Pirtobrutinib

Pirtobrutinib is used to treat mantle cell lymphoma (a fast-growing cancer that begins in the cells of the immune system) in adults that has returned or is unresponsive to other treatments. Pirtobrutinib is also used to treat chronic lymphocytic leukemia (CLL; a type of cancer that begins in the white blood cells) or small lymphocytic lymphoma (SLL; a type of cancer that begins mostly in the lymph nodes) in adults who have already been treated with at least two other chemotherapy medications. Pirtobrutinib is in a class of medications called kinase inhibitors. It works by blocking the action of the protein that signals cancer cells to multiply.

Pirtobrutinib comes as a tablet to take by mouth. It is usually taken with or without food once a day. Take pirtobrutinib at around the same time 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 pirtobrutinib exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Swallow the tablets whole; do not split, chew, or crush them.

Your doctor may need to change your dose or tell you to stop taking pirtobrutinib based on side effects you may experience. Be sure to tell your doctor how you are feeling while taking the medicine. Do not stop taking the medicine until your doctor tells you to.

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

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

Before taking pirtobrutinib,

• tell your doctor and pharmacist if you are allergic to pirtobrutinib, any other medications, or any of the ingredients in pirtobrutinib tablets. Ask your pharmacist for a list of the ingredients.
• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take while taking pirtobrutinib. 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 pirtobrutinib: St. John's Wort. Be sure to let your doctor and pharmacist know that you are taking these medications before you start taking pirtobrutinib. Do not start any of these medications while taking pirtobrutinib without discussing with your healthcare provider.
• tell your doctor if you have an infection or have a condition or take medication that impacts your immune system, have or have ever had kidney disease, a bleeding disorder, used blood thinners, arrhythmia (abnormal heart rate or rhythm), cancer, or high blood pressure.
• tell your doctor if you are pregnant or plan to become pregnant. You should not become pregnant while you are receiving pirtobrutinib. You will need to have a negative pregnancy test before you begin receiving this medication. Use effective birth control during your treatment with pirtobrutinib and for 1 week after your final dose. If you become pregnant while receiving pirtobrutinib, call your doctor.
• tell your doctor if you are breastfeeding. You should not breastfeed while taking pirtobrutinib or for 1 week after your last dose.
• if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking pirtobrutinib.
• plan to avoid unnecessary or prolonged exposure to sunlight and to wear protective clothing, sunglasses, and sunscreen. Pirtobrutinib may make increase your risk of skin cancer.
• you should know that pirtobrutinib may increase your risk of certain infections. Your doctor will likely have you receive certain vaccines before starting pirtobrutinib and put you on some additional medications to prevent infection while receiving pirtobrutinib.
• you should know that pirtobrutinib may increase the risk of getting certain types of cancers which, in addition to skin cancer, may include breast and tumors of the genital or urinary tract. Talk to your doctor about the risk of treatment with pirtobrutinib before starting this medication.

Unless your doctor tells you otherwise, continue your normal diet.

Take the missed dose as soon as you remember it. However, if it has been more than 12 hours, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

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

• tiredness
• headache
• muscle, joint and bone pain
• diarrhea
• constipation
• stomach pain
• nausea
• decreased appetite
• numbness or tingling in your hands, feet, arms, or legs
• rash
• mouth sores
• difficulty falling asleep or staying asleep
• swelling

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

• fever, chills, cough, weakness, flu-like symptoms, or any other signs of infection
• blood in your stools or stools that look like tar, pink or brown urine, unusual or unexpected bleeding, vomiting blood or vomit that looks like coffee grounds, coughing up blood or blood clots, increased bruising, dizziness, weakness, confusion, changes in speech, or headache that lasts a long time
• fast or irregular heart rate, fainting, chest discomfort, shortness of breath
• falling
• memory problems

Pirtobrutinib 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 (https://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

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 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. https://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 (https://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

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.

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

Before having any laboratory test, tell your doctor and the laboratory personnel that you are taking pirtobrutinib.

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.

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