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TOBI Podhaler Tobramycin 28 mg Capsule, 56-count — NDC 49502-401-57 (Billing 49502-0401-57)

by Viatris Specialty LLC · 7 BLISTER PACK in 1 BOX, UNIT-DOSE / 8 CAPSULE in 1 BLISTER PACK

This is a package of 56 capsules of TOBI Podhaler Tobramycin 28 mg Capsule from Viatris Specialty LLC, marketed since Sep 2021 and currently FDA-listed.

NDC 49502-0401-57
🏷️ FDA NDC (as labeled) 49502-401-57 billing pads the product segment with a zero
This package
Contains56-count Pack sizes3 compare ↓
Also priced by: Part D plans $51.48/unit — full pricing hub ↓
Product page 49502-0401-24 Also comes in: 8 capsules 49502-401-09 50176 capsules 49502-401-24
Rx only Brand On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

NDC database record

One package, one record: these facts belong to NDC 49502-401-57 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
49502 labeler · 401 product · 57 package
Package marketed since
Oct 4, 2022
Sample package
Yes — professional sample, not for sale
Listing certified through
Dec 31, 2027
Barcode (UPC-A, from the NDC)
3 4950240157 2
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 49502-401-57
Product NDC 49502-401
11-digit billing NDC 49502040157
RxCUI 1374569, 1374570, 1374573, 1374574, 1661466, 1661559, 1661560, 1661567
UNII VZ8RRZ51VK
Application # NDA201688
SPL Set ID c4b5bb1f-e158-4ac1-9c35-e98a416c743a
Established class (EPC) Aminoglycoside Antibacterial
Chemical class Aminoglycosides
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2021-09-01
Route ORAL, RESPIRATORY (INHALATION)
Dosage form CAPSULE
Substance TOBRAMYCIN

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GPI-14 07000070000120
GPI class Tobi Podhaler
GCN Seq No 067462
GCN 30025
HICL code 017765
Ingredient (HICL) Tobramycin
HIC1 code W
Therapeutic class — broad (HIC1) Anti-Infecting Agents
HIC2 code W1
Therapeutic class — intermediate (HIC2) Antibiotics
HIC3 code W1F
Therapeutic class — specific (HIC3) Aminoglycoside Antibiotics
AHFS code 08:12.02.00
AHFS class Aminoglycoside Antibiotics
FDB label name TOBI PODHALER 28 MG INHALE CAP
FDB brand name Tobi Podhaler
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 067462
  • GCN: 30025
  • GPI-14 (Medi-Span): 07000070000120
  • HICL (First Databank): 017765
  • AHFS class code: 08:12.02.00
  • RxCUI (RxNorm): 1374569
Why two NDCs? The FDA registers this code as 49502-401-57 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 49502-0401-57. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

RxNorm drug class

This medicine belongs to the Aminoglycoside Antibacterial class.

Pharmacologic class Aminoglycoside Antibacterial
Drug family (ATC) Other aminoglycosides, Antibiotics
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

Clinical

Label name TOBI PODHALER 28 MG INHALE CAP Ingredient Tobramycin
📗 Our plain-language guide HelloPharmacist
  • It depends on the form. Inhaled tobramycin treats Pseudomonas aeruginosa lung infection in cystic fibrosis. Eye drops and ointment treat external eye infections. The injection trea...
  • You breathe it in by mouth, usually twice a day about 12 hours apart, for 28 days. Then you take 28 days off. TOBI Podhaler capsules must never be swallowed; they are used only wit...
  • Cough, shortness of breath, fever, sore throat, hoarseness and headache are common with the inhaled form. Mention them to your care team if they bother you.
  • Call about ringing in the ears, hearing loss, dizziness or balance trouble, new muscle weakness, or wheezing after a dose. These can be signs of serious effects.
📖 Read our full Tobramycin guide →
8
Nutrient depletion considerations

Tobramycin may be associated with lower levels of 8 nutrients — worth a chat with your pharmacist, not a cause for alarm.

🧪 Full Tobramycin nutrient depletion report →
An association is not a deficiency. Educational only — don't start or stop anything without professional guidance.
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · Q2 2026 $51.48 $2,882.85 / 56 capsules
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
49502-0401-09 49502-401-09 8 CAPSULE in 1 BOX, UNIT-DOSE Sample 2022-10-04 — Active
49502-0401-24 49502-401-24 Main listing 224 PACKAGE in 1 BOX, UNIT-DOSE / 56 BLISTER PACK in 1 PACKAGE / 4 CAPSULE in 1 BLISTER PACK 2021-09-01 — Active
49502-0401-57 You're viewing this 7 BLISTER PACK in 1 BOX, UNIT-DOSE / 8 CAPSULE in 1 BLISTER PACK Sample 2022-10-04 — Active

This pack shows little to no recent Medicaid volume — a different pack size carries most fills. See all packs ↓

Pack size FAQ

What quantity is in this package?
This is a 56-count package — 7 blister pack in 1 box, unit-dose / 8 capsule in 1 blister pack.
How does this package differ from NDC 49502-0401-09?
Both are TOBI Podhaler Tobramycin 28 mg Capsule — the drug itself is identical. This page's package is the 56-count one, while NDC 49502-0401-09 is the 8 capsules package.
What NDC number is used to bill for this package of TOBI Podhaler Tobramycin 28 mg Capsule?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
TOBI Podhaler 28 mgthis 49502-0401-57 Viatris 56 capsules — — FDA listed —
About this product: this is the brand-name version. We did not find an FDA-approved generic match for this exact strength, form and route.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2013
First FDA approval
Mar 2013
📍
2026
Currently FDA-listed
13 years listed
🛡️
2030
Latest patent/protection listed
not a guaranteed launch date
🔒No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route. Patent/protection dates below may affect future generic timing.

