Brand Name
IFEX
Generic Name
Ifosfamide
View Brand Information FDA approval date: December 30, 1988
Classification: Alkylating Drug
Form: Injection
What is IFEX (Ifosfamide)?
Ifosfamide Injection is indicated for use in combination with certain other approved antineoplastic agentsfor third-line chemotherapy of germ cell testicular cancer. It should be used in combination with mesna for prophylaxis of hemorrhagic cystitis. Ifosfamide Injection is an alkylating drug indicated for use in combination with certain other approved antineoplastic agents for third-line chemotherapy of germ cell testicular cancer. It should be used in combination with mesna for prophylaxis of hemorrhagic cystitis.
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Brand Information
IFEX (ifosfamide)
WARNING: MYELOSUPPRESSION, ENCEPHALOPATHY, NEPHROTOXICITY and UROTOXICITY
- Myelosuppression can be severe and lead to fatal infections. Monitor blood counts prior to and at intervals after each treatment cycle
- Encephalopathy can be severe and may result in death. Monitor for CNS toxicity and discontinue treatment for encephalopathy
- Nephrotoxicity can be severe and result in renal failure. Hemorrhagic cystitis can be severe and can be reduced by the prophylactic use of mesna
1INDICATIONS AND USAGE
IFEX is indicated for use in adults in combination with certain other approved antineoplastic agents for third-line chemotherapy of germ cell testicular cancer.
2DOSAGE FORMS AND STRENGTHS
For injection: white, crystalline powder available in:
- 1 gram single-dose vial for reconstitution
- 3 gram single-dose vial for reconstitution
3CONTRAINDICATIONS
IFEX is contraindicated in patients with:
- Known hypersensitivity to administration of ifosfamide.
- Urinary outflow obstruction.
4OVERDOSAGE
No specific antidote for IFEX is known.
Patients who receive an overdose should be closely monitored for the development of toxicities. Serious consequences of overdosage include manifestations of dose-dependent toxicities such as CNS toxicity, nephrotoxicity, myelosuppression, and mucositis
Management of overdosage would include general supportive measures to sustain the patient through any period of toxicity that might occur, including appropriate state-of-the-art treatment for any concurrent infection, myelosuppression, or other toxicity. Ifosfamide as well as ifosfamide metabolites are dialyzable.
Cystitis prophylaxis with mesna may be helpful in preventing or limiting urotoxic effects with overdose.
5DESCRIPTION
IFEX (ifosfamide for injection, USP) single-dose vials for constitution and administration by intravenous infusion each contain 1 gram or 3 grams of sterile ifosfamide.
Ifosfamide is a alkylating drug chemically related to the nitrogen mustards and a synthetic analog of cyclophosphamide. Ifosfamide is 3-(2-chloroethyl)-2-[(2-chloroethyl)amino]tetrahydro-2H-1,3,2-oxazaphosphorine 2-oxide. The molecular formula is C
Ifosfamide is a white crystalline powder soluble in water. There are no excipients in the formulation. Each vial contains 1 gram or 3 grams of sterile ifosfamide alone.
Its structural formula is:
6CLINICAL STUDIES
Patients with refractory testicular cancer (n=59) received a combination of ifosfamide, cisplatin, and either etoposide (VePesid) or vinblastine (VIP) as third-line therapy or later. The selection of etoposide or vinblastine (“V” in the VIP regimen) was guided by the therapeutic effect achieved with prior regimens. The contribution of ifosfamide to the VIP combination was determined in patients treated with cisplatin-etoposide prior to ifosfamide- cisplatin-etoposide or those who received cisplatin-vinblastine prior to ifosfamide-cisplatin-vinblastine.
A total of 59 patients received a third-line salvage regimen which consisted of ifosfamide 1.2 g/m
In a study, 50 fully evaluable patients with germ cell testicular cancer were treated with IFEX in combination with cisplatin and either vinblastine or etoposide after failing (47 of 50 patients) at least two prior chemotherapy regimens consisting of cisplatin/vinblastine/bleomycin, (PVB), cisplatin/vinblastine/actinomycin D/bleomycin/cyclophosphamide, (VAB6), or the combination of cisplatin and etoposide. Patients were selected for remaining cisplatin sensitivity because they had previously responded to a cisplatin containing regimen and had not progressed while on the cisplatin containing regimen or within 3 weeks of stopping it. Patients served as their own control based on the premise that long term complete responses could not be achieved by retreatment with a regimen to which they had previously responded and subsequently relapsed.
