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IFOSFAMIDE
Overview
What is IFOSFAMIDE?
Ifosfamide for Injection (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 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 CHClNOP and its molecular weight is 261.1. 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:
What does IFOSFAMIDE look like?
What are the available doses of IFOSFAMIDE?
1 gram single-dose vial
3 gram single-dose vial
What should I talk to my health care provider before I take IFOSFAMIDE?
How should I use IFOSFAMIDE?
Ifosfamide for Injection is 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.
Ifosfamide for Injection should be administered intravenously at a dose of 1.2 grams per m per day for 5 consecutive days. Treatment is repeated every 3 weeks or after recovery from hematologic toxicity.
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. Mesna should be used to reduce the incidence of hemorrhagic cystitis. Ifosfamide for Injection should be administered as a slow intravenous infusion lasting a minimum of 30 minutes. Studies of Ifosfamide for Injection in patients with hepatic or renal impairment have not been conducted [see Use in Specific Populations (, )].
Injections are prepared for parenteral use by adding or (benzyl alcohol or parabens preserved), to the vial and shaking to dissolve. Before parenteral administration, the substance must be completely dissolved. Use the quantity of diluents shown below to constitute the product:
Solutions of ifosfamide may be diluted further to achieve concentrations of 0.6 to 20 mg/mL in the following fluids:
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. Benzyl-alcohol-containing solutions can reduce the stability of ifosfamide.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
What interacts with IFOSFAMIDE?
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What are the warnings of IFOSFAMIDE?
Sorry No Records found
What are the precautions of IFOSFAMIDE?
Sorry No Records found
What are the side effects of IFOSFAMIDE?
Sorry No records found
What should I look out for while using IFOSFAMIDE?
Ifosfamide for Injection is contraindicated in patients with:
What might happen if I take too much IFOSFAMIDE?
No specific antidote for Ifosfamide for Injection 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 [see ].
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.
How should I store and handle IFOSFAMIDE?
Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). Ifosfamide for injection is available in single-dose vials as follows: NDC 10019-925-01 1-gram Single-Dose Vial NDC 10019-926-02 3-gram Single-Dose VialStore 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 Ifosfamide for Injection. 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. Skin reactions associated with accidental exposure to Ifosfamide for Injection may occur. To minimize the risk of dermal exposure, always wear impervious gloves when handling vials and solutions containing Ifosfamide for Injection. If Ifosfamide for Injection solution contacts the skin or mucosa, immediately wash the skin thoroughly with soap and water or rinse the mucosa with copious amounts of water.Ifosfamide for injection is available in single-dose vials as follows: NDC 10019-925-01 1-gram Single-Dose Vial NDC 10019-926-02 3-gram Single-Dose VialStore 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 Ifosfamide for Injection. 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. Skin reactions associated with accidental exposure to Ifosfamide for Injection may occur. To minimize the risk of dermal exposure, always wear impervious gloves when handling vials and solutions containing Ifosfamide for Injection. If Ifosfamide for Injection solution contacts the skin or mucosa, immediately wash the skin thoroughly with soap and water or rinse the mucosa with copious amounts of water.Ifosfamide for injection is available in single-dose vials as follows: NDC 10019-925-01 1-gram Single-Dose Vial NDC 10019-926-02 3-gram Single-Dose VialStore 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 Ifosfamide for Injection. 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. Skin reactions associated with accidental exposure to Ifosfamide for Injection may occur. To minimize the risk of dermal exposure, always wear impervious gloves when handling vials and solutions containing Ifosfamide for Injection. If Ifosfamide for Injection solution contacts the skin or mucosa, immediately wash the skin thoroughly with soap and water or rinse the mucosa with copious amounts of water.Ifosfamide for injection is available in single-dose vials as follows: NDC 10019-925-01 1-gram Single-Dose Vial NDC 10019-926-02 3-gram Single-Dose VialStore 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 Ifosfamide for Injection. 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. Skin reactions associated with accidental exposure to Ifosfamide for Injection may occur. To minimize the risk of dermal exposure, always wear impervious gloves when handling vials and solutions containing Ifosfamide for Injection. If Ifosfamide for Injection solution contacts the skin or mucosa, immediately wash the skin thoroughly with soap and water or rinse the mucosa with copious amounts of water.Ifosfamide for injection is available in single-dose vials as follows: NDC 10019-925-01 1-gram Single-Dose Vial NDC 10019-926-02 3-gram Single-Dose VialStore 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 Ifosfamide for Injection. 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. Skin reactions associated with accidental exposure to Ifosfamide for Injection may occur. To minimize the risk of dermal exposure, always wear impervious gloves when handling vials and solutions containing Ifosfamide for Injection. If Ifosfamide for Injection solution contacts the skin or mucosa, immediately wash the skin thoroughly with soap and water or rinse the mucosa with copious amounts of water.Ifosfamide for injection is available in single-dose vials as follows: NDC 10019-925-01 1-gram Single-Dose Vial NDC 10019-926-02 3-gram Single-Dose VialStore 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 Ifosfamide for Injection. 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. Skin reactions associated with accidental exposure to Ifosfamide for Injection may occur. To minimize the risk of dermal exposure, always wear impervious gloves when handling vials and solutions containing Ifosfamide for Injection. If Ifosfamide for Injection solution contacts the skin or mucosa, immediately wash the skin thoroughly with soap and water or rinse the mucosa with copious amounts of water.
