JAYPIRCA pirtobrutinib 100 mg Tablet, Coated, 60-count
🆔 Identity & classification
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🏷️ RxNorm drug class
This medicine belongs to the Kinase Inhibitor class.
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🏭 Manufacturer & labeler
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🩺 Clinical
Pirtobrutinib is used to treat mantle cell lymphoma (a fast-growing cancer that begins in the cells of the immune system) and chronic lymphocytic leukemia (CLL; a type of cancer that begins in the white blood cells) small lymphocytic lymphoma (SLL; a type of cancer that begins mostly in the lymph nodes). Pirtobrutinib is in a class of medications called kinase inhibitors. It works by blocking the action of the protein that signals cancer cells to multiply.
Read the full MedlinePlus article ↗- Jaypirca is used for two types of blood cancer — mantle cell lymphoma (MCL) and chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) — specifically when the disease...
- What exactly is Jaypirca treating, and why is it being prescribed to me instead of other options?
- You should take it at the same time every day — consistency matters more than the specific hour. The good news is you can take it with or without food, so you can fit it into your...
- Does it matter what time of day I take Jaypirca, or whether I take it with food?
Patient education
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🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
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UNII M28OL1HH48
Croscarmellose sodium is a plant-based substance derived from cellulose. It acts as a disintegrant, helping tablets and capsules break down quickly in the digestive system so the medicine can be absorbed.
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UNII 4AQJ3LG584
A synthetic blue dye combined with aluminum to create a stable colorant. It's used in medicines and supplements to add blue color or create specific shades for product identification and appearance.
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UNII 36BGF0E889
Hypromellose acetate succinate is a modified plant cellulose used as a film coating on tablets and capsules. It helps protect the medicine and control where it dissolves in the digestive tract.
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UNII 3NXW29V3WO
Hypromellose is a plant-based thickener made from cellulose. It's used in medicines as a binder to hold ingredients together, a coating for tablets, and a thickener for liquids.
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UNII EWQ57Q8I5X
Lactose monohydrate is a natural sugar derived from milk. It serves as a filler and binder in tablets and capsules, helping create the proper size, texture, and consistency of the medicine.
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UNII 70097M6I30
Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
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UNII OP1R32D61U
Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
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UNII ETJ7Z6XBU4
Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
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UNII 15FIX9V2JP
Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.
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UNII XHX3C3X673
Triacetin is a clear, oily liquid made from glycerin and acetic acid. It works as a plasticizer and solvent in medicines, helping soften coatings and improve how liquids mix together in formulations.
10 inactive ingredients listed in the exact product block matched to this NDC.
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ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.Inactive ingredient FAQ
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💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per each | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | $382.43 | $22,945.72 / 60 tablets |
| Medicare drug plans payPart D · Q2 2026 | $382.83 | $22,969.80 / 60 tablets |
Where does this data come from?
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Jaypirca 100 mgthis 00002-7026-60 | Eli | 60 tablets | — | — | FDA listed | — |
Where does this data come from?
⏳ Availability & generic status
We did not find an FDA-approved generic match for this exact strength, form and route. Patent/protection dates below may affect future generic timing.
Why the date isn’t exact: Generic timing can change because patents may be challenged, settled, licensed, added, removed, or worked around with a narrower label — and FDA approval does not always mean a pharmacy can get the generic today.
🛈 What do these terms mean?
- Patent
- Legal protection listed in the Orange Book that may delay generic approval or launch. Issued by the U.S. Patent & Trademark Office.
- Substance patent
- Covers the active drug molecule itself — the hardest to design around. A generic generally can’t launch until it expires.
- Formulation (product) patent
- Covers a specific formulation or dosage form. A generic can sometimes work around it with a different formulation.
- Method-of-use patent
- A patent covering one specific approved use of the drug — not necessarily the whole molecule. A generic can sometimes launch with a “skinny label” that carves out the protected use and keeps the others.
- Skinny label
- A generic label that omits a still-patented use when the FDA allows it — letting a generic reach the market for the unprotected uses.
- Exclusivity
- FDA-granted marketing protection, separate from patents — e.g. 5-yr new chemical entity, 7-yr orphan drug, or a +6-month pediatric extension.
- Paragraph IV
- A generic applicant’s formal challenge to a listed patent. It can potentially lead to earlier generic entry, but often involves litigation or a settlement.
- RLD / RS
- Reference Listed Drug — the brand product the FDA uses as the reference for generic applications. Reference Standard — the product the FDA expects generics to compare against in bioequivalence testing.
- TE / AB rating
- FDA therapeutic-equivalence rating. An AB rating generally means the FDA considers a generic therapeutically equivalent to — and substitutable for — the brand.
- LOE (loss of exclusivity)
- The latest patent or exclusivity currently listed — the loss-of-exclusivity / latest-listed-protection date shown on this page. Paragraph-IV challenges and settlements can move the real date earlier; FDA approval and a manufacturer’s decision to market can move it later.
