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DRUGS & SUPPLEMENTS
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Myelosuppression can be severe and lead to fatal infections. Monitor blood counts prior to and at intervals after each treatment cycle. CNS toxicities can be severe and result in encephalopathy and death. Monitor for CNS toxicity and discontinue treatment for encephalopathy. Nephrotoxicity can be severe and result in renal failure. Hemorrhagic cystitis can be severe and can be reduced by the prophylactic use of mesna.
WARNING: MYELOSUPPRESSION, NEUROTOXICITY, and UROTOXICITY
See full prescribing information for complete boxed warning.
Ifex 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.
Ifex is an alkylating drug 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. (1)
Ifex should be administered intravenously at a dose of 1.2 grams per m2 per day for 5 consecutive days. Treatment is repeated every 3 weeks or after recovery from hematologic toxicity.
In order to prevent bladder toxicity, Ifex 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. Ifex should be administered as a slow intravenous infusion lasting a minimum of 30 minutes. Studies of Ifex in patients with hepatic or renal impairment have not been conducted .
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. Before parenteral administration, the substance must be completely dissolved. Use the quantity of diluents shown below to constitute the product:
Dosage Strength | Quantity of Diluent | Final Concentration |
1 gram | 20 mL | 50 mg per mL |
3 grams | 60 mL | 50 mg per mL |
Solutions of Ifex 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 Injections, 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 Ifex should be refrigerated and used within 24 hours. Benzyl-alcohol-containing solutions can reduce the stability of Ifex.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
Dosage and duration of treatment and/or treatment intervals depend on the scheme of combination therapy, the patient’s general state of health and organ function, and the results of laboratory monitoring. (2)
1 gram single-dose vial
3 gram single-dose vial
Single dose vials: 1 gram, 3 grams (3)
Ifex is contraindicated in patients with:
Treatment with Ifex 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 Ifex 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 Ifex include pneumonias, as well as other bacterial, fungal, viral, and parasitic infections. Latent infections can be reactivated. In patients treated with Ifex, 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, Ifex should not be given to patients with a WBC count below 2000/µL and/or a platelet count below 50,000/µL.
Ifex 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.
Administration of Ifex can cause CNS toxicity and other neurotoxic effects. The risk of CNS toxicity and other neurotoxic effects necessitates careful monitoring of the patient. Neurologic manifestations consisting of somnolence, confusion, hallucinations, blurred vision, psychotic behavior, extrapyramidal symptoms, urinary incontinence, seizures, and in some instances, coma, have been reported following Ifex therapy. There have also been reports of peripheral neuropathy associated with Ifex use.
Ifex neurotoxicity may become manifest within a few hours to a few days after first administration and in most cases resolves within 48 to 72 hours of Ifex discontinuation. Symptoms may persist for longer periods of time. Supportive therapy should be maintained until their complete resolution. Occasionally, recovery has been incomplete. Fatal outcomes of CNS toxicity have been reported. Recurrence of CNS toxicity after several uneventful treatment courses has been reported. If encephalopathy develops, administration of Ifex should be discontinued.
Due to the potential for additive effects, drugs acting on the CNS must be used with particular caution or, if necessary, be discontinued in case of ifosfamide-induced encephalopathy.
Manifestations of CNS toxicity may impair a patient’s ability to operate an automobile or other heavy machinery.
Ifex is both nephrotoxic and urotoxic. Glomerular and tubular kidney function must be evaluated before commencement of therapy as well as during and after treatment. Monitor urinary sediment regularly for the presence of erythrocytes and other signs of uro/nephrotoxicity.
Monitor serum and urine chemistries, including phosphorus and potassium regularly. Administer appropriate replacement therapy as indicated. Renal parenchymal and tubular necrosis have been reported in patients treated with Ifex. Acute tubular necrosis, acute renal failure, and chronic renal failure secondary to Ifex therapy have been reported, and fatal outcome from nephrotoxicity has been documented.
Disorders of renal function, (glomerular and tubular) following Ifex administration are very common. Manifestations include a decrease in glomerular filtration rate, increased serum creatinine, proteinuria, enzymuria, cylindruria, aminoaciduria, phosphaturia, and glycosuria as well as tubular acidosis. Fanconi syndrome, renal rickets, and growth retardation in children as well as osteomalacia in adults also have been reported. Development of a syndrome resembling SIADH (syndrome of inappropriate antidiuretic hormone secretion) has been reported with Ifex.
