Lamivudine (Page 6 of 7)

14.2 Pediatric Subjects

Clinical Endpoint Trial

ACTG300 was a multicenter, randomized, double-blind trial that provided for comparison of lamivudine plus zidovudine with didanosine monotherapy. A total of 471 symptomatic, HIV-1-infected therapy-naive (less than or equal to 56 days of antiretroviral therapy) pediatric subjects were enrolled in these 2 treatment arms. The median age was 2.7 years (range: 6 weeks to 14 years), 58% were female, and 86% were non-white. The mean baseline CD4+ cell count was 868 cells per mm3 (mean: 1,060 cells per mm3 and range: 0 to 4,650 cells per mm3 for subjects aged less than or equal to 5 years; mean: 419 cells per mm3 and range: 0 to 1,555 cells per mm3 for subjects aged over 5 years) and the mean baseline plasma HIV-1 RNA was 5.0 log10 copies per mL. The median duration on trial was 10.1 months for the subjects receiving lamivudine plus zidovudine and 9.2 months for subjects receiving didanosine monotherapy. Results are summarized in Table 11.

Table 11. Number of Subjects (%) Reaching a Primary Clinical Endpoint (Disease Progression or Death)
Endpoint Lamivudine plus Zidovudine (n = 236) Didanosine (n = 235)
HIV-1 disease progression or death (total) 15 (6.4%) 37 (15.7%)

Physical growth failure

7 (3.0%) 6 (2.6%)

Central nervous system deterioration

4 (1.7%) 12 (5.1%)

CDC Clinical Category C

2 (0.8%) 8 (3.4%)

Death

2 (0.8%) 11 (4.7%)

Additional pediatric use information for patients aged 3 months and above is approved for ViiV Healthcare Company’s EPIVIR® (lamivudine) tablets and oral solution. However, due to ViiV Healthcare Company’s marketing exclusivity rights, this drug product is not labeled with that pediatric information.

16 HOW SUPPLIED/STORAGE AND HANDLING

Lamivudine Oral Solution, USP, 10 mg per mL

A clear, colorless strawberry flavored liquid, contains 10 mg of lamivudine in each 1 mL.

Plastic bottle of 240 mL (NDC 54838-566-70) with child-resistant closure. This product does not require reconstitution.

Recommended Storage:

Store in tightly closed bottles at 25°C (77°F) [see USP Controlled Room Temperature].

17 PATIENT COUNSELING INFORMATION

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

Patients with Hepatitis B or C Co-infection

Inform patients co-infected with HIV-1 and HBV that deterioration of liver disease has occurred in some cases when treatment with lamivudine was discontinued. Advise patients to discuss any changes in regimen with their healthcare provider [see Warnings and Precautions (5.1)].

Inform patients with HIV-1/HCV co-infection that hepatic decompensation (some fatal) has occurred in HIV-1/HCV co-infected patients receiving combination antiretroviral therapy for HIV-1 and interferon alfa with or without ribavirin [see Warnings and Precautions (5.3)].

Differences in Formulations of Lamivudine

Advise patients that lamivudine oral solution contains a higher dose of the same active ingredient (lamivudine) as EPIVIR-HBV oral solution. If a decision is made to include lamivudine in the HIV-1 treatment regimen of a patient co-infected with HIV-1 and HBV, the formulation and dosage of lamivudine in lamivudine oral solution (not EPIVIR-HBV) should be used [see Warnings and Precautions (5.1)].

Lactic Acidosis/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 if they develop clinical symptoms suggestive of lactic acidosis or pronounced hepatotoxicity [see Warnings and Precautions (5.2)].

Risk of Pancreatitis

Advise parents or guardians to monitor pediatric patients for signs and symptoms of pancreatitis [see Warnings and Precautions (5.4)].

Immune Reconstitution Syndrome

Advise patients to inform their healthcare provider immediately of any signs and symptoms of infection as inflammation from previous infection may occur soon after combination antiretroviral therapy, including when lamivudine is started [see Warnings and Precautions (5.5)].

