EPIVIR HBV (Page 6 of 6)

14.2 Pediatric Subjects

The safety and efficacy of EPIVIR-HBV were evaluated in a double-blind clinical trial in 286 subjects aged 2 to 17 years, who were randomized (2:1) to receive 52 weeks of EPIVIR-HBV (3 mg per kg once daily to a maximum of 100 mg once daily) or placebo. All subjects had compensated chronic hepatitis B accompanied by evidence of hepatitis B virus replication (positive serum HBeAg and positive for serum HBV DNA by a research branched-chain DNA assay) and persistently elevated serum ALT levels. The combination of loss of HBeAg and reduction of HBV DNA to below the assay limit of the research assay, evaluated at Week 52, was observed in 23% of subjects treated with EPIVIR-HBV and 13% of placebo-treated subjects. Normalization of serum ALT was achieved and maintained to Week 52 more frequently in subjects treated with EPIVIR-HBV compared with placebo (55% versus 13%). As in the adult controlled trials, most subjects treated with EPIVIR-HBV had decreases in HBV DNA below the assay limit early in treatment, but about one-third of subjects with this initial response had reappearance of assay-detectable HBV DNA during treatment. Adolescents (aged 13 to 17 years) showed less evidence of treatment effect than younger pediatric subjects.

16 HOW SUPPLIED/STORAGE AND HANDLING

EPIVIR-HBV tablets contain 100 mg of lamivudine, are butterscotch-colored, film-coated, biconvex, capsule-shaped tablets imprinted with “GX CG5” on one side. Packaged as follows:

Bottles of 60 tablets (NDC 0173-0662-00) with child-resistant closure.

Store EPIVIR-HBV tablets at 25°C (77°F); excursions permitted between 15°C and 30°C (59°F and 86°F) [see USP Controlled Room Temperature].

EPIVIR‑HBV oral solution is a clear, colorless to pale yellow, strawberry‑banana-flavored liquid. Each mL of the solution contains 5 mg of lamivudine. Packaged as follows:

Plastic bottles of 240 mL (NDC 0173-0663-00) with child-resistant closure. This product does not require reconstitution.

Store EPIVIR-HBV oral solution at controlled room temperature of 20°C to 25°C (68°F to 77°F) (see USP) in tightly closed bottles.

17 PATIENT COUNSELING INFORMATION

Advise the patient to read the FDA-approved patient labeling (Patient Information).

Severe Acute Exacerbation of Hepatitis after Discontinuation of Treatment

Inform patients that discontinuation of anti-hepatitis B therapy, including EPIVIR-HBV, may result in severe acute exacerbations of hepatitis B including decompensation of liver disease. Advise patients not to discontinue EPIVIR-HBV without first informing their healthcare provider [see Warnings and Precautions (5.1)].

Risk of Development of HIV-1 Resistance in Patients with HIV-1 Co-infection

Counsel patients on the importance of testing for HIV to avoid inappropriate therapy and development of resistance to HIV. HIV counseling and testing should be offered before starting EPIVIR-HBV and periodically during therapy. Inform patients that if they have or develop HIV infection and are not receiving effective HIV treatment, EPIVIR-HBV may increase the risk of development of resistance to HIV medications. Advise patients that EPIVIR-HBV contains a lower dose of the same active ingredient (lamivudine) as HIV drugs containing lamivudine [see Dosage and Administration (2.1), Warnings and Precautions (5.2)].

Emergence of HBV Resistance

Inform patients that emergence of resistant hepatitis B virus and worsening of disease can occur during treatment. Patients should promptly report any new or worsening symptoms to their physician [see Warnings and Precautions (5.3)].

Lactic Acidosis/Severe Hepatomegaly with Steatosis

Advise patients that lactic acidosis and severe hepatomegaly with steatosis have been reported with use of nucleoside analogues and other antiretrovirals. Advise patients to stop taking EPIVIR-HBV if they develop clinical symptoms suggestive of lactic acidosis or pronounced hepatotoxicity [see Warnings and Precautions (5.4)].

