Vincristine-Richter
Instructions for use:
- 1. Release form and composition
- 2. Indications for use
- 3. Contraindications
- 4. Method of application and dosage
- 5. Side effects
- 6. Special instructions
- 7. Drug interactions
- 8. Analogs
- 9. Terms and conditions of storage
- 10. Terms of dispensing from pharmacies
Vincristine-Richter is an antineoplastic agent.
Release form and composition
The dosage form of the drug is a lyophilisate for the preparation of a solution for intravenous administration, white or white with a slight yellowish tinge (in dark glass vials, 10 vials in a cardboard box complete with 10 ampoules of solvent).
The active substance is vincristine sulfate, 1 mg in 1 bottle.
The excipient is lactose.
The solvent contains: benzyl alcohol, sodium chloride, water for injection (up to 10 ml).
Indications for use
- Acute leukemia;
- Neuroblastoma;
- Choriocarcinoma of the uterus;
- Hodgkin's disease;
- Non-Hodgkin lymphomas;
- Wilms tumor;
- Ewing's sarcoma;
- Rhabdomyosarcoma;
- Kaposi's sarcoma;
- Multiple myeloma.
Contraindications
- Neurodystrophic pathologies, including the demyelinated form of Charcot-Marie-Tooth syndrome;
- Concurrent radiation therapy involving the liver area;
- Pregnancy and lactation;
- Hypersensitivity to the main and / or auxiliary components of the drug.
The drug is used with caution in suppression of bone marrow hematopoiesis, decreased liver function, a history of neuropathy, acute infectious diseases, previous chemotherapy or radiotherapy, as well as in elderly patients.
Method of administration and dosage
Vincristine-Richter is for intravenous administration only.
The injection is carried out 1 time in 7 days for 1 minute, avoiding extravasation.
To obtain an injection solution, the lyophilisate is mixed with a solvent, the content of vincristine in 1 ml of the mixture is 0.1 mg. If necessary, the resulting solution can be diluted with 0.9% sodium chloride solution.
The finished solution is injected within 1 minute by jet injection directly into a vein or through an infusion set during drip infusion of 0.9% sodium chloride solution.
The dosage is prescribed by the attending physician individually, taking into account the clinical condition of the patient and the applied therapy regimen.
For adults, a single dose is 1.0-1.4 mg / m2 of body surface, but not more than 2 mg. The maximum dose of the entire course of therapy is 10-12 mg / m2.
The initial dose for children weighing up to 10 kg is determined at the rate of 0.05 mg per 1 kg of body weight per week. For children weighing more than 10 kg, the drug is prescribed at a dose of 1.5-2.0 mg / m2 of body surface.
For patients with reduced liver function, it is recommended to reduce the dose of vincristine by 2 times.
Side effects
The manifestation of side effects depends on the dose used and is usually reversible:
- From the side of the central and peripheral nervous system: neuralgia, convulsions with increased blood pressure, paresthesia, neuropathy, pain in the jaws, pharynx and in the parotid glands, depression, severe headache, dizziness, sleep disturbances, hallucinations, decreased muscle strength, gait disturbance, loss of deep tendon reflexes, ataxia, ptosis, transient blindness, optic atrophy, nystagmus, diplopia, hearing loss. The neurotoxicity of the drug is a dose-limiting factor;
- On the part of the cardiovascular system: increase or decrease in blood pressure. When using Vincristine-Richter as part of polychemotherapy in patients with previously irradiated mediastinum, there is a possibility of angina pectoris and myocardial infarction;
- From the digestive system: anorexia, nausea, abdominal pain, vomiting, constipation or diarrhea, paralytic intestinal obstruction (more often in children), necrosis and / or perforation of the small intestine, stomatitis;
- From the endocrine system: rarely - a syndrome caused by a violation of the secretion of antidiuretic hormone, the consequences of which lead to hyponatremia;
- From the urinary system: bladder atony, polyuria, dysuria, edema, hyperuricemia and nephropathy;
- On the part of the respiratory system: when used simultaneously with mitomycin C - severe shortness of breath and bronchospasm;
- From the hematopoietic system: rarely - moderate leukopenia, anemia, thrombocytopenia;
- Allergic reactions: skin rash, anaphylaxis, edema;
- Other side effects: alopecia, weight loss, fever, azoospermia, myalgia, arthralgia, amenorrhea.
If a solution of vincristine gets under the skin, inflammation of the subcutaneous fat, phlebitis, and necrosis of surrounding tissues may occur.
Pediatric patients generally tolerate cancer therapy more easily than adults.
Elderly patients are especially susceptible to neurotoxicity.
special instructions
Treatment is carried out under the supervision of a specialist in anticancer chemotherapy.
Intrathecal administration is strictly prohibited, it can lead to death.
During treatment, regular hematological monitoring should be carried out. When diagnosing leukopenia, special care should be taken when administering repeated doses. In case of an increase in the level of uric acid, the patient should be prescribed drugs that inhibit its synthesis.
With an increase in the level of liver function tests, the dose of the drug should be reduced.
It is recommended to conduct regular studies to determine the level of sodium ions in the blood serum; in case of hyponatremia, appropriate solutions should be administered.
Particular attention should be paid to patients with a history of neuropathy.
If signs of neurotoxicity appear, the drug should be discontinued.
Immediately stop the administration of the solution in case of extravasation, and the unused dose of the drug must be injected into another vein.
During the period of treatment, the regularity of the intestines is maintained by taking laxatives or using an enema.
Patients should use reliable contraception, both during treatment and for 3 months after.
If there is pain in the eyes or a sensation of a sharp decrease in vision, an ophthalmologic examination should be performed.
In case of contact with eyes, rinse immediately with plenty of water.
During the period of treatment, it is recommended to refrain from work, the performance of which requires an increased concentration of attention and speed of psychomotor reactions, including driving.
Drug interactions
Vincristine-Richter can only be diluted with 0.9% sodium chloride solution.
You can not use the drug with CYP3A4 inhibitors, this combination leads to a decrease in the metabolic rate of vincristine and increases its toxic effects on the body.
CYP3A4 isoenzyme inducers reduce the effectiveness of the drug.
Verapamil increases the toxicity of vincristine.
Simultaneous administration of the drug with prednisolone and other myelosuppressive drugs may enhance the inhibition of bone marrow hematopoiesis.
Prescribing in combination with neurotoxic drugs such as nifedipine, itroconazole, isoniazid can increase side effects from the nervous system.
The simultaneous use of vincristine with uricosuric agents increases the risk of nephropathy; ototoxic drugs - negatively affects the hearing organs; mitomycin C - can cause severe bronchospasm.
The drug reduces the effectiveness of digoxin, phenytoin, ciprofloxacin, anti-gout drugs.
Vincristine-Richter should be administered first, 12-24 hours before the use of L-asparaginase, if a complex treatment is necessary.
Do not mix vincristine with other medicines in the same syringe.
Analogs
Vincristine-Richter analogs are: Vincristine-Teva, Vero-Vincristine, Vinorelbin, Vinkarelbin, Vinkatera, Vinelbin, Velbin, Vinblastine, Zhavlor, Navelbin, Navelbin, Maverex, Rosevin, Tsituvin.
Terms and conditions of storage
Store in a dark place at a temperature of 2 to 8 ° C. Keep out of the reach of children.
The shelf life is 3 years.
Terms of dispensing from pharmacies
Dispensed by prescription.
Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!
