Vinblastine-Richter

2024 Author: Rachel Wainwright | [email protected]. Last modified: 2023-12-15 07:39

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

Vinblastine-Richter is a herbal anticancer drug.

Release form and composition

The dosage form of Vinblastine-Richter is a lyophilisate for preparing a solution for intravenous (intravenous) administration: a porous mass of yellowish-white or white color; solvent - colorless, transparent, without mechanical impurities (lyophilisate - in brown glass bottles of 5 mg; solvent - in colorless glass ampoules of 5 ml; 1 bottle and 1 ampoule in plastic trays, in a cardboard box 10 pallets).

The active ingredient in 1 bottle: vinblastine sulfate - 5 mg.

The composition of the solvent (0.9% sodium chloride solution): sodium chloride, water for injection.

Indications for use

non-Hodgkin lymphomas;
Hodgkin's disease;
germ cell tumors of the testicle and ovaries;
chronic lymphocytic leukemia;
Kaposi's sarcoma;
bladder cancer;
fungal mycosis (generalized stages);
Letterer's disease - Siwe (histiocytosis X).

Contraindications

Absolute:

pronounced inhibition of bone marrow function;
viral / bacterial infections;
pregnancy and the period of breastfeeding;
individual intolerance to the components of the drug.

Relative (diseases / conditions in which Vinblastine-Richter should be used with caution):

thrombocytopenia;
recent or ongoing myelosuppressive chemotherapy or radiotherapy;
hyperuricemia;
leukopenia;
functional disorders of the liver;
elderly age.

Method of administration and dosage

Vinblastine-Richter can only be administered intravenously. Extravasation should be avoided, intrathecal administration is prohibited.

The dosage regimen is determined individually based on the characteristics of the patient and the chemotherapy regimen used.

Standard single dose:

adults: 5.5–7.4 mg / m2 ^of body surface;
children: 3.75–5 mg / m2 ^of body surface.

The frequency of administration is 1 time in 7 or 14 days.

Modes with a Monday increase in doses can also be applied:

adults: the first dose is 3.7 mg / m ², after which every week the dose is increased by 1.8-1.9 mg / m ² until reaching the maximum - 18.5 mg / m ² (with a leukocyte count of at least 4000 / μl of blood);
children: the first dose is 2.5 mg / m ², after which every week the dose is increased by 1.25 mg / m ² until the maximum is 12.5 mg / m ².

The dose is increased until one of three conditions is met:

a decrease in the number of leukocytes to 3000 / μl;
decrease in tumor size;
reaching the maximum single dose.

After this, the patient is transferred to maintenance doses that are less than the final value of the last dose (adults - by 1.8-1.9 mg / m ², children - by 1.25 mg / m ²), administered 1 time in 7-14 days …

With a serum bilirubin level in the blood above 3 mg / 100 ml, it is recommended to reduce the dose by 2 times.

You need to introduce a freshly prepared solution. For its preparation, the lyophilized powder contained in the vial should be dissolved in the supplied solvent immediately before administration. If necessary, the drug can be diluted with 0.9% sodium chloride solution to a concentration of 1 mg / 1 ml. Do not use other solutions.