Hepatitis B Transmission

Advise patients that treatment with EPIVIR‑HBV has not been shown to reduce the risk of transmission of HBV to others through sexual contact or blood contamination.

Drug Interactions

Inform patients that EPIVIR-HBV may interact with some drugs; therefore, patients should be advised to report to their healthcare provider the use of any prescription or non-prescription medication or herbal products. Advise patients to avoid chronic use of sorbitol-containing prescription and over-the-counter medicines when possible. Taking EPIVIR-HBV with chronically administered sorbitol-containing medicines may decrease the concentrations of lamivudine [see Drug Interactions (7.2)].

Sucrose Content of EPIVIR-HBV Oral Solution

Advise diabetic patients that each 20‑mL dose of EPIVIR‑HBV oral solution contains 4 grams of sucrose (1 mL = 200 mg of sucrose) [see Description (11)].

Pregnancy Registry

Advise patients that there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to EPIVIR-HBV during pregnancy [see Use in Specific Populations (8.1)].

Missed Dosage

Instruct patients that if they miss a dose of EPIVIR-HBV, to take it as soon as they remember. Advise patients not to double their next dose or take more than the prescribed dose [see Dosage and Administration (2)].

EPIVIR‑HBV is a trademark owned by or licensed to the GSK group of companies.

EPIVIR is a trademark owned by or licensed to the ViiV Healthcare group of companies.

Distributed by:

GlaxoSmithKlineResearch Triangle Park, NC 27709

©2020 GSK group of companies or its licensor.

EPH:8PI

PHARMACIST‑DETACH HERE AND GIVE INSTRUCTIONS TO PATIENT

PATIENT INFORMATION

EPIVIR-HBV (EP-i-veer h-b-v)

(lamivudine)

tablets

EPIVIR-HBV (EP-i-veer h-b-v)

(lamivudine)

oral solution

What is the most important information I should know about EPIVIRHBV?

EPIVIR-HBV can cause serious side effects, including:

Worsening liver disease. Your hepatitis B infection may become worse after stopping treatment with EPIVIR-HBV. Worsening liver disease can be serious and may lead to death. If you stop treatment with EPIVIR-HBV, your healthcare provider will need to check your health and do blood tests to check your liver for at least several months after you stop taking EPIVIR-HBV.
Risk of HIV-1 resistance in people with unknown HIV-1 infection or in people with untreated HIV-1 infection. If you have or get HIV-1 (Human Immunodeficiency Virus type 1) that is not being treated with medicines while taking EPIVIR-HBV, the HIV-1 virus may develop resistance to certain HIV-1 medicines and become harder to treat.
Your healthcare provider should offer you counseling and testing for HIV-1 infection before you start treatment for hepatitis B with EPIVIR-HBV and during treatment.
EPIVIR-HBV tablets and EPIVIR‑HBV oral solution contain a lower dose of lamivudine than other medicines that contain lamivudine and are used to treat HIV-1 infection.
Resistant Hepatitis B Virus (HBV). The hepatitis B virus can change (mutate) during your treatment with EPIVIR-HBV and become harder to treat (resistant). If this happens, your liver disease can become worse and may lead to death. Tell your healthcare provider right away if you have any new symptoms.

What is EPIVIR-HBV?

EPIVIR‑HBV is a prescription medicine used to treat long-term (chronic) hepatitis B virus (HBV) when the disease is progressing and there is liver swelling (inflammation).

It is not known if EPIVIR-HBV is safe and effective in:

people with chronic HBV who have a severely damaged liver that is unable to work properly (decompensated liver disease)
people with HIV-1, hepatitis C virus, or hepatitis D (delta) virus
people who have had a liver transplant
children with chronic HBV less than 2 years of age

EPIVIR-HBV does not stop you from spreading HBV to others by sex, sharing needles, or being exposed to your blood. Avoid doing things that can spread HBV infection to others.

