Taletrectinib (Ibtrozi™)

How to Take Taletrectinib

Taletrectinib is taken as a capsule by mouth once daily on an empty stomach. This means you should not have any food for at least 2 hours before and 2 hours after taking the medication. Swallow the capsule whole. Do not crush, chew or open the capsules. Do not take a missed dose. Take the next dose as scheduled. If you vomit after taking your dose, do not take an extra dose. Instead, take your next dose as scheduled.

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.

Avoid sun exposure. If you have to be outdoors, protect your skin with sunscreen. Protect your skin while you are on this medication and for at least 5 days after stopping the medication.

The blood levels of this medication can be affected by certain foods and medications, so they should be avoided. These include (but are not limited to): St. John’s wort, grapefruit, grapefruit juice, itraconazole, diltiazem, fluconazole, verapamil, rifampin, bosentan, efavirenz, repaglinide, and midazolam.

Tell your provider if you take medication for “heartburn” as these may affect how your cancer medication works. You should not take taletrectinib at the same time as some heartburn medications. Some examples of heartburn medications include proton pump inhibitors (PPIs), such as omeprazole (Prilosec®), lansoprazole (Prevacid®), pantoprazole (Protonix®); H2 blockers, such as famotidine (Pepcid®); and antacids, such as calcium carbonate (Tums®) and calcium carbonate with magnesium hydroxide (Rolaids®). If needed, please ask your care team the best heartburn medication to use and when to take it. 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 pouring 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 down the toilet or throw in the trash.

Where do I get this medication?

Certain cancer medications are only available through specialty pharmacies. If you need to get this medication through a specialty pharmacy, your provider will help you start this process. Where you can fill your prescriptions may also be influenced by your prescription drug coverage. Ask your health care provider or pharmacist for assistance in identifying where you can get this medication.

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 Taletrectinib

There are a number of things you can do to manage the side effects of taletrectinib. 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:

Liver Toxicity

This medication can cause liver toxicity, which your oncology care team may monitor for using blood tests called liver function tests. Tell your healthcare provider if you notice yellowing of the skin or eyes, if your urine looks dark or brown, or if you have pain in your abdomen (belly), as these can be signs of liver toxicity.

Diarrhea

Your oncology care team can recommend medications to relieve diarrhea. Also, try eating low-fiber, bland foods, such as white rice and boiled or baked chicken. Avoid raw fruits, vegetables, whole grain breads, cereals and seeds. Soluble fiber is found in some foods and absorbs fluid, which can help relieve diarrhea. Foods high in soluble fiber include: applesauce, bananas (ripe), canned fruit, orange sections, boiled potatoes, white rice, products made with white flour, oatmeal, cream of rice, cream of wheat, and farina. Drink 8-10 glasses of non-alcoholic, un-caffeinated fluid a day to prevent dehydration.

Low Red Blood Cell Count (Anemia)

Your red blood cells are responsible for carrying oxygen to the tissues in your body. When the red cell count is low, you may feel tired or weak. You should let your oncology care team know if you experience any shortness of breath, difficulty breathing, or pain in your chest. If the count gets too low, you may receive a blood transfusion.

Nausea and/or Vomiting

Talk to your oncology care team so they can prescribe medications to help you manage nausea and vomiting. In addition, dietary changes may help. Avoid things that may worsen the symptoms, such as heavy or greasy /fatty, spicy, or acidic foods (lemons, tomatoes, oranges). Try saltines or ginger ale to lessen symptoms. Call your oncology care team if you are unable to keep fluids down for more than 12 hours or if you feel lightheaded or dizzy at any time.

Low White Blood Cell Count (Leukopenia or Neutropenia)

White blood cells (WBC) are important for fighting infection. While receiving treatment, your WBC count can drop, putting you at a higher risk of getting an infection. You should let your doctor or nurse know right away if you have a fever (temperature greater than 100.4°F or 38°C), sore throat or cold, shortness of breath, cough, burning with urination, or a sore that doesn't heal. Tips to preventing infection:

• Washing hands, both yours and your visitors, is the best way to prevent the spread of infection.
• Avoid large crowds and people who are sick (i.e.: those who have a cold, fever or cough or live with someone with these symptoms).
• When working in your yard, wear protective clothing including long pants and gloves.
• Do not handle pet waste.
• Keep all cuts or scratches clean.
• Shower or bathe daily and perform frequent mouth care.
• Do not cut cuticles or ingrown nails. You may wear nail polish, but not fake nails.
• Ask your oncology care team before scheduling dental appointments or procedures.
• Ask your oncology care team before you, or someone you live with has any vaccinations.

Electrolyte Abnormalities

This medication can affect the normal levels of electrolytes (potassium, magnesium, calcium, etc.) in your body. Your levels will be monitored using blood tests. If your levels become too low, your care team may prescribe specific electrolytes to be given by IV or taken by mouth. Do not take any supplements without first consulting with your care team.

Nail and Skin Changes

This medication has some unique nail and skin side effects that you may develop. Patients may develop a rash. While this rash may look like acne, it is not, and should not be treated with acne medications. The rash may appear red, swollen, crusty, dry and feel sore. You may also develop very dry skin, which may crack, be itchy or become flaky or scaly. The rash typically starts in the first week of treatment, but can occur at any time during treatment. Tips for managing your skin include:

• Use a thick, alcohol-free emollient lotion or cream on your skin at least twice a day, including right after bathing.
• Avoid sun exposure, as it can worsen the rash or cause a severe burn. Use a sunscreen with an SPF of 30 or higher and wear a hat and sunglasses to protect your head and face from the sun.
• Bathe/shower in cool or lukewarm (not hot) water and pat your skin dry.
• Use soaps, lotions and laundry detergents without alcohol, perfumes, or dyes.
• Wear gloves to wash dishes or do housework or gardening.
• Drink plenty of water and try not to scratch or rub your skin.
• Notify your healthcare team if you develop a rash, as they can provide suggestions to manage the rash and/or prescribe a topical medication to apply to the rash or an oral medication.
• If you develop peeling or blistering of the skin, notify your healthcare team right away.

While receiving this medication, you may develop an inflammation of the skin around the nail bed/cuticle areas of toes or fingers, which is called paronychia. It can appear red, swollen or pus filled. Nails may develop "ridges" in them or fall off. You may also develop cuts or cracks that look like small paper cuts in the skin on your toes, fingers or knuckles. These side effects may appear several months after starting treatment, but can last for many months after treatment stops.

• Follow the same recommendations for your skin (above).
• Don't bite your nails or cuticles or cut the cuticles.
• Keep your fingernails and toenails clean and dry.
• You may use nail polish, but do not wear fake nails.
• Notify your doctor or nurse if any nails fall off or you develop any of these side effects or other skin abnormalities.

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

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 Changes: Taletrectinib can cause changes to your lungs including interstitial lung disease and pneumonitis. Contact your provider if you are experiencing any new or worsening lung symptoms, including shortness of breath, difficulty breathing, new cough, or fever.
• Heart Problems: This medication can cause slow or abnormal heartbeats or an abnormal heart rhythm called QT prolongation. Notify your oncology care team right away if you feel abnormal heartbeats or if you feel dizzy or faint.
• 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 your 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.
• Myalgia: This medication can also cause muscle pain. Talk to your provider about how to manage this discomfort.
• 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. Effective birth control is necessary during treatment and for at least 3 weeks after treatment. 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 taking this medication or for 3 weeks after your last dose.