FDA records indicate that there are no current recalls for this drug.
Are you a medical professional?
Trending Topics
Shoprite Childrens Acetaminophen Recall
Get an alert when a recall is issued.
Questions & Answers
Side Effects & Adverse Reactions
There is currently no warning information available for this product. We apologize for any inconvenience.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
Cyclophosphamide is indicated for the treatment of:
- •
- malignant lymphomas (Stages III and IV of the Ann Arbor staging system), Hodgkin’s disease, lymphocytic lymphoma (nodular or diffuse), mixed-cell type lymphoma, histiocytic lymphoma, Burkitt’s lymphoma
- •
- multiple myeloma
- •
- 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)
- •
- mycosis fungoides (advanced disease)
- •
- neuroblastoma (disseminated disease)
- •
- adenocarcinoma of the ovary
- •
- retinoblastoma
- •
- carcinoma of the breast
Cyclophosphamide, although effective alone in susceptible malignancies, is more frequently used concurrently or sequentially with other antineoplastic drugs.
Cyclophosphamide is indicated for the treatment of biopsy proven minimal change nephrotic syndrome in pediatrics patients who failed to adequately respond to or are unable to tolerate adrenocorticosteroid therapy.
Limitations of Use:
The safety and effectiveness for the treatment of nephrotic syndrome in adults or other renal disease has not been established.
History
There is currently no drug history available for this drug.
Other Information
Cyclophosphamide is a synthetic antineoplastic drug chemically related to the nitrogen mustards. 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 is a white crystalline powder with the molecular formula C7H15Cl2N2O2P•H2O and a molecular weight of 279.1. Cyclophosphamide is soluble in water, saline, or ethanol.
Cyclophosphamide for Injection, USP is a sterile white powder available as 500 mg, 1 g, and 2 g strength vials.
- •
- 500 mg vial contains 534.5 mg cyclophosphamide monohydrate equivalent to 500 mg cyclophosphamide
- •
- 1 g vial contains 1069.0 mg cyclophosphamide monohydrate equivalent to 1 g cyclophosphamide
- •
- 2 g vial contains 2138.0 mg cyclophosphamide monohydrate equivalent to 2 g cyclophosphamide
Sources
Shoprite Childrens Acetaminophen Manufacturers
-
Wakefern Food Corporation
Shoprite Childrens Acetaminophen | Baxter Healthcare Corporation
During or immediately after the administration, adequate amounts of fluid should be ingested or infused to force diuresis in order to reduce the risk of urinary tract toxicity. Therefore, cyclophosphamide should be administered in the morning.
2.1 Dosing for Malignant DiseasesAdults and Pediatric Patients
Intravenous
When used as the only oncolytic drug therapy, the initial course of cyclophosphamide 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. 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.Oral
Oral cyclophosphamide dosing is usually in the range of 1 mg per kg per day to 5 mg per kg per day for both initial and maintenance dosing.Many other regimens of intravenous and oral cyclophosphamide have been reported. Dosages must be adjusted in accord with evidence of antitumor activity and/or leukopenia. The total leukocyte count is a good, objective guide for regulating dosage.
When cyclophosphamide is included in combined cytotoxic regimens, it may be necessary to reduce the dose of cyclophosphamide as well as that of the other drugs.
2.2 Dosing for Minimal Change Nephrotic Syndrome in Pediatric PatientsAn oral dose of 2 mg per kg daily for 8 to 12 weeks (maximum cumulative dose 168 mg per kg) is recommended. Treatment beyond 90 days increases the probability of sterility in males [see Use in Specific Populations (8.4)].
2.3 Preparation, Handling and AdministrationHandle and dispose of cyclophosphamide in a manner consistent with other cytotoxic drugs.1 Caution should be exercised when handling and preparing Cyclophosphamide for Injection, USP. To minimize the risk of dermal exposure, always wear gloves when handling vials containing Cyclophosphamide for Injection, USP.
Cyclophosphamide for Injection, USPIntravenous Administration
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Do not use cyclophosphamide vials if there are signs of melting. Melted cyclophosphamide is a clear or yellowish viscous liquid usually found as a connected phase or in droplets in the affected vials.
Cyclophosphamide does not contain any antimicrobial preservative and thus care must be taken to assure the sterility of prepared solutions. Use aseptic technique.
For Direct Intravenous Injection
Reconstitute Cyclophosphamide with 0.9% Sodium Chloride Injection, USP only, using the volumes listed below in Table 1. Gently swirl the vial to dissolve the drug completely. Do not use Sterile Water for Injection, USP because it results in a hypotonic solution and should not be injected directly.
Table 1: Reconstitution for Direct Intravenous InjectionStrength
Volume of
0.9% Sodium ChlorideCyclophosphamide
Concentration500 mg
25 mL
20 mg per mL
1 g
50 mL
2 g
100 mL
For Intravenous Infusion
Reconstitution of Cyclophosphamide:
Table 2: Reconstitution in preparation for Intravenous Infusion
Reconstitute Cyclophosphamide using 0.9% Sodium Chloride Injection, USP or Sterile Water for Injection, USP with the volume of diluent listed below in Table 2. Add the diluent to the vial and gently swirl to dissolve the drug completely.Strength
Volume of
DiluentCyclophosphamide
Concentration500 mg
25 mL
20 mg per mL
1 g
50 mL
2 g
100 mL
Dilution of Reconstituted Cyclophosphamide:
• 5% Dextrose Injection, USP • 5% Dextrose and 0.9% Sodium Chloride Injection, USP • 0.45% Sodium Chloride Injection, USP
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. Duration of the infusion also should be appropriate for the volume and type of carrier fluid to be infused.
Storage of Reconstituted and Diluted Cyclophosphamide Solution:
If not used immediately, for microbiological integrity, cyclophosphamide solutions should be stored as described in Table 3.
Table 3: Storage of Cyclophosphamide Solutions * Storage time is the total time cyclophosphamide is in solution including the time it is reconstituted in 0.9% Sterile Sodium Chloride Injection, USP or Sterile Water for Injection, USP.Diluent
Storage
Room Temperature
Refrigerated
Reconstituted Solution (Without Further Dilution)
0.9% Sodium Chloride Injection, USP
up to 24 hrs
up to 6 days
Sterile Water for Injection, USP
Do not store; use immediately
Diluted Solutions*
0.45% Sodium Chloride Injection, USP
up to 24 hrs
up to 6 days
5% Dextrose Injection, USP
up to 24 hrs
up to 36 hrs
5% Dextrose and 0.9% Sodium Chloride Injection, USP
up to 24 hrs
up to 36 hrs
Use of Reconstituted Solution for Oral Administration
Liquid preparations of cyclophosphamide for oral administration may be prepared by dissolving cyclophosphamide for injection in Aromatic Elixir, National Formulary (NF). Such preparations should be stored under refrigeration in glass containers and used within 14 days.
-
Wakefern Food Corporation
Login To Your Free Account