Repotrectinib (re-poe-TREK-ti-nib)

Treats non-small cell lung cancer (NSCLC) and solid tumors.

Brand Name(s):

Augtyro

When This Medicine Should Not Be Used:

How to Use This Medicine:

Capsule

• Take your medicine as directed. Your dose may need to be changed several times to find what works best for you.
• Swallow the capsule whole with water at the same time each day. Do not open, chew, crush, or dissolve it. Do not take capsules that are broken, cracked, or damaged.
• 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 a dose is missed or if you vomit, skip the missed dose. Take the next dose at the regular scheduled time. Do not take extra medicine to make up for a missed 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 repotrectinib works. Tell your doctor if you are using itraconazole, midazolam, rifampin, or birth control pills.
• Do not eat grapefruit or drink grapefruit juice while you are using this medicine.

Warnings While Using This Medicine:

• It is not safe to take this medicine during pregnancy. It could harm an unborn baby. Tell your doctor right away if you become pregnant. If you are woman who can 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 2 months after the last dose. Male patients who have female partners should use effective birth control during treatment and for at least 4 months after the last dose.
• Do not breastfeed during treatment and for 10 days after the last dose.
• Tell your doctor if you have kidney disease, liver disease, lung or breathing problems, or nerve problems.
• This medicine may cause the following problems:
  • Nervous system problems
  • Lung or breathing problems, including interstitial lung disease (ILD), pneumonitis
  • Liver problems
  • High uric acid in the blood
  • Muscle problems, including myalgia
  • Increased risk of bone fractures
• This medicine may cause blurred vision, dizziness, memory loss, mental status change, confusion, hallucinations, having trouble with balance or coordination, or trouble with concentration and attention. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.
• 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
• Bone, muscle, or joint pain
• Chest pain, cold sweat, bluish-colored skin, trouble breathing
• Dark urine or pale stools, nausea, vomiting, loss of appetite, stomach pain, yellow skin or eyes
• Dizziness, fainting, tiredness, memory loss, mood changes
• Numbness, tingling, or burning pain in your hands, arms, legs, or feet
• Unsteadiness, trembling, or other problems with muscle control or coordination

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

• Change or loss of taste
• Constipation

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