Cosentix

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

Cosentix: 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: Cosentyx

ATX code: L04AC10

Active ingredient: secukinumab (Secukinumab)

Producer: Novartis Pharma, AG (Novartis Pharma, AG) (Switzerland)

Description and photo update: 2019-06-02

Lyophilisate for the preparation of a solution for subcutaneous administration Cosentix

Cosentix is an interleukin inhibitor.

Release form and composition

Dosage forms of Cosentix:

solution for subcutaneous (s / c) administration: transparent or opalescent, from colorless to light yellow [1 ml each in pre-filled syringes in auto-injectors (syringe pens) or pre-filled syringes with a device for passive needle protection, in a cardboard box 1–2 syringe-pens or 1 blister containing 1–2 syringes with a device for passive needle protection];
lyophilisate for preparation of a solution for subcutaneous administration: powder or amorphous white mass (150 mg each in colorless glass vials with a volume of 6 ml, in a cardboard box 1 vial).

Each pack also contains instructions for the use of Cosentix.

Composition of 1 ml solution:

active substance: secukinumab - 150 mg;
auxiliary components: polysorbate-80, methionine, water for injection, trehalose dihydrate, histidine or histidine hydrochloride monohydrate.

Composition of 1 bottle of lyophilisate:

active substance: secukinumab - 150 mg;
auxiliary components: polysorbate-80, sucrose, histidine or histidine hydrochloride monohydrate.

Pharmacological properties

Pharmacodynamics

Secukinumab is a fully human antibody, immunoglobulin G1 (IgGl). Selectively binds to and neutralizes the pro-inflammatory cytokine interleukin-17A (IL-17A), which is expressed by various types of cells, including synoviocytes and keratinocytes. IL-17A is involved in the normally proceeding reactions of inflammation and the immune response, plays a key role in the pathogenesis of the development of plaque psoriasis, ankylosing spondylitis, and psoriatic arthritis. With these diseases in patients in the blood and affected areas of the skin, an increased concentration of IL-17A, produced by innate immune cells and lymphocytes, was revealed.

In skin affected by plaque psoriasis, IL-17A production is higher than in intact skin. In the synovial fluid of patients with psoriatic arthritis, in the subchondral bone marrow of the facet joint bones in patients with ankylosing spondylitis, a high concentration of cells that produce IL-17A is found.

IL-17A also promotes the development of inflammatory processes in tissues, neutrophil infiltration, destruction of tissues and bones. Promotes tissue remodeling, including fibrosis and angiogenesis.

Secukinumab has a targeted effect on IL-17 and inhibits its interaction with the IL-17 receptor, as a result of which it suppresses the release of pro-inflammatory cytokines, mediators of tissue damage and chemokines, and reduces the contribution of IL-17A to the development of inflammatory and autoimmune diseases.

In clinically significant concentrations, the drug reaches the skin, where it reduces the content of local inflammatory markers, as a result, the severity of redness, flaking and thickening of psoriatic lesions decreases.

While using Cosentix for 2-7 days, the concentration of total IL-17A (free and associated with secukinumab) increases due to a decrease in the clearance of IL-17A associated with secukinumab. This indicates that secukinumab selectively captures free IL-17A.

According to the results of the study, the increased infiltration of epidermal neutrophils and various neutrophil-bound markers in the skin damaged by plaque psoriasis after 1-2 weeks of treatment with the drug is significantly reduced.

In patients with psoriatic arthritis and ankylosing spondylitis, a decrease in the concentration of C-reactive protein (a marker of inflammation) is observed after 1–2 weeks of using secukinumab.

Pharmacokinetics

After a single subcutaneous administration of Cosentix at a dose of 150 or 300 mg to patients with plaque psoriasis, the maximum plasma concentration (C _max) is reached within 5-6 days and is 13.7 ± 4.8 or 27.3 ± 9.5 μg / ml respectively.

After the initial administration of the drug once a week for 1 month, the time to reach C _max was 31–34 days.

In the equilibrium state, which is reached after 20 weeks with a monthly administration regimen, C _max after a subcutaneous injection of a dose of 150 or 300 mg was 27.6 or 55.2 μg / ml, respectively.

With prolonged maintenance therapy with a monthly administration of Cosentix, a 2-fold increase in C _max and AUC (area under the concentration-time curve) was noted compared to exposure after a single administration of secukinumab.

After a single intravenous (IV) injection, the mean volume of distribution in the terminal phase (Vz) in patients with plaque psoriasis ranged between 7.1 and 8.6 L. This probably indicates the limited distribution of the drug in the periphery.

