Renal Dose Adjustment (Based on CrCl)
- 60 mL/min and at least 60 kg: 200 mg PO bid
- 60 mL/min and <60 kg: 125 mg PO bid
- 30-59 mL/min and at least 60 kg: CAPS 200 mg PO qd or oral SOLN 200 mg PO qd or 100 mg PO bid
- 30-59 mL/min and <60 kg: CAPS 125 mg PO qd or SOLN 150 mg PO qd or SOLN 75 mg bid
- 10-29 mL/min and at least 60 kg: CAPS 125 mg PO qd; SOLN 150 mg PO qd
- 10-29 mL/min and < 60 kg: CAPS 125 mg PO qd; SOLN 100 mg qd
- <10 mL/min and at least 60 kg: SOLN 100 mg PO qd
- <100 mL/min and < 60 kg: SOLN 75 mg PO qd
- Hemodialysis and continuous ambulatory peritoneal dialysis, same as CrCl <10; supplemental doses unnecessary.
Hepatic Dose Adjustment
- Hepatic impairment: Use with caution; monitor closely for toxicity
- Fatal and nonfatal pancreatitis has occurred during monotherapy or in combination regimens in both treatment-naive and treatment-experienced patients, regardless of degree of immunosuppression. Suspend therapy in patients with suspected pancreatitis and discontinue in patients with confirmed pancreatitis (US Black Box Warning). Patients having therapy in combination with stavudine are at increased risk for pancreatitis
- Use the drug with extreme caution and only if clearly indicated in patients having risk factors for pancreatitis. Closely monitor patients with advanced HIV-1 infection, especially geriatrics, as they are at increased risk of pancreatitis
- Dose modification is essential in patients with renal impairment
- Women are more prone to lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, with the use of nucleoside analogs alone or in combination with other antiretrovirals (US Black Box Warning); obesity and prolonged therapy with nucleosides are the associated risk factors
- Fatal lactic acidosis has occurred in pregnant women treated with the combination of didanosine and stavudine with other antiretroviral agents
- The combination of didanosine and stavudine should be used with caution during pregnancy and is recommended only if the potential benefit clearly outweighs the potential risk (US Black Box Warning)
- Therapy should be suspended if the patient develops clinical signs or symptoms with or without laboratory findings consistent with symptomatic hyperlactatemia, lactic acidosis, or pronounced hepatotoxicity
- Safety and efficacy have not been established in HIV-infected patients with significant underlying liver disease
- Monitor patients with preexisting liver dysfunction, including chronic active hepatitis, having an increased frequency of liver function abnormalities, including severe and potentially fatal hepatic adverse events; on evidence of worsening liver disease in such patients, consider interruption or discontinuation of therapy
- Avoid combination of hydroxyurea, didanosine, and stavudine as fatal hepatic events have occurred
- Hepatotoxicity and hepatic failure resulting in death have occurred during post-marketing surveillance in HIV-infected patients treated with hydroxyurea and other antiretroviral agents
- Post-marketing cases of non-cirrhotic portal hypertension have occurred, including cases leading to liver transplantation or death
- Monitor patients for early signs of portal hypertension during routine medical visits
- Perform LFTs, complete blood count, international normalized ratio (INR) and ultrasonography
- Discontinue therapy in patients with evidence of non-cirrhotic portal hypertension
- Patients with advanced HIV disease, history of neuropathy, or patients being treated with neurotoxic drug including stavudine are more prone to peripheral neuropathy. Discontinue therapy on occurrence of peripheral neuropathy.
- Retinal changes and optic neuritis have occurred in patients taking didanosine. Periodically perform retinal examinations
- Immune reconstitution syndrome has occurred in patients treated with combination antiretroviral therapy
- During the initial phase of combination antiretroviral treatment, patients may develop an inflammatory response to indolent or residual opportunistic infections. Further evaluation and treatment is needed.
- Redistribution/accumulation of body fat including central obesity, dorsocervical fat enlargement (buffalo hump), peripheral wasting, facial wasting, breast enlargement, and "cushingoid appearance" have occurred in patients receiving antiretroviral therapy
Cautions: Use cautiously in:
- Renal impairment
- Hepatic impairment
- Risk of hepatic disease
- History of peripheral neuropathy
- Prolonged therapy with nucleoside
- Concurrent neurotoxic agents
- Gout
- Advanced HIV disease
- Females
- Obesity
Pregnancy Category:B
Breastfeeding: HIV-infected mothers should generally not breastfeed their infants. In countries in which no acceptable, feasible, sustainable and safe replacement feeding is available, exclusive breastfeeding for 6 months is recommended for HIV-infected mothers to reduce the risk of HIV transmission from the mother to the infant compared with mixed feeding. In these settings, abrupt weaning at 4 months does not reduce the risk of HIV transmission or produce an overall health benefit compared to continued breastfeeding, and increases the risk of infant death in HIV-infected infants. Extended antiretroviral prophylaxis in breastfed infants with antiretroviral reduces the rate of HIV transmission during breastfeeding by about half, but the optimal regimen and duration of prophylaxis has not yet been defined. Prefer an alternate drug especially while nursing a newborn or preterm infant as there is little published experience with emtricitabine during breastfeeding. This information is based upon LactMed database (available at http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT last accessed 31 December 2010). Centers for disease control and prevention recommend that to avoid risking postnatal transmission of HIV-1 infected mothers should not breast-feed their infants. Unknown whether didanosine is excreted in human milk. Manufacturer advises to instruct infected mothers to avoid breast-feeding during therapy because of both the potential for HIV-1 transmission and the potential for serious adverse reactions in nursing infants.
Pricing data from www.DrugStore.com in U.S.A.
- Videx 4 GM SOLR [Bottle] (B-M SQUIBB ONCOLOGY/IMMUNOLOGY)
200 gm = $119.99
600 gm = $339.99 - Didanosine 200 MG CPDR [Bottle] (TEVA PHARMACEUTICALS USA)
30 mg = $158.99
90 mg = $438.95 - Didanosine 400 MG CPDR [Bottle] (TEVA PHARMACEUTICALS USA)
30 mg = $253.42
90 mg = $730.95 - Videx EC 400 MG CPDR [Bottle] (B-M SQUIBB ONCOLOGY/IMMUNOLOGY)
30 mg = $376.38
90 mg = $1109.77 - Didanosine 250 MG CPDR [Bottle] (TEVA PHARMACEUTICALS USA)
30 mg = $173.99
90 mg = $479.97 - Videx EC 250 MG CPDR [Bottle] (B-M SQUIBB ONCOLOGY/IMMUNOLOGY)
30 mg = $259.99
90 mg = $747.94
Warning: This pricing information is subject to change at the sole discretion of DS Pharmacy. For the most current and up-to-date pricing information, please visit drugstore.com.
