Version May 2024
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 the degree of immunosuppression. Suspend didanosine in patients with suspected pancreatitis; discontinue didanosine in patients with confirmed pancreatitis.
Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogs alone or in combination, including didanosine and other antiretrovirals. Fatal lactic acidosis has been reported in pregnant individuals who received the combination of didanosine and stavudine with other antiretroviral agents. Coadministration of didanosine and stavudine is contraindicated because of increased risk of serious and/or life-threatening events. Suspend treatment if clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity occur.
Note: All Videx formulations (brand and generic) have been discontinued in the United States for more than 1 year.
HIV-1 infection, treatment: Oral:
Note: Didanosine is no longer recommended for use in the treatment of HIV (HHS [adult] 2019).
Dosing based on patient weight:
Pediatric powder for oral solution:
<60 kg: 125 mg twice daily (preferred) or 250 mg once daily
≥60 kg: 200 mg twice daily (preferred) or 400 mg once daily
Delayed-release capsule:
20 kg to <25 kg: 200 mg once daily
25 kg to <60 kg: 250 mg once daily
≥60 kg: 400 mg once daily
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
Dosing based on patient weight, creatinine clearance, and dosage form: See table.
|
Creatinine Clearance (mL/minute) |
≥60 kg |
<60 kg | ||
|---|---|---|---|---|
|
Powder for Oral Solution |
Delayed Release Capsule |
Powder for Oral Solution |
Delayed Release Capsule | |
|
Note: Per manufacturer, not suitable for use in patients <60 kg with CrCl <10 mL/minute; use alternate formulation. | ||||
|
≥60 |
200 mg twice daily (preferred) or 400 mg once daily |
400 mg once daily |
125 mg twice daily (preferred) or 250 mg once daily |
250 mg once daily |
|
30 to 59 |
200 mg once daily or 100 mg twice daily |
200 mg once daily |
150 mg once daily or 75 mg twice daily |
125 mg once daily |
|
10 to 29 |
150 mg once daily |
125 mg once daily |
100 mg once daily |
125 mg once daily |
|
<10 |
100 mg once daily |
125 mg once daily |
75 mg once daily |
See Note. |
Patients requiring hemodialysis or CAPD: Dose per CrCl <10 mL/minute. Didanosine is not removed via CAPD and minimal amount of dose (≤7%) is removed by hemodialysis; no supplemental dosing necessary.
No dosage adjustment necessary.
Refer to adult dosing. Elderly patients have a higher frequency of pancreatitis (10% versus 5% in younger patients); monitor renal function and dose accordingly.
(For additional information see "Didanosine (United States and Canada: Not available): Pediatric drug information")
Note: All Videx formulations (brand and generic) have been discontinued in the United States for more than 1 year.
Note: Gene mutation and antiretroviral (ARV) resistance patterns should be evaluated (refer to www.iasusa.org for more information) when necessary.
HIV-1 infection, treatment: Oral: Note: Although FDA approved, didanosine is no longer recommended for use in children and adolescents due to higher rates of adverse effects than other nucleoside reverse transcriptase inhibitors (HHS [pediatric] 2018). If used, should be in combination with other ARV agents:
Infants 1 to 8 months (HHS [pediatric] 2018): Oral solution:
Infants 1 to <3 months: 50 mg/m2/dose every 12 hours. Note: Manufacturer's labeling not recommended (100 mg/m2/dose); pharmacokinetic data suggest toxicity may occur at this higher dose (HHS [pediatric] 2018).
Infants ≥3 to 8 months: 100 mg/m2/dose every 12 hours.
Infants >8 months, Children, and Adolescents:
Oral solution:
Twice-daily dosing: Infants >8 months, Children, and Adolescents: 120 mg/m2/dose (range: 90 to 150 mg/m2/dose) every 12 hours; do not exceed weight-based adult dose (HHS [pediatric] 2018; manufacturer labeling).
Once-daily dosing for treatment-naive patients: Children ≥3 year and Adolescents: 240 mg/m2/dose once daily; maximum dose: 400 mg/dose (HHS [pediatric] 2018).
