Cyclophosphamide does not contain any antimicrobial preservative and thus care must be taken to assure the sterility of. Cyclophosphamide monohydrate c7397 product information sheet. Highlights of prescribing information these highlights do not include all the information needed to use rydapt safely and effectively. Cyclophosphamide is a known teratogen with significant limb abnormalities and cognitive impairment resulting from firsttrimester exposure. Cyclophosphamide does not contain any antimicrobial preservative and thus care must be taken to assure the sterility of prepared solutions. Contraindications known hypersensitivity to the active substance. Cyclophosphamide is indicated for the treatment of biopsy proven minimal change nephrotic syndrome in. Although the protocol allowed further therapy, only 15% received both drugs for 9 or more courses.
When protected from light and stored at 5 c the loss was 0. Cyclophosphamide tablets, usp are for oral use and contain 25 mg or 50 mg cyclophosphamide anhydrous. A guide to the dosage regimens used for most indications is given below. A pharmacy bulk package is a container of a sterile preparation for parenteral use that contains many single doses. A cyclophosphamide dose reduction or omission may be required if leukopenic iii. Your doctor will check that the number of red blood cells, white blood cells and platelets is high enough before and during your treatment with cyclophosphamide. Cyclophosphamide interferes with oogenesis and spermatogenesis. Tap along the timeline to move to different parts of the audio file. Cyclophosphamide is a prescription medicine that is licensed to treat certain kidney problems in children and various types of cancer. Dosage may be reduced, delayed or discontinued in patients with bone.
Dose of cyclophosphamide may need to be adjusted according to renal function decline or recovery. Package insert thiotepa for injection, usp description thiotepa for injection is an ethyleniminetype compound. Daratumumab, bortezomib, cyclophosphamide and dexamethasone in newly diagnosed and relapsed multiple myeloma. The recommended dosage and schedule in combination with fludarabine and cyclophosphamide is. Cytarabine injection, an antineoplastic, is a sterile solution of cytarabine for intravenous and subcutaneous use which contains no preservative and is available in 20 mgml mg50 ml pharmacy bulk package. The unchanged drug has an elimination halflife of 3 to 12 hours. When given with kisqali, refer to the full prescribing information for the recommended dose of the aromatase inhibitor being used. Cyclophosphamide induced sterility may be irreversible in some patients. Cyclophosphamide also works by decreasing your immune systems. Intravenous cyclophosphamide for renal patients protocol. The chemical name for cyclophosphamide is 2 h1,3,2oxazaphosphorin2amine, n,nbis2chloroethyltetrahydro, 2oxide, monohydrate. During or immediately after the administration, adequate amounts of fluid should be ingested or infused to force diuresis to reduce the risk of urinary tract.
Cyclophosphamide is well absorbed after oral administration with a bioavailability greater than 75%. These highlights do not include all the information needed to use advate safely and effectively. Each capsule for oral administration contains 25 mg or 50 mg cyclophosphamide anhydrous, usp and the following inactive ingredients. Hepatotoxicity see full prescribing information for complete boxed warning. Cyclophosphamide is a synthetic antineoplastic drug chemically related to the nitrogen mustards. Information for the patient mock up cyclophosphamide 50 mg tablets by caroline mcdermott at this product is available as the above name but will be referred to as cyclophosphamide throughout the following leaflet. Cyclophosphamide can be recommended for use in treatment of. Administer a lymphodepleting regimen of cyclophosphamide and fludarabine before infusion of yescarta 2. Apr 08, 2019 belimumab package insert pdf belimumab has been studied in a limited number of sle patients with renal syringe are provided at the end of the package leaflet see stepbystep.
Ifosfamide is a white crystalline powder that is soluble in water. Dailymed cyclophosphamide injection, powder, for solution. Farber cancer institute last revised 22018 patient and family education committee 4. Oct 08, 2019 cyclophosphamide interferes with oogenesis and spermatogenesis. Cytoxan tablets cyclophosphamide tablets, usp are for oral use and contain 25 mg or 50 mg cyclophosphamide anhydrous. Highlights of prescribing information these highlights do not include all the information needed to use herceptin hylecta safely and effectively. Rituxan rituximab is indicated, in combination with fludarabine and cyclophosphamide fc, for the treatment of patients with previously untreated and previously treated cd20positive cll. Cyclophosphamide fda prescribing information, side effects. Cyclophosphamide is one of a number of medications first developed as a chemotherapy drug a medication used in the treatment of cancer. Read all of this leaflet carefully before you start taking this medicine because it contains important information. Cytoxan cyclophosphamide for injection, usp cytoxan tablets. Lyophilized cytoxan cyclophosphamide for injection, usp. It is also used to treat nephrotic syndrome in children. Desferal is contraindicated in patients with severe renal disease or anuria, since the drug and the iron.
Cytoxan cyclophosphamide for injection, usp cytoxan tablets cyclophosphamide tablets, usp description cytoxan cyclophosphamide for injection, usp is a sterile white powder containing cyclophosphamide mono hydrate. Cyclophosphamide is used to treat various types of cancer. Cyclophosphamide is an alkylating drug indicated for treatment of. Sandoz is launching cyclophosphamide injection, usp, through collaboration with jiangsu hengrui medicine co. The molecular formula is c7h15cl2n2o2p and its molecular weight is 261.
