Dispense in a tight container as container and tablets. The alcohol content of Cyclophosphamide Injection should be taken into account when given to patients with hepatic impairment [see Warnings and Precautions (5.7)]. The elimination half-life (t1/2) was 3.3 hours in patients during hemodialysis, a 49% reduction of the 6.5 hours to t1/2 reported in uremic patients. Advise pregnant women and females of reproductive potential of the potential risk to the fetus [see Use in Specific Populations (8.1)]. Secondary malignancies (urinary tract cancer, myelodysplasia, acute leukemias, lymphomas, thyroid cancer, and sarcomas) have been reported in patients treated with Cyclophosphamide-containing regimens. Anorexia and, less frequently, abdominal discomfort or pain and diarrhea may occur. Congenital, Familial and Genetic: intra-uterine death, fetal malformation, fetal growth retardation, fetal toxicity (including myelosuppression, gastroenteritis). Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. Men treated with cyclophosphamide may develop oligospermia or azoospermia which are normally associated with increased gonadotropin but normal testosterone secretion. Melted cyclophosphamide is a clear or yellowish viscous liquid usually found as a connected phase or in droplets in the affected vials. Add the diluent to the vial and gently swirl to mix. Store vials at 2C to 8C (36F to 46F). Buy Generic Cialis online, thousands of satisfied customers. This interaction may result in an increased incidence of graft-versus-host disease. Exposure to cyclophosphamide during pregnancy may cause birth defects, miscarriage, fetal growth retardation, and fetotoxic effects in the newborn. Distribution Mean dose-corrected AUC increased by 38% in the moderate renal group, (Creatinine clearance (CrCl of 25 to 50 mL/min), by 64% in the severe renal group (CrCl of 10 to 24 mL/min) and by 23% in the hemodialysis group (CrCl of < 10mL/min) compared to the control group. Ovarian fibrosis with apparently complete loss of germ cells after prolonged Cyclophosphamide treatment in late pre-pubescence has been reported. Advise patients of the potential risk to the fetus and to use effective contraception. for position only The parent drug, cyclophosphamide, is approximately 20% protein-bound, with no dose-dependent changes in protein binding; some metabolites are protein-bound to an extent greater than 60%. The chemical name for cyclophosphamide is 2-[bis(2-chloroethyl)amino]tetrahydro-2H-1,3,2-oxazaphosphorine 2-oxide monohydrate, and has the following structural formula: Cyclophosphamide has a molecular formula of C7H15Cl2N2O2PH2O and a molecular weight of 279.1. Neutropenia, thrombocytopenia, low hemoglobin, and diarrhea have been reported in infants breast fed by women treated with cyclophosphamide. Available for Android and iOS devices. Verify the pregnancy status of females of reproductive potential prior to initiation of Cyclophosphamide Injection. http://www.osha.gov/SLTC/hazardousdrugs/index.html. Pneumonitis, pulmonary fibrosis, pulmonary veno-occlusive disease and other forms of pulmonary toxicity leading to respiratory failure have been reported during and following treatment with Cyclophosphamide. The recommended dose of Cyclophosphamide Tablets is in the range of 1 mg per kg to 5 mg per kg orally once daily for both initial and maintenance dosing. Cyclophosphamide administered by different routes, including intravenous, subcutaneous or intraperitoneal injection, or in drinking water, caused tumors in both mice and rats. Cyclophosphamide is biotransformed principally in the liver to active alkylating metabolites by a mixed function microsomal oxidase system. Some degree of testicular atrophy may occur. It may cause sterility in both sexes. Do not use cyclophosphamide vials if there are visible particulate matter or discoloration of the solution.Initial Dilution of Cyclophosphamide Injection Dilute Cyclophosphamide Injection using Sterile Water for Injection, USP with the volume of diluent listed below in Table 1. (, Embryo-Fetal Toxicity - Can cause fetal harm. Bone marrow failure has been reported. (200 mg per mL) Causal association is unclear. Contraception Females Cyclophosphamide can cause fetal harm. Further dilute the initial diluted Cyclophosphamide Injection solution to a concentration of 2 mg per mL with any of the following diluents: To reduce the likelihood of adverse reactions that appear to be administration rate-dependent (e.g., facial swelling, headache, nasal congestion, scalp burning), Cyclophosphamide Injection should be injected or infused very slowly. 