Delayed-release capsule: Children ≥6 years weighing ≥20 kg who are able to swallow a capsule whole:
20 kg to <25 kg: 200 mg once daily.
25 kg to <60 kg: 250 mg once daily.
≥60 kg: 400 mg once daily.
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
Infants, Children, and Adolescents: A decrease in dose should be considered in pediatric patients with renal impairment. The following guidelines have been used by some clinicians (Aronoff 2007): Oral: Oral solution:
GFR >50 mL/minute/1.73 m2: No adjustment required.
GFR 30 to 50 mL/minute/1.73 m2: 75 mg/m2/dose every 12 hours.
GFR 10 to 29 mL/minute/1.73 m2: 90 mg/m2/dose every 24 hours.
GFR <10 mL/minute/1.73 m2: 75 mg/m2/dose every 24 hours.
Hemodialysis: 75 mg/m2/dose every 24 hours after dialysis.
Peritoneal dialysis: 75 mg/m2/dose every 24 hours.
Continuous renal replacement therapy (CRRT): 75 mg/m2/dose every 12 hours.
All patients: No adjustment recommended.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. As reported in monotherapy studies; risk of toxicity may increase when combined with other agents.
>10%:
Central nervous system: Peripheral neuropathy (17% to 20%)
Endocrine & metabolic: Increased amylase (≥1.4 x ULN: 15% to 17%)
Gastrointestinal: Diarrhea (19% to 28%), abdominal pain (7% to 13%)
1% to 10%:
Dermatologic: Pruritus (≤9%), skin rash (≤9%)
Endocrine & metabolic: Increased uric acid (>12 mg/dL: 2% to 3%)
Gastrointestinal: Pancreatitis (6% to 7%)
Hepatic: Increased serum AST (>5 x ULN: 7% to 9%), increased serum ALT (>5 x ULN: 6% to 9%), increased serum alkaline phosphatase (>5 x ULN: 1% to 4%)
<1%, postmarketing, and/or case reports: Acute renal failure, alopecia, anaphylactoid reaction, anemia, anorexia, arthralgia, chills, diabetes mellitus, dyspepsia, fever, flatulence, hepatic failure, hepatitis, hyperglycemia, hypoglycemia, increased creatine phosphokinase, increased gamma-glutamyl transferase, lactic acidosis, leukopenia, lipoatrophy (buttocks, face, limbs), myalgia, myopathy, optic neuritis, pain, parotid gland enlargement, portal hypertension (noncirrhotic), retinal pigment changes (depigmentation), rhabdomyolysis, severe hepatomegaly with steatosis, sialadenitis, symptomatic hyperlactatemia, thrombocytopenia, weakness, xerophthalmia, xerostomia
Coadministration with allopurinol, ribavirin, or stavudine
Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
Canadian labeling: Additional contraindications (not in US labeling): Hypersensitivity to didanosine or any component of the formulation
Concerns related to adverse effects:
• Immune reconstitution syndrome: Patients may develop immune reconstitution syndrome resulting in the occurrence of an inflammatory response to an indolent or residual opportunistic infection during initial HIV treatment or activation of autoimmune disorders (eg, Graves’ disease, polymyositis, Guillain-Barré syndrome) later in therapy; further evaluation and treatment may be required.
• Lactic acidosis/hepatomegaly: [US Boxed Warning]: Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported, with nucleoside analogues alone or in combination, including didanosine and other antiretrovirals. Risk may be increased with female gender, obesity, or prolonged exposure. Fatal lactic acidosis has been reported in pregnant individuals who received the combination of didanosine and stavudine with other antiretroviral agents. Use caution when administering to patients with known risk factors for liver disease. Suspend treatment in any patient who develops clinical or laboratory findings suggestive of lactic acidosis or hepatotoxicity (transaminase elevation may/may not accompany hepatomegaly and steatosis).
• Lipoatrophy: May cause loss of subcutaneous fat, especially in the face, limbs, and buttocks. Lipoatrophy incidence and severity are related to cumulative exposure and may be only partially reversible. Monitor patients for signs of lipoatrophy and consider switching to a non-didanosine-containing regimen if lipoatrophy occurs.
