Adefovir Dipivoxil (APOTEX-Adefovir adefovir dipivoxil 10mg tablet bottle)
Adefovir Dipivoxil risk profile, scheduling, and guidance for claims professionals and care workers . Also known as APOTEX-Adefovir adefovir dipivoxil 10mg tablet bottle, APO-Adefovir adefovir dipivoxil 10mg tablet bottle.
Adefovir Dipivoxil (brand names: APOTEX-Adefovir adefovir dipivoxil 10mg tablet bottle, APO-Adefovir adefovir dipivoxil 10mg tablet bottle) is classified as Low risk (1 risk points) by AllMeds. It is a S4 medication under the TGA in Australia. FDA approved in the United States. Antiviral for hepatitis B with potential for kidney toxicity but minimal CNS effects.
Key Takeaways
- TGA Schedule: S4 in Australia
- Risk level: Low (1 points)
Scheduling and Classification
| Jurisdiction | Classification | Status |
|---|---|---|
| Australia (TGA) | S4 | Not PBS listed |
| United States (FDA) | Rx only | FDA approved |
Risk Profile
Antiviral for hepatitis B with potential for kidney toxicity but minimal CNS effects.
Regulatory and Compliance Guidance
When Adefovir Dipivoxil appears on a claimant's medication list, claims professionals should assess whether the prescribing is appropriate for the compensable injury, whether the duration is within guidelines, and whether there are interactions with other medications on the claim.
Australia TGA / PBS / State Schemes
Classified as S4 under the Therapeutic Goods Administration (TGA).
United States FDA / CDC / State WC
FDA approved for use in the United States.
FDA Boxed Warning: WARNING: SEVERE ACUTE EXACERBATIONS OF HEPATITIS, NEPHROTOXICITY, HIV RESISTANCE, LACTIC ACIDOSIS AND SEVERE HEPATOMEGALY WITH STEATOSIS Severe acute exacerbations of hepatitis have been reported in patients who have discontinued anti-Hepatitis B therapy including adefovir dipivoxil 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, resumption of anti-Hepatitis B therapy may be warranted [See Warnings and Precautions (5. 1 ) ]. In patients at risk of or having underlying renal dysfunction, chronic administration of adefovir dipivoxil tablets may result in nephrotoxicity. These patients should be monitored closely for renal function and may require dose adjustment [See Warnings and Precautions (5. 2 ) and Dosage and Administration (2.2) ] . HIV resistance may emerge in chronic hepatitis B patients with unrecognized or untreated Human Immunodeficiency Virus (HIV) infection treated with anti-hepatitis B therapies, such as therapy with adefovir dipivoxil tablets, that may have activity against HIV [See Warnings and Precautions (5. 3 ) ] . Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogs alone or in combination with other antiretrovirals [See Warnings and Precautions (5. 4 ) ] . WARNING: SEVERE ACUTE EXACERBATIONS OF HEPATITIS, NEPHROTOXICITY, HIV RESISTANCE, LACTIC ACIDOSIS AND SEVERE HEPATOMEGALY WITH STEATOSIS See full prescribing information for complete boxed warning . Severe acute exacerbations of hepatitis may occur in patients who discontinue adefovir dipivoxil tablets. Monitor hepatic function closely in these patients. ( 5.1 ) Chronic use of adefovir dipivoxil tablets may result in nephrotoxicity in patients at risk of renal dysfunction or having underlying renal dysfunction. Monitor renal function closely in these patients. Dose adjustment may be required. ( 5.2 ) HIV resistance may emerge in chronic hepatitis B patients with unrecognized or untreated HIV infection. ( 5.3 ) Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogues. ( 5.4 )
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Medical Disclaimer: This content is for informational purposes for claims professionals and care workers. It is not medical advice. Always consult a qualified healthcare professional for clinical decisions. Drug information is sourced from TGA, FDA, MHRA, PBS, NICE, and CDC databases and may not reflect the latest updates. AllMeds does not replace clinical judgement.