Ten of 50 fully evaluable patients were still alive 2 to 5 years after treatment. Four of the 10 long term survivors were rendered free of cancer by surgical resection after treatment with the ifosfamide regimen; median survival for the entire group of 50 fully evaluable patients was 53 weeks.
7REFERENCES
- OSHA Hazardous Drugs. OSHA.
8HOW SUPPLIED/STORAGE AND HANDLING
IFEX (ifosfamide for injection, USP) is available in single-dose vials as follows:
- IFEX (ifosfamide for injection)
- NDC 0338-3991-01 1-gram Single-Dose Vial
- NDC 0338-3993-01 3-gram Single-Dose Vial
Store at controlled room temperature 20°C to 25°C (68°F to 77°F).
Protect from temperatures above 30°C (86°F).
9PATIENT COUNSELING INFORMATION
Myelosuppression
- Advise patients that treatment with IFEX may cause myelosuppression which can be severe and lead to infections and fatal outcomes.
- Inform patients of the risks associated with the use of IFEX and plan for regular blood monitoring during therapy
- Inform patients to report fever or other symptoms of an infection
- Advise patients on the risks of bleeding and anemia
Encephalopathy
- Advise patients on the risk of encephalopathy and other neurotoxic effects with fatal outcome
- Inform patients that IFEX may impair the ability to operate an automobile or other heavy machinery
Nephrotoxicity and Urotoxicity
- Advise patients on the risk of bladder and kidney toxicity.
- Advise patients of the need to increase fluid intake and frequent voiding to prevent accumulation in the bladder
Cardiotoxicity
- Advise patients on the risk of cardiotoxicity and fatal outcome.
- Advise patients to report preexisting cardiac disease and manifestations of cardiotoxicity
Pulmonary Toxicity
- Advise patients on the risk of pulmonary toxicity leading to respiratory failure with fatal outcome.
- Inform patients to report signs and symptoms of pulmonary toxicity
Secondary Malignancies
- Advise patients on the risk of secondary malignancies due to therapy
Veno-occlusive Liver Disease
- Advise patients on the risk of veno-occlusive liver disease
Embryo-Fetal Toxicity
- Advise pregnant women and females of reproductive potential of the potential risk to a fetus. Advise females to inform their healthcare provider of a known or suspected pregnancy
- Advise females of reproductive potential to use effective contraception during treatment with IFEX and for 12 months after the last dose
- Advise male patients with female partners of reproductive potential to use effective contraception during treatment with IFEX and for 6 months after the last dose
Lactation
- Advise women not to breastfeed during treatment with IFEX and for 1 week after the last dose
Infertility
- Advise females and males of reproductive potential that IFEX may cause temporary or permanent infertility
Skin and Subcutaneous Tissue Disorders
- Advise patients on the risk of alopecia, wound healing, and other serious skin and subcutaneous tissue disorders
Gastrointestinal Disorders
- Advise patients that the therapy may cause gastrointestinal disorders and alcohol may increase nausea and vomiting
- Advise patients on the risk of stomatitis and the importance of proper oral hygiene
Eye Disorders
- Advise patients on the risk of eye disorders such as visual impairment, blurred vision, and eye irritation
Ear and Labyrinth Disorders
- Advise patients on the risk of ear and labyrinth disorders such as deafness, vertigo, and tinnitus
Manufactured by:
Baxter Healthcare Corporation
Deerfield, IL 60015 USA
For Product Inquiry 1-800 ANA DRUG (1-800-262-3784)
Made in Germany
Baxter, Ifex and Viaflex are trademarks of Baxter International Inc.
