Victose
Victoza: instructions for use and reviews
- 1. Release form and composition
- 2. Pharmacological properties
- 3. Indications for use
- 4. Contraindications
- 5. Method of application and dosage
- 6. Side effects
- 7. Overdose
- 8. Special instructions
- 9. Application during pregnancy and lactation
- 10. Use in childhood
- 11. In case of impaired renal function
- 12. For violations of liver function
- 13. Use in the elderly
- 14. Drug interactions
- 15. Analogs
- 16. Terms and conditions of storage
- 17. Terms of dispensing from pharmacies
- 18. Reviews
- 19. Price in pharmacies
Latin name: Victoza
ATX code: A10BX07
Active ingredient: liraglutide (Liraglutide)
Manufacturer: Novo Nordisk, A / S (Novo Nordisk, A / S) (Denmark)
Description and photo update: 2019-26-08
Prices in pharmacies: from 8518 rubles.
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Victoza is a glucagon-like polypeptide (GLP) receptor agonist; hypoglycemic agent.
Release form and composition
Dosage form - solution for subcutaneous administration: colorless or almost colorless (3 ml * in glass cartridges sealed in a disposable plastic syringe pen for multiple injections, in a cardboard box of 1, 2 or 3 syringe pens).
* 1 syringe pen (3 ml) contains 10 doses of 1.8 mg, 15 doses of 1.2 mg or 30 doses of 0.6 mg.
Active substance: liraglutide, in 1 ml - 6 mg.
Auxiliary components: hydrochloric acid / sodium hydroxide qs, sodium hydrogen phosphate dihydrate, phenol, propylene glycol, water for injection.
Pharmacological properties
Pharmacodynamics
Liraglutide is an analogue of human GLP-1 (glucagon-like peptide-1). Produced by recombinant DNA (deoxyribonucleic acid) biotechnology using the Saccharomyces cerevisiae strain, which has 97% homology with human GLP-1; binds to and activates GLP-1 receptors in humans.
The GLP-1 receptor is a target for native GLP-1, which is an endogenous incretin hormone that stimulates glucose-dependent insulin secretion in the β-cells of the pancreas. In comparison with native GLP-1, the pharmacodynamic and pharmacokinetic profiles of liraglutide allow it to be administered once a day.
When injected subcutaneously, the long-acting profile of the substance is based on three mechanisms:
- self-association, which ensures delayed absorption of liraglutide;
- binding to albumin;
- a higher level of enzymatic stability in relation to DPP-4 (dipeptidyl peptidase-4) and NEP (enzyme of neutral endopeptidase), due to which a long T 1/2 (half-life) of the substance from the plasma is provided.
The effect of liraglutide is based on interaction with specific GLP-1 receptors, as a result of which the level of cAMP (cyclic adenosine monophosphate) increases. Under the action of the substance, glucose-dependent stimulation of insulin secretion is observed, and the function of β-cells of the pancreas also improves. Simultaneously with this, glucose-dependent suppression of excessively increased secretion of glucagon occurs. Thus, with an increase in the concentration of glucose in the blood, the secretion of glucagon is suppressed and the secretion of insulin is stimulated.
On the other hand, in patients with hypoglycemia, liraglutide decreases insulin secretion without suppressing glucagon secretion. The mechanism for reducing the level of glycemia also includes a slight delay in gastric emptying. Through mechanisms that reduce hunger and reduce energy expenditure, liraglutide leads to a decrease in adipose tissue and a decrease in body weight.
GLP-1 is a physiological regulator of appetite and calorie intake; receptors for this peptide are located in several areas of the brain that are involved in appetite regulation.
In studies on animals, it was found that through the specific activation of GLP-1 receptors, liraglutide enhances satiety signals and weakens hunger signals, thereby leading to weight loss.
Also, according to the results of animal studies, liraglutide slows down the development of diabetes. The substance is a powerful factor in the specific stimulation of the proliferation of pancreatic β-cells and prevents β-cell death (apoptosis), which is induced by cytokines and free fatty acids. Thus, liraglutide increases insulin biosynthesis and increases β-cell mass. After normalization of glucose concentration, liraglutide ceases to increase the mass of β-cells of the pancreas.
Victoza has a long-lasting 24-hour effect and improves glycemic control, which is achieved by lowering fasting and postprandial blood glucose concentrations in type 2 diabetes.