Tubular damage may become apparent during therapy, months or even years after cessation of treatment. Glomerular or tubular dysfunction may resolve with time, remain stable, or progress over a period of months or years, even after completion of Ifex treatment.
The risk and expected benefits of Ifex therapy should be carefully weighed when considering the use of Ifex in patients with preexisting renal impairment or reduced nephron reserve.
Urotoxic side effects, especially hemorrhagic cystitis, have been very commonly associated with the use of Ifex. These urotoxic effects can be reduced by prophylactic use of mesna.
Hemorrhagic cystitis requiring blood transfusion has been reported with Ifex. The risk of hemorrhagic cystitis is dose-dependent and increased with administration of single high doses compared to fractionated administration. Hemorrhagic cystitis after a single dose of Ifex has been reported. Past or concomitant radiation of the bladder or busulfan treatment may increase the risk for hemorrhagic cystitis.
Before starting treatment, it is necessary to exclude or correct any urinary tract obstructions [see Contraindications (4)].
During or immediately after administration, adequate amounts of fluid should be ingested or infused to force dieresis in order to reduce the risk of urinary tract toxicity. Obtain a urinalysis prior to each dose of Ifex. 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 Ifex should be given with vigorous oral or parenteral hydration.
Ifex should be used with caution, if at all, in patients with active urinary tract infections.
Manifestations of cardiotoxicity reported with Ifex treatment include:
Fatal outcome of ifosfamide-associated cardiotoxicity has been reported.
The risk of developing cardiotoxic effects is dose-dependent. It is increased in patients with prior or concomitant treatment with other cardiotoxic agents or radiation of the cardiac region and, possibly, renal impairment.
Particular caution should be exercised when Ifex is used in patients with risk factors for cardiotoxicity and in patients with preexisting cardiac disease.
Interstitial pneumonitis, pulmonary fibrosis, and other forms of pulmonary toxicity have been reported with Ifex treatment. Pulmonary toxicity leading to respiratory failure as well as fatal outcome has also been reported. Monitor for signs and symptoms of pulmonary toxicity and treat as clinically indicated.
Treatment with Ifex involves the risk of secondary tumors and their precursors as late sequelae. The risk of myelodysplastic alterations, some progressing to acute leukemias, is increased. Other malignancies reported after use of Ifex or regimens with Ifex include lymphoma, thyroid cancer, and sarcomas.
The secondary malignancy may develop several years after chemotherapy has been discontinued.
Veno-occlusive liver disease has been reported with chemotherapy that included Ifex.
Ifex can cause fetal harm when administered to a pregnant woman. Fetal growth retardation and neonatal anemia have been reported following exposure to ifosfamide-containing chemotherapy regimens during pregnancy. Ifex is genotoxic and mutagenic in male and female germ cells. Embryotoxic and teratogenic effects have been observed in mice, rats and rabbits at doses 0.05 to 0.075 times the human dose.
Women should not become pregnant and men should not father a child during therapy with Ifex. Further, men should 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 this drug or after treatment, the patient should be apprised of the potential hazard to a fetus.
Ifex interferes with oogenesis and spermatogenesis. Amenorrhea, azoospermia, and sterility in both sexes have been reported. Development of sterility appears to depend on the dose of Ifex, duration of therapy, and state of gonadal function at the time of treatment. Sterility may be irreversible in some patients.
Female Patients
Amenorrhea has been reported in patients treated with Ifex. The risk of permanent chemotherapy-induced amenorrhea increases with age. Pediatric patients treated with Ifex during prepubescence subsequently may not conceive and those who retain ovarian function after completing treatment are at increased risk of developing premature menopause.
Male Patients
Men treated with Ifex may develop oligospermia or azoospermia. Pediatric patients treated with Ifex during prepubescence might not develop secondary sexual characteristics normally, but may have oligospermia or azoospermia. Azoospermia may be reversible in some patients, though the reversibility may not occur for several years after cessation of therapy. Sexual function and libido are generally unimpaired in these patients. Some degree of testicular atrophy may occur. Patients treated with Ifex have subsequently fathered children.
Anaphylactic/anaphylactoid reactions have been reported in association with Ifex.
