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Instruction for use: PegIntron

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Dosage form: Lyophilizate for the preparation of a solution for intranasal administration

Active substance: Peginterferonum alfa-2b

ATX

L03AB Interferons

Pharmacological group:

Interferons

The nosological classification (ICD-10)

B18.0 Chronic viral hepatitis B with delta-agent: Chronic viral hepatitis B; Chronic active hepatitis B; Chronic viral hepatitis B; Chronic hepatitis B HBeAg-positive

B18.1 Chronic viral hepatitis B without delta-agent: Chronic viral hepatitis B; Chronic active hepatitis B; Chronic viral hepatitis B; Chronic hepatitis B; Chronic hepatitis B HBeAg-negative

B18.2 Chronic viral hepatitis C: Hepatitis C; Recurrence of chronic hepatitis C; Chronic active hepatitis C; Chronic viral hepatitis C; Chronic hepatitis C without cirrhosis; Chronic hepatitis C with compensated cirrhosis; Chronic hepatitis C

Composition and release form

Powder lyophilized for the preparation of solution for injection 1 fl.

Peginterferon alfa-2b (as a lyophilized powder) 50 μg; 80 μg; 100 μg; 120 μg

Auxiliary substances: sodium hydrophosphate; Sodium dihydrogen phosphate; Sucrose; Polysorbate 80

In vials, in a contour-cell package 1 bottle, complete with a solvent (water for injection) in ampoules of 0.7 ml; In a pack of cardboard 1 set.

Powder lyophilized for solution for injection 1 syringe pen

Peginterferon alfa-2b (as a lyophilized powder) 50 μg; 80 μg 100 μg; 120 μg; 150 μg

Auxiliary substances: sodium hydrophosphate; Sodium dihydrogen phosphate; Sucrose; Polysorbate 80

In two-chamber syringes-pens complete with a solvent (water for injection - 0,7 ml), with a sterile needle and 2 napkins; In a pack of cardboard 1 set.

Description of dosage form

The lyophilizate is white or almost white in color and does not contain extraneous inclusions.

Solvent (water for injection) is a clear, colorless solution that does not contain visible particles.

Characteristic

Peginterferon alfa-2b is a covalent conjugate of recombinant interferon alfa-2b and monomethoxypolyethylene glycol. The average molecular weight is about 31,300 Da.

Pharmachologic effect

Mode of action - immunomodulating.

Pharmacodynamics

Recombinant interferon alpha-2b is obtained from an E. coli clone that contains a genetically engineered plasmid hybrid encoding human leukocyte alpha-2b interferon. In vitro and in vivo studies suggest that the biological activity of PegIntron® is due to interferon alpha-2b. Cellular effects of interferons are due to binding to specific receptors on the cell surface. Studies of other interferons demonstrated their species specificity. However, certain types of monkeys, such as rhesus monkeys, are sensitive to the pharmacodynamic effects of human type I interferons. By binding to the cell wall, interferon initiates a sequence of intracellular reactions that involve induction of certain enzymes. This process is believed to mediate, at least in part, the various cellular effects of interferons, including suppression of viral replication in infected cells, inhibition of cell proliferation, and immunomodulatory properties such as increased phagocytic activity of macrophages and specific cytotoxicity of lymphocytes for target cells. Any or all of these effects may mediate the therapeutic activity of interferon. Recombinant interferon alpha-2b also inhibits viral replication in vitro and in vivo. Although the exact mechanism of antiviral action of recombinant interferon alpha-2b is not known, nevertheless, it is believed that the drug alters the metabolism of body cells. This leads to suppression of viral replication; If it does occur, the resulting virions are unable to exit the cell.

The pharmacodynamics of PegIntron® in increasing doses was studied in a single application in healthy volunteers by studying changes in temperature in the oral cavity, concentrations of effector proteins such as serum neopterin and 2'5'-oligoadenylate synthetase, as well as the numbers of leukocytes and neutrophils. Patients receiving PegIntron® showed a slight dose-dependent increase in body temperature. After a single administration of PegIntron® at a dose of 0.25 to 2.0 μg / kg / week, a dose-dependent increase in serum neopterin concentration was noted. The decrease in the number of neutrophils and leukocytes at the end of the 4th week correlated with the dose of PegIntron®.

