Voriconazole (Page 6 of 15)

Clinical Trials Experience in Pediatric Patients

The safety of Voriconazole was investigated in 105 pediatric patients aged 2 to less than 18 years, including 52 pediatric patients less than 18 years of age who were enrolled in the adult therapeutic studies.

Serious Adverse Reactions and Adverse Reactions Leading to DiscontinuationIn clinical studies, serious adverse reactions occurred in 46% (48/105) of Voriconazole treated pediatric patients. Treatment discontinuations due to adverse reactions occurred in 12 /105 (11%) of all patients. Hepatic adverse reactions (i.e. ALT increased; liver function test abnormal; jaundice) 6% (6/105) accounted for the majority of Voriconazole treatment discontinuations.

Most Common Adverse Reactions

The most common adverse reactions occurring in ≥5% of pediatric patients receiving Voriconazole in the pooled pediatric clinical trials are displayed by body system, in Table 8.

Table 8: Adverse Reactions Occurring in ≥5% of Pediatric Patients Receiving Voriconazole in the Pooled Pediatric Clinical Trials
Body System Adverse Reaction Pooled Pediatric Data *N=105 n (%)
Abbreviations: ALT = alanine aminotransferase; LFT = liver function test
*
Reflects all adverse reactions and not treatment-related only.
Pooled reports include such terms as: amaurosis (partial or total blindness without visible change in the eye); asthenopia (eye strain); chromatopsia (abnormally colored vision); color blindness; diplopia; photopsia; retinal disorder; vision blurred, visual acuity decreased, visual brightness; visual impairment. Several patients had more than one visual disturbance.
Pooled reports include such terms as: abdominal pain and abdominal pain, upper.
§
Pooled reports include such terms as: ALT abnormal and ALT increased.
Pooled reports include such terms as: hallucination; hallucination, auditory; hallucination, visual. Several patients had both visual and auditory hallucinations.
#
Pooled reports include such terms as: renal failure and a single patient with renal impairment.
Þ
Pooled reports include such terms as: rash; rash generalized; rash macular; rash maculopapular; rash pruritic.
Blood and Lymphatic Systems Disorders Thrombocytopenia 10 (10)
Cardiac Disorders Tachycardia 7 (7)
Eye Disorders Visual Disturbances 27 (26)
Photophobia 6 (6)
Gastrointestinal Disorders Vomiting 21 (20)
Nausea 14 (13)
Abdominal pain 13 (12)
Diarrhea 12 (11)
Abdominal distention 5 (5)
Constipation 5 (5)
General Disorders and Administration Site Conditions Pyrexia 25 (25)
Peripheral edema 9 (9)
Mucosal inflammation 6 (6)
Infections and Infestations Upper respiratory tract infection 5 (5)
Investigations ALT abnormal § 9 (9)
LFT abnormal 6 (6)
Metabolism and Nutrition Disorders Hypokalemia 11 (11)
Hyperglycemia 7 (7)
Hypocalcemia 6 (6)
Hypophosphotemia 6 (6)
Hypoalbuminemia 5 (5)
Hypomagnesemia 5 (5)
Nervous System Disorders Headache 10 (10)
Dizziness 5 (5)
Psychiatric Disorders Hallucinations 5 (5)
Renal and Urinary Disorders Renal impairment # 5 (5)
Respiratory Disorders Epistaxis 17 (16)
Cough 10 (10)
Dyspnea 6 (6)
Hemoptysis 5 (5)
Skin and Subcutaneous Tissue Disorders Rash Þ 14 (13)
Vascular Disorders Hypertension 12 (11)
Hypotension 9 (9)

The following adverse reactions with incidence less than 5% were reported in 105 pediatric patients treated with Voriconazole:

Blood and Lymphatic System Disorders: anemia, leukopenia, pancytopenia

Cardiac Disorders: bradycardia, palpitations, supraventricular tachycardia

Eye Disorders: dry eye, keratitis

Ear and Labyrinth Disorders: tinnitus, vertigo

Gastrointestinal Disorders: abdominal tenderness, dyspepsia

General Disorders and Administration Site Conditions: asthenia, catheter site pain, chills, hypothermia, lethargy

Hepatobiliary Disorders: cholestasis, hyperbilirubinemia, jaundice

Immune System Disorders: hypersensitivity, urticaria

Infections and Infestations: conjunctivitis

Laboratory Investigations: AST increased, blood creatinine increased, gamma-glutamyl transferase increased

Metabolism and Nutrition Disorders: hypercalcemia, hypermagnesemia, hyperphosphatemia, hypoglycemia

Musculoskeletal and Connective Tissue Disorders: arthralgia, myalgia

Nervous System Disorders: ataxia , convulsion, dizziness, nystagmus, paresthesia, syncope

Psychiatric Disorders: affect lability, agitation, anxiety, depression, insomnia

Respiratory Disorders: bronchospasm, nasal congestion, respiratory failure, tachypnea

Skin and Subcutaneous Tissue Disorders: alopecia, dermatitis (allergic, contact, and exfoliative), pruritus

Vascular Disorders: flushing, phlebitis

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