ixabepilone (IXEMPRA)

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Trade Name: IXEMPRA

Following information is meant for : Wholesalers, Suppliers, Exporters, Doctors, CROs, Comparator Supplies, Hospitals, MOH Tender Supplies, Generic, Brand, Cooperate Sourcing, India, Institutional Buyers.

Manufacturer: R-Pharm US Operating, LLC

Presentation: KIT, HUMAN PRESCRIPTION DRUG

Storage and handling

Disclaimer:

These products are NOT FOR SALE in US territories. We offer them for Exports outside of US Territories to Trade Professionals or patients with a valid prescription.
Trademark shown are property of their respective owners and GNH India does not lay any claim on them.

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WARNING: TOXICITY IN HEPATIC IMPAIRMENT
See full prescribing information for complete boxed warning.

IXEMPRA (ixabepilone) is indicated in combination with capecitabine for the treatment of patients with metastatic or locally advanced breast cancer resistant to treatment with an anthracycline and a taxane, or whose cancer is taxane resistant and for whom further anthracycline therapy is contraindicated. Anthracycline resistance is defined as progression while on therapy or within 6 months in the adjuvant setting or 3 months in the metastatic setting. Taxane resistance is defined as progression while on therapy or within 12 months in the adjuvant setting or 4 months in the metastatic setting.n
IXEMPRA is indicated as monotherapy for the treatment of metastatic or locally advanced breast cancer in patients whose tumors are resistant or refractory to anthracyclines, taxanes, and capecitabine.n

IXEMPRA, a microtubule inhibitor, in combination with capecitabine is indicated for the treatment of metastatic or locally advanced breast cancer in patients after failure of an anthracycline and a taxane (n n n ).nn n n
IXEMPRA as monotherapy is indicated for the treatment of metastatic or locally advanced breast cancer in patients after failure of an anthracycline, a taxane, and capecitabine (n n n ).nn n n

IXEMPRA (ixabepilone) for injection must be constituted with supplied DILUENT. The ixabepilone concentration in constituted solution is 2 mg/mL. Constituted solution must be diluted with one of the specified fluids, to a final ixabepilone concentration of 0.2 mg/mL to 0.6 mg/mL. The final solution must be used within 6 hours of preparation (n n n ).nn nn

The recommended dose of IXEMPRA is 40 mg/mn n n infused intravenously over 3 hours every 3 weeks (n n n ).nn n n
Dose reduction is required in certain patients with elevated AST, ALT, or bilirubin (n n n , n n n ).nn n n

IXEMPRA for injection, 15 mg supplied with DILUENT for IXEMPRA, 8 mL.n
IXEMPRA for injection, 45 mg supplied with DILUENT for IXEMPRA, 23.5 mL.n

IXEMPRA for injection, 15 mg supplied with DILUENT for IXEMPRA, 8 mL (n n n )nn n n
IXEMPRA for injection, 45 mg supplied with DILUENT for IXEMPRA, 23.5 mL (n n n )nn n n

IXEMPRA is contraindicated in patients with a history of a severe (CTC grade 3/4) hypersensitivity reaction to agents containing Cremophorn n n EL or its derivatives (eg, polyoxyethylated castor oil) n n n n
IXEMPRA is contraindicated in patients who have a neutrophil count <1500 cells/mmn n n or a platelet count <100,000 cells/mmn n n n n
IXEMPRA in combination with capecitabine is contraindicated in patients with AST or ALT >2.5 x ULN or bilirubin >1 x ULN n n n n

Hypersensitivity to drugs formulated with Cremophorn n n EL (n n n ).nn n n
Baseline neutrophil count <1500 cells/mmn n n or a platelet count <100,000 cells/mmn n n (n n n ).nn n n
Patients with AST or ALT >2.5 x ULN or bilirubin >1 x ULN must not be treated with IXEMPRA in combination with capecitabine (n n n ).nn n n

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Peripheral Neuropathy: Monitor for symptoms of neuropathy, primarily sensory. Neuropathy is cumulative, generally reversible, and should be managed by dose adjustment and delays (n n n , n n n ).nn n n
Myelosuppression: Primarily neutropenia. Monitor with peripheral blood cell counts and adjust dose as appropriate (n n n , n n n ).nn n n
Hypersensitivity reaction: Must premedicate all patients with an Hn n n antagonist and an Hn n n antagonist before treatment (n n n , n n n ).nn n n
Fetal harm can occur when administered to a pregnant woman. Women should be advised not to become pregnant when taking IXEMPRA (n n n , n n n ).nn n n

