Pricing
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Fosfa is indicated for:
Pharmacology
Ifosfamide is a prodrug that needs metabolic activation by liver cytochrome P450 enzymes to produce its cytotoxic effect. This activation happens through hydroxylation at the ring carbon, forming the unstable intermediate 4-hydroxyifosfamide and its ring-opened aldo tautomer. This intermediate then breaks down into the cytotoxic and urotoxic compound acrolein, the alkylating agent isophosphoramide mustard, and several other nontoxic byproducts. The precise mechanism of action has not been fully established, but ifosfamide's cytotoxic effect is thought to come mainly from DNA crosslinks formed when isophosphoramide mustard alkylates guanine at the N-7 position. These inter-strand and intra-strand DNA crosslinks lead to cell death.
Ifosfamide's pharmacokinetics are dose-dependent in humans. At single doses of 3.8 to 5 g/m2, plasma concentrations decline in two phases, with a mean terminal elimination half-life of about 15 hours. At doses of 1.6 to 2.4 g/m2 per day, plasma decline follows a single exponential phase, with a terminal elimination half-life of about 7 hours.
Ifosfamide's pharmacokinetics are also time-dependent in humans. In a study of 15 patients with cancer given 1.5 g/m2 intravenously over 0.5 hours once daily for 5 days, the median elimination half-life fell from 7.2 hours on Day 1 to 4.6 hours on Day 5, while median clearance rose from 66 mL/min on Day 1 to 115 mL/min on Day 5. The volume of distribution on Day 5 did not differ significantly from that on Day 1.
Dosage Reference
Reference Information Only
Dosages shown are general references from official sources. Always consult your doctor or pharmacist for personalized dosing.
Adults:
Ifosfamide should be given 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 blood-related toxicity (platelets at least 100,000/mL, white blood cell count, WBC, at least 4,000/mL). To help prevent bladder toxicity, ifosfamide should be given along with generous hydration, consisting of at least 2 liters of oral or intravenous fluid per day. A protective agent such as Mesna (Mes-D) should also be used to prevent hemorrhagic cystitis. Ifosfamide should be given as a slow intravenous infusion lasting at least 30 minutes. Although ifosfamide has been given to a small number of patients with compromised liver or kidney function, studies establishing optimal dosing schedules for such patients have not been carried out.
Side Effects
Adverse Reactions from Clinical Trials: Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. The adverse reactions and frequencies below are based on 30 publications describing clinical experience with fractionated administration of Ifodex as monotherapy, with a total dose of 4 to 12 g/m2 per course.
Cautions & Contraindications
Warnings & Precautions
Myelosuppression, Immunosuppression, and Infections Treatment with Ifodex may cause myelosuppression and significant suppression of immune responses, which can lead to severe infections. Fatal outcomes of Ifodex-associated myelosuppression have been reported. Ifodex-induced myelosuppression can cause leukopenia, neutropenia, thrombocytopenia (which is linked to a higher risk of bleeding), and anemia. The leukocyte count usually reaches its lowest point about two weeks after administration. When Ifodex is given together with other chemotherapy or hematotoxic agents, or with radiation therapy, severe myelosuppression is often seen. The risk of myelosuppression depends on the dose and is higher when a single high dose is given compared with divided doses. The risk is also higher in patients with reduced renal function. Severe immunosuppression has led to serious infections, some of them fatal. Sepsis and septic shock have also been reported. Infections linked to Ifodex include pneumonia and other bacterial, fungal, viral, and parasitic infections. Latent infections can wake up again, and reactivation has been reported for several viral infections in patients treated with Ifodex. Infections must be treated properly. Antimicrobial prophylaxis may be considered in some cases of neutropenia, at the discretion of the managing physician. If neutropenic fever occurs, antibiotics and/or antimycotics must be given. Close blood monitoring is recommended. White blood cell (WBC) count, platelet count and hemoglobin should be checked before each dose and at suitable intervals afterwards. Unless clinically essential, Ifodex should not be given to patients with a WBC count below 2000/microliter or a platelet count below 50,000/microliter, or both. Ifodex should be given cautiously, if at all, to patients who have an infection, severe immunosuppression, or poor bone marrow reserve. This may show up as leukopenia, granulocytopenia, extensive bone marrow metastases, prior radiation therapy, or prior therapy with other cytotoxic agents. Central Nervous System Toxicity and Neurotoxicity Ifodex can cause CNS toxicity and other neurotoxic effects, so the patient needs careful monitoring. Neurologic effects reported after Ifodex therapy include somnolence, confusion, hallucinations, blurred vision, psychotic behavior, extrapyramidal symptoms, urinary incontinence, seizures, and, in some cases, coma. Peripheral neuropathy has also been reported with Ifodex use. Ifosfamide neurotoxicity may appear within a few hours to a few days after the first dose, and in most cases it resolves within 48 to 72 hours of stopping Ifodex. Some symptoms may last longer. Supportive therapy should continue until they have fully resolved. Occasionally, recovery is incomplete. Fatal outcomes of CNS toxicity have been reported, and CNS toxicity has recurred after several uneventful treatment courses. If encephalopathy develops, Ifodex should be stopped. Because of the risk of additive effects, drugs that act on the CNS, such as antiemetics, sedatives, narcotics, or antihistamines, must be used with particular caution or, if necessary, stopped in case of Ifodex-induced encephalopathy. CNS toxicity may affect a patient's ability to drive a car or operate other heavy machinery. Renal and Urothelial Toxicity and Effects Ifosfamide is both nephrotoxic and urotoxic. Women should not become pregnant, and men should not father a child during therapy with Ifosfamide. Men should also avoid fathering a child for up to 6 months after therapy ends. If this drug is used during pregnancy, or if the patient becomes pregnant while taking Ifodex or after treatment, the patient should be told about the potential hazard to the fetus. Effects on Fertility Ifosfamide interferes with oogenesis and spermatogenesis. Amenorrhea, azoospermia, and sterility have been reported in both sexes.
