Cisplasan Dosage/Direction for Use



Full Prescribing Info
Dosage/Direction for Use
Do not use needles or i.v. sets containing aluminium parts because Al reacts with CISPLASAN. Causing precipitate formation and a loss of potency.
Prehydration therapy: A prehydration therapy is required 8-12 hours before the CISPLASAN administration. This consist of 1-2 L physiological saline solution per m2 body surface area (BSA) per infusion over at least 2-3 hours.
Cisplatin administration: Short-term infusion: i.v. Infusion over 15 minutes. The CISPLASAN dose to be administered is given immediately following an i.v. administration of 62.5 mL 20% mannitol solution.
Long-term infusion: i.v. Infusion over 1-8 hours. The CISPLASAN dose to be administered is diluted with 1- 2 L physiological saline solution.
The solution can contain 50 g glucose and 18.75 g mannitol/L.
Dosages of monochemotherapy: 50-120 mg CISPLASAN per m2 BSA at 3-4 weeks intervals; or 50 mg CISPLASAN per m2 BSA on day 1 and 8 at 3-4 weeks intervals; or 15-20 mg CISPLASAN per m2 BSA on day 1-5 at 3-4 weeks intervals. CISPLASAN is generally administered in chemotherapeutics combinations in which the dose is accordingly reduced.
Post hydration therapy: Adequate fluids must be given during the period after the CISPLASAN administration, i.e. in the (6-12) 24 hours following the drug administration (this consist of 2-31 physiological saline solution/m2 BSA together with a 5% glucose solution at a ratio 1:1.5). The urine volume during the post hydration should be at least 100-200 mL/h. A forced diuresis must be induced in the case of inadequate excretion.
Forced diuresis: For patients who have received proper prehydration and posthydration therapy and CISPLASAN doses below 60 mg/m2 BSA, and who have normal renal function, the administration of mannitol to induce a diuresis can be replaced by careful balancing and weight control. Mannitol must be administered when the retention ≥ 1000 mL.
For CISPLASAN doses above 60 mg/m2 BSA, mannitol administration (8 g/m2) BSA is obligatory immediately prior to the first CISPLASAN administration. Only after the onset of a minimal diuresis of 250 mL within 30 minutes may the CISPLASAN administration be started.
During the therapy with CISPLASAN, attention must be paid to electrolyte losses, namely losses of potassium, magnesium, and calcium and an appropriate replacement therapy must be carried out as required. An adequate antiemetic therapy best with serotonin-receptor antagonist with or without dexamethasone, is to be carried out as required. Larger fluid losses, resulting from vomiting or diarrhea are to be replaced.
Various therapy regimens recommended the following dose reductions for patients with impaired renal failure: Serum creatinine ≤ 2 mg/dL: No reduction in the CISPLASAN dose, some therapy regimens recommend a dose reduction of a 50% of the standard dose already in the serum creatinine range 1.5-2 mg/dL. The clinical benefits and risks must be assessed here individually. It is particularly important to also differentiate between the benefit-risk relationship of a CISPLASAN administration in patients with healthy kidneys by whom renal function impairment are observed after CISPLASAN administration, and the benefits and risks involved with such a treatment in patients with preexisting renal impairment.
Serum creatinine ≥ 2 mg/dL: Stop the CISPLASAN therapy until the serum creatinine is again ≤ 2 mg/dL. If the recovery phase until reaching this value takes longer than 6 weeks, then an alternative treatment with an other cytostatic agent is to be started. CISPLASAN administrated as an intravenous infusion.
As with other potentially toxic compounds, handle the solution of CISPLASAN with caution. Accidental exposure to CISPLASAN may cause skin reaction. The use of gloves is recommended. If CISPLASAN powder or solution contact with skin or mucosa, immediately wash the skin or mucosa thoroughly with soap and water.
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