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Ixempra Kit (IXABEPILONE)
Ixempra Kit works by disrupting cell division, preventing cancer cells from growing and multiplying.
At a glance
| Generic name | IXABEPILONE |
|---|---|
| Sponsor | R-Pharm Us Llc |
| Drug class | Microtubule Inhibitor |
| Target | Apoptosis regulator Bcl-2 |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | FDA-approved |
| First approval | 2007 |
Mechanism of action
Imagine your cells are like a city with roads and buildings. Microtubules are like the roads that help cells divide and grow. Ixempra Kit blocks these roads, making it hard for cancer cells to build new roads and grow, ultimately leading to cell death.
Approved indications
- Metastatic or locally advanced breast cancer with capecitabine
- Metastatic or locally advanced breast cancer as a single agent
Boxed warnings
- WARNING: TOXICITY IN PATIENTS WITH HEPATIC IMPAIRMENT IXEMPRA in combination with capecitabine is contraindicated in patients with AST or ALT >2.5 x ULN or bilirubin >1 x ULN due to increased risk of toxicity and neutropenia-related death [see Contraindications ( 4 ) and Warnings and Precautions ( 5.3 )]. WARNING: TOXICITY IN PATIENTS WITH HEPATIC IMPAIRMENT See full prescribing information for complete boxed warning. IXEMPRA ® in combination with capecitabine is contraindicated in patients with AST or ALT >2.5 x ULN or bilirubin >1 x ULN due to increased risk of toxicity and neutropenia-related death. ( 4 , 5.3 )
Common side effects
- Pseudocirrhosis
- Neutrophil count decreased
- White blood cell count decreased
- Portal hypertension
- Anaemia
- Neutropenia
- Dehydration
- Disease progression
- Platelet count decreased
- Peripheral sensory neuropathy
- Vomiting
Drug interactions
- atazanavir
- boceprevir
- carbamazepine
- conivaptan
- dexamethasone
- ketamine
- ketoconazole
- lopinavir
- mibefradil
- nefazodone
- nelfinavir
- phenobarbital
Key clinical trials
- Ixabepilone and Temsirolimus in Treating Patients With Solid Tumors That Are Metastatic or Cannot Be Removed by Surgery (PHASE1)
- Anti-tumor Effect of Ixabepilone in Metastatic Breast Cancer (mBC) Selected by the Ixabepilone DRP. (PHASE2)
- Ixabepilone in Treating Participants With Significant Residual Disease of HER2/Neu Negative Invasive Breast Cancer After Systemic Therapy (PHASE2)
- Paclitaxel, Carboplatin, and Bevacizumab or Paclitaxel, Carboplatin, and Temsirolimus or Ixabepilone, Carboplatin, and Bevacizumab in Treating Patients With Stage III, Stage IV, or Recurrent Endometrial Cancer (PHASE2)
- Investigational Drug in Combination With Two Chemotherapy Drugs in Women With Locally Recurrent or Metastatic Breast Cancer (PHASE1,PHASE2)
- Pharmacodynamic Biomarkers of Standard Anti-microtubule Drugs as Assessed by Early Tumor Biopsy
- Evaluation of Weekly Ixabepilone With or Without Biweekly Bevacizumab (PHASE2)
- BMS-247550 in Treating Patients With Cancers That Have Not Responded to Previous Therapy (PHASE1)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Ixempra Kit CI brief — competitive landscape report
- Ixempra Kit updates RSS · CI watch RSS
- R-Pharm Us Llc portfolio CI