Ixempra

IV Preparation

If kit refrigerated, warm kit at room temp for 30 min (dissolves precipitate in diluent if any and produces clear diluent)

Reconstitute vials with supplied diluent: 15 mg with the 8 mL diluent; 45 mg with the 23.5 mL diluent (final conc 2 mg/mL)

Aseptically withdraw diluent and add to drug vial; swirl and invert to completely dissolve

Reconstituted solution stable for 1 hr at room temp and light

Dilute further in LR ~250 mL in DEHP-free bag

Stable for up to 6 hr at room temp and light (including 3 hr infusion time, ie upto 3 hr idle storage+3 hr infusion)

IV Administration

Use 0.2-1.2 micron inline filter

Use DEHP-free infusion apparatus

Infuse over 3 hr

Storage

Store original kit refrigerated and unopened

Ixempra is part of the drug class:

• Other cytotoxic antibiotics

Your doctor or pharmacist can provide more information about ixabepilone.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

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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]

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

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

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)

Do not use ixabepilone if you are pregnant. It could harm the unborn baby.

You should not receive this medication if you are allergic to ixabepilone, or to a medication ingredient called Cremophor (synthetic castor oil). You may not be able to receive ixabepilone if you have severe liver disease, or severely low platelets or white blood cell counts.

Before you receive ixabepilone, tell your doctor if you have liver disease, heart disease, nerve problems, diabetes, bone marrow suppression, or a weak immune system.

Ixabepilone can lower blood cells that help your body fight infections. Avoid being near people who are sick or have infections. Your blood may need to be tested often. Visit your doctor regularly.

Tell your doctor at once if you develop signs of infection, such as fever, chills, body aches, flu symptoms, pale skin, easy bruising or bleeding, or sores in your mouth and throat.

Avoid drinking alcohol during your treatment with ixabepilone.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Storage

Parenteral

2–8° C in original package; protect from light.1

Reconstituted solutions may be stored at room temperature for ≤1 hour in room light.1

Solutions diluted in appropriate injections are stable at room temperature and room light for ≤6 hours.1 2 (See Dilution under Dosage and Administration.)

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly. Blood tests may be needed to check for unwanted effects.

Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. If you think you have become pregnant while using the medicine, tell your doctor right away.

Check with your doctor right away if you are having burning, numbness, tingling, or painful sensations in the arms, hands, legs, or feet. These could be symptoms of a condition called peripheral neuropathy.

Ixabepilone injection can temporarily lower the number of white blood cells in your blood, increasing the chance of getting an infection. It can also lower the number of platelets, which are necessary for proper blood clotting. If this occurs, there are certain precautions you can take, especially when your blood counts are low, to reduce the risk of infection or bleeding:

• If you can, avoid people with infections. Check with your doctor immediately if you think you are getting an infection or if you get a fever or chills, cough or hoarseness, lower back or side pain, or have painful or difficult urination.
• Check with your doctor immediately if you notice any unusual bleeding or bruising; black, tarry stools; blood in the urine or stools; or pinpoint red spots on your skin.
• Be careful when using a regular toothbrush, dental floss, or toothpick. Your medical doctor, dentist, or nurse may recommend other ways to clean your teeth and gums. Check with your medical doctor before having any dental work done.
• Do not touch your eyes or the inside of your nose unless you have just washed your hands and have not touched anything else in the meantime.
• Be careful not to cut yourself when you are using sharp objects such as safety razors and fingernail or toenail cutters.
• Avoid contact sports or other situations where bruising or injury could occur.

This medicine may cause serious allergic reactions, including anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Tell your doctor right away if you have a rash; itching; swelling of the face, tongue, and throat; trouble with breathing; or chest pain after you receive the medicine.

Check with your doctor right away if you have chest pain, difficulty with breathing, a fast or pounding heartbeat, or unusual weight gain. These could be symptoms of a serious heart problem.

Ixabepilone contains alcohol, which may cause some people to become dizzy or drowsy. If any of these side effects occur, do not drive, use machines, or do anything else that could be dangerous if you are not alert.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal (e.g., St. John's wort) or vitamin supplements.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

• Black, tarry stools
• body aches or pain
• burning, numbness, tingling, or painful sensations
• burning pain on urination
• chest pain
• chills
• cough
• difficult or labored breathing
• ear congestion
• fever
• headache
• 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
• sneezing
• 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
• wheezing