🛡️ Latest patent/protection date listed: FDA patent/protection data lists protections through Nov 2030. This may affect when a full generic version becomes widely available, but it is not a guaranteed launch date.
📅 FDA approved Mar 22, 2013 RLD RS ⏳ ~4.1 yr to latest listed protection

Why the date isn’t exact: Generic timing can change because patents may be challenged, settled, licensed, added, removed, or worked around with a narrower label — and FDA approval does not always mean a pharmacy can get the generic today.

Patents & exclusivity — FDA Orange Book
US 8869794 — method of use (U-909)
US 10207066 — method of use (U-909)
2013 2015 2017 2019 2021 2023 2025 2027 2029 2031
Today
LOE
Substance patent Formulation patent Method-of-use patent Exclusivity Pediatric +6mo
🏛️FDA exclusivity
FDA-granted marketing protection. It’s separate from patents and may be shorter than patent protection.
🧪Product / substance patents
Patents covering the active ingredient, product, formulation, or related drug features.
🎯Method-of-use patents
Patents covering specific approved uses. These can sometimes be carved out with a “skinny label,” but not always.
🛈 What do these terms mean?
Patent
Legal protection listed in the Orange Book that may delay generic approval or launch. Issued by the U.S. Patent & Trademark Office.
Substance patent
Covers the active drug molecule itself — the hardest to design around. A generic generally can’t launch until it expires.
Formulation (product) patent
Covers a specific formulation or dosage form. A generic can sometimes work around it with a different formulation.
Method-of-use patent
A patent covering one specific approved use of the drug — not necessarily the whole molecule. A generic can sometimes launch with a “skinny label” that carves out the protected use and keeps the others.
Skinny label
A generic label that omits a still-patented use when the FDA allows it — letting a generic reach the market for the unprotected uses.
Exclusivity
FDA-granted marketing protection, separate from patents — e.g. 5-yr new chemical entity, 7-yr orphan drug, or a +6-month pediatric extension.
Paragraph IV
A generic applicant’s formal challenge to a listed patent. It can potentially lead to earlier generic entry, but often involves litigation or a settlement.
RLD / RS
Reference Listed Drug — the brand product the FDA uses as the reference for generic applications. Reference Standard — the product the FDA expects generics to compare against in bioequivalence testing.
TE / AB rating
FDA therapeutic-equivalence rating. An AB rating generally means the FDA considers a generic therapeutically equivalent to — and substitutable for — the brand.
LOE (loss of exclusivity)
The latest patent or exclusivity currently listed — the loss-of-exclusivity / latest-listed-protection date shown on this page. Paragraph-IV challenges and settlements can move the real date earlier; FDA approval and a manufacturer’s decision to market can move it later.

Built from the FDA Orange Book. The bars above are scaled to each protection’s expiry; the red LOE marker is the last one to lapse.

Listed patents (2)
PatentTypeUse codeExpires
US 8869794 ↗ Method of use U-909 Sep 12, 2028
US 10207066 ↗ Method of use U-909 Nov 4, 2030
Common questions
Is there a generic version of TOBI PODHALER 28 MG INHALE CAP?
No FDA-approved generic equivalent is currently listed in the FDA Orange Book for TOBI PODHALER 28 MG INHALE CAP. Based on the patents and exclusivity currently listed, the Orange Book estimate is that full-label generic entry may be delayed until Nov 2030 — an estimate, not a guaranteed launch date.
The FDA approved a generic — why can’t I get it at my pharmacy yet?
FDA approval and pharmacy availability are two different things. The FDA can approve a generic years before it actually reaches pharmacies, because the brand company may still hold patents or have a settlement that delays the launch. A manufacturer also has to choose to make and sell it, and have supply ready. So a drug can be “FDA-approved generic exists” and still be brand-only at the counter today.
Why do different websites show different generic release dates?
Generic availability is not based on one single date. Some sources use the first exclusivity expiration, some use the last product patent, and others use the latest method-of-use patent. Patent challenges, settlements, licenses, and label carve-outs can also change the real-world launch date. This page shows the underlying Orange Book dates so you can see why estimates may differ.
What does “FDA listed” mean?
It means the product appears in the FDA’s official NDC directory. That’s a good sign a product exists and is intended for the U.S. market, but on its own it does not confirm a pharmacy can fill it today. Where we have recent retail pricing data (NADAC) for a product, we label it “Availability likely” instead.
What does a patent or protection date mean here?
It’s the latest date currently listed in the FDA Orange Book for a patent or exclusivity on the brand product. It can affect when a full generic version becomes widely available — but it is not a guaranteed generic launch date. Generics sometimes arrive earlier (through a settlement or patent challenge) or later (a manufacturer still has to make and sell one).
What does “current Orange Book estimate” mean?
It means we are using the latest patent and exclusivity dates currently listed in the FDA Orange Book. It is not a guaranteed launch date.
Can a generic come out before the last patent expires?
Sometimes. A generic company may challenge a patent, settle with the brand manufacturer, receive a license, or obtain approval with a narrower label that avoids a patented use. In other cases, the last listed protection may delay full-label generic competition.
Can a generic come out after the listed dates?
Yes. Even after patents or exclusivity expire, a generic still needs FDA approval and a manufacturer must choose to market it. Supply, litigation, business decisions, or regulatory issues can delay actual availability.
What is the difference between patents and exclusivity?
Patents are legal protections usually issued by the U.S. Patent and Trademark Office. FDA exclusivity is marketing protection granted by the FDA. They are separate, and either one can affect generic timing.
Why are there multiple patent dates?
One drug can have several patents covering different things: the active ingredient, a formulation, a manufacturing process, or a specific approved use. That is why a page may show several expiration dates instead of one simple generic date.
Built from FDA Orange Book patent and exclusivity data. Dates are refreshed from public FDA data when available; the marker is max(latest patent expiry, latest exclusivity expiry). Paragraph-IV settlements and first-filer 180-day exclusivity can shift the real date; a method-of-use patent may allow an earlier skinny-label generic for non-protected indications. Generic launch timing is an estimate, not a guarantee.
Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

