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Drug overview for ADEFOVIR DIPIVOXIL (adefovir dipivoxil):
Generic name: ADEFOVIR DIPIVOXIL (a-DEF-oh-vir DYE-piv-OX-il)
Drug class: Oral Antivirals for Chronic Hepatitis B
Therapeutic class: Anti-Infective Agents
Adefovir dipivoxil is a prodrug of adefovir, an acyclic nucleotide analog antiviral agent that is active against human hepatitis B virus (HBV) and certain other viruses.
No enhanced Uses information available for this drug.
Generic name: ADEFOVIR DIPIVOXIL (a-DEF-oh-vir DYE-piv-OX-il)
Drug class: Oral Antivirals for Chronic Hepatitis B
Therapeutic class: Anti-Infective Agents
Adefovir dipivoxil is a prodrug of adefovir, an acyclic nucleotide analog antiviral agent that is active against human hepatitis B virus (HBV) and certain other viruses.
No enhanced Uses information available for this drug.
DRUG IMAGES
ADEFOVIR DIPIVOXIL 10 MG TAB
The following indications for ADEFOVIR DIPIVOXIL (adefovir dipivoxil) have been approved by the FDA:
Indications:
Chronic hepatitis B
Professional Synonyms:
Chronic hepatitis B virus infection
Chronic hepatitis due to HBV
Indications:
Chronic hepatitis B
Professional Synonyms:
Chronic hepatitis B virus infection
Chronic hepatitis due to HBV
The following dosing information is available for ADEFOVIR DIPIVOXIL (adefovir dipivoxil):
No enhanced Dosing information available for this drug.
Adefovir dipivoxil is administered orally without regard to food.
| DRUG LABEL | DOSING TYPE | DOSING INSTRUCTIONS |
|---|---|---|
| ADEFOVIR DIPIVOXIL 10 MG TAB | Maintenance | Adults take 1 tablet (10 mg) by oral route once daily |
| DRUG LABEL | DOSING TYPE | DOSING INSTRUCTIONS |
|---|---|---|
| ADEFOVIR DIPIVOXIL 10 MG TAB | Maintenance | Adults take 1 tablet (10 mg) by oral route once daily |
The following drug interaction information is available for ADEFOVIR DIPIVOXIL (adefovir dipivoxil):
There are 3 contraindications.
These drug combinations generally should not be dispensed or administered to the same patient. A manufacturer label warning that indicates the contraindication warrants inclusion of a drug combination in this category, regardless of clinical evidence or lack of clinical evidence to support the contraindication.
| Drug Interaction | Drug Names |
|---|---|
| Selected Nephrotoxic Agents/Cidofovir SEVERITY LEVEL: 1-Contraindicated Drug Combination: This drug combination is contraindicated and generally should not be dispensed or administered to the same patient. MECHANISM OF ACTION: Cidofovir is nephrotoxic. Concurrent administration of other nephrotoxic agents may result in additive or synergistic effects on renal function.(1-3) CLINICAL EFFECTS: Concurrent use of cidofovir with nephrotoxic agents such as adefovir, intravenous aminoglycosides, amphotericin B, foscarnet, intravenous pentamidine, tenofovir, vancomycin, voclosporin and non-steroidal anti-inflammatory agents may result in renal toxicity.(1-3) Other nephrotoxic agents include capreomycin, cisplatin, gallium nitrate, high-dose methotrexate, and streptozocin. PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: The Australian,(1) UK,(2) and US(3) manufacturers of cidofovir state that concurrent administration of potentially nephrotoxic agents such as adefovir, intravenous aminoglycosides, amphotericin B, foscarnet, intravenous pentamidine, tenofovir, vancomycin, voclosporin and non-steroidal anti-inflammatory agents may result in renal toxicity.(1-3) Other nephrotoxic agents include capreomycin, cisplatin, gallium nitrate, high-dose methotrexate, and streptozocin. These agents should be discontinued at least 7 days before the administration of cidofovir. DISCUSSION: The safety of cidofovir has not been studied in patients receiving other known potentially nephrotoxic agents. Renal impairment is the major toxicity of cidofovir.(1-3) |
CIDOFOVIR |
