0:00-0:05
[Piano music with a soft beat begins. Scene comes into view of a man in his 70s standing inside his garage as the garage door slowly opens. Soft music continues for the rest of the video]
Living with CLL, I know there's always a chance it can progress. But I can't let it get the better of me.
0:06-0:11
[Close-up of the man looking out of his garage. Information about Jaypirca being the only FDA-approved noncovalent BTK inhibitor appears onscreen]
Which is why I asked my doctor about Jaypirca—a different kind of BTK inhibitor.
0:12-0:19
[Wide shot of the man from behind as he stands looking out of his garage, watching his granddaughter play hopscotch in the driveway. Indication statement appears onscreen]
Jaypirca is for adults with CLL who have already received 2 or more treatments for their cancer, including both a BTK inhibitor and a BCL-2 inhibitor.
0:20-0:22
[Indication statment remains onscreen then fades out. Close up of the man looking out of his garage is shown as sparks begin to animate around his body]
And Jaypirca is an oral, once-daily tablet that I . . .
0:23-0:24
[Camera begins moving around the inside of the garage, as an old-time picture of a man riding a bicycle is shown]
. . . take with or without food, at about the . . .
0:25-0:28
[Camera shifts to the man's work bench. A picture of him with his granddaughter is shown]
. . . same time each day. Which allows me to treat my CLL at home.
0:29-0:34
[Side view of the man at his work bench as he begins taking the training wheels off his granddaughter's bicycle. Sparks slowly animate around his body. Some of the results of Jaypirca from a clinical trial are shown onscreen.]
Jaypirca was studied in a clinical trial of 108 adults with CLL that measured response to treatment. . .
0:35-0:39
[Camera shifts to a back view of the man at his work bench as he continues taking the training wheels off of his granddaughter's bicycle. Sparks continue to slowly animate around his body. Some of the results of Jaypirca from a clinical trial are shown onscreen]
. . . and duration of response. 72% saw a response to treatment and had fewer signs of disease.
0:40-0:46
[Close up of the man finishing the job of removing his granddaughter's training wheels is shown. Sparks continue to animate around him. Information from the clinical trial about how many people discontinued Jaypirca due to side effects is displayed onscreen]
In the trial, more than 90% of people were able to continue taking Jaypirca without needing to stop because of side effects.
0:47-0:51
[The man brings the bicycle without training wheels out to his granddaughter who is sitting in the driveway. Sparks are animating around him as he walks toward her. Camera shifts to a close-up of the granddaughter's smiling face. Information from the clinical trial about how many people discontinued Jaypirca due to side effects remains onscreen]
And that matters, because these days I've got a lot going on.
0:52-1:00
[The man pushes his granddaughter on her bicycle down the driveway. Sparks become more numerous and continue animating around him. Possible side effects while taking Jaypirca are shown onscreen]
Jaypirca can cause serious side effects, including: infections, bleeding problems, decrease in blood counts, heart rhythm problems, second primary cancers, and liver problems.
1:01-1:11
[The man's granddaughter begins riding all by herself as she takes off down the driveway and into the cul de sac. Sparks are all around the man now as he smiles, enjoying the moment. The most common side effects while taking Jaypirca are shown onscreen]
The most common side effects include: tiredness; muscle, joint, and bone pain; diarrhea; COVID-19; bruising; and cough. Please see Safety Summary at the end of this video for additional information.
1:12-1:22
[The man's granddaughter circles around him on her bicycle. Camera shifts to a head-on shot of him smiling as sparks animate all around him. The words ”Spark What's Possible” appear in the sky in sparked type, as the camera pulls away from him and his granddaughter]
With Jaypirca, I feel like I can keep moving forward.
1:23-7:30
[Voice over of the Indication and Accelerated Approval statement, along with the Safety Summary for Jaypirca is heard as the safety content scrolls onscreen]
INDICATION AND SAFETY SUMMARY
Jaypirca is a prescription medicine used to treat adults with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who have already received at least 2 treatments for their cancer, including a Bruton's 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.
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
7:31-7:34
[Scene transition to the sign-off screen with the Lilly and Jaypirca logos, legal language, and a message to learn more at Jaypirca.lilly.com]
Jaypirca 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.
Jaypirca is a different kind* of BTK inhibitor for the treatment of relapsed or refractory† MCL and previously treated CLL
*Jaypirca is the only FDA-approved noncovalent BTK inhibitor.
Jaypirca, a , works differently than other BTK inhibitors you may have taken before.
For MCL, it was developed to work after you have taken a covalent BTK inhibitor. For CLL, it works after you have taken a covalent BTK inhibitor and a BCL-2 inhibitor. There are no completed studies comparing Jaypirca to other BTK inhibitors.
†Refractory is when your cancer doesn't respond to treatment.
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