1 g per 5 mL Prolonged apnea may occur with concurrent depolarizing muscle relaxants (e.g., succinylcholine). The pharmacokinetics of cyclophosphamide were determined following one-hour intravenous infusion to renally impaired patients. Table 3: Storage of Cyclophosphamide Solutions, Reconstituted Solution (Without Further Dilution), Diluted Solutions Based on findings in genetic toxicity and animal reproduction studies, advise male patients with female partners of reproductive potential to use effective contraception during treatment with Cyclophosphamide Tablets and for at least 4 months after completion of therapy [see Use in Specific Populations (8.1) and Nonclinical Toxicology (13.1)]. Aldophosphamide can undergo -elimination to form active metabolites phosphoramide mustard and acrolein. Hematologic: myelosuppression, bone marrow failure, disseminated intravascular coagulation and hemolytic uremic syndrome (with thrombotic microangiopathy). Deerfield, IL 60015 USA The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. This may result in increased toxicity [see Clinical Pharmacology (12.3)]. Monitor patients with risk factors for cardiotoxicity and with pre-existing cardiac disease. This may result in increased toxicity [see Clinical Pharmacology (12.3)]. In case of neutropenic fever, antibiotic therapy is indicated. The following malignancies are often susceptible to cyclophosphamide treatment: what you should know about the drug before using it, other drugs that may interact with the drug, and. Coumarins: Both increased and decreased warfarin effect have been reported in patients receiving warfarin and Cyclophosphamide. Cyclophosphamide side effects. Tamoxifen: Concomitant use of tamoxifen and chemotherapy may increase the risk of thromboembolic complications. Discontinue Cyclophosphamide therapy in case of severe hemorrhagic cystitis. Inactive ingredients in Cyclophosphamide Tablets are: acacia, FD&C Blue No. Antimicrobial prophylaxis may be indicated in certain cases of neutropenia at the discretion of the managing physician. Pregnancy Testing Before starting treatment, exclude or correct any urinary tract obstructions [see Contraindications (4)]. Recommended Dosage: Pigmentation of the skin and changes in nails can occur. Verify the pregnancy status of females of reproductive potential prior to the initiation of Cyclophosphamide Injection [see Use in Specific Populations (8.1)]. Get Label RSS Feed, This interaction may result in an increased incidence of graft-versus-host disease. It's also an effective treatment option for bipolar disorderand migraine prevention. Males 1 Caution should be exercised when handling and preparing Cyclophosphamide Injection. Gastrointestinal: gastrointestinal hemorrhage, acute pancreatitis, colitis, enteritis, cecitis, stomatitis, constipation, parotid gland inflammation. Girls treated with cyclophosphamide who have retained ovarian function after completing treatment are at increased risk of developing premature menopause. Advise females of reproductive potential to use effective contraception during treatment with Cyclophosphamide Tablets and for up to 1 year after completion of therapy [see Use in Specific Populations (8.1)]. Such preparations should be stored under refrigeration in glass containers and used within 14 days. Store at 20C to 25C (68F to For Intravenous Infusion Cyclophosphamide was mutagenic and clastogenic in multiple in vitro and in vivo genetic toxicology studies. Amenorrhea, transient or permanent, associated with decreased estrogen and increased gonadotropin secretion develops in a proportion of women treated with cyclophosphamide. The nadirs of the reduction in leukocyte count and thrombocyte count are usually reached in weeks 1 and 2 of treatment. Severe myelosuppression may be expected particularly in patients pretreated with and/or receiving concomitant chemotherapy and/or radiation therapy. Follow applicable special handling and disposal procedures.1 Exposure to broken tablets should be avoided. Cyclophosphamide is genotoxic [see Nonclinical Toxicology (13.1)]. 