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Videx

"The U.S. Food and Drug Administration today approved the first rapid Human Immunodeficiency Virus (HIV) test for the simultaneous detection of HIV-1 p24 antigen as well as antibodies to both HIV-1 and HIV-2 in human serum, plasma, and venous or f"...

Videx

Videx

Videx Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Videx (didanosine) also known as ddI, is used to treat HIV, which causes the acquired immunodeficiency syndrome (AIDS). It is not a cure for HIV or AIDS. It is an antiviral medication. This medication is available in generic form. Common side effects include headache or diarrhea.

The recommended adult total daily dose of Videx is based on body weight, and ranges from 125 mg to 200 mg taken twice daily, or 250 mg to 400 mg taken once daily. Videx may interact with ganciclovir, hydroxyurea, methadone, stavudine, tenofovir, or antibiotics. Tell your doctor all medications and supplements you use. During pregnancy, Videx should be used only when prescribed. It is normal to prescribe HIV medicines for pregnant women with HIV. This has been shown to decrease the risk of giving HIV to the baby. This drug may be part of that treatment. Discuss the risks and benefits with your doctor. It is unknown if this medication passes into breast milk. Because breast milk can transmit HIV, do not breastfeed.

Our Videx (didanosine) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Videx in Detail - Patient Information: Side Effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Didanosine may cause lactic acidosis (a build-up of lactic acid in the body, which can be fatal). Lactic acidosis can start slowly and get worse over time. Get emergency medical help if you have even mild symptoms of lactic acidosis, such as:

  • muscle pain or weakness;
  • numb or cold feeling in your arms and legs;
  • trouble breathing;
  • feeling dizzy, light-headed, tired, or very weak;
  • stomach pain, nausea with vomiting; or
  • fast or uneven heart rate.
  • liver damage - nausea, stomach pain, low fever, loss of appetite, dark urine or stools, jaundice (yellowing of the skin or eyes);
  • pancreatitis - severe pain in your upper stomach spreading to your back, nausea and vomiting, fast heart rate;
  • swelling around your stomach, feeling of fullness, feeling short of breath, coughing up blood;
  • numbness, tingling, or pain in your hands or feet;
  • pale skin, easy bruising or bleeding, feeling light-headed, rapid heart rate, trouble concentrating;
  • fever, chills, body aches, flu symptoms; or
  • any other signs of new infection.

Less serious side effects may include:

  • mild stomach pain, diarrhea;
  • headache;
  • mild rash; or
  • changes in the shape or location of body fat (especially in your arms, legs, face, neck, breasts, and waist).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Videx (Didanosine Pediatric Powder for Oral Solution) »

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Videx FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

The following adverse reactions are discussed in greater detail in other sections:

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Adults

Selected clinical adverse reactions that occurred in adult patients in clinical studies with VIDEX are provided in Tables 3 and 4.

Table 3: Selected Clinical Adverse Reactions from Monotherapy Studies

Adverse Reactions Percent of Patients*
ACTG 116A ACTG 116B/117
VIDEX
n=197
zidovudine
n=212
VIDEX
n=298
zidovudine
n=304
Diarrhea 19 15 28 21
Peripheral Neurologic Symptoms/Neuropathy 17 14 20 12
Abdominal Pain 13 8 7 8
Rash/Pruritus 7 8 9 5
Pancreatitis 7 3 6 2
* The incidences reported included all severity grades and all reactions regardless of causality.

Table 4: Selected Clinical Adverse Reactions from Combination Studies

Adverse Reactions Percent of Patientsa,c
AI 454-148b START 2b
VIDEX + stavudine + nelfinavir
n=482
zidovudine+ lamivudine+ nelfinavir
n=248
VIDEX + stavudine + indinavir
n=102
zidovudine + lamivudine + indinavir
n=103
Diarrhea 70 60 45 39
Nausea 28 40 53 67
Peripheral Neurologic Symptoms/Neuropathy 26 6 21 10
Headache 21 30 46 37
Rash 13 16 30 18
Vomiting 12 14 30 35
Pancreatitis (see below) 1 * less than 1 *
a Percentages based on treated subjects.
b Median duration of treatment 48 weeks.
c The incidences reported included all severity grades and all reactions regardless of causality.
* This event was not observed in this study arm.

Pancreatitis resulting in death was observed in one patient who received VIDEX (didanosine) plus stavudine plus nelfinavir in Study AI454-148 and in one patient who received VIDEX plus stavudine plus indinavir in the START 2 study. In addition, pancreatitis resulting in death was observed in 2 of 68 patients who received VIDEX plus stavudine plus indinavir plus hydroxyurea in an ACTG clinical trial [see WARNINGS AND PRECAUTIONS].

The frequency of pancreatitis is dose related. In phase 3 studies, incidence ranged from 1% to 10% with doses higher than are currently recommended and from 1% to 7% with recommended dose.

Selected laboratory abnormalities in clinical studies with VIDEX are shown in Tables 5-7.

