Pirtobrutinib
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Rithish Nimmagadda,MBBS.[2]
Disclaimer
WikiDoc MAKES NO GUARANTEE OF VALIDITY. WikiDoc is not a professional health care provider, nor is it a suitable replacement for a licensed healthcare provider. WikiDoc is intended to be an educational tool, not a tool for any form of healthcare delivery. The educational content on WikiDoc drug pages is based upon the FDA package insert, National Library of Medicine content and practice guidelines / consensus statements. WikiDoc does not promote the administration of any medication or device that is not consistent with its labeling. Please read our full disclaimer here.
Overview
Pirtobrutinib is an noncovalent (reversible) inhibitor of Bruton's tyrosine kinase (BTK). that is FDA approved for the treatment of elapsed or refractory MCL in adults who have received at least 2 lines of prior systemic therapy, including a BTK inhibitor; designated an orphan drug by FDA for treatment of MCL and also in treatment of CLL or SLL in adults who have received at least 2 prior lines of therapy, including a BTK inhibitor and a B-cell chronic lymphoma 2 (BCL-2) inhibitor (e.g., venetoclax); designated an orphan drug by FDA for treatment of CLL and SLL.. Common adverse reactions include Adverse effects (reported in ≥20% of patients): Fatigue, musculoskeletal pain, diarrhea, COVID-19, bruising, cough. [ref]
Grade 3 or 4 laboratory abnormalities (reported in ≥10% of patients): Neutropenia, lymphopenia, thrombocytopenia, anemia.
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
Mantle Cell Lymphoma -200 mg once daily- Continue therapy until disease progression or unacceptable toxicity occurs.
Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphom -200 mg once daily -Continue therapy until disease progression or unacceptable toxicity occurs.
Off-Label Use and Dosage (Adult)
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
Safety and efficacy not established.
Off-Label Use and Dosage (Pediatric)
Contraindications
none
Warnings
Infectious Complications
Serious and sometimes fatal infections, including bacterial, fungal, or viral infections, and opportunistic infections, observed.
Pneumonia was the most commonly reported grade 3 or 4 infection. Opportunistic Infections, including Pneumocystis jirovecii pneumonia and fungal infections, also observed.
Consider prophylaxis, including vaccinations and anti-infective prophylactic therapy, in patients at increased for opportunistic infections.
Monitor for signs and symptoms of infection during therapy and treat promptly if infection occurs.
If infection occurs, based on severity, reduce the dosage of, temporarily withhold, or permanently discontinue pirtobrutinib.
Hemorrhage
Serious hemorrhagic events, including fatal cases, observed. [ref] Major hemorrhage (serious or grade 3 or higher bleeding or any CNS system bleeding) reported in 3% of patients treated with pirtobrutinib in a clinical trial.
Possible increased risk of hemorrhagic events with concomitant use of pirtobrutinib and antithrombotic agents. Consider risks and benefits and monitor patients for signs of bleeding during concurrent use.
If bleeding occurs, based on severity, reduce the dosage of, temporarily withhold, or permanently discontinue pirtobrutinib.
Consider potential benefits and risks of withholding pirtobrutinib therapy for 3–7 days prior to and following surgery.
Myelosuppression
Cytopenias, including neutropenia, thrombocytopenia, and anemia, reported. Serious (grade 3 or 4) cytopenias observed.
Monitor CBC counts regularly. If myelosuppression occurs, interrupt therapy, reduce dosage, or discontinue therapy as appropriate.
Cardiac Arrhythmias
Cardiac arrhythmias (e.g., atrial fibrillation, atrial flutter, supraventricular tachycardia, cardiac arrest) observed.
Risk may be increased in patients with cardiac risk factors, including hypertension or previous arrhythmias.
Monitor for symptoms of arrhythmias and manage appropriately. If arrhythmias occur, interrupt therapy, reduce dosage, or discontinue therapy as appropriate.
Development of Second Primary Malignancy
Second primary malignancies, including skin cancers and other solid tumors, reported in 9% of pirtobrutinib-treated patients in the clinical trial. Non-melanoma skin cancer was the most frequently reported second primary malignancy, occurring in 4.6% of pirtobrutinib-treated patients.
Monitor patients for the development of second primary malignancies and advise patients to avoid sun exposure.
