Vinblastine-LENS - instructions for use, dose, side effects, contraindications

Active substanceVinblastineVinblastine

Similar drugsTo uncover

Vinblastine-LENS®

lyophilizate in / in

LENS-PHARM, LLC Russia

Vinblastine Richter

lyophilizate in / in

GEDEON RICHTER, OJSC Hungary

Dosage form: & nbsplyophilizate for the preparation of a solution for intravenous administration

Composition:

1 bottle contains:

active substance: vinblastine sulfate 5 mg;

Excipients: no.

Description:

From white to white with a yellowish shade of color, a porous mass.

Pharmacotherapeutic group:Antitumor agent - alkaloid

ATX: & nbsp

L.01.C.A.01 Vinblastine

L.01.C.A Vinca alkaloids and its analogues

Pharmacodynamics:Vinblastine is an alkaloid isolated from a plant of the genus Vinca Periwinkle. It blocks mitotic division of cells in the metaphase of the cell cycle. The action exerts, by contacting microtubules, by inhibiting the formation of mitotic spindles. In tumor cells, the synthesis of DNA and RNA selectively inhibits the inhibition of DNA-dependent RNA polymerase.

Pharmacokinetics:

After intravenous administration, it is quickly distributed in the tissues. Does not penetrate the blood-brain barrier. Binding to proteins is 80%. Metabolised in the liver. It is excreted from the body in three phases with half-lives of duration (average values) of 5 minutes, 2 hours and 30 hours, mainly with bile,, respectively.A small amount of vinblastine in unchanged form and in the form of metabolites is determined in urine.

Indications:

- Lymphogranulomatosis;

- non-Hodgkin's lymphomas;

- choriocarcinoma (resistant to the use of other chemotherapeutic drugs);

- a neuroblastoma;

germinogenic tumors of testis and ovaries;

- Head and neck tumors;

- mammary cancer;

- lung cancer;

- kidney cancer;

- bladder cancer;

- Leterer-Sieve disease (histiocytosis X);

- Kaposi's sarcoma;

mushroom mycosis (generalized stages).

Contraindications:

- Pincreased sensitivity to vinblastine;

- marked suppression of bone marrow function;

- pregnancy and the period of breastfeeding.

Carefully:

With a preliminary or simultaneous myelosuppressive chemotherapy and radiation therapy, as well as in old age, with leukopenia, thrombocytopenia and liver damage.

Dosing and Administration:

Intravenously struined for 1-2 minutes.

Intrathecal use is prohibited!

The dose should be selected taking into account the individual characteristics of the patient and the chemotherapy regimen used, guided by the data of the special literature.

The usual dose is:

- for adults: 5-7.5 mg / m body surface area:

- for children: 4 to 5 mg / m² surface of the body.

The drug is administered once a week or 2 weeks.

Modes of a gradual increase in weekly doses can also be used:

- for adults: 1st dose - 3.7 mg / m², each subsequent weekly dose, with a leukocyte count of at least 4000 / mm³ blood, increased by 1.8-1.9 mg / m²body surface until the maximum single dose of 18.5 mg / m²;

- for children: weekly increase in doses by 1.25 mg / m² carried out on the same principle as in adults, starting with an initial dose of 2.5 mg / m² body surface and up to a maximum dose of 12.5 mg / m².

Doses increase until the number of white blood cells decreases to 3000 / mm³, either the size of the tumor will not decrease or the maximum single dose will not be reached, and then proceed to maintenance doses that are less than the final initial dose for adults by 1.8-1.9 mg / m² and for children at 1.25 mg / m² The surface of the body is injected once every 7-14 days.

At a level of bilirubin in the serum above 51.3 μmol / l, a dose reduction of 50% is recommended.

Apply a freshly prepared solution, for which the contents of the bottle immediately before injection are dissolved in 5 ml of 0.9% sodium chloride solution (other solutions are not recommended).

Side effects:

On the part of the hematopoiesis system: most often leukopenia, granulocytopenia (the lowest level is observed 5-10 days after the last administration, the complete recovery usually occurs within the next 7-14 days); less thrombocytopenia, anemia.

From the gastrointestinal tract: nausea, vomiting, constipation, diarrhea, abdominal pain, paralysis of the intestine, stomatitis, pharyngitis, hemorrhagic enterocolitis or bleeding with an already existing ulcer.

