Didanosine

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Side Effects & Adverse Reactions

1. Pancreatitis:

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.

2. Lactic Acidosis/Severe Hepatomegaly with Steatosis:

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).

3. Retinal Changes and Optic Neuritis

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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Manufacturer Warnings

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FDA Labeling Changes

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Uses

Didanosine delayed-release capsules in combination with other antiretroviral agents is indicated for the treatment of HIV-1 infection in adults. (See Clinical Studies.)

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.

Treatment Response Through week 48* chart

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).

Table 7: Outcomes of Randomized Treatment Through Week 48, AI454-152
	Percent of Patients with HIV RNA <400 copies/mL (<50 copies/mL)
Outcome	didanosine+ stavudine+ nelfinavir n=258	zidovudine/ lamivudinea+ nelfinavir n=253
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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History

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Other Information

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.

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Didanosine Manufacturers

American Health Packaging

Didanosine | American Health Packaging

Adults:
Didanosine should be administered on an empty stomach. Didanosine delayed-release capsules should be swallowed intact.

The recommended daily dose is dependent on body weight and is adminstered as one capsule given on a once-daily schedule as outlined in Table 12.
Table 12: Dosing of Didanosine Delayed-Release Capsules Patient Weight Dosage ≥60 kg 400 mg once daily <60 kg 250 mg once daily Pediatric Patients
Didanosine delayed-release capsules have not been studied in pediatric patients. Please consult the complete prescribing information for didanosine chewable/dispersible buffered tablets and pediatric powder for oral solution for dosage and administration of didanosine to pediatric patients.
Dose Adjustment:
Clinical and laboratory signs suggestive of pancreatitis should prompt dose suspension and careful evaluation of the possibility of pancreatitis. Didanosine use should be discontinued in patients with confirmed pancreatitis (see WARNINGS and PRECAUTIONS, Drug Interactions

). Based on data with buffered didanosine formulations, patients with symptoms of peripheral neuropathy may tolerate a reduced dose of didanosine after resolution of the symptoms of peripheral neuropathy upon drug interruption. If neuropathy recurs after resumption of didanosine, permanent discontinuation of didanosine should be considered.
Concomitant Therapy:
Tenofovir disoproxil fumarate. A dose reduction of didanosine delayed-release capsules to 250 mg (adults weighing ≥60 kg with creatinine clearance ≥60 mL/min) or 200 mg (adults weighing ≥60 kg with creatinine clearance ≥60 mL/min) once taken daily together with tenofovir and a light meal (≤400 kcalories, ≤20% fat) or in the fasted state is recommended. The appropriate dose of didanosine delayed-release capsules coadministered with tenofovir in patients with creatinine clearance <60 mL/min has not been established. (See CLINICAL PHARMACOLOGY, Drug Interactions and PRECAUTIONS, Drug Interactions.)
Renal Impairment:
Dosing recommendations for didanosine delayed-release capsules and didanosine buffered formulations are different for patients with renal impairment. Please consult the complete prescribing information on administration of didanosine buffered formulations to patients with renal impairment. In adult patients with impaired renal function, the dose of didanosine should be adjusted to compensate for the slower rate of elimination. The recommended doses and dosing intervals of didanosine in adult patients with renal insufficiency are presented in Table 13.
Table 13: Recommended Dosage of Didanosine in Renal Impairment by Body Weighta Dosage (mg) Creatinine Clearance (mL/min) ≥ 60 kg < 60 kg 60 400 once daily 250 once daily 30 to 59 200 once daily 125 once daily 10 to 29 125 once daily 125 once daily <10 125 once ddaily b
aBased on studies using a buffered formulation of didanosine

bNot suitable for use in patients <60 kg with CLCR <10 mL/min. An alternate formulation of didanosine should be used.
Patients Requiring Continuous Ambulatory Peritoneal Dialysis (CAPD) or Hemodialysis:
For patients requiring CAPD or hemodialysis, follow dosing recommendations for patients with creatinine clearance less than 10 mL/min, shown in Table 13. It is not necessary to administer a supplement dose of didanosine following hemodialysis.
Hepatic Impairment:
(See WARNINGS and PRECAUTIONS.)

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American Health Packaging

Didanosine | American Health Packaging

Adults:
Didanosine should be administered on an empty stomach. Didanosine delayed-release capsules should be swallowed intact.