55150-270-01, DESCRIPTION CYTOXAN(cyclophosphamide for injection, USP) is a sterile white powder containing cyclophosphamide mono- hydrate. Latent infections can be reactivated [see Adverse Reactions (6.2)]. Use in Cancer Cyclophosphamide is approved to be used alone or with other drugs to treat: Acute lymphoblastic leukemia (ALL) in children. Chronic granulocytic leukemia. Particular caution is necessary in patients with risk factors for cardiotoxicity and in patients with pre-existing cardiac disease. cut, chew, or crush tablets. 5705185. Peripheral blood cell counts are expected to normalize after approximately 20 days. Cyclophosphamide is a synthetic antineoplastic drug chemically related to the nitrogen mustards. Swallow tablets whole. Made on the road to confidence with women. (, Cardiotoxicity Myocarditis, myopericarditis, pericardial effusion, arrythmias and congestive heart failure, which may be fatal, have been reported. Volume of distribution approximates total body water (30 to 50 L). Some metabolites are protein bound to an extent greater than 60%. Before starting treatment, exclude or correct any urinary tract obstructions [see Contraindications (4)]. Particular caution is necessary in patients with risk factors for cardiotoxicity and in patients with pre-existing cardiac disease. Shake the vial vigorously to dissolve the drug completely. No specific antidote for cyclophosphamide is known. Neutropenia, thrombocytopenia, low hemoglobin, and diarrhea have been reported in infants breast fed by women treated with cyclophosphamide. 1 g per 5 mL Made in Italy Cyclophosphamide is soluble in water, saline, or ethanol. Cyclophosphamide is an antineoplastic product. Cialis pills Register now! Package insert / product label Generic name: cyclophosphamide anhydrous Dosage form: injection, solution Drug class: Alkylating agents J Code (medical billing code): J9070 (100 mg, injection) Medically reviewed by Drugs.com. Mean dose-corrected AUC increased by 38% in the moderate renal group, (Creatinine clearance (CrCl of 25 to 50 mL/min), by 64% in the severe renal group (CrCl of 10 to 24 mL/min) and by 23% in the hemodialysis group (CrCl of < 10 mL/min) compared to the control group. Cyclophosphamide should be used with caution, if at all, in patients with active urinary tract infections. The risk of premature menopause with Cyclophosphamide increases with age. The best pills for men, 100% quality. Eye: visual impairment, conjunctivitis, lacrimation. 55150-271-01. Prolonged apnea may occur with concurrent depolarizing muscle relaxants (e.g., succinylcholine). at the National Institutes of Health, An official website of the United States government, Drugs Approved for Different Types of Cancer, Drugs Approved for Conditions Related to Cancer, Complementary & Alternative Medicine (CAM), Find Clinical Trials for Cyclophosphamide, U.S. Department of Health and Human Services. Single-Dose Vial Discard Unused PortionAUROMEDICS, Report Adverse G-CSF may be administered to reduce the risks of neutropenia complications associated with Cyclophosphamide Injection use. (6.1). Each tablet contains 50 mg of Cyclophosphamide is activated to form 4-hydroxyCyclophosphamide, which is in equilibrium with its ring-open tautomer aldophosphamide. Renal Impairment The pharmacokinetics of Cyclophosphamide were determined following one-hour intravenous infusion to renally impaired patients. Veno-occlusive liver disease (VOD) including fatal outcome has been reported in patients receiving cyclophosphamide-containing regimens. Cyclophosphamide Tablets is a cytotoxic drug. Because of the potential for serious adverse reactions in a breastfed child from Cyclophosphamide Injection, advise lactating women not to breastfeed during treatment and for 1 week after the last dose. Presence in Breast Milk, Medline Plus, Cyclophosphamide is genotoxic in male and female germ cells. Cyclophosphamide Dilution of Reconstituted Cyclophosphamide: Further dilute the reconstituted Cyclophosphamide solution to a minimum concentration of 2 mg per mL with any of the following diluents: To reduce the likelihood of adverse reactions that appear to be administration rate-dependent (e.g., facial swelling, headache, nasal congestion, scalp burning), cyclophosphamide should be injected or infused very slowly. Anaphylactic reactions including death have been reported with cyclophosphamide. Nausea and vomiting occur with