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Ixempra

Last reviewed on RxList: 12/28/2016
Ixempra Side Effects Center

Last reviewed on RxList 2/23/2016

Ixempra (ixabepilone) is a cancer (antineoplastic) medication used to treat advanced breast cancer, and is usually given after other cancer medications have been tried without successful treatment. Common side effects of Ixempra include injection site reactions (pain, redness, or swelling), weakness, tiredness, muscle or joint pain, nausea and vomiting (may be severe), stomach pain, diarrhea, constipation, loss of appetite, headache, dizziness, drowsiness, tired feeling, hair loss, or problems with your fingernails or toenails.

The recommended dosage of Ixempra is 40 mg/mē administered intravenously over 3 hours every 3 weeks. Ixempra may interact with dexamethasone, St. John's wort, barbiturates, HIV /AIDS medicines, antibiotics, antifungal medications, seizure medications, or antidepressants. Tell your doctor all medications and supplements you use. Ixempra is not recommended for use during pregnancy. It may harm a fetus. If you become pregnant or think you may be pregnant, tell your doctor. Women and men using this medication should use 2 forms of birth control (e.g., condoms and birth control pills) to prevent pregnancy; consult your doctor. It is unknown if this drug passes into breast milk. Because of the possible risk to the infant, breastfeeding while using this drug is not recommended.

Our Ixempra (ixabepilone) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Ixempra Consumer Information

Get emergency medical help if you have any of these signs of an allergic reaction: hives; warmth or tingly feeling; difficulty breathing; swelling of your face, lips, tongue, or throat.

Tell your caregivers at once if you have any of these serious side effects:

  • numbness, tingling, burning pain, discomfort, or loss of feeling anywhere in your body;
  • fever, chills, body aches, flu symptoms, sores in your mouth and throat;
  • easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin;
  • pale skin, feeling light-headed or short of breath, rapid heart rate, trouble concentrating;
  • sudden numbness or weakness, especially on one side of the body;
  • sudden severe headache, confusion, problems with vision, speech, or balance;
  • pain or burning when you urinate;
  • chest pain or heavy feeling; or
  • redness, swelling, and pain on the palms of your hands or the soles of your feet.

Less serious side effects include:

  • tired feeling;
  • joint or muscle pain;
  • hair loss;
  • nausea, vomiting, stomach pain, loss of appetite;
  • diarrhea or constipation; or
  • problems with your fingernails or toenails.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Ixempra (Ixabepilone)

Ixempra Professional Information

SIDE EFFECTS

The following adverse reactions are discussed in greater detail in other sections.

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, the adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in other clinical trials and may not reflect the rates observed in clinical practice.

Unless otherwise specified, assessment of adverse reactions is based on one randomized study (Study 046) and one single-arm study (Study 081). In Study 046, 369 patients with metastatic breast cancer were treated with IXEMPRA 40 mg/m² administered intravenously over 3 hours every 21 days, combined with capecitabine 1000 mg/m² twice daily for 2 weeks followed by a 1-week rest period. Patients treated with capecitabine as monotherapy (n=368) in this study received 1250 mg/m² twice daily for 2 weeks every 21 days. In Study 081, 126 patients with metastatic or locally advanced breast cancer were treated with IXEMPRA 40 mg/m² administered intravenously over 3 hours every 3 weeks.

The most common adverse reactions ( ≥ 20%) reported by patients receiving IXEMPRA were peripheral sensory neuropathy, fatigue/asthenia, myalgia/arthralgia, alopecia, nausea, vomiting, stomatitis/mucositis, diarrhea, and musculoskeletal pain. The following additional reactions occurred in ≥ 20% in combination treatment: palmar-plantar erythrodysesthesia (hand-foot) syndrome, anorexia, abdominal pain, nail disorder, and constipation. The most common hematologic abnormalities ( > 40%) include neutropenia, leukopenia, anemia, and thrombocytopenia.

Table 4 presents nonhematologic adverse reactions reported in 5% or more of patients. Hematologic abnormalities are presented separately in Table 5.

Table 4: Nonhematologic Drug-related Adverse Reactions Occurring in at Least 5% of Patients with Metastatic or Locally Advanced Breast Cancer Treated with IXEMPRA

