United States - English - NLM (National Library of Medicine)

hikma pharmaceuticals usa inc. - ifosfamide (unii: um20qqm95y) (ifosfamide - unii:um20qqm95y) - ifosfamide 50 mg in 1 ml - ifosfamide injection is indicated for use in combination with certain other approved antineoplastic agentsfor third-line chemotherapy of germ cell testicular cancer. it should be used in combination with mesna for prophylaxis of hemorrhagic cystitis. ifosfamide is contraindicated in patients with: • known hypersensitivity to administration of ifosfamide. • urinary outflow obstruction. ifosfamide 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 ifosfamide 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 ifosfamide was administered on day 11 of gestation. embryo-lethal effects were observed in rats following the administration of 54 mg/m2 doses of ifosfamide from the 6th through the 15th day of gestation

Belgium - English - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

baxter sa-nv - ifosfamide 500 mg - powder for solution for injection - 500 mg - ifosfamide 500 mg - ifosfamide

United States - English - NLM (National Library of Medicine)

baxter healthcare corporation - ifosfamide (unii: um20qqm95y) (ifosfamide - unii:um20qqm95y) - ifosfamide 1 g in 20 ml - 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 is contraindicated in patients with: ifosfamide for injection 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 ifosfamide 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 ifosfamide was administered on day 11 of gestation. embryo-lethal effects were observed in rats following the administration of 54 mg/m2 doses of ifosfamide 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. ifosfamide 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 ifosfamide. 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. ifosfamide is excreted in breast milk. because of the potential for serious adverse events and the tumorigenicity shown for ifosfamide 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 ifosfamide. 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 [see pharmacokinetics (12.3)]. this apparent increase in half-life appeared to be related to increases in volume of distribution of ifosfamide with age. no significant changes in total plasma clearance or 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 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. ifosfamide 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. ifosfamide and its metabolites are dialyzable. no formal studies were conducted in patients with hepatic impairment. ifosfamide is extensively metabolized in the liver and forms both efficacious and toxic metabolites. ifosfamide for injection should be given cautiously to patients with impaired hepatic function.

United States - English - NLM (National Library of Medicine)

fresenius kabi usa, llc - ifosfamide (unii: um20qqm95y) (ifosfamide - unii:um20qqm95y) - ifosfamide 1 g - 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 is contraindicated in patients with: - known hypersensitivity to administration of ifosfamide. - urinary outflow obstruction. pregnancy category d [see warnings and precautions (5.8)] . ifosfamide for injection 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 ifosfamide 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 ifosfamide was administered on day 11 of gestation.  embryo-lethal effects were observed in rats following t

United States - English - NLM (National Library of Medicine)

fresenius kabi usa, llc - ifosfamide (unii: um20qqm95y) (ifosfamide - unii:um20qqm95y) - ifosfamide 1 g - ifosfamide for injection, used in combination with certain other approved antineoplastic agents, is indicated for third line chemotherapy of germ cell testicular cancer.  it should ordinarily be used in combination with a prophylactic agent for hemorrhagic cystitis, such as mesna. continued use of ifosfamide for injection is contraindicated in patients with severely depressed bone marrow function (see warnings and precautions sections).  ifosfamide for injection is also contraindicated in patients who have demonstrated a previous hypersensitivity to it.

New Zealand - English - Medsafe (Medicines Safety Authority)

baxter healthcare ltd - ifosfamide 500mg - powder for injection - 500 mg - active: ifosfamide 500mg - bronchogenic carcinoma (including sclc and nsclc) testicular tumours of all histological variants soft tissue sarcomas (especially leiomyo-, rhabdomyo- and chondrosarcomas) osteosarcoma mammary carcinoma ovarian carcinoma endometrial carcinoma carcinoma of the uterine cervix hypernephroma pancreatic carcinoma malignant lymphomas

Malta - English - Medicines Authority

baxter healthcare limited - ifosfamide - powder for concentrate for solution for infusion - ifosfamide 2 g - antineoplastic agents

United States - English - NLM (National Library of Medicine)

app pharmaceuticals, llc - ifosfamide (unii: um20qqm95y) (ifosfamide - unii:um20qqm95y) - ifosfamide 50 mg in 1 ml

United States - English - NLM (National Library of Medicine)

mylan institutional llc - ifosfamide (unii: um20qqm95y) (ifosfamide - unii:um20qqm95y) - ifosfamide 50 mg in 1 ml

United States - English - NLM (National Library of Medicine)

pfizer laboratories div pfizer inc. - ifosfamide (unii: um20qqm95y) (ifosfamide - unii:um20qqm95y) - ifosfamide 50 mg in 1 ml