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Ifosfamide is a prodrug that requires metabolic activation by hepatic cytochrome P450 isoenzymes to exert its cytotoxic activity. Activation occurs by hydroxylation at the ring carbon atom forming the unstable intermediate 4-hydroxyifosfamide and its ring-opened aldo tautomer, which decomposes to yield the cytotoxic and urotoxic compound acrolein and an alkylating isophosphoramide mustard as well as multiple other nontoxic products. The exact mechanism of action of ifosfamide has not been determined, but its cytotoxic action is primarily through DNA crosslinks caused by alkylation by the isophosphoramide mustard at guanine N-7 positions. The formation of inter- and intra-strand cross-links in the DNA results in cell death.
Non-Clinical Toxicology
Ifosfamide for Injection is contraindicated in patients with:Aminosalicylic acid at a dosage of 12 grams in a rapidly available form has been reported to produce a 20 percent reduction in the acetylation of isoniazid, especially in patients who are rapid acetylators; INH serum levels, half lives and excretions in fast acetylators still remain half of the levels seen in slow acetylators with or without p-aminosalicylic acid. The effect is dose related and, while it has not been studied with the current delayed release preparation, the lower serum levels with this preparation will result in a reduced effect on the acetylation of INH.
Aminosalicylic acid has previously been reported to block the absorption of rifampin. A subsequent report has shown that this blockade was due to an excipient not included in PASER granules. Oral administration of a solution containing both aminosalicylic acid and rifampin showed full absorption of each product.
As a result of competition, Vitamin B absorption has been reduced 55% by 5 grams of aminosalicylic acid with clinically significant erythrocyte abnormalities developing after depletion; patients on therapy of more than one month should be considered for maintenance B.
A malabsorption syndrome can develop in patients on aminosalicylic acid but is usually not complete. The complete syndrome includes steatorrhea, an abnormal small bowel pattern on x-ray, villus atrophy, depressed cholesterol, reduced D-xylose and iron absorption. Triglyceride absorption always is normal.
In one literature report 8 hours after the last dosage of aminosalicylic acid at 2 gm qid serum digoxin levels were reduced 40% in two of ten patients but not changed in the remaining eight.
Treatment with ifosfamide may cause myelosuppression and significant suppression of immune responses, which can lead to severe infections. Fatal outcomes of ifosfamide-associated myelosuppression have been reported. Ifosfamide-induced myelosuppression can cause leukopenia, neutropenia, thrombocytopenia (associated with a higher risk of bleeding events), and anemia. The nadir of the leukocyte count tends to be reached approximately during the second week after administration. When Ifosfamide for Injection is given in combination with other chemotherapeutic/hematotoxic agents and/or radiation therapy, severe myelosuppression is frequently observed. The risk of myelosuppression is dose-dependent and is increased with administration of a single high dose compared with fractionated administration. The risk of myelosuppression is also increased in patients with reduced renal function.
Severe immunosuppression has led to serious, sometimes fatal, infections. Sepsis and septic shock also have been reported. Infections reported with ifosfamide include pneumonias, as well as other bacterial, fungal, viral, and parasitic infections. Latent infections can be reactivated. In patients treated with ifosfamide, reactivation has been reported for various viral infections. Infections must be treated appropriately. Antimicrobial prophylaxis may be indicated in certain cases of neutropenia at the discretion of the managing physician. In case of neutropenic fever, antibiotics and/or antimycotics must be given. 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 after administration. Unless clinically essential, Ifosfamide for Injection should not be given to patients with a WBC count below 2000/µL and/or a platelet count below 50,000/µL.
Ifosfamide for Injection should be given cautiously, if at all, to patients with presence of an infection, severe immunosuppression or compromised bone marrow reserve, as indicated by leukopenia, granulocytopenia, extensive bone marrow metastases, prior radiation therapy, or prior therapy with other cytotoxic agents.
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72Tips
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