Pirtobrutinib
Pirtobrutinib (Jaypirca) is a targeted cancer medicine used to treat certain types of relapsed or refractory blood cancers, including mantle cell lymphoma and chronic lymphocytic leukemia or small lymphocytic lymphoma, in adults who have already tried other therapies.
🧬 Where this information comes from Click to expand
The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 1 clinical label set within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →
📖 Pirtobrutinib: Patient Information Guide
A plain-language walkthrough of Pirtobrutinib — what it treats, how it works, how it’s taken, side effects, warnings and interactions. Tap any section to expand it.
🎯What it's used for▾
Pirtobrutinib is a targeted cancer medicine approved for adults with certain blood cancers that have returned or stopped responding to earlier treatments.
- Jaypirca (oral tablet) treats adults with relapsed or refractory mantle cell lymphoma (MCL) who have received at least two prior lines of therapy, including a BTK inhibitor. This approval is based on tumor response rates under the FDA's accelerated approval pathway, meaning continued approval depends on future trial results confirming clinical benefit.
- Jaypirca (oral tablet) treats adults with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who have previously been treated with a covalent BTK inhibitor.
⚙️How it works▾
Pirtobrutinib is a BTK inhibitor — it blocks a protein called Bruton's tyrosine kinase (BTK), which normally acts as a signaling switch that tells cancerous B-cells to grow, multiply, and spread. By locking onto BTK and shutting down this signal, pirtobrutinib slows or stops the growth of malignant B-cells involved in MCL, CLL, and SLL.
What sets pirtobrutinib apart is how it attaches to BTK: it binds in a non-covalent (non-permanent) way. This matters because older BTK inhibitors bind permanently, and cancer cells can develop a specific mutation (called C481) that breaks that permanent bond and makes the drug stop working. Pirtobrutinib can still block both normal BTK and BTK carrying that C481 mutation, making it an option for patients whose cancer has become resistant to earlier BTK inhibitors.
💊How it's taken▾
Jaypirca is taken as an oral tablet once daily, at the same time each day, with or without food. The tablets must be swallowed whole with water — do not cut, crush, or chew them.
- If a dose is missed by more than 12 hours, skip it and take the next scheduled dose — do not double up.
- Patients with severe kidney impairment require a lower dose, as directed by their prescriber.
- Dose adjustments (reductions or increases) may also be needed depending on side effects or certain interacting medicines — always follow your prescriber's guidance.
🤒Side effects — in detail▾
The most commonly reported side effects with Jaypirca include:
- Decreased neutrophil count (low infection-fighting white blood cells)
- Decreased hemoglobin (anemia — low red blood cells)
- Decreased platelet count (raises bleeding risk)
- Fatigue
- Bruising
- Musculoskeletal pain (muscle and joint pain)
- Diarrhea
- Cough
- Nausea
- Swelling (edema)
Serious reactions requiring prompt medical attention include severe infections (especially pneumonia and sepsis), significant bleeding, heart rhythm problems (such as atrial fibrillation), liver injury, and the development of new cancers — contact your care team right away if any of these occur.
⚠️Warnings & precautions▾
- Serious infections: Fatal and serious bacterial, viral, and fungal infections — including pneumonia and sepsis — have occurred. Patients with CLL/SLL face especially high risk. Report any fever, chills, or signs of infection immediately.
- Bleeding: Serious and sometimes fatal bleeding has been reported, including gastrointestinal and brain bleeding. Risk is higher in patients also taking blood thinners. Tell your doctor before any surgery.
- Low blood counts (cytopenias): Jaypirca can significantly lower levels of neutrophils (white blood cells), platelets, and red blood cells, increasing risk of infection, bleeding, and fatigue. Regular blood count monitoring is required.
- Heart rhythm problems: Atrial fibrillation, atrial flutter, and other arrhythmias have occurred. Tell your doctor about any palpitations, dizziness, fainting, or new shortness of breath.
- Second primary malignancies: New cancers — including non-melanoma skin cancers and others — have developed in patients on Jaypirca. Use sun protection and have regular skin checks.
- Liver injury: Severe, potentially fatal drug-induced liver injury has been reported with BTK inhibitors including Jaypirca. Liver function is monitored before and throughout treatment.
- Fetal harm: Jaypirca can harm a developing baby. Effective contraception is required during treatment and for one week after the last dose.
🔀What it interacts with▾
Pirtobrutinib is processed mainly by liver enzymes, so several medicines can raise or lower its levels — or have their own levels changed by it:
- Strong CYP3A inhibitors (e.g., itraconazole, certain antifungals, some HIV drugs): raise pirtobrutinib blood levels, increasing side effect risk — avoid if possible; a dose reduction is needed if combined.
