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Sporanox Injection

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Sporanox Injection

INDICATIONS

SPORANOX® (itraconazole) Injection/Oral Solution is indicated for empiric therapy of febrile neutropenic patients with suspected fungal infections. (NOTE: In a comparative trial, the overall response rate for itraconazole-treated subjects was higher than for amphotericin B-treated subjects. However, compared to amphotericin B-treated subjects, a larger number of itraconazole-treated subjects discontinued treatment due to persistent fever and a change in antifungal medication due to fever. Whereas, a larger number of amphotericin B-treated subjects discontinued due to drug intolerance. (See Clinical Studies section.)

SPORANOX® (itraconazole) Injection is also indicated for the treatment of the following fungal infections in immunocompromised and non-immunocompromised patients:

  1. Blastomycosis, pulmonary and extrapulmonary;
  2. Histoplasmosis, including chronic cavitary pulmonary disease and disseminated, non-meningeal histoplasmosis; and
  3. Aspergillosis, pulmonary and extrapulmonary, in patients who are intolerant of or who are refractory to amphotericin B therapy.

Specimens for fungal cultures and other relevant laboratory studies (wet mount, histopathology, serology) should be obtained prior to therapy to isolate and identify causative organisms. Therapy may be instituted before the results of the cultures and other laboratory studies are known; however, once these results become available, anti-infective therapy should be adjusted accordingly.

(See CLINICAL PHARMACOLOGY: Special Populations, WARNINGS, and ADVERSE REACTIONS: Post-marketing Experience for more information).

DOSAGE AND ADMINISTRATION

Use only the components [SPORANOX® (itraconazole) Injection ampule, 0.9% Sodium Chloride Injection, USP (Normal Saline) bag and filtered infusion set] provided in the kit: DO NOT SUBSTITUTE.

SPORANOX® (itraconazole injection) Injection should not be diluted with 5% Dextrose Injection, USP, or with Lactated Ringer's Injection, USP, alone or in combination with any other diluent. The compatibility of SPORANOX® (itraconazole injection) Injection with diluents other than 0.9% Sodium Chloride Injection, USP (Normal Saline) is not known. NOT FOR IV BOLUS INJECTION.

NOTE: After reconstitution, the diluted SPORANOX® (itraconazole injection) Injection may be stored refrigerated (2-8°C) or at room temperature (15-25°C) for up to 48 hours, when protected from direct light. During administration, exposure to normal room light is acceptable.

NOTE: Use only a dedicated infusion line for administration of SPORANOX® (itraconazole injection) Injection. Do not introduce concomitant medication in the same bag nor through the same line as SPORANOX® (itraconazole injection) Injection. Other medications may be administered after flushing the line/catheter with 0.9% Sodium Chloride Injection, USP, as described below, and removing and replacing the entire infusion line. Alternatively, utilize another lumen, in the case of a multi-lumen catheter.

Correct preparation and administration of SPORANOX® (itraconazole injection) Injection are necessary to ensure maximal efficacy and safety. A precise mixing ratio is required in order to obtain a stable admixture. It is critical to maintain a 3.33 mg/mL itraconazole:diluent ratio. Failure to maintain this concentration will lead to the formation of a precipitate.

Add the full contents (25 mL) of the SPORANOX® (itraconazole injection) Injection ampule into the infusion bag provided, which contains 50 mL of 0.9% Sodium Chloride Injection, USP (Normal Saline). Mix gently after the solution is completely transferred. Withdraw and discard 15 mL of the solution before administering to the patient. Using a flow control device, infuse 60 mL of the dilute solution (3.33 mg/mL = 200 mg itraconazole, pH apx. 4.8) intravenously over 60 minutes, using an extension line and the infusion set provided. After administration, flush the infusion set with 15-20 mL of 0.9% Sodium Chloride Injection, USP, over 30 seconds-15 minutes, via the two-way stopcock. Do not use Bacteriostatic Sodium Chloride Injection, USP. The compatibility of SPORANOX® (itraconazole injection) Injection with flush solutions other than 0.9% Sodium Chloride Injection, USP (Normal Saline) is not known. Discard the entire infusion line.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

Empiric Therapy in Febrile, Neutropenic Patients with Suspected Fungal Infections (ETFN)

The recommended dose of SPORANOX® (itraconazole injection) Injection is 200 mg b.i.d. for four doses, followed by 200 mg once daily for up to 14 days. Each intravenous dose should be infused over 1 hour. Treatment should be continued with SPORANOX® (itraconazole injection) Oral Solution 200 mg (20 mL) b.i.d. until resolution of clinically significant neutropenia.

The safety and efficacy of SPORANOX® (itraconazole injection) use exceeding 28 days in ETFN is not known.

Treatment of Blastomycosis, Histoplasmosis and Aspergillosis

The recommended intravenous dose is 200 mg b.i.d. for four doses, followed by 200 mg q.d. Each intravenous dose should be infused over 1 hour.

For the treatment of blastomycosis, histoplasmosis and aspergillosis, SPORANOX® (itraconazole injection) can be given as oral capsules or intravenously. The safety and efficacy of

SPORANOX® (itraconazole injection) Injection administered for greater than 14 days is not known.

Total itraconazole therapy (SPORANOX® (itraconazole injection) Injection followed by SPORANOX® (itraconazole injection) Capsules) should be continued for a minimum of 3 months and until clinical parameters and laboratory tests indicate that the active fungal infection has subsided. An inadequate period of treatment may lead to recurrence of active infection.

Use in Patients with Renal Impairment

Limited data are available on the use of intravenous itraconazole in patients with renal impairment.

Hydroxypropyl-β-cyclodextrin, a required component of SPORANOXintravenous formulation, is eliminated through glomerular filtration. Therefore, in patients with severe renal impairment (defined as creatinine clearance below 30 mL/min), the use of SPORANOX® IV is contraindicated. (See CONTRAINDICATIONS.)

In patients with mild (defined as creatinine clearance 50-80 mL/min) and moderate (defined as creatinine clearance 30-49 mL/min) renal impairment, SPORANOX® (itraconazole injection) Injection should be used with caution. Serum creatinine levels should be closely monitored and, if renal toxicity is suspected, consideration should be given to modifying the antifungal regimen to an alternate medication with similar antimycotic coverage. (see CLINICAL PHARMACOLOGY: Special Populations, CONTRAINDICATIONS, and PRECAUTIONS.)

Use in Patients with Hepatic Impairment

Limited data are available on the use of itraconazole in patients with hepatic impairment. Caution should be exercised when this drug is administered in this patient population. (See CLINICAL PHARMACOLOGY: Special Populations, WARNINGS, and PRECAUTIONS).

HOW SUPPLIED

SPORANOX® (itraconazole) Injection for intravenous infusion is supplied as a kit (NDC 50458-298-01), containing one 25 mL colorless glass ampule of itraconazole 10 mg/mL sterile, pyrogen-free solution (NDC 50458-297-10), one 50 mL bag (100 mL capacity) of 0.9% Sodium Chloride Injection, USP (Normal Saline) and one filtered infusion set.

Store at or below 25°C (77°F). Protect from light and freezing.

Keep out of reach of children.

Manufactured for: Ortho Biotech Products, L.P Raritan, NJ 08869. Manufactured by: Hospira, Inc. Lake Forest, IL 60045. Revised March 2009.

Last reviewed on RxList: 5/18/2009
This monograph has been modified to include the generic and brand name in many instances.

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