• Bleeding gums
• blood in the urine or stools
• confusion
• decreased urination
• dizziness
• dry mouth
• fainting
• fast heartbeat
• hives
• hoarseness
• increase in heart rate
• irritation
• itching
• joint pain, stiffness, or swelling
• lightheadedness
• pinpoint red spots on the skin
• rapid breathing
• rash
• sunken eyes
• swelling of the eyelids, face, or lips
• thirst
• trouble with swallowing
• wrinkled skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Bad, unusual, or unpleasant (after) taste
• bone pain
• change in taste
• cracked lips
• diarrhea
• difficulty having a bowel movement (stool)
• discoloration of the fingernails or toenails
• feeling of warmth
• hair loss or thinning of the hair
• heartburn
• lack or loss of strength
• loss of appetite
• nausea
• redness of the face, neck, arms, and occasionally, upper chest
• stomach pain
• sudden sweating
• swelling or inflammation of the mouth
• vomiting
• weight loss

• Darkening of the skin
• flaking and falling off of the skin
• sleeplessness
• trouble with sleeping
• unable to sleep
• watering of the eyes

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Ixempra is contraindicated in patients with a history of a severe (CTC grade 3/4) hypersensitivity reaction to agents containing Cremophor® EL or its derivatives (eg, polyoxyethylated castor oil) [see Warnings and Precautions (5.4)].

Ixempra is contraindicated in patients who have a neutrophil count <1500 cells/mm3 or a platelet count <100,000 cells/mm3 [see Warnings and Precautions (5.2)].

Ixempra in combination with capecitabine is contraindicated in patients with AST or ALT >2.5 x ULN or bilirubin >1 x ULN [see Boxed Warning and Warnings and Precautions (5.3)].

Ixempra (ixabepilone) is a microtubule inhibitor belonging to a class of antineoplastic agents, the epothilones and their analogs. The epothilones are isolated from the myxobacterium Sorangium cellulosum. Ixabepilone is a semisynthetic analog of epothilone B, a 16-membered polyketide macrolide, with a chemically modified lactam substitution for the naturally existing lactone.

The chemical name for ixabepilone is (1 S,3S,7S,10R,11 S,12S,16R)-7,11 -dihydroxy-8,8,10,12,16-pentamethyl-3- [(1E)-1 -methyl-2-(2-methyl-4-thiazolyl)ethenyl]-17-oxa-4-azabicyclo[14.1.0] heptadecane-5,9-dione, and it has a molecular weight of 506.7. Ixabepilone has the following structural formula:

Ixempra (ixabepilone) for injection is intended for intravenous infusion only after constitution with the supplied DILUENT and after further dilution with a specified infusion fluid [see Instructions for Preparation and IV Administration (2.4)]. Ixempra (ixabepilone) for injection is supplied as a sterile, non-pyrogenic, single-use vial providing 15 mg or 45 mg ixabepilone as a lyophilized white powder. The DILUENT for Ixempra is a sterile, non-pyrogenic, solution of 52.8% (w/v) purified polyoxyethylated castor oil and 39.8% (w/v) dehydrated alcohol, USP. The Ixempra (ixabepilone) for injection and the DILUENT for Ixempra are copackaged and supplied as Ixempra Kit

Combination Therapy

In an open-label, multicenter, multinational, randomized trial of 752 patients with metastatic or locally advanced breast cancer, the efficacy and safety of Ixempra (40 mg/m2 every 3 weeks) in combination with capecitabine (at 1000 mg/m2 twice daily for 2 weeks followed by 1 week rest) were assessed in comparison with capecitabine as monotherapy (at 1250 mg/m2 twice daily for 2 weeks followed by 1 week rest). Patients were previously treated with anthracyclines and taxanes. Patients were required to have demonstrated tumor progression or resistance to taxanes and anthracyclines as follows:

• tumor progression within 3 months of the last anthracycline dose in the metastatic setting or recurrence within 6 months in the adjuvant or neoadjuvant setting, and
• tumor progression within 4 months of the last taxane dose in the metastatic setting or recurrence within 12 months in the adjuvant or neoadjuvant setting.

For anthracyclines, patients who received a minimum cumulative dose of 240 mg/m2 of doxorubicin or 360 mg/m2 of epirubicin were also eligible.

Sixty-seven percent of patients were White, 23% were Asian, and 3% were Black. Both arms were evenly matched with regards to race, age (median 53 years), baseline performance status (Karnofsky 70-100%), and receipt of prior adjuvant or neo-adjuvant chemotherapy (75%). Tumors were ER-positive in 47% of patients, ER-negative in 43%, HER2-positive in 15%, HER2-negative in 61%, and ER-negative, PR-negative, HER2-negative in 25%. The baseline disease characteristics and previous therapies for all patients (n=752) are shown in Table 6.

The patients in the combination treatment group received a median of 5 cycles of treatment and patients in the capecitabine monotherapy treatment group received a median of 4 cycles of treatment.

The primary endpoint of the study was progression-free survival (PFS) defined as time from randomization to radiologic progression as determined by Independent Radiologic Review (IRR), clinical progression of measurable skin lesions or death from any cause. Other study endpoints included objective tumor response based on Response Evaluation Criteria in Solid Tumors (RECIST), time to response, response duration, and overall survival.