🧪 Avoiding an ingredient? See Tobramycin inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerViatris Specialty LLC
Application holderVIATRIS SPECIALTY LLC
FDA applicationNDA201688 (NDA)
Labeler code49502
First marketedSep 2021
Product typeHuman Prescription Drug
Portfolio120 products on file

More NDCs from Viatris Specialty LLC labeler code 49502

The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients 🧬 Pharmacokinetics 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📚 References 📄 Patient Package Insert 📖 Instructions for Use 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 117 words ▾

1 INDICATIONS AND USAGE 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 (FEV 1 ) <25% or >80% predicted, or patients colonized with Burkholderia cepacia [see Clinical Studies (14) ] . TOBI Podhaler is an aminoglycoside antibacterial 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 (FEV 1 ) <25% or >80%, or patients colonized with Burkholderia cepacia ( 1 )

⏱️ Dosage and Administration ~1 min read ▾

2 DOSAGE AND ADMINISTRATION 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. • DO NOT swallow TOBI Podhaler capsules ( 2 ) • For use with the Podhaler device only ( 2 ) • For oral inhalation only ( 2 ) • The recommended dosage is the inhalation of four 28 mg capsules twice-daily for 28 days ( 2 )

💊 Dosage Forms and Strengths 51 words ▾

3 DOSAGE FORMS AND STRENGTHS 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. Inhalation powder: 28 mg in a capsule ( 3 )

⛔ Contraindications 23 words ▾

4 CONTRAINDICATIONS TOBI Podhaler is contraindicated in patients with a known hypersensitivity to any aminoglycoside. Known hypersensitivity to any aminoglycoside ( 4 )

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS • Caution should be exercised when prescribing TOBI Podhaler to patients with known or suspected auditory, vestibular, renal, or neuromuscular dysfunction ( 5.2 , 5.3 , 5.4 ) • Ototoxicity, as measured by complaints of hearing loss or tinnitus, was reported in clinical trials ( 5.2 ) • Aminoglycosides may aggravate muscle weakness because of a potential curare-like effect on neuromuscular function ( 5.6 ) • Bronchospasm can occur with inhalation of TOBI Podhaler ( 5.1 ) • Audiograms, serum concentrations, and renal function should be monitored as appropriate ( 5.3 , 5.5 , 5.6 ) • Embryo-Fetal Toxicity: Aminoglycosides can cause fetal harm Apprise women of the potential hazard to the fetus ( 5.6 , 8.1 )

5.1Bronchospasm Bronchospasm has been reported with inhalation of TOBI Podhaler [see Adverse Reactions (6.1) ] . Bronchospasm should be treated as medically appropriate.

5.2Ototoxicity Ototoxicity with use of TOBI Podhaler Caution should be exercised when prescribing TOBI Podhaler to patients with known or suspected auditory or vestibular dysfunction. Ototoxicity, as measured by complaints of hearing loss or tinnitus, was reported by patients in the TOBI Podhaler clinical studies [see Adverse Reactions (6.1) ] . Tinnitus may be a sentinel symptom of ototoxicity, and therefore the onset of this symptom warrants caution.

Ototoxicity, manifested as both auditory (hearing loss) and vestibular toxicity, has been reported with parenteral aminoglycosides. Vestibular toxicity may be manifested by vertigo, ataxia or dizziness. Risk of Ototoxicity Due to Mitochondrial DNA Variants Cases of ototoxicity with aminoglycosides have been observed in patients with certain variants in the mitochondrially encoded 12S rRNA gene (MT-RNR1) , particularly the m.1555A>G variant.

Ototoxicity occurred in some patients even when their aminoglycoside serum levels were within the recommended range. Mitochondrial DNA variants are present in less than 1% of the general US population, and the proportion of the variant carriers who may develop ototoxicity as well as the severity of ototoxicity is unknown. In case of known maternal history of ototoxicity due to aminoglycoside use or a known mitochondrial DNA variant in the patient, consider alternative treatments other than aminoglycosides unless the increased risk of permanent hearing loss is outweighed by the severity of infection and lack of safe and effective alternative therapies.

5.3Nephrotoxicity Caution should be exercised when prescribing TOBI Podhaler to patients with known or suspected renal dysfunction. Nephrotoxicity was not observed during TOBI Podhaler clinical studies but has been associated with aminoglycosides as a class.

5.4Neuromuscular Disorders Caution should be exercised when prescribing TOBI Podhaler to patients with known or suspected neuromuscular dysfunction. TOBI Podhaler should be used cautiously in patients with neuromuscular disorders, such as myasthenia gravis or Parkinson’s disease, since aminoglycosides may aggravate muscle weakness because of a potential curare-like effect on neuromuscular function.

5.5Embryo-Fetal Toxicity Aminoglycosides can cause fetal harm when administered to a pregnant woman. Aminoglycosides cross the placenta, and streptomycin has been associated with several reports of total, irreversible, bilateral congenital deafness in pediatric patients exposed in utero. However, systemic absorption of tobramycin following inhaled administration is expected to be minimal [see Clinical Pharmacology (12.3) ] .

