TOBI Podhaler is indicated for the management of cystic fibrosis patients with Pseudomonas 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 >80% predicted, or patients colonized with Burkholderia cepacia [see Clinical Studies (14)].

DO NOT SWALLOW TOBI PODHALER CAPSULES

FOR USE WITH THE PODHALER DEVICE ONLY

FOR ORAL INHALATION ONLY

TOBI Podhaler capsules must not be swallowed as the intended effects in the lungs will not be obtained. The contents of TOBI Podhaler capsules are only for oral inhalation and should only be used with the Podhaler device.

The recommended dosage of TOBI Podhaler for both adults and pediatric patients 6 years of age and older is the inhalation of the contents of four 28 mg TOBI Podhaler capsules twice-daily for 28 days using the Podhaler device.

Refer to the Instructions For Use (IFU) for full administration information.

Dosage is not adjusted by weight. Each dose of four capsules should be taken as close to 12 hours apart as possible; each dose should not be taken less than 6 hours apart.

TOBI Podhaler is administered twice-daily in alternating periods of 28 days. After 28 days of therapy, patients should stop TOBI Podhaler therapy for the next 28 days, and then resume therapy for the next 28-day on and 28-day off cycle.

TOBI Podhaler capsules should always be stored in the blister and each capsule should only be removed IMMEDIATELY BEFORE USE.

For patients taking several different inhaled medications and/or performing chest physiotherapy, the order of therapies should follow the physician’s recommendation. It is recommended that TOBI Podhaler is taken last.

Inhalation powder:

28 mg: clear, colorless hypromellose capsule with “MYL TPH” in blue radial imprint on one part of the capsule and the Mylan logo in blue radial imprint on the other part of the capsule.

TOBI Podhaler is contraindicated in patients with a known hypersensitivity to any aminoglycoside.

No clinical drug interaction studies have been performed with TOBI Podhaler. In clinical studies, patients receiving TOBI Podhaler continued to take dornase alfa, bronchodilators, inhaled corticosteroids, and macrolides. No clinical signs of drug interactions with these medicines were identified.

Concurrent and/or sequential use of TOBI Podhaler with other drugs with neurotoxic, nephrotoxic, or ototoxic potential should be avoided.

Some diuretics can enhance aminoglycoside toxicity by altering antibiotic concentrations in serum and tissue. TOBI Podhaler should not be administered concomitantly with ethacrynic acid, furosemide, urea, or intravenous mannitol. The interaction between inhaled mannitol and TOBI Podhaler has not been evaluated.

The maximum tolerated daily dose of TOBI Podhaler has not been established.

In the event of accidental oral ingestion of TOBI Podhaler capsules, systemic toxicity is unlikely as tobramycin is poorly absorbed. Tobramycin serum concentrations may be helpful in monitoring overdosage.

Acute toxicity should be treated with immediate withdrawal of TOBI Podhaler, and baseline tests of renal function should be undertaken.

Hemodialysis may be helpful in removing tobramycin from the body.

In all cases of suspected overdosage, physicians should contact the Regional Poison Control Center for information about effective treatment. In the case of any overdosage, the possibility of drug interactions with alterations in drug disposition should be considered.

TOBI Podhaler consists of a dry powder formulation of tobramycin for oral inhalation only with the Podhaler device. The inhalation powder is filled into clear, colorless hypromellose capsules.

Each clear, colorless hypromellose capsule contains a spray dried powder of 28 mg of tobramycin active ingredient with 1,2-distearoyl-sn-glycero-3-phosphocholine (DSPC), calcium chloride, and sulfuric acid (for pH adjustment).

The active component of TOBI Podhaler is tobramycin. Tobramycin is an aminoglycoside antibiotic. Its chemical name is O-3-amino-3-deoxy-α-D-glucopyranosyl-(1→4)-O-[2,6-diamino-2,3,6-trideoxy-α-D-ribo-hexopyranosyl-(1→6)]-2-deoxy-L-streptamine; its structural formula is:

Tobramycin has a molecular weight of 467.52, and its empirical formula is C18H37N5O9. Tobramycin is a white to almost white powder; visually free from any foreign contaminants. Tobramycin is freely soluble in water, very slightly soluble in ethanol, and practically insoluble in chloroform and ether.