• Noncirrhotic portal hypertension: Patients may develop noncirrhotic portal hypertension within months to years of starting didanosine therapy. Signs may include elevated liver enzymes, esophageal varices, hematemesis, ascites, and splenomegaly. Noncirrhotic portal hypertension may lead to liver failure and/or death. Discontinue use in patients with evidence of this condition.
• Ocular effects: Retinal changes (including retinal depigmentation) and optic neuritis have been reported in adults and children using didanosine; patients should undergo retinal examination periodically.
• Pancreatitis: [US Boxed Warning]: Pancreatitis (fatal and nonfatal) has been reported alone or in combination regimens in both treatment-naive and treatment-experienced patients, regardless of degree of immunosuppression. Suspend use in patients with suspected pancreatitis and discontinue in patients with confirmed pancreatitis; frequency is dose related. In patients with risk factors for pancreatitis, use with extreme caution and only if clearly indicated. Patients with advanced HIV-1 infection, especially the elderly, are at increased risk and should be followed closely. Patients with renal impairment may be at greater risk for pancreatitis if treated without dose adjustment.
• Peripheral neuropathy: Peripheral neuropathy (numbness, tingling or pain in the hands or feet) has been reported, more frequently in patients with advanced HIV disease, in patients with a history of neuropathy or in patients being treated with a neurotoxic drug. Discontinue therapy if neuropathy occurs.
Disease-related concerns:
• Hepatic impairment: Use with caution in patients with hepatic impairment; safety and efficacy have not been established in patients with significant hepatic disease. Patients on combination antiretroviral therapy with hepatic impairment may be at increased risk of potentially severe and fatal hepatic toxicity; consider interruption or discontinuation of therapy if hepatic impairment worsens.
• Renal impairment: Use with caution in patients with renal impairment; dose reduction recommended for CrCl <60 mL/minute.
Concurrent drug therapy issues:
• Hydroxyurea and stavudine: Fatal cases of hepatotoxicity/lactic acidosis, pancreatitis, and/or severe peripheral neuropathy have been reported in HIV patients treated with didanosine with hydroxyurea and stavudine; avoid use with hydroxyurea; coadministration with stavudine is contraindicated.
• Tenofovir disoproxil fumarate: Combined use may be associated with increased didanosine toxicity (eg, lactic acidosis, pancreatitis), immunologic nonresponse or CD4 cell decline despite viral suppression, early virologic failure and rapid resistance development; combined use is not recommended (HHS [adult] 2019); manufacturer labeling recommends a didanosine dose reduction if combination is used.
Dosage form specific issues:
• Delayed-release capsules: Didanosine delayed-release capsules are indicated for once-daily use.
• Powder for oral solution: Didanosine powder for oral solution is recommended for use in a twice daily regimen, as there is more efficacy evidence with twice daily administration.
Special populations:
• Pediatric: Dosing recommendations for didanosine powder for oral solution in patients younger than 2 weeks cannot be made because the pharmacokinetics of didanosine in these infants are too variable to determine an appropriate dose. Delayed-release capsules may be used in pediatric patients who weigh at least 20 kg.
Due to an increased risk of toxicities and the availability of alternate agents, didanosine is not recommended as part of an antiretroviral regimen in pediatric (HHS [pediatric] 2018) or in adolescent patients (HHS [adult] 2018). Fatal and nonfatal pancreatitis is more common in adults than children (1% to 7% vs 3% [normal doses]). Retinal depigmentation in children receiving doses >300 mg/m2/day may occur; retinal changes and optic neuritis have been reported in pediatric and adult patients; perform periodic retinal examinations.