Pharmacokinetics

PegIntron® is a well-studied pegylated (ie, polyethylene glycol-linked) interferon alpha-2b derivative and consists mainly of mono-pegylated molecules. T1 / 2 PegIntrona® from the plasma exceeds T1 / 2 of non-pegylated interferon alfa-2b. PegIntron® can be de-impregnated with the release of interferon alpha-2b. The biological activity of the pegylated isomers is qualitatively similar to that of free interferon alpha-2b, but weaker. After sc administration, Cmax in the serum reaches a peak after 15-44 hours and persists for 48-72 hours. Cmax and PEGIntron® AUC increase in proportion to the dose. The apparent volume of distribution averages 0.99 l / kg. With repeated use, cumulation of immunoreactive interferons occurs, however, the biological activity increases insignificantly. T1 / 2 PegIntrona® averages about 30.7 hours (from 27 to 33 hours), an apparent clearance of 22.0 ml / h / kg. Mechanisms for clearance of interferons are not fully described. However, it is known that the proportion of renal clearance is about 30% of the total clearance of PegIntron ®.

At a single application in a dose of 1.0 μg / kg in patients with impaired renal function, an increase in Cmax, AUC and T1 / 2 was found - in proportion to the degree of renal failure. When applied at the same dose (1.0 mcg / kg) for 4 weeks (1 injection per week), a decrease in PegIntron® clearance by 17% was noted in patients with moderate renal insufficiency (Cl creatinine 30-49 ml / min ) And 44% in patients with severe renal insufficiency (Cl creatinine 10-29 ml / min) compared with those with normal renal function. In the group of patients with severe renal insufficiency, the clearance of creatinine was the same in patients on hemodialysis and in patients who did not undergo hemodialysis. With monotherapy, it is necessary to reduce the dose of PegIntron ® in patients suffering from renal insufficiency of moderate and severe severity (see Recommendations for dose adjustment).

The pharmacokinetics of PegIntron ® in patients with severe impairment of liver function have not been studied.

The pharmacokinetics of PegIntron ® for a single application at a dose of 1.0 mcg / kg did not depend on age, so dose changes in the elderly are not required.

The pharmacokinetics of PegIntron® in patients under the age of 18 years have not been specifically studied.

Neutralizing antibodies to interferon were analyzed in serum samples in patients who received PegIntron® in a clinical trial. These antibodies neutralize the antiviral activity of interferon. The detection rate of neutralizing antibodies in patients treated with PegIntron® at a dose of 0.5 mg / kg was 1.1%.

Indication of the PegIntron

Chronic hepatitis B. Treatment of patients aged 18 years in the absence of decompensation of liver disease;

Chronic hepatitis C. Treatment of patients aged 18 years in the absence of decompensation of liver disease.

Contraindications

Hypersensitivity to any component of the drug;

Hypersensitivity to any interferon;

Autoimmune hepatitis or other autoimmune disease in the anamnesis;

Severe mental illness or history of severe mental disorders, in particular severe depression, suicidal thoughts or attempts;

Severe cardiovascular disease, unstable or uncontrolled during the previous 6 months;

Dysfunction of the thyroid gland, which cannot be maintained at a normal level by drug therapy;

Impaired renal function - Cl creatinine less than 50 ml / min (when used in combination with ribavirin);

Decompensated liver disease;

Epilepsy and / or dysfunction of the CNS;

Pregnancy (including a male partner who is supposed to be treated with PegIntron® in combination with ribavirin).

breast-feeding.

Application in pregnancy and breastfeeding

In a study on primates, it was shown that interferon alpha-2b has an abortive effect. Most likely, PegIntron ® also has this effect. Therefore, PegIntron® should not be used during pregnancy.

PegIntron ® can be used in women of reproductive age if they use effective contraceptive methods throughout the treatment. Information about the excretion of components of this drug with breast milk is not. In this regard, breastfeeding women should stop PegIntron® treatment or breastfeeding, given the expected benefit of treatment for the mother and the potential risk to the baby.