The Podhaler device is a plastic device used to inhale the dry powder contained in the TOBI Podhaler capsule. Under standardized in vitro testing at a fixed flow rate of 60 L/min and volume of 2 L for 2 seconds, the Podhaler device has a target delivered dose of 102 mg of tobramycin from the mouthpiece (4 capsules per dose). Peak inspiratory flow rate and inhaled volumes were explored in 96 cystic fibrosis patients aged 6 years and older. Older patients with significant disease progression and associated decreases in forced expiratory volume (FEV1) and younger patients with inhaled volumes <1 L were able to generate inspiratory flow rates and volumes required to receive their medication when following the instructions for use. However, no pediatric patients aged 6 to 10 years with FEV1 less than 40% predicted were evaluated.

The Phase 3 clinical development program included two placebo-controlled studies (Studies 2 and 3) and one open-label study (Study 1), which randomized and dosed 157 and 517 patients, respectively, with a clinical diagnosis of cystic fibrosis, confirmed by quantitative pilocarpine iontophoresis sweat chloride test, well-characterized disease causing mutations in each CFTR gene, or abnormal nasal transepithelial potential difference characteristic of cystic fibrosis.

In the placebo-controlled studies, all patients were aged between 6 and 21 years old and had an FEV1 at screening within the range of 25% to 80% (inclusive) of predicted normal values for their age, sex, and height based upon Knudson criteria. In addition, all patients were infected with P. aeruginosa as demonstrated by a positive sputum or throat culture (or bronchoalveolar lavage) within 6 months prior to screening, and also in a sputum culture taken at the screening visit. Among the 76 patients treated with TOBI Podhaler, 37% were males and 63% were females. Thirty-six patients were between 6 and 12 years of age, and 40 patients were between 13 and 21 years of age. Patients had a mean baseline FEV1 of 56% of predicted normal value.

In both studies, >90% of patients received concomitant therapies for cystic fibrosis-related indications. The most frequently used other antibacterial drugs (any route of administration) were azithromycin, ciprofloxacin, and ceftazidime. Consistent with the population of cystic fibrosis patients, the most frequently used concomitant medications included oral pancreatic enzyme preparations, mucolytics (especially dornase alfa), and selective β2-adrenoreceptor agonists.

Study 2

Study 2 was a randomized, 3-cycle, 2-arm trial. Each cycle comprised of 28 days on treatment followed by 28 days off treatment. The first cycle was double-blind, placebo-controlled with eligible patients randomized 1:1 to TOBI Podhaler (4 times 28 mg capsules twice-daily) or placebo. Upon completion of the first cycle, patients who were randomized to the placebo treatment group received TOBI Podhaler for Cycles 2 and 3. The total treatment period was 24 weeks.

A total of 95 patients were randomized into Study 2 and received TOBI Podhaler (n=46) or placebo (n=49) in Cycle 1. All patients were less than 22 years of age (mean age 13.3 years) and had not received inhaled antipseudomonal antibiotics within four months prior to screening; 56% were female and 84% were Caucasian. This study was stopped early for demonstrated benefit and the primary analysis used the set of patients included in the interim analysis (n=79); 16 patients did not have data on the primary endpoint at that time. Of the 79 patients included in the interim analysis, 18 patients were excluded due to a failure to meet spirometry quality review criteria as determined by an external review panel. This resulted in a total of 61 patients, 29 in the TOBI Podhaler arm and 32 in the placebo arm, who were included in the primary analysis.

