Names and pronunciation
(add-ee-foh′veer) Hepsera
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Drug reference
(add-ee-foh′veer) Hepsera
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Func. class.: Antiviral
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Chem. class.: Nucleoside
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ACTION: Inhibits hepatitis B virus DNA polymerase by competing with natu- ral substrates and by causing DNA termi- nation after its incorporation into viral DNA; causes viral DNA death
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USES: Chronic hepatitis B
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CONTRAINDICATIONS: Hyper- sensitivity Precautions: Pregnancy, labor, breast- feeding, children, geriatric patients, dialy- sis, females, obesity, organ transplant
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Black Box Warning: Severe renal dis- ease, impaired hepatic function, lactic acidosis, HIV, hepatitis B exacerbation Black Box Warning: Increase: lactic acidosis, severe hepatomegaly, NNRTIs, NRTIs, antiretroviral protease inhibitors Drug/Lab Test Increase: ALT, AST, amylase, creatine kinase Black Box Warning: Nephrotoxicity: in- creasing CCr, BUN Black Box Warning: HIV antibody testing before beginning treatment, HIV resistance may occur in chronic hepatitis B patients Black Box Warning: For lactic acidosis, severe hepatomegaly with stenosis; for use of NNRTIs, NRTIs, antiretroviral pro- tease inhibitors (PIs), lactic acidosis with severe hepatomegaly is more common in females, obese patients, and with pro- longed nucleoside use • Geriatric patients more carefully; may develop renal, cardiac symptoms more rapidly Black Box Warning: For exacerbations of hepatitis after discontinuing treatment, monitor LFTs, hepatitis B serology • Pregnancy: if planned or suspected; if pregnant call the Pregnancy Registry: 800-258-4263
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SIDE EFFECTS CNS: Headache GI: Dyspepsia, abdominal pain, nausea, vomiting, diarrhea, hepatomegaly, flatu- lence, pancreatitis GU: Hematuria, glycosuria, nephrotoxic- ity, Fanconi syndrome, renal failure MISC: Fever, rash, weight loss, cough
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INTERACTIONS • Do not use in combination with emtri citabine/tenofovir, emtricitabine/rilpivirine, emtricitabine/efavirenz/tenofovir Increase: serum concentrations and pos- sible nephrotoxicity—aminoglycosides, memantine, emtricitabine, efavirenz, dofetilide, digoxin, cycloSPORINE, aMILoride, quiNINE, quiNIDine, procain- amide, PEMEtrexed, midodrine, metFOR- MIN, NSAIDs, vancomycin, trospium, tri- amterene, tenofovir, tacrolimus, ranitidine, cimetidine, morphine
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DOSAGE AND ROUTES Chronic hepatitis B • Adult/adolescent: PO 10 mg/day, op- timal duration unknown Renal dose • Adult: PO CCr ≥50 mL/min 10 mg q24hr; CCr 30-49 mL/min 10 mg q48hr; CCr 10-29 mL/min 10 mg q72hr; hemodi- A alysis 10 mg q7days after dialysis
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Available forms: Tablets 10 mg
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Administer: • By mouth without regard for food • Take with full glass of water • Store in cool environment; protect from light
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Evaluate: • Therapeutic response: decreased symptoms of chronic hepatitis B, improv- ing LFTs
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CLINICAL CONSIDERATIONS Assess
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Patient and caregiver information: • That optimal duration of treatment is unknown; that product is not a cure; that transmission may still occur • To avoid use with other medications unless approved by prescriber • To notify prescriber of decreased uri- nary output • Not to stop abruptly unless directed; worsening of hepatitis may occur • To report immediately dyspnea, nau- sea, vomiting, abdominal pain, weakness, dizziness, cold extremities • To notify prescriber if pregnancy is planned or suspected; avoid breast- feeding HIGH ALERT
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PHARMACOKINETICS PO: Rapidly absorbed from GI tract, peak 1¾ hr, excreted by kidneys 45%, terminal half-life 7.48 hr
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• Adult/adolescent: PO 10 mg/day, op- timal duration unknown Renal dose
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• Adult: PO CCr ≥50 mL/min 10 mg q24hr; CCr 30-49 mL/min 10 mg q48hr; CCr 10-29 mL/min 10 mg q72hr; hemodi- A alysis 10 mg q7days after dialysis
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