"The U.S. Food and Drug Administration today notified Ranbaxy Laboratories, Ltd., that it is prohibited from manufacturing and distributing active pharmaceutical ingredients (APIs) from its facility in Toansa, India, for FDA-regulated drug product"...
TOBI® is indicated for the management of cystic fibrosis patients with P. aeruginosa.
Safety and efficacy have not been demonstrated in patients under the age of 6 years, patients with forced expiratory volume in 1 second (FEV1) < 25% or > 75% predicted, or patients colonized with Burkholderia cepacia (see Clinical Studies).
DOSAGE AND ADMINISTRATION
The recommended dosage for both adults and pediatric patients 6 years of age and older is 1 single-use ampule (300 mg) administered BID for 28 days. Dosage is not adjusted by weight. All patients should be administered 300 mg BID. The doses should be taken as close to 12 hours apart as possible; they should not be taken less than 6 hours apart.
TOBI® is inhaled while the patient is sitting or standing upright and breathing normally through the mouthpiece of the nebulizer. Nose clips may help the patient breathe through the mouth.
TOBI® is administered BID in alternating periods of 28 days. After 28 days of therapy, patients should stop TOBI® therapy for the next 28 days, and then resume therapy for the next 28 day on/28 day off cycle.
TOBI® is supplied as a single-use ampule and is administered by inhalation, using a hand-held PARI LC PLUS™Reusable Nebulizer with a DeVilbiss® Pulmo-Aide® compressor. TOBI®is not for subcutaneous, intravenous or intrathecal administration.
TOBI® is administered by inhalation over an approximately 15-minute period, using a hand-held PARI LC PLUS™ Reusable Nebulizer with a DeVilbiss® Pulmo-Aide® compressor. TOBI®should not be diluted or mixed with dornase alfa (PULMOZYME®, Genentech) or other medications in the nebulizer.
During clinical studies, patients on multiple therapies were instructed to take them first, followed by TOBI® .
TOBI® 300 mg is available as follows:
5 mL single-dose ampule (carton of 56)
TOBI® should be stored under refrigeration at 2-8°C/36-46°F. Upon removal from the refrigerator, or if refrigeration is unavailable, TOBI® pouches (opened or unopened) may be stored at room temperature (up to 25°C/77°F) for up to 28 days. TOBI® should not be used beyond the expiration date stamped on the ampule when stored under refrigeration (2-8°C/36-46°F) or beyond 28 days when stored at room temperature (25°C/77°F).
TOBI® ampules should not be exposed to intense light. The solution in the ampule is slightly yellow, but may darken with age if not stored in the refrigerator; however, the color change does not indicate any change in the quality of the product as long as it is stored within the recommended storage conditions.
Distributed by: Novartis Pharmaceuticals Corporation East Hanover, New Jersey 07936
Last reviewed on RxList: 5/8/2014
This monograph has been modified to include the generic and brand name in many instances.
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