GS1-2D Exposure to Cyclophosphamide during pregnancy may cause birth defects, miscarriage, fetal growth retardation, and fetotoxic effects in the newborn. 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. Possible cross-sensitivity with other alkylating agents can occur. Patients with severe hepatic impairment have reduced conversion of cyclophosphamide to the active 4-hydroxyl metabolite, potentially reducing efficacy [see Clinical Pharmacology (12.3)]. Cyclophosphamide is a pro-drug that is activated by cytochrome P450s [see Clinical Pharmacology (12.3)]. Tadalafil belongs to a group of medicines called phosphodiesterase 5 (PDE5) inhibitors. Urinary sediment should be checked regularly for the presence of erythrocytes and other signs of urotoxicity and/or nephrotoxicity. The dialyzability of cyclophosphamide was investigated in four patients on long-term hemodialysis. Advise female patients of reproductive potential to avoid pregnancy. All Rights Reserved. Important: The drug information on this page is meant to be educational. Metronidazole: Acute encephalopathy has been reported in a patient receiving cyclophosphamide and metronidazole. 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. View NDC Code(s)NEW! In patients with severe renal impairment, decreased renal excretion may result in increased plasma levels of Cyclophosphamide and its metabolites. Depolarizing muscle relaxants: Cyclophosphamide treatment causes a marked and persistent inhibition of cholinesterase activity. Myocarditis, myopericarditis, pericardial effusion including cardiac tamponade, and congestive heart failure, which may be fatal, have been reported with Cyclophosphamide therapy. Antimycotics and/or antivirals may also be indicated. There is insufficient data from clinical studies of cyclophosphamide available for patients 65 years of age and older to determine whether they respond differently than younger patients. Pigmentation of the skin and changes in nails can occur. General Disorders and Administrative Site Conditions: We comply with the HONcode standard for trustworthy health information. Cyclophosphamide This may result in increased toxicity [see Clinical Pharmacology (12.3)]. (, Urinary Tract and Renal Toxicity Hemorrhagic cystitis, pyelitis, ureteritis, and hematuria can occur. Cyclophosphamide Tablets, USP are for oral use and contain 25 mg or 50 mg Cyclophosphamide (anhydrous). The alcohol content of Cyclophosphamide Injection should be taken into account when given to patients with hepatic impairment [see Warnings and Precautions (5.7)]. Skin rash occurs occasionally in patients receiving the drug. Cyclophosphamide should not be administered to patients with neutrophils 1,500/mm3 and platelets < 50,000/mm3. Medical and/or surgical supportive treatment may be required to treat protracted cases of severe hemorrhagic cystitis. Multiple Myelomas (Myeloma stages II, IIIA, IIIB) (See also DOSAGE AND ADMINISTRATION) 3. Dispense in a tight container This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional. Male mice and rats treated with Cyclophosphamide show alterations in male reproductive organs (e.g., decreased weights, atrophy, changes in spermatogenesis), and decreases in reproductive potential (e.g., decreased implantations and increased post-implantation loss) and increases in fetal malformations when mated with untreated females [see Use in Specific Populations (8.3)]. Cyclophosphamide is ahazardous drug. Hematologic: myelosuppression, bone marrow failure, disseminated intravascular coagulation and hemolytic uremic syndrome (with thrombotic microangiopathy). 55150-271-01. Mesna has been used to prevent severe bladder toxicity. Such preparations should be stored under refrigeration in glass containers and used within 14 days. HAZARDOUS AGENT Do not 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. Auto-induction results in an increase in the total clearance, increased formation of 4-hydroxyl metabolites and shortened t1/2 values following repeated administration at 12- to 24-hour interval. Final Dilution of Cyclophosphamide Injection For Intravenous Infusion Consideration should be given to the alcohol content in Cyclophosphamide Injection on the ability to drive or use machines immediately after the infusion. Each tablet contains 50 mg Skin and its structures: 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. Each tablet contains 50 mg of Advise females of reproductive potential to use effective contraception during treatment with Cyclophosphamide Injection and for up to 1 year after completion of therapy. The following adverse reactions have been identified from clinical trials or post-marketing surveillance. Store at or below 25C (77F) Aldophosphamide can undergo -elimination to form active metabolites phosphoramide mustard and acrolein. Elimination After Dilution Girls treated with Cyclophosphamide who have retained ovarian function after completing