Ixempra Side Effects Center

Last updated on RxList: 2/4/2022
Ixempra Side Effects Center

What Is Ixempra?

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.

What Are Side Effects of Ixempra?

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.

Dosage for Ixempra

The recommended dosage of Ixempra is 40 mg/m2 administered intravenously over 3 hours every 3 weeks.

What Drugs, Substances, or Supplements Interact with Ixempra?

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 During Pregnancy or Breastfeeding

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.

Additional Information

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.

SLIDESHOW

Breast Cancer Awareness: Symptoms, Diagnosis, and Treatment See Slideshow
Ixempra Consumer Information

Get emergency medical help if you have signs of an allergic reaction: itching, hives, rash; feeling dizzy or faint; warmth or tingly feeling; difficulty breathing, chest tightness; pounding heartbeats or fluttering in your chest; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • numbness, tingling, burning pain, discomfort, or loss of feeling anywhere in your body;
  • pain or burning when you urinate;
  • unusual weight gain;
  • pain, blisters, bleeding, or severe rash on the palms of your hands or the soles of your feet;
  • chest pain, difficult breathing;
  • pounding heartbeats or fluttering in your chest;
  • low blood cell counts--fever, chills, tiredness, mouth sores, skin sores, easy bruising, unusual bleeding, pale skin, cold hands and feet, feeling light-headed or short of breath; or
  • signs of a blood clot--sudden numbness or weakness, problems with vision or speech, swelling or redness in an arm or leg.

Common side effects may include:

  • blisters or severe rash on the palms of your hands or the soles of your feet;
  • headache;
  • tiredness;
  • joint or muscle pain;
  • lip, mouth, and esophagus sores;
  • hair loss;
  • fever;
  • anemia, decreased platelets;
  • nausea, vomiting, stomach pain, loss of appetite;
  • diarrhea, 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)

QUESTION

A lump in the breast is almost always cancer. See Answer
Ixempra Professional Information

SIDE EFFECTS

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

  • Peripheral neuropathy [see WARNINGS AND PRECAUTIONS]
  • Myelosuppression [see WARNINGS AND PRECAUTIONS]
  • Hypersensitivity reactions [see WARNINGS AND PRECAUTIONS]
  • Cardiac Adverse Reactions [see WARNINGS AND PRECAUTIONS]

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/m2administered 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 a single agent (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/m2administered 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 Page 11 of 30 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 Adverse Reactions Occurring in at Least 5% of Patients with Metastatic or Locally Advanced Breast Cancer Treated with IXEMPRA

Study 046 Study 081
Adverse Reaction IXEMPRA with capecitabine
n=369
Capecitabine
n=368
IXEMPRA as a Single Agent
n=126
All Grades
(%)
Grade 3/4
(%)
All Grades
(%)
Grade 3/4
(%)
All Grades
(%)
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 Disorders
  Insomniab 9 <1d 2 0 5 0
Nervous System Disorders
  Peripheral neuropathy
    Sensory neuropathyb 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 1dd 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 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 Administration Site Conditions
  Fatigue/astheniab 60 16 29 4 56 13
  Edemab 8 0 5 <1d 9 1d
  Pyrexia 1 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
bA composite of multiple terms.
cThree 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].
dNo grade 4 reports.
ePeripheral sensory neuropathy 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

Study 046 Study 081
IXEMPRA with capecitabine
n=369
Capecitabine
n=368
IXEMPRA as a Single Agent
n=126
Hematology Parameter 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 colony 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 a single agent or in combination with other therapies in clinical 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, 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

The following adverse reaction has been identified during postapproval use of IXEMPRA. Because these reactions are 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.

Procedural Complications: Radiation recall

DRUG INTERACTIONS

Effect Of Other Drugs On IXEMPRA

Strong CYP3A4 Inhibitors

The coadministration of IXEMPRA with a strong CYP3A4 inhibitor increased ixabepilone plasma concentration, which may increase the incidence and severity of adverse reactions of IXEMPRA. Avoid coadministration of IXEMPRA with strong CYP3A4 inhibitors. If the coadministration of IXEMPRA with strong CYP3A4 cannot be avoided, reduce the dose of IXEMPRA [see DOSAGE AND ADMINISTRATION, CLINICAL PHARMACOLOGY].

Moderate Or Weak CYP3A4 Inhibitors

The coadministration of IXEMPRA with moderate or weak CYP3A4 inhibitors may increase the incidence and severity of adverse reactions of IXEMPRA. Monitor for adverse reactions and reduce the dose of IXEMPRA as recommended [see DOSAGE AND ADMINISTRATION, ADVERSE REACTIONS].

Strong CYP3A4 Inducers

The coadministration of IXEMPRA with a strong CYP3A4 inducer, decreased plasma concentrations of ixabepilone, which may decrease the efficacy of IXEMPRA [see CLINICAL PHARMACOLOGY]. Avoid the coadministration IXEMPRA with strong CYP3A4 inducers. If the coadministration of IXEMPRA with a strong CYP3A4 inducer cannot be avoided, increase the dose of IXEMPRA [see DOSAGE AND ADMINISTRATION].

Concomitant Use Of IXEMPRA And Capecitabine

No clinically meaningful differences in the pharmacokinetics of ixabepilone and capecitabine were observed when IXEMPRA was administered in combination with capecitabine (1000 mg/m2) [see CLINICAL PHARMACOLOGY].

Read the entire FDA prescribing information for Ixempra (Ixabepilone)

© 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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