- Strong or moderate CYP3A inducers (e.g., rifampin, efavirenz, bosentan): lower pirtobrutinib levels, potentially making it less effective — avoid if possible; a dose increase may be needed with moderate inducers.
- Antithrombotic agents (blood thinners): combining with Jaypirca increases the risk of serious bleeding — your doctor will weigh the risks and benefits carefully.
- Sensitive CYP2C8, CYP2C19, CYP3A, P-gp, or BCRP substrate drugs: Jaypirca can raise levels of these medications in the blood, potentially intensifying their side effects — check those medicines' labeling for guidance.
- Acid-reducing medicines (e.g., proton pump inhibitors like omeprazole): no clinically significant effect on pirtobrutinib levels.
This is not a complete list of interactions. Always talk with your doctor or pharmacist before starting, stopping, or changing any medication.
📋Before taking it▾
- Tell your prescriber about all medicines you take, including antifungals, antibiotics, HIV treatments, seizure medicines, and blood thinners — many can interact with Jaypirca.
- Tell your prescriber if you have severe kidney disease — a lower dose is required; the effect of dialysis on this medicine is not yet known.
- Tell your prescriber if you have any degree of liver disease — no dose change is needed, but liver function will be monitored throughout treatment.
- Tell your prescriber if you have a history of heart rhythm problems, high blood pressure, or other heart conditions — these may increase your risk of arrhythmias on Jaypirca.
- Pregnancy: Jaypirca can cause serious fetal harm. A pregnancy test is required before starting treatment. Use effective contraception during treatment and for one week after the last dose.
- Breastfeeding: Do not breastfeed during treatment or for one week after the last dose.
- Children: Safety and effectiveness in pediatric patients have not been established.
- Older adults (65+): Clinical trials included many older patients; those 65 and over experienced higher rates of serious side effects and require close monitoring.
📡Pharmacodynamics — effects in the body▾
At the recommended once-daily dose, pirtobrutinib maintains continuous blockade of BTK throughout the entire dosing interval — meaning BTK activity stays suppressed around the clock, regardless of how quickly the body naturally replenishes the BTK protein. Studies in heart rhythm safety showed that pirtobrutinib does not cause clinically meaningful changes in the QTc interval (the part of the heart's electrical cycle measured for arrhythmia risk), even at doses well above the recommended level.
🔬Pharmacokinetics — how your body processes it▾
Pirtobrutinib is well absorbed when taken by mouth, reaching peak blood levels in about 2 hours, and food does not meaningfully affect how much is absorbed overall — though a high-fat meal slightly delays and reduces the peak concentration. The drug is about 96% bound to proteins in the blood and has an effective half-life (the time it takes for blood levels to fall by half) of approximately 20 hours, allowing once-daily dosing to maintain steady levels. It is broken down mainly by the liver enzyme CYP3A4 and then excreted primarily through urine, with a smaller portion in feces. Patients with severe kidney impairment have notably higher drug exposure and require a dose reduction; liver impairment does not require a dose change.
📦How to store it▾
Store JAYPIRCA tablets at room temperature 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F) ( ).
📄 Written from Pirtobrutinib’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Every point is grounded in that labeling — nothing is invented. How we use AI →
🩺 Pharmacist Counseling Corner
Quick, plain-English answers to the questions patients ask most about Pirtobrutinib — the kind of thing our pharmacy team would talk through with you at the counter.
What exactly is Jaypirca treating, and why is it being prescribed to me instead of other options? ▾
Does it matter what time of day I take Jaypirca, or whether I take it with food? ▾
What side effects should I actually expect, and which ones do I need to call my doctor about right away? ▾
Are there medicines I'm already taking that could be a problem with Jaypirca? ▾
Is it safe to get pregnant or breastfeed while taking this medicine? ▾
My doctor mentioned my blood needs to be checked regularly. Why is that necessary? ▾
Is Pirtobrutinib available over the counter? ▾
When was Pirtobrutinib first available? ▾
Who makes Pirtobrutinib? ▾
💬 Answers drafted from Pirtobrutinib’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Grounded in that labeling — nothing is made up. How we use AI →
🧰 Keep exploring
💊 How Pirtobrutinib comes
Pirtobrutinib is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.
