tobramycin inhaled (Rx)

Brand and Other Names:TOBI, Bethkis, more...TOBI Podhaler, Kitabis Pak
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

solution for nebulization

  • 300mg/4mL ampule (Bethkis)
  • 300mg/5mL ampule (TOBI, Kitabis Pak)
  • NOTE: Kitabis Pak includes tobramycin solution and nebulizer (PARI LC PLUS reusable nebulizer and DeVilbiss Pulmo-Aide compressor)

powder for inhalation

  • 28mg/capsule

Pseudomonas aeruginosa Infection

Indicated for management Pseudomonas aeruginosa in patients with cystic fibrosis

Nebulizer: 300 mg inhaled orally via nebulizer BID

Powder for inhalation: 4 capsules (28 mg/capsule) inhaled PO BID

Nebulizer or powder for inhalation: Use in repeated cycles of 28 days on drug, followed by 28 days off drug, then resume therapy with the next 28 day on/28 day off cycle

Dosing Considerations

Safety and efficacy not established in the following patients

  • Age <6 years
  • FEV1 <25% or >80% predicted
  • Colonized with Burkholderia cepacia

Administration

For oral inhalation only

Bethkis: Administer using a hand-held PARI LC Plus reusable nebulizer with a APRI Vios Air compressor over ~15 minutes

TOBI: Administer using a hand-held PARI LC Plus reusable nebulizer with a DeVilbiss Pulmo-Aide compressor over ~15 minutes

Kitabis: Administer using PARI LC PLUS reusable nebulizer and DeVilbiss Pulmo-Aide compressor over ~15 minutes

TOBI Podhaler: For use with Podhaler device for oral inhalation; do not swallow capsules

Doses should be taken as close to 12 hr apart as possible; and, not less than 6 hr apart

Do not dilute or mix with dornase alfa in nebulizer; patients taking multiple therapies should take other nebulized therapies first, followed by tobramycin inhaled

Storage

  • Store ampules refrigerated (2-8°C [36-46°F])
  • Avoid exposure to intense light
  • May store the ampules foil pouches (opened or unopened) at room temperature (up to 25°C [77°F]) for up to 28 days
  • Unrefrigerated solution may slightly darken beyond its normally light yellow color; however the quality/potency of the solution is maintained for up to 28 days

Bronchiectasis (Orphan)

TOBI: Orphan designation for treatment of bronchiectasis patients infected with Pseudomonas aeruginosa

Orphan sponsor

  • Novartis Pharmaceuticals Corp; Drug Regulatory Affairs; One Health Plaza; East Hanover, NJ 07936-1080

Dosage Forms & Strengths

solution for nebulization

  • 300mg/4mL ampule (Bethkis)
  • 300mg/5mL ampule (TOBI, Kitabis Pak)
  • NOTE: Kitabis Pak includes tobramycin solution and nebulizer (PARI LC PLUS reusable nebulizer and DeVilbiss Pulmo-Aide compressor)

powder for inhalation

  • 28mg/capsule

Pseudomonas aeruginosa Infection

Indicated for management Pseudomonas aeruginosa in patients with cystic fibrosis

<6 years: Safety and efficacy not established

≥6 years

  • Nebulizer: 300 mg inhaled orally via nebulizer BID
  • Powder for inhalation: 4 capsules (28 mg/capsule) inhaled PO BID
  • Nebulizer or powder for inhalation: Use in repeated cycles of 28 days on drug, followed by 28 days off drug, then resume therapy with the next 28 day on/28 day off cycle

Dosing Considerations

Safety and efficacy not established in the following patients

  • Age <6 years
  • FEV1 <25% or >80% predicted
  • Colonized with Burkholderia cepacia

Administration

For oral inhalation only

Bethkis: Administer using a hand-held PARI LC Plus reusable nebulizer with a APRI Vios Air compressor over ~15 minutes

TOBI: Administer using a hand-held PARI LC Plus reusable nebulizer with a DeVilbiss Pulmo-Aide compressor over ~15 minutes

Kitabis: Administer using PARI LC PLUS reusable nebulizer and DeVilbiss Pulmo-Aide compressor over ~15 minutes

TOBI Podhaler: For use with Podhaler device for oral inhalation; do not swallow capsules

Doses should be taken as close to 12 hr apart as possible; and, not less than 6 hr apart

For patients taking several different inhaled medications and/or performing chest physiotherapy, it is recommended that TOBI Podhaler is taken last