| Adefovir/Tenofovir SEVERITY LEVEL: 1-Contraindicated Drug Combination: This drug combination is contraindicated and generally should not be dispensed or administered to the same patient. MECHANISM OF ACTION: The mechanism involves competition for active tubular secretion sites in the kidney.(1-4) CLINICAL EFFECTS: Concurrent use of adefovir and tenofovir in the treatment of hepatitis B may result in elevated levels of tenofovir or adefovir. PREDISPOSING FACTORS: Renal impairment or use of concurrent renally excreted drugs. PATIENT MANAGEMENT: The US manufacturer of adefovir(1) and the UK(2) and US(3) manufacturers of tenofovir state that adefovir and tenofovir should be not be administered together. DISCUSSION: Tenofovir is eliminated principally by renal tubular secretion and any competitive inhibition of excretion of tenofovir by adefovir increases the likelihood of increased serum concentrations of tenofovir and resultant toxicity.(1-4) |
BIKTARVY, CIMDUO, COMPLERA, DELSTRIGO, DESCOVY, EFAVIRENZ-EMTRIC-TENOFOV DISOP, EFAVIRENZ-LAMIVU-TENOFOV DISOP, EMTRICITABINE-TENOFOVIR DISOP, GENVOYA, ODEFSEY, STRIBILD, SYMFI, SYMFI LO, SYMTUZA, TENOFOVIR DISOPROXIL FUMARATE, TRUVADA, VEMLIDY, VIREAD |
| Selected Nephrotoxic Agents/Bacitracin SEVERITY LEVEL: 1-Contraindicated Drug Combination: This drug combination is contraindicated and generally should not be dispensed or administered to the same patient. MECHANISM OF ACTION: Bacitracin may cause renal failure due to glomerular and tubular necrosis. Concurrent administration of other nephrotoxic agents may result in additive renal toxicity.(1-3) CLINICAL EFFECTS: Concurrent use of bacitracin with other potentially nephrotoxic agents may result in renal toxicity.(1-3) PREDISPOSING FACTORS: Dehydration and high-dose bacitracin may predispose to adverse renal effects.(1) PATIENT MANAGEMENT: Health Canada states that bacitracin is contraindicated in patients with renal impairment, including those taking other nephrotoxic drugs.(1) The Canadian and US manufacturers of bacitracin state that concomitant use of bacitracin with other potentially nephrotoxic agents should be avoided.(2,3) DISCUSSION: Renal impairment is a major toxicity of bacitracin. Cases of nephrotoxicity have been reported when bacitracin was used off-label.(1-3) |
BACITRACIN, BACITRACIN MICRONIZED, BACITRACIN ZINC |
There are 2 severe interactions.
These drug interactions can produce serious consequences in most patients. Actions required for severe interactions include, but are not limited to, discontinuing one or both agents, adjusting dosage, altering administration scheduling, and providing additional patient monitoring. Review the full interaction monograph for more information.
| Drug Interaction | Drug Names |
|---|---|
| Colistimethate/Selected Nephrotoxic Agents SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction. MECHANISM OF ACTION: Colistimethate can cause nephrotoxicity.(1,2) Concurrent administration of other nephrotoxic agents may result in an increased risk of nephrotoxicity.(1) It is suspected that cephalothin interferes with the excretion of colistimethate resulting in enhanced nephrotoxicity.(2,3) CLINICAL EFFECTS: Concurrent use of colistimethate with other nephrotoxic agents may result in additive nephrotoxic effects. PREDISPOSING FACTORS: Factors predisposing to nephrotoxicity include higher cumulative doses of colistimethate, longer treatment duration, hypovolemia, and critical illness. PATIENT MANAGEMENT: Concurrent use of potentially nephrotoxic agents with colistimethate should be avoided.(1,2) If concurrent use is necessary, it should be undertaken with great caution.(1) DISCUSSION: In a case control study of 42 patients on intravenous colistimethate sodium, NSAIDs were identified as an independent risk factor for nephrotoxicity (OR 40.105, p=0.044).(4) In 4 case reports, patients developed elevated serum creatinine and blood urea nitrogen following concurrent colistimethate and cephalothin (3 patients) or when colistimethate followed cephalothin therapy (1 patient).(3) A literature review found that individual nephrotoxic agents, including aminoglycosides, vancomycin, amphotericin, IV contrast, diuretics, ACE inhibitors, ARBs, NSAIDs, and calcineurin inhibitors, were not consistently associated with additive nephrotoxicity when used with colistimethate. However, when multiple agents (at least 2 additional potential nephrotoxins) were used concurrently, there was a significant correlation to colistimethate nephrotoxicity.(5) |
