Ifosfamide
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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.
Pregnancy
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.
Uses
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.
History
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.
Sources
Ifosfamide Manufacturers
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Mylan Institutional Llc
![Ifosfamide Injection, Solution [Mylan Institutional Llc]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Ifosfamide | Mylan Institutional Llc
Ifosfamide injection should be administered intravenously at a dose of 1.2 g/m2 per day for 5 consecutive days. Treatment is repeated every 3 weeks or after recovery from hematologic toxicity (Platelets ≥ 100,000/μL, WBC ≥ 4,000/μL). In order to prevent bladder toxicity, ifosfamide should be given with extensive hydration consisting of at least 2 liters of oral or intravenous fluid per day. A protector, such as mesna, should also be used to reduce the incidence of hemorrhagic cystitis. Ifosfamide should be administered as a slow intravenous infusion lasting a minimum of 30 minutes. Although ifosfamide has been administered to a small number of patients with compromised hepatic and/or renal function, studies to establish optimal dose schedules of ifosfamide in such patients have not been conducted.
Preparation for Intravenous Administration/ Stability
Ifosfamide injection may be diluted to achieve concentrations of 0.6 to 20 mg/mL in the following fluids:
5% Dextrose injection, USP 0.9% sodium chloride injection, USP lactated Ringer's injection, USP sterile water for injection, USP
Because essentially identical stability results were obtained for sterile water admixtures as for the other admixtures (5% dextrose injection, 0.9% sodium chloride injection, and lactated Ringer's injection), the use of large volume parenteral glass bottles, Viaflex bags or PAB™ bags that contain intermediate concentrations or mixtures of excipients (eg, 2.5% dextrose injection, 0.45% sodium chloride injection, or 5% dextrose and 0.9% sodium chloride injection) is also acceptable.
Further diluted solutions of ifosfamide should be refrigerated and used within 24 hours.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration.
-
App Pharmaceuticals, Llc
Ifosfamide | App Pharmaceuticals, Llc
Ifosfamide for Injection should be administered intravenously at a dose of 1.2 g/m2 per day for 5 consecutive days. Treatment is repeated every 3 weeks or after recovery from hematologic toxicity (Platelets ≥100,000/μL, WBC ≥4,000/μL). In order to prevent bladder toxicity, Ifosfamide for Injection should be given with extensive hydration consisting of at least 2 liters of oral or intravenous fluid per day. A protector, such as mesna, should also be used to prevent hemorrhagic cystitis. Ifosfamide for Injection should be administered as a slow intravenous infusion lasting a minimum of 30 minutes. Although Ifosfamide for Injection has been administered to a small number of patients with compromised hepatic and/or renal function, studies to establish optimal dose schedules of Ifosfamide for Injection in such patients have not been conducted.
Preparation for Intravenous Administration/Stability
Injections are prepared for parenteral use by adding Sterile Water for Injection, USP, or Bacteriostatic Water for Injection, USP (benzyl alcohol or parabens preserved), to the vial and shaking to dissolve. Use the quantity of diluent shown below to constitute the product:
Dosage
Strength
Quantity of
Diluent
Final
Concentration
1 gram
20 mL
50 mg/mL
3 grams
60 mL
50 mg/mL
Solutions of ifosfamide may be diluted further to achieve concentrations of 0.6 to 20 mg/mL in the following fluids:
5% Dextrose Injection, USP
0.9% Sodium Chloride Injection, USP
Lactated Ringer’s Injection, USP
Sterile Water for Injection, USP
Because essentially identical stability results were obtained for Sterile Water admixtures as for the other admixtures (5% Dextrose Injection, 0.9% Sodium Chloride Injection, and Lactated Ringer’s Injection), the use of large volume parenteral glass bottles, Viaflex bags or PAB™ bags that contain intermediate concentrations or mixtures of excipients (e.g., 2.5% Dextrose Injection, 0.45% Sodium Chloride Injection, or 5% Dextrose and 0.9% Sodium Chloride Injection) is also acceptable.
Constituted or constituted and further diluted solutions of Ifosfamide for Injection should be refrigerated and used within 24 hours.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration.
