Pegasys injection 180mcg/0.5ml Roche treat hepatitis B, chronic hepatitis C (0.5ml)
Dosage form Box
Specifications Peginterferon Alfa-2A
Ingredient
Thành phần cho 0.5ml
| Composition information | Content |
| Peginterferon Alfa-2A | 180mcg |
Uses
indications
Pegasys drugs are indicated in the following cases:
Research on effectiveness/clinical
Hepatitis BClinical studies have shown that Pegasys has been effectively treated in the treatment of patients with chronic hepatitis B, including patients with positive HBeAg and patients with negative HBeAg/positive HBEAAG.
Clinical trials are confirmed
In all clinical trials, people who choose patients with chronic hepatitis B have a strong virus that has been determined by HBV DNA, has an increase in ALT concentration and has a liver biopsy results that determine chronic hepatitis diagnosis. In the study of WV16240, people chose HBeAg positive, and in the study of WV16241, people chose patients with negative HBeAg and Anti - HBe.
In both studies, the treatment time is 48 weeks plus 24 weeks of non -treatment monitoring. Both studies compare the group of pegasys combining placebo with the pegasys group combining lamivudine and with the single lamivudine group. There are no HBV -HIV -HIV -infected patients in these clinical trials.
The response ratio at the end of the monitoring phase of these two studies is presented in Table 1. DNA HBV is measured by Test Cobas Amplicor HBV Monitor (limit to detecting 200 copies/ml).
Hepatitis C
Clinical studies have proven that Pegasys is united or coordinated with Copegus (Ribavirin) to be effective in treating patients with chronic hepatitis C, including patients with cirrhosis with compensated liver disease, and HIV -HCV patients.
Clinical trials are confirmed
In clinical trials, people who have chosen patients who have never been treated with chronic hepatitis C have been determined by the HCV RNA content can be detected in serum, have an increase in ALT concentration and have a liver biopsy that determines chronic hepatitis. In the study of NV15495, people only choose patients with diagnosis of cirrhosis (about 80%) or in the transition stage to cirrhosis (about 20%). Clinical trials in those who do not respond and be relapse are also being conducted.
Regarding the treatment regime, treatment time and the results of the study, please see the table 2 and 3. The virus response is defined as not detecting the RNA HCV with the Test COBAS AMPLICOR HCV, version 2.0 (limit for detecting 100 copies/ml, equivalent to 50 international units/mL) and sustainable response is defined when the negative sample is about 6 months after the end of treatment.
Marriage in patients with pegasys combination treatment with Ribavirin, based on genotype and the virus is summarized in Table 3. The results of the study of NV15942 have provided a reasonable basis to set a genotype -based treatment regime for patients (see Table 11).
The difference between treatment regimes is generally not affected by the virus or the presence/presence of cirrhosis; Therefore, the treatment regime is recommended for Genotype 1, 2 or 3 regardless of these initial characteristics.
The efficiency of Pegasys is higher than the Interferon Alfa - 2A has also been shown in the response to histological, even in patients with cirrhosis and HIV -HCV patients.
Considering the ability to shorten the treatment time to 24 weeks for patients with gene 1 and 4 type was surveyed based on the rapid rapid response of viruses in patients who achieved rapid virus response at week 4 in NV15942 study (see Table 4).
Considering the possibility of shortening treatment time to 16 weeks in patients with genes 2 or 3 is surveyed based on sustainable rapid virus response in patients with rapid virus response in week 4 in NV17317 study (see Table 5).
In the study of NV17317 in patients with gene 2 or 3 virus infections, all patients who use Pegasys 180 mcg injected under the skin once a week and Ribavirin dose of 800 mg and are randomly obtained in 16 or 24 -week treatment groups. In general, the 16 -week treatment regimen does not give the results equivalent to the 24 -week regimen (see Table 5).
16 -week treatment for lower sustainable virus response rates (65%) compared to 24 -week regimen (76%). However, a recovery study in patients who achieved negative RNA gold medal at week 4 and had low viral levels (LVL) before treatment showed that the rapid rapid response in the 16 -week regimen was equivalent to the 24 -week treatment (89% and 94%, in order) (see Table 5).
Patients with hepatitis C did not respond to previous treatment
In the MV17150 study, the previous patients did not respond to the Pegylated Interferon Alfa - 2B regimen in collaboration with Ribavirin to be randomly received in four different treatment groups: Pegasys 360 mcg/week for 12 weeks, then use 180 mcg/week for the next 60 weeks; Pegasys 360 mcg/week for 12 weeks, then use 180 mcg/week for the next 36 weeks; Pegasys 180 mcg/week x 72 weeks; or Pegasys 180 mcg/week x 48 weeks. All patients use Ribavirin (1000 or 1200 mg/day) in combination with Pegasys. All regimens have a 24 -week monitoring time. The ratio of sustainable virus response of a group of patients to compare the treatment time or the dosage of Pegasys attack is summarized in Table 6.
Sustainable virus response after 72 weeks of treatment has superior results compared to 48 weeks of treatment.
Sustainable virus response ratio depends on the time of treatment and the characteristics of the patient discovered in the MV17150 study presented in Table 7.
In Halt - c patients with hepatitis C and have fibrosis or high cirrhosis that does not respond to previous treatment using Interferon Alfa or Pegylated Interferon Alfa united or coordinated with Ribavirin to be treated with Pegasys 180 mcg/week and Ribavirin 1000/1200 mg daily. Patients who achieve RNA gold medal at the level of detection after 20 weeks of treatment continue to be used in combination with pegasys with ribavirin for 48 weeks and are monitored without drugs for 24 weeks later.