In connection with the pronounced teratogenic and embryotoxic effect of ribavirin, leading to congenital malformations and fetal death in animals when applied at a dose of 1/20 of the recommended therapeutic dose, combined therapy with PegIntron® and ribavirin during pregnancy is contraindicated. Therapy PegIntron® in combination with ribavirin should begin only after receiving a negative pregnancy test.

Women of childbearing age who are treated with PegIntron® in combination with ribavirin, and their male partners should use effective contraceptives throughout the treatment period and for at least 6 months after the end of treatment, Ribavirin accumulates in cells and is excreted from the body extremely slowly. During this time, you need to repeat the pregnancy test every month.

All possible measures should be taken to prevent the pregnancy of a female partner of a man receiving treatment with PegIntron® and ribavirin. This requires that each of them use an effective contraceptive.

Side effects

Monotherapy. In general, adverse events were mild or moderate and did not require discontinuation of treatment. The most frequent adverse events (≥10% of patients) were: headache, pain and inflammation at the injection site, fatigue, chills, fever, depression, joint pain, nausea, alopecia, musculoskeletal pain, irritability, flu-like symptoms, insomnia , Diarrhea, abdominal pain, asthenia, pharyngitis, weight loss, anorexia, anxiety, impaired concentration, dizziness, reactions at the injection site.

Less frequent adverse events (≥2%, <10% of patients) were: itching, dry skin, malaise, sweating, pain in the right hypochondrium, neutropenia, rash, vomiting, dry mouth, emotional lability, nervousness, dyspnea, viral infections, Drowsiness, thyroid changes, chest pain, dyspepsia, hot flashes, paresthesia, cough, agitation, sinusitis, hypertension, hyperesthesia, blurred vision, confusion, bloating, decreased libido, erythema, pain in the eye, apathy, hypoesthesia, unstable stools , Conjunctivitis, congestion Nose, constipation, menorrhagia, menstrual irregularities.

Serious abnormalities from the central nervous system were rarely noted, incl. Suicidal thoughts and attempts, aggressive behavior, sometimes directed at others, psychosis, including hallucinations.

In 4 and 7% of patients who received PegIntron ® at doses of 0.5 and 1.0 μg / kg, respectively, granulocytopenia (<0.75 · 109 / L) was observed, and 1% and 3% of patients had thrombocytopenia (< 70 · 109 / L). Rare undesirable effects observed with interferon alpha-2b therapy were seizures, pancreatitis, hypertriglyceridemia, arrhythmia, diabetes and peripheral neuropathy.

Combination therapy with ribavirin. In addition to the adverse events that were observed with PegIntronom® monotherapy, the following adverse events were also noted in combination therapy: tachycardia, rhinitis, taste distortion (these undesirable events occurred at a frequency of 5 to 10% of cases), hypotension, syncope, hypertension, lacrimal involvement Glands, tremor, bleeding gums, glossitis, stomatitis, ulcerative stomatitis, hearing loss / disorder, tinnitus, palpitation, thirst, aggressive behavior, fungal infection, prostatitis, otitis media, bronchitis, respiratory infections Arthritis, rhinorrhea, eczema, increased fragility of the hair, reactions of increased sensitivity to sunlight and lymphadenopathy (these undesirable events occurred at a frequency of 2 to 5% of cases). Very rarely, combined treatment with ribavirin and interferon alpha-2b may be associated with aplastic anemia.

Monotherapy or combination therapy with ribavirin. Rarely - ophthalmologic disorders, incl. Retinopathy (including edema of the optic disc), bleeding in the retina, occluding veins or arteries of the retina, focal changes in the retina, reduced visual acuity or limitation of the visual fields, optic neuritis, edema of the optic nerve.

Side effects from the cardiovascular system, in particular, arrhythmia, are most likely associated with a previous cardiovascular disease and previous therapy with drugs that have cardiotoxic effects. Rarely, patients who did not have a history of cardiovascular disease have cardiomyopathy, which can be reversible after discontinuing interferon alfa therapy.

Very rarely: rhabdomyolysis, myositis, renal dysfunction, renal failure, cardiac ischemia, myocardial infarction, cerebral ischemia, cerebral hemorrhage, encephalopathy, ulcerative or ischemic colitis, sarcoidosis (or exacerbation of sarcoidosis), multiforme exudative erythema, Stevens-Johnson syndrome, Toxic epidermal necrolysis, necrosis at the injection site.