Cross-sensitivity between oxazaphosphorine cytotoxic agents has been reported.
Ifex may interfere with normal wound healing.
Ifex is excreted in breast milk. Women must not breastfeed during treatment with Ifex.
In clinical trials of Ifex monotherapy, the most common adverse reactions were alopecia, nausea/vomiting, leukopenia, anemia, CNS toxicity, hematuria, and infection. (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact Baxter Healthcare at phone: 1 866 888 2472 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
Because clinical trials are conducted from 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 Ifex as monotherapy with a total dose of 4 to 12 g/m2 per course.
System Organ Class (SOC) | Adverse Reaction | Percentage (Ratio) |
INFECTIONS AND INFESTATIONS | Infection | 9.9% (112/1128) |
BLOOD AND LYMPHATIC SYSTEM DISORDERS | Leukopenia | -- |
Leukopenia <1 x 103/µL | 43.5% (267/614) | |
Thrombocytopenia | -- | |
Thrombocytopenia, 50 x 103/µL | 4.8% (35/729) | |
Anemia | 37.9% (202/533) | |
METABOLISM AND NUTRITION DISORDERS | Anorexia | 1.1% (15/1317) |
NERVOUS SYSTEM DISORDERS | Central nervous system toxicity | 15.4% (154/1001) |
Peripheral neuropathy | 0.4% (5/1317) | |
CARDIAC DISORDERS | Cardiotoxicity | 0.5% (7/1317) |
VASCULAR DISORDERS | Hypotention | 0.3% (4/1317) |
GASTROINTESTINAL DISORDERS | Nausea/Vomiting | 46.8% (443/964) |
Diarrhea | 0.7% (9/1317) | |
Stomatitis | 0.3% (4/1317) | |
HEPATOBILIARY DISORDERS | Hepatotoxicity | 1.8% (22/1190) |
SKIN AND SUBCUTANEOUS TISSUES DISORDERS | Alopecia | 89.6% (540/603) |
Dermatitis | 0.08% (1/1317) | |
Papular rash | 0.08% (1/1317) | |
RENAL AND URINARY DISORDERS | Hemorrhagic cystitis | -- |
Hematuria | ||
- without mesna | 44.1% (282/640) | |
- with mesna | 21.3% (33/155) | |
Macrohematuria | ||
- without mesna | 11.1% (66/594) | |
- with mesna | 5.2% (5/97) | |
Renal dysfunction | -- | |
Renal structural damage | -- | |
GENERAL DISORDERS AND ADMINISTRATIVE SITE CONDITIONS | Phlebitis | 2.8% (37/1317) |
Neutropenic fever | 1.0% (13/1317) | |
Fatigue | 0.3% (4/1317) | |
Malaise | Unable to calculate |
The following adverse reactions have been reported in the post-marketing experience, listed by MedDRA System Organ Class (SOC), then by Preferred Term in order of severity, where feasible. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
INFECTIONS AND INFESTATIONS:
The following manifestations have been associated with myelosuppression and immunosuppression caused by Ifex: increased risk for and severity of infections†, pneumonias†, sepsis and septic shock (including fatal outcomes), as well as reactivation of latent infections, including viral hepatitis†, Pneumocystis jiroveci†, herpes zoster, Strongyloides, progressive multifocal leukoencephalopathy†, and other viral and fungal infections.
† Severe immunosuppression has led to serious, sometimes fatal, infections.
