Lamivudine

LAMIVUDINE- lamivudine tablet, film coated
Mylan Pharmaceuticals Inc.

WARNING: EXACERBATIONS OF HEPATITIS B and RISK OF HIV-1 RESISTANCE IF LAMIVUDINE TABLETS ARE USED IN PATIENTS WITH UNRECOGNIZED OR UNTREATED HIV-1 INFECTION

Severe acute exacerbations of hepatitis B have been reported in patients who have discontinued anti-hepatitis B therapy (including lamivudine tablets). 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 (5.1)].

Lamivudine tablets are not approved for the treatment of HIV-1 infection because the lamivudine dosage in lamivudine tablets 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. HIV counseling and testing should be offered to all patients before beginning treatment with lamivudine tablets and periodically during treatment [see Warnings and Precautions (5.2)].

1 INDICATIONS AND USAGE

Lamivudine tablets 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:

Due to high rates of resistance development in treated patients, initiation of treatment with lamivudine tablets 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 have not been evaluated in patients co-infected with HIV, hepatitis C virus (HCV), or hepatitis delta virus.
Lamivudine tablets have not been evaluated in liver transplant recipients or in patients with chronic hepatitis B virus infection with decompensated liver disease.

2 DOSAGE AND ADMINISTRATION

2.1 HIV Counseling and Testing

HIV counseling and testing should be offered to all patients before beginning treatment with lamivudine tablets and periodically during treatment because of the risk of emergence of resistant-HIV-1 and limitation of treatment options if lamivudine tablets are 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 (5.2)].

2.2 Recommended Dosage for Adult Patients

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

2.3 Recommended Dosage for Pediatric Patients

The recommended oral dosage of lamivudine 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 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 in Adult Patients with Renal Impairment

Creatinine Clearance (mL/min)

Recommended Dosage of Lamivudine

≥ 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 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 in pediatric patients with renal impairment.

2.5 Important Administration Instructions

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

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 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.

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 AND STRENGTHS

Lamivudine Tablets, USP are available containing 100 mg of lamivudine, USP.

The 100 mg tablets are peach, film-coated, capsule shaped, unscored tablets debossed with M on one side of the tablet and LN4 on the other side.

4 CONTRAINDICATIONS

Lamivudine tablets are contraindicated in patients with a previous hypersensitivity reaction to lamivudine.

5 WARNINGS AND PRECAUTIONS

5.1 Exacerbations of Hepatitis After Discontinuation of Treatment

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 commonly observed after stopping treatment; see Table 4 for more information regarding frequency of posttreatment ALT elevations [see Adverse Reactions (6.1)]. Although most events appear to have been self-limited, fatalities have been reported in some cases. 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 with lamivudine. There is insufficient evidence to determine whether re-initiation of lamivudine alters the course of posttreatment exacerbations of hepatitis.

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