The recommended daily dose is dependent on body weight and is adminstered as one capsule given on a once-daily schedule as outlined in Table 12.
Table 12: Dosing of Didanosine Delayed-Release Capsules Patient Weight Dosage ≥60 kg 400 mg once daily <60 kg 250 mg once daily Pediatric Patients
Didanosine delayed-release capsules have not been studied in pediatric patients. Please consult the complete prescribing information for didanosine chewable/dispersible buffered tablets and pediatric powder for oral solution for dosage and administration of didanosine to pediatric patients.
Dose Adjustment:
Clinical and laboratory signs suggestive of pancreatitis should prompt dose suspension and careful evaluation of the possibility of pancreatitis. Didanosine use should be discontinued in patients with confirmed pancreatitis (see WARNINGS and PRECAUTIONS, Drug Interactions

). Based on data with buffered didanosine formulations, patients with symptoms of peripheral neuropathy may tolerate a reduced dose of didanosine after resolution of the symptoms of peripheral neuropathy upon drug interruption. If neuropathy recurs after resumption of didanosine, permanent discontinuation of didanosine should be considered.
Concomitant Therapy:
Tenofovir disoproxil fumarate. A dose reduction of didanosine delayed-release capsules to 250 mg (adults weighing ≥60 kg with creatinine clearance ≥60 mL/min) or 200 mg (adults weighing ≥60 kg with creatinine clearance ≥60 mL/min) once taken daily together with tenofovir and a light meal (≤400 kcalories, ≤20% fat) or in the fasted state is recommended. The appropriate dose of didanosine delayed-release capsules coadministered with tenofovir in patients with creatinine clearance <60 mL/min has not been established. (See CLINICAL PHARMACOLOGY, Drug Interactions and PRECAUTIONS, Drug Interactions.)
Renal Impairment:
Dosing recommendations for didanosine delayed-release capsules and didanosine buffered formulations are different for patients with renal impairment. Please consult the complete prescribing information on administration of didanosine buffered formulations to patients with renal impairment. In adult patients with impaired renal function, the dose of didanosine should be adjusted to compensate for the slower rate of elimination. The recommended doses and dosing intervals of didanosine in adult patients with renal insufficiency are presented in Table 13.
Table 13: Recommended Dosage of Didanosine in Renal Impairment by Body Weighta Dosage (mg) Creatinine Clearance (mL/min) ≥ 60 kg < 60 kg 60 400 once daily 250 once daily 30 to 59 200 once daily 125 once daily 10 to 29 125 once daily 125 once daily <10 125 once ddaily b
aBased on studies using a buffered formulation of didanosine

bNot suitable for use in patients <60 kg with CLCR <10 mL/min. An alternate formulation of didanosine should be used.
Patients Requiring Continuous Ambulatory Peritoneal Dialysis (CAPD) or Hemodialysis:
For patients requiring CAPD or hemodialysis, follow dosing recommendations for patients with creatinine clearance less than 10 mL/min, shown in Table 13. It is not necessary to administer a supplement dose of didanosine following hemodialysis.
Hepatic Impairment:
(See WARNINGS and PRECAUTIONS.)

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State Of Florida Doh Central Pharmacy

Didanosine | State Of Florida Doh Central Pharmacy

Didanosine delayed-release capsules should be administered on an empty stomach. Didanosine delayed-release capsules should be swallowed intact.
2.1 Recommended Dosage (Adult and Pediatric Patients)
The recommended total daily dose is based on body weight and is administered as one capsule given on a once-daily schedule as outlined in Table 1.

The recommended total daily dose to be administered once daily to pediatric patients weighing at least 20 kg who can swallow capsules is based on body weight (kg), consistent with the recommended adult dosing guidelines (see Table 1). Please consult the complete prescribing information for Didanosine Pediatric Powder for Oral Solution for dosage and administration of didanosine to pediatric patients weighing less than 20 kg or who can not swallow capsules.
Table 1: Recommended Dosage (Adult and Pediatric Patients) Body Weight Dose 20 kg to less than 25 kg 200 mg once daily 25 kg to less than 60 kg 250 mg once daily at least 60 kg 400 mg once daily

2.2 Renal Impairment
Dosing recommendations for didanosine delayed-release capsules and didanosine buffered formulations are different for patients with renal impairment. Please consult the complete prescribing information on administration of didanosine buffered formulations to patients with renal impairment.

