Repotrectinib

(re″ poe trek′ ti nib)

Brand Name(s): Augtyro^®

WHY is this medicine prescribed?

Repotrectinib is used to treat a certain type of non-small cell lung cancer (NSCLC; a type of lung cancer) in adults that has spread to other parts of the body. Repotrectinib is in a class of medications called kinase inhibitors. It works by blocking the action of the abnormal protein that signals cancer cells to multiply. This helps to stop or slow the spread of cancer cells.

Are there OTHER USES for this medicine?

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

HOW should this medicine be used?

Repotrectinib comes as a capsule to take by mouth with or without food. Initially, it is usually taken once a day for 14 days. After 14 days, it is usually taken twice a day for as long as your doctor recommends. Take repotrectinib at around the same time(s) every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take repotrectinib exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Swallow the capsules whole; do not open, chew, crush, or dissolve them.

If you vomit after taking repotrectinib, do not take another dose. Continue your regular dosing schedule the next day.

Your doctor may temporarily or permanently stop your treatment or adjust your dose of repotrectinib depending on your response to treatment and any side effects that you experience. Talk to your doctor about how you are feeling during your treatment. Continue to take repotrectinib even if you feel well. Do not stop taking repotrectinib without talking to your doctor.

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

What SPECIAL PRECAUTIONS should I follow?

Before taking repotrectinib,

• tell your doctor and pharmacist if you are allergic to repotrectinib, any other medications, or any of the ingredients in repotrectinib capsules. Ask your pharmacist for a list of the ingredients.

• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.

• the following nonprescription or herbal products may interact with repotrectinib: St. John's Wort. Be sure to let your doctor and pharmacist know that you are taking this medication before you start taking repotrectinib. Do not start any of this medication while taking repotrectinib without discussing with your healthcare provider.

• You should know that repotrectinib may decrease the effectiveness of hormonal contraceptives (birth control pills, patches, rings, and injections). You will need to use another method of contraception to prevent pregnancy while taking repotrectinib. Talk to your doctor about other ways to prevent pregnancy while you are taking this medication.

• tell your doctor if you have or have ever had a nervous system condition, lung or breathing problems, high levels of uric acid in your blood, gout, osteoporosis, or kidney or liver disease.

• tell your doctor if you are pregnant, plan to become pregnant, or if you plan to father a child. You or your partner should not become pregnant while you are taking repotrectinib. If you are female, you will need to have a pregnancy test before you start treatment, and you should use birth control to prevent pregnancy during your treatment and for 2 months after your final dose. If you are male, you and your partner should use birth control to prevent pregnancy during your treatment with repotrectinib and for 4 months after your final dose. Talk to your doctor about birth control methods that you can use during your treatment. If you or your partner become pregnant while taking repotrectinib, call your doctor. Repotrectinib may harm the fetus.

• tell your doctor if you are breastfeeding or plan to breastfeed. You should not breastfeed while taking repotrectinib and for 10 days after your final dose.

• you should know that repotrectinib may make you dizzy or confused. Do not drive a car or operate machinery until you know how this medication affects you.

What SPECIAL DIETARY instructions should I follow?

Do not eat grapefruit or drink grapefruit juice while taking this medication.

What should I do IF I FORGET to take a dose?

If you miss a dose of repotrectinib, skip that dose and take your next dose at the regular time. Do not take a double dose to make up for a missed one.

What SIDE EFFECTS can this medicine cause?

Repotrectinib may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• change in how things taste or loss of taste
• headache
• nausea
• constipation
• diarrhea
• tiredness, weakness, or fatigue
• swelling of the face, eyes, arms, legs, hands, or feet
• weight gain
• burning, tingling, or numbness of the hands and feet

Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately or get emergency medical treatment:

• yellowing of the skin or eyes, nausea, vomiting, loss of appetite, pain in upper right side of your stomach, dark urine, or light-colored stools
• new or worsening cough, wheezing, shortness of breath, or trouble breathing
• muscle pain, tenderness, or weakness
• difficulty with learning, memory, attention, or problem solving
• mood changes such as anxiety, depression, confusion, or agitation
• dizziness, feeling unsteady, or having trouble keeping your balance
• sleep problems, including excessive sleepiness or difficulty falling or staying asleep
• hallucinations (seeing things or hearing voices that do not exist)
• trouble speaking or understanding
• double vision, blurred vision, eye sensitivity to light, loss of vision, or other changes in vision
• pain, redness, or swelling in the joints, especially in the big toe
• pain in the lower back or lower stomach
• pink, brown, red, cloudy, or bad smelling urine
• decreased urination
• bone pain, difficulty moving, or bone abnormalities

Taking repotrectinib may increase the risk that you will experience a bone fracture. Talk to your doctor about the risk of taking this medication and about ways to keep your bones healthy during your treatment.

Repotrectinib may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What should I know about STORAGE and DISPOSAL of this medication?

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from light, excess heat and moisture (not in the bathroom).

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

What should I do in case of OVERDOSE?

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

What OTHER INFORMATION should I know?

Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests before and during your treatment to check your body's response to repotrectinib.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

The American Society of Health-System Pharmacists, Inc. represents that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. makes no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. does not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS^® Patient Medication Information™. © Copyright, 2024. The American Society of Health-System Pharmacists^®, 4500 East-West Highway, Suite 900, Bethesda, Maryland. All Rights Reserved. Duplication for commercial use must be authorized by ASHP.

Selected Revisions: December 15, 2023.