Jaypirca

Generic name: Pirtobrutinib
Dosage form: Oral tablets
Drug class: BTK inhibitors

Usage of Jaypirca

Jaypirca (pirtobrutinib) is an oral kinase inhibitor that is approved under the accelerated approval classification to treat adults 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.

How does Jaypirca work?

Jaypirca works by blocking 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).

Jaypirca was the first non-covalent (reversible) BTK inhibitor to be approved. It can reestablish BTK inhibition in patients previously treated with a covalent BTK inhibitor (Ibrutinib, acalabrutinib, or Zanubrutinib) and extend the benefit of targeting the BTK pathway.

Jaypirca was first FDA-approved on January 27, 2023.

Jaypirca side effects

Jaypirca can cause serious side effects, including:

Infections. These can be severe and may lead to death. Your healthcare provider may prescribe other medicines to lower your risk of getting an infection. Tell your healthcare provider right away if you develop fever, chills, weakness, flu-like symptoms, or any other signs of an infection during treatment.

Bleeding problems (hemorrhage). These can be serious and may lead to death. The risk is increased in those who also take blood thinner medicine. Tell your healthcare provider if you develop 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

a headache that lasts a long time.

Decreased blood cell counts including low levels of white blood cells, platelets, red blood cells, and platelets are common with Jaypirca and can be severe and lead to an increased risk of infection, bleeding, and anemia. Your healthcare provider should do blood tests to check your blood counts regularly during treatment.

Heart rhythm problems (such as atrial fibrillation and atrial flutter). The risk may be higher in those with a history of high blood pressure or heart rhythm problems. Tell your healthcare provider if you develop any of the following signs or symptoms:

fast or irregular heartbeat (palpitations)

dizziness

fainting

chest discomfort

shortness of breath.

New cancers have happened in people during treatment with Jaypirca, including cancers of the skin or other organs. Your healthcare provider will check you for other cancers during treatment. Use sun protection when you are outside in sunlight.

Your healthcare provider may decrease your dose, temporarily stop, or permanently stop treatment if you develop severe side effects.

The most common Jaypirca side effects affecting 20% or more people include:

tiredness

muscle, joint, and bone pain

diarrhea

infections, such as COVID 19

bruising

cough.

Other side effects may include:

swelling

shortness of breath

pneumonia

laboratory test abnormalities (such as low Neutrophil, platelet, hemoglobin, and lymphocyte levels).

These are not all the possible side effects. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Before taking Jaypirca

Before you start treatment, tell your healthcare provider about all of 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 healthcare provider may stop treatment for any planned medical, surgical, or dental procedure.

have bleeding problems or are taking a blood thinner medicine

have or 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 your unborn baby

are breastfeeding or plan to breastfeed.

Pregnancy and breastfeeding

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

It is not known if Jaypirca passes into your breast milk. Do not breastfeed during treatment, and for 1 week after your last dose.

Relate drugs

How to use Jaypirca

Take Jaypirca 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.

Take the tablets 1 time each day at about the SAMe time each day.

Take the tablets with or without food.

Swallow the tablets whole with water. Do not cut, crush, or chew the tablets.

The recommended doSage of MCL, CLL/SLL is 200 mg orally once daily.

The dosage should be reduced in people with kidney disease.

Warnings

Serious and deadly infections caused by bacteria, viruses, or fungi have occurred with Jaypirca, 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.

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

Cytopenias, such as low neutrophils, platelets, or red blood cells can occur. Your healthcare provider will monitor your blood counts regularly throughout treatment.

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

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.

What other drugs will affect Jaypirca

Tell your healthcare provider 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.

Jaypirca 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

Jaypirca may also interact with grapefruit juice, though the effect varies widely among brands of grapefruit juice.

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