Patients who use TOBI Podhaler during pregnancy, or become pregnant while taking TOBI Podhaler should be apprised of the potential hazard to the fetus [see Use in Specific Populations (8.1) ] .

5.6Concomitant Use of Systemic Aminoglycosides Patients receiving concomitant TOBI and parenteral aminoglycoside therapy should be monitored as clinically appropriate for toxicities associated with aminoglycosides as a class. Serum tobramy… [Excerpted — this section continues on DailyMed.]

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The most common adverse reactions (≥10 % of TOBI Podhaler and TOBI patients in primary safety population) are cough, lung disorder, productive cough, dyspnea, pyrexia, oropharyngeal pain, dysphonia, hemoptysis, and headache ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Viatris at 1-877-446-3679 (1-877-4-INFO-RX) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. TOBI Podhaler has been evaluated for safety in 425 cystic fibrosis patients exposed to at least one dose of TOBI Podhaler, including 273 patients who were exposed across three cycles (6 months) of treatment. Each cycle consisted of 28 days on-treatment (with 112 mg administered twice-daily) and 28 days off-treatment.

Patients with serum creatinine ≥2 mg/dL and blood urea nitrogen (BUN) ≥40 mg/dL were excluded from clinical studies. There were 218 males and 207 females in this population, and reflecting the cystic fibrosis population in the U.S., the vast majority of patients were Caucasian. There were 221 patients ≥20 years old, 121 patients ≥13 to <20 years old, and 83 patients ≥6 to <13 years old.

There were 239 patients with screening FEV 1 % predicted ≥50%, 156 patients with screening FEV 1 % predicted <50%, and 30 patients with missing FEV 1 % predicted. The primary safety population reflects patients from Study 1, an open-label study comparing TOBI Podhaler with TOBI (tobramycin inhalation solution, USP) over three cycles of 4 weeks on treatment followed by 4 weeks off treatment. Randomization, in a planned 3:2 ratio, resulted in 308 patients treated with TOBI Podhaler and 209 patients treated with TOBI.

For both the TOBI Podhaler and TOBI groups, mean exposure to medication for each cycle was 28 to 29 days. The mean age for both arms was between 25 and 26 years old. The mean baseline FEV 1 % predicted for both arms was 53%.

Table 1 displays adverse drug reactions reported by at least 2% of TOBI Podhaler patients in Study 1, inclusive of all cycles (on and off treatment). Adverse drug reactions are listed according to MedDRA system organ class and sorted within system organ class group in descending order of frequency. Table 1: Adverse Reactions Reported in Study 1 (Occurring in ≥2% of TOBI Podhaler Patients) Primary System Organ Class Preferred Term TOBI Podhaler N=308 % TOBI N=209 % Respiratory, thoracic, and mediastinal disorders Cough 48.4

31.1Lung disorder This includes adverse events of pulmonary or cystic fibrosis exacerbations 33.8

30.1Productive cough 18.2

19.6Dyspnea 15.6

12.4Oropharyngeal pain 14.0

10.5Dysphonia 13.6

3.8Hemoptysis 13.0

12.4Nasal congestion 8.1

7.2Rales 7.1

6.2Wheezing 6.8

6.2Chest discomfort 6.5

2.9Throat irritation 4.5

1.9Gastrointestinal disorders Nausea 7.5

9.6Vomiting 6.2

5.7Diarrhea 4.2

1.9Dysgeusia 3.9

0.5Infections and infestations Upper respiratory tract infection 6.8

8.6Investigations Pulmonary function test decreased 6.8

8.1Forced expiratory volume decreased 3.9

1.0Blood glucose increased 2.9

0.5Vascular disorders Epistaxis 2.6

1.9Nervous system disorders Headache 11.4

12.0General disorders and administration site conditions Pyrexia 15.6

12.4Musculoskeletal and connective tissue disorders Musculoskeletal chest pain 4.5

4.8Skin and subcutaneous tissue disorders Rash 2.3

2.4Adverse drug reactions that occurred in <2% of patients treated with TOBI Podhaler in Study 1 were: bronchospasm (TOBI Podhaler 1.6%, TOBI 0.5%); deafness including deafness unilateral (reported as mild to moderate hearing loss or increased hearing loss) (TOBI Podhaler 1.0%, TOBI 0.5%); and tinnitus (TOBI Podhaler 1.9%, TOBI 2.4%). Discontinuations in Study 1 were higher in the TOBI Podhaler arm compared to TOBI (27%… [Excerpted — this section continues on DailyMed.]

🔄 Drug Interactions 124 words ▾

7 DRUG INTERACTIONS 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. Concurrent and/or sequential use of TOBI Podhaler with other drugs with neurotoxic, nephrotoxic, or ototoxic potential should be avoided ( 7 )

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS

8.1Pregnancy Risk Summary Aminoglycosides can cause fetal harm. Published literature reports that use of streptomycin, an aminoglycoside, can cause total, irreversible, bilateral congenital deafness when administered to a pregnant woman [ Warnings and Precautions (5.5) ] . Although there are no available data on TOBI Podhaler use in pregnant women to inform a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes, systemic absorption of tobramycin following inhaled administration is expected to be minimal [see Clinical Pharmacology (12.3) ] .

There are risks to the mother associated with cystic fibrosis in pregnancy (see Clinical Considerations ) . In animal reproduction studies with subcutaneous administration of tobramycin in pregnant rats and rabbits during organogenesis there were no adverse developmental outcomes; however, ototoxicity was not evaluated in the offspring from these studies (see Data ) . Advise pregnant women of the potential risk to a fetus.

The estimated background risk of major birth defects and miscarriage for the indicated populations are unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.