Built from the FDA Orange Book. The bars above are scaled to each protection’s expiry; the red LOE marker is the last one to lapse.
| Patent | Type | Use code | Expires |
|---|---|---|---|
| US 10918622 ↗ | Method of use | U-3518 | Dec 16, 2036 |
| US 10918622 ↗ | Method of use | U-3518 | Dec 16, 2036 |
| US 10695323 ↗ | Drug substance | U-3518 | Dec 16, 2036 |
| US 10695323 ↗ | Drug substance | U-3518 | Dec 16, 2036 |
| US 10464905 ↗ | Method of use | U-3518 | Dec 16, 2036 |
| US 10464905 ↗ | Method of use | U-3518 | Dec 16, 2036 |
| US 12220401 ↗ | Drug substance | U-3518 | Dec 16, 2036 |
| US 12220401 ↗ | Drug substance | U-3518 | Dec 16, 2036 |
| US 10464905 ↗ | Method of use | U-4362 | Dec 16, 2036 |
| US 10464905 ↗ | Method of use | U-4362 | Dec 16, 2036 |
| US 10918622 ↗ | Method of use | U-4362 | Dec 16, 2036 |
| US 10918622 ↗ | Method of use | U-4362 | Dec 16, 2036 |
| US 10695323 ↗ | Drug substance | U-4362 | Dec 16, 2036 |
| US 10695323 ↗ | Drug substance | U-4362 | Dec 16, 2036 |
| US 12220401 ↗ | Drug substance | U-4362 | Dec 16, 2036 |
| US 12220401 ↗ | Drug substance | U-4362 | Dec 16, 2036 |
| US 10342780 ↗ | Drug substance | — | Dec 16, 2036 |
| US 10342780 ↗ | Drug substance | — | Dec 16, 2036 |
| US 12109193 ↗ | Drug product | — | Sep 14, 2041 |
| US 12268666 ↗ | Drug product | — | Jul 29, 2039 |
| US 12268666 ↗ | Drug product | — | Jul 29, 2039 |
| US 12109193 ↗ | Drug product | — | Sep 14, 2041 |
| Code | What it grants | Expires |
|---|---|---|
| I-981 | New indication (3-year) | Dec 2, 2028 |
| NCE | New Chemical Entity (5-year) | Jan 27, 2028 |
| ODE-424 | Orphan Drug Exclusivity (7-year) | Jan 27, 2030 |
| ODE-451 | Orphan Drug Exclusivity (7-year) | Dec 1, 2030 |
| ODE-518 | Orphan Drug Exclusivity (7-year) | Dec 3, 2032 |
| I-981 | New indication (3-year) | Dec 2, 2028 |
| NCE | New Chemical Entity (5-year) | Jan 27, 2028 |
| ODE-424 | Orphan Drug Exclusivity (7-year) | Jan 27, 2030 |
| ODE-451 | Orphan Drug Exclusivity (7-year) | Dec 1, 2030 |
| ODE-518 | Orphan Drug Exclusivity (7-year) | Dec 3, 2032 |
Is there a generic version of JAYPIRCA 100 MG TABLET?
The FDA approved a generic — why can’t I get it at my pharmacy yet?
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🗺️ Medicaid utilization & spend
💊 Medicaid utilization by pack size
📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
🔬 Reported adverse events (FAERS)
Top reported reactions
Age at onset
Reporter sex
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📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 00002-7026-60 You're viewing this | 60 TABLET, COATED in 1 BOTTLE (0002-7026-60) | 2023-01-27 | Active |
| 00002-7026-99 | 30 TABLET, COATED in 1 BOTTLE (0002-7026-99) | 2023-02-15 | Active |
You're viewing the largest of 2 pack sizes for this product.
In Medicaid, this is the most-dispensed pack of this product — about 100% of fills over the last four reported quarters. See all packs ↓
Pack size FAQ
What quantity is in NDC 00002-7026-60?
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🧭 About this NDC listing & data coverage
What data is (and isn’t) available for this NDC — tap to expand
| NDC identity (package / product / labeler codes) | ✓ Available |
| Labeler | ✓ Available |
| Product & package description | ✓ Available |
| Marketing category & status | ✓ Available |
| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | ✓ Available |
| Package photos | ✓ Available |
| Inactive ingredients (structured) | ✓ Available |
| NADAC pharmacy acquisition price (CMS) | — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey. |
| Orange Book / therapeutic-equivalence data | ✓ Available |
| HCPCS J-code billing crosswalk | — Not published for this NDC Most self-administered / retail products have no J-code — that is normal. |
| Medicaid utilization (CMS SDUD) | ✓ Available |
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📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE JAYPIRCA ® is a kinase inhibitor indicated 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. ( 1.1 ). This indication is 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. Adult patients with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) who have previously been treated with a covalent BTK inhibitor. ( 1.2 ).
1.1Mantle Cell Lymphoma JAYPIRCA ® is indicated 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. This indication is approved under accelerated approval based on response rate [see Clinical Studies ( 14.1 )]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.
1.2Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma JAYPIRCA is indicated for the treatment of adult patients with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) who have previously been treated with a covalent BTK inhibitor.
