Universal reference book for medicines
Product name: PegIntron В® (PegIntron В® )

Active substance: peginterferon alfa-2b

Type: Interferon.
Immunomodulating drug with antiviral action
Manufacturer: SCHERING-PLOUGH LABO (Belgium) manufactured by SCHERING-PLOUGH (Singapore)
Composition, form of production and packaging
Lyophilized powder for the preparation of a solution for injections of
white or almost white color, not containing extraneous inclusions;
solvent - a clear, colorless liquid that does not contain visible particles.
1 f.
0.5 ml of finished p-ra
peginterferon alfa-2b 50 Ојg 50 Ојg

Excipients: sodium hydrophosphate, sodium dihydrogen phosphate, sucrose, polysorbate 80.

Solvent: water d / u - 0.7 ml *.

* - the solvent is added in an excessive amount to compensate for losses when dissolving the lyophilizate and introducing the prepared solution.

Glass vials with a volume of 2 ml (1) complete with a solvent (amp 1 pc.) - packs of cardboard.

Lyophilized powder for the preparation of a solution for injections of white or almost white color, not containing extraneous inclusions;
solvent - a clear, colorless liquid that does not contain visible particles.
1 f.
0.5 ml of finished p-ra
peginterferon alfa-2b 80 Ојg 80 Ојg

Excipients: sodium hydrophosphate, sodium dihydrogen phosphate, sucrose, polysorbate 80.

Solvent: water d / u - 0.7 ml *.

* - the solvent is added in an excessive amount to compensate for losses when dissolving the lyophilizate and introducing the prepared solution.

Glass vials with a volume of 2 ml (1) complete with a solvent (amp 1 pc.) - packs of cardboard.

Lyophilized powder for the preparation of a solution for injections of white or almost white color, not containing extraneous inclusions;
solvent - a clear, colorless liquid that does not contain visible particles.
1 f.
0.5 ml of finished p-ra
peginterferon alfa-2b 100 Ојg 100 Ојg

Excipients: sodium hydrophosphate, sodium dihydrogen phosphate, sucrose, polysorbate 80.

Solvent: water d / u - 0.7 ml *.

* - the solvent is added in an excessive amount to compensate for losses when dissolving the lyophilizate and introducing the prepared solution.

Glass vials with a volume of 2 ml (1) complete with a solvent (amp 1 pc.) - packs of cardboard.

Lyophilized powder for the preparation of a solution for injections of white or almost white color, not containing extraneous inclusions;
solvent - a clear, colorless liquid that does not contain visible particles.
1 f.
0.5 ml of finished p-ra
peginterferon alfa-2b 120 Ојg 120 Ојg

Excipients: sodium hydrophosphate, sodium dihydrogen phosphate, sucrose, polysorbate 80.

Solvent: water d / u - 0.7 ml *.

* - the solvent is added in an excessive amount to compensate for losses when dissolving the lyophilizate and introducing the prepared solution.

Glass vials with a volume of 2 ml (1) complete with a solvent (amp 1 pc.) - packs of cardboard.

Lyophilized powder for the preparation of a solution for injections of white or almost white color, not containing extraneous inclusions;
solvent - a clear, colorless liquid that does not contain visible particles.
1 syringe pen 0.5 ml of the finished product

peginterferon alfa-2b 50 Ојg 50 Ојg

Excipients: sodium hydrophosphate, sodium dihydrogen phosphate, sucrose, polysorbate 80.

Solvent: water d / u - 0.7 ml *.

* - the solvent is added in an excessive amount to compensate for losses when dissolving the lyophilizate and introducing the prepared solution.

Syringe pens are two-chambered with a solvent (1) - contour plastic packaging (1) complete with a needle d / p injection and napkins (2 pcs.) - packs of cardboard.

