Información del Paciente

Bienvenidos

Para nuestros pacientes y familias de habla hispana interesados en un tratamiento para el cáncer de mama metastásico, R-Pharm US ha desarrollado un folleto con información completa sobre nuestro producto. Esto incluye información del paciente, efectos secundarios comunes y graves, información de seguridad importante, apoyo al paciente y recursos adicionales.

¡R-Pharm US se compromete a apoyar a los pacientes en la lucha contra el cáncer de mama metastásico!

Indications and Important Safety Informationexpand

Important Safety Information
WARNING: Toxicity in hepatic impairment

IXEMPRA^® (ixabepilone) in combination with capecitabine is contraindicated in patients with AST or ALT >2.5 × ULN or bilirubin >1 × ULN due to increased risk of toxicity and neutropenia-related death
In combination with capecitabine, the overall frequency of grade 3/4 adverse reactions, febrile neutropenia, serious adverse reactions, and toxicity-related deaths was greater in patients with hepatic impairment
Caution should be used when using IXEMPRA as monotherapy in patients with AST or ALT >5 × ULN. Use of IXEMPRA in patients with AST or ALT >10 × ULN or bilirubin >3 × ULN is not recommended
With monotherapy, grade 4 neutropenia, febrile neutropenia, and serious adverse reactions were more frequent in patients with hepatic impairment

Contraindications

IXEMPRA is contraindicated in patients:
- with a known history of a severe (CTC grade 3/4) hypersensitivity reaction to agents containing Cremophor^® EL or its derivatives such as polyoxyethylated castor oil
- who have a baseline neutrophil count <1500 cells/mm³ or a platelet count <100,000 cells/mm³

Peripheral neuropathy

Peripheral neuropathy was common. Patients treated with IXEMPRA should be monitored for symptoms of neuropathy, such as burning sensation, hyperesthesia, hypoesthesia, paresthesia, discomfort, or neuropathic pain
Neuropathy occurred early during treatment; ~75% of new onset or worsening neuropathy occurred during the first 3 cycles. Patients experiencing new or worsening peripheral neuropathy may require changes in the dose or discontinuation of IXEMPRA
Neuropathy was the most frequent cause of treatment discontinuation due to drug toxicity. Caution should be used when treating patients with diabetes mellitus or preexisting peripheral neuropathy

Myelosuppression

Myelosuppression is dose-dependent and primarily manifested as neutropenia
Patients should be monitored for myelosuppression; frequent peripheral blood cell counts are recommended for all patients receiving IXEMPRA
Patients who experience severe neutropenia or thrombocytopenia should have their dose reduced. Neutropenia-related deaths occurred in 1.9% of 414 patients with normal hepatic function or mild hepatic impairment treated with IXEMPRA in combination with capecitabine. Neutropenia-related death occurred in 0.4% of 240 patients with IXEMPRA as monotherapy

Hypersensitivity reaction

Premedicate with an H₁ and an H₂ antagonist approximately 1 hour before IXEMPRA infusion and observe for hypersensitivity reactions (eg, flushing, rash, dyspnea, and bronchospasm)
In case of severe hypersensitivity reactions, infusion of IXEMPRA should be stopped and aggressive supportive treatment (eg, epinephrine, corticosteroids) started
Patients who experience a hypersensitivity reaction in one cycle of IXEMPRA must be premedicated in subsequent cycles with a corticosteroid in addition to the H₁ and H₂ antagonists, and extension of the infusion time should be considered

Pregnancy

Women should be advised not to become pregnant when taking IXEMPRA. If this drug is used during pregnancy or the patient becomes pregnant, the patient should be apprised of the potential hazard to the fetus

Cardiac adverse reactions

Caution should be exercised in patients with a history of cardiac disease. Discontinuation of IXEMPRA should be considered in patients who develop cardiac ischemia or impaired cardiac function due to reports of cardiovascular adverse reactions (eg, myocardial ischemia, supraventricular arrhythmia, and ventricular dysfunction). The frequency of cardiac adverse reactions (myocardial ischemia and ventricular dysfunction) was higher in the IXEMPRA in combination with capecitabine (1.9%) than in the capecitabine alone (0.3%) treatment group