Sustainable virus response depends on previous treatment regimens. The lowest treatment results in patients who do not respond to the Pegylated Interferon combination regimen with Ribavirin, thereby determining the most difficult -to -treat group of patients who do not respond, and equivalent to the sustainable viral response rate in 48 -week treatment groups in MV17150 study. Despite the higher sustainable response rate in patients who do not respond to Interferon or Pegylated Interferon used before, the effectiveness of treatment in these easier treatment people is still significantly lower than those who are newly treated for the first time (see Table 8).
Hepatitis C in patients recurrent after treatment
In a study with most gene -type patients with a relapse after 48 weeks of treatment with Pegylated Interferon Alfa - 2 and Ribavirin, patients treated for 72 weeks with Pegasys 180 mcg/week in combination with Ribavirin with dosage by body weight or ordinary Interferon regimen (9 mcG) daily in combination with ribavirin -using dose by weight. The sustainable response rate reaches 42% in patients with Pegasys groups in combination with Ribavirin for 72 weeks.
In an open study in patients with hepatitis C genotype 2 and 3 recurrence after 24 weeks treatment with Pegasys and Ribavirin, patients treated with Pegasys 180 mcg/week and Ribavirin 1000 or 1200 mg (by body weight) daily for 48 weeks and non -drug monitoring for 24 weeks. Sustainable response rate is 64%.
HIV -infected - HCV
In the study of NR15961, 860 HIV -HIV -HCV patients were randomly selected and treated with Pegasys 180 cmg/week and placebo; Pegasys 180 mcg/week and Ribavirin 800 mg/day; or Interferon Alfa - 2A 3miu three times per week and Ribavirin 800 mg/day for 48 weeks; Next is the 24 -week monitoring without treatment. Sustainable virus response in three treatment groups summarized for all patients and Genotype was presented in Table 9.
Mechanism of action
On In vitro, Pegasys has anti -proliferation and anti -virus activity of Interferon Alfa - 2A. The interferon is associated with specific receptors on the surface of the cell, causing a complex intracellular signal trigger and quickly activates the gene copying process. The genes are activated by Interferon that regulates many biological effects including inhibiting virus copies in infected cells, inhibits cell proliferation and immunity regulating.
RNA HCV concentration decreased by two phases in patients with hepatitis C response to Pegasys treatment. The first phase occurred within 24 to 36 hours after the first and second Pegasys doses occurred in the next 4 to 16 weeks in patients who achieved sustainable response. Compared to conventional interferon Alfa, Pegasys used at a dose of 180 mcg per week increases virus clearance and improves the response of the virus at the end of the treatment stage.
Pegasys stimulates the production of acting proteins, such as serum neopterin and 2 ′, 5 ′ - oligoadenylate synthetase, depending on the dose. The stimulation of 2 ′, 5 ′ - oligoadenylate synthetase reaches the maximum after using single doses from 135 mcg to 180 mcg pegasys; And maintain this maximum level throughout the distance a week between two doses. The level and time of Pegasys activated 2 ′, 5 ′ - oligodenylate synthetase decreases in objects over 62 years old and in patients with severe renal impairment (creatinine clearance from 20 to 40 ml/min). It is still unknown about the clinical relevance of these findings with the pharmacokinetic parameters of Pegasys.
Dynamic pharmacokinetics
Pegasys pharmacokinetics are studied in healthy volunteers and patients infected with hepatitis C virus (see Table 10). Results in patients with chronic hepatitis B in patients with chronic hepatitis C.
absorption
The absorption of Pegasys is maintained with plasma peaks achieved after use 72 to 96 hours. Serum concentration can be determined for 3 to 6 hours after the injection under the single -dose 180 mcg pegasys. Within 24 hours, about 80% of serum peak concentration reached. Pegasys's absolute bioavailability is 84% and is similar to the interferon Alfa - 2A.
Distribution
In humans, Pegasys is found mainly in the blood and in extracellular fluid with distribution volume in a stable state (VSS) about 6-14 liters after intravenous injection. Based on mice studies, it is found that the drug is distributed to the liver, kidneys, and bone marrow, as well as concentrated in the blood.
Metabolism
Metabolic is the main clearance mechanism of Pegasys. Pegasys metabolic data has not been fully learned. In humans, the body clearance of Pegasys is about 100 ml/hour, 100 times lower than the natural interferon Alfa - 2A. Rat studies show that Pegasys metabolic products are excreted in urine and less than excreted in the bile. There are less than 10% of the dose excreted in the form of Peginterferon Alfa - 2A unchanged. When the PEG part continues to be associated with Interferon Alfa - 2A, both PEG and Interferon Alfa - 2A are transformed.
Elimination
After using intravenous lines, in healthy objects, Pegasys's last waste time is approximately 60 hours. For regular interferon, this time is 3 to 4 hours. The final waste time in patients after subcutaneous injection is longer with an average value of 160 hours (from 84 hours to 353 hours). The final waste time is determined after using under the skin can not only reflect the elimination phase of the compound, but also reflect the prolonged absorption of Pegasys.
The area below the curve indicates the drug concentration over time (AUC) and the CMAX peak concentration increases proportional to the observed dose found in healthy objects and patients with chronic hepatitis C after taking Pegasys once a week. PEGASYS pharmacokinetics parameters in healthy subjects are injected under the single -dose Pegasys 180 mcg; And in patients with chronic hepatitis C treated with Pegasys 180 mcg once a week for 48 weeks; Presented in Table 10.
