PARI, the makers of cystic fibrosis nebulized antibiotic therapy Kitabis Pak, have announced that the product has been added to state healthcare systems across the United States, and now belongs to the Preferred Drug List (PDL) for multiple state programs, which increases access to the only FDA approved co-packaging of tobramycin inhalation solution combined with the PARI LC PLUS nebulizer handset. Each set of Kitabis Pak includes a 28-day course of generic tobramycin inhalation solution plus the PARI LC PLUS nebulizer handset. The handset is the only nebulizer that has been approved to deliver the tobramycin inhalation solution. For more information visit www.Kitabis.com/patient-access/PDL
Cystic fibrosis is a life-threatening disease that affects 30,000 patients in the United States alone; the disease is caused by a genetic mutation that leads to poorly hydrated and thickened mucus secretions in the lungs.
“Patients with CF that are covered by these Medicaid plans, and prescribed Kitabis Pak will have complete access to the only nebulizer handset used in the clinical trials for tobramycin inhalation solution. The goal of Kitabis Pak is to increase patient access through this strategic co-packaging of both drug and device in one box,” noted Lisa Cambridge, the director of Medical Science & Pharmaceutical Alliances at PARI.
Kitabis Pak is the equivalent therapy to TOBI (tobramycin inhalation solution, USP) and it has received the AN designation in the FDA’s Orange Book, indicating that it is a safe bioequivalent for CF patients.
Mary Lester added: “Expanded patient access to Kitabis Pak is welcome news for both CF patients and healthcare professionals. A new LC PLUS nebulizer handset co-packaged with each course of drug not only improves patient access to the right device, but also helps maintain drug delivery and address the challenges of nebulizer maintenance and acquisition.”
Kitabis Pak (and its co-packaging of tobramycin inhalation solution plus the PARI LC PLUS Reusable Nebulizer) is suited to manage cystic fibrosis in adults but also in pediatric patients 6 years old and older that carry P. aeruginosa. Efficacy and safety are not scientifically demonstrated in those under 6 years, those with FEV1 <25 percent or >75 percent predicted, or patients who have Burkholderia cepacia.
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