COLISTIMETHATE, COLISTIMETHATE SODIUM, COLY-MYCIN M PARENTERAL |
| Selected Nephrotoxic Agents/Foscarnet SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction. MECHANISM OF ACTION: Foscarnet is nephrotoxic. Concurrent administration of other nephrotoxic agents may result in additive or synergistic effects on renal function.(1) Concurrent intravenous pentamidine may also result in hypocalcemia.(1) CLINICAL EFFECTS: Concurrent use of foscarnet with nephrotoxic agents such as acyclovir, adefovir, intravenous aminoglycosides, amphotericin B, cyclosporine, methotrexate, non-steroidal anti-inflammatory agents, intravenous pentamidine, tacrolimus, tenofovir, vancomycin and voclosporin may result in renal toxicity.(1) Other nephrotoxic agents include capreomycin, cisplatin, gallium nitrate, high-dose methotrexate, and streptozocin. PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: The US manufacturer of foscarnet state that concurrent administration of potentially nephrotoxic agents such as acyclovir, intravenous aminoglycosides, amphotericin B, cyclosporine, methotrexate, tacrolimus, and intravenous pentamidine should be avoided.(1) Other nephrotoxic agents include adefovir, capreomycin, cisplatin, gallium nitrate, high-dose methotrexate, non-steroidal anti-inflammatory agents, streptozocin, tenofovir, vancomycin and voclosporin. If concurrent therapy is warranted, monitor renal function closely. In patients receiving concurrent foscarnet and pentamidine, also monitor serum calcium levels and instruct patients to report severe muscle spasms, mental/mood changes, and/or seizures.(1) DISCUSSION: The safety of foscarnet has not been studied in patients receiving other known potentially nephrotoxic agents. Renal impairment is the major toxicity of foscarnet.(1) |
FOSCARNET SODIUM, FOSCAVIR |
There are 2 moderate interactions.
The clinician should assess the patient’s characteristics and take action as needed. Actions required for moderate interactions include, but are not limited to, discontinuing one or both agents, adjusting dosage, altering administration.
| Drug Interaction | Drug Names |
|---|---|
| Selected Nephrotoxic Agents/Adefovir SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed. MECHANISM OF ACTION: Recommended doses of adefovir have been associated with delayed nephrotoxicity.(1-4) Concurrent administration of other nephrotoxic agents may result in additive or synergistic effects on renal function.(1) CLINICAL EFFECTS: Concurrent use of adefovir with nephrotoxic agents such as intravenous aminoglycosides, amphotericin B, cyclosporine, tacrolimus,tenofovir, vancomycin, voclosporin and non-steroidal anti-inflammatory agents may result in renal toxicity.(1) Other nephrotoxic agents include capreomycin, cisplatin, gallium nitrate, high-dose methotrexate, intravenous pentamidine, and streptozocin. PREDISPOSING FACTORS: Patients with pre-existing renal impairment(1,2) or receiving multiple nephrotoxic agents appear to be at greater risk for nephrotoxicity. PATIENT MANAGEMENT: Evaluate renal function prior to initiation of concurrent therapy and continue renal function monitoring during therapy. Dose adjustments may be required for impaired renal function. Weigh the risks and benefits of concurrent therapy in patients with treatment-emergent nephrotoxicity. DISCUSSION: Because of the known risks for adefovir nephrotoxicity, particularly at higher than recommended doses, the safety of adefovir has not been studied in patients receiving other known potentially nephrotoxic agents. |
