Lonquex® [Lipegfilgrastim]

For adults, the drug is prescribed as a single sc injection of 6 mg (1 syringe) 24 hours after the end of each cycle of cytotoxic chemotherapy.

Significant differences in the effectiveness and safety of the drug Lonkveks patients of different ages in clinical studies have not been identified. In this regard, there is no need for dose adjustment in elderly patients.

In patients with renal / hepatic insufficiency, dose adjustment is not required.

The safety and efficacy of using Lonquex in children and adolescents under the age of 18 years has not been established (data not available).

Information on the technique of conducting s / c injections

Before the injection is necessary to conduct special patient education.

1. One blister with a syringe should be taken out of the refrigerator and the syringe with the preparation removed.

2. Check the expiration date on the label of the syringe. Do not use the drug if the last day of the specified month has expired.

3. It is necessary to check the appearance of the solution for injection. The solution should be clear, colorless and free from visible solid particles. Do not use the drug if the solution is cloudy or contains visible particles.

4. Hold the syringe at room temperature for 30 minutes or warm it in your hand for a few minutes. Do not heat the drug in other ways (for example, in a microwave or in hot water).

5. Do not remove the protective cap from the needle until the preparation for the injection has been completed.

6. Wash hands thoroughly.

7. Choose a well-lit, comfortable place. Arrange everything necessary for the injection (syringe with the preparation, a napkin moistened with alcohol, sterile gauze tampon) in such a way that it is easy to use.

8. Carefully, without rotating, pulling in a straight line, without touching the needle, remove the protective cap from the needle.

9. If there are small air bubbles in the syringe, gently tap the syringe with your finger, holding the needle upward so that air bubbles collect in the upper part of the syringe, and slowly press down on the piston to remove all air from the syringe. The syringe with the drug should not be shaken. Shaking vigorously can destroy lipagfilgrastim and inactivate it.

10. The most optimal areas for S / C injections are the anterolateral surface of the thigh and the stomach, with the exception of the area around the navel. If the injection is performed by another person, then an injection can be made into the outer surface of the shoulder.

11. The skin at the injection site should be disinfected with a napkin moistened with alcohol, and the skin should be folded with the thumb and forefinger without pressure.

12. Fully insert the needle into the base of the skin fold at an angle of at least 45 degrees.

13. Gently pull the syringe plunger to make sure that the vessel has not been punctured. If blood appears in the syringe, it is necessary to remove the needle and introduce it to another location.

14. After inserting the needle, the solution should be injected under the skin, slowly and evenly pressing on the plunger of the syringe, while continuing to keep the skin in the fold.

15. Continue pressing on the syringe plunger until all the solution has been injected. Stop pushing on the syringe plunger is possible only after the introduction of the entire dose of the drug. The needle safety device will immediately work: the needle is removed from the injection site and, together with the syringe, is automatically placed inside the protective device. If the syringe does not have a needle safety device, after injection of the entire dose of the drug, remove the needle from the injection site and put a protective cap on the needle.

16. Attach a sterile gauze pad to the injection site for a few seconds.

17. Each syringe should be used for one injection only.Do not re-enter the solution remaining in the syringe.

Disposal of used syringes

A needle safety device prevents accidental needle pricking, so special precautions are not required when disposing. Dispose of used syringes in accordance with the instructions of the medical institution or doctor. Syringes without a safety device needles before disposal are placed in a container of durable material.

Not recommended the use of the drug Lonveks during pregnancy. In preclinical studies revealed no toxic effects on reproductive function. Experience of use in pregnant women is limited.

It is not known whether lipegfilgrastim is excreted in breast milk, so the likelihood of side effects in children during breastfeeding cannot be excluded. The decision to discontinue breastfeeding or to discontinue / suspend treatment with Lonquex should be made taking into account the expected benefits of breastfeeding for the infant and treatment with Lonquex for the mother.

Treatment with Lonquex is carried out only under the supervision of a physician with experience in the use of colony-stimulating factors, with the necessary diagnostic capabilities.