Preparation for Intravenous Administration/Stability
Injections are prepared for parenteral use by adding Sterile Water for Injection, USP, or Bacteriostatic Water for Injection, USP (benzyl alcohol or parabens preserved), to the vial and shaking to dissolve. Use the quantity of diluent shown below to constitute the product:
Dosage
Strength
Quantity of
Diluent
Final
Concentration
1 gram
20 mL
50 mg/mL
3 grams
60 mL
50 mg/mL
Solutions of ifosfamide may be diluted further to achieve concentrations of 0.6 to 20 mg/mL in the following fluids:
5% Dextrose Injection, USP
0.9% Sodium Chloride Injection, USP
Lactated Ringer’s Injection, USP
Sterile Water for Injection, USP
Because essentially identical stability results were obtained for Sterile Water admixtures as for the other admixtures (5% Dextrose Injection, 0.9% Sodium Chloride Injection, and Lactated Ringer’s Injection), the use of large volume parenteral glass bottles, Viaflex bags or PAB™ bags that contain intermediate concentrations or mixtures of excipients (e.g., 2.5% Dextrose Injection, 0.45% Sodium Chloride Injection, or 5% Dextrose and 0.9% Sodium Chloride Injection) is also acceptable.
Constituted or constituted and further diluted solutions of Ifosfamide for Injection should be refrigerated and used within 24 hours.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration.
-
App Pharmaceuticals, Llc
Ifosfamide | App Pharmaceuticals, Llc
Ifosfamide injection should be administered intravenously at a dose of 1.2 g/m2 per day for 5 consecutive days. Treatment is repeated every 3 weeks or after recovery from hematologic toxicity (Platelets ≥100,000/μL, WBC ≥4,000/μL). In order to prevent bladder toxicity, ifosfamide should be given with extensive hydration consisting of at least 2 liters of oral or intravenous fluid per day. A protector, such as mesna, should also be used to prevent hemorrhagic cystitis. Ifosfamide should be administered as a slow intravenous infusion lasting a minimum of 30 minutes. Although ifosfamide has been administered to a small number of patients with compromised hepatic and/or renal function, studies to establish optimal dose schedules of ifosfamide in such patients have not been conducted.
Preparation for Intravenous Administration/Stability
Ifosfamide injection may be diluted to achieve concentrations of 0.6 to 20 mg/mL in the following fluids:
5% Dextrose Injection, USP
0.9% Sodium Chloride Injection, USP
Lactated Ringer’s Injection, USP
Sterile Water for Injection, USP
Because essentially identical stability results were obtained for sterile water admixtures as for the other admixtures (5% Dextrose Injection, 0.9% Sodium Chloride Injection, and Lactated Ringer’s Injection), the use of large volume parenteral glass bottles, Viaflex bags or PAB™ bags that contain intermediate concentrations or mixtures of excipients (e.g., 2.5% Dextrose Injection, 0.45% Sodium Chloride Injection, or 5% Dextrose and 0.9% Sodium Chloride Injection) is also acceptable.
Further diluted solutions of ifosfamide should be refrigerated and used within 24 hours.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration.
Preparation for Intravenous Administration/Stability
Ifosfamide injection may be diluted to achieve concentrations of 0.6 to 20 mg/mL in the following fluids:
5% Dextrose Injection, USP
0.9% Sodium Chloride Injection, USP
Lactated Ringer’s Injection, USP
Sterile Water for Injection, USP
Because essentially identical stability results were obtained for sterile water admixtures as for the other admixtures (5% Dextrose Injection, 0.9% Sodium Chloride Injection, and Lactated Ringer’s Injection), the use of large volume parenteral glass bottles, Viaflex bags or PAB™ bags that contain intermediate concentrations or mixtures of excipients (e.g., 2.5% Dextrose Injection, 0.45% Sodium Chloride Injection, or 5% Dextrose and 0.9% Sodium Chloride Injection) is also acceptable.
Further diluted solutions of ifosfamide should be refrigerated and used within 24 hours.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration.
-
Teva Parenteral Medicines, Inc.
Ifosfamide | Actavis Pharma, Inc.
2.1 General InstructionsFor the relief of the signs and symptoms of osteoarthritis of the knee(s), the recommended dose is 40 drops per knee, 4 times a day.
Apply diclofenac sodium topical solution to clean, dry skin.
To avoid spillage, dispense diclofenac sodium topical solution 10 drops at a time either directly onto the knee or first into the hand and then onto the knee. Spread diclofenac sodium topical solution evenly around front, back and sides of the knee. Repeat this procedure until 40 drops have been applied and the knee is completely covered with solution.
To treat the other knee, if symptomatic, repeat the procedure.
Application of diclofenac sodium topical solution in an amount exceeding or less than the recommended dose has not been studied and is therefore not recommended.
2.2 Special PrecautionsAvoid showering/bathing for at least 30 minutes after the application of diclofenac sodium topical solution to the treated knee.
Wash and dry hands after use.
Do not apply diclofenac sodium topical solution to open wounds.
Avoid contact of diclofenac sodium topical solution with eyes and mucous membranes.
Do not apply external heat and/or occlusive dressings to treated knees.
Avoid wearing clothing over the diclofenac sodium topical solution-treated knee(s) until the treated knee is dry.
