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Información de la droga para SPORANOX (ITRACONAZOLE) ORAL SOLUTION (Ortho Biotech Products, L.P.): ADVERSE REACTIONS
SPORANOX® has been associated with rare cases of serious hepatotoxicity, including liver failure and death. Some of these cases had neither pre-existing liver disease nor a serious underlying medical condition. If clinical signs or symptoms develop that are consistent with liver disease, treatment should be discontinued and liver function testing performed. The risks and benefits of SPORANOX® use should be reassessed. (See WARNINGS: Hepatic Effects and PRECAUTIONS: General and Information for Patients.)
Adverse Events Reported in Empiric Therapy in Febrile Neutropenic (ETFN) Patients
Adverse events considered at least possibly drug related in a clinical trial of empiric therapy in 384 febrile, neutropenic patients (192 treated with SPORANOX® and 192 with amphotericin B) with suspected fungal infections are listed in Table 2 below. Patients received a regimen of SPORANOX® Injection followed by SPORANOX® Oral Solution. The dose of SPORANOX® Injection was 200 mg twice daily for the first two days followed by a single daily dose of 200 mg for the remainder of the intravenous treatment period. The majority of patients received between 7 and 14 days of SPORANOX® Injection. The dose of SPORANOX® Oral Solution was 200 mg (20 mL) b.i.d. for the remainder of therapy.
Table 2: Summary of possibly or definitely drug-related adverse events reported in ≥ 2% of subjects (Empiric Therapy Trial in Febrile Neutropenic Patients) Adverse Event SPORANOX ®(N=192) % Amphotericin B(N=192) % Gastrointestinal system disorders Nausea 11 15 Diarrhea 10 9 Vomiting 7 10 Abdominal pain 3 3 Metabolic and nutritional disorders Hypokalemia 9 28 Serum creatinine increased 3 25 LDH increased 2 0 Alkaline phosphatase increased 2 2 Hypomagnesemia 2 4 Blood urea nitrogen increased 1 6 Fluid overload 1 3 Hypocalcemia 1 2 Liver and biliary system disorders Bilirubinemia 6 3 Hepatic function abnormal 3 2 SGPT/ALT increased 3 1 Jaundice 2 1 SGOT/AST increased 2 1 Skin and appendage disorders Rash 5 3 Sweating increased 2 1 CNS and peripheral nervous system Headache 2 2 Body as a whole Edema 2 2 Rigors 1 34 Fever 0 7 Respiratory system disorder Dyspnea 1 3 Urinary system disorder Renal function abnormal 1 12 Cardiovascular disorders, general Hypotension 1 3 Hypertension 0 2 Heart rate and rhythm disorders Tachycardia 1 3
The following additional adverse events considered at least possibly related occurred in between 1 and 2% of patients who received SPORANOX® Injection and Oral Solution: constipation, hypophosphatemia, gamma-GT increased, erythematous rash, pruritus, dizziness, tremor, and pulmonary infiltration.
Adverse Events Reported in Oropharyngeal or Esophageal Candidiasis Trials
U.S. adverse experience data are derived from 350 immunocompromised patients (332 HIV seropositive/AIDS) treated for oropharyngeal or esophageal candidiasis. Table 3 below lists adverse events reported by at least 2% of patients treated with SPORANOX® Oral Solution in U.S. clinical trials. Data on patients receiving comparator agents in these trials are included for comparison.
Treated Patients in U.S. Clinical Trials (Total)
Table 3: Summary of Adverse Events Reported by ≥2% of SPORANOX® Treated Patients in U.S. Clinical Trials (Total) Body System/ Adverse Event Itraconazole Total (n = 350Of the 350 patients, 209 were treated for oropharyngeal candidiasis in controlled studies, 63 were treated for esophageal candidiasis in controlled studies and 78 were treated for oropharyngeal candidiasis in an open study.) % All controlledstudies (n = 272) % Fluconazole (n = 125Of the 125 patients, 62 were treated for oropharyngeal candidiasis and 63 were treated for esophageal candidiasis.) % Clotrimazole (n = 81All 81 patients were treated for oropharyngeal candidiasis.) % Gastrointestinal disorders Nausea Diarrhea Vomiting Abdominal pain Constipation 1111762 1010642 1110871 54170 Body as a whole Fever Chest pain Pain Fatigue 7322 6321 8242 5000 Respiratory disorders Coughing Dyspnea Pneumonia Sinusitis Sputum increased 42222 43223 105043 01001 Skin and appendages disorders Rash Increased sweating Skin disorder unspecified 432 542 462 611 Central/peripheral nervous system Headache Dizziness 42 42 64 61 Resistance mechanism disorders Pneumocystis carinii infection 2 2 2 0 Psychiatric disorders Depression 2 1 0 1
Adverse events reported by less than 2% of patients in U.S. clinical trials with SPORANOX® included: adrenal insufficiency, asthenia, back pain, dehydration, dyspepsia, dysphagia, flatulence, gynecomastia, hematuria, hemorrhoids, hot flushes, implantation complication, infection unspecified, injury, insomnia, male breast pain, myalgia, pharyngitis, pruritus, rhinitis, rigors, stomatitis ulcerative, taste perversion, tinnitus, upper respiratory tract infection, vision abnormal, and weight decrease. Edema, hypokalemia and menstrual disorders have been reported in clinical trials with itraconazole capsules.
Worldwide post-marketing experiences with the use of SPORANOX® (all formulations) include very rare reports (<1/10,000) of the adverse events listed below:
Postmarketing Reports of Adverse Drug Reactions Blood and lymphatic system disorders Very rare Leukopenia, neutropenia, thrombocytopenia Immune system disorders Very rare Serum sickness; angioneurotic edema; anaphylaxis; anaphylactic, anaphylactoid and allergic reactions Metabolism and nutrition disorders Very rare Hypertriglyceridemia, hypokalemia Nervous system disorders Very rare Peripheral neuropathy, paresthesia, hypoesthesia, headache, dizziness Eye disorders Very rare Visual disturbances, including vision blurred and diplopia Ear and labyrinth disorder Very rare Tinnitus, transient or permanent hearing loss Cardiac disorders Very rare Congestive heart failure Respiratory, thoracic and mediastinal disorders Very rare Pulmonary edema Gastrointestinal disorders Very rare Abdominal pain, vomiting, dyspepsia, nausea, diarrhea, constipation, dysgeusia Hepato-biliary disorders Very rare Serious hepatotoxicity (including some cases of fatal acute liver failure), hepatitis, reversible increases in hepatic enzymes Skin and subcutaneous tissue disorders Very rare Toxic epidermal necrolysis, Stevens-Johnson syndrome, erythema multiforme, exfoliative dermatitis, leukocytoclastic vasculitis, urticaria, alopecia, photosensitivity, rash, pruritus Musculoskeletal and connective tissue disorders Very rare Myalgia, arthralgia Renal and urinary disorders Very rare Pollakiuria, urinary incontinence Reproductive system and breast disorders Very rare Menstrual disorders, erectile dysfunction General disorders and administration site conditions Very rare Peripheral edema
There is limited information on the use of SPORANOX® during pregnancy. Cases of congenital abnormalities including skeletal, genitourinary tract, cardiovascular and ophthalmic malformations as well as chromosomal and multiple malformations have been reported during post-marketing experience. A causal relationship with SPORANOX® has not been established. (See CLINICAL PHARMACOLOGY: Special Populations, CONTRAINDICATIONS, WARNINGS, and PRECAUTIONS: Drug Interactions for more information.)
- Drug Information Provided by National Library of Medicine (NLM).