System Organ Classa/Preferred Term Study 046 Study 081
IXEMPRA with capecitabine n=369 Capecitabine n=368 IXEMPRA monotherapy n=126
Total (%) Grade 3/4 (%) Total (%) Grade 3/4 (%) Total (%) Grade 3/4 (%)
Infections and Infestations
  Upper respiratory tract infectionb 4 0 3 0 6 0
Blood and Lymphatic System Disorders
  Febrile neutropenia 5 4c 1 1d 3 3d
Immune System Disorders
  Hypersensitivityb 2 1d 0 0 5 1d
Metabolism and Nutrition Disorders
  Anorexiab 34 3d 15 1d 19 2d
  Dehydrationb 5 2 2 < 1d 2 1d
Psychiatric
  Insomniab 9 < 1d 2 0 5 0
Nervous System Disorders
  Peripheral neuropathy            
    Sensory neuropathyb,e 65 21 16 0 62 14
    Motor neuropathyb 16 5d < 1 0 10 1d
  Headache 8 < 1d 3 0 11 0
  Taste disorderb 12 0 4 0 6 0
  Dizziness 8 1d 5 1d 7 0
Eye Disorders
  Lacrimation increased 5 0 4 < 1d 4 0
Vascular Disorders
  Hot flushb 5 0 2 0 6 0
Respiratory, Thoracic, and Mediastinal Disorders
  Dyspneab 7 1 4 1 9 1d
  Coughb 6 0 2 0 2 0
Gastrointestinal Disorders
  Nausea 53 3d 40 2d 42 2d
  Vomitingb 39 4d 24 2 29 1d
  Stomatitis/mucositisb 31 4 20 3d 29 6
  Diarrheab 44 6d 39 9 22 1d
  Constipation 22 0 6 < 1d 16 2d
  Abdominal painb 24 2d 14 1d 13 2d
  Gastroesophageal reflux diseaseb 7 1d 8 0 6 0
Skin and Subcutaneous Tissue Disorders
  Alopeciab 31 0 3 0 48 0
  Skin rashb 17 1d 7 0 9 2d
  Nail disorderb 24 2d 10 < 1d 9 0
  Palmar-plantar erythrodysesthesia syndromeb,f 64 18d 63 17d 8 2d
  Pruritus 5 0 2 0 6 1d
  Skin exfoliationb 5 < 1d 3 0 2 0
  Skin hyperpigmentationb 11 0 14 0 2 0
Musculoskeletal, Connective Tissue, and Bone Disorders
  Myalgia/arthralgiab 39 8d 5 < 1d 49 8d
  Musculoskeletal painb 23 2d 5 0 20 3d
General Disorders and Administrative Site Conditions
  Fatigue/astheniab 60 16 29 4 56 13
  Edemab 8 0 5 < 1d 9 1d
  Pyrexia 10 1d 4 0 8 1d
  Painb 9 1d 2 0 8 3d
  Chest painb 4 1d < 1 0 5 1d
Investigations
  Weight decreased 11 0 3 0 6 0
a System organ class presented as outlined in Guidelines for Preparing Core Clinical Safety Information on Drugs by the Council for International Organizations of Medical Sciences (CIOMS).
b A composite of multiple MedDRA Preferred Terms.
c NCI CTC grading for febrile neutropenia ranges from Grade 3 to 5. Three patients (1%) experienced Grade 5 (fatal) febrile neutropenia. Other neutropenia-related deaths (9) occurred in the absence of reported febrile neutropenia [see WARNINGS AND PRECAUTIONS].
d No grade 4 reports.
e Peripheral sensory neuropathy (graded with the NCI CTC scale) was defined as the occurrence of any of the following: areflexia, burning sensation, dysesthesia, hyperesthesia, hypoesthesia, hyporeflexia, neuralgia, neuritis, neuropathy, neuropathy peripheral, neurotoxicity, painful response to normal stimuli, paresthesia, pallanesthesia, peripheral sensory neuropathy, polyneuropathy, polyneuropathy toxic and sensorimotor disorder. Peripheral motor neuropathy was defined as the occurrence of any of the following: multifocal motor neuropathy, neuromuscular toxicity, peripheral motor neuropathy, and peripheral sensorimotor neuropathy.
f Palmar-plantar erythrodysesthesia (hand-foot syndrome) was graded on a 1-3 severity scale in Study 046.

Table 5: Hematologic Abnormalities in Patients with Metastatic or Locally Advanced Breast Cancer Treated with IXEMPRA

Hematology Parameter Study046 Study081
IXEMPRA with capecitabine n=369 Capecitabine n=368 IXEMPRA monotherapy n=126
Grade 3 (%) Grade 4 (%) Grade 3 (%) Grade 4 (%) Grade 3 (%) Grade 4 (%)
Neutropeniaa 32 36 9 2 31 23
Leukopenia (WBC) 41 16 5 1 36 13
Anemia (Hgb) 8 2 4 1 6 2
Thrombocytopenia 5 3 2 2 5 2
a G-CSF (granulocyte colony stimulating factor) or GM-CSF (granulocyte macrophage stimulating factor) was used in 20% and 17% of patients who received IXEMPRA in Study 046 and Study 081, respectively.

The following serious adverse reactions were also reported in 1323 patients treated with IXEMPRA as monotherapy or in combination with other therapies in Phase 2 and 3 studies.

Infections and Infestations: sepsis, pneumonia, infection, neutropenic infection, urinary tract infection, bacterial infection, enterocolitis, laryngitis, lower respiratory tract infection

Blood and Lymphatic System Disorders: coagulopathy, lymphopenia

Metabolism and Nutrition Disorders: hyponatremia, metabolic acidosis, hypokalemia, hypovolemia

Nervous System Disorders: cognitive disorder, syncope, cerebral hemorrhage, abnormal coordination, lethargy

Cardiac Disorders: myocardial infarction, supraventricular arrhythmia, left ventricular dysfunction, angina pectoris, atrial flutter, cardiomyopathy, myocardial ischemia

Vascular Disorders: hypotension, thrombosis, embolism, hemorrhage, hypovolemic shock, vasculitis

Respiratory, Thoracic, and Mediastinal Disorders: pneumonitis, hypoxia, respiratory failure, acute pulmonary edema, dysphonia, pharyngolaryngeal pain

Gastrointestinal Disorders: ileus, colitis, impaired gastric emptying, esophagitis, dysphagia, gastritis, gastrointestinal hemorrhage

Hepatobiliary Disorders: acute hepatic failure, jaundice

Skin and Subcutaneous Tissue Disorders: erythema multiforme

Musculoskeletal, Connective Tissue Disorders, and Bone Disorders: muscular weakness, muscle spasms, trismus

Renal and Urinary Disorders: nephrolithiasis, renal failure

General Disorders and Administration Site Conditions: chills

Investigations: increased transaminases, increased blood alkaline phosphatase, increased gamma-glutamyltransferase

Postmarketing Experience

Radiation recall has been reported during postmarketing use of IXEMPRA. Because this reaction was reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate the frequency or establish a causal relationship to drug exposure.

Read the entire FDA prescribing information for Ixempra (Ixabepilone)

Related Resources for Ixempra

Read the Ixempra User Reviews »

© Ixempra Patient Information is supplied by Cerner Multum, Inc. and Ixempra Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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