TOBI Podhaler 28 mg/1

Tobramycin · CAPSULE · Viatris Specialty LLC

No Recall HistoryCurrently in Shortage

Plain English

TOBI Podhaler is a capsule containing tobramycin at 28 mg/1, taken oral. Manufactured by Viatris Specialty LLC.

Key Facts

Brand Name: TOBI Podhaler
Generic Name: Tobramycin
NDC Code (Product): 49502-401
Manufacturer: Viatris Specialty LLC
Strength: 28 mg/1
Dosage Form: CAPSULE
Route: ORAL, RESPIRATORY (INHALATION)
Marketing Status
Application #: NDA201688
Drug Class: Aminoglycoside Antibacterial [EPC]
Marketing Start: 09/01/2021

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

dyspnoea902 reports

off label use878 reports

pneumonia878 reports

infective pulmonary exacerbation of cystic fibrosis834 reports

cough818 reports

cystic fibrosis771 reports

condition aggravated727 reports

drug ineffective712 reports

death699 reports

acute kidney injury680 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

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 & Administration

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 patient…

Contraindications

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

Drug Interactions

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 )

Adverse Reactions

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. 6.1 Clinical 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 …

Frequently Asked Questions

What is TOBI Podhaler used for?

TOBI Podhaler contains Tobramycin. It is a capsule taken oral. Consult your doctor for specific uses.

Is TOBI Podhaler a controlled substance?

TOBI Podhaler is not classified as a controlled substance by the DEA.

What is the generic name for TOBI Podhaler?

The generic name for TOBI Podhaler is Tobramycin. There are 12 other brand versions of Tobramycin.

What is the NDC code for TOBI Podhaler 28 mg/1?

The NDC (National Drug Code) for TOBI Podhaler 28 mg/1 is 49502-401, listed by Viatris Specialty LLC.

Product NDC

49502-401

Package NDC

49502-401-09

Other Tobramycin Brands

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

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