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Pegasys - instructions for use, analogs, reviews and release forms (injections in a solution for subcutaneous injection in a syringe 135 mcg and 180 mcg) drugs for the treatment of hepatitis C and B in adults, children and pregnancy

Pegasys - instructions for use, analogs, reviews and release forms (injections in a solution for subcutaneous injection in a syringe 135 mcg and 180 mcg) drugs for the treatment of hepatitis C and B in adults, children and pregnancy

In this article, you can read the instructions for using the drug Pegasys. Presented are the opinions of visitors to the site - consumers of this medication, as well as opinions of doctors specialists on the use of Pegasys in their practice. A big request is to actively add their feedback on the drug: the medicine helped or did not help get rid of the disease, which were observed complications and side effects, possibly not declared by the manufacturer in the annotation. Analogues of Pegasys in the presence of existing structural analogs. Use to treat hepatitis C and B in adults, children, as well as during pregnancy and lactation.

 

Pegasys - immunomodulating drug.

 

The structure of PEG (bis-monomethoxypolyethylene glycol) directly affects the clinical and pharmacological characteristics of Pegasys. In particular, the size and degree of branching of PEG with a molecular mass of 40 kDa determines the absorption, distribution and excretion of peginterferon alfa-2a.

 

The activity of the Pegasys preparation should not be compared with other pegylated or unpigilated proteins of the same therapeutic class.

 

Just like Interferon alfa-2a, Pegasys has antiviral and antiproliferative activity.

 

In patients with chronic hepatitis C (HCV), a decrease in the level of hepatitis C virus (HCV) RNA in response to Pegasys therapy at a dose of 180 mg occurs in 2 phases. The first phase is observed 24-36 hours after the first injection of the drug, the second phase occurs within the next 4-16 weeks in patients with a stable virologic response. Ribavirin has no significant effect on the kinetics of the virus during the first 4-6 weeks in those patients who receive combination therapy with ribavirin and peginterferon alfa-2a or interferon alpha.

 

Composition

 

Peginterferon alfa-2a (40 kDa) + auxiliary substances.

 

Pharmacokinetics

 

After a single subcutaneous injection of 180 μg of Pegasys to healthy individuals, the drug is determined in the blood serum after 3-6 hours. After 24 hours the serum concentration reaches 80% of the maximum. Serum concentrations reach 80% of the maximum after 24 hours. The absolute bioavailability of peginterferon alfa-2a is 84% ​​and is similar to that of interferon alfa-2a. Peginterferon alfa-2a is found primarily in the blood and extracellular fluid. Peculiarities of the metabolism of peginterferon alfa-2a have not been fully studied. In experimental studies, it has been shown that in radio rats the radio-labeled drug is excreted mainly by the kidneys. The concentration of peginterferon alfa-2a in the serum is maintained throughout the week (168 h) after administration.

 

Patients with cirrhosis and without cirrhosis. Pharmacokinetics of Pegasys in healthy individuals and patients with hepatitis B or C is the same. In patients with compensated cirrhosis, pharmacokinetic characteristics are the same as in patients without cirrhosis (class A on the Child-Pugh scale).

 

Indications

 

Chronic hepatitis C:

  • chronic hepatitis C in adult patients with positive HCV RNA without cirrhosis or with compensated cirrhosis, incl. and with clinically stable co-infection with HIV (monotherapy or combination with ribavirin).

 

The combination with ribavirin is indicated in patients with chronic hepatitis C who have not received therapy before, or with ineffectiveness of previous monotherapy with interferon alpha (pegylated or unpaired) or combined with ribavirin therapy.

 

Monotherapy is indicated in case of intolerance or contraindications to ribavirin.

 

Chronic hepatitis B:

  • chronic hepatitis B HBeAg-positive and HBeAg-negative in adult patients with compensated liver damage and signs of viral replication, increased ALT activity and histologically confirmed liver inflammation and / or fibrosis.

 

Forms of release

 

A solution for subcutaneous administration is 135 μg and 180 μg (injections in a syringe).

 

Instructions for use and how to use them

 

Treatment with Pegasys should be performed under the supervision of a qualified physician with experience in the management of chronic hepatitis B and C.

