Lamivudine

LAMIVUDINE — lamivudine tablet
Ingenus Pharmaceuticals, LLC

WARNING: LACTIC ACIDOSIS AND SEVERE HEPATOMEGALY, EXACERBATIONS OF HEPATITIS B, and DIFFERENT FORMULATIONS OF LAMIVUDINE.

Lactic Acidosis and Severe Hepatomegaly with Steatosis

Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogues and other antiretrovirals.Discontinue LAMIVUDINE if clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity occurs[see Warnings and Precautions (5.1)].

Exacerbations of Hepatitis B

Severe acute exacerbations of hepatitis B have been reported in patients who are co-infected with hepatitis B virus (HBV) and human immunodeficiency virus (HIV-1) and have discontinued LAMIVUDINE. Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in patients who discontinue LAMIVUDINE and are co-infected with HIV-1 and HBV. If appropriate, initiation of anti-hepatitis B therapy may be warranted [see Warnings and Precautions (5.2)].

Important Differences among Lamivudine-containing Products

LAMIVUDINE tablets (used to treat HIV-1 infection) contain a higher dose of the active ingredient (lamivudine) than LAMIVUDINE–HBV tablets (used to treat chronic HBV infection). Patients with HIV-1 infection should receive only dosage forms appropriate for treatment of HIV-1 [see Warnings and Precautions (5.2)].

1 INDICATIONS AND USAGE

LAMIVUDINE is a nucleoside analogue indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus type 1 (HIV-1) infection.

Limitations of Use:

  • The dosage of this product is for HIV-1 and not for HBV.

2 DOSAGE AND ADMINISTRATION

2.1 Recommended Dosage for Adult Patients

The recommended dosage of LAMIVUDINE in HIV-1-infected adults is 300 mg daily, administered as either 150 mg taken orally twice daily or 300 mg taken orally once daily with or without food. If lamivudine is administered to a patient infected with HIV-1 and HBV, the dosage indicated for HIV-1 therapy should be used as part of an appropriate combination regimen [see Warnings and Precautions (5.2)].

2.2 Recommended Dosage for Pediatric Patients

The recommended dosage of EPIVIR oral solution in HIV-1-infected pediatric patients aged 3 months and older is 4 mg per kg taken orally twice daily (up to a maximum of 300 mg daily), administered in combination with other antiretroviral agents.

Once daily dosing in pediatric patients 3 months of age and older in combination with other antiretroviral agents for the treatment of HIV-1 infection.

LAMIVUDINE scored tablet is the preferred formulation for HIV-1-infected pediatric patients who weigh at least 14 kg and for whom a solid dosage form is appropriate. Before prescribing LAMIVUDINE scored tablets, pediatric patients should be assessed for the ability to swallow tablets. For patients unable to safely and reliably swallow LAMIVUDINE tablets, the oral solution formulation should be prescribed [see Warnings and Precautions (5.6)]. The recommended oral dosage of LAMIVUDINE tablets for HIV-l-infected pediatric patients is presented in Table 1.

Table 1. Dosing Recommendations for LAMIVUDINE Scored (150-mg) Tablets in Pediatric Patients
Weight (kg) Twice-daily Dosing Regimen Using Scored 150-mg Tablet
AM Dose PM Dose Total Daily Dose
14 to <20 ½ tablet (75 mg) ½ tablet (75 mg) 150 mg
≥20to <25 ½ tablet (75 mg) 1 tablet (150 mg) 225 mg
≥25 1 tablet (150 mg) 1 tablet (150 mg) 300 mg

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.

2.3 Patients with Renal Impairment

Dosing of LAMIVUDINE is adjusted in accordance with renal function. Dosage adjustments are listed in Table 2 [see Clinical Pharmacology (12.3)].

