TM Owner Eli Lilly
Jaypirca 100mg Tablet
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Indications & Clinical Uses
- Jaypirca 100 mg film-coated tablets contain pirtobrutinib, a non-covalent (reversible) Bruton's tyrosine kinase inhibitor used to treat two blood cancers in adults.
- In the United States it is approved for relapsed or refractory mantle cell lymphoma after at least two lines of systemic therapy including a BTK inhibitor; that indication was granted under accelerated approval based on response rate and continued approval depends on confirmatory trials.
- It is also approved for relapsed or refractory chronic lymphocytic leukaemia or small lymphocytic lymphoma already treated with a covalent BTK inhibitor.
- The European Union granted a conditional marketing authorisation on 30 October 2023 covering relapsed or refractory mantle cell lymphoma and chronic lymphocytic leukaemia in adults previously treated with a BTK inhibitor.
- Jaypirca is swallowed at home but must be prescribed and monitored by a specialist experienced in cancer care.
- A 50 mg tablet is also made and is used for dose reductions.
Side Effects
- The commonest laboratory and clinical findings affect more than 3 in 10 people: reduced neutrophil count in 54 percent, reduced haemoglobin in 43 percent, reduced white cells in 32 percent, tiredness in 31 percent, reduced platelets in 31 percent, reduced lymphocytes in 31 percent and low calcium in 30 percent.
- Diarrhoea, rash and bruising are also frequently reported in the European product information.
- Jaypirca carries NO boxed warning, but the label warns about serious and sometimes fatal bacterial, viral, fungal and opportunistic infections, major bleeding, low blood counts, atrial fibrillation and flutter, second primary cancers including skin cancer, and severe drug-induced liver injury.
- Get urgent medical help for fever or chills, breathlessness, a fast or irregular heartbeat, unusual or prolonged bleeding, black stools, or yellowing of the skin or eyes.
Precautions & Warnings
- Blood counts are checked regularly during treatment, and liver blood tests are taken before and during therapy because severe liver injury has occurred.
- Tell your healthcare provider about any sign of infection; watch for bleeding, and report palpitations, dizziness or breathlessness that could indicate atrial fibrillation.
- Protect your skin from sunlight and have skin checks, as new skin cancers and other second cancers have been reported.
- The dose is reduced in severe kidney impairment.
- Pirtobrutinib can harm an unborn baby: women who can become pregnant must use effective contraception during treatment and for one week after the last dose, and breastfeeding must be avoided during treatment and for one week afterwards.
- Swallow tablets whole with water, with or without food, at the same time each day.
- If a dose is more than 12 hours late, skip it and take the next dose as usual; never double up.
Avoid Interactions
- Medicines that increase pirtobrutinib exposure or toxicity include strong CYP3A inhibitors such as itraconazole, ketoconazole, clarithromycin and ritonavir, which raised exposure by about 49 percent; the Jaypirca dose must be reduced when these cannot be avoided.
- Anticoagulants and antiplatelet drugs, including warfarin, direct oral anticoagulants, aspirin and fish oil or vitamin E supplements, add to the bleeding risk.
- Jaypirca itself raises blood levels of sensitive substrates: midazolam by about 70 percent, repaglinide by about 130 percent, rosuvastatin by about 140 percent and digoxin by up to 35 percent, so these may need monitoring or dose changes.
- Medicines that reduce efficacy include strong and moderate CYP3A inducers such as rifampicin, which cut exposure by 71 percent, plus carbamazepine, phenytoin and St John's wort.
- Tell your prescriber about every medicine, herbal product and supplement you take.
References
Frequently Asked Questions
Jaypirca (pirtobrutinib) treats adults with relapsed or refractory mantle cell lymphoma after at least two prior therapies including a BTK inhibitor, and relapsed or refractory chronic lymphocytic leukaemia or small lymphocytic lymphoma previously treated with a covalent BTK inhibitor. The mantle cell lymphoma use has US accelerated approval.
Jaypirca (pirtobrutinib) is taken as 200 mg by mouth once daily, usually two 100 mg tablets, with or without food. Swallow the tablets whole with water at the same time each day. Treatment continues until the disease progresses or side effects become unacceptable.
The most common Jaypirca (pirtobrutinib) side effects are low neutrophils, low haemoglobin, low platelets, low white cells and tiredness, each affecting about a third of people. Seek urgent help for fever, breathlessness, an irregular heartbeat, unusual bleeding, black stools or yellow skin, which can signal infection, atrial fibrillation, haemorrhage or liver injury.
Avoid strong CYP3A inducers such as rifampicin, carbamazepine and St John's wort with Jaypirca, because they cut pirtobrutinib levels by around 71 percent. Strong CYP3A inhibitors need a dose reduction. Take extra care with blood thinners, aspirin, fish oil and vitamin E, which raise bleeding risk.
If your Jaypirca (pirtobrutinib) dose is more than 12 hours late, skip it and take the next dose at the usual time. Never take two doses together to catch up. Store the tablets at room temperature and keep regular appointments for blood counts and liver tests.
No. Jaypirca (pirtobrutinib) can harm an unborn baby, so it should not be used in pregnancy. Women able to become pregnant must use effective contraception during treatment and for one week after the last dose. Do not breastfeed during treatment or for one week afterwards.
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