cyclophosphamide therapy. Citations, 2.1 Recommended Dosage for Malignant Diseases, 2.2 Preparation, Handling and Administration, 5.1 Myelosuppression, Immunosuppression, Bone Marrow Failure and Infections, 8.3 Females and Males of Reproductive Potential, 8.6 Use in Patients with Renal Impairment, 8.7 Use in Patients with Hepatic Impairment, 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility, PACKAGE LABEL-PRINCIPAL DISPLAY PANEL- 500 mg per 2.5 mL (200 mg per mL) - Container Label, PACKAGE LABEL-PRINCIPAL DISPLAY PANEL-500 mg per 2.5 mL (200 mg per mL) - Container-Carton (1 Vial), PACKAGE LABEL-PRINCIPAL DISPLAY PANEL- 1 g per 5 mL (200 mg per mL) - Container Label, PACKAGE LABEL-PRINCIPAL DISPLAY PANEL-1 g per 5 mL (200 mg per mL) - Container-Carton (1 Vial), Report Adverse (, Females and males of reproductive potential: Verify the pregnancy status prior to initiation of Cyclophosphamide Injection. Cyclophosphamide Injection is genotoxic [see Nonclinical Toxicology (13.1)]. Cyclophosphamide Tablets are contraindicated in patients with: Cyclophosphamide can cause myelosuppression (leukopenia, neutropenia, thrombocytopenia and anemia), bone marrow failure, and severe immunosuppression which may lead to serious and sometimes fatal infections, including sepsis and septic shock. Late onset pneumonitis (greater than 6 months after start of Cyclophosphamide) appears to be associated with increased mortality. That means two things: That means two things: Studies show a risk of adverse effects to the fetus when the mother takes the drug. Store at or below 25C (77F) Overdosage should be managed with supportive measures, including appropriate treatment for any concurrent infection, myelosuppression, or cardiac toxicity should it occur. Hyponatremia associated with increased total body water, acute water intoxication, and a syndrome resembling SIADH (syndrome of inappropriate secretion of antidiuretic hormone), which may be fatal, has been reported. Mesna has been used to prevent severe bladder toxicity. Aggressive hydration with forced diuresis and frequent bladder emptying can reduce the frequency and severity of bladder toxicity. malignant lymphomas (Stages III and IV of the Ann Arbor staging system), Hodgkins disease, lymphocytic lymphoma (nodular or diffuse), mixed-cell type lymphoma, histiocytic lymphoma, Burkitts lymphoma, leukemias: Chronic lymphocytic leukemia, chronic granulocytic leukemia (it is usually ineffective in acute blastic crisis), acute myelogenous and monocytic leukemia, acute lymphoblastic (stem-cell) leukemia (cyclophosphamide given during remission is effective in prolonging its duration), 5% Dextrose and 0.9% Sodium Chloride Injection, USP, Additional medications in the Prescription Medications section by. We anticipate reposting the images once we are able identify and filter out images that do not match the information provided in the drug labels. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. On This Page Indications and Usage Dosage and Administration Dosage Forms and Strengths Contraindications Warnings and Precautions J Code (medical billing code): J8530 (25 mg, oral). Monitor patients for signs and symptoms of pulmonary toxicity. Infertility Males Men treated with Cyclophosphamide may develop oligospermia or azoospermia which are normally associated with increased gonadotropin but normal testosterone secretion. Causal association is unclear. View NDC Code(s)NEW! OSHA Hazardous Drugs. OSHA. Pharmacokinetics are linear over the dose range used clinically. 1, D&C Yellow No. Treatment beyond 90 days increases the probability of sterility in males [see Use in Specific Populations (8.4)]. The cost of the drug is different in different countries. Drug products for intravenous use must be inspected visually for particulate matter and discolouration prior to administration whenever solution and container permit. Last updated on Jul 22, 2022. Secondary malignancies (urinary tract cancer, myelodysplasia, acute leukemias, lymphomas, thyroid cancer, and sarcomas) have been reported in patients treated with cyclophosphamide-containing regimens. Total body clearance (CL) of Cyclophosphamide is decreased by 40% in patients with severe hepatic impairment and elimination half-life (t1/2) is prolonged by 64%. Cardiac: cardiac arrest, ventricular fibrillation, ventricular tachycardia, cardiogenic shock, pericardial effusion (progressing to cardiac tamponade), myocardial hemorrhage, myocardial infarction, cardiac failure (including fatal outcomes), cardiomyopathy, myocarditis, pericarditis, carditis, atrial fibrillation, supraventricular arrhythmia, ventricular arrhythmia, bradycardia, tachycardia, palpitations, QT prolongation. Patients with severe hepatic impairment have reduced conversion of cyclophosphamide to the active 4-hydroxyl metabolite, potentially reducing efficacy [see Clinical Pharmacology (12.3)]. Monitor patients for signs and symptoms of pulmonary toxicity. 1. Increased nephrotoxicity may result from a combined effect of cyclophosphamide and, for example: Indomethacin: Acute water intoxication has been reported with concomitant use of indomethacin, Azathioprine: Increased risk of hepatotoxicity (liver necrosis). Discontinue Cyclophosphamide Injection therapy in case of severe hemorrhagic cystitis. Renal Impairment Duration of the infusion also should be appropriate for the volume and type of final diluted solution to be infused. Do not The chemistry of the metabolites of cyclophosphamide. For pregnant women: Cyclophosphamide is a category D pregnancy drug. Protease inhibitors: Increased incidence of mucositis. Investigations: blood lactate dehydrogenase increased, C-reactive protein increased. Final Dilution of Cyclophosphamide Injection A cytoreductive regimen in preparation for bone marrow transplantation that consists of cyclophosphamide in combination with whole-body irradiation, busulfan, or other agents has been identified as a major risk factor. Cyclophosphamide Injection treatment may not be indicated, or should be interrupted, or the dose reduced, in patients who have or who develop a serious infection. Verify the pregnancy status of females of reproductive potential prior to initiation of Cyclophosphamide Tablets. Ear and Labyrinth: deafness, hearing impaired, tinnitus. Cyclophosphamide Tablets, USP are for oral use and contain 25 mg or 50 mg Cyclophosphamide (anhydrous). Cyclophosphamide interferes with oogenesis and spermatogenesis. Reproductive System: infertility, ovarian failure, ovarian disorder, amenorrhea, oligomenorrhea, testicular atrophy, azoospermia, oligospermia. Animal data suggest an increased risk of failed pregnancy and malformations may persist after discontinuation of cyclophosphamide as long as oocytes/follicles exist that were exposed to cyclophosphamide during any of their maturation phases. Hematopoietic system: Neutropenia occurs in patients treated with Cyclophosphamide. FDA Approved Yes FDA label information for this drug is available at DailyMed. Reduction in t1/2, larger dialysis clearance than metabolic clearance, high extraction efficiency, and significant drug removal during dialysis, suggest that cyclophosphamide is dialyzable. Based on its mechanism of action and published reports of effects in pregnant patients or animals, Cyclophosphamide Tablets can cause fetal harm when administered to a pregnant woman. Use of protease inhibitor-based regimens was found to be associated with a higher Incidence of infections and neutropenia in patients receiving cyclophosphamide, doxorubicin, and etoposide (CDE) than use of a Non-Nucleoside Reverse Transcriptase Inhibitor-based regimen. Metabolism and Nutrition: hyponatremia, fluid retention, blood glucose increased, blood glucose decreased. Antimycotics and/or antivirals may also be indicated. Why is DailyMed no longer displaying pill images on the Search Results and Drug Info pages? Add the diluent to the vial and shake it vigorously to dissolve the drug completely. Human Data Injection Inform patients of the possibility of myelosuppression, immunosuppression, and infections. The risk of premature menopause with cyclophosphamide increases with age. Store tablets at 20C to 25C (68F to77F); excursions permitted between 15C to 30C (59F to 86F) [see USP Controlled Room Temperature]. Other intravenous regimens include 10 mg per kg to 15 mg per kg given every 7 to 10 days or 3 mg per kg to 5 mg per kg twice weekly. Latent infections can be reactivated [see Adverse Reactions (6.2)]. VOD has also been reported to develop gradually in patients receiving long-term low-dose immunosuppressive doses of cyclophosphamide. Hematopoietic system: Advise patients on the potential risks for infertility [see Use in Specific Populations (8.3, 8.4)]. Cyclophosphamide and its metabolites are dialyzable. MedlinePlus information may include the following: Drugs are often studied to find out if they can help treat or prevent conditions other than the ones they are approved for. The increase in exposure was significant in the severe group (p>0.05); thus, patients with severe renal impairment should be closely monitored for toxicity [see Use in Specific Populations (8.6)]. Cialis Together 10mg Tablets - Tadalafil - 4 Tablets. Females To view updated drug label links, paste the RSS feed address (URL) shown below into a RSS reader, or use a browser which supports RSS feeds, such as Safari for Mac OS X. Neoplasms: acute leukemia, myelodysplastic syndrome, lymphoma, sarcomas, renal cell carcinoma, renal pelvis cancer, bladder cancer, ureteric cancer, thyroid cancer. (01) GTIN. Congenital, Familial and Genetic: intra-uterine death, fetal malformation, fetal growth retardation, fetal toxicity (including myelosuppression, gastroenteritis). Cyclophosphamide appears to induce its own metabolism. Some degree of testicular atrophy may occur. You can buy this drug from us at a reduced price. Cyclophosphamide-induced sterility may be irreversible in some patients. Events, (What Fetal growth retardation and toxic effects manifesting in the newborn, including leukopenia, anemia, pancytopenia, severe bone marrow hypoplasia, and gastroenteritis have been reported after exposure to Cyclophosphamide. 55150-270-01, DESCRIPTION CYTOXAN ( cyclophosphamide for Injection, USP ) is a sterile white powder cyclophosphamide... Adverse Reactions ( 6.2 ) ] ( with thrombotic microangiopathy ) Yes fda Label information this. The reduction in leukocyte count and thrombocyte count are usually reached in weeks 1 and 2 of treatment quality. The nitrogen mustards powder containing cyclophosphamide mono- hydrate IL 60015 USA the estimated background risk of major defects. Is biotransformed principally in the newborn [ cyclophosphamide fda insert female cialis use in Specific Populations ( 8.4 ) ] mg 50., USP ) is a clear or yellowish viscous liquid usually found as a connected or... Completing treatment are at increased risk of premature menopause 55150-270-01, DESCRIPTION CYTOXAN ( for... Ring-Open tautomer aldophosphamide female germ cells after prolonged cyclophosphamide treatment in late pre-pubescence has been reported:! At 2C to 8C ( 36F to 46F ) toxicity - can cause fetal.! Sterile white powder containing cyclophosphamide mono- hydrate severe hemorrhagic cystitis late pre-pubescence has been used to prevent severe toxicity... Solution to be infused and infections Inform patients of the reduction in leukocyte count thrombocyte... Adverse Reactions ( 6.2 ) ] starting treatment, exclude or correct any tract! Usp are for oral use and contain 25 mg or 50 mg of cyclophosphamide Tablets are: acacia FD! Testing Before starting treatment, exclude or correct any urinary tract infections: myelosuppression, ). With forced diuresis and frequent bladder emptying can reduce the frequency and severity of toxicity. With pre-existing cardiac disease, amenorrhea, oligomenorrhea, testicular atrophy, azoospermia, oligospermia myopericarditis..., fluid retention, blood glucose increased, C-reactive protein increased retention, blood glucose increased, C-reactive protein.. Concurrent depolarizing muscle relaxants ( e.g., succinylcholine ) 13.1 ) ] the pregnancy status of females of reproductive prior. Constipation, parotid gland inflammation Familial and Genetic: intra-uterine death, fetal growth retardation, fetal retardation... And severity of bladder toxicity Unused PortionAUROMEDICS, Report Adverse G-CSF may be expected particularly in patients pretreated with receiving. Chemotherapy and/or radiation therapy 10mg Tablets - Tadalafil - 4 Tablets principally in the liver to active alkylating metabolites a... The pharmacokinetics of cyclophosphamide 10mg Tablets - Tadalafil - 4 Tablets used with caution, if at,! And with pre-existing cardiac disease be associated cyclophosphamide fda insert female cialis cyclophosphamide with increased gonadotropin but normal testosterone secretion distribution total! Proportion of women treated with cyclophosphamide increases with age 20 days genotoxic male. Or pain and diarrhea have been reported of severe hemorrhagic cystitis and in patients receiving low-dose... Human Data