Letevmo Capsule 40 mg (Selpercatinib)

Adult dose

Administer this drug orally twice daily (approximately every 12 hours) until disease progression or unacceptable toxicity occurs. Swallow the capsules whole. Do not crush or chew the capsules. Do not take a missed dose unless at least 6 hours remain until the next scheduled dose. If vomiting occurs after taking this drug, do not take an additional dose; take the next dose at the next scheduled time. Avoid concomitant use of this drug with proton pump inhibitors, histamine-2 (H2) receptor antagonists, or locally acting antacids. If concomitant use cannot be avoided: • Administer this drug with food when given concomitantly with a proton pump inhibitor. • Administer this drug 2 hours before or 10 hours after an H2 receptor antagonist. • Administer this drug 2 hours before or 2 hours after a locally acting antacid. Permanently discontinue this drug in patients who do not tolerate 3 dose reductions. Hepatotoxicity, Grade 3 or 4: Withhold this drug until recovery to Grade 1 or baseline, and monitor AST/ALT weekly. Resume at a reduced dose at the second dose level, and monitor AST and ALT weekly for up to 4 weeks after reaching the dose administered before the Grade 3 or 4 AST or ALT elevation. After at least 2 weeks without recurrence, increase the dose to the first dose level; then, after at least 4 additional weeks without recurrence, increase the dose to the dose administered before the Grade 3 or 4 AST or ALT elevation. Discontinue this drug if Grade 3 or 4 AST or ALT elevations recur despite dose modification. Interstitial lung disease (ILD)/pneumonitis, Grade 2: Withhold this drug until recovery. Resume treatment at a reduced dose. Discontinue this drug if ILD/pneumonitis recurs. Interstitial lung disease (ILD)/pneumonitis, Grade 3 or 4: Discontinue this drug if ILD/pneumonitis is confirmed. Hypertension, Grade 3: Withhold this drug if Grade 3 hypertension persists despite optimal antihypertensive treatment. Resume treatment at a reduced dose once hypertension is controlled. Hypertension, Grade 4: Discontinue this drug. QT interval prolongation, Grade 3: Withhold this drug until recovery to baseline, Grade 0, or Grade 1. Resume treatment at a reduced dose. QT interval prolongation, Grade 4: Discontinue this drug. Hemorrhage, Grade 3 or 4: Withhold this drug until recovery to baseline, Grade 0, or Grade 1. Discontinue this drug in the event of severe or life-threatening hemorrhage. Hypersensitivity reaction, any grade: Withhold this drug until the adverse reaction resolves. Initiate corticosteroids. Resume treatment at a reduced dose at the third dose level while continuing corticosteroids. Discontinue this drug if the reaction recurs. Increase the dose by one dose level each week until reaching the dose administered before the onset of the hypersensitivity reaction, then gradually taper the corticosteroids. Hypothyroidism, Grade 3 or 4: Withhold this drug until recovery to Grade 1 or baseline. Discontinue this drug based on severity. Other adverse drug reactions, Grade 3 or 4: Withhold this drug until recovery to baseline, Grade 0, or Grade 1. Resume treatment at a reduced dose. Discontinue this drug in the event of a severe or life-threatening adverse reaction. Avoid concomitant use of this drug with strong and moderate CYP3A inhibitors. If concomitant use of a strong or moderate CYP3A inhibitor cannot be avoided, reduce the dose of this drug according to Table 3. After discontinuing the inhibitor for 3~5 times its elimination half-life, resume this drug at the dose administered before initiation of the CYP3A inhibitor. Current dose of this drug: 120mg orally twice daily: with a moderate CYP3A inhibitor, administer 80mg orally twice daily; with a strong CYP3A inhibitor, administer 40mg orally twice daily. Current dose of this drug: 160mg orally twice daily: with a moderate CYP3A inhibitor, administer 120mg orally twice daily; with a strong CYP3A inhibitor, administer 80mg orally twice daily. For patients with severe hepatic impairment, reduce the recommended dose of this drug according to the recommendations in Table 4. Current dose of this drug: 120mg orally twice daily: recommended dose of this drug, 80mg orally twice daily. Current dose of this drug: 160mg orally twice daily: recommended dose of this drug, 80mg orally twice daily.

Child dose

Less than 50kg: Recommended dose 120mg; 1st dose reduction 80mg orally twice daily; 2nd dose reduction 40mg orally twice daily; 3rd dose reduction 40mg orally once daily. 50kg or more: Recommended dose 160mg; 1st dose reduction 120mg orally twice daily; 2nd dose reduction 80mg orally twice daily; 3rd dose reduction 40mg orally twice daily.

This medication should not be administered to patients who are allergic to this drug or its components. Before taking this medication, liver function tests must be conducted, and liver function should be regularly monitored every two weeks for the first three months after initiation and monthly thereafter. If liver function abnormalities are severe, the medication may need to be temporarily discontinued, the dosage reduced, or completely stopped. If symptoms such as difficulty breathing, cough, or fever occur, consult a physician immediately, and discontinue the medication and seek testing if interstitial lung disease or pneumonia is suspected. Patients with high blood pressure should have their blood pressure well controlled before starting this medication, and should continue to monitor their blood pressure regularly after administration and take antihypertensive medications as needed. QT interval related cardiac examinations may be necessary for patients with heart disease or those taking related medications due to the risk of prolonged QT interval. Due to the risk of bleeding, inform a doctor immediately if any bleeding symptoms occur, and discontinue the drug if severe bleeding occurs. If hypersensitivity symptoms such as fever, rash, arthralgia, or myalgia appear, the medication should be stopped, and steroid treatment initiated. Once symptoms improve, dosing can be gradually adjusted according to a physician's order. Due to the risk of tumor lysis syndrome, high-risk patients should receive hydration and be carefully monitored. This medication should be discontinued at least 7 days prior to surgery and should not be resumed until the surgical wound has completely healed. This medication may cause hypothyroidism, so regular thyroid function tests should be conducted before and during treatment, and thyroid hormone therapy may be necessary if needed. Should be avoided in pregnant women as it may harm the fetus; women who are pregnant should not take this medication, and fertile women and men should use effective contraception during and for one week after treatment. In children and adolescents, this medication may impact bone growth, so growth plate status should be monitored regularly. This medication may interact with certain gastrointestinal medications (antacids, proton pump inhibitors, etc.), reducing its effectiveness, so co-medication should be avoided or dosing times adjusted. Moreover, when used with drugs that inhibit or induce enzymes involved in drug metabolism in the liver, there may be an increased risk of side effects or reduced drug effectiveness, so caution is advised. Breastfeeding women should avoid nursing during and for one week after taking this medication. Patients with decreased kidney or liver function should consult a doctor before taking this medication, and particularly for those with severe liver impairment, dosage adjustments may be necessary. This medication should be kept out of reach of children and should not be transferred to another container for storage.

• Hepatotoxicity
• AST increase
• ALT increase
• interstitial lung disease
• pneumonia
• respiratory distress
• cough
• fever
• hypertension
• QT interval prolongation

This medication is sensitive to air and moisture, so it should be stored in a tightly sealed container. It is advisable to store it at room temperature, between 1 to 30 degrees Celsius.

Appearance

An opaque gray hard capsule containing a white to almost white to light yellow powder, with 'Lilly', '3977', and '40 mg' printed in black ink.

Package unit

Blister - 56 capsules/box [14 capsules/blister * 4]