 

With combined therapy with Pegasys, ribavirin should be used according to the instructions for the medical use of ribavirin.

 

Standard dosing regimen

 

The drug is administered subcutaneously, into the anterior abdominal wall or thigh, once a week.

 

Before administration, the preparation should be inspected for impurities and discoloration.

 

Patients should be carefully instructed about the importance of proper storage and disposal of used materials and caution against the reuse of any needles and syringes.

 

Chronic hepatitis B

 

With HBeAg-positive and HBeAg-negative chronic hepatitis B, the drug is prescribed in a single dose of 180 μg once a week for 48 weeks.

 

Chronic hepatitis C

 

Patients who were not previously treated

 

The recommended dose of Pegasys is 180 μg 1 time / week in monotherapy or in combination with ribavirin (orally). Ribavirin should be taken with meals.

 

When combined with ribavirin, the duration of therapy and the dose of ribavirin depend on the genotype of the virus.

 

Patients previously treated

 

The recommended dose of Pegasys in combination with ribavirin is 180 μg 1 time / week.The dose of ribavirin is 1000 mg per day (body weight <75 kg) and 1200 mg (body weight ≥75 kg).

 

If a virus is found at week 12 of treatment, therapy should be discontinued. The recommended total duration of therapy is 48 weeks. When deciding on the treatment of patients with genotype 1 who did not respond to previous treatment with pegylated interferon and ribavirin, the recommended total duration of therapy should be 72 weeks.

 

Co-infection with HIV-HCG

 

Pegasys is administered at a dose of 180 μg once a week as monotherapy or in combination with ribavirin (800 mg) for 48 weeks regardless of the genotype. The safety and efficacy of combination therapy with ribavirin at a dose of more than 800 mg and a duration of less than 48 weeks has not been adequately studied.

 

Renal insufficiency

 

At the terminal stage of renal failure, a dose reduction of Pegasys is recommended to 135 μg. Regardless of the initial dose and severity of renal failure, such patients should be carefully monitored and reduced in case of adverse reactions.

 

Liver failure

 

In patients with compensated cirrhosis of the liver (class A on the Child-Pugh scale), Pegasys is effective and safe.In patients with decompensated cirrhosis (grade B / C on the Child-Pugh scale or bleeding from varicose-esophageal veins of the esophagus), the use of Pegasys was not studied.

 

Elderly age

 

In elderly patients, correction of the recommended dose (180 μg once a week) is not required.

 

Children

 

The safety and efficacy of the drug in persons under the age of 18 years are not established. Pegasys solution is contraindicated in newborns and children under 3 years old, because it contains benzyl alcohol, which can cause neurological and other complications in this age group, sometimes fatal.

 

Patients after liver transplantation

 

The safety and efficacy of Pegasys monotherapy or its combination with ribavirin in patients after liver and other organ and tissue transplantation have not been established. As with the appointment of other alpha interferons, the use of Pegasys as monotherapy or in combination with ribavirin revealed cases of rejection of hepatic and renal transplants.

 