In patients with chronic hepatitis C, serum concentration is stable when taking a dose a week 2 to 3 times higher than when using a single dose, and reaching a stable state within 5 to 8 weeks. Once a stable state has been achieved, there is no accumulation of Peginterferon Alfa - 2A. The ratio between the peak concentration and the lowest concentration after 48 weeks of treatment is about 1.5 to 2. The serum concentration of Peginterferon Alfa - 2A is maintained for 1 week (168 hours).
pharmacokinetics and pharmacokinetic energy in special subjects
Patients with renal failure
There is no significant relationship between pharmacokinetics and Creatinine clearance of Pegasys 180 in 23 people with renal function from normal to severe renal failure (creatinine clearance from 20 to> 100 ml/minute). In patients with end -stage kidney disease, blood decrease, 25% to 45% decrease, and when taking 135 mcg dose to create the same concentration as when using 180 mcg dose in people with normal renal function. Regardless of the starting dose or the degree of renal failure, it is necessary to monitor the patient closely and if the reactions are harmful, the Pegasys 180 dose must be reduced appropriately during the treatment. Please refer to the prescription information of Ribavirin.
Gender
Pegasys 180 pharmacokinetics are similar between healthy men and women.
Older people
The area below the curve indicates the medium -sized drug concentration (AUC) in moderate increase in the elderly over 62 years old, but the peak concentration is similar in the elderly and under 62 years old. Based on the concentration of the drug, the pharmacological response, and tolerance, no need to use the dose of Pegasys at a lower start for older patients.
Patients with cirrhosis and non -cirrhosis
The pharmacy of Pegasys 180 is similar in healthy people and patients with chronic hepatitis B and hepatitis C. The concentration and data on pharmacokinetics between patients with cirrhosis and compensation liver disease and patients without cirrhosis.injection site
Should only be injected pegasys under the abdomen and thighs. The concentration of Pegasys 180 decreases in pegasys 180 injection studies at the arm compared to the abdomen and thighs.
Before taking Pegasys injection 180mcg/0.5ml Roche treat hepatitis B, chronic hepatitis C (0.5ml)
How to use
Whenever using solutions or vials used by infusion, must be observed with the eye to detect strange impurities or discoloration of the drug before use.
When used at home, give patients a hard -to -puncture bag to hold the syringes and needles that have been used. The patient should carefully guide the importance of the cancellation properly and note not to reuse the syringe and needle.
Dosage
chronic hepatitis B
The recommended dose of Pegasys 180 for chronic hepatitis B in both cases is positive and negative HBeAg is 180 mcg, once a week, injected under the abdomen or thighs. The recommended treatment time is 48 weeks.Chronic hepatitis C
Pegasys recommended dose, single -use or coordinated with Ribavirin, is 180 mcg once a week, injected under the abdomen or thighs. Ribavirin should be used with food. The time for using Pegasys 180 is recommended for 48 weeks.
Ribavirin's daily treatment and daily dose in coordination with Pegasys 180 are determined by genotype (genotype) of the virus.
Patients with gene -type HCV infected with a positive RNA test at 4 weeks need to use a 48 -week treatment regimen regardless of the number of viruses before treatment. The 24 -week regimen can be considered in gene 1 patients with low virus (Low Viral Load - LVL) (≤ 800,000 IU/mL) before the start of treatment or genotype 4 negative RNA HCV tests at the 4th week and maintain negative RNA HCV status at the 24th week.
However, the 24 -week regimen may be accompanied by a higher risk of relapse than 48 weeks of treatment. In these patients, the ability to tolerate coordination treatment regimen and prognostic factors such as the level of cirrhosis should be considered when deciding the treatment time. It is necessary to consider more carefully when deciding to shorten the treatment time in patients with gene -type virus infection 1 and have a high number of viruses before treatment (HVL) (> 800,000 IU/mL) when the RNA gold medal test is negative at week 4 and maintain that situation until the 24th week due to limited data shows that it may have a bad effect on the ability to respond to the effectiveness. sieve).
Patients infected with genotype 2 or 3 tests of RNA hcv positive week 4 should be treated for 24 weeks regardless of the number of viruses before treatment. The 16 -week treatment regimen can be selected in some patients with a gene 2 or 3 with the number of viruses before low treatment and the negative HCV RNA test at the 4th week.
The total 16 -week treatment time may be associated with the higher risk of relapse than the 24 -week treatment regimen. In these patients, the ability to tolerate the coordination treatment regimen and prognostic factors such as the level of cirrhosis should be considered when considering changing treatment compared to the standard regimen. The shortening of treatment time in patients with gene 2 or 3 has a high number of viruses tested in RNA in week 4 needs to be considered more cautious because it can have an adverse effect on the ability to respond to sustainable viruses.Existing documents about patients infected with genotype 5 or 6 are limited; Therefore, it is necessary to use a coordination regimen with Ribavirin 1,000/1,200 mg for 48 weeks.
Table 11. The recommended dose for the medication regimen for medical treatment of HCV
Genotype
PEGASYS 180 dose
Ribavirin dose
Treatment time
180 micrograms
24 weeks or 48 weeks.
48 weeks. 180 micrograms 48 weeks.
180 micrograms 24 weeks or 48 weeks.
180 micrograms 48 weeks.