It is supplied as a nonpyrogenic, sterile lyophilized powder for intravenous, intracavitary or intravesical administration, containing 15 mg and 30 mg of thiotepa. Cyclophosphamide for injection, usp is a sterile white cake available as 500 mg, 1 g, and 2 g strength vials. Cytoxan tablets cyclophosphamide tablets, usp are for oral use and contain 25 mg or 50 mg cyclophosphamide. Multiple myelomas myeloma stages ii, iiia, iiib see also dosage and administration 3. Caution should be used when treating patients with cyclophosphamide who have preexisting heart disease. Multiple myelomas myeloma stages ii, iiia, iiib see also dosage and. Drug name mechanism of action and pharmacokinetics indications and status adverse effects dosing. Nail changes can occur such as dark lines or changes in color. Cyclophosphamide is soluble in water, saline and ethanol. Medscape prescription drug monographs are based on fdaapproved labeling.
Sep 17, 2019 cyclophosphamide has a molecular formula c 7 h 15 cl 2 n 2 o 2 p h 2 o and a molecular weight of 279. A few of the types of cancer that it may be used to treat include leukemia, ovarian cancer, and lymphomas. Its prescribed for nonhodgkin lymphoma, hodgkin lymphoma, multiple. Cyclophosphamide is used alone or in combination with other medications to treat hodgkins lymphoma hodgkins disease and nonhodgkins lymphoma types of cancer that begin in a type of white blood cells that normally fights infection. Cyclophosphamide for injection, usp ndc 1001995501 500 mg vial, carton of 1 ndc 1001995601. This medicine is used to treat many types of cancer like lymphoma, myeloma, leukemia, breast cancer, and ovarian cancer, to name a few. Cyclophosphamide, although effective alone in susceptible malignancies, is more frequently used concurrently or sequentially with other antineoplastic drugs. Ifosfamide is 32chloroethyl22chloroethyl aminotetrahydro2h1,3,2oxazaphosphorine 2oxide.
Highlights of prescribing information these highlights do not. Herceptin hylecta trastuzumab and hyaluronidaseoysk injection, for subcutaneous use initial u. In a study conducted by the gynecological oncology group gog, 410 patients with stage iii or iv disease 1 cm residual disease after staging. Anthracyclines including doxorubicin should not be administered in combination with other cardiotoxic agents unless the patients cardiac function is closely monitored. Get a printable copy pdf file of the complete article 251k, or click on a page image below to browse page by page. Cyclophosphamide comes as a tablet to take by mouth once a day. Commence infusion in the morning, so that frequent voiding occurs and cyclophosphamide metabolites do not rest in the bladder for prolonged periods. Development of sterility appears to depend on the dose of cyclophosphamide, duration of therapy, and the state of gonadal function at the time of treatment. Cyclophosphamide has a molecular formula of c 7 h 15 cl 2 n 2 o 2 ph 2 o and a molecular weight of 279. Cyclophosphamide is also being studied in the treatment of other types of cancer.
There is positive evidence of human fetal risk, but the benefits from use. Take cyclophosphamide at around the same time every day. See actual entry in rtecs for complete information. Based on mechanism of action and published reports of effects in pregnant patients or animals, drug can cause fetal harm when. Follow the directions on your prescription label carefully, and ask your. Dec 14, 2016 cyclophosphamide tablets are for oral use. See full prescribing information for herceptin hylecta. Easy to read fda package insert, drug facts, dosage and administration, and adverse effects for cytoxan cyclophosphamide.
Leukemias see also dosage and administration a chronic lymphocytic leukemia cll rai stages ii, iii, iv binet stages b, cnote. Sections or subsections omitted from the full prescribing information. Thiotepa is a synthetic product with antitumor activity. Cyclophosphamide for injection, usp is a sterile white powder containing cyclophosphamide and is supplied in vials for single dose use. Learn about benlysta belimumab, an fdaapproved prescription infusion or selfinjectable lupus medication to help treat your request your free info kit.
Cyclophosphamide is commonly used with doxorubicin hydroxydaunorubicin, vincristine oncovin, and prednisone known as the chop regimen, with or without other agents, in the treatment of various types of intermediategrade nonhodgkin lymphoma. The contents are intended for use in a pharmacy admixture program and are restricted to the preparation of admixtures for intravenous infusion. Cyclophosphamide for injection, usp, is a chemotherapy agent used to treat certain types of. Pegasys package insert for all instructions regarding pegasys dosing and administration. Purchase cyclophosphamide assistance snap purchase cyclophosphamide helps eligible lowincome ohioans stretch their food budgets and buy healthy food. Tc can be given either before breast cancer surgery neoadjuvant to shrink the size of the tumor, or after surgery adjuvant to kill any cancer cells that may be still present in the body. Cytoxan cyclophosphamide for injection, usp cytoxan. Isoniazid tablets usp national institutes of health.
