Plegridi - Instructions For The Use Of Injections, Reviews, Drug Price, Analogues

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

Plegridi

Plegridi: 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: Plegridy

ATX code: L03AB13

Active ingredient: peginterferon beta-1a (Peginterferon beta-1a)

Manufacturer: Wetter Pharma-Fertigung, GmbH & Co. KG (Vetter Pharma-Fertigung, GmbH & Co. KG) (Germany)

Description and photo update: 2019-25-11

Prices in pharmacies: from 24614 rubles.

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Plegridi is an immunomodulatory agent for the treatment of relapsing-remitting multiple sclerosis in adults.

Release form and composition

The drug is produced in the form of a solution for subcutaneous (s / c) administration: slightly opalescent or transparent, pale yellow or colorless liquid [0.5 ml (63/94/125 μg) in a syringe made of transparent colorless glass equipped with a stainless needle steel, closed with a cap made of thermoplastic elastomer and polypropylene, and a piston rod with bromobutyl seal; in a plastic pallet, sealed with plastic film or paper, 1 syringe and instructions for the use of Plegridi; packaging for the initial course - in a cardboard box 2 pallets (63 and 94 μg), for the continuation of the course - in a cardboard box 2 or 6 pallets (125 μg). 0.5 ml (63/94/125 μg) in a glass syringe placed in a plastic syringe pen for single use; in a plastic tray 2 syringe pens (63 and 94 μg or 125 and 125 μg);packaging for the initial course - in a cardboard box 1 pallet (63 and 94 μg), for the continuation of the course - in a cardboard box 1 pallet (2 syringe pens 125 μg each), or in a cardboard box 3 packs with 1 pallet (2 syringe pens 125 mcg each); the dosages are additionally marked with different colors, orange - 63 μg, blue - 94 μg and gray - 125 μg; instructions for use, enclosed in each cardboard box, can be folded or in the form of a color booklet; packs and / or boxes may be equipped with a sticker first opening control].enclosed in each cardboard box, can be folded or in the form of a color booklet; packs and / or boxes may be equipped with a sticker first opening control].enclosed in each cardboard box, can be folded or in the form of a color booklet; packs and / or boxes may be fitted with a sticker-type first tamper evident control].

1 syringe / pen contains:

• active substance: peginterferon beta-1a (in terms of protein) - 63, 94 or 125 μg;
• additional components: sodium acetate trihydrate, L-arginine hydrochloride, polysorbate 20, glacial acetic acid, water for injection.

Pharmacological properties

Pharmacodynamics

The active substance Plegridi is a conjugate of interferon beta-1a, genetically isolated from the cells of the ovaries of a Chinese hamster and one linear molecule of methoxypolyethylene glycol-O-2-methylpropionaldehyde (mPEG), having a mass of 20 kDa, in a proportion of 1 mol of protein / 1 mol of polymer … The conjugate has an average molecular weight of about 44 kDa, of which about 23 kDa is protein. The medicinal product does not include preservatives.

The exact mechanism of action of the drug in the treatment of multiple sclerosis has not been established. Plegridi interacts with type I interferon receptors on the surface of cell membranes and leads to the launch of a cascade of intracellular reactions that regulate the expression of interferon-dependent genes. Drug-mediated biological effects have been suggested to include increased expression of anti-inflammatory cytokines, including interleukin (IL) -4, IL-10, IL-27, as well as decreased expression of pro-inflammatory cytokines such as interferon-γ, IL-2, IL-12, tumor necrosis factor α (TNF-α), and blocking the passage of activated T cells across the blood-brain barrier (BBB). However, additional mechanisms can be used. Due to the fact that the pathophysiology of multiple sclerosis is only partially established,It was not possible to fully elucidate the way peginterferon beta-1a interacts with specific binding sites in the body.