NEOPLASMS, BENIGN AND MALIGNANT AND UNSPECIFIED (INCL CYSTS AND POLYPS):
As treatment-related secondary malignancy*, Acute leukemia* (Acute myeloid leukemia)*, Acute promyelocytic leukemia*, Acute lymphocytic leukemia*, Myelodysplastic syndrome, Lymphoma (Non-Hodgkin’s lymphoma), Sarcomas*, Renal cell carcinoma, Thyroid cancer
BLOOD AND LYMPHATIC SYSTEM DISORDERS:
Hematotoxicity*, Myelosuppression manifested as Bone marrow failure, Agranulocytosis; Febrile bone marrow aplasia; Disseminated intravascular coagulation, Hemolytic uremic syndrome, Hemolytic anemia, Neonatal anemia, Methemoglobinemia
IMMUNE SYSTEM DISORDERS:
Angioedema*, Anaphylactic reaction, Immunosuppression, Urticaria, Hypersensitivity reaction
ENDOCRINE DISORDERS:
Syndrome of inappropriate antidiuretic hormone secretion (SIADH)
METABOLISM AND NUTRITION DISORDERS:
Tumor lysis syndrome, Metabolic acidosis, Hypokalemia, Hypocalcemia, Hypophosphatemia, Hyperglycemia, Polydipsia
PSYCHIATRIC DISORDERS:
Panic attack, Catatonia, Mania, Paranoia, Delusion, Delirium, Bradyphrenia, Mutism, Mental status change, Echolalia, Logorrhea, Perseveration, Amnesia
NERVOUS SYSTEM DISORDERS:
Convulsion*, Status epilepticus (convulsive and nonconvulsive), reversible posterior leukoencephalopathy syndrome, Leukoencephalopathy, Extrapyramidal disorder, Asterixis, Movement disorder, Polyneuropathy, Dysesthesia, Hypothesia, Paresthesia, Neuralgia, Gait disturbance, Fecal incontinence, Dysarthria
EYE DISORDERS:
Visual impairment, Vision blurred, Conjunctivitis, Eye irritation
EAR AND LABYRINTH DISORDERS:
Deafness, Hypoacusis, Vertigo, Tinnitus
CARDIAC DISORDERS:
Cardiotoxicity*, Cardiac arrest*, Ventricular fibrillation*, Ventricular tachycardia*, Cardiogenic shock*, Myocardial infarction*, Cardiac failure*, Bundle branch block left, Bundle branch block right, Pericardial effusion, Myocardial hemorrhage, Angina pectoris, Left ventricular failure, Cardiomyopathy*, Congestive cardiomyopathy, Myocarditis*, Arrhythmia*, Pericarditis, Atrial fibrillation, Atrial flutter, Bradycardia, Supraventricular extrasystoles, Premature atrial contractions, Ventricular extrasystoles, Myocardial depression, Palpitations, Ejection fraction decreased*, Electrocardiogram ST-segment abnormal, Electrocardiogram T-wave inversion, Electrocardiogram QRS complex abnormal
VASCULAR DISORDERS:
Pulmonary embolism, Deep vein thrombosis, Capillary leak syndrome, Vasculitis, Hypertension, Flushing, Blood pressure decreased
RESPIRATORY, THORACIC, AND MEDIASTINAL DISORDERS:
Respiratory failure*, Acute respiratory distress syndrome*, Pulmonary hypertension*, Interstitial lung disease* as manifested by Pulmonary fibrosis*, Alveolitis allergic, Interstitial pneumonitis, Pneumonitis*, Pulmonary edema*, Pleural effusion, Bronchospasm, Dyspnea, Hypoxia, Cough
GASTROINTESTINAL DISORDERS:
Cecitis, Colitis, Enterocolitis, Pancreatitis, Ileus, Gastrointestinal hemorrhage, Mucosal ulceration, Constipation, Abdominal pain, Salivary hypersecretion
HEPATOBILIARY DISORDERS:
Hepatic failure*, Hepatitis fulminant*, Veno-occlusive liver disease, Portal vein thrombosis, Cytolytic hepatitis, Cholestasis
SKIN AND SUBCUTANEOUS TISSUE DISORDERS:
Toxic epidermal necrolysis, Stevens-Johnson syndrome, Palmar-plantar erythrodysesthesia syndrome, Radiation recall dermatitis, Skin necrosis, Facial swelling, Petechiae, Macular rash, Rash, Pruritus, Erythema, Skin hyperpigmentation, Hyperhidrosis, nail disorder
MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDER:
Rhabdomyolysis, Osteomalacia, Rickets, Growth retardation, Myalgia, Arthralgia, Pain in extremity, Muscle twitching
RENAL AND URINARY DISORDERS:
Fanconi syndrome, Tubulointerstitial nephritis, Nephrogenic diabetes insipidus, Phosphaturia, Aminoaciduria, Polyuria, Enuresis, Feeling of residual urine
Fatal outcomes from acute and chronic renal failure have been documented.
