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

Jaypirca was studied in a clinical trial that included people with mantle cell lymphoma (MCL) that came back or did not respond to previous treatment, and who had already received one or more treatments for their cancer, including a Bruton tyrosine kinase (BTK) inhibitor medicine. The trial evaluated 120 people for their response to treatment (a response means their cancer shrank or stopped spreading) and how long the response lasted. People in the trial took Jaypirca once daily until their disease got worse or they were no longer able to tolerate treatment.

Half of adults who took Jaypirca saw a response to treatment and had 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:

of adults with MCL (60 out of 120) saw their cancer shrink and stop spreading while taking Jaypirca

Of the 50%:

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

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.

SELECT SAFETY INFORMATION

Warnings - Jaypirca may cause serious side effects, including:
Decrease in blood cell counts (cytopenia). Decrease in white blood cells, platelets, and red blood cells is common with Jaypirca but can also be severe. This may increase your risk of infection, bleeding, and anemia. Your doctor will do blood tests regularly during treatment to monitor your counts.

In a clinical trial, Jaypirca started working quickly, with some people seeing their cancer reduce in size and stop spreading as soon as 7 to 8 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.

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 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.

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

Heart rhythm problems (atrial fibrillation and atrial flutter). Changes in heartbeat can happen 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 skin cancers during treatment. Use sun protection when you are outside in sunlight.

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

Common side effects

The most common side effects of Jaypirca include:

tiredness
muscle, joint, and bone pain
diarrhea
swelling

shortness of breath
pneumonia
bruising

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
are pregnant or plan to become pregnant. Jaypirca can harm an 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 to.
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, 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 MCL APP

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

INDICATIONS

Jaypirca™ (JAY-PIHR-KAA) is a 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 two or more treatments for their cancer, including a Bruton tyrosine kinase (BTK) 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.