Lamivudine

LAMIVUDINE- lamivudine tablet, film coated
KAISER FOUNDATION HOSPITALS

BOXED WARNING

WA RN ING: RISK OF LACTIC ACIDOSIS, EXACERBATIONS OF HEPATITIS B UPON DISCONTINUATION OF LAMIVUDINE TABLETS (HBV), AND RISK OF HIV-1 RESISTANCE IF LAMIVUDINE TABLETS (HBV) IS USED IN PATIENTS WITH UNRECOGNIZED OR UNTREATED HIV-1

L actic Acidosis and Severe Hepatomegaly

Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogues alone or in combination, including lamivudine tablets (HBV). Suspend treatment if clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity occur [see Warnings and Precautions ( 5.1)] .

Exacerbations ofHepatitis B UponDiscontinuationof Lamivudine Tablets (HBV)

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

R isk of HIV-1 Resistance if Lamivudine Tablets (HBV) Is Used in Patients With Unrecognized or Unt reated HIV-1 Infection

Lamivudine tablets (HBV) are not approved for the treatment of HIV-1 infection because the lamivudine dosage in lamivudine tablets (HBV) is subtherapeutic and monotherapy is inappropriate for the treatment of HIV-1 infection. HIV-1 resistance may emerge in chronic hepatitis B-infected patients with unrecognized or untreated HIV-1 infection. Counseling and testing should be offered to all patients before beginning treatment with lamivudine tablets (HBV) and periodically during treatment [see Warnings and Precautions ( 5.3)].

1 INDICATIONS & USAGE

Lamivudine tablets (HBV) are indicated for the treatment of chronic hepatitis B virus (HBV) infection associated with evidence of hepatitis B viral replication and active liver inflammation [see Clinical Studies ( 14.1, 14.2)] .

The following points should be considered when initiating therapy with lamivudine tablets (HBV):

  • Due to high rates of resistance development in treated patients, initiation of treatment with lamivudine tablets (HBV) should only be considered when the use of an alternative antiviral agent with a higher genetic barrier to resistance is not available or appropriate.
  • Lamivudine tablets (HBV) have not been evaluated in patients co-infected with HIV, hepatitis C virus (HCV), or hepatitis delta virus.
  • Lamivudine tablets (HBV) have not been evaluated in liver transplant recipients or in patients with chronic hepatitis B virus infection with decompensated liver disease.
  • Lamivudine tablets (HBV) have not been evaluated in pediatric patients younger than 2 years of age with chronic HBV infection.

2 DOSAGE & ADMINISTRATION

2.1 HIV Counseling and Testing

HIV counseling and testing should be offered to all patients before beginning treatment with lamivudine tablets (HBV) and periodically during treatment because of the risk of emergence of resistant-HIV-1 and limitation of treatment options if lamivudine tablets (HBV) is prescribed to treat chronic hepatitis B infection in a patient who has unrecognized HIV-1 infection or acquires HIV-1 infection during treatment [see Warnings and Precautions ( 5.3)] .

2.2 Dosage in Adult Patients

The recommended oral dosage of lamivudine tablets (HBV) is 100 mg once daily.

2.3 Dosage in Pediatric Patients

The recommended oral dosage of lamivudine tablets (HBV) for pediatric patients aged 2 to 17 years is 3 mg per kg once daily up to a maximum daily dosage of 100 mg. The oral solution formulation should be prescribed for patients requiring a dosage less than 100 mg or if unable to swallow tablets.

2.4 Dosage Adjustment in Adult Patients With Renal Impairment

Dosage recommendations for adult patients with reduced renal function are provided in Table 1 [see Clinical Pharmacology ( 12.3)] .

Table 1. Dosage of Lamivudine Tablets (HBV) in Adult Patients With Renal Impairment

Cre atinine Clearance ( m L/min) Rec o mme nded Dosage of Lamivudine Tablets (HBV)
≥50 100 mg once daily
30-49 100 mg first dose, then 50 mg once daily
15-29 100 mg first dose, then 25 mg once daily
5-14 35 mg first dose, then 15 mg once daily
<5 35 mg first dose, then 10 mg once daily

Following correction of the dosage for renal impairment, no additional dosage modification of lamivudine tablets (HBV) is required after routine (4-hour) hemodialysis or peritoneal dialysis [see Clinical Pharmacology ( 12.3)] .

There are insufficient data to recommend a specific dosage of lamivudine tablets (HBV) in pediatric patients with renal impairment.

2.5 Important Administration Instructions

  • Lamivudine tablets (HBV) may be administered with or without food.
  • The tablets may be used interchangeably [see Clinical Pharmacology ( 12.3)] .
  • The oral solution should be used for doses less than 100 mg.
  • Lamivudine tablets (HBV) should not be used with other medications that contain lamivudine or medications that contain emtricitabine [see Warnings and Precautions ( 5.4)].

2.6 Assessing Patients During Treatment

Patients should be monitored regularly during treatment by a physician experienced in the management of chronic hepatitis B. During treatment, combinations of such events such as return of persistently elevated ALT, increasing levels of HBV DNA over time after an initial decline below assay limit, progression of clinical signs or symptoms of hepatic disease, and/or worsening of hepatic necroinflammatory findings may be considered as potentially reflecting loss of therapeutic response. Such observations should be taken into consideration when determining the advisability of continuing therapy with lamivudine tablets (HBV).
The optimal duration of treatment, the durability of HBeAg seroconversions occurring during treatment, and the relationship between treatment response and long-term outcomes such as hepatocellular carcinoma or decompensated cirrhosis are not known.

3 DOSAGE FORMS & STRENGTHS

  • Lamivudine tablets (HBV): 100 mg are pink colored, capsule shaped, biconvex, film coated tablets, debossed with ‘37’ on one side and ‘I’ on the other side.

4 CONTRAINDICATIONS

Lamivudine tablets (HBV) are contraindicated in patients who have experienced a previous hypersensitivity reaction (e.g., anaphylaxis) to lamivudine or to any component of the tablets.

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