Sinnovex - Instructions For Use, Reviews Of Injections, The Price Of The Drug

2024 Author: Rachel Wainwright | [email protected]. Last modified: 2023-12-15 07:39

CinnoVex

Sinnovex: instructions for use and reviews

1. 1. Release form and composition
2. 2. Pharmacological properties
3. 3. Indications for use
4. 4. Contraindications
5. 5. Method of application and dosage
6. 6. Side effects
7. 7. Overdose
8. 8. Special instructions
9. 9. Application during pregnancy and lactation
10. 10. Use in childhood
11. 11. In case of impaired renal function
12. 12. For violations of liver function
13. 13. Use in the elderly
14. 14. Drug interactions
15. 15. Analogs
16. 16. Terms and conditions of storage
17. 17. Terms of dispensing from pharmacies
18. 18. Reviews
19. 19. Price in pharmacies

Latin name: CinnoVex

ATX code: L03AB07

Active ingredient: interferon beta-1a (Interferon beta-1a)

Manufacturer: SinnGen, Co. (CinnaGen, Co.) (Iran)

Description and photo update: 2019-30-12

Sinnovex is an interferon belonging to the pharmacotherapeutic group of medical immunobiological drugs (MIBP) -cytokines; used in multiple sclerosis.

Release form and composition

Dosage form Sinnovex - lyophilisate for the preparation of a solution for intramuscular administration, is a lyophilized mass from white to almost white; the set includes a solvent - a colorless transparent liquid [lyophilisate - 6 million International Units (IU), or 30 μg, in vials of neutral transparent colorless glass with a volume of 3 ml, sealed with a rubber stopper, crimped in an aluminum cap with a plastic cap equipped with a first opening control; solvent - 1 ml in ampoules made of neutral colorless glass with a volume of 2 ml. In a sealed plastic tray, 1 bottle with lyophilisate + 1 ampoule with a solvent + 1 disposable empty syringe + 2 needles are packed; 4 trays and 8 alcohol wipes are placed in a carton box together with instructions for using SinoVex. The original packaging is protected by two special stickers with the manufacturer's logo and the inscription “CinnaGen QA Approved CinnaGen”].

Composition for 1 bottle of lyophilisate:

• active substance: interferon beta-1a - 6 million IU (30 μg);
• auxiliary ingredients: human albumin - 15 mg; sodium hydrogen phosphate - 5.7 mg; sodium chloride - 5.8 mg; sodium dihydrogen phosphate - 1.2 mg.

1 ampoule with solvent contains water for injection in an amount of 1 ml.

Pharmacological properties

Pharmacodynamics

The active component of Sinnovex, interferon beta-1a, is produced using recombinant deoxyribonucleic acid (DNA) technology by introducing the human interferon beta genome into a Chinese hamster ovary (CHO) cell culture. It is a glycosylated polypeptide and contains 166 amino acids with a molecular weight of 22,500 kDa, the sequence of which in the polypeptide chain is similar to that of the natural human interferon beta.

Interferons are natural proteins produced by eukaryotic cells in response to viral infection and to the influence of other biological factors. They are cytokines and are mediators of antiviral, immunomodulatory, and antiproliferative activity of the body.

The synthesis of beta-interferon is carried out by various types of cells, including macrophages and fibroblasts. Both natural beta-interferon and recombinant interferon beta-1a, which is part of SinoVex, exist in a glycosylated form and contain a single complex hydrocarbon fragment linked to the N atom. Glycosylation of proteins affects their activity, stability, biodistribution and half-life (T _1/2).

The biological efficacy of Sinnovex is determined by the ability of interferon beta-1a to bind to specific receptors on the surface of human cells and trigger a complex cascade of intercellular interactions of a large number of gene products and markers, leading to interferon-mediated expression. These include the main class I histocompatibility complex, 2 '/ 5'-oligoadenylate synthetase, Mx protein, b2-microglobulin, and neopterin. Some of these compounds were detected in the serum and cell fractions of the blood of patients treated with SinoVex. After intramuscular injection of a single dose of interferon beta-1a, their serum levels remained elevated for at least 4 to 7 days.

Since the pathophysiology of multiple sclerosis (MS) has not yet been sufficiently studied, it is not possible to reliably relate the mechanism of action of SinoVex in the treatment of this disease to the triggering of the biological interactions described above. The efficacy of the drug was confirmed in double-blind randomized trials in which patients with relapsing MS took part (SinoVex - n = 41, comparison drug Avonex - n = 43). According to the study design, patients were followed for different times. The drug SinoVex was taken under the supervision of 60 participants in the study for 2 years. It was found that the total number of patients who showed an exacerbation of disability, determined according to the Kaplan-Meier table, by the end of the second year, with the appointment of Avonex was 34%, with the use of SinoVex - 32%.