In the primary analysis, TOBI Podhaler significantly improved lung function compared with placebo as measured by the relative change in FEV1 % predicted from baseline to the end of Cycle 1 dosing. This analysis adjusted for the covariates of baseline FEV1 % predicted, age, and region, and imputed for missing data. Treatment with TOBI Podhaler and placebo resulted in relative increases in FEV1 % predicted of 12.54% and 0.09%, respectively (LS mean difference = 12.44%; 95% CI: 4.89, 20.00; p=0.002). Analysis of absolute changes in FEV1 % predicted showed LS means of 6.38% for TOBI Podhaler and -0.52% for placebo with a difference of 6.90% (95% CI: 2.40, 11.40). Improvements in lung function were achieved during the subsequent cycles of treatment with TOBI Podhaler, although the magnitude was reduced (Figure 1).

The percentage of patients using new antipseudomonal antibiotics in Cycle 1 was greater in the placebo treatment group (18.4%) compared with the TOBI Podhaler treatment group (13.1%). During the first cycle, 8.7% of TOBI Podhaler patients and 10.2% of placebo patients were treated with parenteral antipseudomonal antibiotics. In Cycle 1, two patients (4.4%) in the TOBI Podhaler treatment group required respiratory-related hospitalizations, compared with six patients (12.2%) in the placebo treatment group.

Figure 1 – Study 2: Mean Relative Change in FEV1 % Predicted from Baseline in Cycles 1 to 3 by Treatment Group

Study 3

Study 3 was a randomized, double-blind, placebo-controlled trial, similar in design to Study 2. Eligible patients were randomized 1:1 to receive TOBI Podhaler (4 times 28 mg capsules twice-daily) or placebo for one cycle (28 days on-treatment and 28 days off-treatment).

A total of 62 patients were randomized into Study 3 and allocated to TOBI Podhaler (n=32) or placebo (n=30). All patients were less than 22 years of age (mean age 12.9 years) and had not received inhaled antipseudomonal antibiotics within 4 months prior to screening; 64.5% were female and 98.4% were Caucasian.

In this study, the results were not statistically significant for the primary lung function endpoint when adjusting for the covariates of age (<13 years, ≥13 years) and FEV1 % predicted at screening (<50%, ≥50%) and imputing for missing data. Improvement in lung function for TOBI Podhaler compared with placebo was evaluated using the relative change in FEV1 % predicted from baseline to the end of Cycle 1 dosing. Treatment with TOBI Podhaler (8.19%) compared to placebo (2.27%) failed to achieve statistical significance in relative change in FEV1 % predicted (LS mean difference = 5.91%; 95% CI: -2.54, 14.37; p=0.167). Analyses of absolute changes in FEV1 % predicted showed LS means of 4.86% for TOBI Podhaler and 0.48% for placebo with a difference of 4.38% (95% CI:-0.17, 8.94).

Study 1

Study 1 was a randomized, open-label, active-controlled parallel arm trial. Eligible patients were randomized 3:2 to TOBI Podhaler (4 times 28 mg capsules twice-daily) or TOBI (300 mg/5 mL twice-daily). Treatment was administered for 28 days, followed by 28 days off therapy (one cycle) for three cycles. The total treatment period was 24 weeks. The time to administer a dose of TOBI Podhaler (10th to 90th percentiles) ranged from 2 to 7 minutes at the end of the dosing period for Cycle 1, and 2 to 6 minutes at the end of the dosing period for Cycle 3.

A total of 517 patients were randomized in Study 1 and received TOBI Podhaler (n=308) or TOBI (n=209). Patients were predominantly 20 years of age or older (mean age 25.6 years) with no inhaled antipseudomonal antibiotic use within 28 days prior to study drug administration; 45% were female and 91% were Caucasian.

