Patient information: uses, side effects, how to take - Jaypirca

What is JAYPIRCA?

JAYPIRCA is a prescription medicine used to treat adults with:

mantle cell lymphoma (MCL) that has come back (relapsed) or did not respond to previous treatment (refractory) and who have already received at least 2 treatments for their cancer, including a Bruton tyrosine kinase (BTK) inhibitor medicine.
relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who have previously been treated for their cancer with a covalent BTK inhibitor medicine.
CLL or SLL who have not previously been treated for their cancer and who have no known 17p deletion.

It is not known if JAYPIRCA is safe and effective in children.

Before taking JAYPIRCA, tell your healthcare provider about all of your medical conditions, including if you:

have an infection or have been advised that you are at increased risk of infection
have had recent surgery or plan to have surgery. Your healthcare provider may stop JAYPIRCA for any planned medical, surgical, or dental procedure.
have bleeding problems or are taking a blood thinner medicine
have or had heart rhythm problems
have high blood pressure
have a history of other cancers including skin cancer
have kidney problems
have liver problems
are pregnant or plan to become pregnant. JAYPIRCA can harm your unborn baby.
Females who are able to become pregnant:
- Your healthcare provider will do a pregnancy test before starting treatment with JAYPIRCA.
- Use effective birth control (contraception) during treatment with JAYPIRCA and for 1 week after your last dose of JAYPIRCA.
- Tell your healthcare provider right away if you become pregnant or think you are pregnant during treatment with JAYPIRCA.
are breastfeeding or plan to breastfeed. It is not known if JAYPIRCA passes into your breast milk. Do not breastfeed during treatment with JAYPIRCA and for 1 week after your last dose of JAYPIRCA.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Taking JAYPIRCA with certain other medicines may affect how JAYPIRCA or the other medicines work and can cause side effects.

How should I take JAYPIRCA?

Take JAYPIRCA exactly as your healthcare provider tells you.
Do not change your dose or stop taking JAYPIRCA unless your healthcare provider tells you to do so.
Take JAYPIRCA 1 time each day at about the same time each day.
Take JAYPIRCA with or without food.
Swallow JAYPIRCA whole with water. Do not cut, crush, or chew the tablets.
If you miss a dose of JAYPIRCA, take it as soon as you remember on the same day. If it has been more than 12 hours from the time you usually take JAYPIRCA, skip the missed dose, and take your next dose on the next day at your usual time.

What are the possible side effects of JAYPIRCA?

JAYPIRCA can cause serious side effects, including:

Infections can happen during treatment with JAYPIRCA. These infections can be serious and may lead to death. Your healthcare provider may prescribe vaccines and certain medicines if you have an increased risk of getting infections. Tell your healthcare provider right away if you develop any signs or symptoms of infection, including:
fever
chills
weakness
flu-like symptoms
any other signs of infection

Bleeding problems (hemorrhage). Bleeding problems can happen during treatment with JAYPIRCA and can be serious and may lead to death. Your risk of severe bleeding may increase if you are also taking a blood thinner medicine. Tell your healthcare provider if you develop any signs or symptoms of bleeding, including:

blood in your stools or black stools (looks like tar)
pink or brown urine
unexpected bleeding, or bleeding that is severe or you cannot control
vomit blood or vomit that looks like coffee grounds
cough up blood or blood clots

increased bruising
dizziness
weakness
confusion
changes in your speech
headache that lasts a long time

Decreased blood cell counts, including white blood cells, platelets, and red blood cells. This may increase your risk of infection, bleeding, and anemia. Your healthcare provider should do blood tests to check your blood counts regularly during treatment with JAYPIRCA.
Heart rhythm problems. Heart rhythm problems including atrial fibrillation and atrial flutter have happened in people treated with JAYPIRCA. Your risk for heart rhythm problems may be increased if you have high blood pressure or have had heart rhythm problems in the past. Tell your healthcare provider if you develop any of the following signs or symptoms:
fast or irregular heartbeat (palpitations)
dizziness
fainting
chest discomfort
shortness of breath
Second primary cancers. New cancers have happened in people during treatment with JAYPIRCA, including cancers of the skin or other organs. Your healthcare provider will check you for other cancers during treatment with JAYPIRCA. Use sun protection when you are outside in sunlight.
Liver Problems that may be severe, life-threatening, or lead to death. Your healthcare provider will do blood tests to check your liver before and during treatment with JAYPIRCA. Tell your healthcare provider or get medical help right away if you develop any signs of liver problems, including:
stomach pain or discomfort
dark-colored urine
yellow skin and eyes

Your healthcare provider may decrease your dose, temporarily stop, or permanently stop treatment with JAYPIRCA if you develop severe side effects.

The most common side effects of JAYPIRCA include:

decreased white blood cell counts

decreased red blood cell counts

These are not all the possible side effects of JAYPIRCA.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store JAYPIRCA?

Store JAYPIRCA at room temperature between 68°F to 77°F (20°C to 25°C).
JAYPIRCA comes in a bottle with a child-resistant cap.

Keep JAYPIRCA and all medicines out of the reach of children.

General information about the safe and effective use of JAYPIRCA.

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use JAYPIRCA for a condition for which it was not prescribed. Do not give JAYPIRCA to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about JAYPIRCA that is written for health professionals.

What are the ingredients in JAYPIRCA?

Active ingredient: pirtobrutinib

Inactive ingredients: croscarmellose sodium, hypromellose acetate succinate, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and silicon dioxide. The tablet film coating contains FD&C Blue #2, hypromellose, titanium dioxide, and triacetin.

Marketed by Lilly USA, LLC, Indianapolis, IN 46285, USA

JAYPIRCA is a registered trademark of Eli Lilly and Company.

JAY-0007-PPI-20261002

For more information, go to www.jaypirca.com or call 1-800-LillyRx (1-800-545-5979).

Jaypirca (Pirtobrutinib): Uses, Side Effects and Dosage