Measuring the progress of disability was calculated as an increase of 1 point in its indicator on the EDSS scale (Expanded Disability Status Scale), which persisted for at least six months. To top it off, it was found that therapy with CinnoVex reduced the frequency of relapses by one third per year. The data were obtained from the study of the results of treatment, which lasted from one year or more.

Pharmacokinetics

When studying the pharmacokinetic characteristics of interferon beta-1a, measurements of the antiviral activity of interferon were taken as a basis.

A single intramuscular injection of SinoVex provides peak levels of antiviral activity in plasma in the interval from 5 to 15 hours after injection; T _1/2 is ~ 10 h. Taking into account the corresponding correction for the rate of absorption of the drug from the injection site, its calculated bioavailability is ~ 40%.

Indications for use

SinoVex is recommended for the treatment of the following conditions / diseases:

• Recurrent multiple sclerosis (RMS), characterized by at least two relapses during the previous 3-year period without signs of disease progression between relapses (to slow the progression of disability and increase the intervals between relapses by more than 2 years);
• demyelination due to an active inflammatory process, which requires intravenous administration of corticosteroids, if a diagnosis other than MS is excluded.

Contraindications

Absolute:

• pregnancy and lactation period;
• severe depression, suicidal ideation, severe depression;
• epilepsy with seizures that are difficult to control with drugs;
• age up to 12 years;
• increased individual sensitivity to human serum albumin, natural / recombinant interferon beta or any other component of the lyophilisate.

Relative contraindications for which SinoVex is used with caution:

• depression, depressive disorders;
• history of seizures, as well as uncontrolled or inadequately controlled treatment of epilepsy with the use of antiepileptic drugs;
• severe renal and / or hepatic impairment;
• oppression of bone marrow hematopoiesis;
• diseases of the cardiovascular system: angina pectoris, myocardial infarction, decompensated heart failure, arrhythmia.

Sinnovex, instructions for use: method and dosage

A solution prepared from SinoVex lyophilisate and solvent is intended for intramuscular administration.

Administration of the drug is initiated under the guidance and supervision of a specialist experienced in the treatment of MS.

The recommended dosing regimen for the treatment of RMS: adult patients are injected intramuscularly at 6 million IU (30 μg) 1 time / week.

Therapy can be started with the introduction of 1 time / week. a full dose of 30 mcg or (to adapt the body to SinoVex) with the introduction of a half dose of 15 mcg and its step-by-step increase to a full one. After the initial period, the dose is gradually increased to a sufficient effective dose of 30 μg 1 time / week. In the future, adhere to this dosage regimen.

A higher dose (for example, 60 mcg 1 time / week) does not bring additional enhancement of the therapeutic effect.

If possible, injections should be made on the same day of the week, at the same time, changing the injection site of the solution every week.

The doctor determines the duration of the course individually. After 2 years from the start of treatment, the patient needs to undergo a clinical examination, on the basis of which the diagnosis is verified and the continuation of therapy can be recommended. If chronic progressive MS is diagnosed, the drug is discontinued.

The patient can independently inject SinoVex with the permission of the attending physician, after learning the intramuscular injection of the solution.

Step-by-step recommendations for self-injecting patients:

1. When opening the package for the first time, it is important to make sure that the drug is complete. One package contains 4 trays with one-time doses of the product in each and 8 hermetically sealed bags with antiseptic alcohol wipes. The tray contains: 1 bottle with SinoVex lyophilizate + 1 ampoule with solvent + 1 disposable syringe + 2 needles (for solution preparation and for injection).
2. The drug should be removed from the refrigerator, left at room temperature from 15 to 30 ° C for about half an hour. External heat sources such as hot water cannot be used to heat solvent ampoules.
3. Wash hands thoroughly. Place the single dose tray and two antiseptic wipes on a clean, horizontal surface. Carefully open the tray packaging and remove its contents. In addition, it is advisable to prepare sterile medical cotton wool, bactericidal adhesive plaster and any disinfectant solution (ethyl alcohol 70%).
4. Open the package with the syringe. Take one of the two needles out of the package. Without removing the protective cap put on the syringe needle and turn it into ¹ / ₂ turns. Using an alcohol wipe, break the ampoule with solvent along the red line on the neck. Remove the cap from the needle without rotating it, absorb the solvent from the opened ampoule into the syringe. Set aside the protective cap for later use. If air bubbles enter the syringe, gently squeeze the plunger and hold the syringe vertically with the needle up, get rid of them, and then put the protective cap on the needle.
5. Remove the cap from the vial with lyophilisate. Wipe the top of the bottle and the cork with an alcohol wipe.
6. Remove the protective cap from the needle. Pierce the rubber stopper of the vial with lyophilisate with a needle, direct it to the side wall. After that, slowly introduce the entire contents of the syringe with the solvent into the vial.
7. Leaving the syringe with the needle in the vial, gently rotate it until all the powder is dissolved. Do not shake the bottle vigorously, as this will lead to the formation of foam. Do not use a solution that is cloudy, contains solid particles or is colored other than light yellow.
8. Immerse the plunger completely into the syringe before drawing the solution to remove air from it. Place the bottle on a work surface and hold it at a slight angle. The needle must be completely in the bottle, the position of its tip must be visually monitored for constant immersion in the solution. Slowly pull the plunger and withdraw the solution into the syringe until the mark on the side surface is 1 ml. Remove the syringe and needle from the vial, and immediately put on the protective cap. Detach the needle from the syringe while rotating the needle, do not touch the outlet with your hands.
9. Remove the second injection needle from the package (a standard needle for intramuscular injection). Attach the needle to the syringe, turning it a ¹ / ₂ circulation, remove the protective plastic cap and put it aside. To remove air bubbles, turn the syringe with the needle up and tap it, carefully collecting the bubbles at the top. Remove air by slowly pressing the piston, being careful not to pour out more than one drop of solution. Put a cap on the needle and put aside the syringe while preparing the injection site.
10. Choose a site for injection, wipe it with a new alcohol wipe. Remove the cap from the needle and insert it into the muscle tissue through the skin. The solution should be injected slowly. After that, you need to remove the needle with a syringe, wipe the injection site with an alcohol wipe, and, if necessary, seal it with a plaster.
11. After a week, a different place on the body is chosen for the next injection.
12. When the current circumstances do not allow an injection, and the solution has already been prepared, it can be stored at a temperature of 2–8 ° C in the refrigerator for no more than 5.5–6 hours. The injection is performed according to the above scheme, after having brought the solution to room temperature.

The prepared solution is not suitable for further use if it is stored in the refrigerator for more than 6 hours or at room temperature for more than 30 minutes.

Side effects

The most common adverse reaction of the human body to the use of interferons is influenza-like syndrome. Symptoms may include weakness, feeling tired, muscle pain, fever, chills, headache, and nausea. They are usually more pronounced at the beginning of therapy; as treatment continues, the frequency of side effects decreases. To relieve this symptomatology, an analgesic-antipyretic is prescribed, which the patient must take before the injection of SinoVex and then take it at intervals of 1 every 6 hours within 24 hours after each injection. Before using any drug simultaneously with interferon beta-1a, you must consult a doctor. If he prescribes an antipyretic analgesic, it is necessary to carefully adhere to the recommendations for its use and not to increase the dose beyond the prescribed dose.

During any period of therapy, neurological symptoms similar to an exacerbation of RMS may appear: transient episodes of muscle hypertonia / muscle weakness, which limit the ability to voluntary movements. They are usually short-lived, associated in time with the introduction of SinoVex and may be repeated with subsequent injections. Sometimes, neurological symptoms are also accompanied by flu-like syndrome.

The scale of the distribution of the frequency of side effects when using Sinnovex: very often - more than 0.1 patient-years *; often - from 0.01 to 0.1 patient-years; infrequently - from 0.000 1 to 0.001 patient-years; rarely - from 0.000 01 to 0.000 1 patient-years; extremely rare - less than 0.000 01 patient-years; frequency unknown - no frequency estimate can be made from the available data.

Note

* Patient-years is the sum of individual units of time during which a patient participating in the study received CinnoVex before he developed this adverse reaction.