Lower Virologic Suppression Rates and Increased Risk of Viral Resistance with Oral Solution

Additional pediatric use information for patients aged 3 months and above is approved for ViiV Healthcare Company’s EPIVIR® (lamivudine) tablets and oral solution. However, due to ViiV Healthcare Company’s marketing exclusivity rights, this drug product is not labeled with that pediatric information.

Sucrose Content of Lamivudine Oral Solution

Advise diabetic patients that each 15-mL dose of lamivudine oral solution contains 3 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 lamivudine during pregnancy [see Use in Specific Populations (8.1)].

Lactation

Instruct women with HIV-1 infection not to breastfeed because HIV-1 can be passed to the baby in the breast milk [see Use in Specific Populations (8.2)].

Missed Dosage

Instruct patients that if they miss a dose of lamivudine, 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 and RETROVIR are registered trademarks of the ViiV Healthcare group of companies.

EPIVIR-HBV is a registered trademark of the GSK group of companies.

The other brands listed are trademarks of their respective owners and are not trademarks of the Lannett group of companies. The makers of these brands are not affiliated with and do not endorse the Lannett group of companies or its products.

Distributed by:

Lannett Company, Inc.

Philadelphia, PA 19136

10-1111

Rev. 01/2021

PHARMACIST-DETACH HERE AND GIVE INSTRUCTIONS TO PATIENT

PATIENT INFORMATION

Lamivudine ( la miv’ ue deen) Oral Solution, USP

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

Lamivudine can cause serious side effects, including:

  • Worsening of hepatitis B virus in people who have HIV-1 infection. If you have HIV-1 (Human Immunodeficiency Virus type 1) and hepatitis B virus (HBV) infection, your HBV may get worse (flare-up) if you stop taking lamivudine. A “flare-up” is when your HBV infection suddenly returns in a worse way than before. Worsening liver disease can be serious and may lead to death.

  • Do not run out of lamivudine. Refill your prescription or talk to your healthcare provider before your lamivudine is all gone.
  • Do not stop lamivudine without first talking to your healthcare provider.
  • If you stop taking lamivudine, your healthcare provider will need to check your health often and do blood tests regularly for several months to check your liver.
  • Resistant Hepatitis B Virus (HBV). If you have HIV-1 and hepatitis B, the hepatitis B virus can change (mutate) during your treatment with lamivudine and become harder to treat (resistant).

  • Use with interferon and ribavirin-based regimens. Worsening of liver disease that has caused death has happened in people infected with both HIV-1 and hepatitis C virus who are taking antiretroviral medicines and are also being treated for hepatitis C with interferon with or without ribavirin. If you are taking lamivudine and interferon with or without ribavirin, tell your healthcare provider if you have any new symptoms.

What is lamivudine?

Lamivudine is a prescription medicine used together with other antiretroviral medicines to treat Human Immunodeficiency Virus (HIV-1) infection.

HIV-1 is the virus that causes Acquired Immune Deficiency Syndrome (AIDS).

Lamivudine oral solution (used to treat HIV-1 infection) contains a higher dose of the same active ingredient (lamivudine) than is in the medicine EPIVIR-HBV oral solution (used to treat HBV). If you have both HIV-1 and HBV, you should not use EPIVIR-HBV to treat your infections.

The safety and effectiveness of lamivudine have not been established in children under 3 months of age.

Who should not take lamivudine?

Do not take lamivudine if you are allergic to lamivudine or any of the ingredients in lamivudine. See the end of this Patient Information leaflet for a complete list of ingredients in Lamivudine Oral Solution.

What should I tell my healthcare provider before taking lamivudine?

Before you take lamivudine, tell your healthcare provider if you:

  • have or have had liver problems, including hepatitis B or C virus infection.
  • have kidney problems.
  • have diabetes. Each 15-mL dose (150 mg) of lamivudine oral solution contains 3 grams of sucrose.
  • are pregnant or plan to become pregnant. Taking lamivudine during pregnancy has not been associated with an increased risk of birth defects. Talk to your healthcare provider if you are pregnant or plan to become pregnant.