Table 5: Selected Laboratory Abnormalities from Monotherapy Studies

Parameter Percent of Patients
ACTG 116A ACTG 116B/117
VIDEX
n=197
zidovudine
n=212
VIDEX
n=298
zidovudine
n=304
SGOT (AST) (greater than 5 x ULN) 9 4 7 6
SGPT (ALT) (greater than 5 x ULN) 9 6 6 6
Alkaline phosphatase (greater than 5 x ULN) 4 1 1 1
Amylase (at least 1.4 x ULN) 17 12 15 5
Uric acid (greater than 12 mg/dL) 3 1 2 1
ULN = upper limit of normal.

Table 6: Selected Laboratory Abnormalities from Combination Studies (Grades 3-4)

Parameter Percent of Patientsa
AI454-148b START 2b
VIDEX + stavudine + nelfinavir
n=482
zidovudine + lamivudine + nelfinavir
n=248
VIDEX + stavudine + indinavir
n=102
zidovudine + lamivudine + indinavir
n=103
Bilirubin (greater than 2.6 x ULN) less than 1 less than 1 16 8
SGOT (AST) (greater than 5 x ULN) 3 2 7 7
SGPT (ALT) (greater than 5 x ULN) 3 3 8 5
GGT (greater than 5 x ULN) NC NC 5 2
Lipase (greater than 2 x ULN) 7 2 5 5
Amylase (greater than 2 x ULN) NC NC 8 2
ULN = upper limit of normal.
NC = Not Collected.
a Percentages based on treated subjects.
b Median duration of treatment 48 weeks.

Table 7: Selected Laboratory Abnormalities from Combination Studies (All Grades)

Parameter Percent of Patientsa
AI454-148b START 2 b
VIDEX + stavudine + nelfinavir
n=482
zidovudine+ lamivudine+ nelfinavir
n=248
VIDEX + stavudine + indinavir
n=102
zidovudine + lamivudine + indinavir
n=103
Bilirubin 7 3 68 55
SGOT (AST) 42 23 53 20
SGPT (ALT) 37 24 50 18
GGT NC NC 28 12
Lipase 17 11 26 19
Amylase NC NC 31 17
NC = Not Collected.
a Percentages based on treated subjects.
b Median duration of treatment 48 weeks.

Pediatric Patients

In clinical trials, 743 pediatric patients between 2 weeks and 18 years of age have been treated with didanosine. Adverse reactions and laboratory abnormalities reported to occur in these patients were generally consistent with the safety profile of didanosine in adults.

In pediatric phase 1 studies, pancreatitis occurred in 2 of 60 (3%) patients treated at entry doses below 300 mg/m²/day and in 5 of 38 (13%) patients treated at higher doses. In study ACTG 152, pancreatitis occurred in none of the 281 pediatric patients who received didanosine 120 mg/m² every 12 hours and in less than 1% of the 274 pediatric patients who received didanosine 90 mg/m² every 12 hours in combination with zidovudine [see Clinical Studies].

Retinal changes and optic neuritis have been reported in pediatric patients.

Postmarketing Experience

The following adverse reactions have been identified during postapproval use of didanosine. Because they are reported voluntarily from a population of unknown size, estimates of frequency cannot be made. These reactions have been chosen for inclusion due to their seriousness, frequency of reporting, causal connection to VIDEX, or a combination of these factors.

Blood and Lymphatic System Disorders - anemia, leukopenia, and thrombocytopenia.

Body as a Whole - alopecia, anaphylactoid reaction, asthenia, chills/fever, pain, and redistribution/accumulation of body fat [see WARNINGS AND PRECAUTIONS].

Digestive Disorders - anorexia, dyspepsia, and flatulence.

Exocrine Gland Disorders - pancreatitis (including fatal cases) [see BOXED WARNING, WARNINGS AND PRECAUTIONS], sialoadenitis, parotid gland enlargement, dry mouth, and dry eyes.

Hepatobiliary Disorders - symptomatic hyperlactatemia/lactic acidosis and hepatic steatosis [see BOXED WARNING, WARNINGS AND PRECAUTIONS]; non-cirrhotic portal hypertension [see WARNINGS AND PRECAUTIONS]; hepatitis and liver failure.

Metabolic Disorders - diabetes mellitus, hypoglycemia, and hyperglycemia.

Musculoskeletal Disorders - myalgia (with or without increases in creatine kinase), rhabdomyolysis including acute renal failure and hemodialysis, arthralgia, and myopathy.

Ophthalmologic Disorders - retinal depigmentation and optic neuritis [see WARNINGS AND PRECAUTIONS].

Use with Stavudine- and Hydroxyurea-Based Regimens

When didanosine is used in combination with other agents with similar toxicities, the incidence of these toxicities may be higher than when didanosine is used alone. Thus, patients treated with VIDEX in combination with stavudine, with or without hydroxyurea, may be at increased risk for pancreatitis and hepatotoxicity, which may be fatal, and severe peripheral neuropathy [see WARNINGS AND PRECAUTIONS]. The combination of VIDEX and hydroxyurea, with or without stavudine, should be avoided.

Read the entire FDA prescribing information for Videx (Didanosine Pediatric Powder for Oral Solution) »

A A A

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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