Storage

  • Store ampules refrigerated (2-8°C [36-46°F])
  • Avoid exposure to intense light
  • May store the ampules foil pouches (opened or unopened) at room temperature (up to 25°C [77°F]) for up to 28 days
  • Unrefrigerated solution may slightly darken beyond its normally light yellow color; however the quality/potency of the solution is maintained for up to 28 days
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Interactions

Interaction Checker

and tobramycin inhaled

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    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

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            Adverse Effects

            >10%

            Voice alteration (12.8%)

            1-10%

            Myalgia (4.7%)

            Laryngitis (4.3%)

            Tinnitus (3%)

            Epistaxis (3%)

            Postmarketing Reports

            General disorders: Malaise

            Ear and labyrinth disorders: Hearing loss

            Skin and subcutaneous tissue disorders: Hypersensitivity, pruritus, urticaria, rash

            Nervous system disorders: Aphonia, dysgeusia

            Respiratory, thoracic, and mediastinal disorders: Bronchospasm, oropharyngeal pain, sputum discolored

            Decreased appetite

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            Warnings

            Contraindications

            Hypersensitivity

            Cautions

            Known or suspected renal, auditory, vestibular, or neuromuscular dysfunction

            Carefully monitor if on concomitant parenteral aminoglycosides

            Tinnitus occurred in clinical trials of inhaled tobramycin; however, ototoxicity did not occur; postmarketing experience, patients receiving therapy have reported hearing loss; vestibular toxicity may be manifested by vertigo, ataxia or dizziness; patients with known or suspected auditory or vestibular dysfunction should be closely monitored when receiving therapy; monitoring might include obtaining audiometric evaluations and serum tobramycin levels; if ototoxicity is noted, the patient should be managed as medically appropriate, including potentially discontinuing therapy

            Nephrotoxicity not observed in clinical trials, but has been associated with aminoglycosides as a class; patients with known or suspected renal dysfunction or taking concomitant nephrotoxic drugs should have serum concentrations of tobramycin and laboratory measurements of renal function obtained at discretion of treating physician; if nephrotoxicity develops, patient should be managed as medically appropriate, including potentially discontinuing therapy

            May exacerbate muscular disorders (eg, myasthenia gravis, Parkinson disease); therapy may aggravate muscle weakness because of a potential curare-like effect on neuromuscular function; neuromuscular blockade, respiratory failure, and prolonged respiratory paralysis may occur more commonly in patients with underlying neuromuscular disorders, such as myasthenia gravis or Parkinson’s disease

            Bronchospasm can occur; prolonged respiratory paralysis may occur in patients receiving concomitant neuromuscular blocking agents; if neuromuscular blockade occurs, it may be reversed by administration of calcium salts but mechanical assistance may be necessary; bronchospasm that occurs during therapy should be treated as medically appropriate

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            Pregnancy & Lactation

            Pregnancy

            Aminoglycosides can cause fetal harm; aminoglycosides cross the placenta; published literature reports that use of streptomycin, an aminoglycoside, can cause total, irreversible, bilateral congenital deafness when administered to a pregnant woman; although there are no available data on ophthalmic use of tobramycin 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

            There are risks to mother associated with cystic fibrosis in pregnancy; 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; advise pregnant women of potential risk to a fetus

            Cystic fibrosis may increase risk for preterm delivery

            Lactation

            There are no data on presence of drug in either human or animal milk, the effects on breastfed infant, or 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; therapy may cause alteration in intestinal flora of breastfeeding infant; the developmental and health benefits of breastfeeding should be considered along with mother's clinical need for therapy and any potential adverse effects on breastfed infant from drug or from underlying maternal condition

            Therapy may cause intestinal flora alteration; advise a woman to monitor breastfed infant for loose or bloody stools and candidiasis (thrush, diaper rash)

            Pregnancy Categories

            A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA: Information not available.

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            Pharmacology

            Mechanism of Action

            Aminoglycoside that acts by disrupting protein synthesis, leading to altered cell membrane permeability, progressive disruption of the cell envelope, and eventual cell death

            In vitro activity against wide range of gram-negative organisms including Pseudomonas aeruginosa

            Absorption

            Sputum Concentration (10 min post dose): 1154 mcg/g (range: 39-8085 mcg/g)

            Serum Concentration (1 hr post dose): 0.95 mcg/mL (single dose); 1.05 mcg/mL (after 20 weeks of therapy)

            Elimination

            Half-life: 2 hr (IV)

            Excretion: Unabsorbed drug eliminated primarily in expectorated sputum

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            Formulary

            FormularyPatient Discounts

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            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
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            Code Definition
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            Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.