REPRODUCTIVE SYSTEM AND BREAST DISORDERS:
Infertility, Ovarian failure, Premature menopause, Amenorrhea, Ovarian disorder, Ovulation disorder, Azoospermia, Oligospermia, Impairment of spermatogenesis, Blood estrogen decreased, Blood gonadotrophin increased
CONGENITAL, FAMILIAL AND GENETIC DISORDERS:
Fetal growth retardation
GENERAL DISORDERS AND ADMINISTRATIVE SITE CONDITIONS:
Multi-organ failure*, General physical deterioration, Injection/Infusion site reactions including swelling, inflammation, pain, erythema, tenderness, pruritus; Chest pain, Edema, Mucosal inflammation, Pain, Pyrexia, Chills
* Including fatal outcomes
Ifex is a substrate for both CYP3A4 and CYP2B6.
CYP3A4 inducers (e.g., carbamazepine, phenytoin, fosphenytoin, phenobarbital, rifampin, St. John Wort) may increase the metabolism of Ifex to its active alkylating metabolites. CYP3A4 inducers may increase the formation of the neurotoxic/nephrotoxic Ifex metabolite, chloroacetaldehyde. Closely monitor patients taking Ifex with CYP3A4 inducers for toxicities and consider dose adjustment.
CYP3A4 inhibitors (e.g., ketoconazole, fluconazole, itraconazole, sorafenib, aprepitant, fosaprepitant, grapefruit, grapefruit juice) may decrease the metabolism of Ifex to its active alkylating metabolites, perhaps decreasing the effectiveness of Ifex treatment.
.
Ifex can cause fetal harm when administered 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 Ifex is capable of causing gene mutations and chromosomal damage in vivo. In pregnant mice, resorptions increased and anomalies were present at day 19 after a 30 mg/m2 dose of Ifex was administered on day 11 of gestation. Embryo-lethal effects were observed in rats following the administration of 54 mg/m2 doses of Ifex from the 6th through the 15th day of gestation and embryotoxic effects were apparent after dams received 18 mg/m2 doses over the same dosing period. Ifex is embryotoxic to rabbits receiving 88 mg/m2/day doses from the 6th through the 18th day after mating. 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 Ifex. Further, men should 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 this drug or after treatment, the patient should be apprised of the potential hazard to a fetus.
Ifex is excreted in breast milk. Because of the potential for serious adverse events and the tumorigenicity shown for Ifex in animal studies, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. Women must not breastfeed during treatment with Ifex.
Safety and effectiveness have not been established in pediatric patients.
In general, dose selection for an elderly patient should be cautious, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
A study of patients 40 to 71 years of age indicated that elimination half-life appears to increase with advancing age. This apparent increase in half-life appeared to be related to increases in volume of distribution of Ifex with age. No significant changes in total plasma clearance or renal or non-renal clearance with age were reported.
Ifex 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 renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.
No formal studies were conducted in patients with renal impairment. Ifex and its metabolites are known to be excreted by the kidneys and may accumulate in plasma with decreased renal function. Patients with renal impairment should be closely monitored for toxicity and dose reduction may be considered. Ifex and its metabolites are dialyzable.
No formal studies were conducted in patients with hepatic impairment. Ifex is extensively metabolized in the liver and forms both efficacious and toxic metabolites. Ifex should be given cautiously to patients with impaired hepatic function.
No specific antidote for Ifex 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.
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. Ifex as well as Ifex metabolites are dialyzable.
Cystitis prophylaxis with mesna may be helpful in preventing or limiting urotoxic effects with overdose.
Ifex (ifosfamide for injection, USP) single-dose vials for constitution and administration by intravenous infusion each contain 1 gram or 3 grams of sterile Ifex. Ifex is a chemotherapeutic agent chemically related to the nitrogen mustards and a synthetic analog of cyclophosphamide. Ifex 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. Ifex 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 Ifex alone.
Its structural formula is:
Ifex Container Label
NDC 0338-3991-01
Ifex
Ifex FOR INJECTION, USP
Rx only
1 g
SINGLE-DOSE VIAL
This vial contains 1g Ifex.
Add 20 mL Sterile Water for
Injection, USP, or Sterile
Bacteriostatic Water for Injection,
USP, (benzyl alcohol or parabens
preserved), shaking to dissolve,
for a reconstituted concentration
of 50 mg per mL.
Store at controlled room
temperature 20° C to 25° C
(68° F to 77° F)
Protect from temperatures
above 30° C (86° F).
FOR IV USE
READ ACCOMPANYING
PACKAGE INSERT for detailed
indications, dosage, and
precautions.