ABELCET, AFINITOR, AFINITOR DISPERZ, AMBISOME, AMIKACIN SULFATE, AMPHOTERICIN B, AMPHOTERICIN B LIPOSOME, ANAPROX DS, ANJESO, ARTHROTEC 50, ARTHROTEC 75, ASTAGRAF XL, BROMFENAC SODIUM, BUPIVACAINE-KETOROLAC-KETAMINE, CALDOLOR, CAMBIA, CELEBREX, CELECOXIB, CISPLATIN, COMBOGESIC, COMBOGESIC IV, CONSENSI, COXANTO, DAYPRO, DICLOFENAC, DICLOFENAC POTASSIUM, DICLOFENAC SODIUM, DICLOFENAC SODIUM ER, DICLOFENAC SODIUM MICRONIZED, DICLOFENAC SODIUM-MISOPROSTOL, EC-NAPROSYN, ELYXYB, ENVARSUS XR, ETODOLAC, ETODOLAC ER, EVEROLIMUS, FELDENE, FENOPROFEN CALCIUM, FENOPRON, FLURBIPROFEN, FYARRO, GENTAMICIN SULFATE, GENTAMICIN SULFATE IN NS, HYDROCODONE-IBUPROFEN, IBU, IBUPAK, IBUPROFEN, IBUPROFEN LYSINE, IBUPROFEN-FAMOTIDINE, INDOCIN, INDOMETHACIN, INDOMETHACIN ER, INFLAMMACIN, INFLATHERM(DICLOFENAC-MENTHOL), KANAMYCIN SULFATE, KEMOPLAT, KETOPROFEN, KETOPROFEN MICRONIZED, KETOROLAC TROMETHAMINE, KIPROFEN, LODINE, LOFENA, LUPKYNIS, LURBIPR, MECLOFENAMATE SODIUM, MEFENAMIC ACID, MELOXICAM, METHOTREXATE, METHOTREXATE SODIUM, NABUMETONE, NABUMETONE MICRONIZED, NALFON, NAPRELAN, NAPROSYN, NAPROTIN, NAPROXEN, NAPROXEN SODIUM, NAPROXEN SODIUM CR, NAPROXEN SODIUM ER, NAPROXEN-ESOMEPRAZOLE MAG, NEOMYCIN SULFATE, NEOPROFEN, OXAPROZIN, PENTAM 300, PENTAMIDINE ISETHIONATE, PHENYLBUTAZONE, PIROXICAM, PROGRAF, R.E.C.K.(ROPIV-EPI-CLON-KETOR), RELAFEN DS, ROPIVACAINE-CLONIDINE-KETOROLC, ROPIVACAINE-KETOROLAC-KETAMINE, SIROLIMUS, SPRIX, STREPTOMYCIN SULFATE, SULINDAC, SUMATRIPTAN SUCC-NAPROXEN SOD, SYMBRAVO, TACROLIMUS, TACROLIMUS XL, TEMSIROLIMUS, TOBRAMYCIN, TOBRAMYCIN SULFATE, TOLECTIN 600, TOLMETIN SODIUM, TORISEL, TORONOVA II SUIK, TORONOVA SUIK, TORPENZ, TOXICOLOGY SALIVA COLLECTION, TRESNI, TREXIMET, VANCOMYCIN, VANCOMYCIN HCL, VANCOMYCIN HCL-0.9% NACL, VANCOMYCIN HCL-D5W, VIMOVO, VIVLODEX, ZIPSOR, ZORTRESS, ZORVOLEX, ZYNRELEF |
| Selected Nephrotoxic Agents/Immune Globulin IV (IGIV) SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed. MECHANISM OF ACTION: Immune Globulin Intravenous (IGIV) products, particularly those containing sucrose, can cause renal dysfunction, acute renal failure, osmotic nephrosis, and/or death. Concurrent administration of other nephrotoxic agents may result in additive or synergistic effects on renal function.(1-4) CLINICAL EFFECTS: Concurrent use of Immune Globulin Intravenous (IGIV) products with nephrotoxic agents such as adefovir, intravenous aminoglycosides, amphotericin B, non-steroidal anti-inflammatory agents, tenofovir, and vancomycin may result in renal toxicity.(1-4) Other nephrotoxic agents include capreomycin, gallium nitrate, and streptozocin. PREDISPOSING FACTORS: Patients at risk of acute renal failure include those with any degree of pre-existing renal insufficiency, diabetes mellitus, advanced age (above 65 years of age), volume depletion, sepsis, paraproteinemia, or receiving known nephrotoxic drugs.(1-4) Renal dysfunction and acute renal failure occur more commonly in patients receiving IGIV products containing sucrose.(3-4) PATIENT MANAGEMENT: For patients at risk of renal dysfunction or renal failure, the US manufacturers of Immune Globulin Intravenous (IGIV) products recommends administration at the minimum dose and infusion rate practicable; ensure adequate hydration in patients before administration; and monitor renal function and urine output with assessment of blood urea nitrogen (BUN) and serum creatinine before initial infusion and at regular intervals during therapy.(1-3) Concurrent administration of potentially nephrotoxic agents should be avoided.(1) Review prescribing information for IGIV product to be administered for sucrose content. If concurrent therapy is warranted, monitor renal function closely. In high risk patients, consider selecting an IGIV product that does not contain sucrose. DISCUSSION: The safety of Immune Globulin Intravenous (IGIV) has not been studied in patients receiving other known potentially nephrotoxic agents. Renal impairment is a major toxicity of IGIV products.