Side effect

  • upper respiratory tract infection;
  • bronchitis;
  • Candidiasis of the oral cavity;
  • herpes simplex;
  • fungal and bacterial infections;
  • pneumonia;
  • skin infections;
  • endocarditis;
  • otitis externa;
  • neoplasm of the liver;
  • thrombocytopenia, anemia, lymphadenopathy, pancytopenia, aplastic anemia;
  • sarcoidosis;
  • thyroiditis;
  • anaphylaxis;
  • systemic lupus erythematosus;
  • rheumatoid arthritis;
  • idiopathic or thrombotic thrombocytopenic purpura;
  • angioedema;
  • hypothyroidism;
  • hyperthyroidism;
  • diabetes;
  • anorexia;
  • dehydration;
  • depression;
  • anxiety;
  • insomnia;
  • aggressiveness;
  • nervousness;
  • decreased libido;
  • suicidal thoughts;
  • hallucinations;
  • suicide;
  • mental disorders;
  • headache;
  • dizziness;
  • violation of concentration of attention;
  • memory impairment;
  • migraine;
  • tremor;
  • a violation of taste sensations;
  • nightmarish dreams;
  • drowsiness;
  • coma;
  • convulsions;
  • neuritis of the facial nerve;
  • impaired vision;
  • pain in the eyeball;
  • inflammatory diseases of the eyes;
  • hemorrhage into the retina;
  • corneal ulcer;
  • loss of vision;
  • earache;
  • loss of hearing;
  • tachycardia;
  • palpitation;
  • peripheral edema;
  • arterial hypertension;
  • myocardial infarction;
  • congestive heart failure;
  • angina pectoris;
  • arrhythmia;
  • pericarditis;
  • cardiomyopathy;
  • dyspnea;
  • cough;
  • nose bleed;
  • nasal congestion;
  • rhinitis;
  • sore throat;
  • diarrhea;
  • nausea, vomiting;
  • abdominal pain;
  • dyspepsia;
  • bleeding gums;
  • glossitis;
  • stomatitis;
  • flatulence;
  • dryness of the oral mucosa;
  • gastrointestinal bleeding;
  • alopecia;
  • dermatitis;
  • itching;
  • dry skin;
  • rash;
  • increased sweating;
  • psoriasis;
  • hives;
  • eczema;
  • photosensitivity reaction;
  • night sweating;
  • toxic epidermal necrolysis;
  • Stevens-Johnson syndrome;
  • erythema multiforme;
  • myalgia;
  • arthralgia;
  • pain in the back, neck, bones;
  • muscle weakness;
  • myositis;
  • kidney failure;
  • impotence;
  • fever;
  • chills;
  • pain;
  • asthenia;
  • weakness;
  • irritability;
  • reactions at the injection site;
  • retardation;
  • tides;
  • thirst;
  • decreased body weight;
  • ischemic stroke;
  • rhabdomyolysis.

 

Contraindications

  • autoimmune hepatitis;
  • severe hepatic impairment;
  • decompensated cirrhosis of the liver;
  • cirrhosis with a score of ≥6 on the Child-Pugh scale in patients with co-infection with HIV-HCG, provided that the increase in this indicator is not associated with indirect hyperbilirubinemia due to the use of drugs such as atazanavir and indinavir;
  • severe cardiovascular diseases in the stage of decompensation, incl. with an unstable, poorly controlled course in the preceding 6 months;
  • children under 3 years of age (since the drug contains an auxiliary substance benzyl alcohol);
  • pregnancy;
  • the period of breastfeeding;
  • hypersensitivity to alpha interferons, genetically engineered preparations obtained with E. coli, to polyethylene glycol or any other component of the drug.

 

Application in pregnancy and lactation

 

Category C.

 

The effect of Pegasys on fertility has not been studied. With the appointment of peginterferon alfa-2a, as well as other alpha interferons, lengthening of the menstrual cycle is noted, with a decrease and a later onset of maximum concentrations of 17 beta-estradiol and Progesterone in animals. After the withdrawal of the drug, the normalization of the menstrual cycle was observed.

 

The effect of peginterferon alfa-2a on male fertility has not been studied. However, the introduction of interferon alpha-2a for 5 months did not affect fertility in animals.

 

The teratogenic effects of Pegasys have not been studied.The use of interferon alfa-2a led to a significant increase in the number of spontaneous abortions in rhesus monkeys. In the offspring born on time, no teratogenic effects were noted. However, when treating Pegasys with other alpha interferons, women of childbearing age should use effective methods of contraception.

 

Pegasys should not be administered during pregnancy.

 

It is not known whether peginterferon alfa-2a or its components are excreted in breast milk. To avoid the undesirable effects of Pegasys or ribavirin on the baby during breastfeeding, either breastfeeding or therapy should be discontinued, taking into account the potential benefits of therapy for the mother.

 

For combination with ribavirin: category X.

 

In animal studies, pronounced teratogenic effects of ribavirin and the ability to cause fetal death have been identified. Ribavirin is contraindicated in pregnant women and in men whose partners are pregnant.

