Pirtobrutinib

What is Pirtobrutinib?

• Pirtobrutinib (Jaypirca) is a kinase inhibitor.

Pirtobrutinib

What are the uses of this medicine?

• Pirtobrutinib (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 two or more treatments for their cancer, including a Bruton tyrosine kinase (BTK) inhibitor medicine.

How does this medicine work?

• An orally available, selective, non-covalent Bruton's tyrosine kinase (BTK) inhibitor with potential antineoplastic activity.
• Upon oral administration, pirtobrutinib selectively and reversibly binds to BTK.
• This prevents both the activation of the B-cell antigen receptor (BCR) signaling pathway and BTK-mediated activation of downstream survival pathways, thereby inhibiting the growth of malignant B-cells that overexpress BTK.
• Reversible binding of LOXO-305 may preserve antitumor activity in the presence of certain acquired resistance mutations, including C481 mutated BTK, and limit toxicity associated with inhibition of other non-BTK kinases.
• BTK, a member of the Src-related BTK/Tec family of cytoplasmic tyrosine kinases, is overexpressed or mutated in B-cell malignancies; it plays an important role in the development, activation, signaling, proliferation and survival of B-lymphocytes.

Who Should Not Use this medicine ?

• This medicine have no usage limitations.

What drug interactions can this medicine cause?

• Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
• Your doctor may need to change the doses of your medications or monitor you carefully for side effects.

Be sure to mention any of the following:

• Strong CYP3A Inhibitors
• Strong or Moderate CYP3A Inducers

• Tell your doctor what herbal products you are taking, especially St. John's Wort.

Is this medicine FDA approved?

• Pirtobrutinib was approved for medical use in the United States in January 2023.

How should this medicine be used?

Recommended dosage:

• The recommended dosage of Jaypirca is 200 mg orally once daily until disease progression or unacceptable toxicity.

Administration:

• Take Jaypirca exactly as your healthcare provider 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 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 the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Tablets: 50 mg, 100 mg.

This medicine is available in fallowing brand namesː

• Jaypirca

What side effects can this medication cause?

The most common side effects of this medicine include:

• tiredness
• muscle, joint, and bone pain
• diarrhea
• swelling
• shortness of breath
• pneumonia
• bruising

Less common, but serious side effects may include:

• Infections
• hemorrhage
• Decrease in blood cell counts
• atrial fibrillation and atrial flutter
• Second primary cancers

What special precautions should I follow?

• Fatal and serious infections (including bacterial, viral, or fungal infections) and opportunistic infections have occurred in patients treated with Jaypirca. Monitor for signs and symptoms of infection, evaluate promptly, and treat.
• Fatal and serious hemorrhage has occurred with Jaypirca. Monitor for bleeding and manage appropriately.
• Grade 3 or 4 cytopenias, including neutropenia, anemia, and thrombocytopenia have developed in patients treated with Jaypirca. Monitor complete blood counts during treatment.
• Atrial fibrillation and atrial flutter were reported in recipients of Jaypirca. Monitor for symptoms of arrhythmias and manage appropriately.
• Second primary malignancies, including non-skin carcinomas, developed in patients treated with Jaypirca monotherapy. Other malignancies have developed, including skin cancers and other carcinomas. Monitor and advise patients to use sun protection.
• Based on findings in animals, Jaypirca can cause fetal harm when administered to a pregnant woman. Advise females of reproductive potential of potential risk to a fetus and to use effective contraception.
• Advise women not to breastfeed during treatment with Jaypirca and for one week after the last dose.

What to do in case of emergency/overdose?

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.

Can this medicine be used in pregnancy?

• Based on findings from animal studies, Jaypirca can cause fetal harm when administered to a pregnant woman.
• Jaypirca can harm your unborn baby.

Females who are able to become pregnant:

• Your healthcare provider will do a pregnancy test before starting treatment with Jaypirca.
• You should use effective birth control (contraception) during treatment with Jaypirca and for 1 week after your last dose of Jaypirca.
• Tell your healthcare provider right away if you become pregnant or think you are pregnant during treatment with Jaypirca.

Can this medicine be used in children?

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

What are the active and inactive ingredients in this medicine?

• Active ingredient: pirtobrutinib
• 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.

Who manufactures and distributes this medicine?

• Marketed by Lilly USA, LLC, Indianapolis, IN, USA
• Jaypirca is a trademark of Eli Lilly and Company.

What should I know about storage and disposal of this medication?

• Store Jaypirca at room temperature between 68°F to 77°F (20°C to 25°C).
• Jaypirca comes in a bottle with a child-resistant cap.

• Dailymed label info on Pirtobrutinib
• FDA Pirtobrutinib

Pirtobrutinib Resources
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