Plegridi is an interferon beta-1a conjugated at the N-terminal amino acid residue of the alpha-amino group to 1 linear methoxy polyethylene glycol molecule. Interferons are associated with many cellular reactions, classified as immunomodulatory, antiviral, antiproliferative. The pharmacological characteristics of Plegridi correspond to those for interferon beta-1a and are presumably due to the protein part of this molecule.

Pharmacodynamic responses to drug administration were assessed by measuring the induction of interferon-dependent genes, including those encoding 2 ', 5'-oligoadenylate synthetase (2', 5'-OAS), several cytokines and chemokines, protein A of myxovirus resistance (M × A) and neopterin (D-erythro-1, 2, 3-trihydroxypropylpterin) - a substance formed with the participation of an interferon-induced enzyme - guanosine triphosphate cyclohydrolase 1 (GTPCH 1).

In healthy volunteers, gene induction was greater in terms of maximum concentration (C _max) and exposure (area under the concentration-time curve - AUC), when compared with non-pegylated interferon beta-1a against the background of intramuscular (i / m) administration of the latter and Plegridi in the same dose, calculated by activity - 6 million international units (6 MMU). This response was more stable and was observed for a longer time when using peginterferon beta-1a: an increased concentration was recorded up to 15 days compared to 4 days against the background of the introduction of non-pegylated interferon beta-1a.

Elevated levels of neopterin were found in both healthy volunteers and patients with multiple sclerosis. Along with this, a continuous and prolonged increase over 10 days was noted in the case of the use of Plegridi, compared with 5 days with the introduction of non-pegylated interferon beta-1a. The content of neopterin decreased to baseline values two weeks after the use of peginterferon beta-1a.

The safety and efficacy of Plegridi in patients with relapsing-remitting multiple sclerosis who have at least 2 relapses in the last three years and 1 relapse in the last year [the sum of scores according to ESSR (Extended Disability Assessment Scale) ≤ 5] was determined for one year in placebo controlled phase of a two-year randomized double-blind study (ADVANCE). Peginterferon beta-1a was administered to 1512 patients subcutaneously at a dose of 125 μg once every 2 weeks (n = 512) or once every 4 weeks (n = 500), and patients also received placebo (n = 500). Annual relapse rate was the primary endpoint.

Used once every 2 weeks for one year, the drug reduced the relapse rate by 36% when compared with placebo. The effect also persisted in subgroup analyzes that were pooled according to demographics and baseline disease characteristics. The risk of relapse was significantly reduced by 39% (p = 0.0003), and the threat of persistent progression of disability after 12 weeks of admission by 38% (p = 0.0383), after 24 weeks - by 54% (p = 0.0069). The number of HD ⁺ foci (foci accumulating gadolinium) decreased by 86%, the number of newly increased or new T2 foci - by 67%, T1-hypointense foci when compared with placebo - by 53% (in all cases, p <0.0001).

The clinical efficacy of Plegridi was recorded as early as 6 months after the start of its administration once every 2 weeks at a dose of 125 μg; at the same time, when compared with placebo, the number of new and newly enlarged T2 lesions decreased by 61%. According to magnetic resonance imaging (MRI) data, the most significant reduction in the number of relapses and endpoints per year was recorded in people in the group using peginterferon beta-1a 125 μg every 2 weeks, compared with patients who received the agent every 4 weeks.

Analysis of the results of studies lasting two years confirmed the preservation of the effectiveness recorded after one year of therapy. A retrospective analysis of the data showed that in the group of people who used the drug at a dose of 125 μg every 2 weeks, compared with the group who received it every 4 weeks, there was a significantly lower incidence of endpoints, including the annual frequency of relapses (by 24%, p = 0.0209), threat of relapse (by 24%, p = 0.0212), threat of progression of persistent disability 24 weeks after the start of treatment (by 36%, p = 0.0459). Based on the MRI examination, a lower incidence of endpoints was established - the number of T1-hypointense foci by 53%, new or newly enlarged T2-foci - by 60%, HD ⁺ foci - by 71% (for all p <0.0001).