When alpha interferons were used, a wide range of abnormal autoimmune and immune mediated disorders was noted, including idiopathic thrombocytopenic purpura and thrombotic thrombocytopenic purpura.

Interaction

With repeated joint use of PegIntron® and Rebetol (ribavirin), no signs of pharmacokinetic interaction between them have been identified.

In HIV patients receiving highly active antiretroviral therapy (HAART), the risk of developing lactic acidosis is increased. Therefore, when adding the combination PegIntron® + ribavirin to HAART, caution should be exercised.

In the study of the use of repeated doses of PegIntron® (1.5 mg / kg once a week for 4 weeks), the activity of cytochromes CYP1A2, CYP3A4 or N-acetyltransferase was not suppressed, and the activity of cytochromes CYP2C8 / C9 and CYP2D6 was noted. Therefore, care should be taken when prescribing PegIntron® together with drugs that are metabolized by CYP2C8 / C9 or CYP2D6.

Dosing and Administration

SC. Therapy PegIntron® should be started by a doctor who has experience in treating patients with hepatitis B and C, and further under his supervision.

Chronic hepatitis B

PegIntron® is administered at a dose of 0.5 or 1.0 μg / kg once a week for 24 to 52 weeks. The dose is chosen taking into account the expected efficacy and safety. Patients with hard-to-treat chronic hepatitis B caused by the genotype C or D virus may require higher doses of the drug and a longer course of treatment to achieve a therapeutic effect.

It is recommended to alternate the injection site.

Chronic hepatitis C

Monotherapy. PegIntron® is administered at a dose of 0.5 or 1.0 μg / kg once a week for at least 6 months. The dose is selected taking into account the expected efficacy and safety. If after the first 6 months of treatment, RNA virus is eliminated from serum, the treatment is continued for another 6 months (i.e., for a total of 1 year); If the elimination of the RNA virus does not occur, the treatment is stopped.

If undesirable effects or changes in laboratory parameters are observed during treatment, the dose of PegIntron® is adjusted (see Dose Correction Guidelines); If undesirable effects persist or reappear after a dose change, PegIntron® treatment is discontinued.

Application in case of impaired renal function. - see Recommendations for dose adjustment.

Application in case of impaired liver function. The safety and efficacy of PegIntron® treatment in these patients have not been studied, therefore, PegIntron® should not be used.

Use in elderly patients (65 years and older). Dependence of pharmacokinetics of PegIntron ® on age was not revealed. The results of a study of pharmacokinetics in the elderly after a single dose of PegIntron® suggest that a dose adjustment with age is not required.

Use in patients under the age of 18 years. PegIntron ® is not recommended for children and adolescents under the age of 18, Experience in the use of the drug in these patients is absent.

It is recommended that each time choose a new location for injection.

Combination therapy with ribavirin. The most common optimal treatment for chronic hepatitis C is combination therapy with interferon alfa-2b preparations (including peginterferon alfa-2b) and ribavirin. When prescribing combination therapy, it is also necessary to follow the instructions for the medical use of ribavirin. In combination therapy with ribavirin, PegIntron® is administered as a subcutaneous injection at a dose of 1.5 μg / kg once a week. Ribavirin should be taken orally daily. The daily dose of ribavirin for combination therapy is calculated as a function of body weight (Table 1):

Table 1

Body weight, kg The daily dose of ribavirin, mg The number of capsules of 200 mg, pcs.
<65 800 4ŕ
65–85 1000 5á
>85 1200 6â
A - 2 in the morning and 2 in the evening;B - 2 in the morning and 3 in the evening;

C – 3 in the morning and 3 in the evening.

Reception of ribavirin is combined with a meal.

Combined therapy can also be guided by a combined table for dosing PegIntron® and ribavirin (Table 2):

Table 2

Body weight, kg PegIntron Ribavirin
Dosage of the syringe-pen or vial, mcg / 0.5 ml Dose for administration 1 time per week, ml Daily dose, mg Quantity of 200 mg capsules, pcs..
<40 50 0,5 800 4ŕ
40–50 80 0,4 800 4ŕ
51–64 80 0,5 800 4ŕ
65–75 100 0,5 1000 5á
76–85 120 0,5 1000 5 á
>85 150 * 0,5 1200 6â
* This dosage is for pen-syringe only;A - 2 in the morning and 2 in the evening;

B - 2 in the morning and 3 in the evening;

At 3 in the morning and 3 in the evening.

