IFEX (Page 5 of 6)

14 CLINICAL 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/m2 /day intravenously on days 1 to 5, cisplatin 20 mg/m2 /day intravenously on days 1 to 5, and either etoposide 75 mg/m2 /day intravenously on days 1 to 5 or vinblastine 0.22 mg/kg intravenously on day 1. Efficacy results with the VIP regimen were compared to data pooled from six single agent phase II trials conducted between August 1980 and October 1985 including a total of 90 patients of whom 65 were eligible as controls of this study. Twenty-three patients in the VIP regimen became free of disease with VIP alone or VIP plus surgery, whereas a single patient in the historical control group achieved complete response. The median survival time exceeded two years in the VIP group versus less than one year in the control group. Performance status ≥ 80, embryonal carcinoma and minimal disease were favorable prognostic factors for survival. In all prognostic categories, the difference between VIP and historical controls remained highly significant.

Table 1. Efficacy Results
*
Gehan-Breslow and Mantel-Cox tests

Number. (%) of Patients

VIP

Control

p-value

Total Patients

59 (100)

65 (100)

Disease-free

23 (39)

1 (2)

< 0.001

Chemotherapy alone

15 (25)

1 (2)

< 0.001

Chemotherapy plus surgery

8 (14)

0

Overall Response

32 (54)

2 (3)

< 0.001

Time to progression (weeks)

Median

19

4

< 0.001*

Range

1 – 205+

1 – 29

Disease-free interval (weeks)

Median

114

29

Range

13 – 205+

Survival (weeks)

Median

53

10

< 0.001*

Range

1 – 205+

1 – 123+

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.

15 REFERENCES

1.
NIOSH Alert: Preventing occupational exposures to antineoplastic and other hazardous drugs in healthcare settings. 2004. U.S. Department of Health and Human Services, Public Health Service, Centers for Disease Control and Prevention, National Institute for Occupational Safety and Health, DHHS (NIOSH) Publication No. 2004-165.

16 HOW 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).

Exercise caution when handling IFEX. The handling and preparation of ifosfamide should always be in accordance with current guidelines on safe handling of cytotoxic agents. Several guidelines on this subject have been published.1-4 Skin reactions associated with accidental exposure to IFEX may occur. To minimize the risk of dermal exposure, always wear impervious gloves when handling vials and solutions containing IFEX. If IFEX solution contacts the skin or mucosa, immediately wash the skin thoroughly with soap and water or rinse the mucosa with copious amounts of water.

17 PATIENT COUNSELING INFORMATION

Myelosuppression, Immunosuppression, and Infections

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 [see Boxed Warning, Warnings and Precautions (5.1)].
Inform patients to report fever or other symptoms of an infection [see Boxed Warning, Warnings and Precautions (5.1), Adverse Reactions (6.2)].
Advise patients on the risks of bleeding and anemia [see Warnings and Precautions (5.1, 5.8), Adverse Reactions (6.2)], Use in Specific Populations (8.1)].

Central Nervous System Toxicity, Neurotoxicity

Advise patients on the risk of CNS toxicity and other neurotoxic effects with fatal outcome [see Boxed Warning, Warnings and Precautions (5.2)].

Renal and Urothelial Toxicity and Effects

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 [see Warnings and Precautions (5.3)].

Cardiotoxicity

Advise patients on the risk of cardiotoxicity and fatal outcome. Advise patients to report preexisting cardiac disease and manifestations of cardiotoxicity [see Warnings and Precautions (5.4), Adverse Reactions (6.2)].

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 [see Warnings and Precautions (5.5)].

Secondary Malignancies

Advise patients on the risk of secondary malignancies due to therapy [see Warnings and Precautions (5.6)].

Veno-occlusive Liver Disease

Advise patients on the risk of veno-occlusive liver disease [see Warnings and Precautions (5.7)].

Pregnancy

Advise patients on the potential hazard to a fetus if a patient becomes pregnant or fathers a child during therapy and for up to 6 months after therapy.
Advise patients to use effective contraception during therapy and for up to 6 months after therapy [see Warnings and Precautions (5.8), Adverse Reactions (6.2)].

Lactation

Advise patients on the potential for serious adverse reactions and tumorigenicity when children are breastfed during therapy [see Use in Specific Populations (8.3)].

Reproductive System Disorders

Advise patients on the risk of amenorrhea, premature menopause, and sterility [see Warnings and Precautions (5.9), Adverse Reactions (6.2)].

Skin and Subcutaneous Tissue Disorders

Advise patients on the risk of alopecia, wound healing, and other serious skin and subcutaneous tissue disorders [see Warnings and Precautions (5.11), Adverse Reactions (6.2)].

Gastrointestinal Disorders

Advise patients that the therapy may cause gastrointestinal disorders and alcohol may increase nausea and vomiting [see Adverse Reactions (6.2)].
Advise patients on the risk of stomatitis and the importance of proper oral hygiene [see Adverse Reactions (6.2)].

Eye Disorders

Advise patients on the risk of eye disorders such as visual impairment, blurred vision, and eye irritation [see Adverse Reactions (6.2)].

Ear and Labyrinth Disorders

Advise patients on the risk of ear and labyrinth disorders such as deafness, vertigo, and tinnitus [see Adverse Reactions (6.2)].

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-30-01-800

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