Clinical Considerations Disease-Associated Maternal and/or Embryo/Fetal Risk Cystic fibrosis may increase the risk for preterm delivery. Data Animal Data No reproduction toxicology studies have been conducted with TOBI Podhaler. However, subcutaneous administration of tobramycin at doses of up to 100 (rat) or 20 (rabbit) mg/kg/day during organogenesis was not associated with adverse developmental outcomes.

Doses of tobramycin ≥40 mg/kg/day were severely maternally toxic to rabbits and precluded the evaluation of adverse developmental outcomes. Ototoxicity was not evaluated in offspring during non-clinical reproductive toxicity studies with tobramycin.

8.2Lactation Risk Summary There are no data on the presence of tobramycin following administration of TOBI Podhaler in either human or animal milk, the effects on the breastfed infant, or the effects on milk production. Limited published data on other formulations of tobramycin in lactating women indicate that tobramycin is present in human milk. However, systemic absorption of tobramycin following inhaled administration is expected to be minimal [see Clinical Pharmacology (12.3) ] .

Tobramycin may cause alteration in the intestinal flora of the breastfeeding infant (see Clinical Considerations ) . The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for TOBI Podhaler and any potential adverse effects on the breastfed infant from TOBI Podhaler or from the underlying maternal condition. Clinical Considerations Tobramycin may cause intestinal flora alteration.

Advise a woman to monitor the breastfed infant for loose or bloody stools and candidiasis (thrush, diaper rash).

8.4Pediatric Use Patients 6 years and older were included in the Phase 3 studies with TOBI Podhaler; 206 patients below 20 years of age received TOBI Podhaler. No dosage adjustments are needed based on age. The overall pattern of adverse events in pediatric patients was similar to the adults.

Dysgeusia (taste disturbance) was more commonly reported in younger patients six to 19 years of age than in patients 20 years and older, 7.4% versus 2.7%, respectively. Safety and effectiveness in pediatric patients below the age of 6 years have not been established.

8.5Geriatric Use Clinical studies of TOBI Podhaler did not include sufficient numbers of subjects aged 65 years and over to determine whether they respond differently from younger subjects. Tobramycin is known to be substantially excreted by the kidney, and the risk of adverse reactions to this drug m… [Excerpted — this section continues on DailyMed.]

🤰 Pregnancy ~1 min read ▾

8.1Pregnancy Risk Summary Aminoglycosides can cause fetal harm. Published literature reports that use of streptomycin, an aminoglycoside, can cause total, irreversible, bilateral congenital deafness when administered to a pregnant woman [ Warnings and Precautions (5.5) ] . Although there are no available data on TOBI Podhaler use in pregnant women to inform a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes, systemic absorption of tobramycin following inhaled administration is expected to be minimal [see Clinical Pharmacology (12.3) ] .

There are risks to the mother associated with cystic fibrosis in pregnancy (see Clinical Considerations ) . In animal reproduction studies with subcutaneous administration of tobramycin in pregnant rats and rabbits during organogenesis there were no adverse developmental outcomes; however, ototoxicity was not evaluated in the offspring from these studies (see Data ) . Advise pregnant women of the potential risk to a fetus.

The estimated background risk of major birth defects and miscarriage for the indicated populations are unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.

Clinical Considerations Disease-Associated Maternal and/or Embryo/Fetal Risk Cystic fibrosis may increase the risk for preterm delivery. Data Animal Data No reproduction toxicology studies have been conducted with TOBI Podhaler. However, subcutaneous administration of tobramycin at doses of up to 100 (rat) or 20 (rabbit) mg/kg/day during organogenesis was not associated with adverse developmental outcomes.

Doses of tobramycin ≥40 mg/kg/day were severely maternally toxic to rabbits and precluded the evaluation of adverse developmental outcomes. Ototoxicity was not evaluated in offspring during non-clinical reproductive toxicity studies with tobramycin.

🧒 Pediatric Use 93 words ▾

8.4Pediatric Use Patients 6 years and older were included in the Phase 3 studies with TOBI Podhaler; 206 patients below 20 years of age received TOBI Podhaler. No dosage adjustments are needed based on age. The overall pattern of adverse events in pediatric patients was similar to the adults.

Dysgeusia (taste disturbance) was more commonly reported in younger patients six to 19 years of age than in patients 20 years and older, 7.4% versus 2.7%, respectively. Safety and effectiveness in pediatric patients below the age of 6 years have not been established.

🧓 Geriatric Use 84 words ▾

8.5Geriatric Use Clinical studies of TOBI Podhaler did not include sufficient numbers of subjects aged 65 years and over to determine whether they respond differently from younger subjects. 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 (5.2 , 5.5) ].

🆘 Overdosage 111 words ▾

10 OVERDOSAGE 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.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Tobramycin is an aminoglycoside antibacterial [see Clinical Pharmacology (12.4) ] .

12.3Pharmacokinetics Absorption TOBI Podhaler contains tobramycin, a cationic polar molecule that does not readily cross epithelial membranes. TOBI Podhaler is specifically formulated for administration by oral inhalation. The systemic exposure to tobramycin after inhalation of TOBI Podhaler is expected to result from pulmonary absorption of the dose fraction delivered to the lungs as tobramycin and is not absorbed to any appreciable extent when administered via the oral route.

Serum Concentrations After inhalation of a 112 mg single dose (4 times 28 mg capsules) of TOBI Podhaler in cystic fibrosis patients, the maximum serum concentration (C max ) of tobramycin was 1.02 ± 0.53 mcg/mL (mean ± SD) and the median time to reach the peak concentration (T max ) was 1 hour. In comparison, after inhalation of a single 300 mg dose of TOBI, C max was 1.04 ± 0.58 mcg/mL and median T max was 1 hour. The extent of systemic exposure (AUC 0-12 ) was also similar: 4.6 ± 2.0 mcg∙h/mL following the 112 mg TOBI Podhaler dose and 4.8 ± 2.5 mcg∙h/mL following the 300 mg TOBI dose.

