Kitabis Pak

Name: Kitabis Pak

Kitabis Pak Side Effects

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • hearing problems, ringing in your ears;
  • severe dizziness, spinning sensation, balance problems, feeling like you might pass out;
  • swelling, rapid weight gain, little or no urinating;
  • muscle weakness;
  • coughing up blood; or
  • new or worsening breathing problems.

Common side effects may include:

  • headache;
  • fever, cough, throat pain, hoarse voice; or
  • unusual or unpleasant taste in your mouth.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Kitabis Pak Usage

Take Kitabis Pak exactly as prescribed.

Kitabis Pak comes as an oral inhalation solution and is taken twice a day.

Each dose of Kitabis Pak should take about 15 minutes to finish.

Do not mix the medicine in Kitabis Pak with other medicines including Pulmozyme in your nebulizer.

If you are taking other medicines inhaled through your mouth (bronchodilators), your healthcare provider will tell you how to take your medicine the right way.

If you miss a dose, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take your next dose at the regular time. Do not take two doses of Kitabis Pak at the same time.

Kitabis Pak Dosage

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

  • the condition being treated
  • other medical conditions you have
  • other medications you are taking
  • how you respond to this medication
  • your weight
  • your height
  • your age
  • your gender

The recommended dose of Kitabis Pak is one ampule of tobramycin inhalation solution inhaled by mouth in the morning and 1 ampule of tobramycin solution inhaled by mouth in the evening using your PARI LC PLUS Reusable Nebulizer with a DeVilbiss Pulmo-Aide air compressor.

Each dose of Kitabis Pak should be used as close to 12 hours apart as possible. Do not use your dose of Kitabis Pak less than 6 hours apart.

Indications and usage

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 [see Clinical Studies (14)].

Dosage forms and strength

Inhalation solution: 300 mg/5mL in a single-use ampule

Contraindications

Tobramycin inhalation solution is contraindicated in patients with a known hypersensitivity to any aminoglycoside.

Use in specific populations

Pregnancy

Pregnancy Category D [See Warnings and Precautions (5.5)]

Aminoglycosides can cause fetal harm (e.g., congenital deafness) when administered to a pregnant woman. No adequate and well-controlled studies of tobramycin inhalation solution have been conducted in pregnant women. If tobramycin inhalation solution is used during pregnancy, or if the patient becomes pregnant while taking tobramycin inhalation solution, the patient should be apprised of the potential hazard to the fetus.

No reproduction toxicology studies have been conducted with tobramycin inhalation solution. However, subcutaneous administration of tobramycin at doses of 100 or 20 mg/kg/day during organogenesis was not teratogenic in rats or rabbits, respectively. Doses of tobramycin ≥40 mg/kg/day were severely maternally toxic to rabbits and precluded the evaluation of teratogenicity. Ototoxicity was not evaluated in offspring during nonclinical reproduction toxicity studies with tobramycin.

Nursing Mothers

It is not known if tobramycin inhalation solution will reach sufficient concentrations after administration by inhalation to be excreted in human breast milk. Because of the potential for ototoxicity and nephrotoxicity in nursing infants from tobramycin inhalation solution, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric Use

The safety and efficacy of tobramycin inhalation solution have not been studied in pediatric patients under 6 years of age.

Geriatric Use

Clinical studies of tobramycin inhalation solution did not include patients aged 65 years and over. Tobramycin is known to be substantially excreted by the kidney, and the risk of adverse reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, it may be useful to monitor renal function [see Warnings and Precautions (5.3)].

Clinical studies

Two identically designed, double-blind, randomized, placebo-controlled, parallel group, 24-week clinical studies (Study 1 and Study 2) at a total of 69 cystic fibrosis centers in the United States were conducted in cystic fibrosis patients with P. aeruginosa with tobramycin inhalation solution. Subjects who were less than 6 years of age, had a baseline creatinine of >2 mg/dL, or had Burkholderia cepacia isolated from sputum were excluded. All subjects had baseline FEV1 % predicted between 25% and 75%. In these clinical studies, 258 patients received tobramycin inhalation solution therapy on an outpatient basis (see Table 2) using a PARI LC PLUS nebulizer along with a DeVilbiss Pulmo-Aide compressor.

