Active Ingredient: Cyclophosphamide
For this indication, competent medicine agencies globally authorize below treatments:
Intravenous
3 - 6 mg per kg of body weight
From 3 To 6 mg per kg of body weight once every day
Dosage must be individualised.
Doses and duration of treatment and/or treatment intervals depend on the therapeutic indication, the scheme of a combination therapy, the patient’s general state of health and organ function, and the results of laboratory monitoring (in particular, blood cell monitoring).
In combination with other cytostatics of similar toxicity, a dose reduction or extension of the therapy-free intervals may be necessary.
Use of hematopoiesis stimulating agents (colony-stimulating factors and erythropoiesis stimulating agents) may be considered to reduce the risk of myelosuppressive complications and/or help facilitate the delivery of the intended dosing.
Prior, during and 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.
It is within the responsibility of the physician to decide on the use of cyclophosphamide according to the operative treatment guidelines.
The doses below can be regarded as general guidelines:
Hematologic and solid tumours:
For daily treatment: 3-6 mg/kg body weight (= 120-240 mg/m² body surface area), injected intravenously.
Cyclophosphamide is inert until activated by enzymes in the liver. However, as with all cytotoxic agents, it is recommended that reconstitution should be performed by trained personnel, in a designated area.
Those handling the preparation should wear protective gloves. Care should be taken to avoid splashing material into the eyes. The material should not be handled by women who are pregnant or who are breast-feeding.
The choice of solvent for reconstituting cyclophosphamide depends on the route of administration to be used.
If the solution is to be used for IV infusion, cyclophosphamide is reconstituted by adding sterile water for injection or 0.9% sterile sodium chloride solution.
Reconstituted cyclophosphamide should be further diluted in 5% dextrose or 0.9% sodium chloride solution prior to infusion.
If the solution is to be used for direct injection, cyclophosphamide is reconstituted by adding 0.9% sterile sodium chloride solution.
Please note that only cyclophosphamide reconstituted in 0.9% sterile sodium chloride solution is suitable for bolus injection.
Cyclophosphamide reconstituted in water is hypotonic and should not be injected directly.
Intravenous administration should preferably be conducted as an infusion.
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 (ranging from 30 minutes to 2 hours) should be appropriate for the volume and type of carrier fluid to be infused.
Before intravenous use, the substance must be completely dissolved.
Drug products for intravenous use must be inspected visually for particulate matter and discolouration prior to administration whenever solution and container permit.
Intravenous
120 - 240 mg per m² of body surface area (BSA)
From 120 To 240 mg per m² of body surface area (BSA) once every day
Dosage must be individualised.
Doses and duration of treatment and/or treatment intervals depend on the therapeutic indication, the scheme of a combination therapy, the patient’s general state of health and organ function, and the results of laboratory monitoring (in particular, blood cell monitoring).
In combination with other cytostatics of similar toxicity, a dose reduction or extension of the therapy-free intervals may be necessary.
Use of hematopoiesis stimulating agents (colony-stimulating factors and erythropoiesis stimulating agents) may be considered to reduce the risk of myelosuppressive complications and/or help facilitate the delivery of the intended dosing.
Prior, during and 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.
It is within the responsibility of the physician to decide on the use of cyclophosphamide according to the operative treatment guidelines.
The doses below can be regarded as general guidelines:
Hematologic and solid tumours:
For daily treatment: 3-6 mg/kg body weight (= 120-240 mg/m² body surface area), injected intravenously.
Cyclophosphamide is inert until activated by enzymes in the liver. However, as with all cytotoxic agents, it is recommended that reconstitution should be performed by trained personnel, in a designated area.
Those handling the preparation should wear protective gloves. Care should be taken to avoid splashing material into the eyes. The material should not be handled by women who are pregnant or who are breast-feeding.
The choice of solvent for reconstituting cyclophosphamide depends on the route of administration to be used.
If the solution is to be used for IV infusion, cyclophosphamide is reconstituted by adding sterile water for injection or 0.9% sterile sodium chloride solution.
Reconstituted cyclophosphamide should be further diluted in 5% dextrose or 0.9% sodium chloride solution prior to infusion.
If the solution is to be used for direct injection, cyclophosphamide is reconstituted by adding 0.9% sterile sodium chloride solution.
Please note that only cyclophosphamide reconstituted in 0.9% sterile sodium chloride solution is suitable for bolus injection.
Cyclophosphamide reconstituted in water is hypotonic and should not be injected directly.
Intravenous administration should preferably be conducted as an infusion.
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 (ranging from 30 minutes to 2 hours) should be appropriate for the volume and type of carrier fluid to be infused.
Before intravenous use, the substance must be completely dissolved.
Drug products for intravenous use must be inspected visually for particulate matter and discolouration prior to administration whenever solution and container permit.
Intravenous
10 - 15 mg per kg of body weight
From 10 To 15 mg per kg of body weight once every 3 day(s)
Dosage must be individualised. Doses and duration of treatment and/or treatment intervals depend on the therapeutic indication, the scheme of a combination therapy, the patient’s general state of health and organ function, and the results of laboratory monitoring (in particular, blood cell monitoring).
