Sevabertinib (Hyrnuo®)

How to Take this Medication

This medication comes in a tablet form to be taken by mouth. It is often taken two times a day and should be taken with food. Swallow the tablets whole. Do not cut, crush, or chew the tablets. If you miss a dose, take it as soon as possible before your next scheduled dose. Do not take two doses at the same time 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.

Certain medications can change the effectiveness of this medication, so make sure your provider is aware of all the medications, vitamins, and supplements you are taking. Foods to avoid include grapefruit and grapefruit juice. Medications that can affect or be affected by this medication include, but are not limited to verapamil, ketoconazole, rifampin, phenytoin, St. John’s wort, and modafinil. 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 down the toilet or throw it in the trash.

Where do I get this medication?

This medication is available through select specialty pharmacies. Your oncology team will work with your prescription drug plan to identify an in-network specialty pharmacy for 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 without 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

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

Diarrhea

Diarrhea can be a serious side effect of this medication. As soon as you start to have diarrhea, you should start taking anti-diarrheal medications and start drinking more fluids. Notify your care provider if you start to have 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.

Rash and Skin Reactions

Some patients may develop a rash, dry skin, or itchy bumps. Rashes can be serious, including acneiform dermatitis. Use an alcohol-free moisturizer on your skin and lips. Avoid moisturizers with perfumes or scents. Your oncology care team can recommend a topical medication if itching is bothersome. If your skin does crack or bleed, be sure to keep the area clean to avoid infection. Your skin may be more sensitive to the sun, which can result in severe sunburn or rash. Sun sensitivity can last even after chemotherapy is completed, up to at least 2 months after treatment. Avoid the sun between 10am to 2pm when it is strongest. Wear sunscreen (at least SPF 30 with UVA/UVB protection) every day and reapply when in the sun for long periods of time. Wear sunglasses with UVA/UVB protection, a hat, and long sleeves/pants to protect your skin, and try to find shade whenever possible.

Tell your oncology care team about any rash that develops, as this can be a reaction. They can give you more tips on caring for your skin.

Nail Changes

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.

Pancreas Problems

This medication can increase the enzymes amylase and lipase which may be signs of issues with your pancreas. You will have these levels checked while you take this medication. If you have sudden stomach pain or discomfort, nausea, or vomiting you should call your provider right away as these are signs of pancreatitis.

Electrolyte Abnormalities

This medication can affect the normal levels of electrolytes (calcium, sodium, potassium, magnesium, 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.

Liver Toxicity

This medication can cause liver toxicity, which your doctor may monitor for using blood tests called liver function tests. You will have these levels checked before you start treatment, every two weeks for one month, then monthly. Notify your healthcare provider if you notice yellowing of the skin or eyes, your urine appears dark or brown or pain in your abdomen, as these can be signs of liver toxicity.

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.

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.

Mouth Ulcers (Mucositis/Stomatitis)

Certain cancer treatments can cause sores or soreness in your mouth and/or throat. Notify your oncology care team if your mouth, tongue, inside of your cheek or throat becomes white, ulcerated, or painful. Performing regular mouth care can help prevent or manage mouth sores. If mouth sores become painful, your doctor or nurse can recommend a pain reliever.

• Brush with a soft-bristle toothbrush or cotton swab twice a day.
• Avoid mouthwashes that contain alcohol. A baking soda and/or salt with warm water mouth rinse (2 level teaspoons of baking soda or 1 level teaspoon of salt in an eight-ounce glass of warm water) is recommended 4 times daily.
• If your mouth becomes dry, eat moist foods, drink plenty of fluids (6-8 glasses), and suck on sugarless hard candy.
• Avoid smoking and chewing tobacco, drinking alcoholic beverages, and citrus juices.

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.

Kidney Problems

This medication can cause kidney problems, including an increased creatinine level, which your oncology care team may monitor for using blood tests. Notify your healthcare provider if you notice decreased urine output, blood in the urine, swelling in the ankles, or loss of appetite.

High Cholesterol/Triglyceride Level

This medication can cause high levels of cholesterol and/or triglycerides in your blood. Your healthcare providers will monitor for this using blood tests and after may prescribe medication to help manage increased lipid levels

Important but Less Common Side Effects

• Interstitial Lung Disease/Pneumonitis:  Patients can develop interstitial lung disease (scarring of the lung tissue) or pneumonitis (inflammation of the lungs) while taking this medication. Notify your healthcare provider right away if you develop any new or worsening symptoms, including trouble breathing or shortness of breath, chest pain, cough, or fever.
• Ocular (Eye) Toxicity:  This medication can cause problems with your eyes. Tell your care team about any new or worsening vision or eye symptoms, such as blurry vision, redness, eye pain, excess tears or discharge from your eye, sensitivity to light, or a feeling that something is in your eye. You may need to see an ophthalmologist for treatment.

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 one week after your last dose. Even if your menstrual cycle stops or you believe you are not producing sperm, you could still be fertile and conceive. You should consult with your healthcare team before breastfeeding while receiving this medication or for one week after your last dose.