Lamivudine (Page 5 of 6)

14.2 Pediatric Subjects

Clinical Endpoint Trial

ACTG300 was a multicenter, randomized, double-blind trial that provided for comparison of lamivudine plus RETROVIR (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 tablets plus RETROVIR 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 RETROVIR ( n = 236 ) Didanosine ( n = 235 )
HIV-1 disease progression or death (total)Physical growth failureCentral nervous deteriorationCDC Clinical Category CDeath15 (6.4%)7 (3.0%)4 (1.7%)2 (0.8%)2 (0.8%)37 (15.7%)6 (2.6%)12 (5.1%)8 (3.4%)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.Once-daily Dosing

16 HOW SUPPLIED/STORAGE AND HANDLING

Lamivudine Tablets USP contain 150 mg of Lamivudine, are white, diamond-shaped, scored film-coated tablets, debossed one side with “001” on either side of scoreline. Packaged as follows:

Bottle of 60 tablets (NDC 64330-001-01) with child-resistant closure.

Recommended Storage:

Store Lamivudine Tablets USP at 20° to 25°C (68° to 77°F) excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

17 PATIENT COUNSELING INFORMATION

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

Lactic Acidosis/Hepatomegaly

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 lamivudine tablets if they develop clinical symptoms suggestive of lactic acidosis or pronounced hepatotoxicity [see Warnings and Precautions (5.1)].

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 (5.2)].

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 tablets contain a higher dose of the same active ingredient (lamivudine) as EPIVIR -HBV tablets. 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 tablet (not EPIVIR -HBV) should be used [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)].

Redistribution/Accumulation of Body Fat

Inform patients that redistribution or accumulation of body fat may occur in patients receiving antiretroviral therapy and that the cause and long-term health effects of these conditions are not known at this time [see Warnings and Precautions (5.7)].

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 trademark licensed to the GSK group of companies.

Manufactured By

Centaur Pharmaceuticals Private Limited

Plot No. 4, International Biotech Park, Phase II,

Hinjewadi, Pune-411 057,

INDIA

Manufactured For

Centaur Pharmaceuticals Private Limited.

‘Centaur House’, Near Grand Hyatt,

Shanti Nagar, Vakola, Santacruz (East)

Mumbai, Maharashtra, 400055, INDIA

Revised: 11/2016

—————————————————————————————— PHARMACIST-DETACH HERE AND GIVE INSTRUCTIONS TO PATIENT

PATIENT INFORMATION

Lamivudine (la-miv’-ue-deen) Tablets USP

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

Lamivudine can cause serious side effects, including:

  • Build-up of an acid in your blood (lactic acidosis). Lactic acidosis can happen in some people who take lamivudine tablets. 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 • feel cold, especially in your arms and legs

• unusual (not normal) muscle pain • feel dizzy or light-headed

• trouble breathing • have a fast or irregular heartbeat

• stomach pain with nausea and vomiting

  • Serious liver problems can happen in people who take lamivudine tablets. 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 • loss of appetite for several days or

yellow (jaundice) longer

• dark or “tea-colored” urine • nausea

• light-colored stools (bowel movements) • 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, very overweight (obese), or have been taking nucleoside analog medicines for a long time.

  • 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 tablets. 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 tablets. Refill your prescription or talk to your healthcare provider before your lamivudine tablets are all gone.
  • Do not stop lamivudine tablets without first talking to your healthcare provider.
  • If you stop taking lamivudine tablets, 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 tablets 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 tablets 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 tablets (used to treat HIV-1 infection) contain a higher dose of the same active ingredient (lamivudine) than is in the medicine lamivudine-HBV tablets (used to treat HBV). If you have both HIV-1 and HBV, you should not use lamivudine-HBV to treat your infections.

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

Who should not take lamivudine tablets?

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

What should I tell my healthcare provider before taking lamivudine tablets?

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

  • have or have had liver problems, including hepatitis B or C virus infection.
  • have kidney problems.
  • have diabetes
  • are pregnant or plan to become pregnant. Taking lamivudine tablets 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 tablets.
  • You should not breastfeed if you have HIV-1 because of the risk of passing HIV-1 to your baby.
  • Talk with your healthcare provider about the best way to feed 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 s tart taking a new medicine without telling your healthcare provider. Your healthcare provider can tell you if it is safe to take lamivudine tablets with other medicines.

How should I take lamivudine tablets?

  • Take lamivudine tablets exactly as your healthcare provider tells you to take it.
  • If you miss a dose of lamivudine tablets, 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 tablets.
  • Lamivudine tablets may be taken with or without food.
  • For children 3 months and older, your healthcare provider will prescribe a dose of lamivudine tablets based on your child’s body weight.
  • Tell your healthcare provider if you or your child has trouble swallowing tablets. Lamivudine also comes as a liquid (oral solution).
  • Do not run out of lamivudine tablets. 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 tablets, call your healthcare provider or go to the nearest hospital emergency room right away.

What are the possible s ide effects of lamivudine tablets ?

  • Lamivudine tablets can cause serious s ide effects including:
  • See “What is the most important information I should know about lamivudine tablets ?”
  • Ris k of inflammation of the pancreas (pancreatitis). Children may be at risk for developing pancreatitis during treatment with lamivudine tablets if they:

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 tablets 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 tablets.
  • Changes in body fat can happen in people who take HIV-1 medicines. These changes may include an increased amount of fat in the upper back and neck (“buffalo hump”), breast, and around the middle of your body (trunk). Loss of fat from the legs, arms, and face may also happen. The exact cause and long-term health effects of these conditions are not known.

T he most common side effects of lamivudine tablets in adults include:

• Headache • nasal signs and symptoms

• Nausea • diarrhea

• generally not feeling well • cough

• tiredness

The most common side effects of lamivudine tablets 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 tablets. Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store lamivudine tablets?

  • Store lamivudine tablets at room temperature between 68°F to 77°F (20°C to 25°C).

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

General information about the safe and effective use of lamivudine tablets.

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use lamivudine tablets for a condition for which it was not prescribed. Do not give lamivudine tablets 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 tablets that is written for health professionals.

What are the ingredients in lamivudine tablets?

Active ingredient: lamivudine

Inactive ingredients:

Lamivudine scored 150-mg film-coated tablets: hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, sodium starch glycolate, and titanium dioxide.

Manufactured By:

Centaur Pharmaceuticals Private Limited

Plot No. 4, International Biotech Park, Phase II,

Hinjewadi, Pune-411 057,

INDIA

Manufactured For:

Centaur Pharmaceuticals Private Limited.

‘Centaur House’, Near Grand Hyatt,

Shanti Nagar, Vakola, Santacruz (East)

Mumbai, Maharashtra, 400055,India

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

Revised: 11/2016

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