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION Recommended dosage: 200 mg orally once daily; swallow whole with water, with or without food. Do not cut, crush, or chew tablets. ( 2.1 ) Manage toxicity using treatment interruption, dosage reduction, or discontinuation. ( 2.2 ) Reduce dose in patients with severe renal impairment. ( 2.3 , 8.6 )
2.1Recommended Dosage The recommended dosage of JAYPIRCA is 200 mg orally once daily until disease progression or unacceptable toxicity. Advise patients of the following: Swallow tablets whole with water. Do not cut, crush, or chew tablets. Take JAYPIRCA at the same time each day. JAYPIRCA may be taken with or without food. If a dose of JAYPIRCA is missed by more than 12 hours, do not make up the dose and take the next dose as scheduled.
2.2Dosage Modifications for Adverse Reactions Recommended dosage modifications of JAYPIRCA for adverse reactions are presented in Table 1 [see Warnings and Precautions ( 5.1 , 5.2 , 5.3 , and 5.4 )] . Table 1: Recommended Dosage Modification of JAYPIRCA for Adverse Reactions Dose modification is not recommended for asymptomatic lymphocytosis. Asymptomatic lipase increase may not necessarily warrant dose modification. a Evaluate the benefit-risk before resuming treatment at the same dose for a Grade 4 non-hematological toxicity.
Adverse Reaction Occurrences Requiring Dosage Modification Modification (Starting Dosage: 200 mg once daily) Grade 3 or greater non-hematologic toxicity a Absolute neutrophil count < 1 to 0.5 x 10 9 /L with fever and/or infection Absolute neutrophil count < 0.5 x 10 9 /L lasting 7 or more days Platelet count < 50 to 25 x 10 9 /L with bleeding Platelet count < 25 x 10 9 /L First occurrence Interrupt JAYPIRCA until recovery to Grade 1 or baseline; restart at original dosage (200 mg once daily) a . Second occurrence Interrupt JAYPIRCA until recovery to Grade 1 or baseline; restart at 100 mg once daily.
Third occurrence Interrupt JAYPIRCA until recovery to Grade 1 or baseline; restart at 50 mg once daily. Fourth occurrence Discontinue JAYPIRCA.
2.3Dosage Modifications for Patients with Severe Renal Impairment For patients with severe renal impairment (eGFR 15-29 mL/min), reduce the JAYPIRCA dose to 100 mg once daily if the current dose is 200 mg once daily otherwise reduce the dose by 50 mg. If the current dosage is 50 mg once daily, discontinue JAYPIRCA [see Use in Specific Populations ( 8.7 ), Clinical Pharmacology ( 12.3 )] . No dosage adjustment of JAYPIRCA is recommended in patients with mild to moderate renal impairment (eGFR 30-89 mL/min).
2.4Dosage Modifications for Concomitant Use with Strong CYP3A Inhibitors Avoid concomitant use of strong CYP3A inhibitors with JAYPIRCA [see Drug Interactions ( 7.1 ), Clinical Pharmacology ( 12.3 )] . If concomitant use of a strong CYP3A inhibitor is unavoidable, reduce the JAYPIRCA dose by 50 mg. If the current dosage is 50 mg once daily, interrupt JAYPIRCA treatment for the duration of strong CYP3A inhibitor use.
After discontinuation of a strong CYP3A inhibitor for 5 half-lives, resume the JAYPIRCA dose that was taken prior to initiating the strong CYP3A inhibitor.
2.5Dosage Modifications for Concomitant Use with CYP3A Inducers Avoid concomitant use of strong or moderate CYP3A inducers with JAYPIRCA [see Drug Interactions ( 7.1 ), Clinical Pharmacology ( 12.3 )] . If concomitant use with moderate CYP3A inducers is unavoidable and the current dosage of JAYPIRCA is 200 mg once daily, increase the dose to 300 mg. If the current dosage is 50 mg or 100 mg once daily, increase the dose by 50 mg.
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS Tablets: Each 50 mg tablet is blue, arc-triangle shaped, film-coated, and debossed with “Lilly 50” on one side and “6902” on the other side. Each 100 mg tablet is blue, round, film-coated, and debossed with “Lilly 100” on one side and “7026” on the other side. Tablets: 50 mg, 100 mg ( 3 ).
⛔ Contraindications ▾
4 CONTRAINDICATIONS None. None ( 4 ).
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS Infections: Monitor for signs and symptoms of infection, evaluate promptly, and treat. ( 5.1 ) Hemorrhage: Monitor for bleeding and manage appropriately. ( 5.2 ) Cytopenias: Monitor complete blood counts during treatment.
( 5.3 ) Cardiac Arrythmias: Monitor for symptoms of arrhythmias and manage appropriately. ( 5.4 ) Second Primary Malignancies: Other malignancies have developed, including skin cancers and other carcinomas. Monitor and advise patients to use sun protection.
( 5.5 ) Hepatotoxicity, Including Drug-Induced Liver Injury: Monitor hepatic function throughout treatment. ( 5.6 ) Embryo-Fetal Toxicity: Can cause fetal harm. Advise females of reproductive potential of potential risk to a fetus and to use effective contraception.