Recommended duration of treatment

Patients infected with the genotype 1 virus: in patients infected with the genotype 1 virus, after 12 weeks of treatment, there is no elimination of the RNA of the virus from serum, the appearance of a persistent virologic response while continuing treatment is highly unlikely. Patients who have a virologic response after 12 weeks of treatment should continue therapy for a further 9 months (the total duration of treatment is 48 weeks). Patients with a low virus concentration (no more than 2,000,000 copies / ml) who underwent elimination of RNA virus after 4 weeks of treatment and no RNA virus were detected in the subsequent period, up to 24 weeks of therapy, therapy after 24 weeks may be discontinued (The total duration of the course is 24 weeks) or continued for 24 weeks (the total duration of the course is 48 weeks). However, it should be borne in mind that the risk of relapse after a 24-week course of treatment is higher than after a 48-week course.

Patients infected with the genotype 2 or 3 virus: the recommended duration of treatment for all patients in this group is 24 weeks.

Patients infected with the genotype 4 virus: it was generally noted that patients in this group are not easily treatable. Limited clinical data (66 patients) show the possibility of using the same treatment tactics in patients of this group as in the group of patients infected with the genotype 1 virus.

Recommendations for dose adjustment

In the event of serious adverse events or laboratory abnormalities during the use of PegIntron® or PegIntron® and ribavirin, the dose should be adjusted or the drug should be stopped until the elimination of adverse events.

Monotherapy (Table 3)

Table 3

Laboratory indicators Reduction of the dose of peginterferon alfa-2b to half the therapeutic dose, if Stopping injections of peginterferon alfa-2b if
Number of neutrophils <0,75·109/l <0,5·109/l
Platelet count <50·109/l <25·109/l
Combined therapy (Table 4)Table 4
Laboratory indicators Reduction of only a dose of ribavirin to 600 mg / day *, if Reduction of only the dose of peginterferon alfa-2 b to half the therapeutic dose, if Discontinuation of ribavirin and peginterferon alfa-2b, if
Hemoglobin content <10 g / dL - <8.5 g / dL
The hemoglobin content in patients with heart disease in the stage of compensation The level of hemoglobin decreased by ≥2 g / dL for any 4 weeks during treatment (continuous use of a reduced dose) <12 g / dL 4 weeks after dose reduction
Number of leukocytes - <1,5·109/l <1.0 • 109 / L
Number of neutrophils - <0,75·109/l <0.5 • 109 / L
Platelet count - <50·109/l <25 • 109 / L
Content of bound bilirubin - - 2.5 × VPN **
Free bilirubin content > 5 mg / dL - > 4 mg / dL (more than 4 weeks)
Creatinine content - - > 2 mg / dL
Alanine aminotransferase / - - 2 × (reference value)
Aspartate aminotransferase Reduction of only a dose of ribavirin to 600 mg / day *, if > 10 × VPN **

* Patients who had reduced the dose of ribavirin to 600 mg / day should take 1 caps. In the morning and 2 caps. In the evening.

** Upper limit of normal values.

If, after dose adjustment, the tolerability of therapy is not improved, the use of PegIntron ® and / or ribavirin should be discontinued.

Correction of dose in renal failure. In monotherapy in patients with moderate renal insufficiency (Cl creatinine - 30-50 ml / min), the initial dose of PegIntron® should be reduced by 25%. In patients with severe renal failure (Cl creatinine - 10-29 ml / min), including patients undergoing hemodialysis, the initial dose of PegIntron® should be reduced by 50%. If during the treatment the serum creatinine increases more than 2 mg / dl, PegIntronom® therapy should be discontinued.

When taking combination therapy with PegIntronom® and ribavirin, patients with Cl creatinine of at least 50 ml / min should be careful about the possible development of anemia.

Combination therapy with PegIntron® and ribavirin for patients with Cl creatinine below 50 ml / min should not be performed.

Instructions for the preparation of injection solutions

PegIntron® in syringe-pens. The lyophilized powder and the solvent are in a syringe-pen and mixed before administration.