Adult Patients

In adult patients with impaired renal function, the dose of didanosine should be adjusted to compensate for the slower rate of elimination. The recommended doses and dosing intervals of didanosine in adult patients with renal insufficiency are presented in Table 2.
Table 2: Recommended Dosage in Patients with Renal Impairment by Body Weight* * Based on studies using a buffered formulation of didanosine. † Not suitable for use in patients less than 60 kg with CL cr less than 10 mL/min. An alternate formulation of didanosine should be used.
Creatinine Clearance
(mL/min) Dosage (mg) at least 60 kg less than 60 kg at least 60 400 once daily 250 once daily 30 to 59 200 once daily 125 once daily 10 to 29 125 once daily 125 once daily less than 10 125 once daily †

Pediatric Patients

Urinary excretion is also a major route of elimination of didanosine in pediatric patients, therefore the clearance of didanosine may be altered in pediatric patients with renal impairment. Although there are insufficient data to recommend a specific dose adjustment of didanosine in this patient population, a reduction in the dose should be considered (see Table 2).

Patients Requiring Continuous Ambulatory Peritoneal Dialysis (CAPD) or Hemodialysis

For patients requiring CAPD or hemodialysis, follow dosing recommendations for patients with creatinine clearance of less than 10 mL/min, shown in Table 2. It is not necessary to administer a supplemental dose of didanosine following hemodialysis.
2.3 Dose Adjustment
Concomitant Therapy with Tenofovir Disoproxil Fumarate

In patients who are also taking tenofovir disoproxil fumarate, a dose reduction of didanosine delayed-release capsules to 250 mg (adults weighing at least 60 kg with creatinine clearance of at least 60 mL/min) or 200 mg (adults weighing less than 60 kg with creatinine clearance of at least 60 mL/min) once daily taken together with tenofovir disoproxil fumarate and a light meal (400 kcalories or less, 20% fat or less) or in the fasted state is recommended. The appropriate dose of didanosine delayed-release capsules coadministered with tenofovir disoproxil fumarate in patients with creatinine clearance of less than 60 mL/min has not been established [see Drug Interactions (7 ) and Clinical Pharmacology(12.3)].

Hepatic Impairment

No dose adjustment is required in patients with hepatic impairment [see Warnings andPrecautions (5.3) and Clinical Pharmacology (12.3)].

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Aurobindo Pharma Limited

Didanosine | Aurobindo Pharma Limited

Didanosine delayed-release capsules should be administered on an empty stomach. Didanosine delayed-release capsules should be swallowed intact. 2.1 Recommended Dosage (Adult and Pediatric Patients)
The recommended total daily dose is based on body weight and is administered as one capsule given on a once-daily schedule as outlined in Table 1.

The recommended total daily dose to be administered once daily to pediatric patients weighing at least 20 kg who can swallow capsules is based on body weight (kg), consistent with the recommended adult dosing guidelines (see Table 1). Please consult the complete prescribing information for didanosine pediatric powder for oral solution for dosage and administration of didanosine to pediatric patients weighing less than 20 kg or who can not swallow capsules.
Table 1: Recommended Dosage (Adult and Pediatric Patients) Body Weight Dose 20 kg to less than 25 kg
200 mg once daily
25 kg to less than 60 kg
250 mg once daily
at least 60 kg
400 mg once daily
2.2 Renal Impairment
Dosing recommendations for didanosine delayed-release capsules and didanosine pediatric powder for oral solution are different for patients with renal impairment. Please consult the complete prescribing information on administration of didanosine pediatric powder for oral solution to patients with renal impairment.

Adult Patients

In adult patients with impaired renal function, the dose of didanosine delayed-release capsules should be adjusted to compensate for the slower rate of elimination. The recommended doses and dosing intervals of didanosine delayed-release capsules in adult patients with renal insufficiency are presented in Table 2.
Table 2: Recommended Dosage in Patients with Renal Impairment by Body Weighta Creatinine
Clearance
(mL/min) Dosage (mg) at least 60 kg less than 60 kg a Based on studies using a buffered formulation of didanosine.
b Not suitable for use in patients less than 60 kg with CLcr less than 10 mL/min. An alternate formulation of didanosine should be used.
at least 60
30-59
10-29
less than 10
400 once daily
200 once daily
125 once daily
125 once daily
250 once daily
125 once daily
125 once daily
b

Pediatric Patients

Urinary excretion is also a major route of elimination of didanosine in pediatric patients, therefore the clearance of didanosine may be altered in pediatric patients with renal impairment. Although there are insufficient data to recommend a specific dose adjustment of didanosine delayed-release capsules in this patient population, a reduction in the dose should be considered (see Table 2).