( 5.7 , 8.1 , 8.3 )
5.1Infections Fatal and serious infections (including bacterial, viral, or fungal infections) and opportunistic infections have occurred in patients treated with JAYPIRCA. Across clinical trials, Grade 3 or higher infections occurred in 25% of 704 patients, most commonly pneumonia (20%), with fatal infections occurring in 5% of patients. Sepsis occurred in 6% of patients and febrile neutropenia in 3.8%.
In patients with CLL/SLL, Grade 3 or higher infections occurred in 32% of patients, with fatal infections occurring in 8%. Opportunistic infections after treatment with JAYPIRCA have included, but are not limited to, Pneumocystis jirovecii pneumonia and fungal infection [see Adverse Reactions ( 6.1 )] . Consider prophylaxis, including vaccinations and antimicrobial prophylaxis, in patients who are at increased risk for infections, including opportunistic infections.
Monitor patients for signs and symptoms of infection, evaluate promptly, and treat appropriately. Based on severity, reduce dose, temporarily withhold, or permanently discontinue JAYPIRCA [see Dosage and Administration ( 2.2 )] .
5.2Hemorrhage Fatal and serious hemorrhage has occurred with JAYPIRCA. Major hemorrhage (defined as Grade 3 or higher bleeding or any central nervous system bleeding) occurred in 2.6% of 704 patients treated with JAYPIRCA, including gastrointestinal hemorrhage; fatal hemorrhage occurred in 0.3% of patients. Bleeding of any grade, excluding bruising and petechiae, occurred in 16% of patients [see Adverse Reactions ( 6.1 )] .
Major hemorrhage occurred in 0.6% of patients taking JAYPIRCA without antithrombotic agents and 2.0% of patients taking JAYPIRCA with antithrombotic agents. Consider the risks and benefits of antithrombotic agents when co-administered with JAYPIRCA. Monitor patients for signs of bleeding.
Based on severity of bleeding, reduce dose, temporarily withhold, or permanently discontinue JAYPIRCA [see Dosage and Administration ( 2.2 )] . Consider the benefit-risk of withholding JAYPIRCA for 3 to 7 days pre- and post-surgery depending upon the type of surgery and risk of bleeding.
5.3Cytopenias JAYPIRCA can cause cytopenias, including neutropenia, thrombocytopenia, and anemia. Across clinical trials, Grade 3 or 4 cytopenias, including decreased neutrophils (27%), decreased platelets (13%), and decreased hemoglobin (11%) developed in patients treated with JAYPIRCA. Grade 4 decreased neutrophils developed in 15% of patients and Grade 4 decreased platelets developed in 6% of patients [see Adverse Reactions ( 6.1 )] .
Monitor complete blood counts regularly during treatment. Based on severity, reduce dose, temporarily withhold, or permanently discontinue JAYPIRCA [see Dosage and Administration ( 2.2 )].
5.4Cardiac Arrhythmias Cardiac arrhythmias, including atrial fibrillation and atrial flutter, were reported in recipients of JAYPIRCA. Atrial fibrillation or flutter were reported in 3.4% of patients, with Grade 3 or 4 atrial fibrillation or flutter reported in 1.6% of 704 patients across clinical trials [see Adverse Reactions ( 6.1 )] . Other serious cardiac arrhythmias such as supraventricular tachycardia and cardiac arrest occurred in 0.4% of patien…
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Infections [see Warnings and Precautions ( 5.1 )] Hemorrhage [see Warnings and Precautions ( 5.2 )] Cytopenias [see Warnings and Precautions ( 5.3 )] Atrial Fibrillation and Atrial Flutter [see Warnings and Precautions ( 5.4 )] Second Primary Malignancies [see Warnings and Precautions ( 5.5 )] Hepatotoxicity, including DILI [see Warnings and Precautions ( 5.6 )] Most common adverse reactions (≥ 30%), including laboratory abnormalities, are fatigue, neutrophil count decreased, platelet count decreased, hemoglobin decreased, leukocytes decreased, lymphocyte count decreased and calcium decreased.
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Eli Lilly and Company at 1-800-LillyRx (1-800-545-5979) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be compared to rates in the clinical trials of another drug and may not reflect the rates observed in the general patient population. The data in the WARNINGS AND PRECAUTIONS reflect exposure to JAYPIRCA as a single-agent, administered at 200 mg once daily in 704 patients with hematologic malignancies in the BRUIN and the BRUIN-CLL-321 studies. Among these 704 patients, the median duration of exposure was 12 months; 65% were exposed for at least 6 months and 50% were exposed for at least one year.
In this pooled safety population, the most common (≥ 30%) adverse reactions, including laboratory abnormalities, were decreased neutrophil count (54%), decreased hemoglobin (43%), decreased leukocytes (32%), fatigue (31%), decreased platelets (31%), decreased lymphocyte count (31%), and calcium decreased (30%) Mantle Cell Lymphoma BRUIN The safety of JAYPIRCA was evaluated in the BRUIN trial, an open-label, multicohort, single-arm study in patients with previously treated MCL who received a prior BTK inhibitor [see Clinical Studies ( 14.1 ) ] .