The primary purpose of Study 1 was to evaluate safety. Interpretation of efficacy results in Study 1 is limited by several factors including open-label design, testing of multiple secondary endpoints, and missing values for the outcome of FEV1 % predicted. The number (%) of patients with missing values for FEV1 % predicted at Weeks 5 and 25 in the TOBI Podhaler treated group were 40 (13.0%) and 86 (27.9%) compared to 15 (7.2%) and 40 (19.1%) in the TOBI treated group. Using imputation of the missing data, the mean differences (TOBI Podhaler minus TOBI) in the percent relative change from baseline in FEV1 % predicted at Weeks 5 and 25 were -0.87 (95% CI: -3.80, 2.07) and 1.62 (95% CI: -0.90, 4.14), respectively.

1.

Clinical and Laboratory Standards Institute (CLSI). Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria that Grow Aerobically – Ninth Edition; Approved Standard. CLSI Document M7-A9. CLSI, 950 West Valley Rd., Suite 2500, Wayne, PA 19087, 2012.

2.

CLSI. Performance Standards for Antimicrobial Disk Susceptibility Tests; Approved Standard – 11th ed. CLSI document M02-A11. CLSI, 2012.

3.

CLSI. Performance Standards for Antimicrobial Susceptibility Testing; 22nd Informational Supplement. CLSI document M100-S22. CLSI, 2012

Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use).

Important Administration Information

Information on the long-term efficacy and safety of TOBI Podhaler is limited. There is no information in patients with limited pulmonary reserve (FEV1 <25% predicted). Decreased susceptibility of Pseudomonas aeruginosa to tobramycin has been seen with use of TOBI Podhaler. The relationship between in vitro susceptibility test results and clinical outcome with TOBI Podhaler therapy is not clear. Occurrence of decreased susceptibility on treatment should be monitored, and treatment with an alternative therapy should be considered if clinical worsening is observed.

TOBI Podhaler may not be tolerated by all patients. Patients should be instructed to consider alternative therapy if they are unable to tolerate TOBI Podhaler. Patients should be advised to complete a full 28-day course of TOBI Podhaler, even if they are feeling better. After 28 days of therapy, patients should stop TOBI Podhaler therapy for the next 28 days, and then resume therapy for the next 28-day on and 28-day off cycle.

Patients should be advised that if they have been prescribed a 7-day pack of TOBI Podhaler either immediately before or during a 28-day treatment with TOBI Podhaler, then they must count each day of use toward the 28 day on-treatment part of their cycle. Patients should only take a total of 28 consecutive days of treatment during a cycle.

Similarly, patients should be advised that if they have been prescribed a 1-day pack of TOBI Podhaler either immediately before or during a 28-day treatment with TOBI Podhaler, then they must count each day of use toward the 28 day on-treatment part of their cycle. Patients should only take a total of 28 consecutive days of treatment during a cycle.

It is important for patients to understand how to correctly administer TOBI Podhaler capsules using the Podhaler device. It is recommended that caregivers and patients be adequately trained in the proper use of the TOBI Podhaler prior to use. [See Instructions for Use at the end of the Patient Information leaflet.] Caregivers should provide assistance to children using TOBI Podhaler (including preparing the dose for inhalation) particularly for those aged 10 years or younger, and should continue to supervise them until they are able to use the Podhaler device properly without help.

For patients taking several different inhaled medications and/or performing chest physiotherapy, advise the patient regarding the order in which they should take the therapies. It is recommended that TOBI Podhaler be taken last.

Difficulty Breathing:

Advise patients to inform their physicians if they experience shortness of breath or wheezing after administration of Tobi Podhaler. Tobi Podhaler can cause a narrowing of the airway [see Warnings and Precautions (5.1)].

Hearing Loss:

Advise patients to inform their physician if they experience ringing in the ears, dizziness, or any changes in hearing because Tobi Podhaler has been associated with hearing loss [see Warnings and Precautions (5.2)].

Kidney Damage:

Advise patients to inform their physician if they have any history of kidney problems because Tobi Podhaler is in a class of drugs that have caused kidney damage [see Warnings and Precautions (5.3)].

Embryo-Fetal Toxicity:

Advise pregnant women that aminoglycosides can cause irreversible congenital deafness when administered to a pregnant woman [see Warnings and Precautions (5.5) and Use in Specific Populations (8.1)].

