Vincristinum Richter

Vincristinum Richter – antineoplastic means.

Form of release and structure

Dosage form of drug – lyophilisate for preparation of solution for intravenous administration, color, white or white with a subtle yellowish shade (in bottles of dark glass, on 10 bottles in a cardboard pack complete with 10 ampoules of solvent).

Active agent – Vincristinum sulfate, in 1 bottle of 1 mg.

Excipient – lactose.

Are a part of solvent: benzyl alcohol, sodium chloride, water for injections (to 10 ml).

Indications to use

• Acute leukosis;
• Neuroblastoma;
• Uterus choriocarcinoma;
• Hodzhkin's disease;
• Nekhodzhkinsky lymphoma;
• Vilms's tumor;
• Ewing's sarcoma;
• Rhabdomyosarcoma;
• Kaposha's sarcoma;
• Multiple myeloma.

Contraindications

• Neurodystrophic pathologies, including the demyelinated form of a syndrome of Sharko-Mari-Tuta;
• Simultaneous radiation therapy with involvement of area of a liver;
• Pregnancy and period of feeding by a breast;
• Hypersensitivity to the basic and/or auxiliary components of drug.

With care use drug at oppression of a marrowy hemopoiesis, liver depression of function, existence of the neuropathy in the anamnesis, acute infectious diseases preceding chemotherapy or radiotheraphy and also at patients of advanced age.

Route of administration and dosage

Vincristinum Richter is intended only for intravenous administration.

Injection carry out 1 time in 7 days within 1 minute, without allowing an ekstravazation.

For receiving injection solution lyophilisate is mixed with solvent, the maintenance of Vincristinum in 1 ml of mix - 0,1 mg. If necessary the received solution it is possible to dilute 0,9% with sodium chloride solution.

Ready solution is entered within 1 minute by a jet injection directly into a vein or through infusional set during drop injection of 0,9% of solution of sodium chloride.

The dosage is appointed by the attending physician individually, taking into account a clinical condition of the patient and the applied scheme of therapy.

For adults the single dose makes 1,0-1,4 mg/sq.m of a body surface, but no more than 2 mg. The maximum dose of all course of therapy – 10-12 mg/sq.m.

The initial dose for children weighing up to 10 kg is defined at the rate of 0,05 mg on 1 kg of body weight a week. To children weighing more than 10 kg drug appoint 1,5-2,0 mg/sq.m of a body surface in a dose.

For patients with reduced function of a liver the dose of Vincristinum is recommended to be reduced twice.

Side effects

Manifestation of side effects depends on the applied dose and usually has reversible character:

• From the central and peripheral nervous system: neuralgia, spasms with increase in arterial pressure, paresthesia, neuropathy, jaw, drink pain and in the field of parotid glands, a depression, a severe headache, dizziness, sleep disorders, hallucinations, decrease in an animal force, gait disturbance, loss of deep tendon jerks, an ataxy, a ptosis, a passing blindness, an atrophy of an optic nerve, a nystagmus, a diplopia, decrease in hearing. The neurotoxicity of drug is the factor limiting a dose;
• From cardiovascular system: increase or lowering of arterial pressure. At use of Vincristinum Richter as a part of polychemotherapy patients with earlier irradiated mediastinum, have a probability of developing of stenocardia and myocardial infarction;
• From the alimentary system: anorexia, nausea, abdominal pains, vomiting, a lock or diarrhea, paralytic intestinal impassability (is more often at children), a necrosis and/or perforation of a small intestine, stomatitis;
• From endocrine system: seldom – the syndrome caused by disturbance of secretion of antidiuretic hormone which effects lead to a hyponatremia;
• From an urinary system: bladder atony, polyuria, dysuria, hypostases, hyperuricemia and nephropathy;
• From respiratory system: at simultaneous use with mitomitsiny With – a heavy asthma and a bronchospasm;
• From system of a hemopoiesis: seldom – a moderate leukopenia, anemia, thrombocytopenia;
• Allergic reactions: skin rash, anaphylaxis, hypostases;
• Other side effects: alopecia, decrease in body weight, fervescence, azoospermism, mialgiya, arthralgia, amenorrhea.

At Vincristinum solution hit under skin there can be an inflammation of a hypodermic fatty tissue, phlebitis, a necrosis of surrounding fabrics.

Patients of children's age usually transfer antineoplastic therapy easier, than adults.

Patients of advanced age are especially subject to influence of a neurotoxicity.

Special instructions

Treatment is carried out under observation of the specialist in antineoplastic chemotherapy.

Intrathecal introduction is strictly forbidden, it can lead to death.

During treatment it is necessary to exercise regular hematologic control. When diagnosing a leukopenia it is necessary to observe extra care at introduction of repeated doses. In case of increase in level of uric acid the patient should appoint the drugs inhibiting its synthesis.

At increase in level of hepatic tests the dose of drug should be reduced.

Carrying out regular researches on determination of level of maintenance of ions of sodium in blood serum is recommended, in case of a hyponatremia it is necessary to enter the corresponding solutions.

Special attention should be paid to patients with neuropathy in the anamnesis.

In case of signs of a neurotoxicity it is necessary to cancel drug use.

To immediately stop administration of solution in case of an ekstravazation, and the unused dose of drug needs to be entered into other vein.

During treatment the regularity of work of intestines is supported by reception of purgatives or by means of an enema.

Patients have to use well-tried remedies of contraception, both during treatment, and within 3 months later.

At emergence of pain in eyes or feeling of sharp decrease in sight it is necessary to conduct ophthalmologic examination.

In case of hit of solution in eyes – it is necessary to wash out immediately them a large amount of water.

During treatment it is recommended to refrain from works which performance demands the increased concentration of attention and speed of psychomotor reactions, including control of vehicles.

Medicinal interaction

It is possible to dilute Vincristinum Richter only 0.9% with sodium chloride solution.

It is impossible to use drug with CYP3A4 inhibitors, such combination leads to reduction of speed of metabolism of Vincristinum and promotes increase in its toxic impact on an organism.

Inductors of isoenzymes CYP3A4 reduce efficiency of drug.

Verapamil increases toxicity of Vincristinum.

The concomitant use of drug with Prednisolonum and other myelosuppressive medicines can promote strengthening of oppression of a marrowy hemopoiesis.

Appointment in a combination with neurotoxic drugs, such as nifedipine, итроконазол, an isoniazid can strengthen side effects from a nervous system.

Simultaneous use of Vincristinum with uricosuric means increases risk of a nephropathy; ototoksichesky drugs – negatively influences acoustic organs; mitomitsiny With – can cause a heavy bronchospasm.

Drug reduces efficiency of effect of digoxin, Phenytoinum, ciprofloxacin, antigouty means.

The first need to enter Vincristinum Richter, in 12-24 hours prior to L-asparaginase use, in case of need complex treatment.

It is impossible to mix Vincristinum with other medicines in one syringe.

Terms and storage conditions

To store in the place protected from light at a temperature from 2 to 8 °C. To protect from children.

Period of validity – 3 years.