Cyclophosphamide

Cyclophosphamide Manufacturers

• Baxter Healthcare Corporation
  

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  Cyclophosphamide | Baxter Healthcare Corporation

  

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  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 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 Patients

  An 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 Administration

  Handle 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 Injection

  Strength

  Volume of
  0.9% Sodium Chloride

  Cyclophosphamide Concentration

  500 mg

  25 mL

  20 mg per mL

  1 g

  50 mL

  2 g

  100 mL

  For Intravenous Infusion

  Reconstitution of Cyclophosphamide:
  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.

  Table 2: Reconstitution in preparation for Intravenous Infusion

  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:
  Further dilute the reconstituted Cyclophosphamide solution to a minimum concentration of 2 mg per mL with any of the following diluents:

    • 5% Dextrose Injection, USP • 5% Dextrose and 0.9% Sodium Chloride Injection, USP • 0.45% Sodium Chloride Injection, USP

  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.

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• Baxter Healthcare Corporation
  

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  Cyclophosphamide | Pharmagel International Inc

  

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  Apply product thoroughly, rubbing hands together briskly until absorbed. Apply as needed. Store at room temperature.

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• Baxter Healthcare Corporation
  

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  Cyclophosphamide | Pharmagel International Inc

  

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  Apply sparingly to blemishes after cleansing. Allow to penetrate and dry before applying other preparations. For best results,

  use twice daily.

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• Physicians Total Care, Inc.
  

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  Cyclophosphamide | Physicians Total Care, Inc.

  

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  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 Solutions

  Extemporaneous 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.

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• 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 Diseases

  Adults 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 Patients

  An 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 Administration

  Handle 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 Chloride

  Cyclophosphamide

  Concentration 500 mg 25 mL 1 g 50 mL 20 mg per mL 2 g 100 mL

  For Intravenous Infusion

  Reconstitution of Cyclophosphamide:
  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.

  Table 2: Reconstitution in preparation for Intravenous Infusion 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:
  Further dilute the reconstituted Cyclophosphamide solution to a minimum concentration of 2 mg per mL with any of the following diluents:

  5% Dextrose Injection, USP 5% Dextrose and 0.9% Sodium Chloride Injection, USP 0.45% Sodium Chloride Injection, USP

  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.

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• 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 Diseases

  Adults 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 Patients

  An 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 Administration

  Handle 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 Injection

  Strength

  Volume of
  0.9% Sodium Chloride

  Cyclophosphamide Concentration

  500 mg

  25 mL

  20 mg per mL

  1 g

  50 mL

  2 g

  100 mL

  For Intravenous Infusion

  Reconstitution of Cyclophosphamide:
  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.

  Table 2: Reconstitution in preparation for Intravenous Infusion

  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:
  Further dilute the reconstituted Cyclophosphamide solution to a minimum concentration of 2 mg per mL with any of the following diluents:

  • 5% Dextrose Injection, USP • 5% Dextrose and 0.9% Sodium Chloride Injection, USP • 0.45% Sodium Chloride Injection, USP

  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.

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• Roxane Laboratories, Inc.
  

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  Cyclophosphamide | Roxane Laboratories, Inc.

  

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  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 Patients

  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 Patients

  An 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 Administration

  Handle 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.

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