IXEMPRA: Package Insert and Label Information (Page 4 of 4)

15 REFERENCES

  1. Preventing Occupational Exposures to Antineoplastic and Other Hazardous Drugs in Health Care Settings. NIOSH Alert 2004-165.
  2. OSHA Technical Manual, TED 1-0.15A, Section VI: Chapter 2. Controlling Occupational Exposure to Hazardous Drugs. OSHA, 1999. http://www.osha.gov/dts/osta/otm/otm_vi/otm_vi_2.html
  3. American Society of Health-System Pharmacists. ASHP guidelines on handling hazardous drugs. Am J Health-Syst Pharm. 2006;63:1172-1193.
  4. Polovich, M., White, J. M., & Kelleher, L.O. (eds.) 2005. Chemotherapy and biotherapy guidelines and recommendations for practice (2nd. ed.) Pittsburgh, PA: Oncology Nursing Society.

16 HOW SUPPLIED/STORAGE AND HANDLING

IXEMPRA is supplied as a Kit containing one vial of IXEMPRA® (ixabepilone) for injection and one vial of DILUENT for IXEMPRA.

NDC 70020-1910-1 IXEMPRA® Kit containing one vial of IXEMPRA® (ixabepilone) for injection, 15 mg and one vial of DILUENT for IXEMPRA, 8 mL
NDC 70020-1911 -1 IXEMPRA® Kit containing one vial of IXEMPRA® (ixabepilone) for injection, 45 mg and one vial of DILUENT for IXEMPRA, 23.5 mL

IXEMPRA Kit must be stored in a refrigerator at 2° C to 8° C (36° F to 46° F). Retain in original package until time of use to protect from light.

Procedures for proper handling and disposal of antineoplastic drugs [see References (15)] 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.

17 PATIENT COUNSELING INFORMATION

[see FDA-Approved Patient Labeling]

17.1 Peripheral Neuropathy

Patients should be advised to report to their physician any numbness and tingling of the hands or feet [see Warnings and Precautions (5.1)].

17.2 Fever/Neutropenia

Patients should be instructed to call their physician if a fever of 100.5° F or greater or other evidence of potential infection such as chills, cough, or burning or pain on urination develops [see Warnings and Precautions (5.2)].

17.3 Hypersensitivity Reactions

Patients should be advised to call their physician if they experience urticaria, pruritus, rash, flushing, swelling, dyspnea, chest tightness, or other hypersensitivity-related symptoms following an infusion of IXEMPRA [see Warnings and Precautions (5.4)].

17.4 Pregnancy

Patients should be advised to use effective contraceptive measures to prevent pregnancy and to avoid nursing during treatment with IXEMPRA [see Warnings and Precautions (5.5) and Use in Specific Populations (8.1, 8.3)].

17.5 Cardiac Adverse Reactions

Patients should be advised to report to their physician chest pain, difficulty breathing, palpitations, or unusual weight gain [see Warnings and Precautions (5.6)].

IXEMPRA® (ixabepilone) for injection Manufactured by: Baxter Oncology GmbH, 33790 Halle/Westfalen, Germany
DILUENT for IXEMPRA Manufactured by: Baxter Oncology GmbH, 33790 Halle/Westfalen, Germany
Distributed by R-Pharm US LLC, Princeton, NJ 08543 USA

R-PHARM US

RPH-00002

5645-0008

Rev January 2016

FDA-Approved Patient Labeling

Patient Information

IXEMPRA ® Kit

(pronounced as ĭk-’sĕm-pră)

(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.

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

Your healthcare provider should do blood tests to check your liver function:

  • before you begin receiving IXEMPRA
  • as needed while you are receiving IXEMPRA

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).

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.

Who should not receive IXEMPRA?

Do not receive injections of IXEMPRA if you:

  • are allergic to a medicine, such as TAXOL®, that contains Cremophor® EL or polyoxyethylated castor oil.
  • have low white blood cell or platelet counts. Your healthcare provider will check your blood counts.
  • are also taking a cancer medicine called capecitabine and you have liver problems. See “What is the most important information I should know about IXEMPRA?”

What should I tell my healthcare provider before receiving IXEMPRA?

IXEMPRA may not be right for you.

