Cisplatin 1 mg/ml concentrate for solution for infusion, 1 vial x 50ml, Accord
Price: 250 Euro + shipping
e-mail: sales@gerovital-gh3.com
Bucharest, Romania (EU)
 
Cisplatin is indicated for the treatment of:
 
metastatic or advanced testicular cancer
metastatic or advanced ovarian cancer
metastatic or advanced bladder cancer
metastatic or advanced squamous cell carcinoma of the head and neck
metastatic or advanced non-small cell lung cancer
metastatic or advanced small cell lung cancer.
Cisplatin is indicated in combination with other chemotherapeutic agents or radiotherapy in the treatment of cervical cancer.
Cisplatin can be used both as monotherapy and in combination therapy.
Dosage
Dosage Adults and children
The dose of cisplatin depends on the primary disease, the anticipated response and whether cisplatin is used as monotherapy or as part of combination chemotherapy. The dosing instructions are applicable to both adults and children.
 
For monotherapy, the following two treatment regimens are recommended:
 
50 to 120 mg/m2 as a single dose, every 3 to 4 weeks;
 
15 to 20 mg/m2 per day for five days, every 3 to 4 weeks.
 
If cisplatin is used in combination therapy, the dose of cisplatin should be reduced. A usual dose is 20 mg/m2 or more every 3 to 4 weeks.
 
For the treatment of cervical cancer, it is used in combination with radiotherapy. A usual dose is 40 mg/m2 weekly for 6 weeks.
 
For warnings or precautions to be taken before starting the next treatment cycle, see section 4.4.
 
In patients with renal impairment or bone marrow suppression, the dose should be reduced accordingly.
 
Cisplatin solution for infusion prepared according to the instructions (see section 6.6) should be administered by intravenous infusion over 6 to 8 hours.
 
Adequate hydration should be maintained 2 to 12 hours before and for at least 6 hours after administration of cisplatin. Hydration is necessary to create the necessary diuresis during and after treatment with cisplatin. This is achieved by intravenous infusion with one of the following solutions: 0.9% sodium chloride solution.
 
Method of administration
 
Cisplatin 1 mg/ml sterile concentrate must be diluted before administration. For instructions on dilution of the product before administration, see section 6.6.
 
The diluted solution must only be administered intravenously by infusion (see below). For administration,
 
any device containing aluminium that may come into contact with cisplatin (intravenous infusion sets, needles, catheters, syringes) should be avoided.
 
Hydration prior to cisplatin treatment:
 
Intravenous infusion of 100-200 ml/hour for 6 to 12 hours, in a total amount of at least 1 litre
 
Hydration after completion of cisplatin administration:
 
Intravenous infusion of a further 2 litres at a rate of 100-200 ml/hour for 6 to 12 hours.
 
If urine output is less than 100-200 ml/hour after hydration, forced diuresis is necessary. This can be achieved by intravenous administration of 37.5 g mannitol as a 10% solution (mannitol 375 ml 10% solution) or by administration of a diuretic if renal function is normal.
 
Administration of mannitol or a diuretic is also necessary when the administered dose of cisplatin is greater than 60 mg/m2.
 
The patient must consume large amounts of fluids for 24 hours after cisplatin infusion to ensure adequate urine output.
Contraindications
 
Hypersensitivity to cisplatin or to any of the excipients listed in section 6.1.
 
Cisplatin may cause allergic reactions in some patients. Use is contraindicated in patients with a history of allergic reaction to cisplatin or other platinum compounds or to any component of the formulation. Cisplatin induces nephrotoxicity, which is cumulative. Therefore, this medicinal product is contraindicated in patients with pre-existing renal impairment.
 
Cisplatin has also been shown to be neurotoxic in the event of accumulation in the body (in particular, ototoxic) and should not be administered to patients with pre-existing hearing impairment. Cisplatin is also contraindicated in patients with myelosuppression and in those who are dehydrated. Patients receiving cisplatin should not breast-feed (see section 4.6).
 
Concomitant administration of yellow fever vaccine is contraindicated.
 
Warnings
 
This agent should only be administered under the supervision of oncologists in specialized units, under conditions that allow for adequate monitoring and surveillance. Life support equipment should be available to control anaphylactic reactions.
 
Cisplatin reacts with aluminum, forming a black platinum precipitate. All IV sets, needles, catheters, and syringes containing aluminum should be avoided.
 
The infusion solution should not be mixed with other drugs or additives.
 
Proper monitoring and management of the treatment and its complications are possible only if strict conditions for adequate diagnosis and accurate treatment are available.
 
Nephrotoxicity
 
Cisplatin produces severe cumulative nephrotoxicity, which may be potentiated by the administration of aminoglycoside antibiotics. Serum creatinine, plasma urea or creatinine clearance, and magnesium, sodium, potassium, and calcium levels should be measured before initiation of therapy and before each subsequent cycle. Cisplatin should not be administered more frequently than once every 3-4 weeks.
 
A urine output of 100 mL/hour or greater tends to reduce the nephrotoxicity of cisplatin. This can be achieved by prior hydration with 2 liters of an appropriate intravenous solution and similar hydration after cisplatin treatment (recommended amount 2,500 mL/m2/24 hours). If intensive hydration is not sufficient to maintain an adequate urine output, an osmotic diuretic (e.g., mannitol) can be administered.
 
Neuropathy
 
Cases of severe neuropathy have been reported.
 
These neuropathies may be irreversible and are manifested by paraesthesia, areflexia, loss of proprioception and a perception of vibrations. Loss of motor function has also been reported. Regular neurological consultation is recommended.
 
Neurotoxicity appears to be cumulative. The absence of symptoms of peripheral neuropathy should be established before each treatment cycle.
 
Ototoxicity
 
Ototoxicity has been observed in up to 31% of patients treated with cisplatin at a single dose of 50 mg/m2 and is manifested by tinnitus and/or hearing impairment at high frequencies (between 4000 Hz and 8000 Hz).