Side effects

hematopoietic system: most often - leukopenia, granulocytopenia (the lowest level is usually observed 5-10 days after the last injection, in most cases, full recovery occurs within the next 1-2 weeks); less often - anemia, thrombocytopenia;
nervous system: peripheral neuritis, diplopia, paresthesia, decrease or loss of deep tendon reflexes, dizziness, depression, convulsions, headache, weakness, pain in the jaw, neuritis of the VIII pair of cranial nerves (complete / partial deafness, nystagmus, dizziness);
digestive system: nausea, constipation, vomiting, stomatitis, pharyngitis, hemorrhagic enterocolitis, decreased appetite, diarrhea, paralytic intestinal obstruction, pain in the abdominal cavity, bleeding from previously diagnosed ulcers of the gastrointestinal tract;
respiratory system: bronchospasm (usually when combined with mitomycin) with cyanosis, acute respiratory failure, shortness of breath and often with the formation of pneumonitis and pulmonary infiltrates;
cardiovascular system: increased blood pressure, myocardial ischemia, including angina pectoris or myocardial infarction (usually when combined with cisplatin and bleomycin), microangiopathy (Raynaud's syndrome when combined with bleomycin);
local reactions: redness / pain at the injection site, phlebitis; if Vinblastine-Richter gets under the skin - inflammation of the subcutaneous fatty tissue, and, possibly, necrosis;
skin and cutaneous appendages: urticaria, alopecia;
others: uric acid nephropathy, hyperuricemia, fatigue, weakness, ossalgia, myalgia, pain in the area of tumor nodes, amenorrhea and azoospermia (sometimes irreversible). When prescribing doses exceeding the recommended ones, a syndrome of inadequate secretion of antidiuretic hormone is noted.

special instructions

Therapy can only be carried out under the supervision of a physician who has experience in the use of anticancer chemotherapy.

Before starting the injection of the drug, you must make sure that the needle is in the vein. When extravasation of Vinblastine-Richter, it is necessary to immediately stop its introduction, the remaining solution is injected into another vein. It is recommended to introduce hyaluronidase into the affected area.

During therapy, it is necessary to regularly monitor the number of leukocytes, platelets and hemoglobin levels. Also, during the period of treatment, it is necessary to monitor the activity of liver enzymes and serum bilirubin in the blood.

With a decrease in the number of leukocytes to 3000 / μL, Vinblastine-Richter is canceled. Also, the drug is canceled when signs of neurointoxication appear.

To avoid the development of acute uric acid nephropathy, serum uric acid levels in the blood should be regularly monitored and patients should be provided with adequate fluid intake. If necessary, the use of allopurinol is recommended. During treatment, women of childbearing age need to use non-hormonal reliable methods of contraception.

Vaccination with a live viral vaccine during the period of therapy is prohibited.

To prevent severe irritation or possible ulceration of the cornea in case of accidental contact with the drug in the eyes, they should be immediately washed thoroughly with water.

Some adverse reactions (for example, neurotoxicity) can have a negative effect on the ability to drive vehicles. Be careful when performing potentially hazardous work.

Drug interactions

When combined with ototoxic drugs, caution is required.

Conducting therapy simultaneously with neurotoxic drugs (isoniazid, L-asparaginase) is prohibited.

With the combined use of Vinblastine-Richter with certain drugs / substances, the following effects may develop:

phenytoin: a decrease in its plasma concentration, which may cause a decrease in its anticonvulsant activity;
mitomycin: the likelihood of developing acute bronchospasm;
bleomycin: the likelihood of developing Raynaud's syndrome;
bleomycin and cisplatin: there have been cases of cerebrovascular accident, myocardial infarction;
drugs with an action similar to Vinblastine-Richter: increased thrombocytopenic and leukopenic effects (taking into account the blood picture, an adjustment of the vinblastine dose may be required);
drugs with an anti-gout effect (sulfinpyrazone, colchicine, allopurinol, probenicid): an increase in the level of uric acid in the blood (it may be necessary to adjust their doses to prevent the development of hyperuricemia; for prophylactic purposes and for the treatment of hyperuricemia caused by vinblastine, it is advisable to use allopurinol);
medicines containing platinum: an increased risk of damage to the VIII pair of cranial nerves.

The interval between discontinuation of Vinblastine-Richter and vaccination with a live / attenuated viral vaccine is determined by the type and degree of drug immunosuppression, the underlying disease and other factors; it can last 3–12 months.

Analogs

Vinblastine-Richter analogs are: Vinblastine-LENS, Vinblastine-TEVA.

Terms and conditions of storage

Store in a place protected from light at a temperature of 2-8 ° C. Keep out of the reach of children.

Shelf life:

lyophilisate - 2 years;
solvent - 5 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!