Lyophilized powder for the preparation of a solution for injections of white or almost white color, not containing extraneous inclusions;
solvent - a clear, colorless liquid that does not contain visible particles.
1 syringe pen 0.5 ml of the finished product

peginterferon alfa-2b 80 Ојg 80 Ојg

Excipients: sodium hydrophosphate, sodium dihydrogen phosphate, sucrose, polysorbate 80.

Solvent: water d / u - 0.7 ml *.

* - the solvent is added in an excessive amount to compensate for losses when dissolving the lyophilizate and introducing the prepared solution.

Syringe pens are two-chambered with a solvent (1) - contour plastic packaging (1) complete with a needle d / p injection and napkins (2 pcs.) - packs of cardboard.

Lyophilized powder for the preparation of a solution for injections of white or almost white color, not containing extraneous inclusions;
solvent - a clear, colorless liquid that does not contain visible particles.
1 syringe pen 0.5 ml of the finished product

peginterferon alfa-2b 100 Ојg 100 Ојg

Excipients: sodium hydrophosphate, sodium dihydrogen phosphate, sucrose, polysorbate 80.

Solvent: water d / u - 0.7 ml *.

* - the solvent is added in an excessive amount to compensate for losses when dissolving the lyophilizate and introducing the prepared solution.

Syringe pens are two-chambered with a solvent (1) - contour plastic packaging (1) complete with a needle d / p injection and napkins (2 pcs.) - packs of cardboard.

Lyophilized powder for the preparation of a solution for injections of white or almost white color, not containing extraneous inclusions;
solvent - a clear, colorless liquid that does not contain visible particles.
1 syringe pen 0.5 ml of the finished product

peginterferon alfa-2b 120 Ојg 120 Ојg

Excipients: sodium hydrophosphate, sodium dihydrogen phosphate, sucrose, polysorbate 80.

Solvent: water d / u - 0.7 ml *.

* - the solvent is added in an excessive amount to compensate for losses when dissolving the lyophilizate and introducing the prepared solution.

Syringe pens are two-chambered with a solvent (1) - contour plastic packaging (1) complete with a needle d / p injection and napkins (2 pcs.) - packs of cardboard.

Lyophilized powder for the preparation of a solution for injections of white or almost white color, not containing extraneous inclusions;
solvent - a clear, colorless liquid that does not contain visible particles.
1 syringe pen 0.5 ml of the finished product

peginterferon alfa-2b 150 Ојg 150 Ојg

Excipients: sodium hydrophosphate, sodium dihydrogen phosphate, sucrose, polysorbate 80.

Solvent: water d / u - 0.7 ml *.

* - the solvent is added in an excessive amount to compensate for losses when dissolving the lyophilizate and introducing the prepared solution.

Syringe pens are two-chambered with a solvent (1) - contour plastic packaging (1) complete with a needle d / p injection and napkins (2 pcs.) - packs of cardboard.

INSTRUCTION FOR THE SPECIALIST.

Description of the drug approved by the manufacturer for the printed edition of 2008.

PHARMACHOLOGIC EFFECT

Interferon.
Immunomodulating drug with antiviral effect. Recombinant interferon alpha-2b is derived from an Escherichia coli clone that contains a genetically engineered plasmid hybrid encoding human leukocyte alpha-2b interferon. In vitro and in vivo studies indicate 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 have demonstrated their species specificity. However, certain types of monkeys, for example, 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 at least partially mediate the various cellular effects of interferons, including suppression of viral replication in infected cells, inhibition of cell proliferation, and immunomodulatory properties such as enhancement of phagocytic activity of macrophages and specific cytotoxicity of lymphocytes for target cells. Any or all of these effects can 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 alfa-2b is not known, nevertheless, it is believed that the drug changes 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 had a slight dose-dependent increase in body temperature. After a single administration of PegIntron at a dose of 0.25 to 2 Ојg / 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