The trial required a platelet count ≥ 50 x 10 9 /L, absolute neutrophil count ≥ 0.75 x 10 9 /L, hepatic transaminases ≤ 2.5 times upper limit of normal (ULN), and an ECOG performance status of 0 to 2. The trial excluded patients with active central nervous system (CNS) involvement by lymphoma, significant cardiovascular disease, major bleeding or grade ≥ 3 arrhythmia with a prior BTK inhibitor, prolonged QTc interval, or need for a strong CYP3A inhibitor or inducer or strong P-gp inhibitor. Patients received JAYPIRCA 200 mg orally once daily until disease progression or unacceptable toxicity (n = 128); 36% were exposed for 6 months or longer and 10% were exposed for at least one year.
The median number of prior therapies was 3 (range: 1-9). The median age was 71 years (range: 46 to 88 years) and 80% of patients were male. Race was reported for all patients; 78% were White, 14% were Asian, 2.3% were Black, and 2.3% were Hispanic or Latino.
Serious adverse reactions occurred in 38% of patients who received JAYPIRCA. Serious adverse reactions that occurred in ≥ 2% of patients were pneumonia (14%), COVID-19 (4.7%), musculoskeletal pain (3.9%), hemorrhage (2.3%), pleural effusion (2.3%), and sepsis (2.3%). Fatal adverse reactions within 28 days of the last dose of JAYPIRCA occurred in 7% of patients, most commonly due to infections (4.7%) including COVID-19 (3.1% of all patients).
Adverse reactions led to dose reductions in 4.7%, treatment interruption in 32%, and permanent discontinuation of JAYPIRCA in 9%. Adverse reactions that resulted in dosage modification in > 5% of patients included pneumonia and neutropenia. Adverse reactions which resulted in permanent discontinuation of JAYPIRCA in > 1% of patients included pneumonia.
The most common adverse reactions (≥ 15%), excluding laboratory terms, were fatigue, musculoskeletal pain, diarrhea, edema, dyspnea, pneumon…
🔄 Drug Interactions ▾
7 DRUG INTERACTIONS Strong CYP3A Inhibitors: Avoid concomitant use. If concomitant use is unavoidable, reduce the JAYPIRCA dose. ( 2.4 , 7.1 ) Strong or Moderate CYP3A Inducers: Avoid concomitant use.
If concomitant use of moderate CYP3A inducers is unavoidable, increase the JAYPIRCA dose. ( 2.5 , 7.1 ) Sensitive CYP2C8, CYP2C19, CYP3A, P-gp, or BCRP Substrates: For substrates where minimal concentration changes may increase the risk of adverse reactions, follow recommendations for co-administration with CYP2C8, CYP2C19, CYP3A, P-gp, or BCRP inhibitors provided in their approved product labeling. ( 7.2 )
7.1Effect of Other Drugs on JAYPIRCA Strong CYP3A Inhibitors Pirtobrutinib is a CYP3A substrate. Concomitant use of JAYPIRCA with a strong CYP3A inhibitor increased pirtobrutinib systemic exposure [see Clinical Pharmacology ( 12.3 )] , which may increase the risk of JAYPIRCA adverse reactions. Avoid concomitant use of strong CYP3A inhibitors during treatment with JAYPIRCA.
If concomitant use of strong CYP3A inhibitors is unavoidable, reduce the JAYPIRCA dosage [see Dosage and Administration ( 2.4 )] . Strong or Moderate CYP3A Inducers Concomitant use of JAYPIRCA with a strong or moderate CYP3A inducer decreased pirtobrutinib systemic exposure [see Clinical Pharmacology ( 12.3 )] , which may reduce JAYPIRCA efficacy. Avoid concomitant use of JAYPIRCA with strong or moderate CYP3A inducers.
If concomitant use of moderate CYP3A inducers is unavoidable, increase the JAYPIRCA dosage [see Dosage and Administration ( 2.5 )] .
7.2Effect of JAYPIRCA on Other Drugs Sensitive CYP2C8, CYP2C19, CYP3A, P-gp, or BCRP Substrates JAYPIRCA is a P-gp inhibitor, a moderate CYP2C8 and BCRP inhibitor, and a weak CYP2C19 and CYP3A inhibitor. Concomitant use of JAYPIRCA with sensitive P-gp, CYP2C8, BCRP, CYP2C19, or CYP3A substrates increased their plasma concentrations [see Clinical Pharmacology ( 12.3 )], which may increase the risk of adverse reactions related to these substrates for drugs which are sensitive to minimal concentration changes. Follow recommendations for sensitive CYP2C8, CYP2C19, CYP3A, P-gp, or BCRP substrates provided in their approved product labeling.
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS Lactation: Advise not to breastfeed ( 8.2 )
8.1Pregnancy Risk Summary Based on findings from animal studies, JAYPIRCA can cause fetal harm when administered to a pregnant woman. There are no available data on JAYPIRCA use in pregnant women to evaluate for a drug-associated risk. In an animal reproduction study, administration of pirtobrutinib to pregnant rats during organogenesis resulted in adverse developmental outcomes, including structural abnormalities, altered fetal growth, and embryo-fetal mortality, at maternal exposures approximately 3-times those in patients at the recommended daily dose of 200 mg (see Data).
