Treatment Guide

Treatment Guide - Schedule & Dose1

2 times a day

Approximately 15 minute nebulization time

28 days on, then 28 days off

Take Kitabis Pak:

  • One single-use ampule (300mg /5mL) twice a day by oral inhalation
  • As close to 12 hours apart as possible, and not less than 6 hours apart
  • In alternating 28 days on drug, followed by 28 days off drug

It is not known if Kitabis Pak is safe and effective when used for more than 3 cycles.

1Kitabis Pak [package insert]. Midlothian, VA: PARI Respiratory Equipment, Inc; 2018.

Helpful Tips

  • Talk to your healthcare team about how to best take Kitabis Pak before starting treatment.
  • Try to take Kitabis Pak at the same times every day.
  • Take Kitabis Pak for all 28 days, even if you feel healthy, to help you manage Pseudomonas aeruginosa in the lungs and improve lung function.
  • When taking other inhaled medicines, such as a bronchodilator, it is recommended that they be taken before Kitabis Pak (read more about the multiple drug treatment order recommendations below).
  • 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.
  • Do not take Kitabis Pak (Tobramycin Inhalation Solution) if you are allergic to tobramycin, or any of the ingredients in Kitabis Pak, or any aminoglycoside antibiotic.

Multiple Drug Treatment Order Recommendation from the CF Foundation2

NOTE: Further study is warranted to assure that this is the optimal approach.

Ask your CF health care team what order of treatments is best for you or your child.

2 “Cystic Fibrosis Pulmonary Guidelines: Chronic Medications for Maintenance of Lung Health” Am J Respir Crit Care Med 2013 Apr;187(7):680-9.

Indication

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 aminoglycoside antibiotic.

Before taking Kitabis Pak, inform your health care provider if you have or have had any hearing problems (including noises in your ears such as ringing or hissing), hearing loss, your mother has had hearing problems after taking an aminoglycoside, you have been told you have certain gene variants related to hearing abnormalities inherited from your mother, 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 if 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.

Please see full prescribing information.

This web site is intended for United States residents only.

Indication

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 aminoglycoside antibiotic.

Before taking Kitabis Pak, inform your health care provider if you have or have had any hearing problems (including noises in your ears such as ringing or hissing), hearing loss, your mother has had hearing problems after taking an aminoglycoside, you have been told you have certain gene variants related to hearing abnormalities inherited from your mother, 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 if 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.

Please see full prescribing information.

This web site is intended for United States residents only.

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