FDA records indicate that there are no current recalls for this drug.
Are you a medical professional?
Trending Topics
Cyclophosphamide 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
Cyclophosphamide Manufacturers
- Baxter Healthcare Corporation
Cyclophosphamide | 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, USP
Intravenous 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 Concentration
500 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 Diluent
Cyclophosphamide
Concentration
500 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
TemperatureRefrigerated
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.
- Baxter Healthcare Corporation
- Baxter Healthcare Corporation
- Physicians Total Care, Inc.
Cyclophosphamide | Physicians Total Care, Inc.
Treatment of Malignant Diseases Adults and Children:Oral cyclophosphamide dosing is usually in the range of 1 to 5 mg/kg/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. Transient decreases in the total white blood cell count to 2000 cells/mm3 (following short courses) or more persistent reduction to 3000 cells/mm3 (with continuing therapy) are tolerated without serious risk of infection if there is no marked granulocytopenia.
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.
Cyclophosphamide and its metabolites are dialyzable although there are probably quantitative differences depending upon the dialysis system being used. Patients with compromised renal function may show some measurable changes in pharmacokinetic parameters of cyclophosphamide metabolism, but there is no consistent evidence indicating a need for cyclophosphamide dosage modification in patients with renal function impairment.
Treatment of Nonmalignant Diseases Biopsy Proven “Minimal Change” Nephrotic Syndrome in Children:An oral dose of 2.5 to 3 mg/kg daily for a period of 60 to 90 days is recommended. In males, the incidence of oligospermia and azoospermia increases if the duration of cyclophosphamide treatment exceeds 60 days. Treatment beyond 90 days increases the probability of sterility. Adrenocorticosteroid therapy may be tapered and discontinued during the course of cyclophosphamide therapy (see PRECAUTIONS: Laboratory Tests).
Preparation and Handling of SolutionsExtemporaneous liquid preparations of cyclophosphamide for oral administration may be prepared by dissolving cyclophosphamide for injection in Aromatic Elixir, N.F. Such preparations should be stored under refrigeration in glass containers and used within 14 days.
- Baxter Healthcare Corporation
Cyclophosphamide | 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 (lyophilized powder), or bottles containing cyclophosphamide tablets. To minimize the risk of dermal exposure, always wear gloves when handling vials containing Cyclophosphamide for Injection, USP (lyophilized powder), or bottles containing cyclophosphamide tablets. The coating of the cyclophosphamide tablets prevents direct contact of persons handling the tablets with the active substance. However, to prevent inadvertent exposure to the active substance, the cyclophosphamide tablets should not be cut, chewed, or crushed. Personnel should avoid exposure to broken tablets. If contact with broken tablets occurs, wash hands immediately and thoroughly.
Cyclophosphamide for Injection, USP
Intravenous 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 Injection Strength Volume of
0.9% Sodium ChlorideCyclophosphamide
Concentration 500 mg 25 mL 1 g 50 mL 20 mg per mL 2 g 100 mLFor Intravenous Infusion
Reconstitution of Cyclophosphamide:
Table 2: Reconstitution in preparation for Intravenous Infusion Strength Volume of
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.
DiluentCyclophosphamide
Concentration 500 mg 25 mL 1 g 50 mL 20 mg per mL 2 g 100 mLDilution 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 hrsUse 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.
- Baxter Healthcare Corporation
Cyclophosphamide | 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 of 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, USP
Intravenous 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 Concentration
500 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 Diluent
Cyclophosphamide
Concentration
500 mg
25 mL
1 g
50 mL
20 mg per 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.
- Roxane Laboratories, Inc.
Cyclophosphamide | Roxane Laboratories, Inc.
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 Diseases Adults and Pediatric PatientsOral 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 8 USE IN SPECIFIC POPULATIONS(8.4)].
2.3 Handling and AdministrationHandle and dispose of cyclophosphamide in a manner consistent with other cytotoxic drugs.1 Caution should be exercised when handling cyclophosphamide containers and capsules. To minimize the risk of dermal exposure, always wear gloves when handling cyclophosphamide containers and capsules. To prevent inadvertent exposure to the active substance, the cyclophosphamide capsules should be swallowed whole. The capsules should not be opened, chewed, or crushed. Exposure to broken capsules should be avoided. If contact with broken capsules occurs, wash hands immediately and thoroughly.
Login To Your Free Account