treatment are at increased risk of developing premature menopause. Storage of Initial and Final Diluted Cyclophosphamide Injection Solutions The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. Advise male patients with female partners of reproductive potential to use effective contraception during treatment with Cyclophosphamide Tablets and for 4 months after completion of therapy [see Use in Specific Populations (8.1, 8.3)]. After oral administration, peak concentrations of Cyclophosphamide occurred at one hour. Copy the URL below and paste it into your RSS Reader application. Advise pregnant women and females of reproductive potential of the potential risk to the fetus [see Use in Specific Populations (8.1)]. . Write a review. Chronic granulocytic leukemia. Table 2: Reconstitution in preparation for Intravenous Infusion. Neoplasms: acute leukemia, myelodysplastic syndrome, lymphoma, sarcomas, renal cell carcinoma, renal pelvis cancer, bladder cancer, ureteric cancer, thyroid cancer. Baxter Healthcare Corporation 17.11 Immunizations *Sections or subsections omitted from the full prescribing information are not listed . Respiratory: pulmonary veno-occlusive disease, acute respiratory distress syndrome, interstitial lung disease as manifested by respiratory failure (including fatal outcomes), obliterative bronchiolitis, organizing pneumonia, alveolitis allergic, pneumonitis, pulmonary hemorrhage; respiratory distress, pulmonary hypertension, pulmonary edema, pleural effusion, bronchospasm, dyspnea, hypoxia, cough, nasal congestion, nasal discomfort, oropharyngeal pain, rhinorrhea. OSHA. Cyclophosphamide is a pro-drug that is activated by cytochrome P450s [see CLINICAL PHARMACOLOGY]. When cyclophosphamide was administered at 4 g/m2 over a 90 minutes infusion, saturable elimination in parallel with first-order renal elimination describe the kinetics of the drug. Advise pregnant women and females of reproductive potential of the potential risk to the fetus. Anorexia and, less frequently, abdominal discomfort or pain and diarrhea may occur. When cyclophosphamide is included in combined cytotoxic regimens, it may be necessary to reduce the dose of Cyclophosphamide Injection as well as that of the other drugs. Overdosage should be managed with supportive measures, including appropriate treatment for any concurrent infection, myelosuppression, or cardiac toxicity should it occur. Risk Summary 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 [see Clinical Pharmacology (12.1) and Nonclinical Toxicology (13.1)]. Last updated on Jul 22, 2022. Events, 77) [see USP Controlled Room Renal and Urinary: renal failure, renal tubular disorder, renal impairment, nephropathy toxic, hemorrhagic cystitis, bladder necrosis, cystitis ulcerative, bladder contracture, hematuria, nephrogenic diabetes insipidus, atypical urinary bladder epithelial cells. 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 Immune: immunosuppression, anaphylactic shock and hypersensitivity reaction. Eye: visual impairment, conjunctivitis, lacrimation. 279 Princeton-Hightstown Rd.E. 1 g per 5 mL Serious consequences of overdosage include manifestations of dose dependent toxicities such as myelosuppression, urotoxicity, cardiotoxicity (including cardiac failure), veno-occlusive hepatic disease, and stomatitis [see Warnings and Precautions (5.1, 5.2, 5.3, and 5.6)]. VOD has also been reported to develop gradually in patients receiving long-term low-dose immunosuppressive doses of Cyclophosphamide. 1 g per 5 mL vial contains 1 gram anhydrous cyclophosphamide (equivalent to 1.07 g cyclophosphamide monohydrate) and 20 mg citric acid dissolved in dehydrated alcohol (3.38 grams). Skin rash occurs occasionally in patients receiving the drug. When used as the only oncolytic drug therapy, the initial course of Cyclophosphamide Injection for patients with no hematologic deficiency usually consists of 40 mg per kg to 50 mg per kg given intravenously in divided doses over a period of 2 to 5 days. Medchal-Malkajgiri District - 500101India, Rx only NDC 55150-270-01 of Cyclophosphamide, USP. Affected patients generally resume regular menses within a few months after cessation of therapy. Dosage form: tablet Pregnancy Testing In patients requiring dialysis, use of a consistent interval between cyclophosphamide administration and dialysis should be considered. Table 1: Reconstitution for Direct Intravenous Injection. Drug Label Information Updated March 15, 2017 If you are a consumer or patient please visit this version. 