Potential for cognitive impairment from excipients

IXEMPRA contains dehydrated alcohol USP. Consideration should be given to the possibility of central nervous system and other effects of alcohol

Adverse reactions

Monotherapy

The most common adverse reactions (≥20%) reported by patients receiving IXEMPRA monotherapy were peripheral sensory neuropathy, 62% (grade 3/4: 14%); fatigue/asthenia, 56% (grade 3/4: 13%); myalgia/arthralgia, 49% (grade 3/4: 8%); alopecia, 48% (grade 3/4: 0%); nausea, 42% (grade 3/4: 2%); stomatitis/mucositis, 29% (grade 3/4: 6%); vomiting, 29% (grade 3/4: 1%); diarrhea, 22% (grade 3/4: 1%); and musculoskeletal pain, 20% (grade 3/4: 3%). Drug-associated hematologic abnormalities (>40%) included neutropenia, leukopenia, anemia, and thrombocytopenia. Grade 3/4 hematologic adverse reactions included neutropenia, 54%; leukopenia, 49%; anemia, 8%; and thrombocytopenia, 7%

Combination with capecitabine

The most common adverse reactions (≥20%) reported by patients receiving IXEMPRA in combination with capecitabine compared to capecitabine alone, respectively, were peripheral sensory neuropathy, 65% vs. 16% (grade 3/4: 21% vs. 0%); palmar-plantar erythrodysesthesia (hand-foot) syndrome, 64% vs. 63% (grade 3/4: 18% vs. 17%); fatigue/asthenia, 60% vs. 29% (grade 3/4: 16% vs. 4%); nausea, 53% vs. 40% (grade 3/4: 3% vs. 2%); diarrhea, 44% vs. 39% (grade 3/4: 6% vs. 9%); vomiting, 39% vs. 24% (grade 3/4: 4% vs. 2%); myalgia/arthralgia, 39% vs. 5% (grade 3/4: 8% vs. <1%); anorexia, 34% vs. 15% (grade 3/4: 3% vs. 1%); stomatitis/mucositis, 31% vs. 20% (grade 3/4: 4% vs. 3%); alopecia, 31% vs. 3% (grade 3/4: 0% vs. 0%); abdominal pain, 24% vs. 14% (grade 3/4: 2% vs. 1%); nail disorder, 24% vs. 10% (grade 3/4: 2% vs. <1%); musculoskeletal pain, 23% vs. 5% (grade 3/4: 2% vs. 0%); and constipation, 22% vs. 6% (grade 3/4: 0% vs. <1%). Drug-associated hematologic abnormalities (>40%) with IXEMPRA in combination with capecitabine and capecitabine alone, respectively, included neutropenia, leukopenia, anemia, and thrombocytopenia. Grade 3/4 hematologic adverse reactions included neutropenia, 68% vs. 11%; leukopenia, 57% vs. 6%; anemia, 10% vs. 5%; and thrombocytopenia, 8% vs. 4%

Cremophor is a registered trademark of BASF AG.

AST = aspartate aminotransferase; ALT = alanine aminotransferase; ULN = upper limit of normal; CTC = common terminology criteria.

Indications

IXEMPRA^® (ixabepilone) is indicated in combination with capecitabine for the treatment of patients with metastatic or locally advanced breast cancer resistant to treatment with an anthracycline and a taxane, or whose cancer is taxane resistant and for whom further anthracycline therapy is contraindicated.

Anthracycline resistance is defined as progression while on therapy or within 6 months in the adjuvant setting or 3 months in the metastatic setting
Taxane resistance is defined as progression while on therapy or within 12 months in the adjuvant setting or 4 months in the metastatic setting

IXEMPRA is indicated as monotherapy for the treatment of metastatic or locally advanced breast cancer in patients whose tumors are resistant or refractory to anthracyclines, taxanes, and capecitabine.

Please see US Full Prescribing Information, including boxed WARNING regarding hepatic impairment.

Medical information

For product information or to report an adverse reaction, please call 1-844-586-8953 or e-mail DrugSafety@propharmagroup.com.

This site is intended for US healthcare professionals.

The R-Pharm US Access and Support logo is a trademark and IXEMPRA^® is a registered trademark of R-Pharm US Operating LLC, a wholly owned subsidiary of R-Pharm US LLC.