Ixempra: Black Box Warnings

Ixempra: Adult Dosing

Dosage forms: IV

chemotherapy

uses, dosing may vary

Info: for all uses, refer to institution protocols and pkg insert prior to prescribing; see pkg insert for toxicity-related dose adjustments

breast CA, advanced or metastatic

40 mg/m^2 IV q3wk

Info: if BSA >2.2 m^2 calculate dose using BSA = 2.2 m^2; give antihstamine premeds; use in combo w/ capecitabine after anthracycline and taxane tx failure or alone after anthracycline, taxane, and capecitabine tx failure

renal dosing

not defined

hepatic dosing

capecitabine combo tx

AST or ALT >2.5x ULN or bilirubin >1x ULN: contraindicated

monotherapy

AST or ALT <10x ULN and bilirubin <1.5x ULN: 32 mg/m^2 IV q3wk; AST and ALT <10x ULN and bilirubin >1.5x ULN to <3x ULN: start 20 mg/m^2 IV q3wk, may incr. to max 30 mg/m^2 IV q3wk in later cycles; AST or ALT >10x ULN or bilirubin >3x ULN: avoid use; Info: limited data for AST or ALT >5x ULN, caution advised

Ixempra: Peds Dosing

This information is currently unavailable or not applicable for this drug.

Ixempra: Contraindications/Cautions

• hypersens. to drug/class/compon.
• hypersens. to castor oil derivatives
• neutrophils <1500
• Plt <100K
• AST or ALT >2.5x ULN or bilrubin >1x ULN (capecitabine combo tx)
• avoid pregnancy
• caution if diabetes mellitus
• caution if neuropathy, mod-severe
• caution if hepatic impairment
• caution if cardiac dz or hx
• caution: diluent contains alcohol 39.8%

Ixempra: Drug Interactions

Contraindicated

• anthrax vaccine

• smallpox vaccine (live vaccinia virus)

• vaccines, live

Avoid/Use Alternative

• alefacept

• amiodarone

• amprenavir

• aprepitant

• atazanavir

• barbiturates

• bexarotene

• bosentan

• carbamazepine

• chloramphenicol

• clarithromycins

• conivaptan

• danazol

• darunavir

• dasatinib

• delavirdine

• dexamethasone

• diltiazem

• efavirenz

• efavirenz/emtricitabine/tenofovir

• erythromycins

• fluconazole

• fluoxetine

• fluvoxamine

• fosamprenavir

• griseofulvins

• growth hormone

• imatinib

• indinavir

• isoniazid

• isoniazid/pyrazinamide/rifampin

• isoniazid/rifampin

• itraconazole

• ketoconazole

• lapatinib

• lopinavir/ritonavir

• mifepristone

• natalizumab

• nefazodone

• nelfinavir

• nevirapine

• olanzapine/fluoxetine

• oxcarbazepine

• palifermin

• phenytoins

• posaconazole

• quinupristin/dalfopristin

• ranolazine

• rifabutin

• rifampin

• rifapentine

• ritonavir

• saquinavir

• tamoxifen

• telithromycin

• tipranavir

• verapamil

• voriconazole

• zafirlukast

Monitor/Modify Tx

• clozapine

• colony-stimulating factors

• dexrazoxane

• flucytosine

• ganciclovir

• hydroxyurea

• mycophenolate mofetil

• primaquine

• pyrimethamine

• pyrimethamine/sulfadoxine

• zidovudine

Caution Advised

• vaccines/toxoids

Ixempra: Adverse Reactions

Serious Reactions

• peripheral neuropathy
• neutropenia
• leukopenia
• anemia
• thrombocytopenia
• febrile neutropenia
• hypersensitivity rxn
• myocardial ischemia/infarction
• arrhythmias
• ventricular dysfxn
• cardiomyopathy
• hand-foot syndrome
• skin exfoliation
• erythema multiforme

Common Reactions

• peripheral neuropathy
• neutropenia
• leukopenia
• anemia
• thrombocytopenia
• fatigue/asthenia
• myalgia/arthralgia
• alopecia
• nausea
• vomiting
• stomatitis/mucositis
• diarrhea
• musculoskeletal pain
• hand-foot syndrome
• anorexia
• abdominal pain
• nail disorder
• constipation
• headache
• rash
• edema
• dyspnea
• pain
• pyrexia
• dizziness
• taste disorders
• hot flashes
• GERD
• hypersensitivity rxn
• others: see pkg insert

Ixempra: Safety Monitoring

Pregnancy: D

Lactation: Possibly Unsafe

Monitoring Parameters: LFTs at baseline, then periodically; CBC w/ diff frequently

Ixempra: Pharmacology

Metabolism: liver extensively; CYP450: 3A4 substrate

Excretion: feces 65% (1.6% unchanged), urine 21% (5.6% unchanged); Half-life: 52h

Class: Mitosis Inhibitors

Mechanism Of Action
binds to microtubules and blocks cells in mitotic phase of cell cycle, leading to cell death

Ixempra: Manufacturer/Pricing

Manufacturer: Bristol-Myers Squibb Co. DEA/FDA: Rx

Ixempra: Patient Education

• Generic Name: ixabepilone

• Pronounced: IX ab EP i lone

• Brand Name: Ixempra

What is the most important information I should know about ixabepilone?

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.