Negative side effects from systems and organs that are possible with the use of SinoVex:

• laboratory data: often - lymphocytopenia, neutropenia, leukopenia, decreased hematocrit, increased blood potassium levels, increased blood urea nitrogen levels; infrequently - thrombocytopenia; frequency unknown - decrease / increase in body weight, deviation from the norm in liver function tests;
• heart and cardiovascular system: often - flushing of the face; frequency unknown - vasodilation, cardiomyopathy, pulsation, arrhythmia, congestive heart failure, tachycardia;
• blood and lymphatic system: frequency unknown - pancytopenia, thrombocytopenia;
• nervous system: very often - headache ²; often - muscle spasms, hypoesthesia; frequency unknown - fainting ³, neurological symptoms, dizziness, hypertension, paresthesia, migraine, convulsions;
• respiratory system: often - rhinorrhea; rarely - shortness of breath;
• digestive tract: often - vomiting, nausea ², diarrhea;
• skin and subcutaneous fat: often - rash, hyperhidrosis, hematomas; infrequently - alopecia; frequency unknown - itching, angioedema, vesicular rash, exacerbation of psoriasis, urticaria;
• musculoskeletal and connective tissue: often - neck pain, muscle spasms, arthralgia, myalgia ², pain in the limbs, back pain, musculoskeletal rigidity, muscle stiffness; frequency unknown - muscle weakness, systemic lupus erythematosus, arthritis;
• endocrine system: frequency unknown - hypothyroidism, hyperthyroidism;
• metabolism and nutrition: often - anorexia;
• general disorders, disorders at the injection site ¹: very often - flu-like syndrome ² (expressed by fever, chills, sweating); often - fatigue, asthenia, pain, night sweats, malaise, at the injection site - pain, erythema and / or hematoma; infrequently - burning sensation at the injection site; frequency unknown - chest pain, at the injection site - abscess, cellulite, inflammation, necrosis, bleeding;
• immune system: frequency unknown - anaphylactic reaction, anaphylactic shock, hypersensitivity reactions (shortness of breath, angioedema, rash, itchy rash, urticaria);
• hepatobiliary system: frequency unknown - hepatic failure, hepatitis, including autoimmune hepatitis;
• reproductive system and mammary gland: infrequently - metrorrhagia, menorrhagia;
• psyche: often - depression, insomnia; the frequency is unknown - psychosis, anxiety, suicide, emotional lability, confusion.

Notes

¹ Reactions at the injection site in very rare cases (for example, with abscess or cellulitis) may require surgery.

² The frequency of these adverse reactions is higher at the beginning of therapy.

³ Fainting after injection of SinoVex, as a rule, is the only episode at the beginning of therapy, with subsequent injections it does not recur.

The aggravation of any of these side reactions or the manifestation of other negative effects not described in the instructions must be reported to the attending physician.

Overdose

The route of administration and dosage form of the drug make an overdose of interferon beta-1a unlikely. At the same time, you should avoid exceeding the prescribed dosage regimen of Sinnovex, like any other drug.

In case of intoxication, the patient is hospitalized to provide him with thorough medical monitoring of the condition, if necessary, appropriate therapy is prescribed.

special instructions

Since the use of interferons increases the risk of depression and suicidal ideation, SinoVex is prescribed with caution when treating patients with depression or depressive disorders. It has been proven that in the group of people suffering from MS, the frequency of such behavioral pathologies increases. Depressive states can occur at any time of therapy with interferon beta-1a, therefore, if any signs of depression or suicidal ideation are manifested, patients should immediately contact their doctor. In the course of therapy, such patients are required to ensure regular monitoring of the condition, if necessary, immediately carry out appropriate medical measures. In some cases, it may be necessary to discontinue therapy with SinoVex.

CinnoVex is prescribed with caution to patients with a history of seizures, as well as currently taking antiepileptic drugs (who have not previously suffered from epileptic seizures). Especially if epilepsy therapy and antiepileptic drugs are inadequately controlled or not controlled at all.

During the use of interferon beta, the development of liver dysfunctions such as an increase in the serum level of liver enzymes in the blood, hepatitis (including autoimmune hepatitis) and liver failure is likely. It has not been established reliably whether these pathologies are a consequence of the use of interferon beta-1a or are caused by the intake of other drugs usually prescribed for the treatment of the underlying disease. Careful monitoring of the condition of patients is required for the development of symptoms of impaired hepatic function, especially when using Sinnovex as part of complex therapy with other hepatotoxic agents.

The use of Sinnovex in the treatment of patients with cardiovascular pathologies such as angina pectoris, myocardial infarction, decompensated heart failure, arrhythmia requires careful monitoring of their condition. Influenza-like syndrome caused by the use of interferon beta-1a can also be stressful on them.

Interferon therapy causes laboratory abnormalities. As a result, in addition to standard laboratory tests, patients with MS are advised to count blood cells (including platelets), determine the leukocyte count and biochemical blood test (including the level of liver enzymes) during treatment. If there are signs of bone marrow function suppression, a more thorough study of the blood count may be necessary, including the determination of cellular elements by fractions and platelets.

