Sporanox Injection
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Sporanox Injection
Sporanox Injection Side Effects Center
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 Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Sporanox Injection FDA Prescribing Information: Side Effects
(Adverse Reactions)
SIDE EFFECTS
SPORANOX® (itraconazole injection) 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: Hepatotoxicity and INFORMATION FOR PATIENTS.)
Adverse Events Reported in Trials in Patients with SPORANOX® (itraconazole injection) Injection
Adverse events considered at least possibly drug related are shown in Table 2 and are based on the experience of 360 patients treated with SPORANOX® (itraconazole injection) Injection in four pharmacokinetic, one uncontrolled and four active controlled studies where the control was amphotericin B or fluconazole. Nearly all patients were neutropenic or were otherwise immunocompromised and were treated empirically for febrile episodes, for documented systemic fungal infections, or in trials to determine pharmacokinetics. The dose of SPORANOX® (itraconazole injection) 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® (itraconazole injection) Injection.
Table 2 Summary of Possibly or Definitely Drug-Related
Adverse Events Reported by ≥ 2% of Subjects
| Adverse Event | Total SPORANOX® Injection (N=360) % | Comparative Studies | ||
| SPORANOX Injection (N=234) % | Intravenous Fluconazole (N=32) % | Intravenous Amphotericin B (N=202) % | ||
| Gastrointestinal system disorders | ||||
| Nausea | 8 | 9 | 0 | 15 |
| Diarrhea | 6 | 6 | 3 | 9 |
| Vomiting | 4 | 6 | 0 | 10 |
| Abdominal pain | 2 | 2 | 0 | 3 |
| Constipation | 0 | 1 | 3 | 0 |
| Metabolic and nutritional disorders | ||||
| Hypokalemia | 5 | 8 | 0 | 29 |
| Alkaline phosphatase increased | 1 | 2 | 3 | 2 |
| Serum creatinine increased | 2 | 2 | 3 | 26 |
| Hypomagnesemia | 1 | 1 | 0 | 5 |
| Blood urea nitrogen increased | 0 | 1 | 0 | 7 |
| Fluid overload | 0 | 0 | 0 | 3 |
| Hypocalcemia | 0 | 0 | 0 | 3 |
| Liver and biliary system disorders | ||||
| Bilirubinemia | 4 | 6 | 9 | 3 |
| SGPT/ALT Increased | 2 | 3 | 3 | 1 |
| Hepatic function abnormal | 1 | 2 | 0 | 2 |
| Jaundice | 1 | 2 | 0 | 0 |
| SGOT/AST increased | 1 | 2 | 0 | 0 |
| Body as a whole - General disorders | ||||
| Pain | 1 | 2 | 0 | 0 |
| Rigors | 0 | 0 | 0 | 34 |
| Fever | 0 | 0 | 0 | 6 |
| Skin and appendages disorders | ||||
| Rash | 3 | 3 | 3 | 3 |
| Sweating increased | 1 | 2 | 0 | 0 |
| Respiratory system disorder | ||||
| Dyspnea | 0 | 0 | 0 | 3 |
| Central and peripheral nervous system disorders | ||||
| Dizziness | 1 | 2 | 0 | 1 |
| Headache | 2 | 2 | 0 | 3 |
| Urinary system disorders | ||||
| Renal function abnormal | 1 | 1 | 0 | 11 |
| Application site disorder | ||||
| Application site reaction | 4 | 0 | 0 | 0 |
| Cardiovascular disorders, general | ||||
| Hypotension | 0 | 0 | 0 | 3 |
| Hypertension | 0 | 0 | 0 | 2 |
| Heart rate and rhythm disorders | ||||
| Tachycardia | 0 | 1 | 0 | 3 |
| Vascular (extracardiac) disorders | ||||
| Vein disorder | 3 | 0 | 0 | 0 |
The following adverse events occurred in less than 2% of patients in clinical trials of SPORANOX® (itraconazole injection) Injection: LDH increased, edema, albuminuria, hyperglycemia, and hepatitis.
Post-marketing Experience
Adverse drug reactions that have been identified during post-approval use of SPORANOX® (itraconazole injection) (all formulations) are listed in the table below. Because these reactions are reported voluntarily from a population of uncertain size, reliably estimating their frequency or establishing a causal relationship to drug exposure is not always possible.
Postmarketing Reports of Adverse Drug Reactions
| Blood and lymphatic system disorders: | Leukopenia, neutropenia, thrombocytopenia |
| Immune system disorders: | Anaphylaxis; anaphylactic, anaphylactoid and allergic reactions; serum sickness; angioneurotic edema |
| Metabolism and nutrition disorders: | Hypertriglyceridemia, hypokalemia |
| Nervous system disorders: | Peripheral neuropathy, paresthesia, hypoesthesia, headache, dizziness |
| Eye disorders: | Visual disturbances, including vision blurred and diplopia |
| Ear and labyrinth disorders: | Transient or permanent hearing loss, tinnitus |
| Cardiac disorders: | Congestive heart failure |
| Respiratory, thoracic and mediastinal | Pulmonary edema disorders: |
| Gastrointestinal disorders: | Abdominal pain, vomiting, dyspepsia, nausea, diarrhea, constipation, dysgeusia |
| Hepato-biliary disorders: | Serious hepatotoxicity (including some cases of fatal acute liver failure), hepatitis, reversible increases in hepatic enzymes |
| Skin and subcutaneous tissue disorders: | Toxic epidermal necrolysis, Stevens-Johnson syndrome, exfoliative dermatitis, leukocytoclastic vasculitis, erythemamultiforme, alopecia, photosensitivity, rash, urticaria, pruritus |
| Musculoskeletal and connective tissue disorders: | Myalgia, arthralgia |
| Renal and urinary disorders: | Urinary incontinence, pollakiuria |
| Reproductive system and breast disorders: | Menstrual disorders, erectile dysfunction |
| General disorders and administration site conditions: | Peripheral edema |
There is limited information on the use of SPORANOX® (itraconazole injection) 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.)
Read the entire FDA prescribing information for Sporanox Injection (Itraconazole Injection) »
Additional Sporanox Injection Information
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