Lamivudine

LAMIVUDINE — lamivudine tablet, film coated
Camber Pharmaceuticals, Inc.

BOXED WARNING

WA RN I NG: LACTIC ACIDOSIS AND SEVERE HEPATOMEGALY WITH STEATOSIS, EXACERBATIONS OF HEPATITIS B, and RISK OF HIV-1 RESISTANCE IF LAMIVUDINE TABLETS (HBV) IS USED IN PATIENTS WITH UNRECOGNIZED OR UNTREATED HIV-1

La ctic a cidosis and s ev ere h epa t o m egaly wi th s tea tosis, in cluding fa tal cas es, have b een repo rted wi th the use of nu cl eoside analogu es and other antiretrovirals. Discontinue lamivudine tablets (HBV) if cli ni cal or labo ra to ry find ings sugg es tive of la ctic a cidosis or p ronoun ced h epa to tox i ci ty o ccur [s ee Warnings and Pr ecautions (5.1 )].
S ev ere a cu te ex a cerba t ions of h epa ti tis B have b een repo rted in pa ti en ts who have dis con tinu ed an ti -h epa ti tis B th erapy (in clud ing lamivudine tablets (HBV) ). H epa tic fun ction shou ld be moni to r ed clos ely wi th bo th clini cal a nd la bo ra to ry follo w -up for at l east s ev eral mon ths in pa ti en ts who dis con t inue an ti -h epa ti tis B th e rapy. If a pp rop ria te, ini tia tion of an ti -h epa ti tis B th erapy may be wa rran t ed [s ee Warnings and Pr ecauti ons (5.2 )].
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.HIV 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 indi cat ed for the t r e atm ent of ch ronic h ep atitis B vi rus ( H B V) in f ection asso ci at ed with evid e n ce of h ep atitis B vi ral r epli c ation and active liv er in f l amm ation [s ee Clini cal Studi es (14.1, 14.2 ) ].

The follo wing points sh ould be consid ered wh en initi ating th era py with lamivudine tablets (HBV):

  • Due to hi gh rat es of resi st an ce d e v elopm ent in t r e at ed p ati ents, initi ation of t reatm ent with lamivudine tablets (HBV) should only be consid e r ed wh en the use of an alt e rn ative ant ivi ral a g ent with a hi gh er g en etic b arri er to r esist an ce is not av ail able or app rop ri a t e.
  • Lamivudine tablets (HBV) h ave not b e en ev alu a t ed in p ati ents co -in fect ed with H I V, h e p atitis C vi rus (HC V), or h e p atitis d elta vi rus.
  • Lamivudine tablets (HBV) h ave not b e en ev alu a t ed in liv er t ra nspl ant recipi ents or in p a ti ents with ch ronic h ep atitis B vi rus in fecti on with d ecomp ens at ed l iv er dis eas e.

2 DOSAGE & ADMINISTRATION

2.1 HIV Counseling and Testing


H IV couns eli ng and t esting should be o f fe r ed to all p ati ents b efo re b e ginn ing t r e atm ent with lamivudine tablets (HBV) and p eriodi cal ly du ri ng t r e atm ent b ecau se of the risk of em e r g e n ce of resist ant — H I V -1 and limit ation of t reatm ent options if lamivudine tablets (HBV) is p re s crib ed to t r e at ch ronic h ep atitis B in fection in a p ati ent who h as un r e c ogni z ed H I V -1 in fection or acqui res H I V-1 in fection du ri ng t reatm e nt [s ee Warnings and Pr e cautions (5. 3 ) ].

2.2 Recommended Dosage for Adult Patients

The r e comm end ed o r al dos age of lamivudine tablets (HBV) is 100 mg on ce d ai l y.

2.3 Recommended Dosage for Pediatric Patients


The r e comm end ed o r al dos age of lamivudine tablets (HBV) for p edi at ric p ati ents a g ed 2 to 17 y e ars is 3 mg p er kg o n ce d ai ly up to a m a ximum d ai ly dos age of 100 m g. The o ral solution fo rmul ation should be p r es crib ed f or p ati ents r eq ui ring a do s a ge l ess th an 100 mg or if u n able to s wallow t abl ets.

2.4 Patients with Renal Impairment


Dos a ge r ecomm end atio ns for adult p ati ents with r edu ced r en al fu n ction are p rovid ed in Table 1 [s ee Clini cal P har ma cology (12. 3 ) ].
Table 1. Dosage of Lamivudine Tablets (HBV) in Adult Pa ti en ts wi th Renal I mpai r ment

Cre a tinine Cl ea ran ce ( m L/ min) Rec o mme nd ed Dosage of Lamivudine Tablets (HBV)
≥50 100 mg on ce d ai ly
30 -49 100 mg fi rst dos e, th en 50 mg on ce d ai ly
15 -29 100 mg fi rst dos e, th en 25 mg on ce d ai ly
5 -14 35 mg fi rst dos e, th en 15 mg on ce d ai ly
<5 35 mg fi rst dos e, th en 10 mg on ce d ai ly

Follo wing co r r ection of the dos a ge f or re n al imp ai rm ent, no addition al dos a ge modi fi cation of lamivudine tablets (HBV) is r equi red a ft er r outine (4 -hou r) h emodi a l ysis or p eriton eal di a l ysis [s ee Clini cal P har ma cology (12. 3 ) ]. Th ere are insu f fi ci ent d a ta to recomm end a sp eci f ic dos a ge of lamivudine tablets (HBV) in p edi at ric p ati ents with ren al imp ai rm ent.

2.5 Important Administration Instructions

• Lamivudine tablets (HBV) 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 (HBV) 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 (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 cont rai ndi cat ed in p ati ents with a previous hypersensitivity reaction to lamivudine.

5 WARNINGS AND PRECAUTIONS

5.1 Lactic Acidosis and Severe Hepatomegaly with Steatosis

L a ctic a cidosis and s ev e re h ep atom eg a ly with st e atosis, in cluding fat al c as es, h ave b een repo rt ed with the use of nu cl eoside an al o g u es al one or in combin ation, in cluding lamivudine tablets (HBV) and oth er anti r et rovi rals. A m ajo ri ty of t h ese c as es h ave b e en in wom en. O b esi ty and p rolong ed nu cl eoside e xposu re m ay be risk fact o rs. Most of th ese rep o rts h ave d es cri b ed p ati ents r e ceivi ng nu cl eoside an al o g u es for t reatm ent of H IV in f e ction, but th ere h ave b een r epo rts of l actic acidosis in p ati ents re c eiving l amivudine for h ep atitis B. C aution should be e x ercis ed wh en administ eri ng lamivudine tablets (HBV) to a ny p ati ent with kno wn risk facto rs for liv er dis eas e; ho wev er, cas es also have b een rep o rt ed in p ati ents with no kno wn risk fac to rs. Treatm ent with lamivudine tablets (HBV) should be susp end ed in a ny p ati ent who d ev elops clini cal or l abo rato ry findi n gs sug g estive of l actic a cid osis or p ronoun ced h e p at oto xi ci ty (whi ch m ay i n clude h ep atom eg a ly and st eatosis ev en in the abs en ce of m a rk ed t ran s amin ase el e v ations ).

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