The use of Sinnovex can cause the appearance of interferon-neutralizing antibodies in the blood serum, which can reduce the activity of interferon beta-1a, as a result of which the clinical efficacy of the drug decreases. According to available data, after 1 year of treatment, antibodies to interferon beta-1a in serum appear in about 8% of patients.

Influence on the ability to drive vehicles and complex mechanisms

It should be borne in mind that adverse reactions from the central nervous system when using interferon beta-1a can minimize the ability of sensitive patients to drive vehicles and complex mechanisms.

Application during pregnancy and lactation

It is contraindicated to use Sinnovex during pregnancy due to the potential risk of adverse reactions - according to the available data, spontaneous abortion is possible.

During breastfeeding, SinoVex is contraindicated due to the potential for negative side effects in an infant.

Women who are fertile should use effective methods of contraception. In case of unintentional conception during treatment with SinoVex or planning pregnancy, the doctor must inform the patient about the potential danger to the fetus and consider the advisability of stopping treatment. For patients who had a high frequency of relapses before starting therapy, it is necessary to compare the risk of increasing their severity due to the cancellation of SinoVex during pregnancy with the likelihood of spontaneous abortion due to the use of interferon beta-1a.

Pediatric use

The safety profile of Sinnovex in children and adolescents over 12 years old when using the drug intramuscularly 1 time / week. at a dose of 30 mcg is similar to that for adults.

There are no clinical data on the use of the drug in children under 12 years of age; therefore, SinoVex is not prescribed for this population of pediatric patients.

With impaired renal function

Patients with severe renal failure should be prescribed SinoVex with caution, under close medical supervision.

For violations of liver function

Patients with severe hepatic impairment should be prescribed SinoVex with caution, under close medical supervision.

Use in the elderly

The number of elderly patients over 65 years of age who participated in clinical trials of SinoVex is insufficient to establish possible differences in the response to therapy in this age group and the response to treatment in younger patients. However, based on the clearance of interferon beta-1a, there are no theoretical prerequisites for the need for dose adjustment in elderly patients.

Drug interactions

The interaction of SinnoVex (interferon beta-1a) with other drugs, including corticosteroids or adrenocorticotropic hormone (ACTH), has not been studied in humans. At the same time, the experience of clinical trials shows that when treating MS during an exacerbation of the disease, SinoVex can be taken with corticosteroids or ACTH.

The ability of interferons to reduce the activity of enzymes of the cytochrome P ₄₅₀ family is known. Therefore, the appointment of Sinnovex simultaneously with drugs, the clearance of which depends largely on the cytochrome P _{450 system} (antidepressants, antiepileptic drugs), requires caution.

Analogs

The analogues of SinoVex are Avonex, Betaferon, Genfaxon, Infibeta, Interferon Beta-1B, Rebif, Teberif, etc.

Terms and conditions of storage

The drug should be stored out of the reach of children and protected from light, at a temperature of 2 to 8 ° C.

Shelf life: lyophilisate - 2 years; solvent - 3 years.

Terms of dispensing from pharmacies

Dispensed by prescription.

Reviews about SinoVex

Drugs for MS therapy are included in the most expensive state procurement program “7 High-Cost Nosologies”, according to which all patients are provided with drugs from the federal budget. In reviews of SinoVex, a generic drug that replaced the original US drug in the purchase, many patients express dissatisfaction with this replacement. They indicate that when using SinoVex, the temperature rises more often, seizures appear, delivering physical pain, these side reactions significantly worsen the quality of life. Due to the intolerance of therapy, some are forced to refuse it. There is evidence that the fraction of interferon-beta-1a in SinnoVex is significantly reduced, and other protein compounds (mainly human serum albumin) are found in overestimated amounts. This indicates a low degree of purification of the drug,a possible inconsistency of the dose of interferon in the vial with the declared 30 μg and the low quality of the drug.

At the same time, it really helps other patients using SinoVex. It softens relapses and exacerbations or completely eliminates them, reduces old foci of the disease and prevents the formation of new ones. Concomitant adverse reactions such as flu-like syndrome, depression, headaches (worse on the day of injection) are considered mild by these patients.

Price for SinoVex in pharmacies

Since the drug is included in the list of Vital and Essential Drugs (Vital and Essential Medicines), there is a registered fixed price of SinoVex, which is for a sealed polymer package with four sets, each of which contains a vial of lyophilisate (30 μg) + an ampoule with a solvent (1 ml) + disposable syringe + disposable needles (2 pcs.) + alcohol wipes (2 pcs.) - 15 645.45 rubles.

The cost of SinoVex in some online pharmacies for a pack of four sets varies from 7300 to 11,500 rubles.

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!