Lactation:

Advise a woman to monitor their breastfed infants for diarrhea and/or bloody stools [see Use in Specific Populations (8.2)].

Cough:

Inform patients that cough was reported with the use of TOBI Podhaler in clinical trials. If coughing that may be experienced with TOBI Podhaler becomes bothersome or cannot be tolerated, advise patients that tobramycin inhalation solution or alternative therapeutic options may be considered.

TOBI (TOH-bee) Podhaler (POD-hay-ler)

(tobramycin inhalation powder)

Important Information:

•

Your healthcare provider should show you or a caregiver how to use TOBI Podhaler the right way before you use it for the first time. Ask your healthcare provider if you have any questions about how to use TOBI Podhaler the right way.

•

The recommended dose of TOBI Podhaler is the contents of 4 capsules inhaled by mouth 2 times each day.

•

TOBI Podhaler comes in a blister card. Each blister card has 8 TOBI Podhaler capsules: 4 capsules for inhalation in the morning and 4 capsules for inhalation in the evening.

•

You must inhale all of the powdered medicine from all 4 TOBI Podhaler capsules to get the full dose. If all of the powdered TOBI Podhaler medicine is not inhaled, you will not get the full dose.

•

After you have inhaled 2 times from a capsule, remove the capsule from the capsule chamber and hold the used capsule up to the light and look through it. It should be empty with only a fine coating of powder left on the inside surface of the capsule (See Figure S).

•

If the capsule is empty, throw it away and continue following the Instructions for Use.

•

If the capsule is not empty, see the section “What to do with a capsule that has not been emptied” below for instructions.

•

You or a caregiver should tell your healthcare provider as soon as possible if you think you or your child has not received the full TOBI Podhaler dose. Your healthcare provider should show you how to use TOBI Podhaler the right way.
 
Follow the instructions below for using your TOBI Podhaler. You will breathe in (inhale) the medicine in the TOBI Podhaler capsules using the Podhaler device. If you have any questions, ask your healthcare provider or pharmacist.
 
TOBI Podhaler is available as a 28-day, 7-day, and 1-day supply package.
 
Each TOBI Podhaler package contains (See Figure A):

•

4 weekly packs (28-day supply), each containing:

•

56 capsules (7 blister cards of 8 capsules). Each blister card contains 8 TOBI Podhaler capsules (4 capsules for inhalation in the morning and 4 capsules for inhalation in the evening).

•

1 Podhaler device and its storage case.
 
and
 

•

1 extra (reserve) Podhaler device (to be used if needed) and its storage case.

 

Or:

•

7-day pack (7-day supply) containing:

•

56 capsules (7 blister cards of 8 capsules). Each blister card contains 8 TOBI Podhaler capsules (4 capsules for inhalation in the morning and 4 capsules for inhalation in the evening).

•

1 Podhaler device and its storage case.

 

Or:

•

1-day pack (1-day supply) containing:

•

8 capsules (1 blister card of 8 capsules). Each blister card contains 8 TOBI Podhaler capsules (4 capsules for inhalation in the morning and 4 capsules for inhalation in the evening).

•

1 Podhaler device and its storage case.

Note:

•

Do not swallow TOBI Podhaler capsules. The powder in the capsule is for you to inhale using the Podhaler device.

•

Only use the Podhaler device that comes in the pack. Do not use TOBI Podhaler capsules with any other device, and do not use the Podhaler device to take any other medicine.

•

When you start a new weekly (7-day) pack of capsules, use the new Podhaler device that is supplied in the pack and throw away (discard) the used device and its storage case. Each Podhaler device is only used for 1 week (7 days).

•

Always keep the TOBI Podhaler capsules in the blister card. Only remove 1 capsule at a time just before you are going to use it.

•

Doses should be inhaled as close to 12 hours apart as possible and not less than 6 hours apart.