 

Ribavirin therapy should not be prescribed until a negative pregnancy test is performed immediately before the proposed start of therapy.Women capable of childbearing, or men whose partners are capable of giving birth, should be informed of teratogenic effects of ribavirin and the need for effective contraception (at least 2 ways) during treatment and for 6 months after the end of therapy (according to the instruction on medical use of ribavirin).

 

Application in elderly patients

 

In elderly patients, correction of the recommended dose (180 μg once a week) is not required.

 

Use in children

 

Safety and effectiveness of the drug in children and adolescents under the age of 18 years are not established. Pegasys solution for subcutaneous administration contains benzyl alcohol, which can cause neurological and other complications in infants and children up to 3 years, sometimes fatal.

 

special instructions

 

In some patients, both during treatment with Pegasys, and so for 6 months after discontinuation of treatment, severe adverse reactions from the CNS were observed: depression, suicidal mood and suicidal attempts. When interferon alpha therapy was used, other side effects from the CNS were observed, incl.aggressive behavior, sometimes directed against other people (for example, homicidal ideas), confusion, violation of mental status. Care should be taken to monitor the condition of patients to identify signs or symptoms of mental disorders. If such symptoms occur, the doctor should be aware of the potential severity of these unwanted phenomena and the need for appropriate treatment. In the event that the symptoms of mental disorders persist or worsen or the suicidal mood is revealed, it is recommended to cancel therapy with Pegasys and provide the necessary treatment.

 

If a decision is made about the need to treat patients with severe mental illnesses (including in anamnesis) with Pegasys, then therapy should be started only after an appropriate examination and treatment of a mental disorder.

 

If Pegasys is used in combination with ribavirin, the physician should be sure to read the instructions for using ribavirin.

 

All patients before the inclusion in the clinical study of chronic hepatitis C liver biopsy,However, in some cases (for example, in patients with genotype 2 or 3) treatment is possible without histological confirmation. It is necessary to take into account the current clinical recommendations for determining the need for liver biopsy before starting treatment.

 

In patients with normal ALT activity, the progression of fibrosis is usually slower than in patients with elevated ALT activity. This must be taken into account, along with other factors (the genotype of the hepatitis C virus, extrahepatic manifestations, the risk of transmission of infection, etc.) that affect the decision on the appropriateness of the treatment.

 

Laboratory indicators before and during treatment

 

Before starting treatment with Pegasys, all patients are recommended to conduct standard general clinical and biochemical blood tests.

 

Pegasys (in the form of monotherapy or in combination with ribavirin) should be used with caution when hemoglobin is less than 12 g / dL.

 

After the beginning of therapy, the general clinical blood test should be repeated after 2 and 4 weeks, and the biochemical - after 4 weeks; Laboratory tests should be performed periodically during therapy.

 

In clinical trials, both the total number of leukocytes and the absolute number of neutrophils decreased with Pegasys treatment, usually from the second week of therapy. The progressive decrease in the absolute number of neutrophils after 8 weeks of therapy was infrequent. Reduction of the absolute number of neutrophils was reversible after dose reduction or drug withdrawal, in most patients this parameter returned to normal after 8 weeks, and returned to baseline in all patients after approximately 16 weeks.

 

Therapy with Pegasys is associated with a decrease in the number of platelets that returned to baseline during the follow-up period after treatment. In some cases, a dose change may be required.

 

In clinical trials with combined treatment with Pegasys and ribavirin, anemia (hemoglobin <10 g / dl) was observed in 15% of patients with chronic hepatitis C. The incidence of anemia depends on the duration of therapy and the dose of ribavirin. In women, the risk of anemia is higher.

 

As with the use of other interferons, caution should be given to Pegasus in combination with other myelotoxic drugs.

 

In the literature, cases of pancytopenia and bone marrow suppression occur 3-7 weeks after the onset of ribavirin in combination with azathioprine. Myelotoxicity was reversible and disappeared within 4-6 weeks after the withdrawal of antiviral therapy of CHC and azathioprine. After the resumption of one of the treatments (antiviral therapy or azathioprine), this effect did not develop in the future.

