Patient Medication Information: uses, side effects, how to take - Jaypirca
What Jaypirca is used for:
For the following indication(s) JAYPIRCA has been approved with conditions (NOC/c). This means it has passed Health Canada’s review and can be bought and sold in Canada, but the manufacturer has agreed to complete more studies to make sure the drug works the way it should. For more information, talk to your healthcare professional.
JAYPIRCA (pirtobrutinib) is used to treat adults with:
- Mantle cell lymphoma (MCL), a type of cancer that affects your blood cells. JAYPIRCA is intended to be used by patients with MCL that have previously had two other treatments (including a type of drug called a BTK inhibitor).
- Chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL), types of cancer that affect your blood cells or lymph nodes. JAYPIRCA is intended to be used by patients with CLL/SLL that have previously had two other treatments (including a type of drug called a BTK inhibitor and a BCL-2 inhibitor).
What is a Notice of Compliance with Conditions (NOC/c)?
A Notice of Compliance with Conditions (NOC/c) is a type of approval to sell a drug in Canada.
Health Canada only gives an NOC/c to a drug that treats, prevents, or helps identify a serious or life-threatening illness. The drug must show promising proof that it works well, is of high quality, and is reasonably safe. Also, the drug must either respond to a serious medical need in Canada or be much safer than existing treatments.
Drug makers must agree in writing to clearly state on the label that the drug was given an NOC/c, to complete more testing to make sure the drug works the way it should, to actively monitor the drug’s performance after it has been sold, and to report their findings to Health Canada
Serious Warnings and Precautions
- Take JAYPIRCA only under the care of a healthcare professional who is experienced in the use of anti-cancer drugs
- Serious bleeding problems may occur when you take JAYPIRCA. This can be bleeding a lot or bleeding that is difficult to stop. For more information, see the “Serious side effects and what to do about them” table, below.
How JAYPIRCA works:
JAYPIRCA blocks a specific protein in the body that helps MCL, CLL and SLL cells grow and survive. This protein is called “Bruton tyrosine kinase” (BTK). By blocking BTK, JAYPIRCA helps to kill these cells and can reduce their number, which can slow down the worsening of the cancer.
The ingredients in JAYPIRCA are:
Medicinal ingredients: pirtobrutinib
Non-medicinal ingredients: croscarmellose sodium, FD&C Blue #2, hypromellose, hypromellose acetate succinate, lactose monohydrate, magnesium stearate, microcrystalline cellulose, silicon dioxide, titanium dioxide and triacetin.
JAYPIRCA comes in the following dosage forms:
Tablets: 50 mg and 100 mg
Do not use JAYPIRCA if:
- You are allergic to pirtobrutinib or any of the other ingredients in this medicine.
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take JAYPIRCA. Talk about any health conditions or problems you may have, including if you:
- have kidney disease or issues with the function of your kidneys.
- have or ever had unusual bruising or bleeding or are on any medicines or supplements that could increase your risk of bleeding.
- recently had low counts of red blood cells (anemia), neutrophils (a type of white blood cell that fights infections) or platelets (components that help the blood to clot).
- have recently had any surgery or are planning to have surgery. Your healthcare professional may ask you to stop taking JAYPIRCA for a short time (3 to 5 days) before and after your surgery. This includes any planned medical, surgical, or dental procedure.
- have or ever had an irregular heartbeat or have other heart and/or blood vessel problems, such as high blood pressure, history of a heart attack or have heart valve damage.
Other warnings you should know about:
- Lactose: This product contains lactose. If you have hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption, you should not take JAYPIRCA.
Infections: Talk to your Healthcare professional if you have an infection or are at an increased risk of developing an opportunistic infection (infections seen in patients with a weakened immune system). Your doctor may give you medicines to treat or prevent infections.
You may get infections during treatment with JAYPIRCA. Contact your healthcare professional if you have fever, chills, weakness, confusion, body aches, cough, cold or flu symptoms, feel tired, feel short of breath, have pain or burning feeling when passing urine. These could be signs of an infection.
- Skin Cancer: Treatment with JAYPIRCA may increase your risk of developing skin cancer. Talk to your healthcare professional if you develop a new lesion or any change in the appearance of an area on the skin. Use sun protection and make regular skin examinations.
Pregnancy, breastfeeding and fertility:
It is unknown whether JAYPIRCA will have an effect on fertility. Talk to your healthcare professional for advice if you are planning to have a baby.
Female Patients:
If you are a woman of childbearing age, you must use a highly effective method of contraception (birth control) during treatment and for 5 weeks after your last dose of JAYPIRCA. Tell your healthcare professional immediately if you become pregnant.
If you are pregnant or breastfeeding, are able to get pregnant or think you are pregnant, ask your healthcare professional for advice before taking this medicine. Do not use JAYPIRCA during pregnancy.
Do not breastfeed while taking JAYPIRCA and for one week after your last dose of JAYPIRCA. It is unknown whether JAYPIRCA passes into breast milk.
Male Patients:
You must use an effective method of contraception (birth control) during your treatment and for 3 months after your last dose of JAYPIRCA.