Pharmacokinetics

The plasma half-life (T _1/2) of peginterferon beta-1a is longer than that of non-pegylated interferon beta-1a. In the course of studies with single and multiple administration of Plegridi, it was found that the level of its active substance depended on the dose, ranging from 63 to 188 μg. The pharmacokinetic parameters of peginterferon beta-1a observed in patients with multiple sclerosis corresponded to the corresponding characteristics in healthy volunteers.

C _{max of} peginterferon beta-1a in blood plasma after its SC administration to patients with multiple sclerosis was noted after 1–1.5 days. After repeated use of Plegridi every 2 weeks at a dose of 125 μg, its C _max (mean ± standard error) was (280 ± 79) pg / ml.

In the case of a single SC administration of peginterferon beta-1a at doses of 63, 125 and 188 μg (which is equivalent to 6, 12 and 18 MMU), an average of 4, 9 and 13 times greater exposure (AUC _{168 h}) and approximately 2; 3.5 and 5 times greater C _max compared to the same indicators of non-pegylated interferon beta-1 when injected intramuscularly at a dose of 30 μg (6 MMU).

After multiple subcutaneous administration of Plegridi every 2 weeks at a dose of 125 μg, the volume of distribution (V _d) of the active ingredient without correction for bioavailability (mean ± standard error) was 481 ± 105 L.

The main route of excretion of peginterferon beta-1a is renal clearance. A fragment of polyethylene glycol covalently bound to interferon beta-1a (a protein) is capable of in vivo changing the properties of an unmodified protein, including reducing renal clearance and decreasing proteolysis, thereby leading to an elongation of T _1/2 from the bloodstream. Therefore, in healthy volunteers, T _1/2 for peginterferon beta-1a is approximately 2 times longer than for non-pegylated interferon beta-1a. In patients with multiple sclerosis in equilibrium, T _1/2 (mean ± standard error) of peginterferon beta-1a was 78 ± 15 hours, and the mean clearance value was 4.1 ± 0.4 l / h.

According to the results of a population analysis of the pharmacokinetics of peginterferon beta-1a, gender and race of patients do not affect the pharmacokinetic parameters of this active substance.

In the process of preclinical studies of the safety of Plegridi in animals, there were no signs of toxicity against the background of subcutaneous injections of doses 55 times higher than the therapeutic, established in mg per 1 kg of body weight.

During tests for reverse mutations in bacteria in vitro (Ames test for the induction of gene mutations), as well as clastogenic activity in a study on human lymphocytes in vitro, peginterferon beta-1a did not show mutagenic activity.

Carcinogenicity studies of the active substance in animals have not been carried out.

Indications for use

Plegridi is recommended for the treatment of relapsing-remitting multiple sclerosis in adults.

Contraindications

Absolute contraindications for therapy with Plegridi are:

• children and adolescents up to 18 years old;
• severe depression and / or suicidal thoughts;
• hypersensitivity to peginterferon, recombinant / natural interferon, or any additional component.

In addition, it is contraindicated to start a course of treatment in women during the established pregnancy.

Plegridi, instructions for use: method and dosage

Plegridi's solution is administered s / c.

Drug therapy should be started under the supervision of a physician experienced in the treatment of multiple sclerosis.

There is no information on the effectiveness of Plegridi's injections when compared with non-pegylated interferon beta, as well as when patients are transferred to drug treatment after using non-pegylated interferon beta. This fact must be taken into account when replacing pegylated interferon with non-pegylated interferon, or in case of replacing the last Plegridi.

Typically, injections are recommended under the skin of the shoulder, thigh, or abdomen. The recommended therapeutic dose of the drug is 125 mcg 1 time in 14 days.

The package intended for starting treatment contains two doses of Plegridi for the first two injections - 63 and 94 mcg.