 

It is necessary to weigh the potential risk and benefit before initiating therapy in patients with CHC with failure of previous therapy and interrupted therapy due to hematologic adverse events, since the use of Pegasys in these patients is not well understood.

 

Endocrine system

 

When using Pegasys, as well as other interferons alpha, there were abnormalities in the thyroid gland function or worsening of pre-existing thyroid diseases. Before starting therapy with Pegasys, the levels of TSH and T4 should be investigated. Treatment with Pegasys can be started or continued if the level of TSH can be maintained within the limits of normal values ​​medically.If there are clinical symptoms of a possible dysfunction of the thyroid gland, it is necessary to examine TSH during therapy.

 

As with other interferon therapy, hypoglycemia, hyperglycemia and diabetes mellitus were observed with the use of Pegasys. In patients with these disorders, which can not be adequately corrected, do not start Pegacis monotherapy or Pegasis / ribavirin combination therapy, and if such conditions develop during therapy, discontinue therapy.

 

The cardiovascular system

 

Arterial hypertension, supraventricular arrhythmias, congestive heart failure, chest pain and myocardial infarction have been associated with alpha interferon therapy, including Pegasys. Patients with cardiovascular pathology before the start of therapy are recommended to make an ECG. In case of worsening of the cardiovascular status, therapy should be interrupted or canceled. In patients with cardiovascular disease, anemia can lead to the need to lower the dose or stop taking ribavirin.

 

Impaired liver function

 

With the development of liver failure Pegasys should be canceled. As with other alpha interferons, an increase in ALT activity compared to baseline was observed during Pegasys therapy, including patients with a virologic response. With a progressive or clinically significant increase in ALT activity, despite a reduction in dose, or if this increase is accompanied by an increase in the level of direct bilirubin, therapy should be discontinued.

 

In contrast to chronic hepatitis C, chronic hepatitis B exacerbation of liver disease occurs frequently and is accompanied by a transient and potentially significant increase in ALT activity. In clinical studies, a sudden increase in ALT activity when treated with Pegasys in patients with CHB was accompanied by mild changes in other laboratory parameters without signs of decompensated liver function. In half the cases of sudden increase in ALT activity, 10 times higher than UGN, the dose of Pegasys was reduced or the therapy was temporarily canceled before the normalization of the index,while in the second half of patients the therapy continued unchanged. It is recommended to monitor liver function more often in all cases.

 

Hypersensitivity reactions

 

When interferon alpha therapy is used, serious serious hypersensitivity reactions of immediate type are rarely observed (for example, urticaria, angioedema, bronchospasm, anaphylaxis). In cases of development of such reactions, therapy is canceled and immediate appropriate medication is prescribed. A transient rash does not require the withdrawal of therapy.

 

Autoimmune diseases

 

In the treatment of alpha interferons described the occurrence of autoantibodies and autoimmune diseases. Patients with a predisposition to the development of autoimmune diseases are at high risk. Patients with signs or symptoms similar to those of autoimmune diseases should undergo a thorough examination and a reassessment of the benefit / risk ratio from the continuation of interferon therapy.

 

Fever and infections

 

Although fever may be associated with influenza-like syndrome, often associated with interferon therapy,it is necessary to exclude other causes of persistent fever (in particular, serious bacterial, viral and fungal infections), especially in patients with neutropenia. When taking alpha interferons, including Pegasys, serious infections (bacterial, viral, fungal) were reported. Immediately assign the appropriate specific therapy and cancel Pegasys.

 

Ophthalmic changes

 

As in the treatment with other interferons, in the treatment with Pegasys, in rare cases, retinopathy was noted, including retinal hemorrhage, "wadded" exudates, optic disc swelling, optic neuritis, and thrombosis of arteries or retinal veins.

 

All patients before the appointment of therapy should conduct an ophthalmological examination to identify pathology of the fundus. If you have a complaint about a worsening of visual acuity or narrowing of the visual fields, a full ophthalmologic examination should be performed immediately. Patients with concomitant diseases of the organ of vision (eg, diabetic or hypertensive retinopathy) should undergo additional examinations during therapy with Pegasys.If the appearance or deterioration of the ophthalmic disease, therapy should be canceled.