All Videx formulations (brand and generic) have been discontinued in the United States for more than 1 year.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product
Capsule Delayed Release, Oral:
Videx EC: 125 mg [DSC], 200 mg [DSC], 250 mg [DSC]
Generic: 200 mg [DSC], 250 mg [DSC], 400 mg [DSC]
Solution Reconstituted, Oral:
Videx: 2 g (100 mL [DSC])
May be product dependent
Capsule, delayed release (Didanosine Oral)
200 mg (per each): $6.18
250 mg (per each): $7.87
400 mg (per each): $12.29
Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product
Capsule Delayed Release, Oral:
Videx EC: 125 mg [DSC], 200 mg [DSC], 250 mg [DSC], 400 mg [DSC]
Oral: Pediatric powder for oral solution: Administer on an empty stomach at least 30 minutes before or 2 hours after eating. Shake well prior to use.
Oral: Videx EC: Administer on an empty stomach at least 30 minutes before or 2 hours after eating; swallow capsule whole.
Bariatric surgery: Some institutions may have specific protocols that conflict with these recommendations; refer to institutional protocols as appropriate. After a Roux-en-Y gastric bypass, the portion of the stomach containing the majority of the hydrochloric acid-producing parietal cells is no longer in contact with food and drugs. The new small stomach pouch where food and drugs are received has a higher pH of 4 to 5 (similar to the duodenum). Therefore, the didanosine capsules could theoretically be opened and the enteric-coated beads sprinkled onto applesauce for administration since there would likely not be enough stomach acid left to destroy the drug. The powder for oral solution contains a buffer and may be appropriate for sleeve gastrectomy or lap band procedures.
Oral: Administer oral solution and delayed-release capsule on an empty stomach 30 minutes before or at least 2 hours after a meal. Some experts have recommended giving without regard to meals in order to improve compliance (HHS [pediatric] 2018).
Oral solution: Shake well before use. The solution contains antacids that may interfere with the absorption of other medications; see dosage interactions field for appropriate dosage spacing for administration of concomitant medications.
Delayed-release capsule: Swallow capsule whole; do not break open or chew. If administered with tenofovir, the delayed-release capsule may be administered with a light meal or in the fasted state.
Undergoes rapid degradation when exposed to an acidic environment; 10% of the drug decomposes to hypoxanthine in <2 minutes at pH <3 at 37°C.
An FDA-approved patient medication guide, which is available with the product information and as follows, must be dispensed with this medication:
Videx: https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020156s053lbl.pdf#page=32
Videx EC: http://www.fda.gov/downloads/Drugs/DrugSafety/UCM199212.pdf
HIV-1 infection: Treatment of HIV-1 infection in combination with other antiretroviral agents. Note: Didanosine is no longer recommended for use in the treatment of HIV (HHS [adult] 2019).
Videx may be confused with Bidex, Lidex
None known.
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.
Alcohol (Ethyl): May enhance the adverse/toxic effect of Didanosine. Specifically, the risk of pancreatitis may be increased. Risk X: Avoid combination
Allopurinol: May increase the serum concentration of Didanosine. Risk X: Avoid combination
Atazanavir: Didanosine may decrease the serum concentration of Atazanavir. Specifically, the buffered formulation of didanosine may decrease atazanavir absorption. Atazanavir may decrease the serum concentration of Didanosine. Reported with enteric coated didanosine capsules. Management: To avoid therapeutic failure of atazanavir, atazanavir should be administered 2 hours before or 1 hour after didanosine. This recommendation applies to both buffered didanosine products and enteric coated didanosine products. Risk D: Consider therapy modification
Cladribine: Agents that Undergo Intracellular Phosphorylation may diminish the therapeutic effect of Cladribine. Risk X: Avoid combination
Darunavir: May decrease the serum concentration of Didanosine. More specifically, this interaction is likely due to the effects of food (with which darunavir/ritonavir and darunavir/cobicistat are taken) on didanosine, which is supposed to be given on an empty stomach. Management: Didanosine should be administered 1 hour prior to or 2 hours after administration of darunavir/ritonavir or darunavir/cobicistat (which must be taken with food). Risk D: Consider therapy modification
Febuxostat: May increase the serum concentration of Didanosine. Risk X: Avoid combination