Ixempra in combination with capecitabine resulted in a statistically significant improvement in PFS compared to capecitabine. The results of the study are presented in Table 7 and Figure 1.

Figure 1: Progression-free Survival Kaplan Meier Curves

There was no statistically significant difference in overall survival between treatment arms in this study, as well as in a second similar study. In the study described above, the median overall survivals were 12.9 months (95% Cl: 11.5, 14.2) in the combination therapy arm and 11.1 months (95% Cl: 10.0,12.5) in the capecitabine alone arm [Hazard Ratio 90 (95% Cl: 0.77,1.05), p-value=0.19j.

In the second trial, comparing Ixempra in combination with capecitabine versus capecitabine alone, conducted in 1221 patients pretreated with an anthracycline and a taxane, the median overall survivals were 16.4 months (95% Cl: 15.0,17.9) in the combination therapy arm and 15.6 months (95% Cl: 13.9,17.0), in the capecitabine alone arm [Hazard Ratio 0.90 (95% Cl: 0.78,1.03), p-value=0.12j.

Monotherapy

Ixempra was evaluated as a single agent in a multicenter single-arm study in 126 women with metastatic or locally advanced breast cancer. The study enrolled patients whose tumors had recurred or had progressed following two or more chemotherapy regimens including an anthracycline, a taxane, and capecitabine. Patients who had received a minimum cumulative dose of 240 mg/m2 of doxorubicin or 360 mg/m2 of epirubicin were also eligible. Tumor progression or recurrence were prospectively defined as follows:

• Disease progression while on therapy in the metastatic setting (defined as progression while on treatment or within 8 weeks of last dose),
• Recurrence within 6 months of the last dose in the adjuvant or neoadjuvant setting (only for anthracycline and taxane),
• HER2-positive patients must also have progressed during or after discontinuation of trastuzumab.

In this study, the median age was 51 years (range, 30-78), and 79% were White, 5% Black, and 2% Asian, Kamofsky performance status was 70-100%, 88% had received two or more prior chemotherapy regimens for metastatic disease, and 86% had liver and/or lung metastases. Tumors were ER-positive in 48% of patients, ER-negative in 44%, HER2-positive in 7%, HER2-negative in 72%, and ER-negative, PR-negative, HER2-negative in 33%.

Ixempra was administered at a dose of 40 mg/m2 intravenously over 3 hours every 3 weeks. Patients received a median of 4 cycles (range 1 to 18) of Ixempra therapy.

Objective tumor response was determined by independent radiologic and investigator review using RECIST. Efficacy results are presented in Table 8.

Do not use Ixempra if you are pregnant. It could harm the unborn baby. You should not receive Ixempra if you are allergic to ixabepilone, or to a medication ingredient called Cremophor (synthetic castor oil). You may not be able to receive Ixempra if you have severe liver disease, or severely low platelets or white blood cell counts.

Before you receive Ixempra, tell your doctor if you have liver disease, heart disease, nerve problems, diabetes, bone marrow suppression, or a weak immune system.

Ixempra can lower blood cells that help your body fight infections. Avoid being near people who are sick or have infections. Your blood may need to be tested often. Visit your doctor regularly.

Tell your doctor at once if you develop signs of infection, such as fever, chills, body aches, flu symptoms, pale skin, easy bruising or bleeding, or sores in your mouth and throat. Avoid drinking alcohol during your treatment with Ixempra.

Applies to ixabepilone: intravenous powder for injection

Hematologic

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.[Ref]

Hematologic side effects have included neutropenia, leukopenia, anemia, and thrombocytopenia in more than 40% of patients. Coagulopathy and lymphopenia have also been reported.[Ref]

Hypersensitivity

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.[Ref]

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.[Ref]

Nervous system

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.[Ref]

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.[Ref]

Cardiovascular

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.[Ref]

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.[Ref]

Musculoskeletal

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.[Ref]

Gastrointestinal

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.[Ref]

Dermatologic

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.[Ref]

Respiratory

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.[Ref]

Hepatic

Hepatic side effects have included acute hepatic failure, jaundice, increased transaminases, increased blood alkaline phosphatase, and increased gamma-glutamyltransferase.[Ref]

Renal

Renal side effects have included nephrolithiasis, urinary tract infection, and renal failure.[Ref]

Metabolic

Metabolic side effects have included hyponatremia, metabolic acidosis, hypokalemia, and hypovolemia.[Ref]

Ocular

Ocular side effects including increased lacrimation (4%) have been reported.[Ref]

Other

Other side effects have included edema (9%), pyrexia (8%), pain (8%), decreased weight (6%), sepsis, infection, bacterial infection, neutropenic infection, neutropenic fever, and chills.[Ref]

Some side effects of Ixempra may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.