 

Changes in the respiratory system

 

As with alpha interferon therapy, adverse reactions from the respiratory system, including dyspnea, pulmonary infiltrates, pneumonia and pneumonitis, were observed with Pegasys. When there is persistent (persistent) infiltrates or infiltrates of unknown origin or if the respiratory function is disrupted, therapy should be canceled.

 

Changes from the skin

 

The use of alpha interferons was associated with exacerbation or induction of psoriasis and sarcoidosis. Patients with psoriasis Pegasys should be administered with caution, and with the appearance or worsening of the disease, consider abolishing therapy.

 

Co-infection with HIV-HCG

 

Before starting treatment, you should carefully consider the possible side effects of antiretroviral drugs, which the patient will take together with drugs for HCV therapy. In patients who simultaneously received stavudine and interferon with or without ribavirin, the incidence of pancreatitis and / or lactic acidosis was 3%.

 

Patients with co-infection with HIV-HCG receiving highly active antiretroviral therapy (HAART) may be at risk for developing lactic acidosis. Therefore, caution is required when adding Pegasys and ribavirin to HAART.

 

In patients with co-infection and severe cirrhosis receiving HAART, combined therapy with ribavirin and interferons, including Pegasys, increases the risk of developing fatal liver failure. The baseline parameters that may be associated with hepatic decompensation in patients with co-infection and cirrhosis include: elevated serum bilirubin, reduced hemoglobin, elevated alkaline phosphatase or reduced platelet count, and didanosine treatment.

 

The simultaneous use of ribavirin and zidovudine is not recommended because of the increased risk of anemia.

 

Careful monitoring is needed to identify signs and symptoms of hepatic decompensation (including ascites, encephalopathy, bleeding from varicose veins, impaired hepatic function, ≥7 on the Child-Pugh scale) in co-infected patients.The Child-Pugh score does not always accurately reflect the presence of hepatic decompensation and can vary under the influence of factors such as indirect hyperbilirubinemia, hypoalbuminemia due to drug therapy. With the development of hepatic decompensation, Pegasys should be immediately withdrawn.

 

Caution should be exercised when administering Pegasys to patients with a low CD4 + lymphocyte count. Due to the lack of data on the efficacy and safety of Pegasys in patients with co-infection with HIV-HCG with a CD4 + lymphocyte count of less than 200 cells / μl.

 

Dental changes

 

Patients receiving combination therapy with Pegasys and ribavirin showed a pathology of teeth and periodontal disease, which can lead to tooth loss. In addition, a long course of treatment with Pegasys and ribavirin can cause dryness of the oral cavity, destructively affecting the teeth and mucous membrane of the mouth. Patients should thoroughly brush their teeth twice a day and regularly undergo examination at the dentist. Some patients may experience vomiting, after which it is recommended to thoroughly rinse your mouth.

 

The use of peginterferon as a long-term maintenance therapy (use outside the recorded indications)

 

In a randomized, controlled trial (HALT-C) in patients with chronic hepatitis C and fibrosis of various stages not responding to previous therapy, monotherapy with Pegasys at a dose of 90 μg per week for 3.5 years did not show a significant reduction in the rate of progression of fibrosis or associated with it clinical phenomena.

 

Influence on ability to drive vehicles and work with machines and mechanisms

 

Pegasys has little or no influence on the ability to drive vehicles and work with machines and mechanisms. When there is dizziness, drowsiness, confusion and weakness, you should stop driving the vehicle or work with machines and mechanisms.

 

Drug Interactions

 

Studies on the study of interaction were conducted only in adults. There was no pharmacokinetic interaction between the Pegasys preparation and ribavirin in patients with chronic hepatitis C and Pegasys and lamivudine in patients with chronic hepatitis B.

 

Pegasys is a moderate inhibitor of the isoenzyme activity of the 1A2 cytochrome P450 isoenzyme activity, an increase in the theophylline AUC is approximately 25%. In patients who simultaneously receive theophylline and Pegasys, it is necessary to monitor the concentration of theophylline in the serum and to carry out an appropriate correction of the theophylline dose. The interaction between theophylline and Pegasys seems to be peaking more than 4 weeks later with Pegasys.

