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Side Effects & Adverse Reactions
FATAL AND NONFATAL PANCREATITIS HAVE OCCURRED DURING THERAPY WITH DIDANOSINE USED ALONE OR IN COMBINATION REGIMENS IN BOTH TREATMENT-NAIVE AND TREATMENT-EXPERIENCED PATIENTS, REGARDLESS OF DEGREE OF IMMUNOSUPPRESSION. DIDANOSINE SHOULD BE SUSPENDED IN PATIENTS WITH SIGNS OR SYMPTOMS OF PANCREATITIS AND DISCONTINUED IN PATIENTS WITH CONFIRMED PANCREATITIS. PATIENTS TREATED WITH DIDANOSINE IN COMBINATION WITH STAVUDINE, WITH OR WITHOUT HYDROXYUREA, MAY BE AT INCREASED RISK FOR PANCREATITIS.
When treatment with life-sustaining drugs known to cause pancreatic toxicity is required, suspension of didanosine therapy is recommended. In patients with risk factors for pancreatitis, didanosine should be used with extreme caution and only if clearly indicated. Patients with advanced HIV infection, especially the elderly, are at increased risk of pancreatitis and should be followed closely. Patients with renal impairment may be at greater risk for pancreatitis if treated without dose adjustment. The frequency of pancreatitis is dose related. In phase 3 studies with buffered formulations of didanosine, incidence ranged from 1% to 10% with doses higher than are currently recommended and 1% to 7% with recommended dose.
Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogues alone or in combination, including didanosine and other antiretrovirals. A majority of these cases have been in women. Obesity and prolonged nucleoside exposure may be risk factors. Fatal lactic acidosis has been reported in pregnant women who received 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 (see PRECAUTIONS, Pregnancy, Reproduction and Fertility). Particular caution should be exercised when administering didanosine to any patient with known risk factors for liver disease; however, cases have also been reported in patients with no known risk factors. Treatment with didanosine should be suspended in any patient who develops clinical or laboratory findings suggestive of symptomatic hyperlactatemia, lactic acidosis, or pronounced hepatotoxicity (which may include hepatomegaly and steatosis even in the absence of marked transaminase elevations).
Retinal changes and optic neuritis have been reported in patients taking didanosine. Periodic retinal examinations should be considered for patients receiving didanosine (see ADVERSE REACTIONS.)
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Didanosine delayed-release capsules in combination with other antiretroviral agents is indicated for the treatment of HIV-1 infection in adults. (See Clinical Studies.)
Study AI454-152 was a 48-week, randomized, open-label study comparing didanosine (400 mg once daily) plus stavudine (40 mg twice daily) plus nelfinavir (750 mg three times daily) to zidovudine (300 mg) plus lamivudine (150 mg) combination tablets twice daily plus nelfinavir (750 mg three times daily) in 511 treatment-naive patients, with a mean CD4 cell count of 411 cells/mm3(range 39 to 1105 cells/mm3) and a mean plasma HIV-1 RNA of 4.71 log10 copies/mL (range 2.8 to 5.9 log10 copies/mL) at baseline. Patients were primarily males (72%) and Caucasian (53%) with a mean age of 35 years (range 18 to 73 years). The percentages of patients with HIV-1 RNA <400 and <50 copies/mL and outcomes of patients through 48 weeks are summarized in Figure 1 and Table 7, respectively.
Figure 1 Treatment Response Through Week 48*, AI454-152
○● didanosine + stavudine + nelfinavir, n= 258
∆▲ zidovudine/lamivudine + nelfinavir, n= 253
*Percent of patients at each time point who have HIV RNA <400 or <50 copies/mL and do not meet any criteria for treatment failure (eg, virologic failure or discontinuation for any reason).
|Percent of Patients with HIV RNA <400 copies/mL (<50 copies/mL)|
|Responderb, c||55% (33%)||56% (33%)|
|Virologic failured||22% (45%)||21% (43%)|
|Death or discontinued due to disease progression||1% (1%)||2% (2%)|
|Discontinued due to adverse event||6% (6%)||7% (7%)|
|Discontinued due to other reasonse||16% (16%)||15% (16%)|
|aZidovudine/lamivudine combination tablet.|
bCorresponds to rates at Week 48 in Figure 1.s decision, never treated, and other reasons.
cSubjects achieved and maintained confirmed HIV RNA <400 copies/mL (<50 copies/mL)
dIncludes viral rebound at or before Week 48 and failure to achieve confirmed HIV RNA <400 copies/mL (<50 copies/mL) through Week 48.
eIncludes lost to follow-up, subject's withdrawal, discontinuation due to physician
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Didanosine delayed-release capsules are an enteric-coated formulation of didanosine, (ddl), a synthetic purine nucleoside analogue active against the Human Immunodeficiency Virus (HIV). Didanosine delayed-release capsules, containing enteric-coated pellets, are available for oral administration in the strengths of 200 mg, 250 mg, and 400 mg of didanosine. The inactive ingredients include croscarmellose sodium, hydroxypropyl cellulose, hypromellose, methacrylic acid copolymer dispersion, microcrystalline cellulose, polydextrose, polyethylene glycol, silicon dioxide, sodium hydroxide, talc, titanium dioxide, triacetin and triethyl citrate.The capsule shell contains FD&C blue no.1, gelatin, and titanium dioxide.The 200 mg capsule shell also contains D&C red no. 33, and FD&C yellow no. 6. The 250 mg capsule shell also contains D&C red no. 28. The 400 mg capsule shell also contains D&C red no.33, and FD&C yellow no. 6. The edible imprinting ink contains D&C yellow no. 10 aluminum lake, FD&C blue no. 1 aluminum lake, FD&C blue no. 2 aluminum lake, FD&C red no. 40 aluminum lake, iron oxide, propylene glycol and shellac glaze.
The chemical name for didanosine is 2', 3'-dideoxyinosine. The structural formula is:
Didanosine is a white crystalline powder with the molecular formula C10H12N4O3 and a molecular weight of 236.2. The aqueous solubility of didanosine at 25° C and pH of approximately 6 is 27.3 mg/mL. Didanosine is unstable in acidic solutions. For example, at pH < 3 and 37° C, 10% of didanosine decomposes to hypoxanthine in less than 2 minutes. In didanosine delayed-release capsules, an enteric coating is used to protect didanosine from degradation by stomach acid.
- American Health Packaging
- American Health Packaging
- State Of Florida Doh Central Pharmacy
- Aurobindo Pharma Limited
- Mylan Pharmaceuticals Inc.
- Physicians Total Care, Inc.
- Barr Laboratories Inc.
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