Pregnancy Registry. There is a pregnancy registry for women who take antiretroviral 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. Do not breastfeed if you take lamivudine.
    • You should not breastfeed if you have HIV-1 because of the risk of passing HIV-1 to your baby.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Some medications interact with lamivudine. Keep a list of your medicines and show it to your healthcare provider and pharmacist when you get a new medicine. You can ask your healthcare provider or pharmacist for a list of medicines that interact with lamivudine.

Do not start taking a new medicine without telling your healthcare provider. Your healthcare provider can tell you if it is safe to take lamivudine with other medicines.

How should I take lamivudine?

  • Take lamivudine exactly as your healthcare provider tells you to take it.

  • If you miss a dose of lamivudine, 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 lamivudine.

  • Lamivudine may be taken with or without food.

  • For children 3 months and older, your healthcare provider will prescribe a dose of lamivudine based on your child’s body weight.

  • Do not run out of lamivudine. The virus in your blood may increase and the virus may become harder to treat. When your supply starts to run low, get more from your healthcare provider or pharmacy.

  • If you take too much lamivudine, call your healthcare provider or go to the nearest hospital emergency room right away.

What are the possible side effects of lamivudine?

  • Lamivudine can cause serious side effects including:
  • See “What is the most important information I should know about lamivudine?”
  • Build-up of an acid in your blood (lactic acidosis). Lactic acidosis can happen in some people who take lamivudine. Lactic acidosis is a serious medical emergency that can cause 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
  • Serious liver problems can happen in people who take lamivudine. In some cases these serious liver problems can lead to death. Your liver may become large (hepatomegaly) and you may develop fat in your liver (steatosis). 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 serious liver problems if you are female or very overweight (obese).

  • Risk of inflammation of the pancreas (pancreatitis). Children may be at risk for developing pancreatitis during treatment with lamivudine if they:
    • have taken nucleoside analogue medicines in the past
    • have a history of pancreatitis
    • have other risk factors for pancreatitis

Call your healthcare provider right away if your child develops signs and symptoms of pancreatitis including severe upper stomach-area pain, with or without nausea and vomiting. Your healthcare provider may tell you to stop giving lamivudine to your child if their symptoms and blood test results show that your child may have pancreatitis.

  • Changes in your immune system (Immune Reconstitution Syndrome) can happen when you start taking HIV-1 medicines. Your immune system may get stronger and begin to fight infections that have been hidden in your body for a long time. Tell your healthcare provider right away if you start having new symptoms after you start taking lamivudine.

The most common side effects of lamivudine in adults include:

  • headache
  • nausea
  • generally not feeling well
  • tiredness
  • nasal signs and symptoms
  • diarrhea
  • cough

The most common side effects of lamivudine in children include fever and cough.

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 lamivudine. 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 lamivudine?

  • Store lamivudine oral solution at room temperature between 68°F to 77°F (20°C to 25°C).
  • Keep bottles of lamivudine oral solution tightly closed.

Keep lamivudine and all medicines out of the reach of children.

General information about the safe and effective use of lamivudine.

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use lamivudine for a condition for which it was not prescribed. Do not give lamivudine to other people, even if they have the same symptoms that you have. It may harm them.

You can ask your healthcare provider or pharmacist for information about lamivudine that is written for health professionals.

What are the ingredients in lamivudine?

Active ingredient: lamivudine

Inactive ingredients: alcohol (5% v/v), edetate disodium, artificial strawberry flavor, citric acid (anhydrous), methylparaben, propylene glycol, propylparaben, sodium citrate (dihydrate), sucrose (200 mg per mL) and purified water.

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

The other brands listed are trademarks of their respective owners and are not trademarks of the Lannett group of companies. The makers of these brands are not affiliated with and do not endorse the Lannett group of companies or its products.

Distributed by:

Lannett Company, Inc.

Philadelphia, PA 19136

10-1189

Rev. 01/2021

This Patient Information has been approved by the U.S. Food and Drug Administration.

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