(1-3) A review of the FDA renal adverse events (RAEs) (i.e. acute renal failure or insufficiency) from June 1985 to November 1998 identified 120 reports worldwide associated with IGIV administration. In the US, the FDA received 88 reports of cases with clinical and/or laboratory findings consistent with RAE (i.e. increased serum creatinine, oliguria, and acute renal failure). Patient cases involved a median age of 60.5 years and 55% were male. Of the 54 patients who developed acute renal failure, 65% were greater than 65 years, 56% had diabetes, and 26% had prior renal insufficiency; 59% had one, 35% had two, and 6% had three of these conditions. Upon review of the IGIV product received, 90% of cases received sucrose-containing IGIV products with the remaining patients receiving either maltose- or glucose-containing products. Approximately 40% of affected patients required dialysis and RAE may have contributed to death in 15% of patients.(4) |
ALYGLO, BIVIGAM, CUTAQUIG, CUVITRU, FLEBOGAMMA DIF, GAMMAGARD LIQUID, GAMMAGARD S-D, GAMMAKED, GAMMAPLEX, GAMUNEX-C, HIZENTRA, HYQVIA, HYQVIA IG COMPONENT, OCTAGAM, PANZYGA, PRIVIGEN, XEMBIFY |
The following contraindication information is available for ADEFOVIR DIPIVOXIL (adefovir dipivoxil):
Drug contraindication overview.
Adefovir dipivoxil is contraindicated in patients with known hypersensitivity to the drug or any ingredient in the formulation.
Adefovir dipivoxil is contraindicated in patients with known hypersensitivity to the drug or any ingredient in the formulation.
There are 2 contraindications.
Absolute contraindication.
| Contraindication List |
|---|
| Lactic acidosis |
| Steatosis of liver |
There are 5 severe contraindications.
Adequate patient monitoring is recommended for safer drug use.
| Severe List |
|---|
| Chronic kidney disease stage 3A (moderate) GFR 45-59 ml/min |
| Chronic kidney disease stage 3B (moderate) GFR 30-44 ml/min |
| Chronic kidney disease stage 4 (severe) GFR 15-29 ml/min |
| Chronic kidney disease stage 5 (failure) GFr<15 ml/min |
| Nephrotoxicity |
There are 3 moderate contraindications.
Clinically significant contraindication, where the condition can be managed or treated before the drug may be given safely.
| Moderate List |
|---|
| Drug resistance to anti-retroviral therapy |
| Kidney disease with reduction in glomerular filtration rate (GFr) |
| Obesity |
The following adverse reaction information is available for ADEFOVIR DIPIVOXIL (adefovir dipivoxil):
Adverse reaction overview.
Adverse effects reported in 3% or more of patients with adequate renal function who received adefovir dipivoxil for 48 weeks in clinical studies include asthenia (13%), headache (9%), abdominal pain (9%), nausea (5%), flatulence (4%), diarrhea (3%) and dyspepsia (3%); these frequencies were similar to those observed in patients receiving placebo (2-14%). Adverse effects reported in 2% or greater of pre- and post-liver transplantation patients who received adefovir dipivoxil in clinical studies include asthenia, abdominal pain, headache, nausea, vomiting, diarrhea, increases in ALT and AST, pruritus, rash, increases in creatinine, renal failure, and renal insufficiency. In addition, transient serum phosphorus concentrations less than 2 mg/dL were observed in approximately 2% of these patients; adefovir dipivoxil therapy was continued and the patients did not require phosphorus supplementation.
Four percent (19 of 467) of pre- and post-liver transplantation patients discontinued adefovir dipivoxil therapy because of adverse renal effects. However, a causal relationship to changes in serum creatinine and serum phosphorus is difficult to assess because of the presence of multiple concomitant risk factors for renal dysfunction in these patients.
