Pirtobrutinib

Pirtobrutinib is a prescription medication used for the treatment of relapsed or refractory mantle cell lymphoma (MCL). 

• Pirtobrutinib is available under the following different brand names: Jaypirca.

Common side effects of Pirtobrutinib include:

• Fatigue, 
• Musculoskeletal pain, 
• Diarrhea, 
• Swelling,
• Shortness of breath, 
• Cough with or without mucus or pus, 
• Fever, 
• Chills, 
• Difficulty breathing, and
• Unusual bruising

Serious side effects of Pirtobrutinib include:

• Hives, 
• Difficulty breathing, 
• Swelling of your face, lips, tongue, or throat, and 
• Abnormal blood lab results (decreased neutrophil count, lymphocyte count, and platelet count)

Rare side effects of Pirtobrutinib include:

• None 

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors;
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out. 

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult dosage

Tablet

• 50 mg
• 100 mg

Mantle Cell Lymphoma

Adult dosage

• 200 mg orally once a day
• Continue until disease progression or unacceptable toxicity.

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Pirtobrutinib has no noted severe interactions with any other drugs.
• Pirtobrutinib has no noted serious interactions with any other drugs.
• Pirtobrutinib has no noted moderate interactions with any other drugs.
• Pirtobrutinib has no noted minor interactions with any other drugs.

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all your products. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, health questions, or concerns.

Contraindications

• None

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Pirtobrutinib?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Pirtobrutinib?”

Cautions

• For all adverse reactions, based on severity, reduce dose, temporarily withhold, or permanently discontinue.
• Grade 3 or 4 cytopenias, including neutropenia, anemia, and thrombocytopenia reported; monitor complete blood cell counts regularly during treatment.
• Atrial fibrillation and atrial flutter occurred; monitor for signs and symptoms of arrhythmias (. g, palpitations, dizziness, syncope, dyspnea) and manage appropriately.
• Second primary malignancies, including non-skin carcinomas, developed; advise patients to use sun protection and monitor for development of second primary malignancies.
• Based on findings in animals, fetal harm may occur when administered to pregnant females
• Infections
  • Serious and fatal infections (e.g., bacterial, viral, or fungal) and opportunistic infections were reported.
  • Consider antimicrobial prophylaxis and vaccinations in patients who are at increased risk for infections.
  • Monitor for signs and symptoms of infection, evaluate promptly, and treat appropriately.
• Hemorrhage
  • Serious and fatal hemorrhage occurred.
  • Major hemorrhage occurred at a higher incidence in patients taking pirtobrutinib without antithrombotic agents than in those taking pirtobrutinib with antithrombotic agents (1.7% vs 0.7%)
  • Consider the risks and benefits of antithrombotic agents when coadministered with pirtobrutinib.
• Monitor for signs of bleeding.
  • Consider the benefit-risk of withholding pirtobrutinib for 3-7 days pre- and post-surgery depending upon the type of surgery and risk of bleeding.
• Drug interaction overview
  • CYP3A4 substrate
    • P-gp inhibitor
    • Moderate CYP2C8 and BCRP inhibitor
    • Weak CYP2C19 and CYP3A inhibitor
• Strong CYP3A inhibitors
  • Avoid coadministration; if unavoidable, reduce the pirtobrutinib dose
  • Strong CYP3A inhibitors increase pirtobrutinib systemic exposure and risk for adverse reactions.
• Strong or moderate CYP3A inducers
  • Avoid coadministration.
  • If the use of moderate CYP3A inducers is unavoidable, increase the pirtobrutinib dose.
  • Strong or moderate CYP3A inducers decrease pirtobrutinib systemic exposure and may reduce pirtobrutinib efficacy.
  • Sensitive CYP2C8, CYP2C19, CYP3A, P-gp, or BCRP substrates
  • Pirtobrutinib may increase plasma concentrations of sensitive P-gp, CYP2C8and, BCRP, which may increase the risk of adverse reactions related to these substrates.
  • Refer to the prescribing information for sensitive CYP2C8, CYP2C19, CYP3A, P-gp, or BCRP substrates for dosing recommendations.

Pregnancy and Lactation

• Based on findings from animal studies, fetal harm may cause when administered to pregnant females
• No data are available on use in pregnant females to evaluate for a drug-associated risk
• Verify pregnancy status in females of reproductive potential before initiating.
• Contraception
  • Females of reproductive potential: Use effective contraception during treatment and for 1 week after the last dose.
• Lactation
  • There are no data on drug presence in human milk or the effects on breastfed children or milk production
  • Advise females not to breastfeed during treatment and for 1 week after the last dose.