Patients Requiring Continuous Ambulatory Peritoneal Dialysis (CAPD) or Hemodialysis

For patients requiring CAPD or hemodialysis, follow dosing recommendations for patients with creatinine clearance of less than 10 mL/min, shown in Table 2. It is not necessary to administer a supplemental dose of didanosine following hemodialysis. 2.3 Dose Adjustment
Concomitant Therapy with Tenofovir Disoproxil Fumarate

In patients who are also taking tenofovir disoproxil fumarate, a dose reduction of didanosine delayed-release capsules to 250 mg (adults weighing at least 60 kg with creatinine clearance of at least 60 mL/min) or 200 mg (adults weighing less than 60 kg with creatinine clearance of at least 60 mL/min) once daily taken together with tenofovir disoproxil fumarate and a light meal (400 kcalories or less, 20% fat or less) or in the fasted state is recommended. The appropriate dose of didanosine delayed-release capsules coadministered with tenofovir disoproxil fumarate in patients with creatinine clearance of less than 60 mL/min has not been established [see Drug Interactions (7) and Clinical Pharmacology (12.3)].

Hepatic Impairment

No dose adjustment is required in patients with hepatic impairment [see Warnings and Precautions (5.3) and Clinical Pharmacology (12.3)].

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Mylan Pharmaceuticals Inc.

Didanosine | Bausch & Lomb Incorporated

Instill one drop of BEPREVE into the affected eye(s) twice a day (BID).

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Physicians Total Care, Inc.

Didanosine | Physicians Total Care, Inc.

Didanosine delayed-release capsules should be administered on an empty stomach. Didanosine delayed-release capsules should be swallowed intact.
2.1 Recommended Dosage (Adult and Pediatric Patients)
The recommended total daily dose is based on body weight and is administered as one capsule given on a once-daily schedule as outlined in Table 1.

The recommended total daily dose to be administered once daily to pediatric patients weighing at least 20 kg who can swallow capsules is based on body weight (kg), consistent with the recommended adult dosing guidelines (see Table 1). Please consult the complete prescribing information for Didanosine Pediatric Powder for Oral Solution for dosage and administration of didanosine to pediatric patients weighing less than 20 kg or who can not swallow capsules.
Table 1: Recommended Dosage (Adult and Pediatric Patients) Body Weight Dose 20 kg to less than 25 kg 200 mg once daily 25 kg to less than 60 kg 250 mg once daily at least 60 kg 400 mg once daily

2.2 Renal Impairment
Dosing recommendations for didanosine delayed-release capsules are different for patients with renal impairment.

Adult Patients

In adult patients with impaired renal function, the dose of didanosine delayed-release capsules should be adjusted to compensate for the slower rate of elimination. The recommended doses and dosing intervals of didanosine delayed-release capsules in adult patients with renal insufficiency are presented in Table 2.
Table 2: Recommended Dosage in Patients with Renal Impairment by Body Weight
Creatinine Clearance
(mL/min) Dosage (mg) at least 60 kg less than 60 kg at least 60 400 once daily 250 once daily 30 to 59 200 once daily 125 once daily 10 to 29 125 once daily 125 once daily less than 10 125 once daily

Pediatric Patients

Urinary excretion is also a major route of elimination of didanosine in pediatric patients, therefore the clearance of didanosine may be altered in pediatric patients with renal impairment. Although there are insufficient data to recommend a specific dose adjustment of didanosine delayed-release capsules in this patient population, a reduction in the dose should be considered (see Table 2).

