Generic name: Pirtobrutinib
Brand name: Jaypirca
Dosage form: tablets (50mg, 100mg)
Drug class: BTK inhibitors

Medically reviewed by Melisa Puckey, BPharm. Last updated on May 2, 2024.

What is pirtobrutinib?

Pirtobrutinib (Jaypirca) is used to treat types of chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), and mantle cell lymphoma (MCL). Pirtobrutinib tablets may help reduce the amount of CLL, SLL, and MCL, and for MCL it may remove the cancer. It can help treat cancer in patients who have already been treated with ibrutinib, acalabrutinib, or zanubrutinib (covalent BTK inhibitors), as it works differently than these cancer medicines.

Pirtobrutinib FDA approval was received on January 27, 2023. It was approved as an accelerated approval based on the response rate. Continued approval for these indications may depend on verification and description of clinical benefit in other trials. Pirtobrutinib brand name is Jaypirca marketed by Lilly USA.

Pirtobrutinib tablet is an oral kinase inhibitor, and more specifically, it is a non-covalent (reversible) BTK inhibitor.

How does pirtobrutinib work?

Pirtobrutinib's mechanism of action is that it blocks BTK, which is a signaling protein found across numerous B-cell leukemia and lymphomas, including MCL, CLL, and SLL, that, when stimulated, activates pathways responsible for B-cell proliferation, activity, and growth. This blocks the activity that leads to the growth of the B-cells and causes cell death of the malignant B-cells. Jaypirca belongs to the class of drugs called Bruton's tyrosine kinase (BTK) inhibitors and is highly selective for BTK (300 times more selective than most other kinases).

What is pirtobrutinib used for?

Pirtobrutinib FDA approval is for adult patients with:

• Relapsed or refractory mantle cell lymphoma (MCL) after at least two lines of treatment, including a BTK inhibitor
• Chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) who have received at least two lines of treatment, including a Bruton's tyrosine kinase (BTK) inhibitor and a BCL-2 inhibitor.

Pirtobrutinib side effects

Common pirtobrutinib side effects

Common pirtobrutinib side effects may include bruising, tiredness, diarrhea, swelling, muscle, joint pain, bone pain, fever, chills, cough with mucus, chest pain, and feeling short of breath.

Serious pirtobrutinib side effects

Get emergency medical help if you have signs of an allergic reaction, such as hives, difficulty breathing, or swelling of your face, lips, tongue, or throat.

Other serious pirtobrutinib side effects. Call your doctor at once if you have:

• chest pressure, racing or pounding heartbeats, fluttering in your chest, feeling short of breath;
• signs of infection - fever, chills, sore throat, body aches, unusual tiredness, loss of appetite, bruising or bleeding;
• bleeding inside your body - weakness, dizziness; pink or brown urine; abnormal vaginal bleeding; bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds; or
• low blood cell counts - fever, chills, tiredness, mouth sores, skin sores, easy bruising, unusual bleeding, pale skin, cold hands and feet, feeling light-headed or short of breath.

Your cancer treatments may be delayed or permanently discontinued if you have certain side effects.

Also, see the ‘Warnings section’.

This is not a complete list of side effects, and others may occur. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Related/similar drugs

Warnings

Infections. Serious and deadly infections caused by bacteria, viruses, or fungi have occurred with pirtobrutinib, 24% were Grade 3 or higher; opportunistic infections such as those caused by Pneumocystis jirovecci pneumonia also occurred. Consider prophylaxis, such as vaccinations and antibiotics in those at increased risk.

Bleeding. Serious and fatal bleeding events (hemorrhage) have also occurred with pirtobrutinib. Monitor for any signs of bleeding and manage appropriately.

Low blood cell counts. Lower than normal blood cell counts, including low neutrophils, platelets, or red blood cells, can occur. Your healthcare provider will monitor your blood counts regularly throughout treatment.

Cardiac arrhythmia. Cardiac arrhythmias may occur, including atrial fibrillation and atrial flutter, and second primary cancers, including skin cancers, have also occurred. Use sun protection when outside.