Advise pregnant women of the potential risk to a fetus. The background risk in the U.S. general population of major birth defects is 2% to 4% and of miscarriage is 15% to 20% of clinically recognized pregnancies. Data Animal Data In an embryo-fetal development study in rats, pregnant animals were administered oral doses of pirtobrutinib at up to 500 mg/kg twice daily during the period of organogenesis.
Doses ≥ 375 mg/kg twice daily caused decreased fetal body weights and increased incidence of malformations and variations in the urinary tract (including absent or abnormal ureters and kidneys), reproductive tract (malpositioned ovaries and misshapen uterus), and bone (misshapen sternebrae). At 500 mg/kg twice daily, total resorption was observed. At 375 mg/kg twice daily in rats, the maternal systemic exposures (AUC) were approximately 3 times the human exposure at 200 mg once daily.
8.2Lactation Risk Summary There are no data on the presence of pirtobrutinib in human milk or the effects on the breastfed child or milk production. Because of the potential for serious adverse reactions in the breastfed child, advise women not to breastfeed during treatment with JAYPIRCA and for one week after the last dose.
8.3Females and Males of Reproductive Potential Based on findings from animal studies, JAYPIRCA can cause fetal harm when administered to a pregnant woman [see Use in Specific Populations ( 8.1 )]. Pregnancy Testing Verify pregnancy status in females of reproductive potential prior to initiating JAYPIRCA. Contraception Females Advise females of reproductive potential to use effective contraception during treatment with JAYPIRCA and for one week after the last dose.
8.4Pediatric Use Safety and effectiveness of JAYPIRCA have not been established in pediatric patients.
8.5Geriatric Use Of the patients with MCL who received the 200 mg dose of JAYPIRCA in BRUIN, 93 (78%) were 65 years of age and older and 39 (33%) were 75 years and older [see Clinical Studies ( 14.1 )] . Clinical studies of JAYPIRCA did not include sufficient numbers of patients with MCL who were less than 65 years of age to determine whether older patients respond differently from younger adult patients. Of the patients with CLL/SLL who received the 200 mg once daily dose of JAYPIRCA in BRUIN and BRUIN-321, 220 (65%) were 65 years of age and older and 78 (33%) were 75 years and older [see Clinical Studies ( 14.2 )] .
No overall differences in effectiveness were observed between younger and older patients. In the pooled safety population in patients with hematologic malignancies in BRUIN and BRUIN CLL-321, 467 (66%) were 65 years of age and older, while 181 (26%) were 75 years of age and older. Patients aged 65 years and older experienced higher rates of Grade 3 and higher adverse reactions and serious adverse reactions compared to patients who were less than 65 years of age.
8.6Renal Impairment Severe renal impairment (eGFR15-29 mL/min) increases pirtobrutinib exposure [see Clinical Pharmacology ( 12.3 )] . Reduce the JAYPIRCA dosage in patients with severe renal impairment [see Dosage and Administration ( 2.3 )] . No dosage adjustment of JAYPIRCA is recommended in patients with mild (60-89 mL/min) or moderate (30-59 mL/min) renal impairment.
8.7 Hepatic Impairment No dosage adjustment of JAYPIRCA is recommended in…
🤰 Pregnancy ▾
8.1Pregnancy Risk Summary Based on findings from animal studies, JAYPIRCA can cause fetal harm when administered to a pregnant woman. There are no available data on JAYPIRCA use in pregnant women to evaluate for a drug-associated risk. In an animal reproduction study, administration of pirtobrutinib to pregnant rats during organogenesis resulted in adverse developmental outcomes, including structural abnormalities, altered fetal growth, and embryo-fetal mortality, at maternal exposures approximately 3-times those in patients at the recommended daily dose of 200 mg (see Data).
Advise pregnant women of the potential risk to a fetus. The background risk in the U.S. general population of major birth defects is 2% to 4% and of miscarriage is 15% to 20% of clinically recognized pregnancies. Data Animal Data In an embryo-fetal development study in rats, pregnant animals were administered oral doses of pirtobrutinib at up to 500 mg/kg twice daily during the period of organogenesis.
Doses ≥ 375 mg/kg twice daily caused decreased fetal body weights and increased incidence of malformations and variations in the urinary tract (including absent or abnormal ureters and kidneys), reproductive tract (malpositioned ovaries and misshapen uterus), and bone (misshapen sternebrae). At 500 mg/kg twice daily, total resorption was observed. At 375 mg/kg twice daily in rats, the maternal systemic exposures (AUC) were approximately 3 times the human exposure at 200 mg once daily.
🧒 Pediatric Use ▾
8.4Pediatric Use Safety and effectiveness of JAYPIRCA have not been established in pediatric patients.