Ganciclovir-Valganciclovir: May increase the serum concentration of Didanosine. Risk C: Monitor therapy
Hydroxyurea: May enhance the adverse/toxic effect of Didanosine. An increased risk of pancreatitis, hepatotoxicity and/or neuropathy may exist. Didanosine may enhance the adverse/toxic effect of Hydroxyurea. An increased risk of pancreatitis, hepatotoxicity and/or neuropathy may exist. Risk X: Avoid combination
Indinavir: Didanosine may decrease the serum concentration of Indinavir. Management: Indinavir should be administered at least 1 hour apart from buffer-containing formulations of didanosine. Risk D: Consider therapy modification
Itraconazole: Didanosine may decrease the serum concentration of Itraconazole. Management: Administer itraconazole at least 2 hours prior to buffered didanosine. This interaction is not expected with enteric-coated didanosine capsules since they do not contain buffering agents. Risk D: Consider therapy modification
Ketoconazole (Systemic): Didanosine may decrease the serum concentration of Ketoconazole (Systemic). Management: Administer oral ketoconazole at least 2 hours prior to buffered didanosine. This interaction is not expected with enteric-coated didanosine capsules since they do not contain buffering agents. Risk D: Consider therapy modification
Levomethadone: May decrease the serum concentration of Didanosine. Risk C: Monitor therapy
Levonadifloxacin: Didanosine may decrease the serum concentration of Levonadifloxacin. Risk X: Avoid combination
Lopinavir: May decrease the serum concentration of Didanosine. This interaction refers only to lopinavir/ritonavir oral solution, which must be taken with food, and is principally the result of a food-didanosine interaction. Management: Didanosine should be administered 1 hour prior to or 2 hours after administration of lopinavir/ritonavir oral solution (which must be taken with food). Didanosine and lopinavir/ritonavir tablets can be administered together. Risk D: Consider therapy modification
Methadone: May decrease the serum concentration of Didanosine. Risk C: Monitor therapy
Orlistat: May decrease the serum concentration of Antiretroviral Agents. Risk C: Monitor therapy
Quinolones: May decrease the serum concentration of Didanosine. Didanosine may decrease the serum concentration of Quinolones. Management: Administer oral quinolones at least 2 hours before or 6 hours after didanosine. Monitor for decreased therapeutic effects of quinolones, particularly if doses cannot be separated as recommended. This does not apply to unbuffered enteric coated didanosine. Risk D: Consider therapy modification
Ribavirin (Oral Inhalation): May enhance the adverse/toxic effect of Didanosine. Ribavirin (Oral Inhalation) may increase serum concentrations of the active metabolite(s) of Didanosine. Risk X: Avoid combination
Ribavirin (Systemic): May enhance the adverse/toxic effect of Didanosine. Ribavirin (Systemic) may increase serum concentrations of the active metabolite(s) of Didanosine. Risk X: Avoid combination
Rilpivirine: May decrease the absorption of Didanosine. Didanosine may decrease the absorption of Rilpivirine. More specifically, simultaneous coadministration of these drugs creates a conflict between recommendations to administer with (rilpivirine) and without (didanosine) food. Management: Administer didanosine on an empty stomach at least 2 hours before or 4 hours after rilpivirine, due to the requirement that rilpivirine be administered with food. Risk D: Consider therapy modification
Stavudine: May enhance the adverse/toxic effect of Didanosine. The risk of lactic acidosis (possibly fatal), hepatomegaly, and pancreatitis may be increased with this combination. Risk X: Avoid combination
Tenofovir Disoproxil Fumarate: May diminish the therapeutic effect of Didanosine. Tenofovir Disoproxil Fumarate may increase the serum concentration of Didanosine. Management: Avoid use of tenofovir disoproxil fumarate and didanosine when possible. If combined in adults with CrCL greater than 60 mL/min, decrease didanosine to 250 mg daily if 60 kg or more or to 200 mg if less than 60 kg. Avoid if CrCL is less than 60 mL/min. Risk D: Consider therapy modification
Tipranavir: May decrease the serum concentration of Didanosine. Management: Separate didanosine and tipranavir administration by at least 2 hours to minimize any potential dosage form-related interaction. Monitor antiviral response closely in patients receiving didanosine in combination with tipranavir/ritonavir. Risk D: Consider therapy modification
Food decreases AUC and Cmax; serum levels may be decreased by 55%. Management: Administer on an empty stomach at least 30 minutes before or 2 hours after eating depending on dosage form.
