrome

Gastrointestinal

Very common (10% or more): Constipation (up to 41%), diarrhea (up to 34%), dry mouth (16%), abdominal pain (17%), stomatitis (17%), nausea (17%)

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

Other

Very common (10% or more): Fatigue/asthenia (up to 38%), pyrexia (up to 22%) edema (up to 29%; (e.g., edema peripheral, face edema, periorbital edema, eyelid edema, edema generalized, swelling)

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

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) (up to 42%)

Frequency not reported: Increased creatine phosphokinase

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

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%)

Renal

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

Nervous system

Common (1% to 10%): Headache (24%), dizziness (19%), peripheral neuropathy (20%), dysgeusia (17%)

Dermatologic

Very common (10% or more): Rash (13%; dermatitis, dermatitis acneiform, eczema, palmar-plantar, erythrodysesthesia syndrome, rash, rash

erythematous, rash macular, rash maculo-papular, rash papular, rash pustular)

Genitourinary

Common (1% to 10%): Urinary tract infection