VIDEX EC SIDE EFFECTS

Generic Name: didanosine delayed-release capsules
Brand Name: Videx EC
Drug Class: HIV, NNRTIs

Last updated on MDtodate: 10/8/2022

SIDE EFFECTS

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

Pancreatitis
Lactic acidosis/severe hepatomegaly with steatosis
Hepatic toxicity
Non-cirrhotic portal hypertension
Peripheral neuropathy
Retinal changes and optic neuritis

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.

Clinical Trials Experience In Adult Subjects

Study AI454-152 was a 48-week, randomized, open-label study comparing VIDEX EC (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. Selected clinical adverse reactions that occurred in combination with other antiretroviral agents are provided in Table 1.

Table 1: Selected Clinical Adverse Reactions, Study AI454-152^a

Adverse Reactions	Percent of Patients^{b c}
Adverse Reactions	VIDEX EC + stavudine + nelfinavir n=258	zidovudine/ lamivudine^d + nelfinavir n=253
Diarrhea	57	58
Peripheral Neurologic Symptoms/Neuropathy	25	11
Nausea	24	36
Headache	22	17
Rash	14	12
Vomiting	14	19
Pancreatitis (see below)	less than 1	*
^a Median duration of treatment was 62 weeks in the VIDEX EC + stavudine + nelfinavir group and 61 weeks in the zidovudine/lamivudine + nelfinavir group. ^b Percentages based on treated patients. ^c The incidences reported included all severity grades and all reactions regardless of causality ^d Zidovudine/lamivudine combination tablet. * This event was not observed in this study arm.

In clinical trials using a buffered formulation of didanosine, pancreatitis resulting in death was observed in one patient who received didanosine plus stavudine plus nelfinavir, one patient who received didanosine plus stavudine plus indinavir, and 2 of 68 patients who received didanosine plus stavudine plus indinavir plus hydroxyurea. In an early access program, pancreatitis resulting in death was observed in one patient who received VIDEX EC plus stavudine plus hydroxyurea plus ritonavir plus indinavir plus efavirenz.

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.

Selected laboratory abnormalities that occurred in a study of VIDEX EC in combination with other antiretroviral agents are shown in Table 2.

Table 2: Selected Laboratory Abnormalities, Study AI454-152a

Parameter	Percent of Patients^b
	VIDEX EC + stavudine + nelfinavir n=258		zidovudine /lamivudine^c + nelfinavir n=253
	Grades 3-4^d	All Grades	Grades 3-4^d	All Grades
SGOT (AST)	5	46	5	19
SGPT (ALT)	6	44	5	22
Lipase	5	23	2	13
Bilirubin	less than 1	9	less than 1	3
^a Median duration of treatment was 62 weeks in the VIDEX EC + stavudine + nelfinavir group and 61 weeks in the zidovudine/lamivudine + nelfinavir group. ^b Percentages based on treated patients. ^c Zidovudine/lamivudine combination tablet. ^d Greater than 5 x ULN for SGOT and SGPT, at least 2.1 x ULN for lipase, and at least 2.6 x ULN for bilirubin (ULN = upper limit of normal).

Clinical Trials Experience In 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. 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 EC, or a combination of these factors.

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

Body as a Whole – abdominal pain, alopecia, anaphylactoid reaction, asthenia, chills/fever, pain.

Digestive Disorders – anorexia, dyspepsia, and flatulence.

Exocrine Gland Disorders – pancreatitis (including fatal cases), sialoadenitis, parotid gland enlargement, dry mouth, and dry eyes.

Hepatobiliary Disorders – symptomatic hyperlactatemia/lactic acidosis and hepatic steatosis ; non-cirrhotic portal hypertension; hepatitis and liver failure.

Metabolic Disorders – diabetes mellitus, elevated serum alkaline phosphatase level, elevated serum amylase level, elevated serum gamma-glutamyltransferase level, elevated serum uric acid level, 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.

SRC: NLM .

Jump To