FDA-filed SPL labeling · retrieved through openFDA

Talazoparib

Talazoparib is a targeted cancer medicine (a PARP inhibitor) used to treat certain types of advanced breast cancer and metastatic prostate cancer in adults with specific gene mutations.

Brand name Talzenna
Drug class Poly(adp-ribose) Polymerase Inhibitors
Rx Form 1 Route Oral
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Jul 10, 2026
🧬 Where this information comes from Click to expand

The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 4 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →

At a glance
Linked label effectiveDec 18, 2025
Clinical labels in scope 4
AvailabilityRx
Earliest approval/marketing year 2018
FDA-listed product records 35
Boxed warningNone found in compared labels
How we combine label and product data →
No current FDA shortage listed · checked Sep 17, 2026
Talazoparib at a glance The quick version — the full detail is in the Patient Information Guide below.
💊
HelloPharmacist Editorial Team Bottom Line
Talazoparib (Talzenna) is a once-daily oral targeted therapy for adults with certain gene-mutation-driven advanced breast cancer or metastatic prostate cancer. Its most important risks are drops in blood cell counts — monitored with monthly blood tests — and rare but serious bone marrow disorders. Women who are pregnant or could become pregnant must use reliable contraception before, during, and for months after treatment.

📖 Talazoparib: Patient Information Guide

A plain-language walkthrough of Talazoparib — what it treats, how it works, how it’s taken, side effects, warnings and interactions. Tap any section to expand it.

🎯What it's used for

Talazoparib is a PARP inhibitor approved for two types of advanced cancer in adults, both linked to specific gene mutations. The only approved brand is Talzenna, taken as an oral capsule.

  • Talzenna (breast cancer): Used alone to treat adults with HER2-negative locally advanced or metastatic breast cancer who carry an inherited (germline) BRCA mutation. An FDA-approved companion diagnostic test must confirm the mutation before starting treatment.
  • Talzenna (prostate cancer): Used in combination with enzalutamide to treat adults with metastatic castration-resistant prostate cancer (mCRPC — prostate cancer that has spread and no longer responds to standard hormone therapy) whose tumors carry mutations in HRR (homologous recombination repair) genes such as ATM, BRCA1, BRCA2, CDK12, and others.
⚙️How it works

Talazoparib targets enzymes called PARP1 and PARP2, which normally help cells repair breaks in their DNA. Many cancer cells — particularly those with mutations in genes like BRCA1, BRCA2, or other HRR genes — already have a weakened ability to fix DNA damage. By blocking PARP, talazoparib prevents this backup repair system from working, and also traps PARP proteins onto DNA strands. The result is an overwhelming buildup of DNA damage in the cancer cells, causing them to stop dividing and die.

This approach — exploiting a cancer cell's existing DNA-repair defect — is sometimes called synthetic lethality. Cells with healthy repair genes can better withstand the loss of PARP activity, which is why the drug is most effective in tumors with these specific gene mutations.

💊How it's taken

Talzenna capsules are taken once daily by mouth, with or without food. Eating a high-fat meal slows absorption somewhat but does not change the total amount of drug absorbed over time. Capsules must be swallowed whole — do not open or dissolve them.

  • The dose for breast cancer differs from the dose used for prostate cancer; your prescriber will set the right amount for your situation.
  • If you vomit or miss a dose, skip it and take your next dose at the regular time — never double up.
  • Your doctor may lower your dose or pause treatment temporarily if side effects become difficult to manage. Blood counts are checked monthly throughout treatment.
🤒Side effects — in detail

The most common side effects of Talazoparib involve blood cell counts and general wellbeing:

  • Anemia (low red blood cells) — fatigue, weakness, shortness of breath
  • Neutropenia (low white blood cells) — higher risk of infections
  • Thrombocytopenia (low platelets) — easy bruising or bleeding
  • Nausea and vomiting
  • Fatigue or weakness
  • Headache
  • Hair loss (alopecia)
  • Decreased appetite and diarrhea

Severe blood count drops are serious and fairly common — call your doctor right away if you develop fever, unusual fatigue, or signs of bleeding. A rare but potentially fatal complication is MDS/AML (a bone marrow disorder); report any prolonged or unusual changes in how you feel to your care team immediately.