Do not take EPIVIR-HBV:

if you are allergic to lamivudine or any of the ingredients in EPIVIR-HBV. See the end of this Patient Information leaflet for a complete list of ingredients in EPIVIR-HBV.

What should I tell my healthcare provider before taking EPIVIR-HBV?

Before taking EPIVIR-HBV, tell your healthcare provider about all of your medical conditions, including if you:

have HIV-1 infection
have kidney problems
have diabetes. Each 20-mL dose (100 mg) of EPIVIR-HBV oral solution contains 4 grams of sucrose.
are pregnant or plan to become pregnant. It is not known if EPIVIR-HBV will harm your unborn baby. Pregnancy Registry. There is a pregnancy registry for women who take antiviral medicines during pregnancy. The purpose of this registry is to collect information about the health of you and your baby. Talk to your healthcare provider about how you can take part in this registry.
are breastfeeding or plan to breastfeed. EPIVIR-HBV can pass into your breast milk and may harm your baby. You and your healthcare provider should decide if you will take EPIVIR-HBV or breastfeed.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Some medicines interact with EPIVIR-HBV. Keep a list of your medicines to show your healthcare provider and pharmacist.

You can ask your healthcare provider or pharmacist for a list of medicines that interact with EPIVIR-HBV.
Do not start taking a new medicine without telling your healthcare provider. Your healthcare provider can tell you if it is safe to take EPIVIR-HBV with other medicines.

EPIVIR-HBV should not be taken if you also take other medicines that contain lamivudine or emtricitabine.

How should I take EPIVIR-HBV?

Take EPIVIR-HBV exactly as your healthcare provider tells you to take it.
If you miss a dose of EPIVIR-HBV, take it as soon as you remember. Do not take 2 doses at the same time or take more than what your healthcare provider tells you to take.
Stay under the care of a healthcare provider during treatment with EPIVIR-HBV.
EPIVIR-HBV may be taken with or without food.
Your healthcare provider may prescribe a lower dose if you have problems with your kidneys.
For children 2 to 17 years of age, your healthcare provider will prescribe a dose of EPIVIR-HBV based on your child’s body weight.
Tell your healthcare provider if you or your child has trouble swallowing tablets. EPIVIR-HBV also comes as a liquid (oral solution).
If you take too much EPIVIR-HBV, call your healthcare provider or go to the nearest hospital emergency room right away.

What are the possible side effects of EPIVIRHBV?

EPIVIR-HBV may cause serious side effects, including:

See “What is the most important information I should know about EPIVIR-HBV?”
Build-up of lactic acid in your blood (lactic acidosis). Lactic acidosis can happen in some people who take EPIVIR-HBV. Lactic acidosis is a serious medical emergency that can lead to death. Call your healthcare provider right away if you get any of the following symptoms that could be signs of lactic acidosis:
feel very weak or tired
unusual (not normal) muscle pain
trouble breathing
stomach pain with nausea and vomiting
feel cold, especially in your arms and legs
feel dizzy or light-headed
have a fast or irregular heartbeat
Severe liver problems. Severe liver problems can happen in people who take EPIVIR-HBV or similar medicines. In some cases these liver problems can lead to death. Your liver may become large (hepatomegaly) and you may develop fat in your liver (steatosis) when you take EPIVIR-HBV. Call your healthcare provider right away if you get any of the following signs or symptoms of liver problems:
your skin or the white part of your eyes turns yellow (jaundice)
dark or “tea-colored” urine
light-colored stools (bowel movements)
loss of appetite for several days or longer
nausea
pain, aching, or tenderness on the right side of your stomach area

You may be more likely to get lactic acidosis or severe liver problems if you are female or very overweight (obese).

The most common side effects of EPIVIR-HBV include ear, nose, and throat infections; sore throat; and diarrhea.

Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of EPIVIR-HBV. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store EPIVIR-HBV?