Dose selection scheme at the beginning of the course of therapy, 1 injection - every 14 days (the marking of the corresponding syringe / pen is indicated):

• I dose: day 1 - dosage 63 mcg, orange;
• II dose: day 14 - dosage 94 mcg, blue;
• III dose: day 28 - dosage 125 mcg (full dose), gray.

Then, every 14 days, as on the 28th day, the full dose should be administered - 125 mcg.

A gradual increase in the dose at the beginning of the course contributes to better tolerance of the flu-like symptoms that sometimes arise at the beginning of the use of interferons. The prophylactic or concomitant intake of anti-inflammatory, antipyretic and / or analgesic drugs can prevent or reduce the severity of these adverse reactions.

If the next dose is missed, if there are 7 or more days left before the next scheduled injection of Plegridi, the missed dose should be administered as soon as possible, and the next dose should be administered according to the plan. If there are less than 7 days left until the next scheduled injection, you should immediately enter the missed dose and start a new schedule of scheduled administrations (1 time in 2 weeks) from the day of injection of the missed dose. It is impossible to inject the solution more often than after 7 days.

Each pre-filled syringe and pen is intended for single use only, it is forbidden to reuse them, after insertion they must be disposed of.

Before the injection, the drug removed from the refrigerator must be warmed to room temperature under natural conditions, for about 30 minutes. External heating sources such as hot water are prohibited. If the solution contained in pre-filled syringes and syringe pens is cloudy or contains visible particles, or has been frozen, then such a preparation cannot be used. The solution should be clear, colorless or pale yellow, and an air bubble is also allowed in it.

Before the injection, it is required to place all the materials necessary for the procedure on a clean, well-lit and flat surface, such as a gauze pad, a cotton swab moistened with alcohol, an adhesive plaster / fixation bandage, a protective container for disposing of used syringes and syringe pens.

After removing the Plegridi package from the refrigerator, remove the filled syringe or syringe pen with the dose corresponding to the current stage of the program. If there is still an unused drug in the package in a syringe pen or syringe, it should be closed and put back in the refrigerator until the next injection.

After evaluating the appearance of the solution and making sure that it corresponds to the above description, after the drug reaches room temperature, you can start the procedure. When using the solution in a pen, make sure that green stripes are visible in the injection status window.

Plegridi should not be injected into areas of the body where the skin is irritated, reddened, infected, or bruised or scarred at the intended injection site. It is recommended to change the injection site and not to inject the solution several times in a row into the same area.

It is necessary to remove the cap from the pen or syringe needle only after everything is ready for the injection.

Before administering the drug, you should thoroughly wash your hands with soap and water. After choosing an area for injection in the area of the shoulder, abdomen or thigh, you should wipe it with a swab soaked in alcohol. The planned injection site must dry before injection.

Performing a Plegridi injection with a filled pen:

1. Pull the cap and remove it; do not put the removed cap back on. Do not touch or press on the guard as it covers the needle. Beware of accidentally touching the needle; after removing the cap, the pen is ready for injection.
2. Position the syringe pen, pressing it to the surface of the injection site at an angle of 90 ° so that you can see the green stripes in the status window. Until the latter are visible, do not use a syringe pen.
3. Press the syringe pen to the injection site and hold it in this position until it stops clicking and green ✓ (check marks) appear. Constantly pressing the pen against the injection site assists in inserting the needle and initiating the injection.
4. Do not make any movements until the end of the injection of the solution, continuing to press the syringe pen to the skin, holding it motionlessly at an angle of 90 ° until the end of the injection. During the introduction of the injection, the pen will click several times, these sounds will stop after the completion of the injection in about 5 seconds. The appearance of green checkmarks in the window will indicate the end of the injection, and the filling of the entire window with the drug with a yellow plunger will indicate the successful full use of the entire dose.
5. Remove the pen from the injection site by lifting it up. The guard should completely cover the needle.