At the end of a 4-week dosing cycle of TOBI Podhaler (112 mg twice-daily), the maximum serum concentration of tobramycin 1 hour after dosing ranged from 1.48 ± 0.69 mcg/mL to 1.99 ± 0.59 mcg/mL (mean ± SD). Sputum Concentrations After inhalation of a 112 mg single dose (4 times 28 mg capsules) of TOBI Podhaler in cystic fibrosis patients, sputum C max of tobramycin was 1048 ± 1080 mcg/g (mean ± SD). In comparison, after inhalation of a single 300 mg dose of TOBI, sputum C max was 737 ± 1028 mcg/g.

The variability in pharmacokinetic parameters was higher in sputum as compared to serum. Distribution A population pharmacokinetic analysis for TOBI Podhaler in cystic fibrosis patients estimated the apparent volume of distribution of tobramycin in the central compartment to be

85.1L for a typical cystic fibrosis (CF) patient. Binding of tobramycin to serum proteins is negligible. Metabolism Tobramycin is not metabolized and is primarily excreted unchanged in the urine.

Elimination Tobramycin is eliminated from the systemic circulation primarily by glomerular filtration of the unchanged compound. Systemically absorbed tobramycin following TOBI Podhaler administration is also expected to be eliminated principally by glomerular filtration. The apparent terminal half-life of tobramycin in serum after inhalation of a 112 mg single dose of TOBI Podhaler was approximately 3 hours in cystic fibrosis patients and consistent with the half-life of tobramycin after TOBI inhalation.

A population pharmacokinetic analysis for TOBI Podhaler in cystic fibrosis patients aged 6 to 58 years estimated the apparent serum clearance of tobramycin to be

14.5L/h. No clinically relevant covariates that were predictive of tobramycin clearance were identified from this analysis.

12.4Microbiology Mechanism of Action Tobramycin is an aminoglycoside antibacterial produced by Streptomyces tenebrarius . It acts primarily by disrupting protein synthesis leading to altered cell membrane permeability, progressive disruption of the cell envelope, and eventual cell death. Tobramycin has in vitro activity against Gram-negative bacteria including P. aeruginosa .

It is bactericidal in vitro at peak concentrations equal to or slightly greater than the minimum inhibitory concentration (MIC). Susceptibility Testing Interpretive criteria for inhaled antibacterial products are not defined. The in vitro antimicrobial susceptibility test methods used to determine the susceptibility for parenteral tobramycin therapy can be used to monitor the susceptibility of P. aeruginosa isolated from cystic fibrosis patients.

(1,2,3) The relationship between in vitro susceptibility test results and clinical outcome with TOBI Podhaler therapy is not clear. A single sputum sample from a cystic fibrosis p… [Excerpted — this section continues on DailyMed.]

🧬 Mechanism of Action 82 words ▾

12.1Mechanism of Action Tobramycin is an aminoglycoside antibacterial [see Clinical Pharmacology (12.4) ] .

Mechanism of Action Tobramycin is an aminoglycoside antibacterial produced by Streptomyces tenebrarius . It acts primarily by disrupting protein synthesis leading to altered cell membrane permeability, progressive disruption of the cell envelope, and eventual cell death. Tobramycin has in vitro activity against Gram-negative bacteria including P. aeruginosa .

It is bactericidal in vitro at peak concentrations equal to or slightly greater than the minimum inhibitory concentration (MIC).

📦 How Supplied / Storage and Handling ~1 min read ▾

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1How Supplied TOBI Podhaler contains aluminum blister-packaged 28 mg TOBI Podhaler (tobramycin inhalation powder) clear, colorless hypromellose capsules 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, and Podhaler devices. Each Podhaler device consists of the inhaler body, mouthpiece, capsule chamber and blue push button. The Podhaler device is provided in a case that protects the device during shipment, storage and its one week in-use period.

Unit dose (blister pack), Box of 224 capsules contains: NDC 49502-401-24 4 weekly packs, each containing: 56 capsules (7 blister cards of 8 capsules) 1 Podhaler device 1 reserve Podhaler device Unit dose (blister pack), Box of 56 capsules (7-day pack) contains: NDC 49502-401-56 56 capsules (7 blister cards of 8 capsules) 1 Podhaler device

16.2Storage and Handling Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). Protect TOBI Podhaler from moisture. o TOBI Podhaler capsules should be used with the Podhaler device only. The Podhaler device should not be used with any other capsules. o Capsules should always be stored in the blister and each capsule should only be removed immediately before use. o Always use the new Podhaler device provided with each weekly pack.

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

📋 Description ~1 min read ▾

11 DESCRIPTION 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 C 18 H 37 N 5 O 9 .

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 (FEV 1 ) 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 FEV 1 less than 40% predicted were evaluated. Tobramycin structural formula

💬 Information for Patients ~3 min read ▾

17 PATIENT COUNSELING INFORMATION 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 (FEV 1 <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 solutio… [Excerpted — this section continues on DailyMed.]

🧬 Pharmacokinetics ~2 min read ▾

12.3Pharmacokinetics Absorption TOBI Podhaler contains tobramycin, a cationic polar molecule that does not readily cross epithelial membranes. TOBI Podhaler is specifically formulated for administration by oral inhalation. The systemic exposure to tobramycin after inhalation of TOBI Podhaler is expected to result from pulmonary absorption of the dose fraction delivered to the lungs as tobramycin and is not absorbed to any appreciable extent when administered via the oral route.

