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indications:
Treatment of: advanced or metastatic testicular cancer, advanced or metastatic ovarian cancer, advanced or metastatic bladder cancer, advanced or metastatic squamous head and neck cancer, advanced or metastatic non-small cell lung cancer, advanced or metastatic small cell lung cancer. In combination with radiotherapy for the treatment of cervical cancer. Cisplatin can be used as monotherapy and in combination therapy.
Composition:
1 ml concentrate for solution for infusion contains 1 mg cisplatin.
Action:
Contraindications:
Hypersensitivity to cisplatin or to other medicines containing platinum or any of the excipients. Patients with bone marrow depression, dehydrated patients and patients with impaired renal or hearing impairment. Breast-feeding. Co-administration of a yellow fever vaccine.
Precautions:
Pregnancy and lactation:
Cisplatin used during pregnancy has a toxic effect on the fetus. Cisplatin can be used during pregnancy only if the benefits of treatment outweigh the potential risk to the fetus. During treatment with cisplatin and for at least 6 months after treatment, effective contraception should be used. This applies to patients of both sexes. If the patient is planning offspring after the end of treatment, a genetic consultation is recommended. Breastfeeding during treatment with cisplatin is contraindicated. Cisplatin can cause chromosomal aberration in human sperm. Men undergoing treatment with cisplatin should use effective methods of contraception and consider the possibility of freezing semen prior to treatment because of possible irreversible infertility.
Side effects:
Very common: bone marrow failure, thrombocytopenia, leukopenia, anemia, hyponatremia, fever. Common: sepsis, arrhythmias, bradycardia, tachycardia. Uncommon: anaphylactoid reactions, hypomagnesemia, ototoxicity, spermatogenesis disorders. Rare: acute leukemia, convulsions, peripheral neuropathy, leukoencephalopathy, reversible posterior leukoencephalopathy syndrome, myocardial infarction, and oral mucositis. Very rare: cardiac arrest. Frequency unknown: infections (infectious complications, fatal cases in some patients), haemolytic anemia with positive Coombs test, increased amylase, inadequate antidiuretic hormone secretion, dehydration, hypokalemia, hypophosphatemia, hyperuricemia, hypocalcemia, tetany, cerebrovascular incident, hemorrhagic stroke, lack of taste due to hemorrhagic stroke, ischemic stroke, cerebral arteritis, Lhermitte's symptom, myelopathy, autonomic neuropathy, blurred vision, acquired color blindness, cortical blindness, optic neuritis, optic nerve edema, retinal pigmentation, tinnitus, deafness, cardiac dysfunction, thrombotic microangiopathy (haemolytic-uremic syndrome), Raynaud's phenomenon, nausea, vomiting, anorexia, hiccups, diarrhea, increased liver enzymes, increased bilirubin in the blood, pulmonary embolism, high tachycardia, alopecia, muscle spasms, acute renal failure, renal failure (including increased blood urea nitrogen and creatinine, uric acid in serum and / or decrease in creatinine clearance), renal tubular disorders, weakness, malaise, extravasation in place applications (local toxic effects on soft tissue caused by extravasation include: inflammation of the subcutaneous tissue, fibrosis and necrosis - often, pain - often, swelling - often and erythema - often).
Dosage:
Cisplatin is used alone or in combination with other chemotherapeutics only under the strict supervision of qualified medical personnel experienced in the treatment of cytostatics. It is important to avoid any contact of cisplatin with needles or intravenous infusion sets that contain aluminum parts. Aluminum reacts with the drug, which causes sediment formation and loss of activity.Adults and children: the dose depends on the underlying disease, the expected response to treatment, and whether cisplatin is used as a monotherapy or as part of combination chemotherapy. Dosage guidelines apply to both adult and pediatric patients.monotherapy. The usual dose used as monotherapy, administered intravenously is 50-120 mg / m2 pc. once, every 3 to 4 weeks or 15-20 mg / m2 pc. every day for 5 days, every 3 to 4 weeks.Combination therapy. When the drug is used in combination with other cytostatics, this may require dose adjustment. The usual dose of cisplatin in combination with other chemotherapeutics is 20 mg / m2 pc. administered once, every 3 to 4 weeks. In the treatment of cervical cancer, cisplatin is used in combination with radiotherapy. The standard dose is 40 mg / m2 pc. weekly for 6 weeks. Do not repeat the treatment cycle until your kidney function is within the normal range (serum creatinine ≤130 μmol / l, 1.5 mg / 100 ml and (or) your blood urea nitrogen, respectively < 25 mg / 100 ml). Do not repeat the course of treatment until the number of blood cells does not reach acceptable values (platelets> 100,000 / mm3white blood cells> 4,000 / mm3). Before starting treatment and any new treatment cycle, audiometric tests are required to detect any hearing changes. In patients with impaired renal function or inhibited bone marrow function, a dose adjustment is necessary. Cisplatin prepared according to the instructions should be administered via intravenous infusion over 6-8 h. It is necessary to maintain adequate hydration by intravenous infusion, 2 to 12 h before administration and for at least 6 h after cisplatin administration. Hydration is necessary to induce sufficient diuresis in time and after using cisplatin. This can be achieved by intravenous infusion with one of the following solutions: 0.9% sodium chloride solution; combination of 0.9% sodium chloride solution with 5% Glucose solution (1: 1). Hydration prior to cisplatin administration: intravenous infusion administered at a rate of 100-200 ml / h for 6-12 h, with a total volume of at least 1 l. Hydration after cisplatin treatment is completed: intravenous infusion of another 2 liters administered at a rate of 100-200 ml / h for 6-12 h. If renal excretion after hydration is less than 100-200 ml / h, it may be necessary to use forced diuresis. Forced diuresis may be induced by intravenous administration of 37.5 g mannitol in the form of a 10% solution or by administration of a diuretic, if the kidney function is normal. Administration of mannitol or a diuretic is also recommended when the cisplatin dose used is greater than 60 mg / m2 pc. In order to ensure the excretion of adequate amounts of urine, the patient should drink large amounts of fluids 24 h after completion of the cisplatin infusion.
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