180 micrograms 800 mg 16 weeks or 24 weeks. 180 micrograms 800 mg 24 weeks. 180 mcg 800 mg 24 weeks. ** RVR = Rapid Viral Response - Virus response quickly (negative HCV) at the 4th week. lvl = 800,000 IU/ml. Chronic hepatitis C has previously treated the previous failure HIV -infected - HCV The recommended dose of Pegasys 180, used monomers or combined with 800 mg of Ribavirin, is 180 mcg once a week injected under the skin for 48 weeks, not depending on the genotype. The safety and effectiveness of Pegasys 180 treatment therapy in combination with Ribavirin uses more than 800 mg per day; Or the treatment time of less than 48 weeks has not been studied. Ability to predict response and non -response Meeting the early virus in week 12, determined by the reduction of the virus or not detecting the concentration of RNA HCV, it has shown that it is possible to predict the ability to respond long -term (see Table 12). Table 12. Predict the ability to respond to viruses at week 12 with the recommended dose of pegasys coordination treatment in HCV patients. Genotype negative positive No long -term response Predict value Response in week 12 Long -term response Predict value Genotype 1 (N = 569) 102 97 95% (97/102) 467 271 58% (271/467) Genotype 2 and 3 (n = 96) 3 3 100% (3/3) 93 81 The ability to predict response and non -response in patients who did not respond to previous treatment In previous patients who have not responded currently being treated with a 72 -week regimen, the best prognosis factor is the ability to inhibit viruses at the 12th week (no RNA gold medal - determined when HCV RNA Special dose instructions Adjust the dose for Pegasys 180 General: When a dose adjustment is required due to medium to severe adultery reactions (clinical and/or subclinical tests), the decrease of the dose at the beginning to 135 mcg is generally appropriate. However, in some cases, the dose is reduced to 90 mcg or 45 mcg is necessary. It is possible to consider increasing the dose to the original dose when the adverse reactions have decreased. Hematology: The reduction of the dose is recommended if the absolute neutral leukemia count (ANC) is below 750 cells/mm3. For patients with ANC value of less than 500 cells/mm3, it is advisable to stop treatment until the ANC value returns to over 1,000 cells/mm3. The treatment with Pegasys 180 should be started at a dose of 90 mcg and need to monitor neutral leukemia. The reduction of the dose to 90 mcg is recommended if the platelet amount is below 50,000 cells/mm3. Must stop treatment if platelets decrease below 25,000 cells/mm3. Liver function: The change of abnormalities in liver function tests is common in patients with chronic hepatitis. However, like other interferon alfa drugs, it is found that when treated with Pegasys 180, there is an increase in the initial ALT concentration in the patient, including patients with viral response. For patients with HCV, the dose should be started to reduce to 135 mcg when there is an increase in ALT concentration on the original value. When ALT concentration increases continuously, although there is a decrease in the dose, or when the alt level increases with bilirubin, or there is evidence of liver loss, should stop treatment. For HBV patients, ALT concentration increases fleeting, sometimes exceeding 10 times the upper limit of normal value, not rare, and this can reflect the immunodeficiency level. It is advisable to consider when continuing to treat and must monitor the liver function regularly during the rising ALT period. If after the dose decreases or stops Pegasys 180 and the alt concentration decreases, the treatment can be repeated. Adjust the dose of ribavirin in coordination therapy To control the treatment of treatment, Ribavirin's dose should be reduced to 600 mg per day (200 mg in the morning and 400 mg in the evening) if one of the following two cases occurs: In case of intolerance to ribavirin, single -treatment treatment with Pegasys 180 can be continued. Instructions for dosage use for special objects: see the item used for children, the item used for the elderly, patients with kidney failure and patients with liver failure. Note: The above dose is for reference only. Specific dosage depends on the condition and level of progression of the disease. For a suitable dose, you need to consult a doctor or medical specialist.What to do when overdose? None of these patients suffer from abnormal, serious or limited events. The weekly dose of up to 540 mcg and 630 mcg has been used in clinical trials Carcinoma kidney cells and chronic cellular leukemia, according to the corresponding sense. The toxicity that causes the dose limits includes fatigue, increased liver enzymes, neutropen leukemia and platelets are always common when treated with interferon. There is no case of ribavirin overdose reported in clinical trials. Please refer to Ribavirin's prescription information. In an emergency, call the 115 emergency center immediately or go to the nearest local health station. What to do when you forget a dose? However, if close to the next dose, skip the forgotten dose and take the next dose at the time as planned. Do not drink twice as prescribed.
Side Effects
When using Pegasys, you may experience unwanted effects (ADR).
bruising, pain, redness, swelling or stimulation at the injection site, stomach pain, vomiting, heartburn, taste changes, dry mouth, loss of appetite, weight loss, diarrhea, dry or itchy skin, hair loss, difficulty sleeping or difficulty maintaining sleep, difficulty focusing or memorizing, sweating, dizziness. Blurred vision, vision change or loss of vision, pale skin, tachycardia, lumbar pain, rash, hives, swelling of the face, throat, tongue, lips, eyes, arms, legs, ankles or lower legs, difficult to swallow, hoarse. The drug can cause other side effects.
The adverse reactions are recorded from other interferon alfa, used or coordinated with Ribavirin, can also be observed when using Pegasys 180 single or Pegasys 180/Ribavirin combination.
Experience from clinical trials
The frequency and severity of the most common adverse reactions in patients treated with Pegasys 180 or Pegasys 180/Ribavirin are similar to patients treated with interferon alfa or interferon alfa/ribavirin, corresponding.
Most of the most common adverse reactions when using Pegasys 180 and Pegasys 180/Ribavirin have a mild to medium level, and can be controlled without the need to adjust the dose or stop treatment.
Chronic hepatitis B
In 48 weeks of clinical trials and 24 weeks of monitoring, the safety of Pegasys 180 in chronic hepatitis B is similar to the safety found in chronic hepatitis C, although the frequency of adverse events is significantly less reported in chronic hepatitis B patients (see Table 3).
