Ifosfamide Recall

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Questions & Answers

Side Effects & Adverse Reactions

Urinary System

Urotoxic side effects, especially hemorrhagic cystitis, have been frequently associated with the use of ifosfamide. It is recommended that a urinalysis should be obtained prior to each dose of ifosfamide. If microscopic hematuria (greater than 10 RBCs per high power field), is present, then subsequent administration should be withheld until complete resolution.

Further administration of ifosfamide should be given with vigorous oral or parenteral hydration.

Hematopoietic System

When ifosfamide is given in combination with other chemotherapeutic agents, severe myelosuppression is frequently observed. Close hematologic monitoring is recommended. White blood cell (WBC) count, platelet count and hemoglobin should be obtained prior to each administration and at appropriate intervals. Unless clinically essential, ifosfamide should not be given to patients with a WBC count below 2000/μL and/or a platelet count below 50,000/μL.

Central Nervous System

Neurologic manifestations consisting of somnolence, confusion, hallucinations and in some instances, coma, have been reported following ifosfamide therapy. The occurrence of these symptoms requires discontinuing ifosfamide therapy. The symptoms have usually been reversible and supportive therapy should be maintained until their complete resolution.


Animal studies indicate that the drug is capable of causing gene mutations and chromosomal damage in vivo. Embryotoxic and teratogenic effects have been observed in mice, rats and rabbits at doses 0.05 to 0.075 times the human dose.

Ifosfamide can cause fetal damage when administered to a pregnant woman. If ifosfamide is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus.

Legal Issues

There is currently no legal information available for this drug.

FDA Safety Alerts

There are currently no FDA safety alerts available for this drug.

Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.


Ifosfamide injection, used in combination with certain other approved antineoplastic agents, is indicated for third line chemotherapy of germ cell testicular cancer. It should be used in combination with a prophylactic agent for hemorrhagic cystitis, such as mesna.


There is currently no drug history available for this drug.

Other Information

Ifosfamide injection sterile, single-dose vials for administration by intravenous infusion each contains 1 gram of ifosfamide, USP. The 1-gram vial also contains 69.0 mg monobasic sodium phosphate monohydrate, USP, 21.3 mg dibasic sodium phosphate anhydrous, USP and water for injection, USP, qs. Ifosfamide is a chemotherapeutic agent 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 C7H15Cl2N2O2P and its molecular weight is 261.1. Its structural formula is:


Ifosfamide is a white crystalline powder that is soluble in water.

Ifosfamide Manufacturers

  • Mylan Institutional Llc
    Ifosfamide Injection, Solution [Mylan Institutional Llc]
  • App Pharmaceuticals, Llc
    Ifosfamide Injection, Powder, Lyophilized, For Solution [App Pharmaceuticals, Llc]
  • App Pharmaceuticals, Llc
    Ifosfamide Injection, Solution [App Pharmaceuticals, Llc]
  • Teva Parenteral Medicines, Inc.
    Ifosfamide Injection [Teva Parenteral Medicines, Inc.]
  • Pfizer Laboratories Div Pfizer Inc.
    Ifosfamide Injection, Solution [Pfizer Laboratories Div Pfizer Inc.]
  • Fresenius Kabi Usa, Llc
    Ifosfamide Injection, Powder, Lyophilized, For Solution [Fresenius Kabi Usa, Llc]
  • Mylan Institutional Llc
    Ifosfamide Injection, Solution [Mylan Institutional Llc ]
  • Baxter Healthcare Corporation
    Ifosfamide Injection, Powder, For Solution [Baxter Healthcare Corporation]

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