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. However, much of the information may also apply to unapproved uses that are being studied. Hepatic: veno-occlusive liver disease, cholestatic hepatitis, cytolytic hepatitis, hepatitis, cholestasis; hepatotoxicity with hepatic failure, hepatic encephalopathy, ascites, hepatomegaly, blood bilirubin increased, hepatic function abnormal, hepatic enzymes increased. Save 2.20. Data Human Data Malformations of the skeleton, palate, limbs and eyes as well as miscarriage have been reported after exposure to Cyclophosphamide in the first trimester. Increased cardiotoxicity may result from a combined effect of cyclophosphamide and, for example: Increased pulmonary toxicity may result from a combined effect of cyclophosphamide and, for example: G-CSF, GM-CSF (granulocyte colony-stimulating factor, granulocyte macrophage colony- stimulating factor): Reports suggest an increased risk of pulmonary toxicity in patients treated with cytotoxic chemotherapy that includes cyclophosphamide and G-CSF or GMCSF. The liver is the major site of Cyclophosphamide activation. Urinary sediment should be checked regularly for the presence of erythrocytes and other signs of urotoxicity and/or nephrotoxicity. Females Hematologic: myelosuppression, bone marrow failure, disseminated intravascular coagulation and hemolytic uremic syndrome (with thrombotic microangiopathy). 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. (, Females and males of reproductive potential: Verify the pregnancy status prior to initiation of Cyclophosphamide Injection. Contraception Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Infertility Psychiatric: confusional state. Malformations of the skeleton, palate, limbs and eyes as well as miscarriage have been reported after exposure to cyclophosphamide in the first trimester. Investigations: blood lactate dehydrogenase increased, C-reactive protein increased. The exact duration of follicular development in humans is not known but may be longer than 12 months [see Nonclinical Toxicology (13.1)]. Monitoring of complete blood counts is essential during Cyclophosphamide Injection treatment so that the dose can be adjusted, if needed. No specific antidote for Cyclophosphamide is known. Cyclophosphamide Tablets should be swallowed whole. The following adverse reactions are discussed in more detail in other sections of the labeling. Initial Dilution of Cyclophosphamide Injection, Table 1: Initial Dilution in Preparation for Intravenous Infusion, Final Dilution of Cyclophosphamide Injection, Storage of Initial and Final Diluted Cyclophosphamide Injection Solutions, Table 2: Storage of Diluted Cyclophosphamide Injection Solutions, Final Diluted Solution for Intravenous Infusion, AuroMedics Pharma LLC product information by RSS, * Volume of diluent has been adjusted for vial overfill, 5% Dextrose and 0.9% Sodium Chloride Injection, USP, 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), Additional medications in the Prescription Medications section by. Storage of Reconstituted and Diluted Cyclophosphamide Solution: If not used immediately, for microbiological integrity, cyclophosphamide solutions should be stored as described in Table 3. But Depakote also has a lot of drug interactionsto consider when you're taking it. Tumor lysis syndrome: like other cytotoxic drugs, cyclophosphamide may induce tumor-lysis syndrome and hyperuricemia in patients with rapidly growing tumors. Patients who received an overdose should be closely monitored for the development of toxicities, and hematologic toxicity in particular. Cyclophosphamide and its metabolites are dialyzable. Recommended Dosage 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%. Oligomenorrhea has also been reported in association with Cyclophosphamide treatment. Helps you get and maintain an erection when you need it. Tamoxifen: Concomitant use of tamoxifen and chemotherapy may increase the risk of thromboembolic complications. The volume of distribution approximates total body water (30 to 50 liters). Some metabolites are protein bound to an extent greater than 60%. At high doses, the fraction of parent compound cleared by 4-hydroxylation is reduced resulting in non-linear elimination of cyclophosphamide in patients. Mean CL and t1/2were 45 8.6 L/kg and 12.5 1.0 hours respectively, in patients with severe hepatic impairment and 63 7.6 L/kg and 7.6 1.4 hours respectively in the control group [see Use in Specific Populations (8.7)]. Cyclophosphamide Injection should be used with caution, if at all, in patients with active urinary tract infections. 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. Follow applicable special handling and disposal procedures.1 Exposure to broken tablets should be avoided. Girls treated with cyclophosphamide who have retained ovarian function after completing treatment are at increased risk of developing premature menopause. Reader cyclophosphamide fda insert female cialis visually for particulate matter and discoloration prior to initiation of Cyclophosphamide, USP patients receiving long-term immunosuppressive. < 50,000/mm3 much of the potential risk to the fetus of erythrocytes and other signs of urotoxicity and/or nephrotoxicity,... ( Myeloma stages II, IIIA, IIIB ) ( see also DOSAGE and )! 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