Contraception is not required to initiate or continue antiretroviral therapy.
Based on the Health and Humans Services (HHS) perinatal HIV guidelines, didanosine is not one of the recommended antiretroviral agents for use in patients with HIV who are trying to conceive.
Maximum viral suppression sustained below the limits of detection prior to conception is recommended for all persons with HIV who are planning a pregnancy. Optimization of the health of the person who will become pregnant is recommended. Selection of or changes to a specific antiretroviral regimen prior to pregnancy should be done as part of a shared decision-making process. In most cases, recommendations from the HHS perinatal HIV guidelines (based on data obtained from cisgender women) can be applied to transgender and gender diverse people assigned female sex at birth.
Health care providers caring for couples planning a pregnancy when one or both partners are diagnosed with HIV may contact the National Perinatal HIV Hotline (1-888-448-8765) for clinical consultation (HHS [perinatal] 2023).
Didanosine crosses the placenta.
Outcome information specific to didanosine use in pregnancy is no longer being reviewed and updated in the Health and Human Services (HHS) perinatal guidelines. Fatal lactic acidosis has been reported in pregnant individuals using didanosine and stavudine in combination with other antiretroviral agents. The HHS perinatal HIV guidelines do not recommend didanosine use in pregnant patients due to toxicity, and patients who are pregnant should be changed to a preferred or alternative therapy.
Maternal antiretroviral therapy (ART) may be associated with adverse pregnancy outcomes including preterm birth, low birth weight, and small for gestational age infants. Actual risks may be influenced by maternal factors, such as disease severity, gestational age at initiation of therapy, and specific ART regimen, therefore close fetal monitoring is recommended. Because there is clear benefit to appropriate treatment, maternal ART should not be withheld due to concerns for adverse neonatal outcomes. Long-term follow-up is recommended for all infants exposed to antiretroviral medications; children not diagnosed with HIV but who were exposed to ART in utero or as a neonate and develop significant organ system abnormalities of unknown etiology (particularly of the CNS or heart) should be evaluated for potential metabolic dysfunction.
ART is recommended for all pregnant people with HIV to maximize their health, maintain the viral load below the limit of detection, and reduce the risk of perinatal transmission. Selection of or changes to a specific antiretroviral regimen during pregnancy should be done as part of a shared decision-making process. Patients on fully suppressive regimens prior to pregnancy generally may continue the same regimen considering known pregnancy outcomes and pharmacokinetic data. Monitoring of patients who are pregnant is more frequent than in patients who are not pregnant. ART initiated during pregnancy can be modified after delivery. In most cases, recommendations from the HHS perinatal HIV guidelines (based on data obtained from cisgender women) can be applied to transgender and gender diverse people assigned female sex at birth.
Data collection to monitor pregnancy and infant outcomes following exposure to ART is ongoing. Health care providers should enroll all patients exposed to antiretroviral medications during pregnancy in the Antiretroviral Pregnancy Registry (1-800-258-4263). Enrollment should be done as early in pregnancy as possible.
Health care providers caring for pregnant patients with HIV and their infants may contact the National Perinatal HIV Hotline (1-888-448-8765) for clinical consultation (HHS [perinatal] 2023).
It is not known if didanosine is present in breast milk.
Maintaining maximum viral suppression during pregnancy and postpartum decreases but does not eliminate the risk of HIV transmission via breast milk. In addition, multiclass-resistant virus has been detected in breastfeeding infants who acquire HIV despite maternal therapy. In the United States, where formula is usually accessible, affordable, safe, and sustainable, and the risk of infant mortality due to diarrhea and respiratory infections is low, the Health and Human Services perinatal HIV guidelines do not recommend breastfeeding for patients with HIV when safer infant feeding options are available. Persons with HIV who maintain an undetectable viral load while taking antiretroviral therapy (ART) should evaluate infant feeding options (formula, banked donor milk, or breastfeeding) as part of a shared decision-making process (if breastfeeding is being considered, see guidelines for measures to reduce the risk of HIV transmission). When the HIV status at delivery is not known, breast milk may be expressed and stored until a negative test is available. If HIV infection is diagnosed after breastfeeding has been initiated, breastfeeding should be discontinued immediately. Breastfeeding is not recommended for persons with HIV who are not taking ART and/or who do not have sustained viral suppression.
