Videx (Didanosine) - Side Effects and Adverse Reactions

A SERIOUS TOXICITY OF VIDEX (didanosine) IS PANCREATITIS, WHICH MAY BE FATAL (see WARNINGS). OTHER IMPORTANT TOXICITIES INCLUDE LACTIC ACIDOSIS/SEVERE HEPATOMEGALY WITH STEATOSIS; RETINAL CHANGES AND OPTIC NEURITIS; AND PERIPHERAL NEUROPATHY (see WARNINGS and PRECAUTIONS).

When VIDEX is used in combination with other agents with similar toxicities, the incidence of these toxicities may be higher than when VIDEX 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).

Adults: Selected clinical adverse events that occurred in adult patients in clinical studies with VIDEX are provided in Tables 8 and 9.

Table 8: Selected Clinical Adverse Events from Monotherapy Studies

Percent of Patients

ACTG 116A ACTG 116B/117

Adverse Events 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

Rash/Pruritus 7 8 9 5

Abdominal Pain 13 8 7 8

Pancreatitis 7 3 6 2

Table 9: Selected Clinical Adverse Events from Combination Studies

Percent of Patients^a

^a Percentages based on treated subjects.

^b Median duration of treatment 48 weeks.

* This event was not observed in this study arm.

AI454-148^b START 2^b

Adverse Events 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

Headache 21 30 46 37

Peripheral Neurologic
Symptoms/Neuropathy 26 6 21 10

Rash 13 16 30 18

Vomiting 12 14 30 35

Pancreatitis (see below) 1 * <1 *

Pancreatitis resulting in death was observed in one patient who received VIDEX (didanosine) plus stavudine plus nelfinavir in Study Al454-148 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).

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 10-12.

Table 10: Selected Laboratory Abnormalities from Monotherapy Studies
ULN = upper limit of normal.

Percent of Patients

ACTG 116A ACTG 116B/117

Parameter VIDEX
n=197 zidovudine
n=212 VIDEX
n=298 zidovudine
n=304

SGOT (AST) (>5 x ULN) 9 4 7 6

SGPT (ALT) (>5 x ULN) 9 6 6 6

Alkaline phosphatase (>5 x ULN) 4 1 1 1

Amylase (≥1.4 x ULN) 17 12 15 5

Uric acid (>12 mg/dL) 3 1 2 1

Table 11: Selected Laboratory Abnormalities from Combination Studies (Grades 3-4)

Percent of Patients^a

ULN = upper limit of normal.

NC = Not Collected.

^a Percentages based on treated subjects.

^b Median duration of treatment 48 weeks.

AI454-148^b START 2^b

Parameter VIDEX +
stavudine +
nelfinavir
n=482 zidovudine +
lamivudine +
nelfinavir
n=248 VIDEX +
stavudine +
indinavir
n=102 zidovudine +
lamivudine +
indinavir
n=103

Bilirubin (>2.6 x ULN) <1 <1 16 8

SGOT (AST) (>5 x ULN) 3 2 7 7

SGPT (ALT) (>5 x ULN) 3 3 8 5

GGT (>5 x ULN) NC NC 5 2

Lipase (>2 x ULN) 7 2 5 5

Amylase (>2 x ULN) NC NC 8 2

Table 12: Selected Laboratory Abnormalities from Combination Studies (All Grades)

Percent of Patients^a

AI454-148^b START 2^b

Parameter VIDEX +
stavudine +
nelfinavir
n=482 zidovudine +
lamivudine +
nelfinavir
n=248 VIDEX +
stavudine +
indinavir
n=102 zidovudine +
lamivudine +
indinavir
n=103

NC = Not Collected.

^a Percentages based on treated subjects.

^b Median duration of treatment 48 weeks.

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

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

Body as a Whole – alopecia, anaphylactoid reaction, asthenia, chills/fever, pain, and redistribution/accumulation of body fat (see PRECAUTIONS: Fat Redistribution).
Digestive Disorders – anorexia, dyspepsia, and flatulence.
Exocrine Gland Disorders – pancreatitis (including fatal cases) (see WARNINGS), sialoadenitis, parotid gland enlargement, dry mouth, and dry eyes.
Hematologic Disorders – anemia, leukopenia, and thrombocytopenia.
Liver – symptomatic hyperlactatemia/lactic acidosis and hepatic steatosis (see WARNINGS); 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).

Pediatric Patients: In clinical trials, 743 pediatric patients between 2 weeks and 18 years of age have been treated with VIDEX. Adverse events 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 q12h and in <1% of the 274 pediatric patients who received didanosine 90 mg/m² q12h in combination with zidovudine (see INDICATIONS AND USAGE: Clinical Studies).

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

Videx (Didanosine) - Side Effects and Adverse Reactions

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ADVERSE REACTIONS

REPORTS OF SIDE EFFECTS / ADVERSE REACTIONS RELATED TO VIDEX

Possible Videx side effects / adverse reactions in 38 year old female

Possible Videx side effects / adverse reactions in 32 year old male

Possible Videx side effects / adverse reactions in 32 year old male