Tablet
How this form is used
- Jaypirca tablets are used to treat adults with relapsed or refractory mantle cell lymphoma (MCL) after at least two prior treatment regimens, including a BTK inhibitor
- Jaypirca tablets are used to treat adults with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) who have previously been treated with a covalent BTK inhibitor
- Jaypirca tablets are taken by mouth once daily, at the same time each day, with or without food
- Jaypirca tablets must be swallowed whole with water — do not cut, crush, or chew them
- If a Jaypirca dose is missed by more than 12 hours, skip that dose and resume the next scheduled dose
- Jaypirca dose may need to be reduced if you have severe kidney impairment or are taking certain interacting medicines — follow your prescriber's instructions
📊 Pirtobrutinib across the U.S. market
How Pirtobrutinib appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.
Also listed with the FDA, not a patient dose form: Powder (5) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.
Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
📈 How widely Pirtobrutinib is used
A general measure of how commonly Pirtobrutinib is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.
Think of this as a proxy for how widely Pirtobrutinib is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.
How commonly is Pirtobrutinib prescribed? Of the 1,596 medications we measure, Pirtobrutinib ranks #1,473 by Medicaid prescriptions — more than 8% of them.
Utilization by Pirtobrutinib product
Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.
pirtobrutinib 100 MG Oral Tablet
Summed across the 1 of 2 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2629343
Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.
Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Pirtobrutinib, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 1 of 2 listed Pirtobrutinib NDCs with Medicaid activity.
🔍 Compare Pirtobrutinib products
A representative set of FDA-listed product records for Pirtobrutinib — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)
| Strength | Route | Manufacturer / Labeler | Category ⓘ | Details |
|---|---|---|---|---|
| 💊Tablet | ||||
| 50 mg | Oral | Eli Lilly and Company × 2 listings | NDA | View NDC → |
| 100 mg | Oral | Eli Lilly and Company × 2 listings | NDA | View NDC → |
| 💊Bulk drug substance | ||||
| 1 kg/kg | — | Eli Lilly Kinsale Limited | BULK INGREDIENT | View NDC → |
| 1 kg/kg | — | Hetero Labs Limited | BULK INGREDIENT | View NDC → |
| 50 kg/100 kg | — | Hovione Farmaciencia Sa | DRUG FOR FURTHER PROCESSING | View NDC → |
| 1 kg/kg | — | MSN Laboratories Private Limited | BULK INGREDIENT | View NDC → |
| 1 kg/kg | — | TAPI Hungary Industries Kft. | BULK INGREDIENT | View NDC → |
Showing 9 of 9 products — FDA National Drug Code Directory. See every product, package size and price: browse all 9 Pirtobrutinib NDCs →
📈 What people report — real-world data (FDA FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Pirtobrutinib — a signal of what to watch for, not proof the drug caused it.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Pirtobrutinib in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
🏛️ The road to your pharmacy
How Pirtobrutinib went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
🚨 Recall history
A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.
Source: openFDA drug enforcement (recall) reports.
RxNorm Concept Web — From Ingredient to Every Form and Strength
This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.
RxCUI 2629338 1 dose form · 2 strengths
-
Dose form (SCDF) Oral Tablet RxCUI 2629342In current FDA listings
Look up RxCUI 2629338 in the RxCUI Atlas →
RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.
📦 Supply & shortage status
Whether Pirtobrutinib is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
🏷️ Sold under these brand names
🏭 Manufacturers & labelers
RxNorm drug class
Pirtobrutinib belongs to the Kinase Inhibitor class.
Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.
🔬 Where this comes from
Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.
How we combine label and product data
HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 1 FDA-filed SPL label set within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. The representative label is the starting point for the displayed reference monograph; the 12 largest stored in-scope SPL records, which may include that representative, are compared section by section, and the longest available version of each section is retained. Forms, routes, brands, labelers, product-listed strengths, and product-record counts are aggregated separately from ingredient-matched FDA NDC Directory records; package records listed above are associated with the linked SPL; and the normalized concept hierarchy comes from NLM RxNorm.
For canonical ingredient pages, bounded product-attributed indication and administration excerpts may be added to the AI evidence, and the generator is instructed to preserve available product, brand, route, and form qualifiers instead of treating one label as universal. Where a section is identified as AI-written, its plain-language text is generated from bounded label evidence. New draft drug pages remain in the admin review queue before first publication. Eli Lilly and Company is the representative DailyMed label linked for verification and dates; it is not the sole source used for the page.
This is general education, not medical advice — always consult your doctor or pharmacist about your medications and any medical condition. For the exact wording of the linked representative label, view that label on DailyMed; some displayed composite sections may come from other in-scope SPL labels. Learn how we use AI and our data sources & update cadence.