⚠️Warnings & precautions
  • Bone marrow suppression (myelosuppression): Drops in red blood cells, white blood cells, and platelets are common and can be severe. Monthly blood tests are required. Severe or prolonged low counts may require dose pauses, reductions, or referral to a blood specialist.
  • MDS/AML (myelodysplastic syndrome / acute myeloid leukemia): A small number of patients developed this serious and sometimes fatal blood cancer during treatment. The risk is higher in people who previously had platinum chemotherapy or radiation. If MDS/AML is confirmed, Talazoparib must be stopped permanently.
  • Fetal harm (embryo-fetal toxicity): Talazoparib can cause serious birth defects, miscarriage, or fetal death. Pregnancy must be ruled out before starting. Effective contraception is required during treatment — for 7 months after the last dose for women, and 4 months after for men whose partners could become pregnant.
🔀What it interacts with

Talazoparib's levels in the body can be affected by several other medicines. Always give your full medication list to your doctor and pharmacist before starting.

  • P-gp inhibitors (e.g., itraconazole, amiodarone, carvedilol, clarithromycin, verapamil): These drugs can significantly raise Talazoparib blood levels, increasing the risk of side effects. Avoid them if possible; if unavoidable, a dose reduction may be needed.
  • BCRP inhibitors: May also increase Talazoparib exposure — your doctor will monitor you more closely for side effects.
  • Enzalutamide (used with Talazoparib for prostate cancer): Taking these together roughly doubles Talazoparib levels. This combination is intentional and prescribed together, but requires close monitoring.
  • Acid-reducing medicines (antacids, PPIs, H2 blockers): These do not meaningfully affect Talazoparib absorption — no special precaution needed.

This is not a complete list of interactions. Always talk with your doctor or pharmacist before starting, stopping, or changing any medication.

📋Before taking it
  • Kidney disease: Moderate or severe kidney impairment causes Talazoparib to build up in the body — a lower dose is required. Mild kidney impairment does not need a dose change. Talazoparib has not been studied in people on hemodialysis.
  • Liver disease: Hepatic impairment (mild to severe) does not significantly affect how the body handles Talazoparib — no dose adjustment is needed for liver problems.
  • Pregnancy: This medicine can seriously harm an unborn baby. Confirm you are not pregnant before starting, use effective contraception during treatment and for 7 months after your last dose.
  • Breastfeeding: Do not breastfeed while taking Talazoparib or for 1 month after the last dose — potential harm to the infant cannot be ruled out.
  • Male fertility and contraception: Men should use effective contraception during treatment and for 4 months after the last dose. Animal studies suggest Talazoparib may impair male fertility.
  • Children: Safety and effectiveness in patients under 18 have not been established.
  • Older adults: No meaningful differences in safety or effectiveness were seen in patients 65 and older compared to younger patients in clinical trials.
  • Previous chemotherapy: Talazoparib should not be started until your blood counts have recovered from any prior chemotherapy.
🚑If you take too much

There is no specific antidote for a Talazoparib overdose, and the exact symptoms of taking too much are not well defined. If an overdose is suspected, treatment should be stopped, and your care team will provide supportive care and treat symptoms as needed.

📡Pharmacodynamics — effects in the body

Talazoparib blocks PARP enzyme activity and traps PARP proteins onto DNA in cancer cells, leading to DNA damage and cell death. At the recommended dose used for breast cancer, Talazoparib does not cause large changes in heart rhythm (specifically, no significant QTc prolongation — a type of electrical change in the heart that can be dangerous). The full relationship between drug levels in the blood and its effects on safety and effectiveness has not been completely mapped out.

🔬Pharmacokinetics — how your body processes it

After a single oral dose, Talazoparib is absorbed fairly quickly, reaching peak blood levels in about 1 hour. Eating a high-fat meal delays that peak and reduces the maximum concentration, but the total amount absorbed is unaffected. The drug has a long half-life of about 90 hours, meaning it stays in the body for an extended time after each dose. Talazoparib is cleared mainly through the kidneys — about 69% is excreted in urine, mostly unchanged — and undergoes minimal liver metabolism, which is why kidney function (but not liver function) significantly affects dosing.

📦How to store it

Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F).

📄 Written from Talazoparib’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Every point is grounded in that labeling — nothing is invented. How we use AI →

54

Supplements & herbs that interact with Talazoparib

54 supplements and herbal products have documented interactions with Talazoparib in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.

Severity mix
  • Major · 2
  • Moderate · 35
  • Minor · 17
Every supplement checked against Talazoparib — ranked by severity The full interaction hub: 2 major · 35 moderate · 17 minor · every one linked to its full report. Check Talazoparib against your exact supplements

Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.

🩺 Pharmacist Counseling Corner

Quick, plain-English answers to the questions patients ask most about Talazoparib — the kind of thing our pharmacy team would talk through with you at the counter.

What exactly does Talzenna treat, and why do I need a genetic test first?
Talzenna is used for two specific cancers: advanced breast cancer (in people with an inherited BRCA gene mutation) and advanced prostate cancer that no longer responds to hormone therapy (in people whose tumor has certain DNA-repair gene mutations). The genetic test matters because the drug only works well when those specific gene faults are present — it's designed to exploit that weakness. Without confirming the mutation, we can't be sure Talzenna is the right choice for you.
How do I take it, and does it matter if I take it with food?
You take Talzenna as a capsule once a day, and you can take it with or without food — whichever fits your routine best. The one important thing is to swallow the capsules whole. Don't open, crush, or dissolve them. If you happen to vomit shortly after a dose or forget a dose entirely, don't try to make it up — just take your next dose at the usual time the following day.
What side effects are most likely, and which ones should I call my doctor about right away?
The most common issues are drops in your blood cell counts — low red cells (which cause fatigue and paleness), low white cells (which raise infection risk), and low platelets (which can cause bruising or bleeding). Nausea, headache, hair loss, and tiredness are also frequent. For that reason, you'll need a blood test every month. Call your doctor right away if you develop a fever, feel unusually exhausted, notice unusual bleeding, or get any signs of infection — these could mean your blood counts have dropped to a dangerous level.
I heard this medicine can cause a type of blood cancer. How serious is that risk?
This is a real but rare risk. In clinical trials, a small number of patients (less than half a percent) developed a serious bone marrow condition called MDS or AML — a type of blood cancer. Most of those patients had previously received strong chemotherapy or radiation, which may have contributed. Your doctor will monitor your blood counts monthly precisely to catch any early warning signs. If that complication is ever confirmed, the medicine would be stopped immediately.
Is it safe to get pregnant or father a child while taking Talzenna?
No — this is a serious concern. Talazoparib can cause major birth defects or fetal death, based on animal studies. If you're a woman who could become pregnant, you need to use reliable contraception during treatment and for 7 months after your last dose. Men whose partners could get pregnant should also use contraception during treatment and for 4 months after stopping. There's also some evidence the drug could affect male fertility. Talk to your doctor before treatment if this is important to you.
Are there any common medicines I should avoid while on Talzenna?
Yes — a handful of drugs can raise Talazoparib levels in your blood, which increases the risk of side effects. These include itraconazole (an antifungal), clarithromycin (an antibiotic), and heart medicines like amiodarone, carvedilol, and verapamil. If you're taking any of these, let your prescriber know before you start Talzenna. Antacids and acid-reflux medicines are fine and don't interfere with how Talzenna is absorbed.
Is Talazoparib available over the counter?
Talazoparib is dispensed by prescription according to its FDA labeling, so it isn't sold over the counter. Your prescriber and pharmacist will determine if it's appropriate for you.
When was Talazoparib first available?
Talazoparib has been available in the United States since at least 2018, based on FDA approval history (Drugs@FDA) and product marketing records.
Who makes Talazoparib?
Talazoparib is supplied by 5 manufacturers listed in the FDA NDC Directory, including Pfizer Laboratories Div Pfizer Inc, U.S. Pharmaceuticals, Catalent Germany Eberbach GmbH.

💬 Answers drafted from Talazoparib’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Grounded in that labeling — nothing is made up. How we use AI →

🧰 Keep exploring

💊 How Talazoparib comes

Talazoparib is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.

Capsule

By mouth
Brands Talzenna
How this form is used
What it may be used for
  • Talzenna capsules are used as a single agent for adults with germline BRCA-mutated, HER2-negative locally advanced or metastatic breast cancer
  • Talzenna capsules are used in combination with enzalutamide for adults with HRR gene-mutated metastatic castration-resistant prostate cancer (mCRPC)
Important instructions
  • Talzenna capsules are taken by mouth once daily, with or without food
  • Swallow Talzenna capsules whole — do not open, crush, or dissolve them
  • If you vomit or miss a dose of Talzenna, take the next scheduled dose at the usual time — do not double up
  • Patients taking Talzenna for prostate cancer also receive enzalutamide and a hormone therapy (GnRH analog), or have had surgical removal of the testes — follow your prescriber's full treatment plan
Available strengths 7 strengths
Show 1 more strength Show fewer strengths
32 FDA-listed product records

📊 Talazoparib across the U.S. market

How Talazoparib appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.

1
Dose forms
5
Manufacturers
1
Brand names
35
FDA-listed product records
2018
First marketed

Also listed with the FDA, not a patient dose form: Powder (3) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.

Pfizer Laboratories Div Pfizer Inc54%
U.S. Pharmaceuticals20%
Catalent Germany Eberbach GmbH17%
Excella GmbH & Co. KG6%
Pfizer Ireland Pharmaceuticals Unlimited Company3%

Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

📈 How widely Talazoparib is used

A general measure of how commonly Talazoparib is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.

Think of this as a proxy for how widely Talazoparib is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.

12
Medicaid prescriptions filled (Q1–Q4 2025)
$197,725 gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Talazoparib prescribed? Of the 1,596 medications we measure, Talazoparib ranks #1,587 by Medicaid prescriptions — more than 1% of them.

Where Talazoparib ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5

Utilization by Talazoparib product

Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.

talazoparib 1 MG Oral Capsule

12 Medicaid prescriptions (Q1–Q4 2025) 100% of Talazoparib prescriptions shown $197,725 gross reimbursement (before rebates) ≈ $16,477 per prescription (gross)

Summed across the 1 of 5 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2099954

Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.

Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Talazoparib, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 1 of 5 listed Talazoparib NDCs with Medicaid activity.

🔍 Compare Talazoparib products

A representative set of FDA-listed product records for Talazoparib — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)

Showing 35 of 35 products — FDA National Drug Code Directory. See every product, package size and price: browse all 35 Talazoparib NDCs →

RxNorm Concept Web — From Ingredient to Every Form and Strength

This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.

Ingredient (IN) Talazoparib RxCUI 2099704 1 dose form · 6 strengths
  1. Dose form (SCDF) Oral Capsule RxCUI 2099945 In current FDA listings
    Clinical drug / strength (SCD) 0.1 MG RxCUI 2639960 0.25 MG RxCUI 2099946 0.35 MG RxCUI 2639964 0.5 MG RxCUI 2591510 0.75 MG RxCUI 2591520 1 MG RxCUI 2099954

Look up RxCUI 2099704 in the RxCUI Atlas →

RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.

🏷️ Sold under these brand names

Talzenna

🏭 Manufacturers & labelers

Pfizer Laboratories Div Pfizer Inc 19 U.S. Pharmaceuticals 7 Catalent Germany Eberbach GmbH 6 Excella GmbH & Co. KG 2 Pfizer Ireland Pharmaceuticals Unlimited Company 1

RxNorm drug class

Talazoparib belongs to the Poly(ADP-Ribose) Polymerase Inhibitor class.

Pharmacologic class Poly(ADP-Ribose) Polymerase Inhibitor
Drug family (ATC) Poly (ADP-ribose) polymerase (PARP) inhibitors
How it works Poly(ADP-Ribose) Polymerase Inhibitors

Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.

🔬 Where this comes from

Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.

📄
FDA-filed drug labels (SPL) Uses, dosing, warnings & side effects from SPL records retrieved through openFDA; the linked representative set can be verified on DailyMed. ✓ Linked label effective Dec 18, 2025
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Talazoparib.
📈
Real-world reportsThe FDA Adverse Event Reporting System (FAERS), served through openFDA.
🚨
Recalls & shortagesopenFDA drug-enforcement reports and the FDA drug-shortage database.
🧾 Clinical label set — FDA-filed SPL labels retained for Talazoparib after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
4
NDC products indexed
35
Distinct labelers/manufacturers represented
5
Linked representative label
Pfizer Laboratories Div Pfizer Inc
Linked label effective
Dec 18, 2025
Composite sections available
22
Linked SPL Set ID
f2423edd-6d24-495c-aec1-c2f457f08d9a
Linked SPL Document ID
e189da1b-d503-48a4-aba3-4f93a3fab2d3
Open the linked representative label on DailyMed ↗

How we combine label and product data

HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 4 FDA-filed SPL label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. The representative label is the starting point for the displayed reference monograph; the 12 largest stored in-scope SPL records, which may include that representative, are compared section by section, and the longest available version of each section is retained. Forms, routes, brands, labelers, product-listed strengths, and product-record counts are aggregated separately from ingredient-matched FDA NDC Directory records; package records listed above are associated with the linked SPL; and the normalized concept hierarchy comes from NLM RxNorm.

For canonical ingredient pages, bounded product-attributed indication and administration excerpts may be added to the AI evidence, and the generator is instructed to preserve available product, brand, route, and form qualifiers instead of treating one label as universal. Where a section is identified as AI-written, its plain-language text is generated from bounded label evidence. New draft drug pages remain in the admin review queue before first publication. Pfizer Laboratories Div Pfizer Inc is the representative DailyMed label linked for verification and dates; it is not the sole source used for the page.

This is general education, not medical advice — always consult your doctor or pharmacist about your medications and any medical condition. For the exact wording of the linked representative label, view that label on DailyMed; some displayed composite sections may come from other in-scope SPL labels. Learn how we use AI and our data sources & update cadence.