PegIntron® in vials. The lyophilized PegIntron ® powder should be diluted only with the applied solvent. PegIntron® should not be mixed with other medications.

Using a sterile syringe, 0.7 ml of water for injection is introduced into the PegIntron® bottle. The bottle is gently shaken until the powder is completely dissolved. The dissolution time should not exceed 10 minutes (usually the powder dissolves more quickly). The required dose is collected in a sterile syringe. For administration, up to 0.5 ml of the solution is used. Like any other preparation for parenteral use, the finished solution should be inspected before administration. The solution must be clear, colorless and free of visible particles. In case of discoloration or appearance of visible particles, the solution should not be used. The finished solution should be used immediately. If you cannot immediately use the prepared solution, it can be stored for no more than 24 hours at a temperature of 2-8 ° C. The solution remaining after the introduction is not subject to further use and it must be disposed of in accordance with the current procedure.

Overdose

In clinical studies, cases of unintentional drug overdose have been reported. In all noted cases, the dose taken exceeded the recommended therapeutic dose by no more than 2 times. Serious reactions were not. The adverse events passed independently and did not require the withdrawal of PegIntron® therapy.

Precautionary measures

Mental and CNS. If PegIntron® is to be prescribed for patients with severe mental disorders (including patients with a history of such abnormalities), treatment can be initiated only after a thorough individual examination and appropriate therapy for the mental disorder.

In some patients during the treatment with PegIntron ®, severe CNS disorders were observed, in particular depression, suicidal ideation and suicide attempts. In the treatment of interferon alfa, there were also other disorders from the central nervous system, incl. Aggressive behavior, sometimes directed at others, confusion and other changes in the mental state. In some patients, especially the elderly, who took higher doses of interferon alpha-2b, there was a marked decrease in pain sensitivity, coma, and encephalopathy. Although these phenomena are mostly reversible, some patients may need up to 3 weeks for complete recovery. When there are mental changes or disorders of the central nervous system, incl. Signs of depression, it is recommended to ensure constant monitoring of such patients during treatment and for 6 months after it, considering the potential severity of such undesirable phenomena. If symptoms persist or worsen, especially depression, suicidal intentions or aggressive behavior, PegIntron® treatment should be discontinued and timely intervention by the psychiatrist should be provided.

The cardiovascular system. In the treatment of PegIntron®, as well as interferon alpha-2b, patients suffering from or suffering from heart failure, myocardial infarction, and / or arrhythmias should be monitored continuously. In patients with heart disease, electrocardiography is recommended before and during treatment. Arrhythmias (mostly supraventricular) tend to be amenable to conventional therapy, but may require the withdrawal of PegIntron®.

Hypersensitivity immediate type. In rare cases, interferon alfa-2b therapy was complicated by immediate-type hypersensitivity reactions (eg, urticaria, angioedema, bronchospasm, anaphylaxis). If such reactions occur against the background of PegIntron®, PegIntron® should be discontinued and immediate symptomatic therapy should be prescribed. Transient rashes do not require discontinuation of treatment.

Function of the kidneys. It is recommended that the kidney function be studied in all patients before PegIntron® therapy is started. During treatment of patients with impaired renal function, they should be carefully monitored. If necessary, the dose of PegIntron® is reduced (see Dose Adjustment Guidelines).

Function of the liver. When signs of decompensation of liver disease should be discontinued PegIntron®.

Fever. Although fever can be observed within the influenza-like syndrome, which is often recorded in interferon treatment, nevertheless, other causes of persistent fever need to be excluded.

Hydration. In patients receiving PegIntron® therapy, adequate hydration should be provided. In some patients hypotension was observed, associated with a decrease in the volume of fluid in the body. In such cases, it may be necessary to replace the fluid.

Diseases that lead to disability. PegIntron® should be used with caution in diseases that lead to disability, such as lung disease (eg, COPD) or diabetes mellitus with a tendency to develop ketoacidosis. Care should also be taken in patients with impaired coagulation (eg, thrombophlebitis, pulmonary embolism) or severe myelosuppression.