Store EPIVIR‑HBV tablets and oral solution at room temperature between 68°F to 77°F (20°C to 25°C).
Keep bottles of EPIVIR-HBV oral solution tightly closed.

Keep EPIVIR-HBV and all medicines out of the reach of children.

General information about the safe and effective use of EPIVIRHBV

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use EPIVIR-HBV for a condition for which it was not prescribed. Do not give EPIVIR-HBV to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about EPIVIR-HBV that is written for health professionals.

For more information call 1-888-825-5249.

What are the ingredients in EPIVIRHBV?

Active ingredient: lamivudine

Inactive ingredients:

EPIVIR-HBV tablets: hypromellose, macrogol 400, magnesium stearate, microcrystalline cellulose, polysorbate 80, red iron oxide, sodium starch glycolate, titanium dioxide, and yellow iron oxide.

EPIVIR-HBV oral solution: artificial strawberry and banana flavors, citric acid (anhydrous), methylparaben, propylene glycol, propylparaben, sodium citrate (dihydrate), and sucrose (200 mg per mL).

Distributed by:

GlaxoSmithKline, Research Triangle Park, NC 27709

EPIVIR-HBV is a trademark owned by or licensed to the GSK group of companies. ©2020 GSK group of companies or its licensor.

EPH:8PIL

This Patient Information has been approved by the U.S. Food and Drug Administration. Revised: 08/2020

PRINCIPAL DISPLAY PANEL

NDC 0173-0662-00

Epivir-HBV

(lamivudine)

Tablets

100 mg

60 Tablets

Each tablet contains 100 mg of lamivudine.

Rx only

See prescribing information for dosage information.

Store at 25o C (77o F); excursions permitted to 15o to 30o C (59o to 86o F) [see USP Controlled Room Temperature].

Do not use if printed safety seal under cap is broken or missing.

Distributed by:

GlaxoSmithKline

Research Triangle Park, NC 27709\

Made in Canada

Trademarks are owned by or licensed to the GSK group of companies.

©2020 GSK or licensor.

62000000058305 Rev. 12/20
Epivir HBV 100 mg tablet 60 count label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL

NDC 0173-0663-00

Epivir-HBV

(lamivudine)

Oral Solution

5 mg/mL

Each mL contains 5 mg of lamivudine.

Rx only

240 mL

Made in Canada

©2020 GSK group of companies or its licensor.

62000000052473 Rev. 9/20
Epivir HBV Oral Solution carton
(click image for full-size original)
EPIVIR HBV lamivudine tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0173-0662
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LAMIVUDINE (LAMIVUDINE) LAMIVUDINE 100 mg
Inactive Ingredients
Ingredient Name Strength
HYPROMELLOSE, UNSPECIFIED
POLYETHYLENE GLYCOL, UNSPECIFIED
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
POLYSORBATE 80
FERRIC OXIDE RED
SODIUM STARCH GLYCOLATE TYPE A POTATO
TITANIUM DIOXIDE
FERRIC OXIDE YELLOW
Product Characteristics
Color YELLOW (butterscotch-colored) Score no score
Shape OVAL (capsule-shaped) Size 11mm
Flavor Imprint Code GX;CG5
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0173-0662-00 60 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021003 12/17/1998
EPIVIR HBV lamivudine solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0173-0663
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LAMIVUDINE (LAMIVUDINE) LAMIVUDINE 5 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS CITRIC ACID
METHYLPARABEN
PROPYLENE GLYCOL
PROPYLPARABEN
TRISODIUM CITRATE DIHYDRATE
SUCROSE
Product Characteristics
Color YELLOW (colorless to yellow) Score
Shape Size
Flavor STRAWBERRY (strawberry-banana) Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0173-0663-00 240 mL in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021004 12/23/1998
Labeler — GlaxoSmithKline LLC (167380711)

Revised: 08/2020 GlaxoSmithKline LLC

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