Ixempra Side Effects
Generic Name: ixabepilone
Note: This page contains information about the side effects of ixabepilone. Some of the dosage forms included on this document may not apply to the brand name Ixempra.
Not all side effects for Ixempra may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.
For the Consumer
Applies to ixabepilone: intravenous powder for solution
In addition to its needed effects, some unwanted effects may be caused by ixabepilone (the active ingredient contained in Ixempra). In the event that any of these side effects do occur, they may require medical attention.
If any of the following side effects occur while taking ixabepilone, check with your doctor or nurse immediately:More common
- Black, tarry stools
- body aches or pain
- burning, numbness, tingling, or painful sensations
- burning pain on urination
- chest pain
- difficult or labored breathing
- ear congestion
- loss of voice
- lower back or side pain
- nasal congestion
- painful or difficult urination
- pale skin
- red, swelling, or painful skin
- runny nose
- scaling of the skin on the hands and feet
- shortness of breath
- sore throat
- sores, ulcers, or white spots on the lips, tongue, or inside the mouth
- swelling of the hands, ankles, feet, or lower legs
- swollen glands
- tightness in the chest
- tingling of the hands and feet
- troubled breathing with exertion
- ulceration of the skin
- unsteadiness or awkwardness
- unusual bleeding or bruising
- unusual tiredness or weakness
- unusual weight gain
- weakness in the arms, hands, legs, or feet
- Bleeding gums
- blood in the urine or stools
- decreased urination
- dry mouth
- fast heartbeat
- increase in heart rate
- joint pain, stiffness, or swelling
- pinpoint red spots on the skin
- rapid breathing
- sunken eyes
- swelling of the eyelids, face, or lips
- trouble with swallowing
- wrinkled skin
Some of the side effects that can occur with ixabepilone may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:More common
- Bad, unusual, or unpleasant (after) taste
- bone pain
- change in taste
- cracked lips
- difficulty having a bowel movement (stool)
- discoloration of the fingernails or toenails
- feeling of warmth
- hair loss or thinning of the hair
- lack or loss of strength
- loss of appetite
- redness of the face, neck, arms, and occasionally, upper chest
- stomach pain
- sudden sweating
- swelling or inflammation of the mouth
- weight loss
- Darkening of the skin
- flaking and falling off of the skin
- trouble with sleeping
- unable to sleep
- watering of the eyes
For Healthcare Professionals
Applies to ixabepilone: intravenous powder for injection
Myelosuppression manifesting primarily as neutropenia can occur. It is generally dose-dependent and can result in infection or death. In clinical studies, grade 4 neutropenia (less than 500 cells/mm3) occurred in 36% of patients treated with ixabepilone (the active ingredient contained in Ixempra) in combination with capecitabine and 23% of patients treated with ixabepilone monotherapy. Patients should be monitored for myelosuppression with frequent peripheral blood cell counts. Dosage reduction should be instituted in patients who experience severe neutropenia or thrombocytopenia.
Hematologic side effects have included neutropenia, leukopenia, anemia, and thrombocytopenia in more than 40% of patients. Coagulopathy and lymphopenia have also been reported.
Hypersensitivity reactions have been reported during ixabepilone (the active ingredient contained in Ixempra) use. Patients with a history of severe hypersensitivity reactions to agents containing polyoxyethylated castor oil should not be treated with ixabepilone. All patients should be premedicated with an H1 and an H2 antagonist approximately one hour before ixabepilone infusion and be observed for hypersensitivity reactions (e.g., flushing, rash, dyspnea and bronchospasm). If a severe hypersensitivity reaction occurs, ixabepilone infusion should be stopped and aggressive supportive treatment (e.g., epinephrine, corticosteroids) started. Patients experiencing a hypersensitivity reaction in one cycle of ixabepilone treatment must be premedicated in subsequent cycles with a corticosteroid in addition to the H1 and H2 antagonists. Extension of the infusion time should also be considered.
Of the 1323 patients treated with ixabepilone in clinical studies, nine patients (1%) experienced severe hypersensitivity reactions including anaphylaxis, and three of the 9 were able to be retreated.
Peripheral neuropathy is a commonly reported side effect associated with ixabepilone (the active ingredient contained in Ixempra) often occurring early during treatment. Patients should be monitored for symptoms of neuropathy, such as burning sensation, hyperesthesia, hypoesthesia, paresthesia, discomfort, or neuropathic pain. A reduction or delay in the dose of ixabepilone may be required in patients experiencing new or worsening symptoms. Extra caution should be used when treating patients with diabetes mellitus or existing moderate to severe neuropathy.
Nervous system side effects have included peripheral neuropathy, fatigue, and asthenia in more than 20% of patients. Insomnia, headache, dizziness, cognitive disorder, syncope, cerebral hemorrhage, abnormal coordination, lethargy, and hot flush have also been reported.
Cardiovascular side effects including myocardial ischemia, ventricular dysfunction, and supraventricular arrhythmias have been associated with ixabepilone (the active ingredient contained in Ixempra) use. Chest pain (5%), myocardial infarction, left ventricular dysfunction, angina pectoris, atrial flutter, cardiomyopathy, thrombosis, embolism, hemorrhage, hypovolemic shock, vasculitis and hypotension have also been reported.
The frequency of myocardial ischemia and ventricular dysfunction was higher when ixabepilone was used in combination with capecitabine (1.9%) than with capecitabine monotherapy (0.3%). Supraventricular arrhythmias were observed in the combination arm (0.5%) and not in the capecitabine monotherapy arm. Caution is recommended in patients with a history of cardiac disease, and discontinuation of ixabepilone should be considered in patients who develop cardiac ischemia or impaired cardiac function.
Musculoskeletal side effects occurring in more than 20% of patients have included myalgia, arthralgia, musculoskeletal pain, and palmar-plantar erythrodysesthesia (hand-foot) syndrome. Muscular weakness, muscle spasms, and trismus have also been reported.
Gastrointestinal side effects have included nausea, vomiting, stomatitis/mucositis, diarrhea, anorexia, abdominal pain, and constipation in more than 20% of patients. Gastroesophageal reflux (6%), taste disorder (6%), ileus, colitis, impaired gastric emptying, esophagitis, dysphagia, gastritis, enterocolitis, and gastrointestinal hemorrhage have also been reported.
Dermatologic side effects have included alopecia (48%), skin rash (9%), and nail disorder (9%). Pruritus (6%), skin exfoliation, skin hyperpigmentation, and erythema multiforme have also been reported. Radiation recall has been reported during postmarketing use but frequency or causal relationship to drug exposure cannot be established.
Respiratory side effects have included dyspnea (9%), upper respiratory tract infection (6%), and cough. Laryngitis, lower respiratory tract infection, pneumonia, pneumonitis, hypoxia, respiratory failure, acute pulmonary edema, dysphonia, and pharyngolaryngeal pain have also been reported.
Hepatic side effects have included acute hepatic failure, jaundice, increased transaminases, increased blood alkaline phosphatase, and increased gamma-glutamyltransferase.
Renal side effects have included nephrolithiasis, urinary tract infection, and renal failure.
Metabolic side effects have included hyponatremia, metabolic acidosis, hypokalemia, and hypovolemia.
Ocular side effects including increased lacrimation (4%) have been reported.
Other side effects have included edema (9%), pyrexia (8%), pain (8%), decreased weight (6%), sepsis, infection, bacterial infection, neutropenic infection, neutropenic fever, and chills.
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