Selpercatinib (sel-per-KA-ti-nib)

Treats lung cancer, thyroid cancer, or solid tumors.

Brand Name(s):

Retevmo

When This Medicine Should Not Be Used:

How to Use This Medicine:

Capsule, Tablet

• Take your medicine as directed. Your dose may need to be changed several times to find what works best for you.
• Swallow the capsule and tablet whole. Do not crush or chew it. Do not take the capsule if you are unable to swallow it.
• Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.
• Missed dose: If your next dose is less than 6 hours away, skip the missed dose and take the medicine at your regular dosing time. If your missed dose is more than 6 hours until the time you normally take a dose, take it as soon as you remember and go back to your regular dosing schedule. If you vomit after taking your medicine, do not take an extra dose.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Some medicines can affect how selpercatinib works. Tell your doctor if you are using bosentan, dabigatran, diltiazem, efavirenz, fluconazole, itraconazole, midazolam, modafinil, repaglinide, rifampin, St John's wort, or verapamil.
• Take this medicine at least 2 hours before or 2 hours after taking antacids that contain aluminum, calcium, magnesium, simethicone, or buffered medicines.
• Take this medicine at least 2 hours before or 10 hours after taking an H2 blocker (including cimetidine, famotidine, nizatidine).
• Take this medicine with food if you are also taking a proton pump inhibitor (including dexlansoprazole, esomeprazole, lansoprazole, omeprazole, pantoprazole sodium, rabeprazole).

Warnings While Using This Medicine:

• This medicine may cause birth defects if either partner is using it during conception or pregnancy. Tell your doctor right away if you or your partner becomes pregnant. If you are female and able to get pregnant, your doctor may give you a pregnancy test before you start using this medicine to make sure you are not pregnant. Use an effective form of birth control during treatment and for at least 1 week after the last dose. Male patients with female partners should use an effective form of birth control during treatment and for at least 1 week after the last dose.
• Do not breastfeed while you are using this medicine and for at least 1 week after your last dose.
• Tell your doctor if you have kidney disease, liver disease, lung disease, high blood pressure, heart disease, heart rhythm problems (including long QT syndrome, slow heartbeat, uncontrolled heart failure), thyroid problems, or bleeding problems. Tell your doctor if you had a recent surgery.
• This medicine may cause the following problems:
  • Liver problems
  • Lung or breathing problems, including interstitial lung disease (ILD), pneumonitis
  • High blood pressure
  • Heart rhythm problems, including QT prolongation
  • Bleeding problems
  • Tumor lysis syndrome (electrolyte and metabolic problems that can be life-threatening)
  • Hypothyroidism (underactive thyroid)
  • Hip joint problems
• This medicine may affect the way your body heals from cuts and wounds. Make sure any doctor who treats you knows that you are using this medicine.
• This medicine could cause infertility. Talk with your doctor before using this medicine if you plan to have children.
• Medicines used to treat cancer are very strong and can have many side effects. Before receiving this medicine, make sure you understand all the risks and benefits. It is important for you to work closely with your doctor during your treatment.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Change in how much or how often you urinate, lower back or side pain
• Chest pain, cough, trouble breathing
• Confusion, headache
• Dark urine or pale stools, nausea, vomiting, loss of appetite, stomach pain, yellow skin or eyes
• Dizziness, fainting, slow, fast, or uneven heartbeat
• Fever, chills, cough, sore throat, body aches
• Hip or knee pain, limping
• Rapid weight gain, swelling in your hands, ankles, or feet, joint or muscle pain
• Unusual bleeding, bruising, or weakness

If you notice these less serious side effects, talk with your doctor:

• Constipation, diarrhea
• Dry mouth
• Tiredness

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088