Platol Special Precautions



Venus Remedies


Full Prescribing Info
Special Precautions
Cisplatin reacts with metallic aluminium to form a black precipitate of platinum. All aluminium containing IV sets, needles, catheters and syringes should be avoided.
Cisplatin may only be administered under the supervision of a physician qualified in oncology with experience in the use of antineoplastic chemotherapy.
Appropriate monitoring and management of the treatment and its complications are only possible if adequate diagnosis and exact treatment conditions are available.
Cisplatin is proven to be cumulative ototoxic, nephrotoxic, and neurotoxic. The toxicity caused by cisplatin may be amplified by the combined use with other medicinal products, which are toxic for the said organs or systems.
Male and female patients during and for at least 6 months after the treatment with cisplatin.
Nephrotoxicity: Cisplatin causes severe cumulative nephrotoxicity. A urine output of 100 mL/hour or greater will tend to minimize cisplatin nephrotoxicity. This can be accomplished by prehydration with 2 litres of an appropriate intravenous solution, and similar post cisplatin hydration (recommended 2,500 mL/m2/24 hours). If vigorous hydration is insufficient to maintain adequate urinary output, an osmotic diuretic may be administered (eg, mannitol). Hyperuricaemia and hyperalbuminaemia may predispose to cisplatin-induced nephrotoxicity.
Neuropathies: Severe cases of neuropathies have been reported.
These neuropathies may be irreversible and may manifest by paresthesia, areflexia and a proprioceptive loss and a sensation of vibrations. A loss of motor function has also been reported. A neurologic examination must be carried out at regular intervals. Special caution must be exercised for patients with peripheral neuropathy not caused by cisplatin.
Ototoxicity: Ototoxicity has been observed in up to 31% of patients treated with a single dose of cisplatin 50mg/m2, and is manifested by tinnitus and/or hearing loss in the high frequency range (4000 to 8000Hz). Decreased ability to hear conversational tones may occur occasionally. Ototoxic effect may be more pronounced in children receiving cisplatin. Hearing loss can be unilateral or bilateral and tends to become more frequent and severe with repeated doses; however, deafness after initial dose of cisplatin has been reported rarely. Ototoxicity may be enhanced with prior simultaneous cranial irradiation and may be related to peak plasma concentration of cisplatin. It is unclear whether cisplatin induced ototoxicity is reversible. Careful monitoring by audiometry should be performed prior to initiation of therapy and prior to subsequent doses of cisplatin. Vestibular toxicity has also been reported.
Before, during and after administration of cisplatin, the following parameters resp. organ functions must be determined: Renal function; Hepatic function; Haematopoiesis functions (number of red and white blood cells and blood platelets); Serum electrolytes (calcium, sodium, potassium, magnesium).
These examinations must be repeated every week over the entire duration of the treatment with cisplatin. Repeating administration of cisplatin must be delayed until normal values are achieved for the following parameters: Serum creatinine < 130 μmol/l rsp. 1.5 mg/dl,
Urea < 25 mg/dl,
White blood cells > 4.000/μl resp. > 4.0 x 109/l,
Blood platelets > 100.000/μl resp. > 100 x 109/l.
Audiogram: results within the normal range.
Allergic phenomena: As with other platinum-based products, hypersensitivity reactions appearing in most cases during perfusion may occur, and necessitate discontinuation of the perfusion and an appropriate symptomatic treatment. Cross reactions, sometimes fatal, have been reported with all the platinum compounds (see Contraindications and Side Effects). Anaphylactic-like reactions to cisplatin have been observed. These reactions can be controlled by administration of antihistamines, adrenaline and/or glucocorticoids.
Hepatic function and haematological formula: The haematological formula and the hepatic function must be monitored at regular intervals.
Carcinogenic potential: In humans, in the rare cases the appearance of acute leukaemia has coincided with use of Cisplatin, which was in general associated with other leukaemogenic agents. Cisplatin is a bacterial mutagen and causes chromosome aberrations in cultures on animal cells. Carcinogenicity is possible but has not been demonstrated. Cisplatin is teratogenetic and embryo toxic in mice.
Injection site reactions: Injection site reactions may occur during the administration of cisplatin. Given the possibility of extravasation, it is recommended to closely monitor the infusion site for possible infiltration during drug administration. A specific treatment for extravasation reactions is unknown at this time.
Preparation of the intravenous solution: As with all other potentially toxic products, precautions are essential when handling the cisplatin solution. Skin lesions are possible in the event of accidental exposure to the product. It is advisable to wear gloves. In the event the cisplatin solution comes into contact with the skin or mucous membranes, wash the skin or mucous membranes vigorously with soap and water.
Conforming to the procedures appropriate for the manipulation and elimination of cytostatic agents is recommended.
Before administering the solution to the patient, verify the clarity of the solution and the absence of particles.
Special care is required for patients with acute bacterial or viral infections.
Male and female patients have to use effective contraception during and for at least 6 months after the treatment with cisplatin.
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