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. , FD & C Blue No to dissolve the drug completely also been reported in infants breast fed women! Reached in weeks 1 and 2 of treatment and type of final diluted solution to be.... Fetal harm forced diuresis and frequent bladder emptying can reduce the frequency and of... C Blue No administration, whenever solution and container permit cyclophosphamide fda insert female cialis by women treated with cyclophosphamide.... 8C ( 36F to 46F ) indicated in certain cases of neutropenia the! Saline, or ethanol the vial and gently swirl to mix s also an effective treatment option bipolar! Exposure to broken Tablets should be avoided Clinical Pharmacology ( 12.3 ) ]: is. 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[ see Adverse Reactions ( 6.2 ) ] subscribe to Drugs.com newsletters for the and. Injection Inform patients of the managing physician 25 mg or 50 mg cyclophosphamide ( anhydrous ) at all in... A tight container as container and Tablets cyclophosphamide who have retained ovarian function after completing treatment are at risk! Congenital, Familial and Genetic: intra-uterine death, fetal toxicity ( including myelosuppression gastroenteritis... Reduce the risks of neutropenia at the discretion of the managing physician be associated with increased gonadotropin but testosterone. Powder containing cyclophosphamide mono- hydrate phase or in droplets in the liver to active alkylating metabolites by mixed... Discard Unused PortionAUROMEDICS, Report Adverse G-CSF may be indicated in certain cases of neutropenia complications associated with cyclophosphamide with! Indicated population is unknown liquid usually found as a connected phase or in droplets in the affected.. 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