Vinorelbin

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

Vinorelbine is an alkaloid, antineoplastic drug.

Release form and composition

Dosage form - concentrate for preparation of solution for infusion: clear liquid from light yellow to colorless (1 ml or 5 ml in a glass bottle, in a cardboard box of 1 or 10 bottles).

1 ml of concentrate contains:

active substance: vinorelbine ditartrate - 13.85 mg, which corresponds to 10 mg of vinorelbine;
auxiliary component: water for injection.

Indications for use

The use of Vinorelbine is indicated for monotherapy and in combination with other antineoplastic agents:

non-small cell lung cancer in a widespread inoperable stage;
refractory or advanced advanced breast cancer after chemotherapy with anthracyclines.

Contraindications

the content of platelets in the blood is less than 75,000 cells / μl, neutrophils are less than 1,500 cells / μl;
a serious illness of an infectious origin, including a period of two weeks after recovery;
severe liver failure, not associated with an oncological process;
period of pregnancy;
breast-feeding;
age up to 18 years;
hypersensitivity to vinca alkaloids.

Vinorelbine should be prescribed with caution in patients with respiratory failure, inhibition of bone marrow hematopoiesis (including against the background of previous radiation or chemotherapy), a history of intestinal obstruction, a history of neuropathy, with constipation, concomitant treatment with inhibitors of the isoenzyme CYP3A4.

Method of administration and dosage

The ready-made solution of the drug is intended exclusively for intravenous (iv) jet slow (5-10 minutes) or drip (within 20-30 minutes) injection.

The concentrate should be diluted in 0.9% sodium chloride solution or 5% dextrose solution to obtain a solution containing 1.5–3 mg vinorelbine in 1 ml.

The doctor determines the dose and mode of administration for each patient individually.

Recommended dosage for monotherapy: at the rate of 25-30 mg per 1 m2 ^of body surface 1 time in 7 days. After each injection of the drug, in order to flush the patient's vein, an additional 250 ml of 0.9% sodium chloride solution should be administered.

The maximum single dose is 60 mg, including for patients with a body surface area of more than 2 m ².

The dosage regimen should be adjusted based on hematological parameters obtained as a result of studies on the day of the next administration of the drug. The level of dose reduction of Vinorelbine depends on the number of neutrophils in the blood:

1500 cells / μL and above: 100% of the usual dose;
1499-1000 cells / μl: 50% of the usual dose;
below 1000 cells / μl: the procedure is canceled. After 7 days, a second analysis is performed to determine the number of neutrophils. With the successive cancellation of three weekly procedures, the use of the drug should be canceled.

If, during the treatment period, against the background of neutropenia, the patient develops fever and / or sepsis, or two weekly administration procedures in a row were missed due to a low neutrophil content, the dose of subsequent injections should be reduced. From the previous dose as a percentage, it should be:

1500 cells / μl and above: 75%;
1499-1000 cells / μl: 37.5%;
below 1000 cells / μl: the drug is canceled.

If, during treatment, the patient develops hyperbilirubinemia, the dose of subsequent injections should be reduced depending on the level of total bilirubin concentration.

Recommended percentage reduction from initial dose of vinorelbine:

less than 34.2 μmol / l: 100%;
35.9-51.3 μmol / L: 50%;
more than 51.3 μmol / l: 25%.

In elderly patients, dose adjustment is not required.

Side effects

from the hematopoietic organs: anemia, neutropenia, thrombocytopenia; with the suppression of bone marrow hematopoiesis - the development of secondary infections, an increase in body temperature over 38 ° C, septicemia, sepsis; extremely rare - complicated septicemia (including fatal);
on the part of the digestive system: nausea, vomiting, stomatitis, anorexia, diarrhea, constipation, a transient increase in the concentration of bilirubin, pancreatitis, increased activity of liver enzymes;
from the immune system: rarely - angioedema, anaphylactic shock;
from the nervous system: headache, paresthesia, hyperesthesia, pain in the jaw region, prolapse or decreased deep tendon reflexes, autonomic neuropathy, peripheral neuropathy, intestinal paresis, weakness in the legs; rarely - transient severe paresthesias with motor and sensory symptoms, paralytic intestinal obstruction;
from the respiratory system: bronchospasm, shortness of breath, acute respiratory distress syndrome; against the background of combination therapy with mitomycin - interstitial pneumonia;
on the part of the cardiovascular system: a decrease or increase in blood pressure, flushing of the face, cold extremities, severe hypotension, ischemic heart disease (myocardial infarction, angina pectoris), pulmonary edema, collapse; extremely rare - palpitations, heart rhythm disturbances, tachycardia;
dermatological reactions: skin rashes, alopecia;
local reactions: at the injection site - pain, burning and / or redness, phlebitis, vein discoloration; in case of extravasation, inflammation of the subcutaneous fat with possible necrosis of adjacent tissues;
others: fever, weakness, pain of various localization (including abdominal pain, pain in joints, muscles, bones, pain in the chest, back, in the area of neoplasms), allergic reactions, hyponatremia, increased creatinine levels, hemorrhagic cystitis, syndrome of inappropriate antidiuretic hormone secretion.

special instructions

The appointment and treatment of Vinorelbin should be carried out by an oncologist with experience in working with anticancer drugs.

Before each procedure for administering the drug in a patient, it is necessary to determine the level of hemoglobin, the number of neutrophils, leukocytes, platelets, since the use of cytostatic agents should be carried out under strict hematological control.

Despite the fact that the contents of the vial after breaking the tightness or the finished solution of the drug retains physical and chemical stability at room temperature for 24 hours, the concentrate should be used immediately after opening the package.

Patients with symptoms of second-degree neurotoxicity or higher should be discontinued from drug therapy.

In case of severe liver dysfunction, the dose should be reduced.

The appearance of dyspnea, hypoxia, and cough of unknown etiology during therapy may be a symptom of pulmonary toxicity, therefore, a thorough examination is required to determine the cause of the malaise.

During the treatment period and within three months after the drug is discontinued, patients of childbearing age must use reliable contraceptives.

There was no increase in hematotoxicity, the number of neutrophils is restored within 5-7 days after their maximum decrease.

Patients with impaired renal function require increased medical supervision.

In case of extravasation, the administration of the drug should be stopped immediately, the remainder of the dose should be injected into another vein.

Do not let the solution get into the eyes; in case of accidental contact, they should be immediately washed thoroughly with water.

Drug interactions

With the simultaneous use of Vinorelbine:

cytostatics contribute to the mutual aggravation of side effects, especially the development of myelosuppression;
mitomycin increases the risk of developing acute respiratory failure;
paclitaxel increases the likelihood of neurotoxicity;
inhibitors and inducers of cytochrome P ₄₅₀ cause disruption of the pharmacokinetics of vinorelbine;
radiation therapy leads to radiosensitization.

Taking the drug after radiation therapy may cause the development of repeated radiation reactions.

Analogs

Vinorelbin analogs are: Velbin, Navelbin, Tsituvin, Vinelbin.

Terms and conditions of storage

Keep out of the reach of children.

Store at 2-8 ° C in a dark place.

Shelf life is 2 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!