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Talzenna 0.1mg Capsule
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Indications & Clinical Uses
- Talzenna 0.1 mg capsules contain talazoparib, a PARP (poly ADP-ribose polymerase) inhibitor manufactured by Pfizer.
- In the United States, Talzenna is approved as a single agent for adults with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm), HER2-negative locally advanced or metastatic breast cancer, selected using an FDA-approved companion diagnostic test.
- It is also approved in combination with the androgen receptor inhibitor enzalutamide for adults with homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer.
- Talazoparib capsules are supplied in several strengths (0.1 mg, 0.25 mg, 0.35 mg, 0.5 mg, 0.75 mg and 1 mg); this 0.1 mg strength is typically used for dose-reduced regimens rather than a standard starting dose.
- Talzenna is taken by mouth once daily and is prescribed and monitored by an oncology specialist; it is not for use outside these approved, biomarker-selected populations.
Side Effects
- The most common side effects of Talzenna, each affecting more than 1 in 5 patients, are low haemoglobin (anaemia), reduced neutrophil and platelet counts, fatigue, nausea, headache, vomiting, hair thinning, diarrhoea and reduced appetite.
- Blood counts are checked before starting, monthly during the first year, and periodically afterward, because Talzenna can cause serious myelosuppression that may require dose interruption, dose reduction or transfusion.
- A small number of patients treated with PARP inhibitors, including talazoparib, have developed myelodysplastic syndrome (MDS) or acute myeloid leukaemia (AML), usually after prolonged treatment; report unexplained, prolonged low blood counts promptly.
- Seek urgent medical attention for unusual bleeding or bruising, signs of infection such as fever, or new shortness of breath.
- Talzenna carries no boxed warning on its current US label, but its myelosuppressive and MDS/AML risks are actively monitored throughout treatment.
Precautions & Warnings
- Before starting Talzenna, tell your healthcare provider about any kidney or liver problems, since dose adjustment is needed in renal impairment and the drug has not been studied in severe hepatic impairment.
- Talzenna can harm an unborn baby: women who can become pregnant should use effective non-hormonal contraception during treatment and for at least 7 months after the last dose, and men with partners who can become pregnant should use contraception for 4 months afterward.
- Do not breastfeed while taking Talzenna or for 1 month after the last dose.
- Talzenna is for oral use only and must be swallowed whole, not opened, crushed or chewed; it can be taken with or without food.
- It should not be combined with other PARP inhibitors.
- Regular blood counts are required throughout treatment to detect myelosuppression or early signs of MDS/AML.
Avoid Interactions
- Talzenna is a substrate of the P-glycoprotein (P-gp) and BCRP transporters, so combining it with strong P-gp inhibitors (for example itraconazole, clarithromycin, ritonavir) increases talazoparib exposure and toxicity; if unavoidable, the Talzenna dose should be reduced.
- BCRP inhibitors can also raise talazoparib levels, so watch for increased side effects when they are used together.
- No dose adjustment is needed with acid-reducing medicines such as proton pump inhibitors.
- Tell your healthcare provider and pharmacist about all prescription and over-the-counter medicines, vitamins and herbal supplements you take, since any new medicine started during treatment should be checked against this interaction profile.
- There is no specific requirement to avoid grapefruit for Talzenna, but any new P-gp or BCRP inhibitor, including some antifungals and antiretrovirals, should be flagged to your care team before you start it.
References
Frequently Asked Questions
Talzenna (talazoparib) is a PARP inhibitor used alone to treat adults with BRCA-mutated, HER2-negative advanced or metastatic breast cancer, or with enzalutamide for HRR gene-mutated metastatic prostate cancer. Your tumor must test positive for the relevant gene mutation before Talzenna is prescribed. It is taken once daily by mouth.
Swallow Talzenna capsules whole, once daily, at about the same time each day, with or without food. Never open, crush or chew the capsules. Your oncologist sets your exact dose and strength based on blood counts and kidney function, which may include this 0.1 mg capsule.
The most common effects are low red cell, white cell and platelet counts, fatigue, nausea, headache, vomiting, hair thinning and reduced appetite. Get urgent care for unexplained bruising, bleeding, fever, or breathlessness, which can signal serious low blood counts or, rarely, a blood cancer such as MDS or AML.
Avoid starting strong P-glycoprotein inhibitors such as itraconazole, clarithromycin or ritonavir without medical advice, since they raise talazoparib levels and side effects. Tell your care team about every medicine and supplement you take. Effective non-hormonal contraception is required, and Talzenna must not be combined with other PARP inhibitors.
Your healthcare provider checks a complete blood count before you start Talzenna, monthly for the first year, and periodically after that. This monitors for anaemia, low white cells and low platelets, which are common and can be serious. Report unusual tiredness, bruising, bleeding or infection between tests.
No. Talzenna can harm an unborn baby, so women who can become pregnant must use effective non-hormonal contraception during treatment and for 7 months after the last dose; men need contraception for 4 months after. Do not breastfeed while taking Talzenna or for 1 month afterward.
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