Peginterferon alfa-2b is a well-studied pegylated (ie, polyethylene glycol-linked) interferon alpha-2b derivative and consists mainly of mono-pegylated molecules.
T1/2 of peginterferon alfa-2b from the plasma exceeds T 1/2 of non - pegylated interferon alfa-2b. Peginterferon alfa-2b can be de-depilated with the release of interferon alpha-2b. The biological activity of pegylated isomers is qualitatively similar to that of free interferon alpha-2b, but is weaker. After SC administration, C max isreached after 15-44 hours and persists for 48-72 hours. The max and AUC of peginterferon alfa-2b increase in proportion to the dose. The apparent V d is an average of 0.99 l / kg. At repeated application there is a cumulation of immunoreactive interferons. However, the biological activity increases slightly.
Excretion

T 1/2 of peginterferon alfa-2b averages about 30.7 hours (from 27 to 33 hours), the clearance is 22 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.
Pharmacokinetics in special clinical cases

At a single application at a dose of 1 Ојg / kg in patients with impaired renal function, an increase in C max , AUC and T 1/2 was found to be proportional to the degree of renal failure.
When applied at the same dose (1 mcg / kg) for 4 weeks (1 injection per week), a decrease in the clearance of peginterferon alfa-2b by 17% was noted in patients with moderate renal insufficiency (KC 30-49 ml / min) and by 44% in patients with severe renal insufficiency (QC 10-29 ml / min) compared with those with normal renal function. In the group of patients with severe renal insufficiency, QC was similar in patients on hemodialysis, and in patients who did not undergo hemodialysis. When monotherapy is necessary to reduce the dose of PegIntron in patients with moderate and severe renal insufficiency.
The pharmacokinetics of PegIntron in patients with pronounced impairment of liver function has not been studied.

The pharmacokinetics of PegIntron for a single administration at a dose of 1 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 study.
These antibodies neutralize the antiviral activity of interferon. The frequency of detection of neutralizing antibodies in patients who received PegIntron at a dose of 0.5 mg / kg was 1.1%.
INDICATIONS

- chronic hepatitis B (treatment of patients with chronic hepatitis B at the age of 18 years in the absence of decompensation of liver disease);

- chronic hepatitis C (treatment of patients with chronic hepatitis C at the age of 18 years in the absence of decompensation of liver disease).

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.
DOSING MODE

Chronic hepatitis B

Therapy with PegIntron should be initiated by a physician with experience in the treatment of patients with hepatitis B, and further under his supervision.

PegIntron is prescribed SC in a dose of 1 to 1.5 Ојg / kg of body weight once a week for 24 to 52 weeks.
The dose should be selected individually, based on the expected efficacy and safety of the drug. 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

Therapy with PegIntron should be initiated by a physician with experience in the treatment of patients with hepatitis C, and further under his supervision.

Monotherapy

PegIntron is given SC at a dose of 0.5 mg / kg or 1 Ојg / 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, the RNA of the virus is eliminated from the serum, the treatment is continued for another 6 months (i.e., generally for 1 year).If after 6 months of treatment there is no elimination of the RNA of the virus, then the treatment is stopped.
If during the treatment there are undesirable phenomena or changes in laboratory parameters, the dose of PegIntron is corrected.
If undesirable effects persist or reappear after a dose change, PegIntron treatment is discontinued.
The safety and efficacy of PegIntron treatment in patients with severe liver dysfunction have not been studied, therefore, PegIntron should not be used in such patients.

Dependence of the pharmacokinetics of PegIntron on age was not revealed.
Results of the study of pharmacokinetics in elderly patients (65 years and older) after a single administration of PegIntron indicate that a dose adjustment with age is not required.
PegIntron is not recommended for children and adolescents under the age of 18 years .
experience with the drug in these patients is absent.
It is recommended that you choose a new injection site every time.

Combination therapy with ribavirin

In combination therapy with ribavirin, PegIntron is administered as a subcutaneous injection at a dose of 1.5 Ојg / kg once a week.