The following adverse reactions are discussed in greater detail in other sections.n
To report SUSPECTED ADVERSE REACTIONS, contact R-Pharm US at 1-844-586-8953 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

The most common adverse reactions (u226520%) are peripheral sensory neuropathy, fatigue/asthenia, myalgia/arthralgia, alopecia, nausea, vomiting, stomatitis/mucositis, diarrhea, and musculoskeletal pain. Additional reactions occurred in u226520% in combination treatment: palmar-plantar erythrodysesthesia syndrome, anorexia, abdominal pain, nail disorder, and constipation (n n n ).nn n n
Drug-associated hematologic abnormalities (>40%) include neutropenia, leukopenia, anemia, and thrombocytopenia (n n n ).nn n n

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Inhibitors of CYP3A4 may increase plasma concentrations of ixabepilone; dose of IXEMPRA must be reduced with strong CYP3A4 inhibitors (n n n ).nn n n
Inducers of CYP3A4 may decrease plasma concentrations of ixabepilone; alternative therapeutic agents with low enzyme induction potential should be considered (n n n ).nn n n

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Experience with overdose of IXEMPRA is limited to isolated cases. The adverse reactions reported in these cases included peripheral neuropathy, fatigue, musculoskeletal pain/myalgia, and gastrointestinal symptoms (nausea, anorexia, diarrhea, abdominal pain, stomatitis). The highest dose mistakenly received was 100 mg/mn n n (total dose 185 mg).nn nn
There is no known antidote for overdosage of IXEMPRA. In case of overdosage, the patient should be closely monitored and supportive treatment should be administered. Management of overdose should include supportive medical interventions to treat the presenting clinical manifestations.n

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 n n n Ixabepilone is a semisynthetic analog of epothilone B, a 16-membered polyketide macrolide, with a chemically modified lactam substitution for the naturally existing lactone.nn nn
The chemical name for ixabepilone is (1 n n n ,3n n n ,7n n n ,10n n n ,11 n n n ,12n n n ,16n n n )-7,11 -dihydroxy-8,8,10,12,16-pentamethyl-3- [(1n n n )-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:nn nn
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 n n n 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 n n n n

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IXEMPRA is supplied as a n n n containing one vial of IXEMPRAn n n (ixabepilone) for injection and one vial of DILUENT for IXEMPRA.nn nn
IXEMPRA n n n must be stored in a refrigerator at 2u00b0 C to 8u00b0 C (36u00b0 F to 46u00b0 F). Retain in original package until time of use to protect from light.nn nn
Procedures for proper handling and disposal of antineoplastic drugs n n n should be followed. To minimize the risk of dermal exposure, impervious gloves should be worn when handling vials containing IXEMPRA, regardless of the setting, including unpacking and inspection, transport within a facility, and dose preparation and administration.nn nn

[see FDA-Approved Patient Labeling]