The safety and efficacy of Lonquex in patients who received high-dose chemotherapy have not been studied. Lonquex should not be used to increase the dose of cytotoxic chemotherapy above the prescribed dosage regimen.

Patients who are sensitive to G-CSF or its derivatives are also at risk of developing hyper-sensitivity reactions to lipagfilgrastim due to possible cross-hypersensitivity. In such patients, Lipagfilgrastim should not be used due to the risk of cross-reaction.

Most drugs of biological origin can cause a response in the form of a certain level of anti-drug antibodies. Such a humoral immune response may in some cases lead to the development of undesirable effects or loss of effectiveness. If the patient does not respond to treatment, further examination should be carried out.

With the development of a severe allergic reaction, appropriate therapy should be carried out followed by careful observation of the patient for several days.

Lonquex drug treatment does not prevent the development of thrombocytopenia and anemia caused by myelosuppressive chemotherapy. Lonquex can also cause thrombocytopenia, so it is recommended to regularly determine the number of platelets and hematocrit. One-component or combined chemotherapeutic regimens known for their ability to cause severe thrombocytopenia should be used with caution.

Perhaps the development of leukocytosis. No adverse events directly associated with leukocytosis were reported. An increase in the number of leukocytes in the blood corresponds to the pharmacodynamic effects of lipagfilgrastim. Given the clinical effects of lipagfilgrastim and the possible risk of developing leukocytosis, the number of leukocytes should be regularly monitored during treatment with lipagfilgrastim. If the number of leukocytes after the expected minimum level exceeds 50 × 109 / l, treatment with lipagfilgrastim should be immediately discontinued.

Increased bone marrow hematopoietic activity in response to growth factor therapy leads to transient positive changes in the visualization of bones, which should be taken into account when interpreting the results of radionuclide scintigraphy.

In myelodysplastic syndrome and chronic myeloid leukemia, the efficacy and safety of using Lonquex drug have not been established. Patients with the above diseases, as well as with precancerous lesions of the myeloid hemopoietic germ, do not use Lonquex. Particular attention should be paid to the differential diagnosis between blast crisis of chronic myeloid leukemia and acute myeloid leukemia.

When using G-CSF, cases of splenomegaly, which are asymptomatic, and rupture of the spleen, including fatal. When using the drug Lonkveks should control the size of the spleen (clinical examination, ultrasound). The rupture of the spleen should be suspected when there is pain in the upper left quadrant of the abdomen and pain in the upper part of the left shoulder.

After the use of the drug Lonkeks reported adverse events from the lungs, in particular interstitial pneumonia. Patients with recent pulmonary infiltrates or a history of pneumonia have a higher risk of developing such adverse events.Symptoms of lung damage, such as cough, fever and shortness of breath in combination with pulmonary infiltrates, confirmed by x-ray, accompanied by deterioration of lung function and an increase in the number of neutrophils, can be the first signs of rdsv. In this case, you should stop using the drug Lonkveks and conduct appropriate therapy.

Sickle cell development has been associated with the use of G-CSF or its derivatives in patients with sickle cell anemia. Therefore, Lonquex should be used with caution in patients with sickle cell anemia, closely monitor relevant clinical and laboratory findings, taking into account the possible enlargement of the spleen and the development of blood vessel thrombosis during therapy with Lonquex.

In patients with an increased risk of hypokalemia due to concomitant disease or the simultaneous use of other drugs that cause hypokalemia, it is recommended to monitor the content of potassium in the blood plasma.

Sodium content in 0.6 ml of Lonquex drug solution (one syringe) less than 1 mmol (23 mg) has no clinical significance.

Due to the fact that sorbitol is a part of Lonquex drug, it is not recommended to use this drug in patients with hereditary fructose intolerance, sucrase / isomaltase deficiency, glucose-galactose malabsorption syndrome.

Influence on ability to drive motor transport and control mechanisms

The drug Lonkveks does not have a significant impact on the ability to drive vehicles and work with mechanisms. Patients should be warned about the possibility of dizziness. If dizziness occurs, you should refrain from performing these types of activities.

Cases of drug overdose Lonkveks not noted.