🧓 Geriatric Use ▾
8.5Geriatric Use Of the patients with MCL who received the 200 mg dose of JAYPIRCA in BRUIN, 93 (78%) were 65 years of age and older and 39 (33%) were 75 years and older [see Clinical Studies ( 14.1 )] . Clinical studies of JAYPIRCA did not include sufficient numbers of patients with MCL who were less than 65 years of age to determine whether older patients respond differently from younger adult patients. Of the patients with CLL/SLL who received the 200 mg once daily dose of JAYPIRCA in BRUIN and BRUIN-321, 220 (65%) were 65 years of age and older and 78 (33%) were 75 years and older [see Clinical Studies ( 14.2 )] .
No overall differences in effectiveness were observed between younger and older patients. In the pooled safety population in patients with hematologic malignancies in BRUIN and BRUIN CLL-321, 467 (66%) were 65 years of age and older, while 181 (26%) were 75 years of age and older. Patients aged 65 years and older experienced higher rates of Grade 3 and higher adverse reactions and serious adverse reactions compared to patients who were less than 65 years of age.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of action Pirtobrutinib is a small molecule, noncovalent inhibitor of BTK. BTK is a signaling protein of the B-cell antigen receptor (BCR) and cytokine receptor pathways. In B-cells, BTK signaling results in activation of pathways necessary for B-cell proliferation, trafficking, chemotaxis, and adhesion.
Pirtobrutinib binds to wild type BTK and BTK harboring C481 mutations, leading to inhibition of BTK kinase activity. In nonclinical studies, pirtobrutinib inhibited BTK-mediated B-cell CD69 expression and inhibited malignant B-cell proliferation. Pirtobrutinib showed dose-dependent anti-tumor activities in BTK wild type and BTK C481S mutant mouse xenograft models.
12.2Pharmacodynamics At the recommended dosage of 200 mg once daily, pirtobrutinib trough concentrations exceeded the BTK IC 96 . BTK occupancy is maintained throughout the dosing interval, regardless of the intrinsic rate of BTK turnover. Cardiac Electrophysiology The effect of a single 900 mg dose of pirtobrutinib (equivalent to approximately 2 times higher than the concentrations achieved at steady state at the recommended dosage of 200 mg once daily) on the QTc interval was evaluated in a placebo-controlled and positive-controlled study in 30 healthy subjects.
Pirtobrutinib had no clinically meaningful effect on the change in QTcF interval (i.e., > 10 ms) and there was no relationship between pirtobrutinib exposure and change in QTc interval.
12.3Pharmacokinetics The pharmacokinetics of pirtobrutinib were characterized in healthy subjects and in patients with cancer. Pirtobrutinib exposure (AUC) and C max increases proportionally following single oral doses ranging from 300 mg to 800 mg (1.5 to 4 times the approved recommended dosage) and once daily doses ranging from 25 – 300 mg (0.125 to 1.5 times the recommended dosage). Steady state was achieved within 5 days of once daily dosing, and the mean (CV%) accumulation ratio was 1.63 (26.7%) based on AUC after administration of 200 mg dosages.
Following administration of the recommended dosage, the geometric mean (CV%) steady-state AUC and C max of pirtobrutinib were 92705 h*ng/mL (39%) and 6503 ng/mL (25%), respectively. The geometric mean (CV%) AUC 0-24 and C max of pirtobrutinib on Cycle 1 Day 8 were 81800 h*ng/mL (66.6%) and 3670 ng/mL (89.5%), respectively. Absorption The absolute bioavailability of pirtobrutinib after a single oral 200 mg dose is 85.5% (range 75.9% to 90.9%).
The median time (range) to reach peak plasma concentration (tmax) is approximately 2 hours (0.833 to 4.15 hours). Effect of Food No clinically significant differences in the pharmacokinetics of pirtobrutinib were observed following administration of a high-fat, high-calorie meal (approximately 800 to 1000 calories with 150 calories from protein, 250 calories from carbohydrate, and 500 to 600 calories from fat) to healthy subjects. A high-fat meal decreased the C max of pirtobrutinib by 23% and delayed t max by 1 hour.
There was no effect on pirtobrutinib AUC. Distribution The mean apparent central volume of distribution of pirtobrutinib is
34.2L. Human protein binding of pirtobrutinib is 96% and is independent of concentration in vitro. Mean blood-to-plasma ratio is 0.79. Elimination The effective half-life of pirtobrutinib is approximately 20 hours and the mean (CV%) apparent clearance is
2.05L/h (35.7 %). Metabolism Pirtobrutinib is primarily metabolized by CYP3A4 and direct glucuronidation by UGT1A8 and UGT1A9, in vitro. Excretion Following a single radiolabeled dose of pirtobrutinib 200 mg to healthy subjects, 37% of the dose was recovered in feces (18% unchanged) and 57% in urine (10% unchanged).