In studies, 88% of patients treated with Pegasys 180 have adverse events, compared to 53% of patients in the comparison group treated with Lamivudine; 6% of patients in the group were treated with Pegasys 180 and 4% of patients in the group treated with Lamivudine with serious adverse events. 5% of patients have to stop treating Pegasys 180 due to adverse events or testing abnormalities, while less than 1% of patients have to stop lamivudine for safety reasons. The rate of stopping drugs in patients with cirrhosis is equivalent to the proportion of all patients in each treatment group. Used with lamivudine does not affect the safety of Pegasys 180.
Chronic hepatitis C
In clinical trials, the rate of stopping treatment for all patients due to adverse events and tests is 9% when treated with Pegasys 180 single and 13% when treating Pegasys 180 in combination with Ribavirin 1000/1200 mg for 48 weeks. Only 1% or 3% of patients are forced to stop treating with Pegasys 180 or Pegasys 180/Ribavirin in the corresponding appropriate, because of the abnormalities in testing.
The rate of stopping drugs in patients with cirrhosis is similar to all other patients. Compared to the 48 -week treatment regimen with Pegasys 180 and Ribavirin 1000/1200 mg, the 24 -week treatment regimen with the daily dose of Ribavirin is 800 mg, reducing serious adverse events (11% compared to 3%), reducing early drug stop rate for safety reasons (13% compared to 5%) and reducing the need to adjust the dose of Ribavirin (39% compared to 19%).
Patients with hepatitis C did not respond to previous treatment
In a clinical study using 72 and 48 weeks for patients who did not respond to Pegylated Interferon Alfa - 2B in combination with Ribavirin, the percentage of treatment due to Pegasys 180 was 12% and Ribavirin was 13% due to side effects or tests with abnormal results, in 72 weeks of treatment. With 48 -week treatment groups, 6% stop treatment of Pegasys 180 and 7% stop Ribavirin treatment. Similarly, for cirrhosis patients, Pegasys 180 and Ribavirin treatment stop rates are 72 weeks higher in the group, (13% and 15%) than the 48 weeks (6% and 6%). Patients stopped previous treatment due to hematetical toxicity were excluded not to participate in this research.
In another clinical study, patients with fibrosis or high cirrhosis (Ishak Score index from 3-6) did not respond to previous treatment that was put into study with platelet counts before treatment leveled by 50000/mm3 and treatment for 48 weeks. Due to the high ratio of fibrosis/fibrosis and the low platelet number of these patients, the frequency of abnormal hematological tests in the first 20 weeks of the study is as follows: Hemoglobin
HIV -infected - HCV
In patients with HIV -HCV co -infected patients, clinical adverse events recorded when using Pegasys 180 monomers or coordinated with Ribavirin, is similar to what is observed in patients infected with HCV. There are only very few data on safety (n = 51) in the co -infected patients with the number of CD4+ cell counts
In the study of NR15961, the rate of stopping treatment for clinical adverse events, tests or cases is identified as AIDS is 16% in the case of using Pegasys 180 single, and 15% in the case of Pegasys 180 combination treatment with Ribavirin 800 mg, for 48 weeks. 4% of patients have to stop Pegasys 180 and 3% of patients to stop Pegasys 180/Ribavirin because of the abnormalities in testing.
In coordinated treatment in co -infected patients, 39% of cases need to adjust the pegasys 180 dose and 37% of the cases need to adjust the dose of ribavirin. Serious adverse events are reported at 21% and 17% of patients using Pegasys 180 monomers or in combination with Ribavirin, in the corresponding sense.
Treatment therapy using Pegasys 180 reduces the absolute count of CD4+ cells without reducing the percentage of CD4+ cells during the treatment period. The CD4+ cell counting index returns to the original value in the research phase of the study. Pegasys 180 treatment therapy has a clear impact on the control of HIV virus in the blood during treatment and during monitoring.
Table 13 shows that adverse reactions occur ≥ 10% of patients using pegasys, pegasys in combination with ribavirin, or interferon alfa - 2b in combination with ribavirin in different indications.