 

In a pharmacokinetic study in 24 patients with chronic hepatitis C, Pegasys at a dose of 180 μg per week for 4 weeks was accompanied by an increase in the average levels of methadone metabolites (simultaneous methadone therapy at a dose of 30 mg to 150 mg, median 95 mg) 15%. The clinical significance of this interaction is not determined. With this combination, it is recommended to carefully monitor the symptoms of methadone intoxication. In particular, in patients receiving high doses of methadone, there is a risk of prolonging the QTc interval.

 

Co-infection with HIV-HCG

 

In an additional 12-week pharmacokinetic study in 47 patients with co-infection with HIV-HCG,whose goal was to determine the effect of ribavirin on the intracellular phosphorylation of certain nucleoside reverse transcriptase inhibitors (NRTIs) (lamivudia and zidovudine or stavudine), there is no obvious evidence of inter-drug interaction. However, due to significant fluctuations in the values, the confidence intervals were quite wide. The simultaneous administration of NRTIs obviously did not affect the exposure of ribavirin in plasma.

 

A combination of didanosine and ribavirin is not recommended. Ribavirin increases the exposure of didanosine and its active metabolite (dideoxyadenosine 5-triphosphate) in vitro, which can lead to the development of fatal hepatic insufficiency, peripheral neuropathy, pancreatitis, symptomatic hyperlactatemia / lactic acidosis.

 

When zidovudine was used in complex HIV therapy, anemia associated with ribavirin was reported to worsen. However, the exact mechanism of this phenomenon is still to be determined. Due to the increased risk of anemia, simultaneous use of ribavirin and zidovudine is not recommended. If combined antiretroviral therapy is already under way, ZDV should be considered, especially in patients who had a history of anemia caused by zidovudine.

 

The combination of telbivudine at a dose of 600 mg per day and Pegasys at a dose of 180 μg once a week is associated with an increased risk of peripheral neuropathy, the mechanism of development of which is unknown. It is impossible to exclude the increased risk of development of peripheral neuropathy and for other interferons (both standard and pegylated). In addition, the efficacy of the combination of telbivudine and alpha interferons (pegylated or standard) has not yet been established.

 

When ribavirin is used in combination with azathioprine, the myelotoxic effect of azathioprine is possible. Ribavirin inhibits inosine monophosphate dehydrogenase, an enzyme involved in the metabolism of azathioprine. In turn, suppression of the activity of this enzyme leads to an increase in the level of 6-methylthioinosine monophosphate, which is associated with the risk of myelotoxicity in patients receiving azathioprine.

 

It is possible to administer ribavirin in combination with azathioprine if the expected benefit of therapy exceeds the potential risk. In such cases, a careful monitoring of the blood composition for the development of myelotoxicity is necessary. If myelotoxicity occurs, the combination therapy should be abolished.

 

Pharmaceutical incompatibility

 

It is forbidden to mix Pegasys with other drugs, because compatibility studies are not available.

 

Analogues of the medicine Pegasys

 

Pegasys does not have structural analogs for the active substance.

 

Analogues for the pharmacological group (interferons):

  • Avonex;
  • Algeron;
  • Altevir;
  • Alfaron;
  • Alfaferon;
  • Betaferon;
  • Viferon;
  • Wallferon;
  • Genfaxon;
  • Grippferon;
  • Ingaron;
  • Inter;
  • Interferal;
  • Interferon alfa-2 human recombinant;
  • Interferon beta-1b is human recombinant;
  • Interferon gamma recombinant human;
  • Interferon leukocyte human;
  • Intron A;
  • Infagel;
  • Inferon;
  • Infibet;
  • Layfferon;
  • Lokferon;
  • Ophthalmoferon;
  • Pegintron;
  • Realdiron;
  • EU Reaferon;
  • Reaferon EU Lipint;
  • Rebif;
  • Ronbetal;
  • Roferon A;
  • SynnoWex;
  • Eberon alpha P;
  • Extavia.

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