Performing a Plegridi injection with a filled syringe:

1. Remove the protective cap from the needle and then do not touch it.
2. Gather the alcohol-treated skin into a fold using your thumb and forefinger. Hold the syringe at a 90 ° angle to the injection site.
3. Quickly (like throwing a dart), insert the needle to the very base into the fold of the skin. Release the fold after insertion. Slowly press the plunger in one light movement, completely emptying the syringe for about 5 seconds.
4. Do not remove the needle from the injection site after completion of the injection for another 5 seconds.
5. Remove the needle while holding the syringe upright. Do not put the protective cap back on the needle.

After the introduction of Plegridi, it is recommended to press on the injection site with a sterile gauze pad for several seconds. If blood appears, it should be blotted and a patch should be applied if necessary.

2 hours after the injection, it is required to check the injection site for swelling, redness or soreness. In the event of a skin reaction that lasts for several days, you should consult your doctor or nurse.

Side effects

When Plegridi was administered subcutaneously every 2 weeks at a dose of 125 mcg, the most common adverse events were the following: flu-like syndrome, erythema at the injection site, headache, chills, fever, asthenia, myalgia, arthralgia, pain / itching at the injection site. An adverse reaction that in most cases led to discontinuation of treatment was influenza-like syndrome (less than 1% of patients).

The undesirable effects, more often recorded in people who received Plegridi every 2 weeks at a dose of 125 μg (n = 512), when compared with people who received placebo for 48 weeks (n = 500), included the following disorders:

• Central and peripheral nervous system: very often - headache, infrequently - seizures;
• immune system: infrequently - hypersensitivity reaction;
• blood and lymphatic system: infrequently - thrombocytopenia; rarely - thrombotic microangiopathy (TMA), including thrombotic thrombocytopenic purpura (TTP) / hemolytic uremic syndrome (HUS);
• psyche: often - depression;
• musculoskeletal and connective tissue: very often - arthralgia, myalgia;
• skin and subcutaneous fat: often - itching; infrequently - urticaria;
• gastrointestinal tract (GIT): often - nausea, vomiting;
• respiratory system: with an unknown frequency - pulmonary arterial hypertension;
• kidneys and urinary tract: rarely - glomerulosclerosis, nephrotic syndrome;
• laboratory and instrumental data: often - an increase in the activity of alanine aminotransferase (ALT), aspartate aminotransferase (AST) and gamma glutamyl transferase (GGT), a decrease in the number of leukocytes, a decrease in hemoglobin levels, an increase in body temperature; infrequently - a decrease in the number of platelets;
• general disorders and reactions at the injection site: very often - chills, fever, itching, pain at the injection site, erythema at the injection site, asthenia, flu-like syndrome; often (noted at the injection site) - a feeling of warmth, pain, discoloration of the skin, hyperthermia, edema, swelling, hematoma, inflammation, rash; rarely - necrosis at the injection site.

The incidence of flu-like symptoms such as chills, hyperpyrexia, pain, flu-like condition, myalgia, fever, and musculoskeletal pain was highest at the beginning of therapy. As a rule, it decreased during the first 6 months. Of the influenza-like symptoms recorded during the study period, 90% were mild or moderate in severity. Cases of development of these effects in a severe degree were not observed.

Erythema, pruritus, pain, or swelling at the injection site was reported in 66% of patients using peginterferon beta-1a every 2 weeks at a dose of 125 mcg, compared with 11% of patients receiving placebo. The most common disorder was injection site erythema. Of the observed side effects at the injection site, up to 95% of them were mild or moderate in severity. In one case (out of 1468 patients), the development of necrosis was recorded, which resolved after the appointment of standard treatment.

Hypersensitivity reactions were observed in 16% of patients who received the drug at a dose of 125 μg, and in 14% in the placebo group. In the Plegridi group, less than 1% experienced serious reactions in the form of angioedema, urticaria, and they quickly resolved after treatment with antihistamines and / or glucocorticosteroid (GCS) drugs. If a serious hypersensitivity reaction develops during treatment, it is necessary to stop using peginterferon beta-1a.