Ribavirin should be taken orally daily.
The daily dose of ribavirin for combination therapy is calculated according to body weight:
Body weight (kg) Daily dose of ribavirin (mg) Number of capsules 200 mg (pcs.)

<65 800 4
(2 in the morning + 2 in the evening)
65-85 1000 5 (2 in the morning + 3 in the evening)

> 85 1200 6 (3 in the morning + 3 in the evening)

The intake of ribavirin is combined with the intake of food.

Combined therapy can also be guided by a combined table for dosing PegIntron and ribavirin.

Body weight (kg) PegIntron Ribavirin

Dosage of the syringe pen or vial (Ојg / 0.5 ml) Dose for administration once a week (ml) Daily dose (mg) Number of capsules 200 mg (pcs.)

<40 50 0.5 800 4 (2 in the morning + 2 in the evening)

40-50 80 0.4 800 4 (2 in the morning + 2 in the evening)

51-64 80 0.5 800 4 (2 in the morning + 2 in the evening)

65-75 100 0.5 1000 5 (2 in the morning + 3 in the evening)

76-85 120 0.5 1000 5 (2 in the morning + 3 in the evening)

> 85 150 * 0.5 1200 6 (3 in the morning + 3 in the evening)

* this dosage is only a syringe-pen.

Recommended duration of treatment

Patients infected with 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 treatment for a further 9 months (the total duration of treatment is 48 weeks).Patients with a low virus concentration (no more than 2 million copies / ml) who had eliminated RNA of the virus after 4 weeks of treatment and no RNA of the virus were detected in the subsequent period - up to 24 weeks of treatment, treatment after 24 weeks may be discontinued (total duration course - 24 weeks) or continued for another 24 weeks (the total course duration 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 genotype 2 or 3 virus

The recommended duration of treatment for all patients in this group is 24 weeks.

Patients infected with genotype 4 virus

In general, it is noted that patients of this group can not be treated with difficulty.
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 virus of genotype 1.
Recommendations for correcting the dosing regimen

In the event of serious adverse events or abnormalities in laboratory indicators during the application of PegIntron or PegIntron and ribavirin, the dose should be adjusted or preparations stopped until the elimination of adverse events.

Monotherapy

Laboratory measures Reduction in the dose of peginterferon alfa-2b to half the therapeutic dose if: Discontinuation of peginterferon alfa-2b injections if:

The number of neutrophils is <750 / ОјL <500 / ОјL

The number of platelets <50 000 / ОјL <25 000 / ОјL

Combination therapy with ribavirin

Laboratory parameters Reduction of the dose of ribavirin alone to 600 mg / day * if: Reduction of the dose of only peginterferon alfa-2b to half the therapeutic dose if: Termination of both ribavirin and peginterferon alfa-2b if:

