RETEVMO 120 mg/1 (Selpercatinib TABLET, COATED) 120 mg/1

RETEVMO is a targeted therapy that acts on the RET (rearranged during transfection) tyrosine kinase pathway, which is implicated in certain cancers. It is used to treat the following conditions:

• RET fusion-positive non-small cell lung cancer: RETEVMO is indicated for the treatment of adult patients with this type of lung cancer.
• RET-altered thyroid cancers: This includes medullary thyroid cancer and other thyroid cancers driven by RET mutations.
• Advanced or metastatic RET-mutant medullary thyroid cancer: RETEVMO is approved for the treatment of patients with advanced or metastatic forms of this cancer.

• Selpercatinib works by selectively inhibiting the RET (rearranged during transfection) tyrosine kinase. This inhibition blocks downstream signaling pathways involved in tumor cell proliferation and survival, thereby exerting anti-tumor activity in specific cancers. By targeting the RET protein, selpercatinib helps to slow or stop the growth of cancer cells that are driven by RET mutations or fusions.

RETEVMO, like all medications, can cause side effects. Common side effects may include fatigue, hypertension, diarrhea, and increased liver enzymes. Serious or rare side effects, although less common, can be more severe and may require immediate medical attention.

Common Side Effects

• Fatigue: Feeling unusually tired or weak.
• Hypertension: Elevated blood pressure.
• Diarrhea: Frequent loose or watery bowel movements.
• Increased liver enzymes: Elevated levels of enzymes that can indicate liver damage.
• Dry mouth: A feeling of dryness in the mouth.
• Nausea: A feeling of sickness in the stomach.
• Vomiting: The expulsion of stomach contents through the mouth.
• Constipation: Difficulty in passing stools.

Serious or Rare Side Effects

• Hepatotoxicity: Liver damage or inflammation.
• Hypersensitivity reactions: Allergic reactions that can be severe.
• Interstitial lung disease: Inflammation of the lungs.
• QTc prolongation: A heart rhythm condition that can be dangerous.
• Peripheral neuropathy: Nerve damage that can cause pain, tingling, or numbness.
• Severe skin reactions: Including rash, itching, or blistering.
• Embryo-fetal toxicity: Potential harm to a developing fetus.
• Renal impairment: Reduced kidney function.

RETEVMO should be used with caution and under the supervision of a healthcare professional. It is important to follow the prescribed dosage and monitor for any adverse effects. Specific precautions include:

• Hepatic impairment: Dose reduction may be necessary in patients with severe hepatic impairment.
• Hypersensitivity: Patients with known hypersensitivity to selpercatinib or any of its components should avoid this medication.
• Pregnancy: RETEVMO may cause harm to a developing fetus. Women of childbearing potential should use effective contraception during treatment.
• Breastfeeding: It is not known whether selpercatinib is excreted in human milk. Caution should be exercised when administering to breastfeeding women.
• Pediatric use: Safety and effectiveness in pediatric patients have not been established.
• Geriatric use: Clinical studies did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently from younger patients.
• Store below 25°C: Keep in the original pack, protect from moisture.

RETEVMO can interact with other medications, which may affect its efficacy or increase the risk of side effects. It is important to inform your healthcare provider about all medications you are taking. Major interactions should be avoided, while moderate interactions require close monitoring.

Major Interactions (Avoid)

• Strong CYP3A inducers: These can decrease the concentration of selpercatinib in the blood, reducing its effectiveness.
• Strong CYP3A inhibitors: These can increase the concentration of selpercatinib, potentially leading to increased side effects.
• Drugs that prolong the QT interval: Combining these with RETEVMO can increase the risk of heart rhythm abnormalities.
• Drugs metabolized by CYP3A: RETEVMO can affect the metabolism of these drugs, leading to increased or decreased concentrations.
• Drugs that are substrates of P-gp or BCRP: RETEVMO can affect the transport of these drugs, potentially altering their effectiveness.

Moderate Interactions (Monitor Closely)

• Moderate CYP3A inducers: These can decrease the concentration of selpercatinib, potentially reducing its effectiveness.
• Moderate CYP3A inhibitors: These can increase the concentration of selpercatinib, potentially leading to increased side effects.
• Drugs that are substrates of OATP1B1 or OATP1B3: RETEVMO can affect the transport of these drugs, potentially altering their effectiveness.
• Drugs that are substrates of BSEP: RETEVMO can affect the transport of these drugs, potentially altering their effectiveness.
• Drugs that are substrates of MRP2: RETEVMO can affect the transport of these drugs, potentially altering their effectiveness.