The adverse reactions are reported ≥ 1% but
Disorders of blood system and lymph nodes: lymph nodes, anemia, platelet reduction. Endocrine disorders: Thyroidism, hyperthyroidism. Eye disorders: blurred vision, dry eyes, eye infections, eye pain. Disorders of ear and inner ears: dizziness, ear pain. Cardiovascular disorders: Brushing the chest, peripheral edema, tachycardia. Bloody disorders: Flushing. Mediastinum, chest and respiratory disorders: sore throat, rhinitis, nasopharyngitis, sinus congestion, shortness of breath when exertion, nosebleeds. Gastrointestinal disorders: vomiting, indigestion, flatulence, dry mouth, mouth ulcer, bleeding, stomatitis, swallowing hard, tongue. Disorders of skin and subcutaneous skin: Skin disorders, ban, eczema, psoriasis, urticaria, sensitive reaction to light, increase sweating, night sweat. Bone disorders, bonding organization, skeletal muscle: Bone pain, back pain, neck pain, cramps, muscle weakness, muscle pain, arthritis. The adverse reactions are recorded ≥ 1% to ≤ 2% in HIV -HIV patients - HCV used to combine Pegasys 180/Ribavirin including: hyperlactic lactic acid/lactic acid infection, influenza, pneumonia, ease of emotion, irrigation, sore throat, laryngitis, lipstick, lipid dysplasia. As well as other treatments with interferon alfa, the following serious or rare serious events have been reported in patients using Pegasys 180 monomers or combination of Pegasys 180/Ribavirin in clinical trials: lower respiratory tract infections, skin infections, external ear infections, pericarditis, overdose, liver disorders, malignant traces In the liver, stomach ulcers, gastrointestinal bleeding, pancreatitis, arrhythmia, atrial fibrillation, pericarditis, autoimmune phenomenon, (for example, spontaneous platelet hemorrhage, thyroid inflammation, psoriasis, rheumatoid arthritis, body lupus erythema), muscle inflammation, peripheral neuritis, Sacoid disease, interstitial pneumonia that is life -threatening, pulmonary obstruction, corneal obstruction, corneal obstruction, portrait infection sense. Interferon Alfa, including Pegasys 180, when used in combination with Ribavirin, can reduce the whole hemorrhage and rarely cause airline anemia. Abnormalities of subclinical tests When using a combination therapy for medals, please refer to Ribavirin's prescription information to grasp the effects of ribavirin on testing parameters. Hematology: Like other interferons, treatment with Pegasys 180 or Pegasys 180/Ribavirin reduces hematological values, often improved when adjusting the dose, and these values will return to the level before treatment within 4 to 8 weeks after stopping treatment. Despite hematopology such as neutropenia, thrombocytopenia and anemia that occur more often in HIV -HC -HC -medals, most of these toxicity can be controlled by adjusting the dose and using growth factors, and rarely stop treatment. hemoglobin and hematocrit: Despite using Pegasys 180 monomers reduced slowly the small amount of hemoglobin and hematocrit, less than 1% of medals, including patients with cirrhosis, need to adjust the dose due to anemia. About 10% of medals are used for 48 weeks of treatment for Pegasys 180/Ribavirin 1000/1200 mg requires a dose reduction due to anemia. Anemia (hemoglobin White blood cells: Pegasys 180 treatment is related to the reduction of both the whole whole white blood cell count (WBC) and the absolute neutrophilic counting (ANC). About 4% of HBV or HCV patients are treated with Pegasys 180 and 5% of medal patients treated with Pegasys 180/Ribavirin, which is absolutely reduced to absolute neutrophil to less than 500 cells/mm3 at some time during treatment. In patients with HIV -HCV co -infected patients, 13% and 11% of patients who use Pegasys 180 and coordinated with ANC reduced less than 500 cells/mm3, in the corresponding appropriate. Platelet counts: Pegasys 180 treatment is related to a decrease in platelet count value. In clinical trials, about 5% of the medalian patients have reduced platelet counts below 50,000 cells/mm3, most of them are patients with cirrhosis and patients at the beginning of the study with low platelet counts about 75,000 cells/mm3. In hepatitis B clinical trials, 14% of patients have a decrease in platelet counts below 50,000/mm3, most of them are patients at the beginning of the study with low platelet counts. In patients with HIV - HCV, 10% and 8% of patients using Pegasys 180 monomers and coordinated coordination are reduced platelets below 50,000/mm3, in the corresponding appropriate. thyroid function: Pegasys 180 treatment is related to significant clinical abnormalities of thyroid tests, requiring clinical intervention. The frequency of observation when treated with Pegasys 180 is similar to treatment with other interferons. triglycerides: Increased triglycerides in patients with Interferon Alfa treatment, including Pegasys 180. Interferon antibodies: three percent of HCV patients (25/835) using Pegasys 180 with or without Ribavirin with antibodies neutralizing low -content resistance. The pathological and clinical significance of the appearance of neutralized antibodies in serum has not been known. There is no obvious correlation between the appearance of antibodies and clinical response or adverse events. Notify the doctor with unwanted effects when using the drug. Instructions on how to handle ADR Stop using the drug. With minor adverse reactions, usually just stop the drug. In case of severe sensitivity or allergic reactions, supportive treatment (airy keeping and using epinephrin, oxygen breathing, antihistamine, corticoid ...). When experiencing side effects of the drug, it is necessary to stop using and notify the doctor or go to the nearest medical facility for timely treatment.
Warnings
Before using the drug you need to read the instructions carefully and refer to the information below.
