Retevmo

About Selpercatinib Capsules

Selpercatinib Capsules are prescribed to:

• Adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who have a RET gene fusion as discovered by an FDA-approved test.
• Adult and pediatric patients aged 12 and above with advanced or metastatic medullary thyroid carcinoma (MTC) with a RET mutation discovered by an FDA-approved test and in need of systemic treatment.
• Adult and pediatric patients aged 12 and above with advanced or metastatic thyroid cancer with a RET gene fusion found by an FDA-approved test, who require systemic treatment and are radioactive iodine-refractory.
• Adults with locally advanced or metastatic solid malignancies with a RET gene fusion who have progressed on or after previous systemic therapy or who have no viable alternative treatment.

Strength

40 mg and 80 mg Selpercatinib capsules

Recommended Dosage:

Adult and pediatric dosage recommendations Weight is depending on age (12 years or older):

• Less than 50 kg: 120 mg twice a day
• 50 kg and above: 160 mg twice daily

Important: If patients experience any adverse reactions from the Selpercatinib, they must consult their treating doctor. 

Warnings & Precautions:

• Prior to starting Retevmo capsules, monitor ALT and AST every 2 weeks for the first 3 months, then monthly afterward and as clinically needed (Hepatotoxicity). Depending on the severity, withhold, reduce the dosage, or discontinue Selpercatinib capsules. 
• It is necessary to monitor pulmonary symptoms (Interstitial Lung Disease (ILD)/Pneumonitis). Based on the severity, withhold, reduce the dosage, or permanently discontinue Selpercatinib.
• Individuals with uncontrolled hypertension, do not begin the Selpercatinib treatment. Prior to beginning the treatment, it is necessary to optimize your blood pressure (BP). After one week, check blood pressure at least monthly and as clinically required. Depending on the severity, withhold, reduce the dosage, or discontinue Selpercatinib.

Common Selpercatinib Side Effects:

• Edema
• Diarrhea
• Fatigue
• Dry mouth
• Hypertension
• Abdominal pain
• Constipation
• Rash
• Nausea
• Headache

Common Grade 3 or 4 laboratory abnormalities:

• Decreased lymphocytes
• Increased alanine aminotransferase (ALT)
• Increased aspartate aminotransferase (AST)
• Decreased sodium
• Decreased calcium

Storage and Handling

Store at a regulated room temperature of 20ºC to 25ºC, with excursions tolerated between 15ºC and 30ºC.