Manufactured by:
Baxter Healthcare Corporation
Deerfield, IL 60015 USA
USA 5561 0780 C 85
Bar Code
N(01)1 03 0338 3991 01 7
Lot:/Exp.:
Ifex Carton Label
1 vial
NDC 0338-3991-01
Ifex
(ifosfamide for injection, USP)
Single-Dose Vial
FOR IV USE
Rx only
1 g
Baxter Logo
Manufactured by
Baxter Healthcare Corporation
Deerfield, IL 60015 USA
See bottom panel for lot
number and expiration date.
Bar Code
N3 0338399101 0
This vial contains 1 g Ifex. Add
20 mL Sterile Water for Injection, USP,
or Sterile Bacteriostatic Water for
Injection, USP, (benzyl alcohol or
parabens preserved), shaking to
dissolve, for a reconstituted
concentration of 50 mg per mL.
READ ACCOMPANYING PACKAGE
INSERT for detailed indications,
dosage, and precautions.
Store at controlled room
temperature 20° C to 25° C
(68° F to 77° F). Protect from
temperatures above 30° C (86° F).
Constituted solutions should be
refrigerated and used within 24 hours.
Manufactured by:
Baxter Healthcare Corporation
Deerfield, IL 60015 USA
Made in Germany
NDC 0338-3993-01
Ifex
Ifex FOR INJECTION, USP
Rx only
3 g
SINGLE-DOSE VIAL
This vial contains 3g Ifex.
Add 60 mL Sterile Water for
Injection, USP, or Sterile
Bacteriostatic Water for Injection,
USP, (benzyl alcohol or parabens
preserved), shaking to dissolve,
for a reconstituted concentration
of 50 mg per mL.
Store at controlled room
temperature 20° C to 25° C
(68° F to 77° F)
Protect from temperatures
above 30° C (86° F).
FOR IV USE
READ ACCOMPANYING
PACKAGE INSERT for detailed
indications, dosage, and
precautions.
Manufactured by:
Baxter Healthcare Corporation
Deerfield, IL 60015 USA
USA 5561 0790 C 86
Bar Code
N(01)1 03 0338 3993 01 1
Lot:/Exp.:
JMXXX
MM.JJJJ
1 vial
NDC 0338-3993-01
Ifex
(ifosfamide for injection, USP)
Single-Dose Vial
FOR IV USE
Rx only
3 g
Baxter Logo
Manufactured by
Baxter Healthcare Corporation
Deerfield, IL 60015 USA
See bottom panel for lot
number and expiration date.
Bar Code
N3 0338399301 4
This vial contains 3 g Ifex.
Add 60 mL Sterile Water for Injection, USP,
or Sterile Bacteriostatic Water for
Injection, USP, (benzyl alcohol or
parabens preserved), shaking to
dissolve, for a reconstituted
concentration of 50 mg per mL.
READ ACCOMPANYING PACKAGE
INSERT for detailed indications,
dosage, and precautions.
Store at controlled room
temperature 20° C to 25° C
(68° F to 77° F). Protect from
temperatures above 30° C (86° F).
Constituted solutions should be
refrigerated and used within 24 hours.
Manufactured by:
Baxter Healthcare Corporation
Deerfield, IL 60015 USA
Made in Germany
Depending on the reaction of the Ifex after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Ifex not safe to drive or operate heavy machine after consumption. Meaning that, do not drive or operate heavy duty machines after taking the capsule if the capsule has a strange reaction on your body like dizziness, drowsiness. As prescribed by a pharmacist, it is dangerous to take alcohol while taking medicines as it exposed patients to drowsiness and health risk. Please take note of such effect most especially when taking Primosa capsule. It's advisable to consult your doctor on time for a proper recommendation and medical consultations.
Is Ifex addictive or habit forming?Medicines are not designed with the mind of creating an addiction or abuse on the health of the users. Addictive Medicine is categorically called Controlled substances by the government. For instance, Schedule H or X in India and schedule II-V in the US are controlled substances.
Please consult the medicine instruction manual on how to use and ensure it is not a controlled substance.In conclusion, self medication is a killer to your health. Consult your doctor for a proper prescription, recommendation, and guidiance.
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The information was verified by Dr. Rachana Salvi, MD Pharmacology