Overdose

No cases of overdose with Plegridi have been reported. If an overdose may develop, appropriate supportive treatment is recommended.

special instructions

Against the background of therapy with interferon beta drugs, cases of an increase in the activity of liver enzymes, the occurrence of hepatitis, autoimmune hepatitis and, rarely, severe liver failure were observed. In the process of using Plegridi, cases of increased activity of liver enzymes were recorded. When using the drug, patients should be monitored for the timely detection of possible symptoms of liver damage.

When treating patients with a history of depressive disorders, Plegridi should be used with caution. Patients should promptly inform their healthcare professional of signs of depression and / or suicidal thoughts. During therapy, it is necessary to establish close monitoring in persons with depression and, if necessary, provide appropriate treatment. It is required to consider the possibility of abolishing peginterferon beta-1a.

In order to reduce the threat of reactions at the injection site to a minimum, it is necessary to administer the solution under aseptic conditions. In the case of skin lesions, accompanied by swelling and / or outflow of fluid from the injection site, you should immediately consult a doctor.

Against the background of the use of Plegridi, cytopenias were noted, including rare cases of severe thrombocytopenia and neutropenia. During the period of treatment, it is required to monitor the symptoms or signs of a decrease in the number of formed elements of peripheral blood.

During therapy with interferon beta, cases of nephrotic syndrome have been recorded in the presence of various nephropathies, including such as lipoid nephrosis (FN), sclerosing glomerulonephritis, focal segmental glomerulosclerosis (FSH), membranous glomerulopathy (MHP) and membranous glomerulophene MPGN). These phenomena were observed at different phases of treatment and could develop several years after the use of interferon beta. During treatment with the drug, periodic examinations should be carried out in order to detect early signs of these complications, for example, proteinuria, edema and renal dysfunction, especially in the presence of an increased threat of kidney damage. Timely therapy of nephrotic syndrome is necessary, as well as an assessment of the feasibility of discontinuing or continuing the use of Plegridi.

During the period of therapy with interferon beta, cases of TMA (including fatal ones) were recorded, manifested in the form of TTP or HUS. These complications were noted at different stages of drug use and could appear several weeks / years after the start of the course. Their early clinical signs include fever, thrombocytopenia, new-onset arterial hypertension, paresis, confusion, and functional impairment of the kidneys. Laboratory findings for suspected TMA include a decrease in platelet count and an increase in lactate dehydrogenase (LDH) activity in a blood smear. If clinical signs of TMA are found, additional studies of platelet counts, LDH levels, blood smears, and renal activity should be performed. If the diagnosis is confirmed, it is required to immediately stop using Plegridi and conduct appropriate treatment, including exchange plasma transfusion.

Interferon therapy proceeds with a change in laboratory parameters. Before using Plegridi, regularly after the start of the course and then periodically (in the absence of clinical symptoms), in addition to standard laboratory tests prescribed for patients with multiple sclerosis, it is recommended to carry out a complete clinical blood test, including counting the number of platelets and a biochemical blood test, including functional liver function tests (ALT and AST levels). Patients with myelosuppression may need intensive monitoring of blood test parameters with counting the number of formed elements and platelets.

With extreme caution, Plegridi should be administered to patients with a history of convulsive seizures, or taking antiepileptic drugs, especially if epilepsy is not well controlled.

Patients with a history of severe heart disease, including coronary artery disease, congestive heart failure, arrhythmia, require constant monitoring during therapy, mainly at the beginning of the course, to identify possible worsening of the severity of symptoms.

Influence on the ability to drive vehicles and complex mechanisms

Central and peripheral nervous system side effects such as nausea during treatment can affect the ability to drive and perform potentially hazardous activities that require increased concentration and responsiveness.

Application during pregnancy and lactation

In the course of treatment with the drug, women with preserved childbearing potential must use the most effective methods of contraception.

