October 27, 2015
Kitabis Pak Receives 2015 WebAward for Outstanding Achievement
PARI’s entry, “Kitabis Pak – See the World in 3D”, received the Pharmaceuticals Standard of Excellence award. Kitabis Pak is the first co-packaging of generic tobramycin inhalation solution with a PARI LC PLUS® Nebulizer for patients with cystic fibrosis.
The WebAwards Competition is the premier award recognition program for Web developers and marketers worldwide. More than 1,500 websites in 96 industry categories from 40 different countries were submitted in the 2015 competition. Entries were judged on design, copy writing, innovation, content, interactivity, navigation, and use of technology.
“This award is another positive recognition for Kitabis Pak,” said Ashley Weigand, director of marketing for PARI Respiratory Equipment. “It is important for us to have a website that is not only visually appealing and easy to navigate, but also educates patients and healthcare providers so that they can make informed healthcare decisions.”
PARI will be exhibiting this week at the National Cystic Fibrosis conference in Phoenix, AZ booth #310 and will provide attendees an opportunity to learn more about Kitabis Pak.
About Kitabis Pak
KITABIS PAK (co-packaging of tobramycin inhalation solution and PARI LC PLUS Reusable Nebulizer) is indicated for the management of cystic fibrosis in adults and pediatric patients 6 years of age and older with P. aeruginosa. Safety and efficacy have not been demonstrated in patients under the age of 6 years, patients with FEV1 <25% or >75% predicted, or patients colonized with Burkholderia cepacia.
About PARI Respiratory Equipment, Inc.
PARI is a leading, worldwide developer and manufacturer of fast and efficient aerosol delivery systems for patients with asthma, chronic lung disease, cystic fibrosis, RSV, VAP, and HAP. PARI’s mission is to improve the lives of those affected by respiratory diseases and those who provide care for them. This is reflected in our comprehensive portfolio of innovative products and services.
About the Web Marketing Association
Since 1997, the Web Marketing Association’s annual WebAward Competition has been setting the standard of excellence for Website development. Independent expert judges from around the world review sites in 96 industries. The best are recognized with a WebAward which helps interactive professionals promote themselves, their companies, and their best work to the outside world.
August 24, 2015
Kitabis Pak One of Ten Notable Drug-Device Approvals of 2014
“Having Kitabis Pak recognized as a notable drug-device approval confirms PARI’s vision to make the prescription process for generic tobramycin and the PARI LC Plus nebulizer more convenient and cost effective for patients.” said Geoff Hunziker, president of PARI USA. “Since Kitabis Pak is one prescription for both the drug and nebulizer handset, it ensures patients receive the proper delivery device for tobramycin inhalation solution.”
The article, naming PARI LC Nebulizer as the integral part of the co-packaging, also summarized Kitabis Pak as the first defined drug-device combination approved for cystic fibrosis providing clarity for clinicians and patients with respect to optimal efficacy and safety with a defined formulation-device pairing.
“We have always believed that it is important for patients and healthcare professionals to understand that tobramycin inhalation solution is only approved for use with the nebulizer handset in Kitabis Pak.” said Jan Zimmermann, Portfolio Manager at PARI USA. “Being recognized in this category alongside other innovative pharmaceutical companies confirms our approach in setting a new standard of care for nebulized drugs.”
July 14, 2015
Access to Kitabis Pak Expands for Patients with Cystic Fibrosis
Kitabis Pak is now on the Preferred Drug List (PDL) for many state programs, increasing access to the only FDA approved co-packaging of tobramycin inhalation solution together with the PARI LC PLUS® nebulizer handset. Each carton of Kitabis Pak contains a 28-day course of generic tobramycin inhalation solution and the PARI LC PLUS nebulizer handset, the only nebulizer handset approved for the delivery of tobramycin inhalation solution. For specific information regarding your state, please visit www.kitabis.com/patient-access/preferred-drug-listing.
“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.” said Lisa Cambridge, MSHS, RRT, director of Medical Science & Pharmaceutical Alliances at PARI. “The goal of Kitabis Pak is to increase patient access through this strategic co-packaging of both drug and device in one box.”
Kitabis Pak is therapeutically equivalent to TOBI (tobramycin inhalation solution, USP) carrying the AN designation in the FDA’s Orange Book.
“Expanded patient access to Kitabis Pak is welcome news for both CF patients and healthcare professionals” says Mary Lester, RRT, RCP, “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.”
June 3, 2015
Kitabis Pak Wins American Package Design Award
Kitabis Pak, approved by the FDA on December 2, is the first packaging of generic tobramycin inhalation solution with a PARI LC PLUS® Nebulizer for patients with cystic fibrosis.
“This award highlights all the hard work we put into this unique product offering of nebulized drug and device. In creating a package that is easy for patients to use, we also wanted to convey that the components suit each other. By using complimentary colors, the packaging visually reflects the fact that tobramycin inhalation solution was designed to be delivered by the PARI LC PLUS Nebulizer,” said Jan Zimmermann, portfolio manager for Kitabis Pak.
“Not only is the packaging attractive, it ensures that with every prescription, every patient has access to the only FDA approved nebulizer handset for tobramycin inhalation solution and the same nebulizer used in clinical trials. It is gratifying that the creative package for this important combination of therapy and delivery device puts us alongside other design winners, such as Target, Burt’s Bees, Revlon, and Tory Burch,” said Ashley Weigand, director of marketing for PARI Respiratory Equipment.
PARI Respiratory Equipment exclusively markets Kitabis Pak and the compressor access program called PARI PROVIDE. Kitabis Pak is a new standard for nebulized drugs similar to asthma & COPD inhalers where the drug and device are prescribed and dispensed together. The price of Kitabis Pak is comparable to the price of generic tobramycin drug alone. PARI PROVIDE takes the program one step further by providing patients with the only FDA approved compressor to deliver tobramycin inhalation solution.