Serum Concentrations After inhalation of a 112 mg single dose (4 times 28 mg capsules) of TOBI Podhaler in cystic fibrosis patients, the maximum serum concentration (C max ) of tobramycin was 1.02 ± 0.53 mcg/mL (mean ± SD) and the median time to reach the peak concentration (T max ) was 1 hour. In comparison, after inhalation of a single 300 mg dose of TOBI, C max was 1.04 ± 0.58 mcg/mL and median T max was 1 hour. The extent of systemic exposure (AUC 0-12 ) was also similar: 4.6 ± 2.0 mcg∙h/mL following the 112 mg TOBI Podhaler dose and 4.8 ± 2.5 mcg∙h/mL following the 300 mg TOBI dose.

At the end of a 4-week dosing cycle of TOBI Podhaler (112 mg twice-daily), the maximum serum concentration of tobramycin 1 hour after dosing ranged from 1.48 ± 0.69 mcg/mL to 1.99 ± 0.59 mcg/mL (mean ± SD). Sputum Concentrations After inhalation of a 112 mg single dose (4 times 28 mg capsules) of TOBI Podhaler in cystic fibrosis patients, sputum C max of tobramycin was 1048 ± 1080 mcg/g (mean ± SD). In comparison, after inhalation of a single 300 mg dose of TOBI, sputum C max was 737 ± 1028 mcg/g.

The variability in pharmacokinetic parameters was higher in sputum as compared to serum. Distribution A population pharmacokinetic analysis for TOBI Podhaler in cystic fibrosis patients estimated the apparent volume of distribution of tobramycin in the central compartment to be

85.1L for a typical cystic fibrosis (CF) patient. Binding of tobramycin to serum proteins is negligible. Metabolism Tobramycin is not metabolized and is primarily excreted unchanged in the urine.

Elimination Tobramycin is eliminated from the systemic circulation primarily by glomerular filtration of the unchanged compound. Systemically absorbed tobramycin following TOBI Podhaler administration is also expected to be eliminated principally by glomerular filtration. The apparent terminal half-life of tobramycin in serum after inhalation of a 112 mg single dose of TOBI Podhaler was approximately 3 hours in cystic fibrosis patients and consistent with the half-life of tobramycin after TOBI inhalation.

A population pharmacokinetic analysis for TOBI Podhaler in cystic fibrosis patients aged 6 to 58 years estimated the apparent serum clearance of tobramycin to be

14.5L/h. No clinically relevant covariates that were predictive of tobramycin clearance were identified from this analysis.

🔬 Clinical Studies ~3 min read ▾

14 CLINICAL STUDIES 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 FEV 1 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 FEV 1 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 β 2 -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 FEV 1 % predicted from baseline to the end of Cycle 1 dosing.

This analysis adjusted for the covariates of baseline FEV 1 % predicted, age, and region, and imputed for missing data. Treatment with TOBI Podhaler and placebo resulted in relative increases in FEV 1 % 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 FEV 1 % 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 w… [Excerpted — this section continues on DailyMed.]

🧪 Nonclinical Toxicology 192 words ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenicity studies were not conducted with TOBI Podhaler. A 2-year rat inhalation toxicology study to assess carcinogenic potential of TOBI (tobramycin inhalation solution, USP) has been completed. Rats were exposed to TOBI for up to 1.5 hours per day for 95 weeks.

Serum levels of tobramycin of up to 35 mcg/mL were measured in rats, in contrast to the maximum 1.99 ± 0.59 mcg/mL level observed in cystic fibrosis patients in TOBI Podhaler clinical trials. There was no drug-related increase in the incidence of any variety of tumor. Additionally, tobramycin has been evaluated for genotoxicity in a battery of in vitro and in vivo tests.

The Ames bacterial reversion test, conducted with 5 tester strains, failed to show a significant increase in revertants with or without metabolic activation in all strains. Tobramycin was negative in the mouse lymphoma forward mutation assay, did not induce chromosomal aberrations in Chinese hamster ovary cells, and was negative in the mouse micronucleus test. Subcutaneous administration of up to 100 mg/kg of tobramycin did not affect mating behavior or cause impairment of fertility in male or female rats.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 189 words ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenicity studies were not conducted with TOBI Podhaler. A 2-year rat inhalation toxicology study to assess carcinogenic potential of TOBI (tobramycin inhalation solution, USP) has been completed. Rats were exposed to TOBI for up to 1.5 hours per day for 95 weeks.

Serum levels of tobramycin of up to 35 mcg/mL were measured in rats, in contrast to the maximum 1.99 ± 0.59 mcg/mL level observed in cystic fibrosis patients in TOBI Podhaler clinical trials. There was no drug-related increase in the incidence of any variety of tumor. Additionally, tobramycin has been evaluated for genotoxicity in a battery of in vitro and in vivo tests.

The Ames bacterial reversion test, conducted with 5 tester strains, failed to show a significant increase in revertants with or without metabolic activation in all strains. Tobramycin was negative in the mouse lymphoma forward mutation assay, did not induce chromosomal aberrations in Chinese hamster ovary cells, and was negative in the mouse micronucleus test. Subcutaneous administration of up to 100 mg/kg of tobramycin did not affect mating behavior or cause impairment of fertility in male or female rats.

📚 References 74 words ▾

15 REFERENCES 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

📄 Patient Package Insert ~3 min read ▾

Patient Information TOBI (TOH-bee) Podhaler (POD-hay-ler) (tobramycin inhalation powder) for oral inhalation use Important information: Do not swallow TOBI Podhaler capsules. TOBI Podhaler capsules are used only with the Podhaler device and inhaled through your mouth (oral inhalation). Never place a capsule in the mouthpiece of the Podhaler device.

