Components:
Medically reviewed by Kovalenko Svetlana Olegovna, PharmD. Last updated on 30.03.2022
![](/style/images/attention_blue.png)
Attention! Information on this page is intended only for medical professionals! Information is collected in open sources and may contain significant errors! Be careful and double-check all the information on this page!
Top 20 medicines with the same components:
Chronic hepatitis B in patients w/ evidence of viral replication & liver inflammation. Points required for initiating Sebivo Tablet therapy: HBeAg +ve: HBV DNA <9log 10 copies/mL, ALT ≥2x ULN; HBeAg -ve: HBV DNA <7log 10 copies/mL.
Sebivo Tablet is an antiviral medication. It works by preventing viral cells from multiplying in the body and infecting new liver cells.
Sebivo Tablet is used to treat chronic hepatitis B in adults. This medicine will not cure hepatitis.
Sebivo Tablet may also be used for purposes not listed in this medication guide.
Usual Adult Dose for Chronic Hepatitis B
600 mg orally once a day
Usual Pediatric Dose for Chronic Hepatitis B
16 years or older: 600 mg orally once a day
Renal Dose Adjustments
CrCl 30 to 49 mL/min:
Tablets: 600 mg orally every 48 hours
Oral solution: 400 mg orally once a day
CrCl less than 30 mL/min (not requiring dialysis):
Tablets: 600 mg orally every 72 hours
Oral solution: 200 mg orally once a day
Liver Dose Adjustments
No adjustment recommended.
Precautions
Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogs alone or in combination with antiretrovirals. Risk factors for lactic acidosis may include female gender, obesity, and prolonged nucleoside exposure. Caution is recommended in patients with risk factors for liver disease; however, cases have also been reported in patients with no known risk factors. Treatment with Sebivo Tablet should be stopped in any patient who develops clinical and laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity (which may include hepatomegaly and steatosis even in the absence of marked transaminase elevations).
Severe acute exacerbations of hepatitis B have been reported in patients who have discontinued antihepatitis B therapy, including therapy with Sebivo Tablet. Patients discontinuing Sebivo Tablet should be closely monitored with clinical and laboratory follow-up for at least several months. If appropriate, resumption of antihepatitis B therapy may be necessary.
Hepatic function should be monitored periodically in all patients during Sebivo Tablet therapy.
Coadministration of Sebivo Tablet with peginterferon alfa-2a is contraindicated due to increased risk of peripheral neuropathy.
Peripheral neuropathy has been reported with Sebivo Tablet alone or in combination with interferons. An increased risk and severity of peripheral neuropathy has been observed with concomitant Sebivo Tablet and peginterferon alfa-2a compared to Sebivo Tablet alone. The safety and effectiveness of Sebivo Tablet in combination with interferons for chronic hepatitis B has not been established. Patients should be advised to report any numbness, tingling, and/or burning sensations in the arms and/or legs, with or without gait disturbance. Sebivo Tablet should be interrupted if peripheral neuropathy is suspected and discontinued if diagnosed.
Myopathy and myositis have been reported with Sebivo Tablet use several weeks to months following treatment initiation. Sebivo Tablet treatment should be interrupted if myopathy is suspected and discontinued if diagnosed. When starting concurrent therapy with other drugs associated with myopathy, physicians should closely monitor patients for signs or symptoms of unexplained muscle pain, tenderness, or weakness.
Safety and efficacy have not been established in liver transplant patients, in patients with decompensated liver disease, or in patients coinfected with human immunodeficiency virus, hepatitis C virus, or hepatitis D virus.
Renal function should be closely monitored before and during treatment in transplant recipients who are receiving immunosuppressants that can affect renal function.
Concurrent administration with drugs that affect renal function may alter serum levels of Sebivo Tablet and/or the other drugs. Close clinical and laboratory monitoring for adverse effects is recommended and appropriate dosage adjustments should be made if indicated.
Clinical studies of Sebivo Tablet did not contain sufficient numbers of subjects aged 65 years and over to determine whether they respond differently from younger subjects. In general, dose selection for the elderly patient should be cautious, keeping in mind the greater frequency of decreased renal function due to concomitant disease or other drug therapy. Renal function should be closely monitored in this patient population.
Sebivo Tablet oral solution contains about 47 mg sodium per 600 mg dose (30 mL).
Safety and efficacy have not been established in Black/African American or Hispanic patients.
Safety and efficacy have not been established in pediatric patients less than 16 years of age.
Dialysis
End-stage renal disease:
Tablets: 600 mg orally every 96 hours
Oral solution: 120 mg orally once a day
Sebivo Tablet should be dosed after hemodialysis sessions when given on hemodialysis days.
Other Comments
Due to higher rates of resistance that may develop with longer term therapy among patients with incomplete viral suppression, therapy should only be started, if pretreatment HBV DNA and ALT measurements are known, in the following patients:
HBeAg-positive: HBV DNA should be less than 9 log10 copies/mL and ALT should be greater than or equal to 2 times upper limit of normal prior to therapy.
HBeAg-negative: HBV DNA should be less than 7 log10 copies/mL prior to therapy.