Cyclophosphamide is soluble in water, saline, or ethanol. Inactive ingredients in cyclophosphamide tablets are. Please refer to the full prescribing information of fulvestrant. Only select registry of toxic effects of chemical substances rtecs data is presented here. Cyclophosphamide fda prescribing information, side. Isoniazid tablets usp rx only warning severe and sometimes fatal hepatitis associated with isoniazid therapy has been reported and may occur or may develop even after many months of treatment. Rheumatoid arthritis ra rituxan rituximab in combination with methotrexate is indicated for the treatment of adult. Chronic lymphocytic leukemias are considered to be a heterogenous group of chronic bcell disorders. Cytoxan cyclophosphamide dosing, indications, interactions. Cyclophosphamide monohydrate cas 6055192 calbiochem empirical formula hill notation. Cyclophosphamide hydrate investigated as a drug, mutagen, natural product, primary irritant, reproductive effector, and tumorigen.
Medscape indicationspecific dosing for cytoxan cyclophosphamide. Cytoxan is both a carcinogen and a tetrotogen causes birth defects. Medlineplus information on cyclophosphamide a lay language summary of important information about this drug that may include the. The lowest goodrx price for the most common version of cyclophosphamide is. Cyclophosphamide, also called cytoxan, is classified as a cytotoxic agent, because it has a toxic effect on many types of cells good cells as well as bad. Full text full text is available as a scanned copy of the original print version. If you need help accessing information in different file formats. Highlights of prescribing information these highlights do not include all the information needed to use votrient safely and effectively. Lyra study article pdf available in british journal of haematology 1853 march. Cyclophosphamide is a white crystalline powder with the molecular formula c 7 h 15 cl 2 n 2 o 2 p h 2 o and a molecular weight of 279.
Federal usa law restricts this drug to use by or on the order of a licensed veterinarian. Cyclophosphamide for injection, usp is a sterile white powder containing cyclophosphamide monohydrate. Definition from the nci drug dictionary detailed scientific definition and other names for this drug. Sandoz launches first generic version of cyclophosphamide. Patients receiving anthracyclines after stopping treatment with other cardiotoxic agents. Dailymed doxorubicin hydrochloride injection, powder. Cyclophosphamide is the generic name of the prescription drug cytoxan, a chemotherapy drug for people with certain cancers. It is a chemotherapy drug that works by slowing or stopping cell growth. Cyclophosphamide has also been used as a single agent in the treatment of lowgrade lymphomas. Cyclophosphamide is a cytotoxic drug for the treatment of malignant disease in. Ribavirin ribavirin tablet, film coated aurobindo pharma. Cyclophosphamide should only be used by clinicians experienced in the use of cancer chemotherapy. Nails usually return to normal after treatment is finished.
Cyclophosphamide has a molecular formula c 7 h 15 cl 2 n 2 o 2 p h 2 o and a molecular weight of 279. For information on carcinogenicity, go here and then scroll down to cyclophosphamide to download a pdf file on this chemical. Highlights of prescribing information the recommended dose. It is eliminated primarily in the form of metabolites. Summary of product characteristics ucl cancer trials centre. These highlights do not include all the information needed to use cuvitru safely and effectively.
Votrient pazopanib tablets, for oral use initial u. Cyclophosphamide for injection, usp, is a chemotherapy agent used to treat certain types of cancer in adults and pediatric patients. Cyclophosphamide can cause infertility in both men and women. List of drug master files dmf of cyclophosphamide active pharmaceutical ingredient api submitted to the u. Desferal is not indicated for the treatment of primary hemochromatosis, since phlebotomy is the method of choice for removing excess iron in this disorder.
Cyclophosphamide cyc is an alkylating agent that was introduced into clinical practice as a chemotherapeutic agent but has also been used to treat a number of systemic autoimmune diseases. Since cyclophosphamide is excreted in the urine, dosage adjustment may. When given with kisqali, the recommended dose of fulvestrant is 500 mg administered on days 1, 15, 29, and once monthly thereafter. Easy to read fda package insert, drug facts, dosage and administration, and adverse effects for cytoxan cyclophosphamide skip to. The recommended duration of treatment for patients previously untreated with ribavirin and interferon is 24 to 48 weeks. Toxic deaths, hepatotoxicity, neutropenia, hypersensitivity reactions, and fluid retention see full. Jun, 20 cyclophosphamide has a molecular formula of c 7 h 15 cl 2 n 2 o 2 ph 2 o and a molecular weight of 279. The length of treatment depends on the types of drugs you are taking, how well your body responds to them, and the type of cancer or condition you have. Although women taking cyclophosphamide can stop having periods, they can still become pregnant, so an effective form of birth control to prevent pregnancy should be used while taking this medication since cyclophosphamide can cause fetal harm. The medicine works by crosslinking dna cells and suppressing the immune system. Rydapt midostaurin capsules, for oral use initial u. Cyclophosphamide should only be administered where there are facilities for regular monitoring of clinical, biochemical and haematological parameters before, during, and after administration and under the direction of a specialist oncology service. Cytoxan is an alkylating agent that forms covalent bonds with the building blocks of dna.
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