Lamivudine (Page 6 of 6)


1
An investigational non-nucleoside reverse transcriptase inhibitor not approved in the United States.Achieved confirmed plasma HIV-1 RNA less than 400 copies/mL and maintained through 48 weeks.Achieved suppression but rebounded by Week 48, discontinued due to virologic failure, insufficient viral response according to the investigator, or never suppressed through Week 48.Includes consent withdrawn, lost to follow-up, protocol violation, data outside the trial-defined schedule, and randomized but never initiated treatment.Roche AMPLICOR HIV-1 MONITOR.Responders at each visit are subjects who had achieved and maintained HIV-1 RNA less than 400 copies per mL without discontinuation by that visit.
2
An investigational non-nucleoside reverse transcriptase inhibitor not approved in the United States.Achieved confirmed plasma HIV-1 RNA less than 400 copies/mL and maintained through 48 weeks.Achieved suppression but rebounded by Week 48, discontinued due to virologic failure, insufficient viral response according to the investigator, or never suppressed through Week 48.Includes consent withdrawn, lost to follow-up, protocol violation, data outside the trial-defined schedule, and randomized but never initiated treatment.Roche AMPLICOR HIV-1 MONITOR.Responders at each visit are subjects who had achieved and maintained HIV-1 RNA less than 400 copies per mL without discontinuation by that visit.

14.2 Pediatric Subjects

Clinical Endpoint Trial: ACTG300 was a multi-center, 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 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) 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 Scored Tablets, 150 mg
White to off-white, film-coated tablets debossed with “MCR” and “313” separated by functional score on one side and plain on other side with functional score. Bottle of 60 tablets (NDC 50742-623-60) with child-resistant closure.

LAMIVUDINE Tablets, 300 mg
Gray, modified diamond-shaped, film-coated tablets engraved with “MCR” and “314” on one side and plain on the reverse side.
Bottle of 30 tablets (NDC 50742-624-30) with child-resistant

closure. Recommended Storage:

Store LAMIVUDINE Tablets at 25°C (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
Inform patients that some HIV medicines, including LAMIVUDINE, can cause a rare, but serious condition called lactic acidosis with liver enlargement (hepatomegaly)[see Warnings and Precautions (5.1)].

Patients with Hepatitis B or C Co-infection
Inform patients co-infected with HIV-1 and HBV should be informed 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 physician[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 and contain a higher dose of the same active ingredient (lamivudine) as LAMIVUDINE-HBV Tablets. If a decision is made to include lamivudine Tablets in the HIV-1 treatment regimen of a patient co-infected with HIV-1 and HBV, the formulation and dosage of lamivudine in LAMIVUDINE (not LAMIVUDINE-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
In some patients with advanced HIV infection, signs and symptoms of inflammation from previous infections may occur soon after anti-HIV treatment is started. It is believed that these symptoms are due to an improvement in the body’s immune response, enabling the body to fight infections that may have been present with no obvious symptoms. Advise patients to inform their healthcare provider immediately of any symptoms of infection [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, including LAMIVUDINE, 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)].

Manufactured For:
Ingenus Pharmaceuticals, LLC
Orlando, FL 32839-6408
Customer toll free number: 1-877-748-1970

Manufactured By
Appco Pharma LLC
Somerset, New Jersey-08873

Revised: 06/2017

MF#200143

PATIENT INFORMATION LAMIVUDINE tablets

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

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. 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
  • Severe 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)
    • loss of appetite for several days or 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 severe liver problems if you are female, very overweight (obese), or have been taking nucleoside analog medicines for a long time or have risks for liver problems.

  • Worsening of hepatitis B 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 HIV-1 medicine used with other antiretroviral medicines to treat HIV-1 infections in adults and children aged 3 months and older. 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 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.

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 to 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 the 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.
  • 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. 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?”
  • 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 pancreatitis
    • 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.
  • Changes in body fat can happen in people who take HIV-1 medicines. These changes may include 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.

The most common side effects of LAMIVUDINE in adults include:

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

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

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.

For more information, call Ingenus Pharmaceuticals, LLC at 1-877-748-1970.

What are the ingredients in LAMIVUDINE?

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.

LAMIVUDINE 300-mg film-coated tablets: back iron oxide, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, sodium starch glycolate, and titanium dioxide.

Manufactured For:
Ingenus Pharmaceuticals, LLC
Orlando, FL 32839-6408

Manufactured By: Appco Pharma LLC
Somerset, New Jersey-08873

Revised: 06/2017

150mg60ct
(click image for full-size original)
label
(click image for full-size original)

LAMIVUDINE lamivudine tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50742-623
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LAMIVUDINE (LAMIVUDINE) LAMIVUDINE 150 mg
Inactive Ingredients
Ingredient Name Strength
CELLULOSE, MICROCRYSTALLINE
HYPROMELLOSES
MAGNESIUM STEARATE
POLYETHYLENE GLYCOL, UNSPECIFIED
POLYSORBATE 80
SODIUM STARCH GLYCOLATE TYPE A POTATO
TITANIUM DIOXIDE
Product Characteristics
Color WHITE Score 2 pieces
Shape DIAMOND (DIAMOND) Size 14mm
Flavor Imprint Code MCR;313
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:50742-623-60 60 TABLET in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA206974 02/01/2017
LAMIVUDINE lamivudine tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50742-624
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LAMIVUDINE (LAMIVUDINE) LAMIVUDINE 300 mg
Inactive Ingredients
Ingredient Name Strength
CELLULOSE, MICROCRYSTALLINE
FERRIC OXIDE RED
HYPROMELLOSES
MAGNESIUM STEARATE
POLYETHYLENE GLYCOL, UNSPECIFIED
POLYSORBATE 80
SODIUM STARCH GLYCOLATE TYPE A POTATO
TITANIUM DIOXIDE
Product Characteristics
Color WHITE Score no score
Shape DIAMOND (DIAMOND) Size 17mm
Flavor Imprint Code MCR;314
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:50742-624-60 30 TABLET in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA206974 02/01/2017
Labeler — Ingenus Pharmaceuticals, LLC (833250017)
Registrant — Arise Pharmaceuticals LLC (079567118)
Establishment
Name Address ID/FEI Operations
Appco Pharma LLC 078510186 ANALYSIS (50742-623), ANALYSIS (50742-624), RELABEL (50742-623), RELABEL (50742-624), REPACK (50742-623), REPACK (50742-624), MANUFACTURE (50742-623), MANUFACTURE (50742-624), PACK (50742-623), PACK (50742-624)

Revised: 12/2018 Ingenus Pharmaceuticals, LLC

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