Do not use this medication without telling your doctor if you are pregnant. It could harm the unborn baby. Use effective birth control, and tell your doctor if you become pregnant during treatment.

Before you receive ixabepilone, tell your doctor if you have liver or heart disease, nerve problems in your hands or feet, diabetes, or bone marrow suppression.

Ixabepilone can lower blood cells that help your body fight infections. This can make it easier for you to bleed from an injury or get sick from being around others who are ill. To be sure your blood cells do not get too low, your blood will need to be tested on a regular basis. Do not miss any scheduled appointments.

Avoid drinking alcohol while you are receiving ixabepilone.

Tell your caregivers at once if you have serious side effects such as numbness, burning, pain, or tingly feeling in your hands or feet, sudden numbness or weakness, especially on one side of the body, chest pain or heavy feeling, fever, chills, body aches, flu symptoms, or redness, swelling, and pain on the palms of your hands or the soles of your feet.

What is ixabepilone?

Ixabepilone is used to treat advanced breast cancer.

Ixabepilone is usually given after other cancer medications have been tried without successful treatment.

Ixabepilone may also be used for other purposes not listed in this medication guide.

What should I discuss with my health care provider before receiving ixabepilone?

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.

Before you receive ixabepilone, tell your doctor if you are allergic to any drugs, or if you have:

• liver disease;
• heart disease;
• nerve problems (especially in your hands or feet);
• diabetes; or
• bone marrow suppression or weak immune system.

If you have any of these conditions, you may need a dose adjustment or special tests to safely take ixabepilone.

FDA pregnancy category D. This medication can cause harm to an unborn baby. Do not use ixabepilone without telling your doctor if you are pregnant. It could harm the unborn baby. Use effective birth control, and tell your doctor if you become pregnant during treatment.

It is not known whether ixabepilone passes into breast milk or if it could harm a nursing baby. Do not receive this medication without telling your doctor if you are breast-feeding a baby.

How is ixabepilone given?

Ixabepilone is given as an injection through a needle placed into a vein. You will receive this injection in a clinic or hospital setting. An ixabepilone is usually given every 3 weeks.

The medicine must be given slowly through an IV infusion, and can take at least 3 hours to complete.

About 1 hour before you receive your ixabepilone injection, you will be given other medications to help prevent an allergic reaction. You may also be given a steroid medication if you have ever had a reaction to an ixabepilone injection.

Ixabepilone can lower blood cells that help your body fight infections. This can make it easier for you to bleed from an injury or get sick from being around others who are ill. To be sure your blood cells do not get too low, your blood will need to be tested on a regular basis. Do not miss any scheduled appointments.

What happens if I miss a dose?

Take the missed dose as soon as you remember. If it is almost time for your next dose, wait until then to take the medicine and skip the missed dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention if you think you have received too much of this medicine.

An overdose of ixabepilone is not expected to produce life-threatening symptoms.

What should I avoid while receiving ixabepilone?

Avoid being near people who have colds, the flu, or other contagious illnesses. Contact your doctor at once if you develop signs of infection.

Avoid drinking alcohol while you are receiving ixabepilone.

What are the possible side effects of ixabepilone?

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, burning, pain, or tingly feeling in your hands or feet;
• sudden numbness or weakness, especially on one side of the body;
• sudden headache, confusion, problems with vision, speech, or balance;
• chest pain or heavy feeling;
• fever, chills, body aches, flu symptoms; 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, diarrhea, stomach pain, loss of appetite;
• diarrhea or constipation; or
• white patches or sores inside your mouth or on your lips.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect.

What other drugs will affect ixabepilone?

The following drugs can interact with ixabepilone. Tell your doctor if you are using any of these:

• dexamethasone (Decadron, Hexadrol);
• St. John's wort;
• a barbiturate such as amobarbital (Amytal), butabarbital (Butisol), mephobarbital (Mebaral), secobarbital (Seconal), or phenobarbital (Luminal, Solfoton);
• HIV /AIDS medicine such as amprenavir (Agenerase), atazanavir (Reyataz), delavirdine (Rescriptor), efavirenz (Sustiva), indinavir (Crixivan), nelfinavir (Viracept), nevirapine (Viramune), ritonavir (Norvir), saquinavir (Invirase, Fortovase);
• an antibiotic such as clarithromycin (Biaxin), erythromycin (E.E.S., E-Mycin, Ery-Tab, Erythrocin), griseofulvin (Fulvicin, Grifulvin, Grisactin), itraconazole (Sporanox), ketoconazole (Nizoral), rifampin (Rifadin, Rimactane, Rifater), telithromycin (Ketek), troleandomycin (Tao), or voriconazole (Vfend);
• seizure medication such as carbamazepine (Carbatrol, Tegretol) or phenytoin (Dilantin); or
• an antidepressant such as amitriptyline (Elavil, Etrafon), doxepin (Sinequan), fluoxetine (Prozac), fluvoxamine (Luvox), imipramine (Janimine, Tofranil), nefazodone (Serzone), nortriptyline (Pamelor), paroxetine (Paxil), and others.

This list is not complete and there may be other drugs that can interact with ixabepilone. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

Where can I get more information?

Your pharmacist can provide more information about ixabepilone.

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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.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise.

Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides.

The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Ixempra: Pill Pictures

This information is currently unavailable or not applicable for this drug.