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Half of adults with MCL who took Jaypirca saw their cancer shrink and stop spreading

Not an actual patient.

Half of adults who took Jaypirca saw a response to treatment and fewer signs of the disease on their scans.

In a clinical trial that measured the number of people who responded to treatment and how long the response lasted:

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50%

OF ADULTS WITH MCL (60 out of 120) saw their cancer shrink and stop spreading while taking Jaypirca

Of the 50%

13%

OF ADULTS (15 out of 120) had a complete response, which means scans and other tests showed no detectable signs of MCL.

38%

OF ADULTS (45 out of 120) had a partial response, which means scans and other tests showed their MCL shrank in response to treatment.

65% were still responding to treatment at 6 months.

For those who saw their MCL shrink and stop spreading, their response lasted a median* of 8.3 months.

*Median is the middle number in a range of numbers.

MCL=mantle cell lymphoma.

SELECT SAFETY INFORMATION

Warnings - Jaypirca may cause serious side effects, including:

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

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In a clinical trial, Jaypirca started working quickly, with some people seeing their cancer reduce in size and stop spreading as soon as 3.5 weeks after starting treatment.

In a clinical trial of Jaypirca, the median time for the cancer to shrink and stop spreading with treatment was 1.8 months, ranging from 3.5 weeks at the lowest to 4.2 months at the highest. Median is the middle number in a range of numbers ordered from lowest to highest.

Jaypirca was studied in a clinical trial that included adults with mantle cell lymphoma (MCL) that came back or did not respond to previous treatment and who had already received at least two prior treatments for their cancer, including a Bruton tyrosine kinase (BTK) inhibitor medicine.

Jaypirca was studied in 120 adults with relapsed or refractory† MCL

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All people in the study had already received at least 2 treatments for their cancer, including a BTK inhibitor

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Trial evaluated response to treatment and how long the response lasted (a response means their cancer shrank and stopped spreading)

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Trial participants took Jaypirca once daily until their disease got worse or they were no longer able to tolerate treatment

†Refractory is when your cancer doesn't respond to treatment.

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Learn about taking Jaypirca and possible side effects

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SAFETY SUMMARY

Warnings - Jaypirca may cause serious side effects, including:

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

Bleeding problems (hemorrhage). Bleeding problems can happen during treatment with Jaypirca. They 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 doctor if you have 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 blood that looks like coffee grinds
  • cough up blood or blood clots
  • increased bruising
  • dizziness
  • weakness
  • confusion
  • changes in your speech
  • headache that lasts a long time

Decrease in blood cell counts. Decrease in white blood cells, platelets, and red blood cells are common with Jaypirca, but can also be severe. This may increase your risk of infection, bleeding, and anemia. Your doctor should do blood tests regularly during treatment to monitor your counts.

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 doctor if you have any of the following symptoms:

  • fast or irregular heartbeat (palpitations)
  • dizziness
  • fainting
  • chest discomfort
  • shortness of breath

Second primary cancers. New cancers have happened during treatment with Jaypirca, including cancers of the skin or other organs. Your doctor will check you for other cancers during treatment. Use sun protection when you are outside in sunlight.

Liver Problems. Liver problems, which may be severe or life-threatening, or lead to death, can happen in people treated with Jaypirca. Your doctor will do blood tests to check your liver before and during treatment with Jaypirca. Tell your doctor or get medical help right away if you have any signs of liver problems, including stomach pain or discomfort, dark-colored urine, or yellow skin and eyes.

Your doctor may decrease your dose, temporarily stop, or permanently stop treatment with Jaypirca if you develop severe side effects.

Common side effects

  • tiredness
  • muscle, joint, and bone pain
  • diarrhea
  • COVID-19
  • bruising
  • cough

These are not all the possible side effects with Jaypirca. Call your doctor for medical advice about side effects. You may report side effects at 1-800-FDA-1088 or www.fda.gov/medwatch.

Before using

Before taking Jaypirca, tell your doctor about all 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 doctor may stop Jaypirca for a planned medical, surgical, or dental procedure
  • have bleeding problems and/or are taking blood thinner medicine
  • have or have 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. If you are able to become pregnant, your doctor will do a pregnancy test before starting treatment
    • Females who are able to become pregnant should use effective birth control (contraception) during treatment and for at least 1 week after the last dose of Jaypirca. Tell your doctor right away if you become pregnant or think you are pregnant during treatment
  • are breastfeeding or plan to breastfeed. It is not known if Jaypirca passes into breast milk. Do not breastfeed during treatment and for at least 1 week after your final dose

Also tell your doctor 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 to take

  • Take Jaypirca exactly as your doctor tells you
  • Do not change your dose or stop taking Jaypirca unless your healthcare provider tells you to do so
  • Take Jaypirca tablets 1 time each day at about the same time each day
  • Take Jaypirca with or without food
  • Swallow Jaypirca tablets 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 you miss taking a dose by more than 12 hours from the time you usually take Jaypirca, skip the missed dose. Take the next dose on the next day at your usual time

Learn more

Jaypirca is a prescription medicine. For more information, call 1-800-545-5979 or go to www.Jaypirca.com. This summary provides basic information about Jaypirca but does not include all information known about this medicine. Read the information that comes with your prescription each time your prescription is filled. This information does not take the place of talking with your doctor. Be sure to talk to your doctor or other healthcare provider about Jaypirca and how to take it. Your doctor is the best person to help you decide if Jaypirca is right for you.

PT CON BS COMBO JUN2024

Jaypirca® is a registered trademark owned or licensed by Eli Lilly and Company, its subsidiaries, or affiliates.

INDICATIONS

Jaypirca® (JAY-PIHR-KAA) is a prescription medicine used to treat adults with:

  • mantle cell lymphoma (MCL) that has come back or did not respond to previous treatment and who have already received at least 2 treatments for their cancer, including a Bruton tyrosine kinase (BTK) inhibitor medicine.
  • chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who have already received at least 2 treatments for their cancer, including a Bruton tyrosine kinase (BTK) inhibitor medicine and a B-cell lymphoma 2 (BCL-2) inhibitor medicine.

Jaypirca was approved based on how many people responded to treatment. Studies are ongoing to confirm the benefit of Jaypirca for this use.

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