contraindicated
Pegasys drugs contraindicated in the following cases:
Contraindications for initial treatment with Pegasys 180 for patients with HIV -HIV -HCV patients with cirrhosis and Child - PUGH ≥ 6. infants and children under 3 years old. Please refer to Ribavirin's prescription information when Pegasys 180 is used in combination with Ribavirin. Single Pegasys regimen or Pegasys 180 with Ribavirin should be conducted under the guidance of a specialist. Treatment can cause adverse reactions with a degree from average to severe, requiring a decrease in dose, temporary or no no more treatment. Please refer to Ribavirin's prescription information on other testing standards. Treatment with Pegasys 180 or Pegasys 180/Ribavirin reduces both the total white blood cell count (WBC) and the absolute neutral leukocytes (ANC), usually starts within the first 2 weeks of treatment. In clinical studies, the continuous decrease in the number of these cells rarely occurs after 4 to 8 weeks of treatment. Dosage reduction is recommended when ANC decreases below 750 cells/mm3. For patients with ANC value of less than 500 cells/mm3, the treatment should be suspended until the ANC value returns to over 1,000 cells/mm3. In clinical trials with Pegasys 180 or Pegasys 180/Ribavirin, an ANC decrease may be recovered after a decrease in dose or stop treatment. Treatment with Pegasys or Pegasys 180/Ribavirin reduces platelet counting, which has returned as before treatment during the post -treatment monitoring phase. The reduction of the dose is recommended when the number of sphere counting decreases below 50,000 cells/mm3 and must stop treatment when the platelet counting decreases below 25,000 cells/mm3. Infections Despite the fever accompanied by the influenza syndrome that has been regularly reported during interferon treatment, it is also necessary to eliminate other causes of persistent fever, especially in patients with neutropenia. Cases of severe infections (caused by bacteria, viruses, fungi) have also been reported during the treatment with interferon alfa, including Pegasys 180. The appropriate anti -infection therapy should be started immediately for patients and should consider stopping treatment with interferon. Autotological disorders The worse condition of autoimmune disease has been reported in patients treated with Interferon Alfa; It is necessary to be very cautious when treating Pegasys 180 or Pegasys 180/Ribavirin for patients with autoimmune disorders. using Interferon Alfa can cause or make psoriasis worse. Should be cautious when using Pegasys 180 single or combination Pegasys 180/Ribavirin for patients with psoriasis. In case of appearance or evolution of psoriasis lesions, it is advisable to consider stopping treatment. Endocrine Like other interferons, Pegasys 180 or Pegasys 180/Ribavirin can cause or aggravate thyroid disabilities and thyroid glands. Hyperglycemia, hypoglycemia and diabetes have been observed in patients treated with interferon alfa. Mental Periodic mental adultery reactions may occur in some patients treated with Interferon, including Pegasys 180 or Pegasys 180/Ribavirin. Depression, suicide ideas, and suicide can occur in patients with or without mental illness before. Should be cautious when treated with Pegasys 180 single or combination Pegasys 180/Ribavirin for patients with a history of depression, and doctors must closely monitor all patients to detect signs of depression. Before starting treatment with Pegasys 180 or Pegasys 180/Ribavirin for patients, doctors need to notify the patient about the possibility of depression, and the patient must immediately report to the doctor about any signs or symptoms of depression. In severe cases, treatment should be stopped and need to apply mental interventions for patients. Science Like other interferons, retinopathy includes retinal hemorrhage, secondary ischemic areas of the retina, which manifests itself in white or gray spots on the retinal surface, gai thorn, optic neuropathy, veins or retinal artery that can cause vision loss, which has also been reported after treatment with Pegasys 180. Cardiovascular Ribavirin anemia can make heart disease worse, so HCV patients with a noticeable or unstable history of heart disease in the previous six months should not use Ribavirin. Cardiovascular events such as hypertension, ventricular arrhythmia, hemorrhagic heart failure, chest pain and myocardial infarction may occur when using Interferon Alfa, including Pegasys 180 and Pegasys 180/Ribavirin. Patients with previous cardiovascular abnormalities should be measured electrocardiograms before treatment. If there is any bad evolution of cardiovascular condition, it is necessary to suspend or stop the treatment. hypersensitivity Hypersensitivity, acute hypersensitivity reactions (e.g. urticaria, angioedema, bronchospasm, anaphylaxis) rarely during treatment with interferon alfa. If the hypersensory reaction occurs during treatment with Pegasys 180 or with Pegasys 180/Ribavirin, it is necessary to stop the drug and conduct appropriate treatments immediately. There is no need to stop the drug if the Red Red Red Red Lung As well as other interferon alfa, pulmonary symptoms, including shortness of breath, lung infiltration, pneumonia, localized pneumonia, including severe cases of life -threatening, reported during treatment with Pegasys 180 monochromatic or coordinated with Ribavirin. If there are signs of lung contamination, or respiratory failure inexplicable or persistent, treatment should be stopped. Liver function In patients with evidence of liver loss during treatment, Pegasys 180 or Pegasys 180/Ribavirin should be stopped. HCV: Like other interferon alfa, the alt concentration increased above the initial level that was observed in patients treated or with Pegasys 180 or with Pegasys 180/Ribavirin, including patients with virus response. When the ALT levels increased continuously, although there was a decrease in the dose, or when the ALT level increased with bilirubin increased, treatment should be stopped. HBV: Unlike HCV, the condition of severe illness during treatment is common and manifested by a significant increase and air of serum ALT levels. In clinical trials with Pegasys 180 in HBV patients, there is a significant increase in transaminase accompanied by slight changes in other liver function assessment standards; And there is no evidence of liver loss. In about half of cases with liver enzymes increasing in excess of the upper limit of normal value, the dose or pegasys stops need to be reduced until the transaminase increase is reduced; While in half of the remaining cases, it is still possible to continue taking the drug at a constant dose. Should monitor more frequent liver function in all cases. HIV -infected - HCV Progressive cirrhosis patients who are treated simultaneously with Haart may increase the risk of liver loss and may die when being treated with Ribavirin in combination with Interferon Alfa, including Pegasys 180. During treatment, it is advisable to closely monitor co -infected patients, periodically assess clinical status and liver function of their liver and should stop treating