Protect the treated knee(s) from sunlight.
Wait until the treated area is dry before applying sunscreen, insect repellant, lotion, moisturizer, cosmetics, or other topical medication to the same knee you have just treated with diclofenac sodium topical solution.
Until the treated knee(s) is completely dry, avoid skin-to-skin contact between other people and the treated knee(s).
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Pfizer Laboratories Div Pfizer Inc.
Ifosfamide | Pfizer Laboratories Div Pfizer Inc.
Ifosfamide injection should be administered intravenously at a dose of 1.2 g/m2 per day for 5 consecutive days. Treatment is repeated every 3 weeks or after recovery from hematologic toxicity (Platelets ≥ 100,000/μL, WBC ≥ 4,000/μL). In order to prevent bladder toxicity, ifosfamide should be given with extensive hydration consisting of at least 2 liters of oral or intravenous fluid per day. A protector, such as mesna, should also be used to reduce the incidence of hemorrhagic cystitis. Ifosfamide should be administered as a slow intravenous infusion lasting a minimum of 30 minutes. Although ifosfamide has been administered to a small number of patients with compromised hepatic and/or renal function, studies to establish optimal dose schedules of ifosfamide in such patients have not been conducted.
Preparation for Intravenous Administration/ StabilityIfosfamide injection may be diluted to achieve concentrations of 0.6 to 20 mg/mL in the following fluids:
5% Dextrose injection, USP 0.9% sodium chloride injection, USP lactated Ringer's injection, USP sterile water for injection, USP
Because essentially identical stability results were obtained for sterile water admixtures as for the other admixtures (5% dextrose injection, 0.9% sodium chloride injection, and lactated Ringer's injection), the use of large volume parenteral glass bottles, Viaflex bags or PAB™ bags that contain intermediate concentrations or mixtures of excipients (eg, 2.5% dextrose injection, 0.45% sodium chloride injection, or 5% dextrose and 0.9% sodium chloride injection) is also acceptable.
Further diluted solutions of ifosfamide should be refrigerated and used within 24 hours.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration.
-
Fresenius Kabi Usa, Llc
Ifosfamide | Fresenius Kabi Usa, Llc
Ifosfamide for Injection should be administered intravenously at a dose of 1.2 g/m2 per day for 5 consecutive days. Treatment is repeated every 3 weeks or after recovery from hematologic toxicity (Platelets ≥100,000/μL, WBC ≥4,000/μL). In order to prevent bladder toxicity, Ifosfamide for Injection should be given with extensive hydration consisting of at least 2 liters of oral or intravenous fluid per day. A protector, such as mesna, should also be used to prevent hemorrhagic cystitis. Ifosfamide for Injection should be administered as a slow intravenous infusion lasting a minimum of 30 minutes. Although Ifosfamide for Injection has been administered to a small number of patients with compromised hepatic and/or renal function, studies to establish optimal dose schedules of Ifosfamide for Injection in such patients have not been conducted.
Preparation for Intravenous Administration/Stability
Injections are prepared for parenteral use by adding Sterile Water for Injection, USP, or Bacteriostatic Water for Injection, USP (benzyl alcohol or parabens preserved), to the vial and shaking to dissolve. Use the quantity of diluent shown below to constitute the product:
Dosage
Strength
Quantity of
Diluent
Final
Concentration
1 gram
20 mL
50 mg/mL
3 grams
60 mL
50 mg/mL
Solutions of ifosfamide may be diluted further to achieve concentrations of 0.6 to 20 mg/mL in the following fluids:
5% Dextrose Injection, USP
0.9% Sodium Chloride Injection, USP
Lactated Ringer’s Injection, USP
Sterile Water for Injection, USP
Because essentially identical stability results were obtained for Sterile Water admixtures as for the other admixtures (5% Dextrose Injection, 0.9% Sodium Chloride Injection, and Lactated Ringer’s Injection), the use of large volume parenteral glass bottles, Viaflex bags or PAB™ bags that contain intermediate concentrations or mixtures of excipients (e.g., 2.5% Dextrose Injection, 0.45% Sodium Chloride Injection, or 5% Dextrose and 0.9% Sodium Chloride Injection) is also acceptable.
Constituted or constituted and further diluted solutions of Ifosfamide for Injection should be refrigerated and used within 24 hours.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration.