From the nervous system: paresthesia, decrease or loss of deep tendon reflexes, peripheral neuritis, depression, headache, convulsions, dizziness, diplopia, weakness, pain in the jaw area.

Allergic reactions: urticaria, bronchospasm.

Local Reactions: pain or redness at the injection site; when the product gets under the skin - inflammation of the subcutaneous fat, phlebitis, and possibly necrosis.

Other: alopecia, hyperuricemia, uric acid nephropathy, myalgia, bone pain, increased blood pressure, increased symptoms in Raynaud's disease, azoospermia, amenorrhea.

When appointing doses above recommended, the syndrome of inadequate secretion of antidiuretic hormone is noted.

Overdose:

In case of an accidental overdose, side effects should be expected to worsen.

There is no specific antidote.

Treatment symptomatic. The following measures are recommended: restriction of fluid intake and the appointment of diuretics in the development of the syndrome of inadequate secretion of antidiuretic hormone; the appointment of anticonvulsants; control of cardiovascular function; careful monitoring of the blood picture, if necessary - blood transfusion; the use of enemas and laxatives (prevention of intestinal obstruction).

Hemodialysis is ineffective in case of an overdose of Vinblastine.

Interaction:

It is forbidden to enter together:

- with neurotoxic drugs (isoniazid, L-asparhinase).

FROM caution can be applied:

- with mitomycin C (acute dyspnea, bronchospasm may occur);

- with phenytoin (the level of phenytoin in the blood decreases, which can lead to a decrease in its anticonvulsant activity);

- when combined vinblastine can increase the toxicity of antidotal agents;

- With the use of vinblastine in combination with bleomycin and cisplatin, cases of myocardial infarction, cerebral circulation disorders were noted;

- when used in combination with preparations containing platinum, the risk of damage to the VIII pair of CHMN increases.

Special instructions:

During treatment, a careful control of the number of leukocytes is required. With a decrease in the number of white blood cells to 3000 / μl, treatment with Vinblastine-LENS® should be stopped.

To prevent acute urine acid diathesis, it is necessary to systematically monitor the level of uric acid in the serum, provide adequate fluid intake and, if necessary, apply allopurinol.

In the process of treatment, it is also necessary to monitor the activity of liver transaminases, LDH and bilirubin levels.

When symptoms of neurointoxication appear, treatment should be discontinued.

Extravasation leads to a painful local reaction and tissue necrosis, so in such cases, the rest of the drug must be injected into another vein; to the affected area introducing hyaluronidase.

During treatment, non-hormonal contraception should be used.

In case of accidental ingestion of Vinblastine-LENS® in the eye, immediately rinse thoroughly with water to prevent severe irritation or possible ulceration of the cornea.

During the period of treatment, vaccination of patients and their families is not recommended.

Effect on the ability to drive transp. cf. and fur:

Some side effects of the drug, such as neuromuscular effects, can adversely affect the ability to drive and perform potentially dangerous activities that require increased concentration and speed of psychomotor reactions.

Form release / dosage:Lyophilizate for the preparation of a solution for intravenous administration, 5 mg.

Packaging:

In the bottles of neutral or orange glass to 5 mg.

1 bottle with instructions for use in a pack of cardboard.

For 5 or 10 bottles together with instructions for use in a pack with partitions or special cardboard sockets.

For 5 or 10 bottles complete with 5 or 10 ampoules of sodium chloride solution isotonic 0.9% for injections of 5 ml together with the instructions for use and a knife ampoule or scarifier in a pack with septums or special cardboard sockets.When using ampoules with incisions or a rupture ring, the ampoule opener or ampoule scaper is not inserted.

For 25, 50, 85 or 100 vials without ampoules with a solvent with instructions for use, based on one instruction for five bottles, in a box of cardboard (for hospitals).

Storage conditions:At a temperature of 2 to 8 ° C, in a place protected from light and inaccessible to children.

Shelf life:

2 years.

Do not use after the expiration date stated on the package

Terms of leave from pharmacies:On prescription

Registration number:P N000203 / 01

Date of registration:18.01.2012 / 29.07.2016

Expiration Date:Unlimited

The owner of the registration certificate:LENS-PHARM, LLC LENS-PHARM, LLC Russia

Manufacturer: & nbsp

LENS-PHARM, LLC Russia

Information update date: & nbsp16.02.2017

Illustrated instructions

Instructions

Vinblastine-LENS® (Vinblastin-LANS®)