immediately if the liver is compensated (PUH - PUG Subclinical tests Before starting to use Pegasys 180 single or combination Pegasys 180/Ribavirin, standard biochemical and hematological tests should be conducted for all patients. After starting treatment, hematological tests should be conducted after 2 and 4 weeks; And biochemical tests should be done after 4 weeks. These tests should be conducted periodically during treatment. Patients who are used in clinical studies using Pegasys 180 are united or in combination with Ribavirin can be considered a rule to determine the initial values that can be accepted for the beginning of the treatment process: used in special subjects Use in children The safety and effectiveness of the drug has not been established in patients under 18 years old. In addition, Pegasys 180 injection solution contains benzyl alcohol. Rarely reports on death in infants and young children due to excessive contact with Benzyl alcohol. People still do not know the amount of Benzyl alcohol to what extent is capable of toxicity or causing harmful effects on babies and young children. Therefore, Pegasys 180 should not be used for babies and children. Used in the elderly Based on pharmacokinetics, pharmacological, tolerance, and safety data from clinical trials, no need to adjust the dose of Pegasys 180 for older patients. Patients with renal failure In patients with end -stage renal disease, the starting dose of Pegasys 180 should be 135 mcg once a week. Regardless of the starting dose or the degree of renal failure, the patient should also be closely monitored during the treatment and should reduce the dose of Pegasys 180 accordingly if the reactions appear harmful. Please refer to Ribavirin's prescription information on using Ribavirin for patients with renal failure. Patients with liver failure Pegasys 180 proved to be effective and safe in patients with compensated cirrhosis (for example, Child Pugh A). Pegasys 180 has not been studied when used for patients with unscathed cirrhosis (for example, Child Pugh B/C or varicose veins of hemorrhage). Classification of Child - Pugh divides patients into groups A, B, and C, or "light", "average" and "heavy" according to the points 5 - 6, 7 - 9 and 10 - 15 respectively. Evaluation abnormal level Points Brain pathology No 1 2 3 ascites No 1 2 3 1 2 3 1 2 3 3.5 1 2 3 1 2 3 should not use Pegasys 180 for pregnant women. The impact of Pegasys 180 on fertility has not been studied. Like other Interferon Alfa, it is observed that the menstrual cycle extends the reduction and extended time to reach the peak concentration of 17α estradiol and progesterone after using Pegasys 180 for female monkeys. The menstrual cycle returns to normal after stopping treatment. There is no research on the impact of Pegasys 180 on fertility in men. However, treatment with Interferon Alfa - 2A does not affect the fertility of male Rhesus monkeys to be used for 5 months at the dose up to 25 x 106 IU/kg/day. The monster effect of Pegasys 180 has not been studied. Treatment with Interferon Alfa - 2A increases the likelihood of causing miscarriage is statistically significant in Rhesus monkeys. No monster effects of the drug on the new generation of newborns are full monthly. However, like other interferon alfa, women who are likely to be pregnant should use effective contraceptive measures during the treatment process with Pegasys 180. Use Ribavirin has recorded an impact of embryo death and/or a significant monster effect in all species using ribavirin. Contraindicated to use Ribavirin therapy for pregnant women and their husband/partner. The female patients or wives/mistresses of male patients who are using Ribavirin need to be very cautious, avoiding pregnancy during this time. Any contraceptive method is likely to fail. Therefore, it is very important that women who have the ability to become pregnant and their husband/partner must use two effective contraceptives during the treatment process and within six months after treatment. Please refer to Ribavirin's prescription information when Pegasys 180 is used in combination with Ribavirin. It is not known whether Pegasys 180 and/or Ribavirin will be secreted through breast milk. Because there are many drugs excreted through breast milk and to avoid any risk of causing serious reactions of Pegasys 180 or Ribavirin to breastfeed, must decide or stop treatment or stop breastfeeding, depending on the importance of the mother's treatment. does not record pharmacokinetic interactions between Pegasys 180 and Ribavirin in clinical clinical trials using Pegasys 180 in combination with Ribavirin. Similarly, Lamivudine does not affect the pharmacokinetics of Pegasys 180 in HBV clinical trials using Pegasys 180 in combination with Lamivudine. Treatment with Pegasys 180 mcg once a week in 4 weeks does not have the impact on the pharmacokinetic properties of Tolbutamide (CYP 2C9), Mephenytoin (CYP 2C19), DEBRISOQUINE (CYP 2D6), and Dapsone (CYP 3A4) in healthy male objects. Pegasys 180 is a Cytochrome P450 1A2 inhibitor in a moderate level, because in the same study, there is a 25% increase in the lower curve (AUC) of theophilline. The comparative effects on theophilline's pharmacokinetics have been recorded after treatment with regular interferon alfa. Interferon Alfa is seen as an impact on the metabolism of some drugs by reducing the activity of cytochrome P450 in the liver mini. Should monitor serum concentration of theophyllline and adjust theophyllline dose suitable for patients using theophyllline combination with Pegasys 180 or Pegasys 180/Ribavirin. In a pharmacokinetics study in 24 medals used at the same time, the maintenance dose (average dose of 95 mg; variables from 30 mg to 150 mg), the treatment with Pegasys 180 dose 180 mcg subcutaneously once a week for 4 weeks has made the average Methadone level higher than the original from 10% to 15%. The clinical significance of this finding is not known; However, patients should be monitored to detect signs and symptoms of methadone poisoning. There is no evidence of drug interaction recorded in 47 HIV -HCV patients. These people have completed a 12 -week pharmacokinetic study to check the effects of ribavirin on intracellular phosphoryl of some enamel inhibitors that copy nucleoside (lamivudine, zidovudine, or stavudine). Ribavirin's plasma concentration does not seem to be affected by the use of the same drugs. Do not use ribavirin simultaneously and Didanosine. Didanosine concentration or its main metabolites (Dideoxyadenosine 5 ′ - Triphosphate) increases when Didanosine is used with ribavirin. Reports of severe liver failure, as well as peripheral neuropathy, acute pancreatitis, and hyperlem of blood lactic acid/lactic acid infection are also reported when using ribavirin. Be cautious when using
pregnancy
breastfeeding period
Drug interaction
Storage
Store in the refrigerator at 2-80C temperature. Do not freeze or shake. Store the whole box to avoid light.
Expiry date: 36 months from the date of manufacture. Do not use overdue drugs stated on the packaging.
Manufacturer: F. Hoffmann-La Roche Ltd ..
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