Table 2: Dosing Regimens in Clinical Studies
Cycle 1 Cycle 2 Cycle 3
28 days 28 days 28 days 28 days 28 days 28 days
TOBRAMYCIN
Inhalation
Solution
regimen
n=258
TOBRAMYCIN No drug
Inhalation
Solution
300 mg
BID
TOBRAMYCIN No drug
Inhalation
Solution
300 mg
BID
TOBRAMYCIN No drug
Inhalation
Solution
300 mg
BID
Placebo
regimen
n=262
Placebo
BID
Placebo
BID
Placebo
BID

All patients received either tobramycin inhalation solution or placebo (saline with 1.25 mg quinine for flavoring) in addition to standard treatment recommended for cystic fibrosis patients, which included oral and parenteral anti-pseudomonal therapy, Beta 2-agonists, cromolyn, inhaled steroids, and airway clearance techniques. In addition, approximately 77% of patients were concurrently treated with dornase alfa.

In each study, tobramycin inhalation solution -treated patients experienced significant improvement in pulmonary function. Improvement was demonstrated in the tobramycin inhalation solution group in Study 1 by an average increase in FEV1 % predicted of about 11% relative to baseline (Week 0) during 24 weeks compared to no average change in placebo patients. In Study 2, tobramycin inhalation solution -treated patients had an average increase of about 7% compared to an average decrease of about 1% in placebo patients. Figure 1 shows the average relative change in FEV1 % predicted over 24 weeks for both studies.

Figure 1: Relative Change From Baseline in FEV1% Predicted

In each study, tobramycin inhalation solution therapy resulted in a significant reduction in the number of P. aeruginosa colony forming units (CFUs) in sputum during the on-drug periods. Sputum bacterial density returned to baseline during the off-drug periods. Reductions in sputum bacterial density were smaller in each successive cycle. (see Figure 2).

Figure 2: Absolute Change From Baseline in Log10 CFUs

Patients treated with tobramycin inhalation solution were hospitalized for an average of 5.1 days compared to 8.1 days for placebo patients. Patients treated with tobramycin inhalation solution required an average of 9.6 days of parenteral anti-pseudomonal antibiotic treatment compared to 14.1 days for placebo patients. During the 6 months of treatment, 40% of tobramycin inhalation solution patients and 53% of placebo patients were treated with parenteral anti-pseudomonal antibiotics.

The relationship between in-vitro susceptibility test results and clinical outcome with tobramycin inhalation solution therapy is not clear. However, 4 tobramycin inhalation solution patients who began the clinical trial with P. aeruginosa isolates having MIC values ≥128 μg/mL did not experience an improvement in FEV1 or a decrease in sputum bacterial density.

How supplied / storage and handling

How Supplied

Kitabis Pak co-packaged kit (NDC 24492-850-56) is available in cartons containing one reusable PARI LC Plus nebulizer (Model No.: 022B81-T) and 14 tobramycin inhalation solution pouches. Each pouch contains four 300mg/5mL ampules of tobramycin inhalation solution for a total of 56 ampules in each carton. Each carton constitutes a 28 day supply.

Storage

  • Tobramycin inhalation solution should be stored under refrigeration at 2-8ºC/36-46ºF. Upon removal from the refrigerator, or if refrigeration is unavailable, tobramycin inhalation solution pouches (opened or unopened) may be stored at room temperature (up to 25ºC/77ºF) for up to 28 days. Tobramycin inhalation solution should not be used beyond the expiration date stamped on the ampule when stored under refrigeration (2-8ºC/36-46ºF) or beyond 28 days when stored at room temperature (25ºC/77ºF).
  • Tobramycin inhalation solution 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.

Principal Display Panel - Kitabis Pak

NDC:  24492-850-56

PARI

KitabisTM Pak

Tobramycin Inhalation Solution, USP

Store in Refrigerator

Includes One PARI LC PLUS Nebulizer Set

Rx only

Kitabis Pak 
tobramycin solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:24492-850
Route of Administration RESPIRATORY (INHALATION) DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Tobramycin (Tobramycin) Tobramycin 300 mg  in 5 mL
Inactive Ingredients
Ingredient Name Strength
Sodium Chloride  
Sulfuric Acid  
Water  
Packaging
# Item Code Package Description
1 NDC:24492-850-56 14 POUCH in 1 CARTON
1 4 AMPULE in 1 POUCH
1 5 mL in 1 AMPULE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA205433 02/19/2015
Labeler - Pari Respiratory Equipment (804736098)
Revised: 01/2016   Pari Respiratory Equipment
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