Non-Hodgkin's lymphoma

Active Ingredient: Cyclophosphamide

Indication for Cyclophosphamide

Population group: only children (1 year - 12 years old) , adolescents (12 years - 18 years old) , adults (18 years old or older)

For this indication, competent medicine agencies globally authorize below treatments:

3-6 mg/kg once daily

Route of admnistration

Intravenous

Defined daily dose

3 - 6 mg per kg of body weight

Dosage regimen

From 3 To 6 mg per kg of body weight once every day

Detailed description

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.

Dosage considerations

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.

Precaution to be taken before manipulating or administering the product

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.

Infusion

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.

Direct injection

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 use

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.

120-240 mg/m² once daily

Route of admnistration

Intravenous

Defined daily dose

120 - 240 mg per m² of body surface area (BSA)

Dosage regimen

From 120 To 240 mg per m² of body surface area (BSA) once every day

Detailed description

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

Dosage considerations

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.

Precaution to be taken before manipulating or administering the product

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.

Infusion

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.

Direct injection

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 use

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.

10-15 mg/kg once every 2-5 days

Route of admnistration

Intravenous

Defined daily dose

10 - 15 mg per kg of body weight

Dosage regimen

From 10 To 15 mg per kg of body weight once every 3 day(s)

Detailed description

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.

Dosage considerations

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.

Precaution to be taken before manipulating or administering the product

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.

Infusion

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.

Direct injection

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 use

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.

1400-600 mg/m² once every 2-5 days

Route of admnistration

Intravenous

Defined daily dose

400 - 600 mg per m² of body surface area (BSA)

Dosage regimen

From 400 To 600 mg per m² of body surface area (BSA) once every 3 day(s)

Detailed description

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.

Dosage considerations

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.

Precaution to be taken before manipulating or administering the product

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.

Infusion

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.

Direct injection

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 use

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.

20-40 mg/kg once every 21-28 days

Route of admnistration

Intravenous

Defined daily dose

20 - 40 mg per kg of body weight

Dosage regimen

From 20 To 40 mg per kg of body weight once every 21 day(s)

Detailed description

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.

Dosage considerations

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.

Precaution to be taken before manipulating or administering the product

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.

Infusion

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.

Direct injection

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 use

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.

800-1600 mg/m² once every 21-28 days

Route of admnistration

Intravenous

Defined daily dose

800 - 1,600 mg per m² of body surface area (BSA)

Dosage regimen

From 800 To 1,600 mg per m² of body surface area (BSA) once every 21 day(s)

Detailed description

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.

Dosage considerations

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.

Precaution to be taken before manipulating or administering the product

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.

Infusion

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.

Direct injection

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 use

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.

100-300 mg daily as a single or divided dose

Route of admnistration

Oral

Defined daily dose

100 - 300 mg

Dosage regimen

From 33.333 To 100 mg 3 time(s) per day every day

Detailed description

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.

Active ingredient

Cyclophosphamide

Cyclophosphamide has been demonstrated to have a cytostatic effect in many tumour types. The active metabolites of cyclophosphamide are alkylating agents which transfer alkyl groups to DNA during the process of cell division, thus preventing normal synthesis of DNA.

Read more about Cyclophosphamide

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