Hemoglobin <10 g / dl - <8.5 g / dL
hemoglobin content of patients with heart disease in the stage of compensation hemoglobin content was reduced to 2 g / dl during any 4 weeks during treatment (permanent use of low dose) <12 g /? for 4 weeks after dose reduction
number of leukocytes - <1500 / l <1000 / mm
number of neutrophil - <75 000 / mkl <500 / ul
number of platelets - <50,000 / mm <25 000 / mkl
content bound bilirubin - - 2.5hVGN **
The free bilirubin> 5 mg / dl -> 4 mg / dl (up to 4 weeks)
creatinine content - -> 2 mg / dl
ALT / AST - - 2 (base e value) and> 10hVGN **
* Patients who have reduced the ribavirin dose to 600 mg / day, must take one 200 mg capsule in the morning and 2 capsules of 200 mg in the evening.
** Upper limit of normal.
If therapy tolerance does not improve after dose adjustment, use of PegIntron and / or ribavirin should be discontinued.
Correction doses in renal failure
With monotherapy in patients with moderate renal impairment (creatinine clearance of 30-50 ml / min) initial dose of PegIntron should be reduced by 25%.
In patients with severe renal impairment (creatinine clearance 10-29 ml / min), including patients undergoing hemodialysis,PegIntron initial dose should be reduced by 50%. If during treatment serum creatinine rises above 2 mg / dl PegIntron therapy should be discontinued.
When assigning the combination therapy PegIntron and ribavirin to patients with mild renal insufficiency (CC not less than 50 ml / min), caution should be exercised with regard to possible development of anemia. Combination therapy PegIntron and ribavirin for patients with CC below 50 ml / min, be conducted should not.
Terms solution for injection
PegIntron in pen
lyophilizate and the solvent are in the pen syringe and mixed prior to administration (procedure described in the package insert).
PegIntron in bottles
Lyophilisate PegIntron should be diluted only the supplied solvent. PegIntron should not be mixed with other medicines. Using a sterile syringe, 0.7 ml of water for injection was injected into the vial with PegIntron. The vial was gently shaken until complete dissolution of the powder. Dissolution time should not exceed 10 minutes; usually a powder dissolves faster. The required dose drawn into a sterile syringe. For administration used 0.5 ml of solution.
As with any other drugs for parenteral use prepared solution should be inspected before administration. The solution should be clear, colorless and free from visible particles. In the case of color change or appearance of visible particles should not use solution. Ready to use solution immediately. If it is impossible to use directly the solution prepared, it can be stored more than 24 hours at a temperature of from 2 В° to 8 В° C. The solution remaining after the administration, the further application is not subject to and must be disposed of in accordance with applicable procedure.
SIDE EFFECT

Monotherapy
The adverse events were generally mild or moderate and did not require discontinuation of treatment.
The most common (≥10%) 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, pain abdominal pain, fatigue, sore throat, weight loss, anorexia, anxiety, impaired concentration, dizziness, injection site reactions.
Less commonly (≥ 2%, <10%)were itching, dry skin, malaise, sweating, pain in the right upper quadrant, neutropenia, rash, vomiting, dry mouth, emotional lability, nervousness, dizziness, viral infection, drowsiness, changes in the thyroid gland, chest pain, dyspepsia, flushing, paresthesia , coughing, agitation, sinusitis, hypertension, hyperesthesia, blurred vision, confusion, bloating, decreased libido, erythema, eye pain, apathy, hypoesthesia, unstable chair, conjunctivitis, nasal congestion, constipation, menorrhagia, menstrual disorders.
Rarely observed serious CNS side effects, including suicidal thoughts and attempts, aggressive behavior, sometimes directed at others, psychosis including hallucinations.
In addition, 4% and 7% of patients treated with PegIntron in doses of 0.5 mcg / kg and 1 mcg / kg granulocytopenia observed respectively (<750 / ml) and in 1% and 3% of patients - Thrombocytopenia (<70,000 / mm ).
Rare adverse events occurring during treatment with interferon alfa-2b, were seizures, pancreatitis, hypertriglyceridemia, arrhythmia, diabetes, and peripheral neuropathy.
Combination therapy with ribavirin
In addition to adverse events were observed during monotherapy PegIntron, the combination therapy were also observed following undesirable phenomena: tachycardia, rhinitis, taste perversion (these adverse events occurred at a frequency of from 5% to 10% of cases), hypotension, syncope, arterial hypertension, lacrimal gland damage, tremors, bleeding gums, glossitis, stomatitis, ulcerative stomatitis, impaired / hearing loss, tinnitus, palpitation, thirst, aggressive behavior, fungal infection, prostatitis, an average of um, bronchitis, respiratory disorders, rhinorrhea, eczema, increased fragility of the hair, reactions of hypersensitivity to sunlight and lymphadenopathy (these adverse events occurred with a frequency from 2% to 5% of cases).
Rarelycombination treatment with ribavirin and interferon alfa-2b may be associated with aplastic anemia.
Monotherapy or combination therapy with ribavirin
Rarely observed ophthalmic disorders, including retinopathy (including papilledema), bleeding in the retina, vein occlusion, or retinal artery, focal retinal changes, decreased visual acuity or visual field limitation, optic neuritis, papilledema. Side effects of the cardiovascular system, particularly arrhythmia, probably associated with the prior diseases and previously conducted therapy with agents having cardiotoxic effect.
Rarely, patients who did not have cardiovascular disease system in history, there is cardiomyopathy, which may be reversible upon discontinuation of therapy with interferon alpha.
Very rarely observed rhabdomyolysis, myositis, renal failure, renal failure, ischemic heart disease, myocardial infarction, cerebral ischemia, cerebral hemorrhage, encephalopathy, ulcerative or ischemic colitis, sarcoidosis (or exacerbation sarcoidosis), exudative erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, necrosis at the injection site.
In the application of interferon alpha was observed a wide range of autoimmune and immune system-mediated disorders, including idiopathic thrombocytopenic purpura, and thrombotic thrombocytopenic purpura.
CONTRAINDICATIONS