The optimal treatment duration has not been established. On-treatment response should guide continued therapy. Alternate treatment is recommended in patients with incomplete viral suppression (HBV DNA greater than or equal to 300 copies/mL) after 24 weeks of therapy. HBV DNA should be monitored every 6 months to assure continued response. Alternate treatment is recommended if patients test positive for HBV DNA at any time after their initial response. Optimal treatment should be guided by resistance testing.
Sebivo Tablet may be taken with or without food. The oral solution may be considered for patients who have difficulty swallowing tablets.
Sebivo Tablet oral solution should be discarded 2 months after opening the bottle.
See also:
What is the most important information I should know about Sebivo Tablet?
Sebivo Tablet tablets are contraindicated in patients with previously demonstrated hypersensitivity to any component of the product.
Use Sebivo Tablet as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- Sebivo Tablet comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Sebivo Tablet refilled.
- Take Sebivo Tablet by mouth with or without food.
- If you have difficulty swallowing Sebivo Tablet, tell your doctor. There may be another form of Sebivo Tablet you can take.
- Take Sebivo Tablet on a regular schedule to get the most benefit from it. Taking Sebivo Tablet at the same time each day will help you remember to take it.
- Continue to take Sebivo Tablet even if you feel well. Do not miss any doses.
- If you miss a dose of Sebivo Tablet, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once. Contact your health care provider if you are not sure what to do.
Ask your health care provider any questions you may have about how to use Sebivo Tablet.
There are specific as well as general uses of a drug or medicine. A medicine can be used to prevent a disease, treat a disease over a period or cure a disease. It can also be used to treat the particular symptom of the disease. The drug use depends on the form the patient takes it. It may be more useful in injection form or sometimes in tablet form. The drug can be used for a single troubling symptom or a life-threatening condition. While some medications can be stopped after few days, some drugs need to be continued for prolonged period to get the benefit from it.Sebivo Tablet is used for treating long term infection of hepatitis B virus in patients who may also show signs of liver damage.
See also:
What other drugs will affect Sebivo Tablet?
Since Sebivo Tablet is eliminated primarily by renal excretion, co-administration of Sebivo Tablet with substances that affect renal function may affect plasma concentrations of Sebivo Tablet and/or the co-administered substance.
At concentrations up to 12 times that used in humans, Sebivo Tablet did not inhibit in vitro metabolism mediated by any of the following human hepatic microsomal CYP450 isoenzymes known to be involved in human drug metabolism: 1A2, 2C9, 2C19, 2D26, 2E1, and 3A4. Sebivo Tablet does not induce CYP450 isoenzymes in animals. Based on these results and the known elimination pathway of Sebivo Tablet, the potential for CYP450-mediated interactions involving Sebivo Tablet with other medicinal products is low.
The steady-state pharmacokinetics of Sebivo Tablet were unaltered following multiple-dose administration in combination with lamivudine, adefovir dipivoxil, ciclosporin or pegylated interferon-α 2a.
See also:
What are the possible side effects of Sebivo Tablet?
Approximately 1500 subjects have been treated with Sebivo Tablet in clinical studies at doses up to 1800 mg/day. Assessment of adverse reactions is primarily based on the pivotal 007 GLOBE study in which 1367 patients with chronic hepatitis B received double-blind treatment with Sebivo Tablet 600 mg/day (n=680) or lamivudine (n=687) for up to 104 weeks.
Median duration of treatment in the 007 GLOBE study was 60 weeks for Sebivo Tablet- and lamivudine-treated patients. The safety profiles of Sebivo Tablet and lamivudine were generally comparable in this study.
Sebivo Tablet was generally well tolerated, with most adverse experiences classified as mild or moderate in severity. In the 007 GLOBE study, patient discontinuations for adverse events, clinical disease progression or lack of efficacy in the first 52 weeks of treatment were 0.3% for Sebivo Tablet and 1.2% for lamivudine. Table 5 lists the adverse reactions recorded in the first 52 weeks of treatment in the 007 GLOBE study by system organ class and by frequency using the following convention: Common (≥1/100; <1/10); uncommon (≥1/1000; <1/100). Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Creatine kinase (CK) elevations occurred in both treatment arms. However, median CK levels were higher in Sebivo Tablet-treated patients by week 52 and did not increase thereafter. Grade 3/4 CK elevations occurred in 7.5% of Sebivo Tablet-treated patients and 3.1% of lamivudine-treated patients by week 52. Most CK elevations were asymptomatic and CK values typically decreased by the next visit on continued treatment. Analysis of clinical adverse events in patients with CK elevations indicated no significant difference between Sebivo Tablet-treated and lamivudine-treated patients.
The incidence of alanine aminotransferase (ALT) flares was similar in the 2 treatment arms in the first 6 months but was lower for Sebivo Tablet after week 24, as shown in Table 6.
Exacerbations of Hepatitis B After Discontinuation of Treatment: Severe acute exacerbations of hepatitis B have been reported in patients who have discontinued antihepatitis B therapy. There are insufficient data on post-treatment exacerbations of hepatitis B after discontinuation of Sebivo Tablet treatment.
Sebivo Tablet is a synthetic thymidine nucleoside analog with specific activity against the hepatitis B virus. Sebivo Tablet is orally administered, with good tolerance, lack of toxicity and no dose-limiting side effects.