Preparation for Intravenous Administration/Stability
Injections are prepared for parenteral use by adding Sterile Water for Injection, USP, or Bacteriostatic Water for Injection, USP (benzyl alcohol or parabens preserved), to the vial and shaking to dissolve. Use the quantity of diluent shown below to constitute the product:
Dosage
Strength
Quantity of
Diluent
Final
Concentration
1 gram
20 mL
50 mg/mL
3 grams
60 mL
50 mg/mL
Solutions of ifosfamide may be diluted further to achieve concentrations of 0.6 to 20 mg/mL in the following fluids:
5% Dextrose Injection, USP
0.9% Sodium Chloride Injection, USP
Lactated Ringer’s Injection, USP
Sterile Water for Injection, USP
Because essentially identical stability results were obtained for Sterile Water admixtures as for the other admixtures (5% Dextrose Injection, 0.9% Sodium Chloride Injection, and Lactated Ringer’s Injection), the use of large volume parenteral glass bottles, Viaflex bags or PAB™ bags that contain intermediate concentrations or mixtures of excipients (e.g., 2.5% Dextrose Injection, 0.45% Sodium Chloride Injection, or 5% Dextrose and 0.9% Sodium Chloride Injection) is also acceptable.
Constituted or constituted and further diluted solutions of Ifosfamide for Injection should be refrigerated and used within 24 hours.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration.
-
Mylan Institutional Llc
Ifosfamide | Mylan Institutional Llc
Ifosfamide injection should be administered intravenously at a dose of 1.2 g/m2 per day for 5 consecutive days. Treatment is repeated every 3 weeks or after recovery from hematologic toxicity (Platelets ≥ 100,000/μL, WBC ≥ 4,000/μL). In order to prevent bladder toxicity, ifosfamide should be given with extensive hydration consisting of at least 2 liters of oral or intravenous fluid per day. A protector, such as mesna, should also be used to reduce the incidence of hemorrhagic cystitis. Ifosfamide should be administered as a slow intravenous infusion lasting a minimum of 30 minutes. Although ifosfamide has been administered to a small number of patients with compromised hepatic and/or renal function, studies to establish optimal dose schedules of ifosfamide in such patients have not been conducted.
Preparation for Intravenous Administration/ StabilityIfosfamide injection may be diluted to achieve concentrations of 0.6 to 20 mg/mL in the following fluids:
5% Dextrose injection, USP 0.9% sodium chloride injection, USP lactated Ringer's injection, USP sterile water for injection, USP
Because essentially identical stability results were obtained for sterile water admixtures as for the other admixtures (5% dextrose injection, 0.9% sodium chloride injection, and lactated Ringer's injection), the use of large volume parenteral glass bottles, Viaflex bags or PAB™ bags that contain intermediate concentrations or mixtures of excipients (eg, 2.5% dextrose injection, 0.45% sodium chloride injection, or 5% dextrose and 0.9% sodium chloride injection) is also acceptable.
Further diluted solutions of ifosfamide should be refrigerated and used within 24 hours.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration.
-
Baxter Healthcare Corporation
Ifosfamide | Actavis Pharma, Inc.
The dose is one drop of dorzolamide hydrochloride-timolol maleate ophthalmic solution in the affected eye(s) two times daily.
If more than one topical ophthalmic drug is being used, the drugs should be administered at least ten minutes apart (see also PRECAUTIONS, Drug Interactions).
![Ifosfamide Injection, Powder, Lyophilized, For Solution [App Pharmaceuticals, Llc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=a311a947-7b78-4226-bfe0-f4aa0be20e27&name=ifosfamide-for-injection-usp-figure-3-104210-vial.jpg)
![Ifosfamide Injection, Solution [App Pharmaceuticals, Llc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=f6fef680-884f-46fc-bf81-0ef7c5db6f32&name=ifosfamide-injection-figure-3-107420-vial.jpg)
![Ifosfamide Injection [Teva Parenteral Medicines, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=4050064a-b326-49d4-ae82-cd06d5ecb007&name=diclofenac-sodium-solution-1_5-percent-5.jpg)
![Ifosfamide Injection, Solution [Pfizer Laboratories Div Pfizer Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=0a7099a9-5c9a-409e-b6f4-c31812a43327&name=ifo-inj-pfizer-figure-02.jpg)
![Ifosfamide Injection, Powder, Lyophilized, For Solution [Fresenius Kabi Usa, Llc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=fb7f49af-ffe9-4969-a69c-8ed14dd0616b&name=np-ifosfamide-for-injection-usp-figure-2-402119D.jpg)
![Ifosfamide Injection, Solution [Mylan Institutional Llc ]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=27f666d5-0d49-42d4-be52-ad8505593f48&name=ifosfamide-inj-mylan-figure-02.jpg)
![Ifosfamide Injection, Powder, For Solution [Baxter Healthcare Corporation]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=d0c28b92-898a-4755-9eaf-58f790a189ab&name=dorzolamide-hcl-and-timolol-7.jpg)
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