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
Examples of other medicines that can affect how well JAYPIRCA works:
- Bosentan, ritonavir (medicine used to treat pulmonary arterial hypertension)
- Efavirenz (medicine used to treat HIV)
- Itraconazole (medicine used to treat fungal infections)
- Rifampicin, rifapentine, rifabutin (antibiotic)
- St. John’s Wort – an herbal medicine used to treat depression
- Carbamazepine, phenytoin, phenobarbital (a barbiturate, a type of medicine used to treat seizures)
- Apalutamide, enzalutamide (medicines used to treat prostate cancer)
Examples of medicines that may be affected by JAYPIRCA:
- Omeprazole (medicine used to reduce gastric acid)
- Repaglinide (medicine used to treat diabetes)
- Digoxin (used to treat heart disorders)
- Rosuvastatin (medicine used to manage blood cholesterol)
- Warfarin (medicine used to prevent blood clots)
- Everolimus, sirolimus, tacrolimus (used to prevent organ rejection and skin conditions)
How to take JAYPIRCA:
- Always take this medicine exactly as your healthcare professional has told you. Check with your healthcare professional if you are not sure.
- JAYPIRCA should be taken at about the same time every day.
You can take the tablets with or without food.
- Swallow the tablet whole with a glass of water.
- Do not chew, crush, or split tablets before swallowing.
- If you vomit after taking JAYPIRCA, do not take an additional dose. Take your next dose at the usual time.
Usual dose:
The recommended dose of JAYPIRCA is 200 mg once a day.
If you get certain side effects while you are taking JAYPIRCA, your healthcare professional may stop treatment temporarily or lower your dose.
Overdose:
If you think you, or a person you are caring for, have taken too much JAYPIRCA, contact a healthcare professional, hospital emergency department, or regional poison control centre immediately, even if there are no symptoms.
Missed Dose:
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 possible side effects from using JAYPIRCA?
These are not all the possible side effects you may have when taking JAYPIRCA. If you experience any side effects not listed here, tell your healthcare professional.
- Bruising
- Unusually frequent or loose stool (diarrhea)
- Constipation
- Tiredness (fatigue)
- Headache
- Joint pain
- Feeling sick (Nausea)
- Belly (abdominal) pain
- Swelling (arm/leg)
- Skin rash
Serious side effects and what to do about them
| Serious side effects and what to do about them | |||
|---|---|---|---|
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |
| Only if severe | In all cases | ||
| Only if severe | In all cases | ||
| Allergic reaction: itchy bumpy rash, difficulty breathing, swelling of your face, lips, tongue or throat | X | ||
| VERY COMMON | |||
| Infection: fever, chills, feeling weak or confused, cough, cold or flu symptoms, shortness of breath, pain or burning feeling when passing urine | X | ||
| Heart Problems (irregular or uncoordinated contractions of the upper chambers of the heart): irregular heartbeats, weak or uneven pulse, dizziness, light headedness, shortness of breath, chest discomfort, fainting or passing out as these are symptoms of heart rhythm problems | X | ||
| Low numbers of cells in the blood (anemia, neutropenia, thrombocytopenia): fever, fainting, bleeding, bruising, weight loss, general pain, lack of energy, severe headache, trouble walking | X | ||
| COMMON | |||
| New cancer such as Non-melanoma skin cancer: lump or discolored patch on the skin that stays after a few weeks and slowly changes. Lumps that are red/pink and firm and sometimes turn into ulcers. Patches that are usually flat and scaly | X | ||
| Hemorrhage (Bleeding): Sudden severe headaches, vision changes, confusion. Nosebleeds and bruise-like collection of blood under tissue (hematoma). Feeling of fullness, bruising in the abdomen. Blood in your vomit, urine or stool. Discolored urine (pink or brown) or stool (black). Difficulty breathing, chest pain or coughing up blood | X | ||
| RARE | |||
| Tumor lysis syndrome (the sudden, rapid death of cancer cells due to the treatment): nausea, shortness of breath, irregular heartbeat, heart rhythm | X | ||
| disturbances, lack of urination, clouding of urine, muscle spasms or twitching, tiredness and/or joint pain, severe muscle weakness, and seizures. Metabolic disorders (kidney failure, abnormal heartbeat) and abnormal blood test results. | |||
| UNKNOWN | |||
| Liver failure: yellowing of the skin or whites of the eyes (jaundice), bleeding easily, swollen abdomen, mental disorientation or confusion, sleepiness, coma | X | ||
If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.
Reporting Side Effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
- Visiting the Web page on Adverse Reaction Reporting (canada.ca/drug-device-reporting) for information on how to report online, by mail or by fax; or
- Calling toll-free at 1-866-234-2345.
NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.
Storage:
- Store JAYPIRCA at room temperature (15°C to 30°C). Do not use this medication after the expiry date (EXP) shown on the bottle.
- Keep out of reach and sight of children.
If you want more information about JAYPIRCA:
- Talk to your healthcare professional
- Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website: (Drug Product Database: Access the database); the manufacturer’s website www.lilly.ca, or by calling 1-888-545-5972.
- The information in this document is current as of the last revision date shown below. For the most current information please visit our website or contact us directly.
- You may need to read this package insert again. Please do not throw it away until you have finished your medicine
JAYPIRCA is a registered trademark owned by or licensed to Eli Lilly and Company, its subsidiaries, or affiliates.
Date of Authorization: 2025-10-17
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