Specific Populations There were no clinically significant differences in the pharmacokinetics of pirtobrutinib based on age (range 22 – 95 years), sex, race/ethnicity (White 84%, Asian 8%), body weight (range 35.7 – 152 kg), mild (total bilirubin ≤ upper limit of normal (ULN) and aspartate aminotra…
🧬 Mechanism of Action ▾
12.1Mechanism of action Pirtobrutinib is a small molecule, noncovalent inhibitor of BTK. BTK is a signaling protein of the B-cell antigen receptor (BCR) and cytokine receptor pathways. In B-cells, BTK signaling results in activation of pathways necessary for B-cell proliferation, trafficking, chemotaxis, and adhesion.
Pirtobrutinib binds to wild type BTK and BTK harboring C481 mutations, leading to inhibition of BTK kinase activity. In nonclinical studies, pirtobrutinib inhibited BTK-mediated B-cell CD69 expression and inhibited malignant B-cell proliferation. Pirtobrutinib showed dose-dependent anti-tumor activities in BTK wild type and BTK C481S mutant mouse xenograft models.
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied JAYPIRCA tablets are supplied as follows: Tablet Strength Description Package Configuration NDC Number 50 mg Blue, film coated, arc-triangle shaped tablets debossed with “Lilly 50” on one side and “6902” on the other side. Bottle with child-resistant closure. Each bottle contains 30 tablets.
0002-6902-30 100 mg Blue, film coated, round tablets debossed with “Lilly 100” on one side and “7026” on the other side. Bottle with child-resistant closure. Each bottle contains 60 tablets.
0002-7026-60 Storage and Handling 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) ([see USP Controlled Room Temperature]).
📋 Description ▾
11 DESCRIPTION Pirtobrutinib is a kinase inhibitor. It is an orally available, small molecule ATP-competitive inhibitor of BTK. The active pharmaceutical ingredient is pirtobrutinib with the molecular formula C 22 H 21 F 4 N 5 O 3 and a molecular weight of 479.44 g/mol.
The chemical name for pirtobrutinib is 5-amino-3-{4-[(5-fluoro-2-methoxybenzamido)methyl]phenyl}-1-[(2 S )-1,1,1-trifluoropropan-2-yl]-1 H -pyrazole-4-carboxamide. Pirtobrutinib is a white to practically white to yellow to brown solid. The aqueous solubility of pirtobrutinib is considered practically insoluble, or insoluble, across the pH 1 to pH 7 range.
Pirtobrutinib tablets are supplied as 50 mg or 100 mg film-coated, debossed tablets for oral administration. Each tablet contains inactive ingredients of croscarmellose sodium, hypromellose acetate succinate, lactose monohydrate, magnesium stearate, microcrystalline cellulose and silicon dioxide. The tablet film coating material contains FD&C Blue #2, hypromellose, titanium dioxide and triacetin.
Chemical Structure
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Patient Information). Infections Advise patients that JAYPIRCA can cause serious infections that may be fatal. Advise patients to report any signs or symptoms of infection (e.g., fever, chills, weakness) [see Warnings and Precautions ( 5.1 )].
Hemorrhage Inform patients to report signs or symptoms of bleeding. Inform patients that JAYPIRCA may need to be interrupted for major surgeries [see Warnings and Precautions ( 5.2 )] . Cytopenias Advise patients of the need for periodic monitoring of blood counts during treatment with JAYPIRCA [see Warnings and Precautions ( 5.3 )] .
Cardiac Arrhythmias Counsel patients to report any signs of palpitations, dizziness, fainting, chest discomfort, and shortness of breath [see Warnings and Precautions ( 5.4 ) ] . Second Primary Malignancies Inform patients that other malignancies have been reported in patients who have been treated with JAYPIRCA, including skin cancer and other solid tumors. Advise patients to use sun protection and to have monitoring for development of other cancers [see Warnings and Precautions ( 5.5 )].
Hepatotoxicity, Including Drug-Induced Liver Injury Inform patients that liver problems, including severe, life-threatening, or fatal hepatitis, drug-induced liver injury and abnormalities in liver tests, may develop during JAYPIRCA treatment. Advise patients to contact their healthcare provider immediately if they experience abdominal discomfort, dark urine, or jaundice [see Warnings and Precautions ( 5.6 )]. Embryo-Fetal Toxicity Advise pregnant women and females of reproductive potential of the potential risk to a fetus.
Advise females of reproductive potential to inform their healthcare provider of a known or suspected pregnancy [see Warnings and Precautions ( 5.7 ) , Use in Specific Populations ( 8.1 , 8.3 )]. Advise females of reproductive potential to use effective contraception during treatment with JAYPIRCA and for one week after the last dose [see Use in Specific Populations ( 8.3 )] . Lactation Advise women not to breastfeed during treatment with JAYPIRCA and for one week after the last dose [see Use in Specific Populations ( 8.2 )] .
Administration Inform patients to take JAYPIRCA orally once daily at approximately the same time each day with or without food and how to make up a missed dose. Advise patients to swallow tablets whole with water. Advise patients not to cut, crush, or chew tablets [see Dosage and Administration ( 2.1 )] .
Marketed by: Lilly USA, LLC, Indianapolis, IN 46285, USA Copyright © 2023, 2025, Eli Lilly and Company. All rights reserved. Pat.: www.lilly.com/patents JAY-0006-USPI-20251216