In patients with plaque psoriasis, the mean systemic clearance (CL) was 0.19 L / day. Clearance was dose-dependent and dose-dependent, as expected for a therapeutic IgG1 monoclonal antibody that interacts with a soluble cytokine target such as IL-17A.

The half-life (T _½) in patients with plaque psoriasis averaged 27 days, in some patients it varied from 17 to 41 days.

With a single and multiple use of Cosentix in patients with plaque psoriasis, the pharmacokinetic parameters were determined in separate studies with intravenous administration from one dose of 0.3 mg / kg to three doses of 10 mg / kg and with subcutaneous administration from one dose of 25 mg up to multiple doses of 300 mg. For all dosing regimens, secukinumab exposure was dose proportional.

In psoriatic arthritis, ankylosing arthritis, and plaque psoriasis, the pharmacokinetic characteristics of secukinumab are the same.

There is no available data on the pharmacokinetics of Cosentix in patients with impaired renal and hepatic function.

According to a population analysis of the pharmacokinetics of secukinumab, in individuals over 65 years of age, the clearance of the drug is similar to that in patients of younger age.

Indications for use

moderate to severe psoriasis if systemic therapy or phototherapy is required;
active psoriatic arthritis with insufficient response to previous therapy with basic drugs (as a single drug or in combination with methotrexate);
active ankylosing spondylitis with insufficient response to standard therapy.

Contraindications

Absolute:

clinically significant infections in the acute stage (for example, active tuberculosis);
pregnancy and the period of breastfeeding;
vaccination with live vaccines;
age up to 18 years;
severe hypersensitivity reactions to any component of the drug.

With caution, Cosentix should be used in the active stage of Crohn's disease, chronic infections at present or in history.

On pre-filled syringes and syringes in auto-injectors, the removable cap contains derivatives of natural rubber latex, which should be taken into account by patients with individual latex intolerance.

Cosentix, instructions for use: method and dosage

The drug Cosentix is intended for subcutaneous administration. For injection, it is recommended to choose a site in the front of the thighs. It is also possible to inject the solution into the lower third of the abdomen, avoiding the 5 cm area around the navel. If someone else is injecting the drug into the patient, it is allowed to inject into the outer surface of the shoulder. The injection sites should be changed each time.

Cosentix should not be injected into areas on which the skin is affected: there is a thickening or thinning, peeling, irritation, redness. It is also necessary to avoid injection into places where there are stretch marks or scars, and into areas of skin affected by psoriasis.

Recommended dosage regimens:

moderate to severe psoriasis: 300 mg each (in the form of two injections of 150 mg) at 0, 1, 2 and 3 weeks. Further, starting from the 4th week, maintenance therapy is carried out with the introduction of Cosentix in the same dose once a month;
active psoriatic arthritis: 150 mg at 0, 1, 2 and 3 weeks; starting from the 4th week - 150 mg once a month. Patients with an inadequate response to anti-TNFα therapy (tumor necrosis factor alpha) are recommended to increase the dose to 300 mg (in the form of two injections of 150 mg each), the administration is carried out according to a similar scheme;
active ankylosing spondylitis: 150 mg at 0, 1, 2 and 3 weeks; starting from the 4th week - 150 mg once a month.

After learning the technique of administering the drug, the doctor can entrust the patient with the self-administration of Cosentix, but must ensure appropriate supervision during the entire treatment.

For the injection you will need:

a drug;
alcohol swab;
gauze or cotton swab;
container for disposal of sharps.

Important safety and storage information:

Keep out of the reach of children;
never leave in places accessible to others;
do not open the sealed pack until the moment of using the drug;
do not use in case of violation of the integrity of the pack or blister, as this can be dangerous;
do not shake syringes with solution;
before insertion, do not touch the protective legs of the syringe, since this can prematurely activate the automatic protective device of the syringe;
do not remove the cap from the needle immediately before the injection;
always examine the preparation for consistency in color and transparency. Do not use the solution in case of cloudiness, discoloration or visible inclusions, as well as in violation of the integrity of the syringe. It is normal for a small air bubble to be present in the solution;
do not reuse syringes, dispose of used syringes in a special container for sharps;
store the drug in a refrigerator at a temperature of 2–8 ° С, do not freeze;
do not use Cosentix after the expiry date stated on the syringe label or carton.

Application of Cosentix in a pre-filled syringe with a device for passive needle protection

Take the drug out of the refrigerator and leave for 15–30 minutes to warm the solution to room temperature.
Wash hands thoroughly with soap and water.
Wipe the site of the future injection with an alcohol solution.
Remove the syringe from the pack and blister.
Examine the preparation for consistency of color and transparency.
Carefully remove the cap from the needle. A drop of solution may be present at the end of the needle, this is normal.
Gently collect the skin fold between the fingers and insert the needle at a 45 ° angle.
While holding the syringe, slowly push the plunger until its base is between the side protection tabs.
Hold the syringe with the plunger depressed for 5 seconds.
Without releasing the plunger, remove the needle, then slowly release the plunger and wait for the automatic safety device to hide the needle.
In case of bleeding, apply a gauze / cotton swab to the injection site for 10 seconds. Do not rub the injection area. If necessary, cover with a plaster.
Place the used syringe in a special container.