Pharmacokinetics
After subcutaneous administration, absorption of liraglutide occurs slowly, T max (time to reach the maximum concentration) in plasma is 8-12 hours. C max (maximum concentration) in plasma after administration of a single 0.6 mg dose of 9.4 nmol / L. When using a dose of 1.8 mg, the average C ss (equilibrium concentration) in plasma reaches approximately 34 nmol / L. The exposure of the substance increases in proportion to the dose. The intraindividual coefficient of variation for AUC (area under the concentration-time curve) after administration of liraglutide in a single dose is 11%. The absolute bioavailability is about 55%.
The apparent V d (volume of distribution) of liraglutide in tissues with the subcutaneous route of administration is 11-17 liters, the value of the average Vd after intravenous administration is 0.07 l / kg. There is a significant binding of liraglutide with blood plasma proteins (> 98%).
Metabolism of liraglutide occurs like large proteins, without the participation of any specific organ as a pathway for excretion. For 24 hours after the administration of a single dose, the main component of the plasma remains unchanged. Two metabolites are found in plasma (≤ 9 and ≤ 5% of the total dose).
Unchanged liraglutide after a dose of [3 H] -liraglutide is not detected in urine or feces. Only a small part of the metabolites associated with the substance is excreted by the kidneys or through the intestines (6 and 5%, respectively). After subcutaneous administration of a single dose of liraglutide, the average clearance from the body is approximately 1.2 l / h with an elimination T 1/2 of about 13 hours.
Indications for use
According to the instructions, Victoza is used for type 2 diabetes in combination with diet and exercise to achieve glycemic control.
Possible ways of using the drug:
- monotherapy;
- combination therapy with one or more oral hypoglycemic agents (thiazolidinediones, sulfonylurea derivatives, metformin) in patients who failed to achieve adequate glycemic control during previous therapy;
- combination therapy with basal insulin in patients who failed to achieve adequate glycemic control using Victoza in combination with metformin.
Contraindications
Absolute:
- diabetic ketoacidosis;
- type 1 diabetes mellitus;
- multiple endocrine neoplasia type 2;
- liver dysfunction;
- severe renal dysfunction;
- diabetic gastroparesis;
- inflammatory bowel disease;
- chronic heart failure III – IV functional class according to the classification of the New York Heart Association (NYHA);
- a history of medullary thyroid cancer, including family history;
- age up to 18 years;
- period of pregnancy and lactation;
- hypersensitivity to any component of Victoza.
Relative:
- diseases of the thyroid gland;
- chronic heart failure I – II functional class according to NYHA classification;
- age over 75 years.
Instructions for the use of Victoza: method and dosage
Victoza should be injected subcutaneously into the abdomen, shoulder or thigh once a day, regardless of meals. The place and time of injection can be changed without dose adjustment; nevertheless, it is desirable to administer the drug at about the same time of day, which is most convenient for the patient.
To improve gastrointestinal tolerance, it is recommended to start treatment with a daily dose of 0.6 mg. At least a week later, the dose is increased to 1.2 mg. If necessary, in order to achieve the best glycemic control, taking into account the clinical effectiveness of Victoza, an increase in the dose to 1.8 mg is possible at least after a week. Higher doses are not recommended.
The drug can be prescribed in addition to ongoing metformin therapy or combination therapy with metformin in combination with thiazolidinedione. The doses of the latter do not need to be adjusted.
Victose can be added to existing sulfonylurea therapy or combination therapy with metformin in combination with sulfonylurea derivatives. In this case, to minimize the risk of developing unwanted hypoglycemia, the dose of sulfonylurea derivatives should be reduced.
Also, Victoza can be added to basal insulin, but to reduce the risk of hypoglycemia, it is necessary to reduce the dose of insulin.
If you miss a dose:
- if no more than 12 hours have passed, you must enter the missed dose as soon as possible;
- if more than 12 hours have passed, the next dose must be administered the next day at the scheduled time, that is, it is not necessary to compensate for the missed dose by introducing an additional or double dose.
Drug use guide
Each pen is designed for individual use.
The drug should be injected using needles up to 8 mm long and up to 32G thick (not included, therefore sold separately). Syringe pens are combined with disposable injection needles NovoTvist and NovoFine.
Do not inject Victoza if the solution looks different from a clear, almost colorless or colorless liquid.
Do not administer the drug if it has been frozen.
Do not store a pen with a needle attached. Throw it away after each injection. This measure prevents leakage, contamination and contamination of the product and ensures that the dosage is accurate.