FDA-Approved Patient Labeling
Patient Information
IXEMPRAn- Arrayn- Array
(pronounced as u012dk-'su0115m-pru0103)
(ixabepilone)
for Injection, for intravenous
infusion only
Read the Patient Information that comes with IXEMPRA (ixabepilone) before you start receiving it and before each injection. There may be new information. This leaflet does not take the place of talking with your healthcare provider about your medical condition or your treatment.n
What is the most important information I should know about IXEMPRA?
Your healthcare provider should do blood tests to check your liver function:n
If blood tests show that you have liver problems, do not receive injections of IXEMPRA along with the medicine capecitabine. Taking these two medicines together if you have liver problems increases your chance of serious problems. These include: serious infection and death due to a very low white blood cell count (neutropenia).n
What is IXEMPRA?
IXEMPRA is a cancer medicine. IXEMPRA is used alone or with another cancer medicine called capecitabine. IXEMPRA is used to treat breast cancer, when certain other medicines have not worked or no longer work.n
Who should not receive IXEMPRA?
Do not receive injections of IXEMPRA if you:n
What should I tell my healthcare provider before receiving IXEMPRA?
IXEMPRA may not be right for you.n
Before you receive IXEMPRA, tell your healthcare provider about all of your medical conditions, including if you:n
Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.n
IXEMPRA and certain other medicines may affect each other causing side effects. IXEMPRA may affect the way other medicines work, and other medicines may affect how IXEMPRA works. Know the medicines you take. Keep a list of your medicines with you to show your healthcare provider.n
How will I receive IXEMPRA?
IXEMPRA is given by an injection directly into your vein (intravenous infusion). IXEMPRA is usually given once every three weeks. Each treatment with IXEMPRA will take about 3 hours.n
Your healthcare provider will decide how much IXEMPRA you will receive and how often you will receive it.n
To lower the chance of allergic reaction, you will receive other medicines about 1 hour before each treatment with IXEMPRA. n n n n
If you have an allergic reaction to IXEMPRA, you will receive a steroid medicine before future doses of IXEMPRA. You may also need to receive your doses of IXEMPRA more slowly.n
What should I avoid while receiving IXEMPRA?
IXEMPRA contains alcohol. If you are dizzy or drowsy, avoid activities that may be dangerous, such as driving or operating machinery.n
Do not drink grapefruit juice while receiving IXEMPRA. Drinking grapefruit juice may cause you to have too much IXEMPRA in your blood and lead to side effects.n
What are the possible side effects of IXEMPRA?
IXEMPRA may cause serious side effects including:n
The most common side effects with IXEMPRA (ixabepilone) used alone or with capecitabine may include:n
Tell your healthcare provider about any side effect that bothers you or that does not go away.n
These are not all of the side effects of IXEMPRA. Ask your healthcare provider or pharmacist for more information if you have questions or concerns.n
General information about IXEMPRA
This patient information leaflet summarizes the most important information about IXEMPRA. Medicines are sometimes prescribed for purposes other than those listed in a Patient Information Leaflet. If you would like more information about IXEMPRA, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about IXEMPRA that is written for health professionals. For more information about IXEMPRA, call 1-844-586-8953.n
IXEMPRAn n n (ixabepilone) for injection Manufactured by: Baxter Oncology GmbH, 33790 Halle/Westfalen, Germanynn nn
DILUENT for IXEMPRA Manufactured by: Baxter Oncology GmbH, 33790 Halle/ Westfalen, Germanyn
Distributed by R-Pharm US LLC, Princeton, NJ 08543 USAn
R-PHARM USn
RPH-00002n
5645-0008n
Rev January 2016n

Principal Display Panel - Carton Label
Single use vials NDC 70020-1910-1
Arrayn- Arrayn- Kit
(ixabepilone) for injectionn
15 mg Rx only
For intravenous infusion only
Each carton contains
1 vial IXEMPRA (ixabepilone) n n n for injection 15 mgnn nn
1 vial DILUENT for IXEMPRA 8 mLn
Constitution and dilution required n n n (see insert).n n n
Refrigerate
Distribute byn
R-Pharm US LLCn
Princeton, NJ 08543 USAn

Principal Display Panel - Carton Label
Single use vials NDC 70020-1911-1
Arrayn- Arrayn- Kit
(ixabepilone) for injectionn
45 mg Rx only
For intravenous infusion only
Each carton contains
1 vial IXEMPRA (ixabepilone) n n n for injection 15 mgnn nn
1 vial DILUENT for IXEMPRA 23.5 mLn
Constitution and dilution required (see insert).
Refrigerate
Distribute byn
R-Pharm US LLCn
Princeton, NJ 08543 USAn

Principal Display Panel - Vial Label
Single use vial NDC 70020-1910-2
Arrayn- Array
15 mg Rx only
For intravenous infusion only
Constitution and dilution required n n n (see insert).n n n
Distributed by R-Pharm US LLCn
Princeton, NJ 08543 USAn

Principal Display Panel - Vial Label
Single use vial NDC 70020-1911-2
Arrayn- Array
45 mg Rx only
For intravenous infusion only
Constitution and dilution required n n n (see insert).n n n
Distributed by R-Pharm US LLCn
Princeton, NJ 08543 USAn

Principal Display Panel - Vial Label
Single use vial NDC 70020-1265-1
Arrayn- Array
8 mL Rx only
Not for direct administration
Distributed by R-Pharm US LLCn
Princeton, NJ 08543 USAn

Principal Display Panel - Vial Label
Single use vial NDC 70020-1266-2
Arrayn- Array
23.5 mL Rx only
Not for direct administration
Distributed by R-Pharm US LLCn
Princeton, NJ 08543 USAn

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GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler, Supplier, Exporters from India of ixabepilone (IXEMPRA) which is also known as IXEMPRA and Manufactured by R-Pharm US Operating, LLC. It is available in strength of .

ixabepilone (IXEMPRA) is supplied for Tenders, Emergency imports, Un - licensed, Specials, Orphan drug, Name patient line, RLD supplies, Reference listed drugs, Comparator Drug, Bio-Similar, Innovator samples, For Clinical trials. Click to know price.