Table 2. Adjustment of Dosage of LAMIVUDINE in Adults and Adolescents (Greater than or Equal to 25 kg) in Accordance with Creatinine Clearance
Creatinine Clearance (mL/min) Recommended Dosage of
≥50 150 mg twice daily or 300 mg once daily
30-49 150 mg once daily
15-29 150 mg first dose, then 100 mg once daily
5-14 150 mg first dose, then 50 mg once daily
<5 50 mg first dose, then 25 mg once daily

No additional dosing of LAMIVUDINE is required after routine (4-hour) hemodialysis or peritoneal dialysis.

Although there are insufficient data to recommend a specific dose adjustment of LAMIVUDINE in pediatric patients with renal impairment, a reduction in the dose and/or an increase in the dosing interval should be considered.

3 DOSAGE FORMS AND STRENGTHS

  • LAMIVUDINE Scored Tablets

150 mg are white to off-white, film-coated, diamond- shaped tablets, debossed with “MCR” and “313” separated by functional score on one side and plain on other side with functional score.

  • LAMIVUDINE Tablets

300 mg are Grey, film-coated, modified diamond-shaped tablets, debossed with “MCR” and “314” on one side and plain on other side.

4 CONTRAINDICATIONS

LAMIVUDINE is contraindicated in patients with a previous hypersensitivity reaction to lamivudine.

5 WARNINGS AND PRECAUTIONS

5.1 Lactic Acidosis and Severe Hepatomegaly with Steatosis

Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogues and other antiretrovirals. A majority of these cases have been in women. Obesity and prolonged nucleoside exposure may be risk factors. Caution should be exercised when administering LAMIVUDINE to any patient with known risk factors for liver disease; however, cases also have been reported in patients with no known risk factors. Treatment with LAMIVUDINE should be suspended in any patient who develops clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity (which may include hepatomegaly and steatosis even in the absence of marked transaminase elevations).

5.2 Patients with and Hepatitis B Virus Co-infection

Posttreatment Exacerbations of Hepatitis

Clinical and laboratory evidence of exacerbations of hepatitis have occurred after discontinuation of lamivudine. These exacerbations have been detected primarily by serum ALT elevations in addition to re-emergence of HBV DNA. Although most events appear to have been self-limited, fatalities have been reported in some cases. Similar events have been reported from postmarketing experience after changes from lamivudine-containing HIV-1 treatment regimens to non-lamivudine-containing regimens in patients infected with both HIV-1 and HBV. The causal relationship to discontinuation of lamivudine treatment is unknown. Patients should be closely monitored with both clinical and laboratory follow-up for at least several months after stopping treatment.

Important Differences among Lamivudine-containing Products

LAMIVUDINE tablets contain a higher dose of the same active ingredient (lamivudine) than LAMIVUDINE-HBV tablets. LAMIVUDINE-HBV was developed for patients with chronic hepatitis B. The formulation and dosage of lamivudine in LAMIVUDINE-HBV are not appropriate for patients co-infected with HIV-1 and HBV. Safety and efficacy of lamivudine have not been established for treatment of chronic hepatitis B in patients co-infected with HIV-1 and HBV. If treatment with LAMIVUDINE-HBV is prescribed for chronic hepatitis B for a patient with unrecognized or untreated HIV-1 infection, rapid emergence of HIV-1 resistance is likely to result because of the subtherapeutic dose and the inappropriateness of monotherapy HIV-1 treatment. If a decision is made to administer lamivudine to patients co-infected with HIV-1 and HBV, LAMIVUDINE tablets, or another product containing the higher dose of lamivudine should be used as part of an appropriate combination regimen.

Emergence of Lamivudine-resistant HBV

Safety and efficacy of lamivudine have not been established for treatment of chronic hepatitis B in subjects dually infected with HIV-1 and HBV (see full prescribing information for LAMIVUDINE-HBV). Emergence of hepatitis B virus variants associated with resistance to lamivudine has also been reported in HIV-1-infected subjects who have received lamivudine-containing antiretroviral regimens in the presence of concurrent infection with hepatitis B virus.

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