•

Small pieces of the capsules can get into your mouth and you may be able to feel these pieces on your tongue. These small pieces will not hurt you if you swallow or inhale them.

•

The extra (reserve) Podhaler device provided in the 28-day supply package may be used if the Podhaler device:

•

is wet, dirty, or broken

•

has been dropped

•

does not seem to be piercing the capsule properly (see Step 17)

Getting ready:

•

Wash and dry your hands (See Figure B).

Preparing your TOBI Podhaler dose

Your Podhaler device comes in a storage case with a lid. The device has a removable mouthpiece, capsule chamber and a button at its base (See Figure C).

Step 1: Just before use, hold the base of the storage case and unscrew the lid by turning it to the left (counter-clockwise) (See Figure D). Set the lid aside.

Step 2: Leave the Podhaler device in the base of the storage case while you prepare your dose (See Figure E).

Step 3: Hold the body of the Podhaler device and unscrew the mouthpiece by turning it to the left (counter-clockwise direction) (See Figure F). Set the mouthpiece aside on a clean, dry surface.

Note: Each blister card contains 8 TOBI Podhaler capsules: 4 capsules for inhalation in the morning and 4 capsules for inhalation in the evening.

Step 4: Take 1 blister card and tear the pre-cut lines along the length (See Figure G) then tear at the pre-cut lines along the width (See Figure H).

Step 5: Peel (by rolling back) the foil that covers 1 TOBI Podhaler capsule on the blister card (See Figure I). Always hold the foil close to where you are peeling.

Step 6: Take out 1 TOBI Podhaler capsule from the blister card (See Figure J). Note: Only peel back the foil from 1 capsule at a time and remove the capsule just before you are going to use it in the device because the blister protects the capsule from moisture.

Step 7: Place the TOBI Podhaler capsule in the capsule chamber at the top of the Podhaler device right away (See Figure K). Do not put the capsule directly into the top of the mouthpiece.

Step 8: Put the mouthpiece back on your Podhaler device and screw the mouthpiece on by turning it to the right (clockwise) until it is tight (See Figure L). Do not overtighten.

Step 9: Remove the Podhaler device from the base of the case. Hold the Podhaler device with the mouthpiece pointing down. Put your thumb on the blue button and press the blue button all the way down (See Figure M). Let go of the blue button. Do not press the blue button more than 1 time. The chances of the capsule breaking into pieces will be increased if the capsule is accidentally pierced (a hole put in it) more than 1 time.

Taking your TOBI Podhaler dose

Note: You will need to repeat Step 10 to Step 14 for each capsule so you inhale each capsule 2 times to empty the capsule.

Step 10: Breathe out (exhale) all the way (See Figure N). Do not blow or exhale into the mouthpiece.

Step 11: Place your mouth over the mouthpiece and close your lips tightly around it (See Figure O).

Step 12: Inhale deeply with a single breath (See Figure P).

Step 13: Remove the Podhaler device from your mouth and hold your breath for about 5 seconds.

Step 14: Exhale and take a few normal breaths away from the Podhaler device. Do not blow or exhale into the mouthpiece.

Step 15: Repeat Step 10 through Step 14 using the same capsule.

•

You must inhale 2 times from each capsule to empty it.

Step 16: Unscrew the mouthpiece by turning it to the left (counterclockwise) and remove the TOBI Podhaler capsule from the capsule chamber (See Figure Q and Figure R below).

Step 17: Hold the used capsule up to the light and look through it. It should be empty with only a fine coating of powder remaining on the inside surface of the capsule (See Figure S). If the capsule is empty, throw it away and go to Step 18.

 

If the capsule is not empty, see “What to do with a capsule that has not been emptied” below for instructions.

What to do with a capsule that has not been emptied:

•

If the capsule is pierced but still contains more than just a fine coating of powder (See Figure T) you must inhale from it again 2 times:

•

Put the capsule back into the Podhaler device capsule chamber with the pierced side of the capsule pointing down.