Fetal/Neonatal Morbidity and Mortality
May cause fetal harm. Embryofetal toxicity (e.g., structural abnormalities, altered fetal growth, embryofetal mortality) observed in animals.
If used during pregnancy, apprise of potential fetal hazard. Advise females of reproductive potential to use effective contraception during treatment and for 1 week after last dose.
Adverse Reactions
Clinical Trials Experience
There is limited information regarding Pirtobrutinib Clinical Trials Experience in the drug label.
Postmarketing Experience
There is limited information regarding Pirtobrutinib Postmarketing Experience in the drug label.
Drug Interactions
Principally metabolized by CYP3A4 and direct glucuronidation by uridine 5'-diphospho-glucuronosyltransferase (UGT) 1A8 and UGT1A9, in vitro.
Pirtobrutinib is an inhibitor of P-glycoprotein (P-gp), a moderate inhibitor of CYP2C8 and breast cancer resistance protein (BCRP), and a weak inhibitor of CYP2C19 and CYP3A
Use in Specific Populations
Pregnancy
Pregnancy Category (FDA):
May cause fetal harm
Pregnancy Category (AUS):
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Pirtobrutinib in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of Pirtobrutinib during labor and delivery.
Nursing Mothers
There is no FDA guidance on the use of Pirtobrutinib in women who are nursing.
Pediatric Use
There is no FDA guidance on the use of Pirtobrutinib in pediatric settings.
Geriatic Use
There is no FDA guidance on the use of Pirtobrutinib in geriatric settings.
Gender
There is no FDA guidance on the use of Pirtobrutinib with respect to specific gender populations.
Race
There is no FDA guidance on the use of Pirtobrutinib with respect to specific racial populations.
Renal Impairment
There is no FDA guidance on the use of Pirtobrutinib in patients with renal impairment.
Hepatic Impairment
There is no FDA guidance on the use of Pirtobrutinib in patients with hepatic impairment.
Females of Reproductive Potential and Males
There is no FDA guidance on the use of Pirtobrutinib in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of Pirtobrutinib in patients who are immunocompromised.
Administration and Monitoring
Administration
There is limited information regarding Pirtobrutinib Administration in the drug label.
Monitoring
There is limited information regarding Pirtobrutinib Monitoring in the drug label.
IV Compatibility
There is limited information regarding the compatibility of Pirtobrutinib and IV administrations.
Overdosage
There is limited information regarding Pirtobrutinib overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.
Pharmacology
There is limited information regarding Pirtobrutinib Pharmacology in the drug label.
Mechanism of Action
There is limited information regarding Pirtobrutinib Mechanism of Action in the drug label.
Structure
There is limited information regarding Pirtobrutinib Structure in the drug label.
Pharmacodynamics
There is limited information regarding Pirtobrutinib Pharmacodynamics in the drug label.
Pharmacokinetics
There is limited information regarding Pirtobrutinib Pharmacokinetics in the drug label.
Nonclinical Toxicology
There is limited information regarding Pirtobrutinib Nonclinical Toxicology in the drug label.
Clinical Studies
There is limited information regarding Pirtobrutinib Clinical Studies in the drug label.
How Supplied
There is limited information regarding Pirtobrutinib How Supplied in the drug label.
Storage
There is limited information regarding Pirtobrutinib Storage in the drug label.
Images
Drug Images
{{#ask: Page Name::Pirtobrutinib |?Pill Name |?Drug Name |?Pill Ingred |?Pill Imprint |?Pill Dosage |?Pill Color |?Pill Shape |?Pill Size (mm) |?Pill Scoring |?NDC |?Drug Author |format=template |template=DrugPageImages |mainlabel=- |sort=Pill Name }}
Package and Label Display Panel
{{#ask: Label Page::Pirtobrutinib |?Label Name |format=template |template=DrugLabelImages |mainlabel=- |sort=Label Page }}
Patient Counseling Information
There is limited information regarding Pirtobrutinib Patient Counseling Information in the drug label.
Precautions with Alcohol
Alcohol-Pirtobrutinib interaction has not been established. Talk to your doctor regarding the effects of taking alcohol with this medication.
Brand Names
Jaypirca®
Look-Alike Drug Names
There is limited information regarding Pirtobrutinib Look-Alike Drug Names in the drug label.
Drug Shortage Status
Price
References
The contents of this FDA label are provided by the National Library of Medicine.