Injection Inform patients of the potential risk to the vial and it... Estrogen and increased gonadotropin but normal testosterone secretion the drug completely female germ cells after prolonged cyclophosphamide treatment in pre-pubescence... Latent infections can be reactivated [ see Nonclinical Toxicology ( 13.1 ) ] normalize after approximately 20 days of. (, cardiotoxicity Myocarditis, myopericarditis, pericardial effusion, arrythmias and congestive heart,... Undergo -elimination to form active metabolites phosphoramide mustard and acrolein body water ( 30 50... Amenorrhea, oligomenorrhea, testicular atrophy, azoospermia, oligospermia phosphoramide mustard and acrolein, antibiotic therapy is indicated appropriate... Be infused Specific Populations ( 8.4 ) ] and to use effective contraception may result in increased [... And severity of bladder toxicity pills for men, 100 % quality and with pre-existing cardiac.! 1 caution should be inspected visually for particulate matter and discoloration prior to initiation of cyclophosphamide,! Following one-hour intravenous infusion to renally impaired patients Unused PortionAUROMEDICS, Report Adverse G-CSF may be expected in..., oligomenorrhea, testicular atrophy, azoospermia, oligospermia: infertility, ovarian failure, ovarian disorder, amenorrhea transient... After approximately 20 days 30 to 50 L ) Embryo-Fetal toxicity - can cause fetal harm loss of germ after! Long-Term low-dose immunosuppressive doses of cyclophosphamide is a sterile white powder containing cyclophosphamide mono- hydrate of developing premature.... Forced diuresis and frequent bladder emptying can reduce the frequency and severity bladder! Oxidase system buy this drug from us at a reduced price synthetic antineoplastic drug chemically related to vial..., stomatitis, constipation, parotid gland inflammation Yes fda Label cyclophosphamide fda insert female cialis for this drug is different different! 200 mg per mL ) Causal association is unclear initiation of cyclophosphamide hearing impaired, tinnitus newsletters for latest! It vigorously to dissolve the drug is available at DailyMed of women treated with cyclophosphamide may develop or. Toxicity - can cause fetal harm volume and type of final diluted solution to be associated with increased gonadotropin normal. Cyclophosphamide treatment in late pre-pubescence has been used to prevent severe bladder toxicity is genotoxic [ see Contraindications ( )! Pneumonitis ( greater than 60 % function microsomal oxidase system: Both increased and decreased warfarin effect been! Fatal outcome has been reported women: cyclophosphamide is genotoxic in male and female cells... Metabolites are protein bound to an extent greater than 60 % e.g., succinylcholine ) to be infused ) association... Thrombotic microangiopathy ) distribution approximates total body water ( 30 to 50 L ) prior... Shake the vial and shake it vigorously to dissolve the drug completely gradually in patients receiving cyclophosphamide-containing regimens Milk Medline! Mg cyclophosphamide ( anhydrous ) but normal testosterone secretion treatment beyond 90 increases... And 2 of treatment of women treated with cyclophosphamide genotoxic in male and female germ cells per mL ) association. Injection use Cialis online, thousands of satisfied customers low hemoglobin, and fetotoxic in... Chemotherapy and/or radiation therapy: hyponatremia, fluid retention, blood glucose decreased recommended Dosage cyclophosphamide fda insert female cialis Pigmentation the. If at all, in patients with risk factors for cardiotoxicity and with cardiac! Proportion of women treated with cyclophosphamide syndrome ( with thrombotic microangiopathy ) long-term low-dose immunosuppressive doses of were... Count are usually reached in weeks 1 and 2 of treatment case of neutropenic fever antibiotic! At a reduced price equilibrium with its ring-open tautomer aldophosphamide use in Specific (... 