Read this Patient Information leaflet before you start using TOBI Podhaler and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or treatment.

What is TOBI Podhaler? TOBI Podhaler is a prescription medicine used to treat people with cystic fibrosis who have a bacterial infection called Pseudomonas aeruginosa . TOBI Podhaler contains an antibacterial medicine called tobramycin (an aminoglycoside).

It is not known if TOBI Podhaler is safe and effective: • in children under 6 years of age • in people who have an FEV 1 less than 25% or greater than 80% predicted • in people who are colonized with a bacterium called Burkholderia cepacia Who should not use TOBI Podhaler? Do not use TOBI Podhaler if you are allergic to tobramycin, any of the ingredients in TOBI Podhaler, or to any other aminoglycoside antibacterial medicines. What should I tell my healthcare provider before using TOBI Podhaler?

Before using TOBI Podhaler, tell your healthcare provider about all of your medical conditions, including if you: • have or have had hearing problems (including noises in your ears such as ringing or hissing), hearing loss, or your mother has had hearing problems after taking an aminoglycoside. • have been told you have certain gene variants (a change in the gene) related to hearing abnormalities inherited from your mother. • have dizziness. • have or have had kidney problems. • have or have had problems with muscle weakness such as myasthenia gravis or Parkinson’s disease. • have or have had breathing problems such as wheezing, coughing, or chest tightness. • have had an organ transplant. • are pregnant or plan to become pregnant.

TOBI Podhaler contains a medicine that can harm your unborn baby. See “ What are the possible side effects of TOBI Podhaler? ” for more information. • are breastfeeding or plan to breastfeed. It is not known if the medicine in TOBI Podhaler (tobramycin inhalation powder) passes into your breast milk.

Tell your healthcare provider about all the medicines you take , including prescription and over-the-counter medicines, vitamins, and herbal supplements. Using TOBI Podhaler with certain other medicines can cause serious side effects. Ask your healthcare provider or pharmacist for a list of these medicines, if you are not sure.

Know the medicines you take. Keep a list of them and show it to your healthcare provider and pharmacist when you get a new medicine. If you are using TOBI Podhaler, you should discuss with your healthcare provider if you should take: • other medicines that may harm your nervous system, kidneys, or hearing • “water pills” (diuretics) such as Edecrin (ethacrynic acid), Lasix (furosemide), or intravenous mannitol • urea How should I use TOBI Podhaler? • See the step-by-step Instructions for Use at the end of this Patient Information leaflet about the right way to use TOBI Podhaler.

Do not use TOBI Podhaler unless your healthcare provider has taught you how to use it the right way. • Use TOBI Podhaler exactly as your healthcare provider tells you to use it. Ask your healthcare provider or pharmacist if you are not sure. • The usual dose for adults and children over 6 years of age is: o The contents of 4 TOBI Podhaler capsules inhaled by mouth in the morning using your Podhaler device and the contents of 4 TOBI Podhaler capsules inhaled by mouth in the evening using your Podhaler device. o Check to see that each capsule is empty after inhaling.

If powder remains in the capsule, repeat inhalation until the capsule is empty. • Each dose of 4 TO… [Excerpted — this section continues on DailyMed.]

📖 Instructions for Use ~3 min read ▾

INSTRUCTIONS FOR USE 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. o 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): o 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 : o 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 : o 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: o is wet, dirty, or broken o has been dropped o does not seem to be piercing the capsule properly (see Step 17) Getting ready: • W… [Excerpted — this section continues on DailyMed.]

📄 Package Label / Principal Display Panel 213 words ▾

PRINCIPAL DISPLAY PANEL – 28 mg 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°C to 30°C (59°F to 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 Reserve Podhaler ® device Use this if your weekly inhaler is not functioning correctly, is wet, dirty, broken, or has dropped on the ground. (See patient information leaflet) Distributed by: Viatris Specialty LLC Morgantown, WV 26505 U.S.A.

Made in Portugal © 2026 Viatris Inc. GTIN: 00349502401244 EXP/LOT Tobi Podhaler Carton Label

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.
50176 capsules49502-0401-24 463 Rx · $5,232,065
8 capsules49502-0401-09 No Medicaid data
56 capsules this page49502-0401-57 No Medicaid data
Drug total (last 4 qtrs): 463 Rx · 99,232 units · $5,232,065 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Tobi Podhaler — the program that covers self-administered drugs. 1 manufacturer.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Tobi Podhaler. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$3.37M
Claims incl. refills
301
Beneficiaries
228
Spend / beneficiary
$14,796.96
Spend / claim
$11,208.33
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Tobramycin — the ingredient across all brands.

Top reported reactions

Death1,775
Pneumonia1,621
Infective Pulmonary Exacerbation Of Cystic Fibrosis1,591
Dyspnoea1,543
Cough1,369
Cystic Fibrosis1,294
Hospitalisation1,068

Age at onset

Neonate52
Infant41
Child354
Adolescent305
Adult2,278
Elderly951

Reporter sex

28,041 reports
Male · 44%
Female · 56%
Unknown · 0%

Serious outcomes

Hospitalization12,469
Life-threatening890
Disabling453
Reports over time (by year) — tap or hover for the count & year
2020 2022 2024 2026 3,064 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

About this NDC listing & data coverage

Finished prescription product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos — Not published for this NDC No photo available yet for this listing.
Inactive ingredients (structured) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available.
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data ✓ Available
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Viatris Specialty LLC. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 2 other package presentations of this same product, including 8 capsules (49502-0401-09), 50176 capsules (49502-0401-24). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Viatris Specialty LLC is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
← 49502-0378-15 · Viatris 49502-0450-93 · Viatris →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.