Adefovir Dipivoxil
Classifications: ANTIVIRAL; NUCLEOTIDE ANALOG
Pregnancy Category: C
ACTION & THERAPEUTIC EFFECT
Inhibits human hepatitis virus (HBV) DNA
polymerase (reverse transcriptase) by competing with its DNA and by causing DNA
chain termination after its incorporation into viral DNA. This results in
inhibition of HBV DNA replication. A nucleotide analog
with activity against human hepatitis
B virus (HBV).
Treatment of chronic hepatitis B.
Hypersensitivity to adefovir; untreated or
unknown human immunodeficiency virus (HIV); exacerbations of hepatitis B,
especially in patients who have discontinued anti-hepatitis B therapy;
lactation.
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| Adefovir Dipivoxil (Hepsera) Uses, Dosage, Side Effects |
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Decreased cardiac function due to concomitant
disease or other drug therapy; concomitant use of highly nephrotoxic drugs; renal
dysfunction; coadministration with drugs that reduce renal function or compete
for active tubular secretion; older adults; pregnancy (category C); children
younger than 2 y. Appropriate infant immunizations should be used to prevent
neonatal acquisition of the hepatitis B virus.
Renal Impairment Dosage Adjustment
CrCl 20–49 mL/min: 10 mg q48h; 10–19 mL/min: 10
mg q72h
Hemodialysis Dosage Adjustment
10 mg q7days following dialysis
- May be
given without regard to food.
- Store in original container at 15°– 30° C
(59°–86° F).
CNS: Asthenia,
headache. GI: Abdominal pain,
nausea, flatulence, diarrhea, dyspepsia, exacerbation of hepatitis
after discontinuation of therapy, hepatomegaly. Metabolic: Increased
ALT, AST, increased creatine kinase, amylase,
lactic acidosis. Urogenital: Hematuria, glycosuria,
increased se rum creatinine, nephrotoxicity. Other: HIV resistance
in patient with unrecognized HIV, hematuria.
Drug: Risk of
lactic acidosis when used with NUCLEOSIDE ANALOGS. Ibuprofen increases bioavailability
of adefovir.
Absorption: Adefovir
dipivoxil is a prodrug. 59% of dose is absorbed as active
drug. Peak: 1–4 h. Distribution:
Minimal protein binding. Metabolism: Adefovir
dipivoxil is rapidly converted to active adefovir. Elimination:
Primarily in urine. Half-Life: 7.5 h.
Black Box
Warning
Adefovir has been associated with severe, acute exacerbations of hepatitis,
nephrotoxicity, HIV resistance, lactic acidosis and severe hepatomegaly with
steatosis.
Assessment
& Drug Effects
- Withhold drug and notify prescriber if lactic
acidosis is suspected [e.g., hyperventilation, lethargy, plasma pH less than
7.35 and lactate greater than 5–6 mol/L (mEq/L)].
- Monitor for and promptly report S&S of
hepatomegaly with steatosis, or other signs of liver injury.
- Monitor lab tests: Baseline and periodic renal
function tests (monitor more often with preexisting impairment or other risk factors
for renal impairment); periodic liver function tests, creatinine kinase, serum
amylase, and routine blood chemistries including serum electrolytes.
Patient
& Family Education
- Report any of the following to prescriber: Blood
in urine, unexplained weakness, or exacerbation of S&S of hepatitis.
- Patients who discontinue adefovir should be
monitored at repeated intervals over a period of time for hepatic function.
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