Repotrectinib (Augtyro™)

Repotrectinib is a type of targeted therapy called a kinase inhibitor. A kinase is an enzyme that promotes cell growth. There are many types of kinases, which control different phases of cell growth. By blocking a particular enzyme from working, this medication can slow the growth of cancer cells. Repotrectinib targets ROS1 found on some cancer cells.

How to Take Repotrectinib

Repotrectinib is a capsule taken by mouth once or twice a day, with or without food. Swallow it whole with water and do not open, crush, chew, or dissolve the capsule. Take the capsule about the same time every day. If you forget to take a dose or throw up after taking it, just take your next dose at your next scheduled time. Do not take two doses to make up for a missed dose.

It is important to make sure you are taking the correct amount of medication every time. Before every dose, check that what you are taking matches what you have been prescribed.

The blood levels of this medication can be affected by certain foods, like grapefruit, and medications. Be sure to tell your healthcare provider about all medications and supplements you take.

Storage and Handling

Store your medication in the original, labeled container at room temperature and in a dry location (unless otherwise directed by your healthcare provider or pharmacist). This medication should not be stored in a pillbox. Keep containers out of reach of children and pets.

If a caregiver prepares your dose for you, they should consider wearing gloves or pour the pills directly from their container into the cap, a small cup, or directly into your hand. They should avoid touching the pills. They should always wash their hands before and after giving you the medication. Pregnant or nursing women should not prepare the dose for you. Ask your oncology team where to return any unused medication for disposal. Do not flush it down the toilet or throw it in the trash.

Where do I get this medication?

Repotrectinib is available through select specialty pharmacies. Your oncology team will work with your prescription drug plan to identify an in-network specialty pharmacy for the distribution of this medication and shipment directly to your home.

Insurance Information

This medication may be covered under your prescription drug plan. Patient assistance may be available to qualifying individuals depending upon prescription drug coverage. Co-pay cards, which reduce the patient co-pay responsibility for eligible commercially (non-government sponsored) insured patients, may also be available. Your care team can help you find these resources if they are available.

Possible Side Effects of Repotrectinib

There are a number of things you can do to manage the side effects of repotrectinib. Talk to your care team about these recommendations. They can help you decide what will work best for you. These are some of the most common or important side effects:

Central Nervous System Reactions

This medication can cause changes in your central nervous system. You can become dizzy, unable to walk well or keep your balance, have trouble sleeping, issues with your memory, have changes in how your brain works, and mood changes. If you notice any of these side effects, you should call your provider right away. You should also not drink alcohol or use machinery until you know how you will react to this medication.

Taste Changes

Nutrition is an important part of your care. Cancer treatment can affect your appetite and, in some cases, the side effects of treatment can make eating difficult. Ask your oncology care team about nutritional counseling services at your treatment center to help with food choices.

• Try to eat five or six small meals or snacks throughout the day, instead of 3 larger meals.
• If you are not eating enough, nutritional supplements may help.
• You may experience a metallic taste or find that food has no taste at all. You may dislike foods or beverages that you liked before receiving cancer treatment. These symptoms can last for several months or longer after treatment ends.
• Avoid any food that you think smells or tastes bad. If red meat is a problem, eat chicken, turkey, eggs, dairy products, and fish without a strong smell. Sometimes cold food has less of an odor.
• Add extra flavor to meat or fish by marinating it in sweet juices, sweet and sour sauce, or dressings. Use seasonings like basil, oregano, or rosemary to add flavor. Bacon, ham, and onion can add flavor to vegetables.

Peripheral Neuropathy (Numbness or Tingling in the Hands and/or Feet)

Peripheral neuropathy is a toxicity that affects the nerves. It causes numbness or a tingling feeling in the hands and/or feet, often in the pattern of a stocking or glove. This can get progressively worse with additional doses of the medication. In some people, the symptoms slowly resolve after the medication is stopped, but for some, it never goes away completely. You should let the oncology care team know if you experience numbness or tingling in the hands and/or feet, as they may need to adjust the doses of your medication.

Constipation

There are several things you can do to prevent or relieve constipation. Include fiber in your diet (fruits and vegetables), drink 8-10 glasses of non-alcoholic fluids a day, and keep active. A stool softener once or twice a day may prevent constipation. If you do not have a bowel movement for 2-3 days, you should contact your healthcare team for suggestions to relieve the constipation.

Fatigue/Weakness

Fatigue is very common during cancer treatment and is an overwhelming feeling of exhaustion that is not usually relieved by rest. While on cancer treatment, and for a period after, you may need to adjust your schedule to manage fatigue. Plan times to rest during the day and conserve energy for more important activities. Exercise can help combat fatigue; a simple daily walk with a friend can help. Talk to your healthcare team for helpful tips on dealing with this side effect.

Important but Less Common Side Effects

• Lung Problems: This medication can cause interstitial lung disease. Symptoms include a new cough, shortness of breath, and difficulty breathing. Call your care team if you experience these symptoms.
• Liver Toxicity: This medication can cause liver toxicity, which your oncology care team may monitor for using blood tests called liver function tests. Notify your healthcare provider if you notice yellowing of the skin or eyes, your urine appears dark or brown, or you have pain in your abdomen, as these can be signs of liver toxicity.
• Myalgia: This medication can also cause muscle pain. Talk to your provider about how to manage this discomfort.
• Hyperuricemia: This medication can cause higher than normal uric acid levels in your blood. This can cause gout and kidney stones. You will have your labs monitored. Call you provider if you have new joint pain or swelling, joints that are hot to the touch, or if your skin becomes shiny and red or purple.
• Bone Fractures: This medication can cause breaks in your bones. To help prevent fractures, wear a seatbelt when in a car, do not participate in contact sports, and make changes to your house to prevent falls (like adding lighting and removing extra furniture). If you think you have a fracture or have any new or worsening pain, call your provider right away.

Reproductive Concerns

Exposure of an unborn child to this medication could cause birth defects, so you should not become pregnant or father a child while on this medication. It is important for women to be using a non-hormonal birth control, as hormonal birth control can be affected by this medication. Effective non-hormonal birth control is necessary during treatment and for at least 2 months after treatment for women. Men should be using effective birth control during treatment and for 4 months after treatment has ended. Even if your menstrual cycle stops or you believe you are not producing sperm, you could still be fertile and conceive. You should not breastfeed while receiving this medication and for at least 10 days after the last dose.