Applies to selpercatinib: oral capsule.

Serious side effects of Selpercatinib

Along with its needed effects, selpercatinib 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 selpercatinib:

More common

• Bleeding gums
• blurred vision
• chest tightness
• constipation
• coughing up blood
• depressed mood
• diarrhea
• difficulty in breathing or swallowing
• dizziness or fainting
• dry skin and hair
• feeling cold
• hair loss
• headache
• hoarseness or husky voice
• increased menstrual flow or vaginal bleeding
• muscle cramps and stiffness
• nervousness
• nosebleeds
• paralysis
• pounding in the ears
• prolonged bleeding from cuts
• red or black, tarry stools
• red or dark brown urine
• slow, fast, irregular, or pounding heartbeat
• stomach pain
• swelling of the hands, ankles, feet, or lower legs
• unusual tiredness or weakness
• vomiting of blood or material that looks like coffee grounds
• weight gain

Less common

• Chest pain
• cough
• fever or chills
• general feeling of discomfort or illness
• hives, itching, skin rash
• irritation
• joint pain, stiffness, or swelling
• loss of appetite
• lower back or side pain
• nausea and vomiting
• redness of the skin
• sore throat
• stomach tenderness
• swelling of the eyelids, face, or lips
• thickening of bronchial secretions
• trouble breathing
• yellow eyes or skin

Other side effects of Selpercatinib

Some side effects of selpercatinib 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

• Dry mouth

For Healthcare Professionals

Applies to selpercatinib: oral capsule.

Hematologic

Very common (10% or more): Leukocytes decreased (43%), platelets decreased (33%), hemorrhage (e.g., epistaxis, hematuria, hemoptysis, contusion, rectal hemorrhage, vaginal hemorrhage, ecchymosis, hematochezia, petechiae, traumatic hematoma, anal hemorrhage, blood blister, blood urine present, cerebral hemorrhage, GI hemorrhage, hemorrhage intracranial, spontaneous hematoma, abdominal wall hematoma, angina bullosa hemorrhagica, diverticulum intestinal hemorrhagic, eye hemorrhage, GI hemorrhage, gingival bleeding, hematemesis, hemorrhagic anemia, intraabdominal hemorrhage, lower GI hemorrhage, melena, mouth hemorrhage, occult blood positive, pelvic hematoma, periorbital hematoma, pharyngeal hemorrhage, pulmonary contusion, purpura, retroperitoneal hematoma, subarachnoid hemorrhage, subdural hemorrhage, upper GI hemorrhage, vessel puncture site hematoma) (15%)

Common (1% to 10%): Hemorrhagic events^[Ref]

Hypersensitivity

Common (1% to 10%): Hypersensitivity^[Ref]

Metabolic

Very common (10% or more): Glucose increased (44%), albumin decreased (42%), calcium decreased (41%), alkaline phosphatase increased (36%), total cholesterol increased (31%), sodium decreased (27%), magnesium decreased (24%), bilirubin increased (23%), glucose decreased (22%)^[Ref]

Hepatic

Very common (10% or more): Increased AST (51%), increased ALT (45%)^[Ref]

Respiratory

Very common (10% or more): Cough (e.g., cough, productive cough) (18%), dyspnea (e.g., dyspnea, dyspnea exertional, dyspnea at rest) (16%)^[Ref]

Other

Very common (10% or more): Fatigue (e.g., fatigue, asthenia, malaise) (35%), edema (e.g., edema, edema peripheral, face edema, eye edema, eyelid edema, generalized edema, localized edema, lymph edema, scrotal edema, peripheral swelling, scrotal swelling, swelling, swelling face, eye swelling, peripheral swelling) (33%)

Frequency not reported: Impaired wound healing^[Ref]

General

The most common adverse reactions, including laboratory abnormalities, (25% or greater) were increased aspartate aminotransferase (AST), increased alanine aminotransferase (ALT), increased glucose, decreased leukocytes, decreased albumin, decreased calcium, dry mouth, diarrhea, increased creatinine, increased alkaline phosphatase, hypertension, fatigue, edema, decreased platelets, increased total cholesterol, rash, decreased sodium, and constipation.^[Ref]

Nervous system

Very common (10% or more): Headache (e.g., headache, sinus headache, tension headache) (23%)^[Ref]

Renal

Very common (10% or more): Creatinine decreased (37%)^[Ref]

Cardiovascular

Very common (10% or more): Hypertension (35%), QT prolongation (17%)^[Ref]

Dermatologic

Very common (10% or more): Rash (e.g., rash erythematous, rash macular, rash maculopapular, rash morbilliform, rash pruritic) (27%)^[Ref]

Endocrine

Common (1% to 10%): Hypothyroidism^[Ref]

Gastrointestinal

Very common (10% or more): Dry mouth (39%), diarrhea (e.g., diarrhea, defecation urgency, frequent bowel movements, anal incontinence) (37%), constipation (25%), nausea (23%), abdominal pain (e.g., abdominal pain, abdominal pain upper, abdominal pain lower, abdominal discomfort, Gi pain) (23%), vomiting (15%)^[Ref]