Application of Cosentix in a pre-filled syringe in an autoinjector

Take the drug out of the refrigerator and leave for 15–30 minutes to warm the solution to room temperature.
Wash hands thoroughly with soap and water.
Wipe the site of the future injection with an alcohol solution and leave to dry.
Remove the cap from the syringe and discard.
Take the syringe at a 90 ° angle to the injection site.
Press the syringe firmly against the skin. During the injection of the drug, two clicks will sound: the first means the start of the injection, the second (will be heard after a few seconds) indicates that the injection is almost over. It is necessary to hold the syringe tightly against the skin while waiting for the green indicator to fill the viewing window and stop moving.
Remove the syringe.
In case of bleeding, apply a gauze / cotton swab to the injection site for 10 seconds. Do not rub the injection area. If necessary, cover with a plaster.
Place the used syringe in a special container.

Application of Cosentix in the form of a lyophilisate for the preparation of a solution for injection

Warm the vial with the drug and sterile injection water to room temperature.
Draw up 1 ml of injection water into a disposable syringe.
Remove the plastic cap from the vial containing the lyophilisate.
Insert the needle into the center of the rubber stopper of the vial and slowly inject the injection water, directing the stream to the lyophilisate.
Tilt the bottle at an angle of approximately 45 °. While holding it with your fingertips, gently rotate for about 1 minute. Do not shake or turn the bottle over.
Leave the bottle in an upright position for at least 10 minutes to completely dissolve the lyophilisate.
Take the bottle again at an angle of 45 ° and rotate for another 1 minute without shaking or inverting.
Leave the bottle upright for 5 minutes. The finished solution should be from colorless to light yellow, transparent or opalescent. Do not use the drug if the lyophilisate is not completely dissolved, or the solution contains visible inclusions, becomes cloudy or has changed color.
When prescribing a dose of 300 mg, prepare the second bottle as described above.
Tilt the bottle at an angle of approximately 45 ° and place the tip of the needle on the bottom of the bottle. Do not overturn the bottle.
In a disposable syringe with a needle of a suitable size (for example, "21G × 2"), carefully withdraw a little more than 1 ml of solution. When prescribing a dose of 300 mg, prepare a second syringe.
Lift the syringe with the needle up and tap it lightly so that the air bubbles move up.
Replace the needle with another “27G × 1/2” size. Remove air bubbles from the syringe and move the plunger to the 1 ml mark.
Disinfect the injection site with an alcohol swab.
Inject the drug.
Dispose of the syringe, needles and solution remaining in the vial.

Side effects

infectious and parasitic diseases: very often (≥ 1/10) - nasopharyngitis, upper respiratory tract infection; often (from ≥ 1/100 to <1/10) - herpes infection of the oral mucosa, pharyngitis, rhinitis; infrequently (from ≥ 1/1000 to <1/100) - candidal infection of the oral cavity, tonsillitis, sinusitis, inflammation of the outer ear, fungal skin lesions;
on the part of the skin and subcutaneous tissues: often - urticaria; rarely (from ≥ 1/10 000 to <1/1000) - anaphylactic reactions;
from the gastrointestinal tract: often - diarrhea;
from the respiratory system: often - rhinorrhea;
on the part of the blood and lymphatic system: infrequently - neutropenia;
on the part of the organs of vision: infrequently - conjunctivitis.

According to the data of clinical studies of Cosentix, less than 1% of patients showed the formation of antibodies to secukinumab, but this did not affect the pharmacokinetic parameters and the effectiveness of treatment.

Overdose

There are no reports of drug overdose cases. In clinical studies, doses up to 30 mg / kg (approximately 2000–3000 mg) were administered intravenously, no dose-limiting toxicity was observed.

In the case of an excessive dose of Cosentix, careful monitoring of the patient's condition is indicated, if necessary, symptomatic therapy is carried out.

special instructions

There is no information available on the effect of Cosentix on fertility. In animals, a decrease in reproductive function was not observed. However, women of reproductive age are advised to use reliable contraceptive methods during treatment with this drug and for at least 20 weeks after its end.

During therapy with secukinumab, an increased risk of developing infections was noted. In clinical studies, cases of infectious diseases were observed, in most cases of mild to moderate nature. Patients with a history of chronic infections and recurrent infections should be prescribed Cosentix after a careful assessment of the balance of benefits and potential risks.

