Tanstrive Tablet

Selpercatinib ® is a kinase inhibitor indicated for the treatment of: Adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with a rearranged during transfection (RET) gene fusion, as detected by an FDA-approved test Adult and pediatric patients 2 years of age and older with advanced or metastatic medullary thyroid cancer (MTC) with a RET mutation, as detected by an FDA-approved test, who require systemic therapy Adult and pediatric patients 2 years of age and older with advanced or metastatic thyroid cancer with a RET gene fusion, as detected by an FDA-approved test, who require systemic therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate) Adult and pediatric patients 2 years of age and older with locally advanced or metastatic solid tumors with a RET gene fusion, as detected by an FDA-approved test, that have progressed on or following prior systemic treatment or who have no satisfactory alternative treatment options RET Fusion-Positive Non-Small Cell Lung Cancer Selpercatinib ® is indicated for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with a rearranged during transfection (RET) gene fusion, as detected by an FDA-approved test. RET -Mutant Medullary Thyroid Cancer Selpercatinib is indicated for the treatment of adult and pediatric patients 2 years of age and older with advanced or metastatic medullary thyroid cancer (MTC) with a RET mutation, as detected by an FDA-approved test, who require systemic therapy. RET Fusion-Positive Thyroid Cancer Selpercatinib is indicated for the treatment of adult and pediatric patients 2 years of age and older with advanced or metastatic thyroid cancer with a RET gene fusion, as detected by an FDA-approved test, who require systemic therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate). Abridged from the full prescribing information.

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Source: US FDA prescribing information, via openFDA. Provided for general information only — it is not a substitute for your doctor's or pharmacist's advice. Always follow your prescriber's instructions.

Hepatotoxicity: Monitor ALT and AST prior to initiating Selpercatinib, every 2 weeks during the first 3 months, then monthly thereafter and as clinically indicated. Withhold, reduce the dose, or permanently discontinue Selpercatinib based on severity. Interstitial Lung Disease (ILD)/Pneumonitis: Monitor for new or worsening pulmonary symptoms. Hypertension: Do not initiate Selpercatinib in patients with uncontrolled hypertension. Optimize blood pressure (BP) prior to initiating Selpercatinib. Monitor BP after 1 week, at least monthly thereafter and as clinically indicated. QT Interval Prolongation: Monitor patients who are at significant risk of developing QTc prolongation. Assess QT interval, electrolytes and TSH at baseline and periodically during treatment. Monitor QT interval more frequently when Selpercatinib is concomitantly administered with strong and moderate CYP3A inhibitors or drugs known to prolong QTc interval. Withhold and reduce the dose or permanently discontinue Selpercatinib based on severity. Hemorrhagic Events: Permanently discontinue Selpercatinib in patients with severe or life-threatening hemorrhage. Hypersensitivity: Withhold Selpercatinib and initiate corticosteroids. Upon resolution, resume at a reduced dose and increase dose by 1 dose level each week until reaching the dose taken prior to onset of hypersensitivity. Continue steroids until patient reaches target dose and then taper. Tumor Lysis Syndrome: Closely monitor patients at risk and treat as clinically indicated. Risk of Impaired Wound Healing: Withhold Selpercatinib for at least 7 days prior to elective surgery. Do not administer for at least 2 weeks following major surgery and until adequate wound healing. The safety of resumption of Selpercatinib after resolution of wound healing complications has not been established. Hypothyroidism: Monitor thyroid function before treatment with Selpercatinib and periodically during treatment. Withhold until clinically stable or permanently discontinue based on severity. Embryo-Fetal Toxicity: Can cause fetal harm. Advise females of reproductive potential of the possible risk to a fetus and to use effective contraception. Slipped Capital Femoral Epiphysis/Slipped Upper Femoral Epiphysis (SCFE/SUFE) in Pediatric Patients: Monitor patients for symptoms indicative of SCFE/SUFE and treat as medically and surgically appropriate Hepatotoxicity Serious hepatic adverse reactions occurred in 4.6% of patients treated with Selpercatinib. Increased AST occurred in 62% of patients, including Grade 3 or 4 events in 11% and increased ALT occurred in 58% of patients, including Grade 3 or 4 events in 13%. The median time to first onset for increased AST was 5 weeks (range: 4.9 days to 6 years) and increased ALT was 4.9 weeks (range: 6 days to 5 years). Abridged from the full prescribing information.

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Source: US FDA prescribing information, via openFDA. Provided for general information only — it is not a substitute for your doctor's or pharmacist's advice. Always follow your prescriber's instructions.

The following clinically significant adverse reactions are described elsewhere in the labeling: Hepatotoxicity Interstitial Lung Disease / Pneumonitis Hypertension QT Interval Prolongation Hemorrhagic Events Hypersensitivity Tumor Lysis Syndrome Risk of Impaired Wound Healing Hypothyroidism Slipped Capital Femoral Epiphysis/Slipped Upper Femoral Epiphysis in Adolescent Patients The most common adverse reactions (≥25%) include: Adult patients with solid tumors: musculoskeletal pain, edema, diarrhea, fatigue, dry mouth, hypertension, abdominal pain, rash, nausea, constipation, cough, headache, vomiting, dyspnea, and hemorrhage. Pediatric patients with solid tumors: musculoskeletal pain, diarrhea, nausea, hemorrhage, pyrexia, abdominal pain, headache, vomiting, fatigue, cough, rash, coronavirus infection, upper respiratory tract infection, and edema. The most common Grade 3 or 4 laboratory abnormalities (≥5%) include: Adult patients with solid tumors: decreased lymphocytes, increased alanine aminotransferase (ALT), decreased sodium, increased aspartate aminotransferase (AST), decreased calcium, and decreased phosphate. Pediatric patients with solid tumors: decreased lymphocytes, decreased calcium, decreased hemoglobin, decreased neutrophils, increased alanine aminotransferase, decreased magnesium, and decreased potassium. Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety population described in the WARNINGS and PRECAUTIONS and below reflects exposure to Selpercatinib as a single agent administered at 160 mg orally twice daily evaluated in 857 patients with advanced solid tumors in LIBRETTO-001. RET Gene Fusion or Gene Mutation Positive Solid Tumors LIBRETTO-001 Among the 857 patients who received Selpercatinib, 74% were exposed for 12 months or longer and 57% were exposed for 24 months or longer. Among these patients, 97% received at least one dose of Selpercatinib at the recommended dosage of 160 mg orally twice daily. The median age was 59 years (range: 15 to 92 years); 0.2% were pediatric patients 12 to 16 years of age; 51% were male; and 68% were White, 24% were Asian, and 3% were Black or African American; and 5% were Hispanic/Latino. The most common tumors were NSCLC (43%), MTC (39%), and non-medullary thyroid carcinoma (8%). Serious adverse reactions occurred in 58% of patients who received Selpercatinib. Abridged from the full prescribing information.

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Source: US FDA prescribing information, via openFDA. Provided for general information only — it is not a substitute for your doctor's or pharmacist's advice. Always follow your prescriber's instructions.