- Autoimmune hepatitis or other autoimmune disease history;
- severe mental illness or severe mental disorders in history, particularly severe depression, suicidal thoughts or attempts;
- a serious disease of the cardiovascular system, unstable or uncontrolled within the previous 6 months;
- impaired function of the thyroid gland, which can not be maintained at a normal level by drug therapy;
- renal dysfunction with CC less than 50 ml / min (when used in combination with Ribavirin);
- decompensated liver disease;
- Epilepsy and / or violation of the central nervous system;
- pregnancy (including pregnancy in women - men partner, which is assumed treatment PegIntron and ribavirin);
- lactation period (breastfeeding);

- Hypersensitivity to any interferon;
- Hypersensitivity to any component of the drug.

PREGNANCY AND LACTATION

In a study on primates it was shown that interferon alfa-2b has an abortive effect. Rather, PegIntron also has such an effect. Therefore, PegIntron should not be used during pregnancy.
PegIntron can be used in women of reproductive age in the event that throughout the treatment they use effective methods of contraception.
Information on the allocation of the components of the drug in breast milk does not. Therefore, women who are breastfeeding should stop treatment PegIntron or breastfeeding, taking into account the expected benefits of treatment for the mother and the potential risk to the infant.
Due to the pronounced teratogenic and embryotoxic effects of ribavirin, leading to birth defects and fetal death in animals when used in a dose of 1/20 of the recommended therapeutic dose, combination therapy PegIntron and ribavirin is contraindicated in pregnancy.
Therapy PegIntron and ribavirin should be initiated only after a negative pregnancy test.
Women of childbearing ageReceiving treatment PegIntron and ribavirin, and their male partners must use effective contraception during treatment period and during at least 6 months after closure, as Ribavirin accumulates intracellularly and excreted from the body very slowly. The need to be repeated monthly pregnancy test during this time.
It is necessary to take all possible measures for prevention of pregnancy women - partners of men treated with PegIntron and ribavirin treatment. For this it is necessary that each of them used an effective contraceptive.
Appointment of PegIntron and ribavirin for women of childbearing age is possible only if their use in the treatment period effective contraceptive.
APPLICATION FOR FUNCTIONS OF THE LIVER

With monotherapy in patients with moderate renal impairment (creatinine clearance of 30-50 ml / min) , PegIntron initial dose should be reduced by 25%.
In patients with severe renal impairment (creatinine clearance 10-29 ml / min), including patients undergoing hemodialysis, an initial dose of PegIntron should be reduced by 50%. If during treatment serum creatinine rises above 2 mg / dl PegIntron therapy should be discontinued.
When assigning the combination therapy PegIntron and ribavirin to patients with mild renal insufficiency (CC not less than 50 ml / min)caution should be exercised with regard to the possible development of anemia. Combination therapy PegIntron and ribavirin for patients with CC below 50 ml / min, be conducted should not


APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS

Safety and efficacy of PegIntron treatment of patients with severe hepatic impairment have not been studied, therefore in these patients the drug should not be used.
SPECIAL INSTRUCTIONS

If desired destination PegIntron patients with severe mental disorders (in t. H. In patients having such disorders indication history) treatment may be initiated only after a careful examination of the individual and the appropriate treatment of a mental disorder.
In some patients during PegIntron therapy, experienced severe CNS side effects (such as depression, suicidal thoughts and suicide attempts). In the treatment of interferon alpha also met other disorders of the central nervous system, including aggressive behavior, sometimes directed at others, confusion and other mental status changes. In some patients, particularly the elderly, treated with higher doses of interferon alfa-2b, there is a marked reduction in pain sensitivity, coma, encephalopathy. Although these phenomena are largely reversible in some patients for a full recovery may take up to 3 weeks. When mental changes or CNS disorders (includingsymptoms of depression) is recommended to provide constant monitoring of these patients during treatment and for six months after its closure, given the potential severity of these adverse events. When saving or increase in symptoms, particularly depression, suicidal ideation or aggressive behavior, it is necessary to cancel the treatment PegIntron and ensure the timely intervention of a psychiatrist.
When PegIntron treatment of patients with heart failure, myocardial infarction and / or arrhythmias (including history) should be kept under constant surveillance. In patients with heart disease before and during treatment ECG is recommended. Arrhythmias (primarily supraventricular) usually amenable to conventional therapy but may require the cancellation of PegIntron.
In rare cases, interferon alfa-2b therapy complicated hypersensitivity reactions of immediate type (e.g., urticaria, angioedema, bronchospasm, anaphylaxis). At occurrence of such reactions during administration of PegIntron PegIntron should be discontinued immediately and appoint adequate symptomatic therapy. Transient rashes do not require discontinuation of treatment.
It is recommended that the study of renal function in all patients prior to initiating therapy PegIntron. During treatment, patients with impaired renal function are followed be closely monitored. If necessary, reduce the dose of PegIntron.
If signs of decompensated liver disease PegIntron discontinue treatment.
While fever may be observed in the framework of the flu-like syndrome, which is often recorded in the treatment of interferon, however, necessary to exclude other causes of persistent fever.
In patients receiving PegIntron therapy, it is necessary to ensure adequate hydration, because some patients had hypotension associated with a decrease in the volume of fluid in the body. In such cases, it may require introduction of substitution fluid.
PegIntron should be used with caution in diseases leading to disability such as pulmonary diseases (e.g., chronic obstructive pulmonary disease) or diabetes mellitus with a tendency to develop ketoacidosis. It is also necessary to use caution in patients with bleeding disorders (eg, thrombophlebitis, pulmonary embolism) or severe myelosuppression.
In rare cases, patients treated with interferon alpha, pulmonary infiltrates evolved unknown etiology, or pneumonia pneumonitis, including fatal. At the onset of fever, cough, shortness of breath and other respiratory symptoms, all patients should be carried out chest X-rays. In the presence of infiltrates on chest radiograph, or signs of impaired lung function of such patients should provide for more careful monitoring and, if necessary, to cancel interferon alpha. Although these reactions were more frequent in patients with chronic hepatitis C and receiving interferon alpha, nevertheless, they were also recorded with this drug in the treatment of patients with cancer. Immediate cancellation of interferon alpha therapy and corticosteroids lead to the disappearance of undesired phenomena in the lungs.
In the treatment of interferon alpha noted the appearance of autoantibodies. Clinical manifestations of autoimmune diseases appears to occur more frequently in the treatment of patients with interferon, n
Alphabetical index of medicines:
A  B  V  G  D  E  J
Z  I  Y  K  L  M  N
O  P  R  S  T  U  F
H  C  CH  SH  E  U  Y

Privacy policy:
Copyright 2009 - 2017. Universal reference book of medicines. All rights reserved.
When using site materials, an active hyperlink is required!