In combination with other cytostatics of similar toxicity, a dose reduction or extension of the therapy-free intervals may be necessary.
Use of hematopoiesis stimulating agents (colony-stimulating factors and erythropoiesis stimulating agents) may be considered to reduce the risk of myelosuppressive complications and/or help facilitate the delivery of the intended dosing.
Prior, during and 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.
It is within the responsibility of the physician to decide on the use of cyclophosphamide according to the operative treatment guidelines.
The doses below can be regarded as general guidelines:
Hematologic and solid tumours:
For intermittent treatment: 10-15 mg/kg body weight (= 400-600 mg/m² body surface area), injected intravenously, with therapy-free intervals of 2 to 5 days.
Cyclophosphamide is inert until activated by enzymes in the liver. However, as with all cytotoxic agents, it is recommended that reconstitution should be performed by trained personnel, in a designated area.
Those handling the preparation should wear protective gloves. Care should be taken to avoid splashing material into the eyes. The material should not be handled by women who are pregnant or who are breast-feeding.
The choice of solvent for reconstituting cyclophosphamide depends on the route of administration to be used.
If the solution is to be used for IV infusion, cyclophosphamide is reconstituted by adding sterile water for injection or 0.9% sterile sodium chloride solution.
Reconstituted cyclophosphamide should be further diluted in 5% dextrose or 0.9% sodium chloride solution prior to infusion.
If the solution is to be used for direct injection, cyclophosphamide is reconstituted by adding 0.9% sterile sodium chloride solution.
Please note that only cyclophosphamide reconstituted in 0.9% sterile sodium chloride solution is suitable for bolus injection.
Cyclophosphamide reconstituted in water is hypotonic and should not be injected directly.
Intravenous administration should preferably be conducted as an infusion.
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 (ranging from 30 minutes to 2 hours) should be appropriate for the volume and type of carrier fluid to be infused.
Before intravenous use, the substance must be completely dissolved.
Drug products for intravenous use must be inspected visually for particulate matter and discolouration prior to administration whenever solution and container permit.
Intravenous
400 - 600 mg per m² of body surface area (BSA)
From 400 To 600 mg per m² of body surface area (BSA) once every 3 day(s)
Dosage must be individualised.
Doses and duration of treatment and/or treatment intervals depend on the therapeutic indication, the scheme of a combination therapy, the patient’s general state of health and organ function, and the results of laboratory monitoring (in particular, blood cell monitoring).
In combination with other cytostatics of similar toxicity, a dose reduction or extension of the therapy-free intervals may be necessary.
Use of hematopoiesis stimulating agents (colony-stimulating factors and erythropoiesis stimulating agents) may be considered to reduce the risk of myelosuppressive complications and/or help facilitate the delivery of the intended dosing.
Prior, during and 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.
It is within the responsibility of the physician to decide on the use of cyclophosphamide according to the operative treatment guidelines.
The doses below can be regarded as general guidelines:
Hematologic and solid tumours:
For intermittent treatment: 10-15 mg/kg body weight (= 400-600 mg/m² body surface area), injected intravenously, with therapy-free intervals of 2 to 5 days.
Cyclophosphamide is inert until activated by enzymes in the liver. However, as with all cytotoxic agents, it is recommended that reconstitution should be performed by trained personnel, in a designated area.
Those handling the preparation should wear protective gloves. Care should be taken to avoid splashing material into the eyes. The material should not be handled by women who are pregnant or who are breast-feeding.
The choice of solvent for reconstituting cyclophosphamide depends on the route of administration to be used.
If the solution is to be used for IV infusion, cyclophosphamide is reconstituted by adding sterile water for injection or 0.9% sterile sodium chloride solution.
Reconstituted cyclophosphamide should be further diluted in 5% dextrose or 0.9% sodium chloride solution prior to infusion.
If the solution is to be used for direct injection, cyclophosphamide is reconstituted by adding 0.9% sterile sodium chloride solution.
Please note that only cyclophosphamide reconstituted in 0.9% sterile sodium chloride solution is suitable for bolus injection.
Cyclophosphamide reconstituted in water is hypotonic and should not be injected directly.
Intravenous administration should preferably be conducted as an infusion.
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 (ranging from 30 minutes to 2 hours) should be appropriate for the volume and type of carrier fluid to be infused.
Before intravenous use, the substance must be completely dissolved.
Drug products for intravenous use must be inspected visually for particulate matter and discolouration prior to administration whenever solution and container permit.
Intravenous
20 - 40 mg per kg of body weight
From 20 To 40 mg per kg of body weight once every 21 day(s)
Dosage must be individualised.
Doses and duration of treatment and/or treatment intervals depend on the therapeutic indication, the scheme of a combination therapy, the patient’s general state of health and organ function, and the results of laboratory monitoring (in particular, blood cell monitoring).
In combination with other cytostatics of similar toxicity, a dose reduction or extension of the therapy-free intervals may be necessary.
Use of hematopoiesis stimulating agents (colony-stimulating factors and erythropoiesis stimulating agents) may be considered to reduce the risk of myelosuppressive complications and/or help facilitate the delivery of the intended dosing.
