Active Ingredient: Cyclophosphamide
For this indication, competent medicine agencies globally authorize below treatments:
Intravenous
500 - 1,000 mg per m² of body surface area (BSA)
From 500 To 1,000 mg per m² of body surface area (BSA) once every 30 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:
Autoimmune diseases: Per month 500-1000 mg/m² body surface area.
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.
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