Patients Requiring Continuous Ambulatory Peritoneal Dialysis (CAPD) or Hemodialysis

For patients requiring CAPD or hemodialysis, follow dosing recommendations for patients with creatinine clearance of less than 10 mL/min, shown in Table 2. It is not necessary to administer a supplemental dose of didanosine following hemodialysis.
2.3 Dose Adjustment
Concomitant Therapy with Tenofovir Disoproxil Fumarate

In patients who are also taking tenofovir disoproxil fumarate, a dose reduction of didanosine delayed-release capsules to 250 mg (adults weighing at least 60 kg with creatinine clearance of at least 60 mL/min) or 200 mg (adults weighing less than 60 kg with creatinine clearance of at least 60 mL/min) once daily taken together with tenofovir disoproxil fumarate and a light meal (400 kcalories or less, 20% fat or less) or in the fasted state is recommended. The appropriate dose of didanosine delayed-release capsules coadministered with tenofovir disoproxil fumarate in patients with creatinine clearance of less than 60 mL/min has not been established [see Drug Interactions (7) and Clinical Pharmacology(12.3)].

Hepatic Impairment

No dose adjustment is required in patients with hepatic impairment [see Warnings andPrecautions (5.3) and Clinical Pharmacology (12.3)].

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Barr Laboratories Inc.

Didanosine | Barr Laboratories Inc.

Didanosine delayed-release capsules should be administered on an empty stomach. Didanosine delayed-release capsules should be swallowed intact.
2.1 Recommended Dosage (Adult and Pediatric Patients)
The recommended total daily dose is based on body weight and is administered as one capsule given on a once-daily schedule as outlined in Table 1.

The recommended total daily dose to be administered once daily to pediatric patients weighing at least 20 kg who can swallow capsules is based on body weight (kg), consistent with the recommended adult dosing guidelines (see Table 1). Please consult the complete prescribing information for Didanosine Pediatric Powder for Oral Solution for dosage and administration of didanosine to pediatric patients weighing less than 20 kg or who can not swallow capsules.
Table 1: Recommended Dosage (Adult and Pediatric Patients)
Body Weight

Dose

20 kg to less than 25 kg

200 mg once daily

25 kg to less than 60 kg

250 mg once daily

at least 60 kg

400 mg once daily

2.2 Renal Impairment
Dosing recommendations for didanosine delayed-release capsules are different for patients with renal impairment.

Adult Patients

In adult patients with impaired renal function, the dose of didanosine delayed-release capsules should be adjusted to compensate for the slower rate of elimination. The recommended doses and dosing intervals of didanosine delayed-release capsules in adult patients with renal insufficiency are presented in Table 2.
Table 2: Recommended Dosage in Patients with Renal Impairment by Body Weighta
Creatinine Clearance

(mL/min)

Dosage (mg)

at least 60 kg

less than 60 kg
at least 60
400 once daily

250 once daily

30 to 59

200 once daily

125 once daily

10 to 29

125 once daily

125 once daily

less than 10

125 once daily

b

a Based on studies using a buffered formulation of didanosine.

b Not suitable for use in patients less than 60 kg with CLcr less than 10 mL/min. An alternate formulation of didanosine should be used.

Pediatric Patients

Urinary excretion is also a major route of elimination of didanosine in pediatric patients, therefore the clearance of didanosine may be altered in pediatric patients with renal impairment. Although there are insufficient data to recommend a specific dose adjustment of didanosine delayed-release capsules in this patient population, a reduction in the dose should be considered (see Table 2).

Patients Requiring Continuous Ambulatory Peritoneal Dialysis (CAPD) or Hemodialysis

For patients requiring CAPD or hemodialysis, follow dosing recommendations for patients with creatinine clearance of less than 10 mL/min, shown in Table 2. It is not necessary to administer a supplemental dose of didanosine following hemodialysis.
2.3 Dose Adjustment
Concomitant Therapy with Tenofovir Disoproxil Fumarate

In patients who are also taking tenofovir disoproxil fumarate, a dose reduction of didanosine delayed-release capsules to 250 mg (adults weighing at least 60 kg with creatinine clearance of at least 60 mL/min) or 200 mg (adults weighing less than 60 kg with creatinine clearance of at least 60 mL/min) once daily taken together with tenofovir disoproxil fumarate and a light meal (400 kcalories or less, 20% fat or less) or in the fasted state is recommended. The appropriate dose of didanosine delayed-release capsules coadministered with tenofovir disoproxil fumarate in patients with creatinine clearance of less than 60 mL/min has not been established [see Drug Interactions (7) and Clinical Pharmacology (12.3)].

Hepatic Impairment

No dose adjustment is required in patients with hepatic impairment [see Warnings and Precautions (5.3) and Clinical Pharmacology (12.3)].

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