•

Screw the mouthpiece back on the Podhaler device by turning it to the right (clockwise) until it is tight.

•

Repeat Step 10 to Step 17.

•

If the capsule is not pierced (See Figure U) you must pierce it again and inhale from it 2 times:

•

Put the capsule back into the Podhaler device capsule chamber.

•

Screw the mouthpiece back on the Podhaler device by turning it to the right (clockwise) until it is tight.

•

Repeat Step 9 to Step 17 making sure to press the blue button all the way down.

 

Note: If you have tried to pierce the capsule 2 times and it is still not pierced, use the extra (reserve) Podhaler device provided in the TOBI Podhaler package instead (only available in the 28-day supply package). If you need a new device, ask your healthcare provider.

 

•

Prepare the extra (reserve) Podhaler device by following Step 1 to Step 3.

•

Then using the same capsule, repeat Step 7 to Step 17.

Step 18: Repeat Step 5 to Step 17 for 3 more times until your full dose (4 capsules) has been taken (See Figure V).

After your TOBI Podhaler dose:

Step 19: Do not store the TOBI Podhaler capsules in the Podhaler device.

Step 20: Put the mouthpiece back on to your Podhaler device and screw the mouthpiece on by turning it to the right (clockwise) until it is tight (See Figure L). Do not overtighten.

Step 21: Wipe the mouthpiece with a clean, dry cloth (See Figure W).

•

Do not wash the Podhaler device with water. Your Podhaler device needs to stay dry at all times to work the right way.

Step 22: Place your Podhaler device back in the storage case base.

Step 23: Place the lid back on the storage case base and screw the cover on by turning it to the right (clockwise) until it is tight (See Figure X).

How should I store TOBI Podhaler?

•

Store your Podhaler device and blister-packaged capsules at room temperature between 68°F to 77°F (20°C to 25°C).

•

Keep the TOBI Podhaler capsules and Podhaler device in a dry place.

•

Store the Podhaler device tightly closed in its storage case when you are not using it.

•

Keep TOBI Podhaler capsules, Podhaler device, and all medicines out of the reach of children.

This Patient Information and Instructions for Use have been approved by the U.S. Food and Drug Administration.

© 2020 Mylan Inc.

Tobi® and Podhaler® are registered trademarks of BGP Products Operations GmbH, a Mylan company.

Manufactured for:
Mylan Specialty L.P.
Morgantown, WV 26505 U.S.A.

Manufactured by:
Mylan Pharmaceuticals Inc.
150 Industrial Road
San Carlos, CA 94070 U.S.A.

Revised: 2/2023
N:TOBRIP:R4/PI:TOBRIP:R4/IFU:TOBRIP:R2

NDC 49502-401-24     Rx only

TOBI® Podhaler®
(tobramycin inhalation powder)

28 mg per capsule

For Oral Inhalation Only

Do not swallow TOBI® Podhaler® capsules

TOBI® Podhaler® capsules are for use with the Podhaler® device only

This package contains a 4-week supply of capsules:
4 weekly packs x 56 capsules per pack

Each capsule contains 28 mg tobramycin with 1,2-distearoyl-sn-glycero-3-phosphocholine (DSPC), calcium chloride, and sulfuric acid (for pH adjustment)

Dosage: See prescribing information.
Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F); protect from moisture.

Capsules Should Always Be Stored in the Blister and Only Removed Immediately Before Use.

Always store the Podhaler® device in its case.

Keep this and all drugs out of the reach of children.

Contents:
4 weekly packs, each containing:
     56 capsules (7 blister cards of 8 capsules)
     1 Podhaler® device
     Patient information leaflet
1 Reserve Podhaler® device
Prescribing Information

Product of Hungary

Manufactured for:
Mylan Specialty L.P.
Morgantown, WV 26505 U.S.A.

Manufactured by:
Mylan Pharmaceuticals Inc.
San Carlos, CA 94070 U.S.A.

© 2020 Mylan Inc.

GTIN: 00349502401244
EXP/LOT