Information is available for counseling and managing patients with HIV who are considering breastfeeding (1-888-448-8765). In most cases, recommendations from the HHS perinatal HIV guidelines (based on data obtained from cisgender women) can be applied to transgender and gender diverse people assigned female sex at birth (HHS [perinatal] 2023).
Take on an empty stomach; administer at least 30 minutes before or 2 hours after eating
Serum potassium, uric acid, creatinine; hemoglobin, CBC with neutrophil and platelet count, CD4 cells; viral load; liver function tests, serum bilirubin, albumin, INR, amylase; weight gain; perform dilated retinal exam every 6 months, ultrasonography (if portal hypertension suspected)
Didanosine, a purine nucleoside (adenosine) analog and the deamination product of dideoxyadenosine (ddA), inhibits HIV replication in vitro in both T cells and monocytes. Didanosine is converted within the cell to the mono-, di-, and triphosphates of ddA. These ddA triphosphates act as substrate and inhibitor of HIV reverse transcriptase substrate and inhibitor of HIV reverse transcriptase thereby blocking viral DNA synthesis and suppressing HIV replication.
Absorption: Subject to degradation by acidic pH of stomach; some formulations are buffered to resist acidic pH; ≤55% reduction in peak plasma concentration is observed in presence of food. Delayed release capsules contain enteric-coated beadlets which dissolve in the small intestine.
Distribution: Extensive intracellular distribution
CSF/plasma ratio: Infants 8 months to Adolescents 19 years: 46% (range: 12% to 85%); Adults: 21%
Vd (apparent):
Age-based:
Infants 8 months to Adolescents 19 years: 28 ± 15 L/m2
Adults: 43.7 ± 8.9 L/m2
Weight-based:
Children 20 kg to <25 kg: 98 ± 30 L
Children 25 kg to <60 kg: 155 ± 55 L
Children ≥60 kg: 363 ± 138 L
Adults ≥60 kg: 308 ± 164 L
Protein binding: <5%
Metabolism: Has not been evaluated in humans; studies conducted in dogs show extensive metabolism with allantoin, hypoxanthine, xanthine, and uric acid being the major metabolites found in urine
Bioavailability: Variable and affected by the presence of food in the GI tract, gastric pH, and the dosage form administered
Infants 8 months to Adolescents 19 years: 25% ± 20%
Adults: 42% ± 12%
Half-life elimination:
Plasma:
Newborns (1 day old): 2 ± 0.7 hours
Infants 2 weeks to 4 months: 1.2 ± 0.3 hours
Infants 8 months to Adolescents 19 years: 0.8 ± 0.3 hours
Adults with normal renal function: 1.5 ± 0.4 hours
Intracellular: Adults: 25 to 40 hours
Elimination: Increased as CrCl decreased
Children 20 kg to <25 kg: 0.75 ± 0.13 hours
Children 25 kg to <60 kg: 0.92 ± 0.09 hours
Children ≥60 kg: 1.26 ± 0.19 hours
Adults ≥60 kg: 1.19 ± 0.21 hours; 2 ± 0.3 hours (renal impairment [CrCl <30 mL/minute]); 4.1 ± 1.2 hours (dialysis)
Time to peak: Delayed release capsules: 2 hours; Powder for suspension: 0.25 to 1.5 hours
Excretion: Unchanged drug excreted in urine
Infants 8 months to Adolescents 19 years: 18% ± 10%
Adults: 18% ± 8%
Altered kidney function: Half-life increased and clearance decreased as the CrCl decreased.
Hepatic function impairment: Mean Cmax and AUC were 19% and 13% higher in patients with moderate to severe hepatic impairment.
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