Side effects
- from the gastrointestinal tract: very often (≥ 1/10) - nausea, diarrhea; often (≥ 1/100 to <1/10) - pain in the upper abdomen, dyspepsia, gastritis, bloating, flatulence, constipation, belching, vomiting, gastroesophageal reflux disease; very rarely (<1/10 000) - pancreatitis (including pancreatic necrosis);
- metabolic and nutritional disorders: often - decreased appetite, anorexia, hypoglycemia (when using Victoza in combination with insulin); infrequently (≥ 1/1000 to <1/100) - dehydration;
- from the immune system: rarely (≥ 1/10 000 to <1/1000) - anaphylactic reactions;
- infections and infestations: often - upper respiratory tract infections;
- from the nervous system: often - headache;
- from the kidneys and urinary tract: infrequently - impaired renal function, acute renal failure;
- from the heart: often - an increase in the heart rate;
- on the part of the skin and subcutaneous tissues: often - rash; infrequently - itching, urticaria;
- others: often - reactions at the injection site; infrequently - malaise.
Overdose
The main symptoms are severe nausea, vomiting, and diarrhea. Convalescence usually occurs without residual effects. There is no evidence of severe hypoglycemia.
Therapy: symptomatic.
special instructions
Victose is not a substitute for insulin.
The drug should not be administered intramuscularly or intravenously.
The use of GLP-1 receptor agonists is associated with the risk of developing acute pancreatitis, therefore, patients should be informed about its characteristic features. If you suspect the development of this disease, you should immediately stop treatment with Victoza, if the diagnosis is confirmed, it is contraindicated to resume the use of the drug. For the same reason, patients with a history of pancreatitis should be under constant supervision during therapy.
When using Victoza in combination with sulfonylurea derivatives or basal insulin, the likelihood of developing hypoglycemia increases. You can reduce the risk by reducing the dose of sulfonylurea derivatives or basal insulin.
Studies on the effect of the drug on the ability to work with complex mechanisms and drive vehicles have not been conducted. It is unlikely that liraglutide has a negative effect on psychomotor and cognitive functions. However, with the use of Victoza, especially in combination with sulfonylurea derivatives or basal insulin, hypoglycemia may develop, therefore, patients should take precautions.
Application during pregnancy and lactation
Victoza is not prescribed during pregnancy / lactation.
There is no adequate information on the use of the drug in pregnant women. During research, the reproductive toxicity of liraglutide was established. The potential risk to humans has not been identified. When preparing a patient for pregnancy or when pregnancy occurs, Viktoza is canceled.
The safety profile of Victoza during lactation has not been studied.
Pediatric use
Victoza therapy is contraindicated in patients under 18 years of age.
With impaired renal function
Victoza is not prescribed for severe renal impairment.
For violations of liver function
Victoza is not prescribed for violations of hepatic function.
Use in the elderly
In patients over 75 years of age, therapy should be carried out with caution.
Drug interactions
Victoza can contribute to a slight delay in gastric emptying, as a result of which a change in the rate of absorption of concomitant oral drugs is possible. According to research data, this phenomenon does not have any clinically significant significance, therefore, dose adjustment is not required. There are isolated cases of acute diarrhea during treatment with liraglutide (it can affect the absorption of concomitantly used oral drugs).
With the combined appointment of warfarin or other coumarin derivatives, it is necessary to monitor the INR (International Normalized Ratio) more often.
Substances added to Victoza can degrade liraglutide, therefore it should not be mixed with other drugs, including infusion solutions.
Analogs
Analogs of Victoza are: Byetta, Liraglutid.
Terms and conditions of storage
Store out of reach of children, protected from light and excessive heat at a temperature of 2–8 ° C (in the refrigerator, but not near the freezer). Do not freeze.
The shelf life is 2.5 years.
Syringe pens in use should be stored for no more than 1 month at a temperature of 2–8 ° C or at a temperature of no more than 30 ° C. Do not freeze. To protect from light, close the syringe with a protective cap.
Terms of dispensing from pharmacies
Dispensed by prescription.
Reviews about Victoza
Reviews about Victoza are mostly positive. Indicate that when using the drug in patients with type 2 diabetes mellitus, there is a decrease in appetite and a persistent decrease in body weight. As a result, general well-being improves and physical activity increases. Insufficient or no therapeutic effect is rarely reported. Victoza's cost is estimated to be high.
Price for Victoza in pharmacies
The approximate price for Viktoza solution of 6 mg / ml (2 syringe pens with 3 ml cartridges) is 9307–12,923 rubles.
Victoza: prices in online pharmacies
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Drug name Price Pharmacy |
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Victoza 6 mg / ml solution for subcutaneous administration 3 ml 2 pcs. RUB 8518 Buy |
Anna Kozlova Medical journalist About the author
Education: Rostov State Medical University, specialty "General Medicine".
Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!