PAB is a trademark of B Braun
HA-30-02-445
10PACKAGE LABEL - PRINCIPLE DISPLAY PANEL
NDC 0338-3991-01
IFEX
IFOSFAMIDE FOR INJECTION, USP
IFOSFAMIDE FOR INJECTION, USP
1 g/vial
Rx only
SINGLE-DOSE VIAL
This vial contains 1g ifosfamide.
Store at controlled room
temperature 20° C to 25° C
(68° F to 77° F)
above 30° C (86° F).
temperature 20° C to 25° C
(68° F to 77° F)
above 30° C (86° F).
FOR IV USE
PACKAGE INSERT for detailed
indications, dosage, and
precautions.
PACKAGE INSERT for detailed
indications, dosage, and
precautions.
Manufactured by:
USA HA-65-01-561
C130
Bar Code
Lot:/Exp.:
JMXXX
1 vial
NDC 0338-3991-01
IFEX
(ifosfamide for injection, USP)
(ifosfamide for injection, USP)
Single-Dose Vial
FOR IV USE
FOR IV USE
Rx only
1 g
Baxter Logo
Manufactured by
Baxter Healthcare Corporation
Deerfield, IL 60015 USA
Manufactured by
Baxter Healthcare Corporation
Deerfield, IL 60015 USA
See bottom panel for lot
Bar Code
This vial contains 1 g ifosfamide. Add
READ ACCOMPANYING PACKAGE
INSERT for detailed indications,
dosage, and precautions.
INSERT for detailed indications,
dosage, and precautions.
Store at controlled room
temperature 20° C to 25° C
(68° F to 77° F). Protect from
temperatures above 30° C (86° F).
temperature 20° C to 25° C
(68° F to 77° F). Protect from
temperatures above 30° C (86° F).
Constituted solutions should be
Manufactured by:
NDC 0338-3993-01
IFEX
IFOSFAMIDE FOR INJECTION, USP
IFOSFAMIDE FOR INJECTION, USP
3 g/vial
Rx only
SINGLE-DOSE VIAL
This vial contains 3g ifosfamide.
Store at controlled room
temperature 20° C to 25° C
(68° F to 77° F)
above 30° C (86° F).
temperature 20° C to 25° C
(68° F to 77° F)
above 30° C (86° F).
FOR IV USE
READ ACCOMPANYING
PACKAGE INSERT for detailed
indications, dosage, and
precautions.
READ ACCOMPANYING
PACKAGE INSERT for detailed
indications, dosage, and
precautions.
Manufactured by:
USA HA-65-01-564
C 132
C 132
Bar Code
Lot:/Exp.:
JMXXX
JJJJ - MM
1 vial
NDC 0338-3993-01
IFEX
(ifosfamide for injection, USP)
(ifosfamide for injection, USP)
Single-Dose Vial
FOR IV USE
FOR IV USE
Rx only
3 g /vial
Baxter Logo
Manufactured by
Baxter Healthcare Corporation
Deerfield, IL 60015 USA
Manufactured by
Baxter Healthcare Corporation
Deerfield, IL 60015 USA
HA-80-02-154
See bottom panel for lot
Baxter Logo
Manufactured by
Baxter Healthcare Corporation
Deerfield, IL 60015 USA
Manufactured by
Baxter Healthcare Corporation
Deerfield, IL 60015 USA
C
(01) 0030338993014
1 vial NDC 0338-3993-01
IFEX
Single Dose Vial
3 g /vial
Baxter Logo
Manufactured by
Baxter Healthcare Corporation
Deerfield, IL 60015 USA
Manufactured by
Baxter Healthcare Corporation
Deerfield, IL 60015 USA
Lot/Exp.:
JMXXXA
2617B5079
Barcode
FOLDING BOX
This vial contains 3 g ifosfamide.
READ ACCOMPANYING PACKAGE
INSERT for detailed indications,
dosage, and precautions.
INSERT for detailed indications,
dosage, and precautions.
Store at controlled room
temperature 20° C to 25° C
(68° F to 77° F). Protect from
temperatures above 30° C (86° F).
temperature 20° C to 25° C
(68° F to 77° F). Protect from
temperatures above 30° C (86° F).
Constituted solutions should be
Manufactured by: