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Patient Information

Advise the patient to read the FDA-approved patient labeling(Patient Information).

  • Inform patients of the potential risks and benefits of adefovir dipivoxil tablets and of alternative modes of therapy.
  • Instruct patients to:
    • Follow a regular dosing schedule to avoid missing doses.
    • Immediately report any severe abdominal pain, muscle pain, yellowing of the eyes, dark urine, pale stools, and/or loss in appetite.
    • Inform their doctor or pharmacist if they develop any unusual symptom(s), or if any known symptom persists or worsens.
  • Advise patients that:
    • The optimal duration of adefovir dipivoxil tablets treatment and the relationship between treatment response and long-term outcomes such as hepatocellular carcinoma or decompensated cirrhosis are not known.
    • Patients should not discontinue adefovir dipivoxil tablets without first informing their physician[See Warnings and Precautions (5.1)].
    • Routine laboratory monitoring and follow-up with a physician is important during adefovir dipivoxil therapy.
    • Obtaining HIV antibody testing prior to starting adefovir dipivoxil tablets is important[See Warnings and Precautions (5.3)].
    • Adefovir dipivoxil tablets should not be administered concurrently with ATRIPLA or COMPLERA or STRIBILD or TRUVADA or VIREAD[See Warnings and Precautions (5.5)].
    • Lamivudine-resistant patients should use adefovir dipivoxil tablets in combination with lamivudine and not as adefovir dipivoxil tablets monotherapy[See Warnings and Precautions. (5.6)].
  • Inform patients that there is an antiretroviral pregnancy registry to monitor fetal outcomes of pregnant women exposed to adefovir dipivoxil [see Use in Specific Populations (8.1)].

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