Patients should be warned of possible symptoms that give rise to suspicion of an infection, in which they should immediately consult a doctor. In severe infectious processes, careful monitoring is required. The use of Cosentix should be canceled until complete recovery.

In clinical studies, an increased susceptibility to tuberculosis was not noted, however, with an active form, the appointment of Cosentix is contraindicated. Before prescribing the drug, anti-tuberculosis therapy is recommended for patients with latent forms of the disease.

There are known cases of worsening Crohn's disease in patients receiving secukinumab. In case of an exacerbation of the disease, careful medical supervision is required.

Cosentix is contraindicated for use in conjunction with live vaccines. If necessary, patients should be vaccinated during the period of therapy with inactivated / killed vaccines. In patients receiving secukinumab, after immunization with inactivated meningococcal and influenza vaccines, an adequate immune response was noted in the form of at least a 4-fold increase in antibody titer, which indicates that Cosentix had no suppressive effect against these types of vaccines.

In case of development of serious allergic or anaphylactic reactions, Cosentix should be urgently canceled and appropriate therapy should be started.

The removable cap of the pre-filled syringe contains natural rubber latex derivatives. Although the natural latex itself is not contained in the cap, the safety of using the drug in this package in patients with hypersensitivity to latex has not been established.

Influence on the ability to drive vehicles and complex mechanisms

There are no data on the negative influence of Cosentix on the ability to concentrate and reaction speed.

Application during pregnancy and lactation

In animal studies, no direct or indirect negative impact on the course of pregnancy, embryonic and fetal development, as well as on childbirth and postnatal development was revealed. However, there is no experience of using secukinumab in pregnant women, therefore, women who are carrying a child are contraindicated to prescribe Cosentix.

It is not known whether secukinumab is excreted in breast milk (however, it has been established that immunoglobulins are excreted in the mother's milk), and therefore Cosentix is contraindicated during lactation.

Pediatric use

Due to the lack of data on the safety and efficacy of secukinumab treatment in children and adolescents under 18 years of age, Cosentix is not used in pediatrics.

With impaired renal function

There is no available data on the pharmacokinetics of the drug in patients with impaired renal function.

For violations of liver function

There are no available data on the pharmacokinetics of Cosentix in patients with impaired liver function.

Use in the elderly

No dose adjustment is required in elderly patients.

Drug interactions

Cosentix is contraindicated for use in conjunction with live vaccines. Patients during the period of therapy can be vaccinated with inactivated vaccines.

Cosentix should not be mixed with any other medicinal products. The lyophilisate can only be diluted with water for injection.

In patients with psoriatic arthritis and ankylosing spondylitis, no interactions were found with the simultaneous use of methotrexate and / or glucocorticosteroids.

There are no direct data on the participation of IL-17A in the expression of isoenzymes of the cytochrome CYP450 system. An increased level of cytokines in a chronic inflammatory process inhibits the formation of some isoenzymes of the cytochrome system. In this regard, secukinumab can normalize the activity of cytochrome CYP450 isoenzymes, which is accompanied by a decrease in the exposure of simultaneously used drugs, which are metabolized with the participation of these isoenzymes. Thus, it cannot be excluded that secukinumab will have a clinically significant effect on drugs that are substrates of isoenzymes of the cytochrome system, which have a narrow therapeutic index, the dose of which is selected individually (for example, warfarin). In such situations, careful monitoring of the combination therapy is recommended.

Analogs

There is no information on the analogues of Cosentix.

Terms and conditions of storage

Store out of the reach of children, protected from light at a temperature of 2-8 ° C. Do not freeze.

The shelf life of the solution for injection is 2 years, the lyophilisate for the preparation of an injection solution is 3 years.

After removal from the refrigerator, the drug should be used within 1 hour.

The solution prepared from the lyophilisate can be stored for no more than 24 hours at a temperature of 2-8 ° C.

Terms of dispensing from pharmacies

Dispensed by prescription.

Reviews about Cosentix

The drug appeared on the domestic pharmaceutical market relatively recently, so there are few reviews about Cosentix. Patients note that after a few injections, the condition improves significantly: small psoriatic rashes disappear, and large ones significantly decrease. The disadvantages include the high cost of the drug.

Price for Cosentix in pharmacies

The approximate price for Cosentix is: 1 syringe pen (1 ml of solution for injection) - 46,800 rubles, 1 bottle of lyophilisate for preparing an injection solution (150 mg) - 44,000 rubles.

Maria Kulkes Medical journalist About the author

Education: First Moscow State Medical University named after I. M. Sechenov, 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!