Vinorelbine

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Vinorelbine

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Navelbin is used in monotherapy as well as in combination with other anticancer drugs. When choosing a dose and mode of administration in each individual case, refer to the special literature.

Concentrate Navelbina entered strictly IV the form of 6-10-minute infusion.

Capsules are taken internally entirely, drinking water without chewing or dissolving them in the mouth.

In monotherapy mode, the usual dose for IV administration is 25-30 mg / m² body surface once a week. Navelb is diluted in 0.9% sodium chloride solution or 5% dextrose solution to a concentration of 1.0-2.0 mg / ml (average 50 ml). After the introduction of the drug, the vein should be washed, adding an additional at least 250 ml of 0.9% sodium chloride solution or 5% dextrose solution.

For patients with a body surface area of ​​2 m² and more than a single dose of navelbine for iv administration should not exceed 60 mg.

The recommended single initial dose of Navelbina for oral administration is 60 mg / m² body surface once a week. After the third dose is recommended to increase to 80 mg / m².

Increase dosage from 60 mg / m² up to 80 mg / m² It can be carried out if during three weeks of Navelbine administration no 4th degree neutropenia (less than 500 / mcl) was noted, or there was one episode of 3th degree neutropenia (less than 1000 / mcl, but more than 500 / mcl), and the number of neutrophils before the next administration did not below 1500 / mkl.

The minimum number of neutrophils (cells / mcl), recorded in the first 3 weeks of receiving Navelbina orally at a dose of 60 mg / m2 in Week	>1000	≥ 500 and	≥ 500 and
The recommended dose, starting with the 4th dose	80 mg / m2		60 mg / m2

If while taking Navelbina in a dose of 80 mg / m² 4 degrees of neutropenia (less than 500 / μl) or 2 cases of 3 degrees of neutropenia (less than 1000 / μl, but more than 500 / μl) are noted, in the next 3 doses, it is necessary to reduce the dose of Navelbin from 80 to 60 mg / m² in Week.

The minimum number of neutrophils (cells / mcl) recorded in the first 3 weeks of receiving Navelbina orally at a dose of 80 mg / m2 in Week	>1000	≥ 500 and	≥ 500 and	< 500
The recommended dose, starting with the 4th dose	80 mg / m2		60 mg / m2

If the number of neutrophils did not decrease less than 500 / μl, or more than one decrease in the number of neutrophils in the range from 500 to 1000 / μl was observed within three weeks of receiving Navelbine at a dose of 60 mg / m² (according to the above recommendations), you can again increase the dose of the drug from 60 to 80 mg / m² in Week.

The recommended doses of Navelbine for oral administration, depending on the patient's surface area (BSA) are given in the following table.

Body surface area (m2)	60 mg / m2	80 mg / m2
	Dose (mg) per week
0.95 to 1.0	60
From 1.05 to 1.14	70
From 1.15 to 1.24	70
From 1.25 to 1.34	80
1.35 to 1.44	80
1.44 to 1.54	90
1.55 to 1.64	100
1.65 to 1.74	100
1.75 to 1.84	110
1.85 to 1.94	110
1.95 or more	120

For patients with BSA 2 m² and the more common single dose of navelbine for oral administration should never exceed 120 mg per week with the appointment of the drug in a dose of 60 mg / m² and 160 mg per week at a dose of 80 mg / m².

The use of Navelbina orally in doses of 60 mg / m² and 80 mg / m2 corresponds to the / in the introduction of Navelbina in doses of 25 mg / m² and 30 mg / m².

With polychemotherapy The dose and frequency of administration of Navelbine (as with a / in the introduction, and with ingestion) depend on the specific program of antitumor therapy.

With a decrease in the number of neutrophils less than 1500 / μl or platelets less than 75 000 / μl (with a / in the introduction) or less than 100 000 / μl (with the ingestion), the next introduction or ingestion of Navelbine is set aside for 1 week. If, due to hematologic toxicity, it was necessary to refrain from 3 weekly injections or administration of the drug, it is recommended to stop using Navelbine.

Patients with severe hepatic impairment Navelbin should be prescribed with caution, at a dose reduced by 33%.

Safety and effectiveness of Navelbina in children not studied.

Special correction dosing regimen Navelbina in the elderly not required.

Adverse reactions

The following side effects were more common than in isolated cases.The following criteria were used to assess the frequency of occurrence of adverse events:

• very often (> 1/10);
• often (> 1 / 100.1 / 10);
• sometimes (> 1/1000, 1/100);
• rarely (> 1/10 000, 1/1000);
• extremely rare (1/10 000).

From the hemopoietic system: very often - neutropenia, anemia, thrombocytopenia, the addition of secondary infections against the background of inhibition of bone marrow hematopoiesis; often - fever (38 ° C) on the background of neutropenia; sometimes - sepsis, septicemia; extremely rare - complicated septicemia, in some cases leading to death. The smallest number of neutrophils is observed on days 7-10 from the start of therapy, recovery occurs in the next 5-7 days. Cumulative hematotoxicity is not observed.

From the peripheral nervous system: very often - paresthesia, hyperesthesia, decrease or loss of deep tendon reflexes; often - weakness in the legs; sometimes severe paresthesias with sensory and motor symptoms are usually reversible.

Since the cardiovascular system: sometimes - increase or decrease in blood pressure, hot flashes and cold extremities; rarely - ischemic heart disease (angina, myocardial infarction), severe hypotension, collapse; extremely rarely - tachycardia, palpitations, heart rhythm disturbances.

On the part of the respiratory system: sometimes - shortness of breath, bronchospasm; rarely, interstitial pneumonia (with combination therapy with mitomycin), acute respiratory distress syndrome.

From the digestive system: very often - nausea, vomiting, stomatitis, constipation, diarrhea, transient increase in liver function tests (ALT, ACT); rarely - pancreatitis, increased bilirubin levels, intestinal paresis.

On the part of the immune system: rarely - anaphylactic shock, angioedema.

Dermatological reactions: often - alopecia; rarely - skin rashes.

Local reactions: often - pain / burning or redness at the injection site, discoloration of veins, phlebitis; with extravasation - cellulite; possibly necrosis of the surrounding tissues.

Other: often - increased fatigue, myalgia, arthralgia, fever, pain of various localization, including chest pain, pain in the lower jaw and in the area of ​​tumor formations; rarely, hyponatremia; very rarely - hemorrhagic cystitis and inadequate secretion syndrome of ADH.

Carefully: prescribe the drug for respiratory failure, inhibition of bone marrow hematopoiesis (including after previous chemotherapy or radiation therapy), constipation or symptoms of intestinal obstruction in history, neuropathy in history.

Drug interactions

When combined with other cytostatics, mutual aggravation of side effects is possible, in the first place - myelosuppression.

When combined with mitomycin C, the development of acute respiratory failure is possible.

When used in conjunction with paclitaxel, the risk of neurotoxicity increases.

Application on the background of radiation therapy leads to radiosensitization. The use of Navelbine after radiation therapy can lead to the reappearance of radiation reactions.

The simultaneous use of the drug with inducers and inhibitors of cytochrome P450 isoenzymes can lead to changes in the pharmacokinetics of vinorelbine.

Pregnancy and Lactation

Special instructions

Overdosage