Changes in the lungs. In rare cases, in patients who received interferon alfa, infiltrates of unclear etiology, pneumonitis or pneumonia developed in the lungs, incl. With a fatal outcome. When fever, cough, dyspnea and other respiratory symptoms occur, all patients should be given a chest x-ray. In the presence of infiltrates on the chest radiograph or signs of pulmonary dysfunction, such patients should be monitored more closely and, if necessary, abolished interferon alfa. Although similar reactions were more common in patients with chronic hepatitis C who received interferon alfa, they were also recorded in patients with oncological diseases treated with this drug. Immediate withdrawal of interferon alfa and treatment of SCS lead to the disappearance of unwanted phenomena from the lungs.

Autoimmune diseases. In the treatment of interferon alpha, the occurrence of autoantibodies was noted. Clinical manifestations of autoimmune diseases appear to arise more often in the treatment of interferon in patients predisposed to the development of autoimmune disorders.

Changes in the organ of vision. Any patient who complains of reduced visual acuity or restriction of visual fields should undergo an ophthalmological examination. Such undesirable reactions often occur in the presence of concomitant diseases, so patients with diabetes mellitus or arterial hypertension before starting treatment with PegIntron ® is recommended to conduct an eye examination.

Changes in the teeth and periodontal. Patients receiving combination therapy with peginterferon and ribavirin showed pathological changes in the teeth and peri-toothed tissues. Dry mouth with prolonged combination therapy with ribavirin and peginterferon alfa-2b may contribute to damage to the teeth and mucous membranes of the oral cavity. Patients should brush their teeth 2 times a day and regularly undergo examination at the dentist. Patients with vomiting should rinse their mouth afterwards.

Changes in the thyroid gland. In patients with chronic hepatitis C who received interferon alfa-2b, there were sometimes abnormalities in thyroid function - hypothyroidism or hyperthyroidism. In clinical trials of interferon alfa-2b, the overall incidence of thyroid dysfunction was 2.8%. These disorders were controlled by standard therapy. The mechanism of the influence of interferon alpha on thyroid function is unknown. Before starting treatment with PegIntronom ® in patients, serum levels of thyroid-stimulating hormone should be determined. In the presence of any violations of the thyroid function, it is recommended to prescribe the usual therapy in such cases. PegIntron® should not be prescribed if such therapy does not allow the maintenance of thyroid-stimulating hormone activity at a normal level. Levels of thyroid-stimulating hormone should also be determined when symptoms of thyroid dysfunction occur when interferon alpha is treated. In the presence of thyroid dysfunction, treatment with PegIntronom® can be continued if the thyroid-stimulating hormone content can be maintained at a normal level by conventional therapy.

Psoriasis and sarcoidosis. Given the available descriptions of cases of exacerbation of psoriasis and sarcoidosis when treated with interferon alpha-2b, PegIntron® should be used in patients with psoriasis or sarcoidosis only if the expected benefit outweighs the possible risk.

Organ transplantation. The effectiveness and safety of the use of PegIntron® (in combination with ribavirin or monotherapy) in recipients for organ transplantation has not been fully understood. Preliminary data show an increase in cases of rejection of the transplanted kidney. It has also been reported that the liver is transplanted, but there is no causal relationship with the use of interferon alfa.

Laboratory research. All patients before and during treatment with PegIntron ® are recommended to perform general and biochemical blood tests and thyroid function tests. The following initial blood values are acceptable: platelets - ≥100000 in mm3, neutrophils - ≥1500 in mm3, thyroid-stimulating hormone - within normal limits. There have been cases of hypertriglyceridemia, as well as an increase in triglyceridemia, sometimes expressed. In this regard, all patients are recommended to monitor the level of lipids in the blood.

Influence on ability of driving of the car and use of difficult technics. When fatigue, drowsiness, or confusion occurs against PegIntron®, it is not recommended to drive or use complicated equipment.

Conditions of supply of pharmacies

According to the prescription of the doctor (lyophilizate for the preparation of solution for the IM and SC the introduction).

Manufacturer

Schering-Plau (Brinnie) Company, County Kok, Ireland.

Storage conditions of the drug PegIntron

At a temperature of 2-8 ° C.

Keep out of the reach of children.

Shelf life of the drug PegIntron

3 years.

Do not use after the expiry date printed on the package.

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