March 16, 2015
FDA Rates Kitabis Pak as Therapeutic Equivalent of TOBI
Kitabis Pak is listed with the AN designation meaning there are no known or suspected bioequivalence problems between Kitabis Pak and TOBI.
“It makes sense that the FDA listed Kitabis Pak as therapeutically equivalent in the Orange Book, because TOBI was developed as tobramycin inhalation solution delivered with the PARI LC PLUS® nebulizer,” said Jan Zimmermann, portfolio manager for Kitabis Pak at PARI. “One prescription for Kitabis Pak ensures access to both tobramycin inhalation solution and the PARI LC PLUS nebulizer handset, co-packaged and dispensed together. In addition, PARI initiated a compressor access program called PARI PROVIDE that is administered through a network of specialty pharmacies.”
The FDA approved the New Drug Application for Kitabis Pak on December 2, 2014. Kitabis Pak is a new standard for nebulized drugs where drug and nebulizer handset are co-packaged similar to asthma inhalers where the drug and device are prescribed and dispensed together. The price of Kitabis Pak is comparable to the price of generic tobramycin drug alone.
“Our definitive goal is to ensure that patients with cystic fibrosis who are prescribed tobramycin inhalation solution also get the nebulizer handset that was used in clinical trials and approved for use with TOBI. Kitabis Pak accomplishes this goal and makes it easy for patients since they come together in an easy to understand kit,” stated Lisa Cambridge, director of PARI’s Medical Science & Pharmaceutical Alliances.
The FDA’s Orange Book was first published in 1980 to respond to requests from states for a list of approved and therapeutically equivalent drugs to help make choices that can reduce drug costs. Additional information is available online at fda.gov.
December 3, 2014
FDA Approves PulmoFlow’s Tobramycin & Nebulizer Combination for Cystic Fibrosis
This is the first nebulized drug and device combination to be approved for patients with cystic fibrosis. Kitabis Pak is in stock and available
now through PARI Respiratory Equipment, Inc.
Kitabis Pak sets a new standard for nebulized drugs similar to asthma & COPD inhalers where the drug and device are prescribed and dispensed together. The price of Kitabis Pak will be similar to the price of generic tobramycin drug alone.
“Patient access to the only approved and proven delivery system for nebulized tobramycin is very important both for the patient and healthcare professional. Knowing that we don’t have to worry about the device any longer is a huge benefit when we prescribe nebulized tobramycin,” said Cheryl Velotta, LPN/CRT of UH Rainbow Babies and Children’s Hospital.
“Our goal is to streamline the process so patients receive tobramycin inhalation solution with the nebulizer proven to deliver it effectively. Kitabis Pak is the easiest and most cost effective way for doctors to prescribe nebulized tobramycin without the added hassle of a separate nebulizer prescription or cost,” added Geoff Hunziker, president of PARI USA.
“The FDA approval and more than a decade of experience of using tobramycin solution for inhalation is based on the delivery by the PARI LC PLUS Nebulizer for safety and efficacy of treatment. No other nebulizer has been proven to be as safe or effective as the original,” said Bruce Montgomery, M.D., former executive vice-president of Research & Development for TOBI®.
In addition to exclusively marketing Kitabis Pak, PARI also offers a compressor access program called PARI PROVIDE for patients who do not have the proper compressor to deliver the tobramycin inhalation solution.
Kitabis Pak (co-packaging of tobramycin inhalation solution and a PARI LC PLUS Reusable Nebulizer) is indicated for the management of cystic fibrosis in adults and pediatric patients 6 years of age and older with P. aeruginosa. Safety and efficacy have not been demonstrated in patients under the age of 6 years, patients with FEV1 <25% or >75% predicted, or patients colonized with Burkholderia cepacia.
Important Safety Information
Do not take Kitabis Pak (Tobramycin Inhalation Solution) if you are allergic to tobramycin, or any of the ingredients in Kitabis Pak, or any aminoglycocide antibiotic.
Before taking Kitabis Pak, inform your health care provider if you have or have had any hearing problems including ringing or other noises in your ears, dizziness, kidney problems, muscle weakness such as myasthenia gravis or Parkinson’s disease, breathing problems such as wheezing, coughing or chest tightness, or have had an organ transplant. Before you inhale Kitabis Pak, inform your health care provider if you are pregnant, plan to become pregnant, are breastfeeding, or plan to breastfeed. It is not known if Kitabis Pak will pass into breast milk.
Tell your health care provider about all the medicines you take. Taking Kitabis Pak with certain other medications can cause serious side effects. If you are taking Kitabis Pak, you should discuss with your health care provider if you should take other medicines that may harm your nervous system, kidneys or hearing, or diuretics (water pills) such as Edecrin® (ethacrynic acid), Lasix® (furosemide), mannitol, or urea.
Kitabis Pak can cause serious side effects including hearing loss or ringing in the ears (ototoxicity), worsening kidney problems (nephrotoxicity), worsening muscle weakness, harm to an unborn baby, and/or severe breathing problems (bronchospasm). Tell your health care provider right away of you have hearing loss or hear noises in your ears (such as ringing or hissing), develop vertigo, dizziness, difficulty with balance, shortness of breath with wheezing, or coughing or chest tightness. Your health care provider may do a blood test and urine test to check how your kidneys are working while you are taking Kitabis Pak.
The most common side effects of Kitabis Pak include cough, sore throat, productive cough, shortness of breath, coughing up blood, worsening of lung problems or cystic fibrosis, changes in your voice (hoarseness), altered taste, and rash. Tell your health care provider about any side effect that bothers you or that does not go away.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
This web site is intended for United States residents only.