Prior, during and 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.
It is within the responsibility of the physician to decide on the use of cyclophosphamide according to the operative treatment guidelines.
The doses below can be regarded as general guidelines:
Hematologic and solid tumours:
For high-dose intermittent treatment: 20-40 mg/kg body weight (= 800-1600 mg/m² body surface area), injected intravenously, with therapy-free intervals of 21 to 28 days.
Cyclophosphamide is inert until activated by enzymes in the liver. However, as with all cytotoxic agents, it is recommended that reconstitution should be performed by trained personnel, in a designated area.
Those handling the preparation should wear protective gloves. Care should be taken to avoid splashing material into the eyes. The material should not be handled by women who are pregnant or who are breast-feeding.
The choice of solvent for reconstituting cyclophosphamide depends on the route of administration to be used.
If the solution is to be used for IV infusion, cyclophosphamide is reconstituted by adding sterile water for injection or 0.9% sterile sodium chloride solution.
Reconstituted cyclophosphamide should be further diluted in 5% dextrose or 0.9% sodium chloride solution prior to infusion.
If the solution is to be used for direct injection, cyclophosphamide is reconstituted by adding 0.9% sterile sodium chloride solution.
Please note that only cyclophosphamide reconstituted in 0.9% sterile sodium chloride solution is suitable for bolus injection.
Cyclophosphamide reconstituted in water is hypotonic and should not be injected directly.
Intravenous administration should preferably be conducted as an infusion.
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 (ranging from 30 minutes to 2 hours) should be appropriate for the volume and type of carrier fluid to be infused.
Before intravenous use, the substance must be completely dissolved.
Drug products for intravenous use must be inspected visually for particulate matter and discolouration prior to administration whenever solution and container permit.
Intravenous
800 - 1,600 mg per m² of body surface area (BSA)
From 800 To 1,600 mg per m² of body surface area (BSA) once every 21 day(s)
Dosage must be individualised.
Doses and duration of treatment and/or treatment intervals depend on the therapeutic indication, the scheme of a combination therapy, the patient’s general state of health and organ function, and the results of laboratory monitoring (in particular, blood cell monitoring).
In combination with other cytostatics of similar toxicity, a dose reduction or extension of the therapy-free intervals may be necessary.
Use of hematopoiesis stimulating agents (colony-stimulating factors and erythropoiesis stimulating agents) may be considered to reduce the risk of myelosuppressive complications and/or help facilitate the delivery of the intended dosing.
Prior, during and 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.
It is within the responsibility of the physician to decide on the use of cyclophosphamide according to the operative treatment guidelines.
The doses below can be regarded as general guidelines:
Hematologic and solid tumours:
For high-dose intermittent treatment: 20-40 mg/kg body weight (= 800-1600 mg/m² body surface area), injected intravenously, with therapy-free intervals of 21 to 28 days.
Cyclophosphamide is inert until activated by enzymes in the liver. However, as with all cytotoxic agents, it is recommended that reconstitution should be performed by trained personnel, in a designated area.
Those handling the preparation should wear protective gloves. Care should be taken to avoid splashing material into the eyes. The material should not be handled by women who are pregnant or who are breast-feeding.
The choice of solvent for reconstituting cyclophosphamide depends on the route of administration to be used.
If the solution is to be used for IV infusion, cyclophosphamide is reconstituted by adding sterile water for injection or 0.9% sterile sodium chloride solution.
Reconstituted cyclophosphamide should be further diluted in 5% dextrose or 0.9% sodium chloride solution prior to infusion.
If the solution is to be used for direct injection, cyclophosphamide is reconstituted by adding 0.9% sterile sodium chloride solution.
Please note that only cyclophosphamide reconstituted in 0.9% sterile sodium chloride solution is suitable for bolus injection.
Cyclophosphamide reconstituted in water is hypotonic and should not be injected directly.
Intravenous administration should preferably be conducted as an infusion.
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 (ranging from 30 minutes to 2 hours) should be appropriate for the volume and type of carrier fluid to be infused.
Before intravenous use, the substance must be completely dissolved.
Drug products for intravenous use must be inspected visually for particulate matter and discolouration prior to administration whenever solution and container permit.
Oral
100 - 300 mg
From 33.333 To 100 mg 3 time(s) per day every day
Dosage must be individualized.
Doses and duration of treatment and/or treatment intervals depend on the therapeutic indication, the scheme of a combination therapy, the patient’s general state of health and organ function, and the results of laboratory monitoring (in particular, blood cell monitoring).
The dosage regimen used for most indications is 100-300 mg daily as a single or divided dose.
This treatment should be continued until a clear remission or improvement is seen or be interrupted when the extent of leucopenia becomes unacceptable.
In combination with other cytostatics of similar toxicity, a dose reduction or extension of the therapy-free intervals may be necessary.
Activation of cyclophosphamide requires hepatic metabolism; therefore, oral and intravenous administrations are preferred.
Use of hematopoiesis stimulating agents (colony-stimulating factors and erythropoiesis stimulating agents) may be considered to reduce the risk of myelosuppressive complications and/or help facilitate the delivery of the intended dosing.
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.
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