Before you receive IXEMPRA, tell your healthcare provider about all of your medical conditions, including if you:

  • have liver problems
  • have heart problems or a history of heart problems
  • have had an allergic reaction to IXEMPRA. You will receive medicines before each injection of IXEMPRA to decrease the chance of an allergic reaction. See “How will I receive IXEMPRA?”
  • are pregnant or plan to become pregnant. You should not receive IXEMPRA during pregnancy because it may harm your unborn baby. Talk with your healthcare provider about how to prevent pregnancy while receiving IXEMPRA. Tell your healthcare provider right away if you become pregnant or think you are pregnant while receiving IXEMPRA.
  • are breast-feeding. It is not known if IXEMPRA passes into breast milk. You and your healthcare provider should decide if you will receive IXEMPRA or breast-feed. You should not do both.

Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.

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.

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.

Your healthcare provider will decide how much IXEMPRA you will receive and how often you will receive it.

To lower the chance of allergic reaction, you will receive other medicines about 1 hour before each treatment with IXEMPRA. See “What are the possible side effects of IXEMPRA?”

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.

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.

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.

What are the possible side effects of IXEMPRA?

IXEMPRA may cause serious side effects including:

  • Numbness, tingling, or burning in the hands or feet can occur while receiving IXEMPRA (neuropathy). These symptoms may be new or get worse while you are receiving IXEMPRA. These symptoms often occur early during treatment with IXEMPRA. Tell your healthcare provider if you have any of these symptoms. Your dose of IXEMPRA may need to be decreased, stopped until your symptoms get better, or totally stopped.
  • Low white blood cell count (neutropenia). White blood cells help protect the body from infections caused by bacteria. If you get a fever or infection when your white blood cells are very low, you can become seriously ill and die. You may need treatment in the hospital with antibiotic medicines. Your healthcare provider will monitor your white blood cell count often with blood tests. Tell your healthcare provider right away or go to the nearest hospital emergency room if you have a fever (temperature above 100.5° F) or other sign of infection, such as chills, cough, burning or pain when you urinate, any time between treatments with IXEMPRA.
  • Allergic Reactions. Severe allergic reactions can occur with IXEMPRA and may cause death in rare cases. Allergic reactions are most likely to occur while IXEMPRA is being injected into your vein. Tell your healthcare provider right away if you get any of the following signs and symptoms of an allergic reaction:
    • itching, hives (raised itchy welts), rash
    • flushed face
    • sudden swelling of face, throat or tongue
    • chest tightness, trouble breathing
    • feel dizzy or faint
    • feel your heart beating (palpitations)
  • Harm to an unborn child. See “What should I tell my healthcare provider before receiving IXEMPRA?”
  • Heart problems. IXEMPRA might cause decreased blood flow to the heart, problems with heart function, and abnormal heart beat. This is seen more often in patients who also take capecitabine. Tell your healthcare provider right away if you have any of the following symptoms:
    • chest pain,
    • difficulty breathing,
    • feel your heart beating (palpitations), or
    • unusual weight gain.

The most common side effects with IXEMPRA (ixabepilone) used alone or with capecitabine may include:

  • tiredness
  • loss of appetite
  • disorders of toenails and fingernails
  • hair loss
  • fever
  • decreased red blood cells (anemia)
  • joint and muscle pain
  • headache
  • decreased platelets (thrombocytopenia)
  • nausea, vomiting, diarrhea, constipation, and abdominal pain
  • sores on the lip, in the mouth and esophagus
  • tender, red palms and soles of feet (hand-foot syndrome) that looks like a sunburn; the skin may become dry and peel. There may also be numbness and tingling.

Tell your healthcare provider about any side effect that bothers you or that does not go away.

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.

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.

IXEMPRA® (ixabepilone) for injection Manufactured by: Baxter Oncology GmbH, 33790 Halle/Westfalen, Germany

DILUENT for IXEMPRA Manufactured by: Baxter Oncology GmbH, 33790 Halle/ Westfalen, Germany

Distributed by R-Pharm US LLC, Princeton, NJ 08543 USA

R-PHARM US

RPH-00002

5645-0008

Rev January 2016

Principal Display Panel — Carton Label

Single use vials NDC 70020-1910-1

IXEMPRA® Kit

(ixabepilone) for injection

15 mg Rx only

For intravenous infusion only

Each carton contains

1 vial IXEMPRA (ixabepilone)
for injection 15 mg

1 vial DILUENT for IXEMPRA 8 mL

Constitution and dilution required (see insert).