If during therapy unintentional conception or pregnancy is planned, the woman should be informed of the potential risks, and it is also required to consider discontinuing the use of Plegridi. If there is a high relapse rate before starting treatment, a careful assessment of the threat of severe relapse after drug withdrawal as a result of pregnancy and an increased risk of spontaneous abortion during treatment should be made.

There are limited data on the use of peginterferon beta-1a in pregnant women, and the findings indicate an increased risk of spontaneous abortion. During pregnancy, starting drug therapy is contraindicated.

Whether peginterferon beta-1a is excreted in human breast milk has not been determined. Taking into account the possibility of serious side effects in a newborn, if therapy is necessary during lactation, it is necessary to stop breastfeeding.

There is no evidence of the effect of peginterferon beta-1a on human fertility. Anovulatory effects in animals were recorded when using the drug in very high doses.

Pediatric use

In children and adolescents, the efficacy and safety of an immunomodulatory agent has not been studied, as a result of this, therapy with Plegridi is contraindicated in patients under 18 years of age.

With impaired renal function

Based on the results of clinical studies, in the presence of mild, moderate or severe renal failure, as well as in end-stage renal disease, no dose adjustment of Plegridi is required. Nevertheless, patients with severe renal insufficiency are advised to administer the drug with extreme caution.

For violations of liver function

Evaluation of the pharmacokinetic parameters of peginterferon beta-1a in patients with hepatic insufficiency has not been carried out.

In the setting of severe hepatic impairment, Plegridi should be used with caution under close medical supervision. During the period of therapy, patients should be periodically examined for signs of liver damage.

Use in the elderly

Due to the limited number of elderly patients included in clinical trials, the safety and efficacy of Plegridi for the treatment of this age group has been insufficiently studied. However, according to the results obtained using population analysis of pharmacokinetic data in persons under 65 years of age, age does not affect the clearance of peginterferon beta-1a.

Drug interactions

Interaction studies of peginterferon beta-1a with other drugs / drugs have not been conducted.

Based on clinical data, patients with multiple sclerosis can use Plegridi in combination with GCS during the period of relapse of the disease.

It should be borne in mind that in humans and animals, interferons weaken the activity of hepatic isozymes of the cytochrome P450 system. It is recommended to use peginterferon beta-1a with extreme caution in combination with drugs characterized by a narrow therapeutic index, in which clearance is largely dependent on the cytochrome P450 system of liver microsomes, in particular, with antidepressants and certain classes of antiepileptic drugs.

Analogs

Plegridi's analogues are Avonex, Rebif, Betaferon, Interal-P, Ronbetal, Extavia.

Terms and conditions of storage

Store in a place out of reach of children, protected from light, at a temperature of 2 to 8 ° C, without freezing.

The shelf life is three years.

In the absence of a refrigerator, the solution can be stored in a place protected from light at temperatures up to 25 ° C, no more than 30 days.

Terms of dispensing from pharmacies

Dispensed by prescription.

Reviews about Plegridi

There are very few reviews of Plegridi on specialized sites and forums dedicated to discussing therapies for the treatment of remitting multiple sclerosis in adults. Basically, patients in them note the effectiveness of the drug and its prolonged action, which makes it possible to reduce the frequency of injections to 1 injection every 14 days. This fact increases the adherence of patients to therapy.

At the same time, against the background of treatment with the drug, all indicate the occurrence of pronounced side effects, mainly in the form of a flu-like state observed within 2 days after the administration of Plegridi.

Price for Plegridi in pharmacies

The price of Plegridi, a solution for subcutaneous administration (125 μg / 0.5 ml), can be 24,300 rubles. per package containing 2 syringes of 0.5 ml.

Plegridi: prices in online pharmacies

Drug name Price Pharmacy

Plegridi 125 μg / 0.5 ml solution for subcutaneous administration of 0.5 ml 2 pcs. RUB 24614 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!