Fetal Harm. This medicine can cause fetal harm. Females of reproductive potential should use effective contraception.

It is not known if this medicine is safe and effective in children.

Before taking this medicine

Tell your doctor if you have or have ever had:

• an infection or have been told you are at an increased risk of infection;
• recent surgery, or plan to have surgery or a dental procedure;
• bleeding problems or are taking a blood thinner medicine;
• heart rhythm problems;
• high blood pressure;
• other types of cancer, including skin cancer; or
• kidney disease.

Pregnancy

Tell your healthcare provider if you are pregnant, plan to become pregnant or become pregnant, as pirtobrutinib may harm an unborn baby. Do not use this medicine if you are pregnant. Your healthcare provider will do a pregnancy test before starting treatment in females who can become pregnant. Females who are able to become pregnant should use effective birth control (contraception) during treatment and for 1 week after their last dose. Tell your healthcare provider right away if you become pregnant or think you are pregnant during treatment.

Breastfeeding

Tell your healthcare provider if you are breastfeeding or planning to breastfeed, as it is not known if pirtobrutinib passes into your breast milk. Do not breastfeed during treatment and for 1 week after your last dose.

How should I take this medicine?

Pirtobrutinib instructions

Take pirtobrutinib tablets 1 time each day at about the same time each day. Tablets can be taken with or without food. Tablets should be swallowed whole with water. Do not cut, crush, or chew the tablets.

General Information

Take pirtobrutinib tablets exactly as your healthcare provider tells you. Do not change your dose or stop treatment unless your healthcare provider tells you to do so.

You will need to have blood tests often.

Using this medicine may increase your risk of developing cancer. Ask your doctor about your individual risk.

Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors.

Pirtobrutinib Dosing Information

Usual Adult Dose of Jaypirca for CLL, SLL, and MCL
Dose: 200 mg orally once daily
Length of Therapy: Until disease progression or unacceptable toxicity occurs.
Comments: These indications are approved under accelerated approval based on response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.
Use:

• For the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL) after at least two lines of systemic therapy, including a BTK inhibitor.
• For the treatment of adult patients with chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) who have received at least two lines of treatment, including a Bruton's tyrosine kinase (BTK) inhibitor and a BCL-2 inhibitor.

Jaypirca brand is available in 50 mg and 100 mg tablets.

What happens if I miss a dose?

If you miss a dose, 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 pirtobrutinib, skip the missed dose, and take your next dose on the next day at your usual time.

What other drugs will affect pirtobrutinib?

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

Pirtobrutinib interacts with other drugs that are metabolized in a certain way. Tell your doctor if you are taking medicines that contain any of the following drugs:

• strong CYP3A inhibitors: cobicistat, ritonavir, itraconazole, ketoconazole, posaconazole, voriconazole, ceritinib, clarithromycin, idelalisib, nefazodone, nelfinavir
• strong CYP3A inducers: apalutamide, carbamazepine, enzalutamide, ivosidenib, lumacaftor, mitotane, phenytoin, rifampin, St. John’s wort
• moderate CYP3A inducers: bosentan, cenobamate, dabrafenib, efavirenz, etravirine, lorlatinib, pexidartinib, phenobarbital, primidone, sotorasib

Pirtobrutinib may also interact with grapefruit juice, though the effect varies widely among brands of grapefruit juice.
For more information on interactions with pirtobrutinib, click on the link below.

Jaypirca Package Insert

Review the Jaypirca Package Insert for more detailed information about this medicine. Discuss any medical questions you have with your doctor or other health care provider. This is not all the information you need to know about this medicine for safe and effective use, and it does not take the place of talking to your doctor about your treatment.

Storage

• Store tablets at room temperature between 68°F to 77°F (20°C to 25°C).
• The tablets come in a bottle with a child-resistant cap.
• Keep all medicines out of the reach of children and pets.

Ingredients

Active ingredients: pirtobrutinib

Jaypirca 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.

Jaypirca Manufacturer

Eli Lilly and Company.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer