Ixabepilone Injection
Ixabepilone injection (IXEMPRA) is a microtubule inhibitor used to treat metastatic or locally advanced breast cancer that has stopped responding to other chemotherapy drugs.
🧬 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 1 clinical label set 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 →
⚠️ FDA Boxed Warning — the FDA’s strongest safety alert ▾
Important safety warning: IXEMPRA combined with capecitabine must NOT be given to patients with moderate or severe liver problems. Specifically, if your liver enzyme levels (AST or ALT) are more than 2.5 times the upper limit of normal, or if your bilirubin level is above the upper limit of normal, using this combination significantly increases the risk of severe toxicity and death related to dangerously low white blood cell counts (neutropenia). If you have liver problems, tell your doctor before starting treatment. This restriction applies to the combination regimen; your doctor will assess whether single-agent IXEMPRA may still be an option depending on the degree of liver impairment.
📖 Ixabepilone Injection: Patient Information Guide
A plain-language walkthrough of Ixabepilone Injection — 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▾
Ixabepilone injection (IXEMPRA) is a microtubule inhibitor approved for metastatic or locally advanced breast cancer in patients who have already received other chemotherapy.
- IXEMPRA in combination with capecitabine: for patients whose breast cancer has become resistant to both an anthracycline and a taxane, or whose cancer is taxane-resistant and further anthracycline therapy is not safe.
- IXEMPRA as a single agent: for patients whose breast cancer is resistant or no longer responding to anthracyclines, taxanes, and capecitabine — meaning all three prior options have failed.
⚙️How it works▾
Ixabepilone is a semi-synthetic analog of a natural compound called epothilone B. It works by binding tightly to beta-tubulin — a protein that makes up microtubules, the internal scaffolding cancer cells need to divide. By stabilizing these structures and blocking their normal dynamic movement, ixabepilone traps cancer cells in the middle of cell division, ultimately causing them to die.
One notable feature of ixabepilone is that it has low susceptibility to several common cancer drug-resistance mechanisms — including efflux pumps like P-glycoprotein (P-gp) and MRP-1, which cancer cells sometimes use to push chemotherapy drugs out. This makes it useful in cancers that have become resistant to other treatments.
💊How it's taken▾
IXEMPRA is given as an intravenous (IV) infusion in a clinical or hospital setting — it is not taken by mouth. Each infusion runs over approximately 3 hours and is given once every 3 weeks.
- All patients must take premedication (an H1 antihistamine and an H2 antihistamine) about 1 hour before the infusion to reduce the risk of allergic reactions.
- Patients who have had a prior allergic reaction to IXEMPRA need an additional corticosteroid before future infusions.
- Dose adjustments may be made based on blood counts, side effects, and liver function — follow your oncology team's guidance at the start of each treatment cycle.
🤒Side effects — in detail▾
The most common side effects reported with IXEMPRA include:
- Peripheral sensory neuropathy — numbness, tingling, or pain in hands and feet
- Fatigue and weakness
- Muscle and joint pain
- Hair loss (alopecia)
- Nausea and vomiting
- Mouth sores (stomatitis/mucositis)
- Diarrhea
- Low blood counts: neutropenia (low white blood cells), leukopenia, anemia, and thrombocytopenia (low platelets)
- When used with capecitabine: hand-foot syndrome (palmar-plantar erythrodysesthesia), loss of appetite, abdominal pain, nail changes, and constipation
Serious reactions to report immediately include fever or signs of infection (from low white blood cell counts), severe or rapidly worsening nerve symptoms, chest pain or irregular heartbeat, and signs of a severe allergic reaction such as difficulty breathing or swelling during infusion.
⚠️Warnings & precautions▾
- Neutropenia (dangerously low white blood cells): This is the most serious risk. Severe, life-threatening, or fatal cases have occurred. Blood counts are monitored throughout treatment, and dosing may be delayed or reduced.
- Peripheral neuropathy: Nerve damage causing tingling, numbness, or pain in the hands and feet is very common and may require dose reduction or stopping treatment.
- Liver impairment: Patients with liver problems face a higher risk of severe side effects. IXEMPRA combined with capecitabine is contraindicated in patients with elevated liver enzymes or bilirubin above specific thresholds. Single-agent use also requires dose adjustments and should be avoided in severe liver impairment.
- Hypersensitivity reactions: Severe allergic reactions, including anaphylaxis, have occurred. Premedication is required before every infusion, and the infusion must be stopped immediately if a serious reaction develops.
- Cardiac risks: Myocardial ischemia (reduced blood flow to the heart) and ventricular dysfunction have been reported. Patients with a history of heart disease require close monitoring.
- Embryo-fetal toxicity: IXEMPRA can cause serious harm to an unborn baby. Effective contraception is required during and after treatment.
- Alcohol content: Each dose of IXEMPRA contains a significant amount of ethanol (alcohol), which may impair the ability to drive or operate machinery right after the infusion.
🔀What it interacts with▾
Ixabepilone is processed primarily by a liver enzyme called CYP3A4, so drugs that affect this enzyme can change how much ixabepilone is in your body:
- Strong CYP3A4 inhibitors (e.g., ketoconazole and similar antifungals, certain HIV medications): raise ixabepilone blood levels by up to 79%, increasing side effect risk — avoid if possible, or dose must be reduced.
- Strong CYP3A4 inducers (e.g., rifampin, certain anti-seizure drugs): lower ixabepilone blood levels by about 43%, potentially reducing effectiveness — avoid if possible, or dose may need to be increased.
- Moderate or weak CYP3A4 inhibitors: may also raise ixabepilone levels; monitor for increased side effects.
- Capecitabine: used together in one approved combination regimen; some changes in drug levels occur, but these are not considered clinically significant for the approved combination.
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▾
- Liver disease: Must be disclosed before starting treatment — dosing must be adjusted, and the combination with capecitabine is contraindicated if liver function is significantly impaired.
- Allergy to Cremophor EL (polyoxyethylated castor oil, found in some medications): IXEMPRA is contraindicated — tell your doctor about any past reactions to drugs formulated with this ingredient.
- Very low white blood cell count: Treatment cannot start if neutrophil counts are below a safe threshold.
- Pregnancy: IXEMPRA can cause serious fetal harm. Pregnancy should be ruled out before starting, and effective contraception is required during treatment and for 7 months (women) or 4 months (men) after the last dose.
- Breastfeeding: Do not breastfeed during treatment or for 2 weeks after the last dose.
- Heart disease: A history of cardiac conditions requires close monitoring during treatment.
- Older adults (65+): More likely to experience severe side effects; close monitoring is recommended.
- Children: Safety and effectiveness have not been established in pediatric patients; alcohol content in the formulation is an additional consideration.
- Mild-to-moderate kidney disease: No clinically meaningful effect on drug levels; however, severe kidney impairment or use with capecitabine requires attention from your care team.
🚑If you take too much▾
In cases where patients received approximately 2.5 times the recommended dose, symptoms included peripheral neuropathy, fatigue, muscle pain, and gastrointestinal effects such as nausea, diarrhea, and abdominal pain. There is no known antidote for an IXEMPRA overdose. If an overdose is suspected, patients should be closely monitored and given supportive medical care as needed.
📡Pharmacodynamics — effects in the body▾
At the cellular level, ixabepilone causes microtubule bundles to form in a concentration-dependent way — a measurable sign that it is interfering with normal cell division machinery. At recommended doses, IXEMPRA does not cause large, clinically meaningful increases in the QT interval (the heart's electrical recovery time), though small increases cannot be fully ruled out. Patients with cardiac concerns are monitored accordingly.
🔬Pharmacokinetics — how your body processes it▾
After a single IV dose, ixabepilone distributes widely throughout the body (volume of distribution greater than 1,000 liters) and is 67–77% bound to proteins in the blood. It is broken down primarily by the liver enzyme CYP3A4 and has a terminal half-life of approximately 52 hours, meaning it takes roughly two days for blood levels to fall by half. Most of the drug is eliminated as metabolites — about 65% through feces and 21% through urine. Patients with severe liver impairment have significantly higher drug exposure (up to 81% more), which is why liver function plays a central role in dosing decisions.
📦How to store it▾
stored in a refrigerator at 2° C to 8° C (36° F to 46° F). protect from light.
📄 Written from Ixabepilone Injection’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 →
🩺 Pharmacist Counseling Corner
Quick, plain-English answers to the questions patients ask most about Ixabepilone Injection — the kind of thing our pharmacy team would talk through with you at the counter.
Why am I getting this drug if I've already tried other chemotherapy? ▾
Why do I have to take antihistamines before every infusion? ▾
My hands and feet feel tingly and numb — is that normal, and should I be worried? ▾
How will I know if my white blood cell count is too low? ▾
Can I drive home after my infusion? ▾
Is it safe to get pregnant or try to conceive while on this treatment? ▾
Is Ixabepilone Injection available over the counter? ▾
When was Ixabepilone Injection first available? ▾
💬 Answers drafted from Ixabepilone Injection’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
📊 Ixabepilone Injection across the U.S. market
How Ixabepilone Injection 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.
Also listed with the FDA, not a patient dose form: Kit (3) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.
🔍 Compare Ixabepilone Injection products
A representative set of FDA-listed product records for Ixabepilone Injection — 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.)
| Route | Manufacturer / Labeler | Category ⓘ | Details |
|---|---|---|---|
| 💊Kits | |||
| Intravenous | R-Pharm US Operating, LLC × 3 listings | NDA | View NDC → |
Showing 3 of 3 products — FDA National Drug Code Directory. See every product, package size and price: browse all 3 Ixabepilone Injection NDCs →
📈 What people report — real-world data (FDA FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Ixabepilone Injection — a signal of what to watch for, not proof the drug caused it.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Ixabepilone Injection in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
🏛️ The road to your pharmacy
How Ixabepilone Injection went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
🚨 Recall history
A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.
Source: openFDA drug enforcement (recall) reports.
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.
RxCUI 337523 1 dose form · 2 strengths
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Dose form (SCDF) Injection RxCUI 1726270No current FDA listing
Look up RxCUI 337523 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.
📦 Supply & shortage status
Whether Ixabepilone Injection is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
🏷️ Sold under these brand names
🏭 Manufacturers & labelers
RxNorm drug class
Ixabepilone Injection belongs to the Microtubule Inhibitor class.
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.
How we combine label and product data
HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 1 FDA-filed SPL label set 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.
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. R-Pharm US Operating, LLC 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.