"The U.S. Food and Drug Administration today approved Dotarem (gadoterate meglumine) for use in magnetic resonance imaging (MRI) of the brain, spine and associated tissues of patients ages 2 years and older.
Dotarem is a gadolinium-based"...
- a history of one or more episodes of PJP
- a peripheral CD4+ (T4 helper/inducer) lymphocyte count less than or equal to 200/mm³.
These indications are based on the results of an 18-month randomized, doseresponse trial in high risk HIV-infected patients and on existing epidemiological data from natural history studies.
The patient population of the controlled trial consisted of 408 patients, 237 of whom had a history of one or more episodes of PJP. The remaining patients without a history of PJP included 55 patients with Kaposi's sarcoma and 116 patients with other AIDS diagnoses, ARC or asymptomatic HIV infection. Patients were randomly assigned to receive NebuPent (pentamidine isethionate) via the Respirgard® II nebulizer at one of the following three doses: 30 mg every two weeks (n=135), 150 mg every two weeks (n=134) or 300 mg every four weeks (n=139). The results of the trial demonstrated a significant protective effect (p < 0.01) against PJP with the 300 mg every four week dosage regimen compared to the 30 mg every two week dosage regimen. The 300 mg dose regimen reduced the risk of developing PJP by 50 to 70% compared to the 30 mg regimen. A total of 293 patients (72% of all patients) also received zidovudine at sometime during the trial. The analysis of the data demonstrated the efficacy of the 300 mg dose even after adjusting for the effect of zidovudine.
The results of the trial further demonstrate that the dose and frequency of dosing are important to the efficacy of NebuPent (pentamidine isethionate) prophylaxis in that multiple analyses consistently demonstrated a trend toward greater efficacy with 300 mg every four weeks as compared to 150 mg every two weeks.
No dose-response was observed for reduction in overall mortality; however, mortality from PJP was low in all three dosage groups.
DOSAGE AND ADMINISTRATION
IMPORTANT: NEBUPENT (pentamidine isethionate) MUST BE DISSOLVED ONLY IN STERILE WATER FOR INJECTION, USP. DO NOT USE SALINE SOLUTION FOR RECONSTITUTION BECAUSE THE DRUG WILL PRECIPITATE. DO NOT MIX THE NEBUPENT (pentamidine isethionate) SOLUTION WITH ANY OTHER DRUGS. DO NOT USE THE RESPIRGARD® II NEBULIZER TO ADMINISTER A BRONCHODILATOR.
The contents of one vial (300 mg) must be dissolved in 6 mL Sterile Water for Injection, USP. Place the entire reconstituted contents of the vial into the Respirgard® II nebulizer reservoir for administration.
The recommended adult dosage of NebuPent (pentamidine isethionate) for the prevention of Pneumocystis jiroveci pneumonia is 300 mg once every four weeks administered via the Respirgard® II nebulizer.
The dose should be delivered until the nebulizer chamber is empty (approximately 30 to 45 minutes). The flow rate should be 5 to 7 liters per minute from a 40 to 50 pounds per square inch (PSI) air or oxygen source. Alternatively, a 40 to 50 PSI air compressor can be used with flow limited by setting the flowmeter at 5 to 7 liters per minute or by setting the pressure at 22 to 25 PSI. Low pressure (less than 20 PSI) compressors should not be used.
Freshly prepared solutions for aerosol use are recommended. After reconstitution with sterile water, the NebuPent (pentamidine isethionate) solution is stable for 48 hours in the original vial at room temperature if protected from light.
|Product No.||NDC No.|
|87715||63323-877-15||NebuPent® (pentamidine isethionate) 300 mg lyophilized product in single dose vials, indivi-dually packaged.|
Store dry product at 20°to 25°C (68°to 77°F) [see USP Controlled Room Temperature].
Protect the dry product and the reconstituted solution from light.
APP Pharmaceuticals, LLC Schaumburg, IL 60173. Revised: December 2010
Last reviewed on RxList: 4/4/2011
This monograph has been modified to include the generic and brand name in many instances.
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