Refrigerate

Distribute by

R-Pharm US LLC

Princeton, NJ 08543 USA

Principal Display Panel -- Carton Label
(click image for full-size original)

Principal Display Panel — Carton Label

Single use vials NDC 70020-1911-1

IXEMPRA® Kit

(ixabepilone) for injection

45 mg Rx only

For intravenous infusion only

Each carton contains

1 vial IXEMPRA (ixabepilone) for injection 15 mg

1 vial DILUENT for IXEMPRA 23.5 mL

Constitution and dilution required (see insert).

Refrigerate

Distribute by

R-Pharm US LLC

Princeton, NJ 08543 USA

Principal Display Panel -- Carton Label
(click image for full-size original)

Principal Display Panel — Vial Label

Single use vial NDC 70020-1910-2

IXEMPRA®
(ixabepilone) for injection

15 mg Rx only

For intravenous infusion only

Constitution and dilution required (see insert).

Distributed by R-Pharm US LLC

Princeton, NJ 08543 USA

Principal Display Panel -- Vial Label
(click image for full-size original)

Principal Display Panel — Vial Label

Single use vial NDC 70020-1911-2

IXEMPRA®
(ixabepilone) for injection

45 mg Rx only

For intravenous infusion only

Constitution and dilution required (see insert).

Distributed by R-Pharm US LLC

Princeton, NJ 08543 USA

Principal Display Panel -- Vial Label
(click image for full-size original)

Principal Display Panel — Vial Label

Single use vial NDC 70020-1265-1

DILUENT for IXEMPRA® (ixabepilone) for injection

8 mL Rx only

Not for direct administration

Distributed by R-Pharm US LLC

Princeton, NJ 08543 USA

Principal Display Panel -- Vial Label
(click image for full-size original)

Principal Display Panel — Vial Label

Single use vial NDC 70020-1266-2

DILUENT for IXEMPRA® (ixabepilone) for injection

23.5 mL Rx only

Not for direct administration

Distributed by R-Pharm US LLC

Princeton, NJ 08543 USA

Principal Display Panel -- Vial Label
(click image for full-size original)
IXEMPRA ixabepilone kit
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0015-1910
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0015-1910-12 1 KIT in 1 PACKAGE, COMBINATION None
Quantity of Parts
Part # Package Quantity Total Product Quantity
Part 1 1 VIAL, SINGLE-USE 15 mg
Part 2 1 VIAL, SINGLE-USE 8 mL
Part 1 of 2
IXEMPRA ixabepilone injection, solution
Product Information
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ixabepilone (ixabepilone) ixabepilone 15 mg in 15 mg
Packaging
# Item Code Package Description Multilevel Packaging
1 15 mg in 1 VIAL, SINGLE-USE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA022065 10/16/2007 10/31/2017
Part 2 of 2
DILUENT diluent injection, solution
Product Information
Route of Administration INTRAVENOUS DEA Schedule
Inactive Ingredients
Ingredient Name Strength
polyoxyl 35 castor oil
alcohol
Packaging
# Item Code Package Description Multilevel Packaging
1 8 mL in 1 VIAL, SINGLE-USE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA022065 10/16/2007 10/31/2017
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA022065 10/16/2007 10/31/2017
IXEMPRA ixabepilone kit
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0015-1911
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0015-1911-13 1 KIT in 1 PACKAGE, COMBINATION None
Quantity of Parts
Part # Package Quantity Total Product Quantity
Part 1 1 VIAL, SINGLE-USE 45 mg
Part 2 1 VIAL, SINGLE-USE 23.5 mL
Part 1 of 2
IXEMPRA ixabepilone injection, solution
Product Information
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ixabepilone (ixabepilone) ixabepilone 45 mg in 45 mg
Packaging
# Item Code Package Description Multilevel Packaging
1 45 mg in 1 VIAL, SINGLE-USE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA022065 10/16/2007 10/31/2017
Part 2 of 2
DILUENT diluent injection, solution
Product Information
Route of Administration INTRAVENOUS DEA Schedule
Inactive Ingredients
Ingredient Name Strength
polyoxyl 35 castor oil
alcohol
Packaging
# Item Code Package Description Multilevel Packaging
1 23.5 mL in 1 VIAL, SINGLE-USE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA022065 10/16/2007 10/31/2017
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA022065 10/16/2007 10/31/2017
Labeler — E.R. Squibb & Sons, L.L.C. (968242821)

Revised: 01/2016 E.R. Squibb & Sons, L.L.C.

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