Pirtobrutinib is used in adults to treat mantle cell lymphoma.

Pirtobrutinib may also be used for purposes not listed in this medication guide.

Use only as directed. Tell your doctor if you use other medicines or have other medical conditions or allergies.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

You may take pirtobrutinib once a day with or without food, but take it at the same time each day.

Swallow the tablet whole and do not crush, chew, or break it.

Your blood will need to be tested often.

Using pirtobrutinib may increase your risk of developing cancer. Ask your doctor about your individual risk.

Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors.

Store at room temperature away from moisture and heat.

Usual Adult Dose for Mantle Cell Lymphoma:

200 mg orally once daily

Length of Therapy: Until disease progression or unacceptable toxicity occurs.

Comments:
-Swallow tablets whole with water. Do not cut, crush, or chew tablets.
-This indication is approved under accelerated approval based on response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

Use: For the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL) after at least two lines of systemic therapy, including a BTK inhibitor.

Tell your doctor if you have or have ever had:

• an infection or have been told you are at an increased risk of infection;

• recent surgery, or plan to have surgery or a dental procedure;

• bleeding problems or are taking a blood thinner medicine;

• heart rhythm problems;

• high blood pressure;

• other types of cancer, including skin cancer; or

• kidney disease.

You will need to take a pregnancy test before treatment with pirtobrutinib.

May harm an unborn baby. Do not use if you are pregnant. Use effective birth control while using pirtobrutinib and for at least 1 week after your last dose. Tell your doctor if you become pregnant.

Do not breastfeed while using pirtobrutinib, and for at least 1 week after your last dose.

Use the medicine as soon as you can, but skip the missed dose if you are more than 12 hours late for the dose. Do not use two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

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. 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.

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

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Get emergency medical help if you have signs of an allergic reaction: hives, difficult breathing, swelling of your face, lips, tongue, or throat.

Pirtobrutinib may cause serious side effects. Call your doctor at once if you have:

• chest pressure, racing or pounding heartbeats, fluttering in your chest, feeling short of breath;

• signs of infection--fever, chills, sore throat, body aches, unusual tiredness, loss of appetite, bruising or bleeding;

• bleeding inside your body--weakness, dizziness; pink or brown urine; abnormal vaginal bleeding; bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds; or

• low blood cell counts--fever, chills, tiredness, mouth sores, skin sores, easy bruising, unusual bleeding, pale skin, cold hands and feet, feeling light-headed or short of breath.

Your cancer treatments may be delayed or permanently discontinued if you have certain side effects.

Common side effects of pirtobrutinib may include:

• bruising;

• tiredness;

• diarrhea;

• swelling;

• muscle, joint, or bone pain; or

• fever, chills, cough with mucus, chest pain, feeling short of breath.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Sometimes it is not safe to use certain medicines at the same time. Some drugs can affect your blood levels of other drugs you use, which may increase side effects or make the medicines less effective.

Many drugs can affect pirtobrutinib. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here. Tell your doctor about all other medicines you use.

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.