Contraindications
Ifosfamide should not be used in people who are hypersensitive to it or who have a blockage affecting the outflow of urine.
Pregnancy & Breastfeeding
Pregnancy Category D. Ifosfamide can cause fetal harm when given to a pregnant woman. Fetal growth retardation and neonatal anemia have been reported following exposure to ifosfamide-containing chemotherapy regimens during pregnancy. Animal studies indicate that ifosfamide is capable of causing gene mutations and chromosomal damage in living organisms. In pregnant mice, resorptions increased and anomalies were present at day 19 after a 30 mg/m2 dose of ifosfamide was given on day 11 of gestation. Embryo lethal effects were observed in rats following administration of 54 mg/m2 doses of ifosfamide from the 6th through the 15th day of gestation, and embryotoxic effects were apparent after mothers received 18 mg/m2 doses over the same period. Ifosfamide is embryotoxic to rabbits receiving 88 mg/m2 per day doses from the 6th through the 18th day after mating, and the number of anomalies was also significantly increased over the control group.
Women should not become pregnant and men should not father a child during therapy with ifosfamide. Men should also not father a child for up to 6 months after the end of therapy. If this drug is used during pregnancy, or if the patient becomes pregnant while taking it or after treatment, she should be told of the potential hazard to a fetus.
Nursing mothers: ifosfamide is excreted in breast milk. Because of the potential for serious adverse events and the tumor causing potential shown for ifosfamide in animal studies, a decision should be made whether to stop nursing or stop the drug, taking into account how important the drug is to the mother. Women must not breastfeed during treatment with ifosfamide.
Pediatric use: safety and effectiveness have not been established in pediatric patients.
Geriatric use (section 8.5): in general, dose selection for an elderly patient should be cautious, reflecting the greater frequency of decreased liver, kidney, or heart function, and of other illness or drug therapy in this age group. A study of patients 40 to 71 years of age indicated that the elimination half life appears to increase with advancing age. This apparent increase in half life appeared to be related to an increase in the volume of distribution of ifosfamide with age. No significant changes in total plasma clearance, or in renal or non renal clearance, with age were reported. Ifosfamide and its metabolites are known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired kidney function. Because elderly patients are more likely to have decreased kidney function, care should be taken in dose selection, and it may be useful to monitor kidney function.
This is discussed further under use in patients with renal impairment (section 8.6).
⚠️ Talk to your doctor before taking any medicine during pregnancy or while breastfeeding.
Storage
Keep the Ifosfamide vial in its original carton and store it at 2°-8° C. Protect it from light. Keep it out of reach of children.
Drug Interactions
Common questions about Fosfa 2 gm
What is Fosfa 2 gm IV Infusion?
Fosfa 2 gm IV Infusion is a medicine that contains Ifosfamide. It is made by Drug International Unani Ltd. It belongs to the Cytotoxic Chemotherapy group of medicines.
What is Fosfa used for?
Fosfa is used for: Urinary Tract Infection, Cancer.
What are the side effects of Fosfa?
Adverse Reactions from Clinical Trials: Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. The adverse reactions and frequencies below are based on 30 publications describing clinical experience with fractionated administration of Ifodex as monotherapy, with a total dose of 4 to 12 g/m2 per course.
Can I take Fosfa during pregnancy or while breastfeeding?
Pregnancy Category D. Ifosfamide can cause fetal harm when given to a pregnant woman. Talk to your doctor before taking any medicine during pregnancy or while breastfeeding.
How should I store Fosfa?
Keep the Ifosfamide vial in its original carton and store it at 2°-8° C. Protect it from light.
Can I take other medicines with Fosfa?
Some medicines can interact with Ifosfamide, for example: Glimepiride, Carbamazepine, Fluconazole, Itraconazole, Sorafenib, Aprepitant. Tell your doctor or pharmacist about every medicine you take.
Do I need a prescription for Fosfa?
Fosfa is a prescription (Rx) medicine. Take it as your doctor advises.