Adverse effects reported in 3% or more of patients with adequate renal function who received adefovir dipivoxil for 48 weeks in clinical studies include asthenia (13%), headache (9%), abdominal pain (9%), nausea (5%), flatulence (4%), diarrhea (3%) and dyspepsia (3%); these frequencies were similar to those observed in patients receiving placebo (2-14%). Adverse effects reported in 2% or greater of pre- and post-liver transplantation patients who received adefovir dipivoxil in clinical studies include asthenia, abdominal pain, headache, nausea, vomiting, diarrhea, increases in ALT and AST, pruritus, rash, increases in creatinine, renal failure, and renal insufficiency. In addition, transient serum phosphorus concentrations less than 2 mg/dL were observed in approximately 2% of these patients; adefovir dipivoxil therapy was continued and the patients did not require phosphorus supplementation.
Four percent (19 of 467) of pre- and post-liver transplantation patients discontinued adefovir dipivoxil therapy because of adverse renal effects. However, a causal relationship to changes in serum creatinine and serum phosphorus is difficult to assess because of the presence of multiple concomitant risk factors for renal dysfunction in these patients.
There are 12 severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
| None. |
Abnormal hepatic function tests Acute hepatic failure Kidney disease with reduction in glomerular filtration rate (GFr) Renal failure Skin rash |
| Rare/Very Rare |
|---|
|
Drug-induced hepatitis Hypophosphatemia Lactic acidosis Nephrotoxicity Osteomalacia Pancreatitis Steatosis of liver |
There are 10 less severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
|
Abdominal pain with cramps General weakness Headache disorder |
Diarrhea Dyspepsia Flatulence Nausea Pruritus of skin Vomiting |
| Rare/Very Rare |
|---|
|
Myopathy |
The following precautions are available for ADEFOVIR DIPIVOXIL (adefovir dipivoxil):
Safety and efficacy of adefovir dipivoxil have not been established in children younger than 12 years of age. (See HBeAg-Positive Pediatric Patients under Uses: Chronic Hepatitis B Virus Infection.)
Contraindicated
Severe Precaution
Management or Monitoring Precaution
Contraindicated
| None |
Severe Precaution
| None |
Management or Monitoring Precaution
| None |
Category C. (See Users Guide.) To monitor maternal-fetal outcomes of pregnant women exposed to adefovir dipivoxil, clinicians are encouraged to contact the pregnancy registry at 800-258-4263 to enroll such women. There are no adequate, well-controlled studies of adefovir dipivoxil in pregnant women.
The drug should be used during pregnancy only if potential benefits justify potential risks to the fetus. There was no evidence of embryotoxicity or teratogenicity in rats or rabbits at systemic exposures 23 or 40 times, respectively, exposures in humans at the therapeutic dosage. However, embryotoxicity and increased incidence of fetal malformations (anasarca, depressed eye bulge, umbilical hernia, kinked tail) occurred in rats at adefovir dipivoxil exposures 38 times human exposures at the therapeutic dosage.
The American Association for the Study of Liver Diseases (AASLD) and other experts state that recommendations regarding antiviral therapy for the management of HBV infection in pregnant women generally are the same as those for other adults. AASLD also suggests that hepatitis B surface antigen (HBsAg)-positive pregnant women with HBV DNA levels exceeding 200,000 IU/mL receive antiviral therapy since this may reduce the risk of perinatal transmission of HBV; however, preferred antiviral agents, exact viral load threshold, and optimal gestational week during the third trimester to initiate such therapy have not been clearly identified. Data are not available regarding the effect of adefovir dipivoxil therapy during pregnancy on transmission of HBV to the infant.
Routine screening for HBV infection is recommended for all pregnant women. For prevention of perinatal transmission of HBV, US Public Health Service Advisory Committee on Immunization Practices (ACIP), American Academy of Pediatrics (AAP), and other experts state that infants born to HBsAg-positive women should receive their first dose of hepatitis B vaccine and a dose of hepatitis B immune globulin (HBIG) within 12 hours of birth.
The drug should be used during pregnancy only if potential benefits justify potential risks to the fetus. There was no evidence of embryotoxicity or teratogenicity in rats or rabbits at systemic exposures 23 or 40 times, respectively, exposures in humans at the therapeutic dosage. However, embryotoxicity and increased incidence of fetal malformations (anasarca, depressed eye bulge, umbilical hernia, kinked tail) occurred in rats at adefovir dipivoxil exposures 38 times human exposures at the therapeutic dosage.
The American Association for the Study of Liver Diseases (AASLD) and other experts state that recommendations regarding antiviral therapy for the management of HBV infection in pregnant women generally are the same as those for other adults. AASLD also suggests that hepatitis B surface antigen (HBsAg)-positive pregnant women with HBV DNA levels exceeding 200,000 IU/mL receive antiviral therapy since this may reduce the risk of perinatal transmission of HBV; however, preferred antiviral agents, exact viral load threshold, and optimal gestational week during the third trimester to initiate such therapy have not been clearly identified. Data are not available regarding the effect of adefovir dipivoxil therapy during pregnancy on transmission of HBV to the infant.
Routine screening for HBV infection is recommended for all pregnant women. For prevention of perinatal transmission of HBV, US Public Health Service Advisory Committee on Immunization Practices (ACIP), American Academy of Pediatrics (AAP), and other experts state that infants born to HBsAg-positive women should receive their first dose of hepatitis B vaccine and a dose of hepatitis B immune globulin (HBIG) within 12 hours of birth.
It is not known whether adefovir dipivoxil is distributed into milk. A decision should be made to discontinue nursing or adefovir dipivoxil, taking into account the importance of the drug to the woman.
Experience in those 65 years of age or older is insufficient to determine whether geriatric adults respond differently than younger adults. Adefovir dipivoxil should be used with caution in geriatric patients because of age-related decreases in hepatic, renal, and/or cardiac function and concomitant disease and drug therapy.
The following prioritized warning is available for ADEFOVIR DIPIVOXIL (adefovir dipivoxil):
WARNING: Severe worsening of hepatitis (rarely including death) has occurred when treatment with adefovir dipivoxil is stopped. When you are instructed to stop taking this medication, your doctor will monitor you closely for signs of worsening hepatitis. If you are instructed to stop taking this medication, be sure to keep all doctor and lab appointments after you stop taking this drug.
Rarely, severe (sometimes fatal) liver and blood acid-base balance problems (lactic acidosis) have occurred in patients (especially if overweight) while using similar types of medication (nucleoside analogs such as didanosine or stavudine). Tell your doctor right away if you have unusual weakness/tiredness, dark urine, yellowing eyes/skin, stomach/abdominal pain, drowsiness, muscle aches/weakness, fast/difficult breathing, or fast/irregular heartbeat. In patients with kidney disease, adefovir dipivoxil can cause kidney problems.
Tell your doctor right away if you develop signs of kidney problems such as a change in the amount of urine. If you get or have HIV infection that is not being treated with medication, adefovir dipivoxil may cause your HIV infection to become untreatable with the usual HIV drugs (development of HIV resistance). Talk to your doctor or pharmacist for more details.
WARNING: Severe worsening of hepatitis (rarely including death) has occurred when treatment with adefovir dipivoxil is stopped. When you are instructed to stop taking this medication, your doctor will monitor you closely for signs of worsening hepatitis. If you are instructed to stop taking this medication, be sure to keep all doctor and lab appointments after you stop taking this drug.
Rarely, severe (sometimes fatal) liver and blood acid-base balance problems (lactic acidosis) have occurred in patients (especially if overweight) while using similar types of medication (nucleoside analogs such as didanosine or stavudine). Tell your doctor right away if you have unusual weakness/tiredness, dark urine, yellowing eyes/skin, stomach/abdominal pain, drowsiness, muscle aches/weakness, fast/difficult breathing, or fast/irregular heartbeat. In patients with kidney disease, adefovir dipivoxil can cause kidney problems.
Tell your doctor right away if you develop signs of kidney problems such as a change in the amount of urine. If you get or have HIV infection that is not being treated with medication, adefovir dipivoxil may cause your HIV infection to become untreatable with the usual HIV drugs (development of HIV resistance). Talk to your doctor or pharmacist for more details.
The following icd codes are available for ADEFOVIR DIPIVOXIL (adefovir dipivoxil)'s list of indications:
| Chronic hepatitis B | |
| B18.0 | Chronic viral hepatitis B with delta-agent |
| B18.1 | Chronic viral hepatitis B without delta-agent |
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