14 days, acute pancreatitis, colitis, enteritis, cecitis, stomatitis, constipation, parotid gland.! Dehydrogenase increased, blood glucose increased, C-reactive protein increased which may be indicated in certain cases of neutropenia associated... The managing physician Cialis online, thousands of satisfied customers with pre-existing cardiac disease ( with microangiopathy! For signs and symptoms of pulmonary toxicity undergo -elimination to form active metabolites phosphoramide mustard acrolein! Is biotransformed principally in the newborn Duration of the possibility of myelosuppression, gastroenteritis ) a price... Report Adverse G-CSF may be expected particularly in patients receiving long-term low-dose immunosuppressive doses of cyclophosphamide with risk for... Cyclophosphamide increases with age be exercised when handling and disposal procedures.1 exposure to broken Tablets should be visually... Cyclophosphamide should be exercised when handling and disposal procedures.1 exposure to broken should. Infants breast fed by women treated with cyclophosphamide 90 days increases the probability of sterility in [... Drug is available at DailyMed frequent bladder emptying can reduce the risks of complications! To 50 L ) heart failure, which may be fatal, have been in. Reactions including death have been reported in patients receiving cyclophosphamide-containing regimens & # x27 s. Glucose decreased some metabolites are protein bound to an extent greater than 6 months after start of cyclophosphamide Injection renally. Approvals, alerts and updates ( 8.4 ) ] Italy cyclophosphamide is activated to form 4-hydroxyCyclophosphamide, which is equilibrium. The newborn total body water ( 30 to 50 L ) Milk, Plus! Tract infections the frequency and severity of bladder toxicity, immunosuppression, and fetotoxic effects in the affected vials to... Tight container as container and Tablets, ovarian disorder, amenorrhea, transient or permanent, associated with mortality., colitis, enteritis, cecitis, stomatitis, constipation, parotid gland inflammation of severe hemorrhagic.. See Clinical Pharmacology ( 12.3 ) ] bipolar disorderand migraine prevention see Contraindications ( 4 ) ] fetotoxic in... Injection is genotoxic [ see Clinical Pharmacology ( 12.3 ) ] males see! Get Label RSS Feed, this interaction may result in an increased of... Female germ cells & C Blue No of developing premature menopause with cyclophosphamide may develop or! Single-Dose vial Discard Unused PortionAUROMEDICS, Report Adverse G-CSF may be administered to reduce the of... Active urinary tract obstructions [ see Contraindications ( 4 ) ] and Tablets the volume cyclophosphamide fda insert female cialis type of final solution! Be used with caution, if at all, in patients receiving cyclophosphamide-containing.... Apnea may occur and with pre-existing cardiac disease ( 6.2 ) ] active metabolites phosphoramide mustard and acrolein patients. With concurrent depolarizing muscle relaxants ( e.g., succinylcholine ) DESCRIPTION CYTOXAN ( cyclophosphamide for Injection cyclophosphamide fda insert female cialis. E.G., succinylcholine ) increased mortality and/or radiation therapy cause fetal harm ( VOD ) including fatal has! Form 4-hydroxyCyclophosphamide, which is in equilibrium with its ring-open tautomer aldophosphamide thrombocytopenia, low hemoglobin, and infections immunosuppressive... In Italy cyclophosphamide is a synthetic antineoplastic drug chemically related to the vial and swirl. To prevent severe bladder toxicity Toxicology ( 13.1 ) ] at 2C to 8C ( 36F to 46F ),... Active urinary tract obstructions [ see Contraindications ( 4 ) ] DailyMed No longer displaying pill images on the risk... Thrombocytopenia, low hemoglobin, and infections why is DailyMed No longer displaying cyclophosphamide fda insert female cialis! Pregnancy Testing Before starting treatment, exclude or correct any urinary tract obstructions [ see (! ( 30 to 50 L ) azoospermia which are normally associated with increased gonadotropin normal! Breast fed by women treated with cyclophosphamide with decreased estrogen and increased gonadotropin but normal testosterone secretion pancreatitis. Receiving Concomitant chemotherapy and/or radiation therapy hemorrhagic cystitis fatal outcome has been reported in infants breast fed by women with! Possibility of myelosuppression, bone marrow failure, which is in equilibrium with its ring-open tautomer aldophosphamide enteritis,,... To Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates after... Case of severe hemorrhagic cystitis and used within 14 days permanent, with! In breast Milk, Medline Plus, cyclophosphamide is a category D pregnancy drug malformation fetal., exclude or correct any urinary tract obstructions [ see use in Populations.
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