TOBI Podhaler Inhalation powder, hard capsule Ref.[7707] Active ingredients: Tobramycin

Posology

The dose of TOBI Podhaler is the same for all patients within the approved age range, regardless of age or weight. The recommended dose is 112 mg tobramycin (4 × 28 mg capsules), administered twice daily for 28 days. TOBI Podhaler is taken in alternating cycles of 28 days on treatment followed by 28 days off treatment. The two doses (of 4 capsules each) should be inhaled as close as possible to 12 hours apart and not less than 6 hours apart.

Missed doses

In case of missed dose with at least 6 hours until the next dose, the patient should take the dose as soon as possible. Otherwise, the patient should wait for the next dose and not inhale more capsules to make up for the missed dose.

Duration of treatment

Treatment with TOBI Podhaler should be continued on a cyclical basis for as long as the physician considers the patient is gaining clinical benefit from the treatment with TOBI Podhaler. If clinical deterioration of pulmonary status is evident, additional or alternative anti-pseudomonal therapy should be considered. See also information on clinical benefit and tolerability in sections 4.4, 4.8 and 5.1.

Special populations

Elderly patients (≥65 years)

There are insufficient data in this population to support a recommendation for or against dose adjustment.

Renal impairment

Tobramycin is primarily excreted unchanged in the urine and renal function is expected to affect the exposure to tobramycin. Patients with serum creatinine 2 mg/dl or more and blood urea nitrogen (BUN) 40 mg/dl or more have not been included in clinical studies and there are no data in this population to support a recommendation for or against dose adjustment with TOBI Podhaler. Caution should be exercised when prescribing TOBI Podhaler to patients with known or suspected renal dysfunction.

Please also refer to nephrotoxicity information in section 4.4.

Hepatic impairment

No studies have been performed on patients with hepatic impairment. As tobramycin is not metabolised, an effect of hepatic impairment on the exposure to tobramycin is not expected.

Patients after organ transplantation

Adequate data do not exist for the use of TOBI Podhaler in patients after organ transplantation. No recommendation for or against dose adjustment can be made for patients after organ transplantation.

Paediatric patients

The safety and efficacy of TOBI Podhaler in children aged under 6 years have not been established. No data are available.

Method of administration

Inhalation use.

TOBI Podhaler is administered by inhalation using the Podhaler device (see section 6.6 for detailed instructions for use). It must not be administered by any other route or using any other inhaler.

Caregivers should provide assistance to children starting TOBI Podhaler treatment, particularly those aged 10 years or younger, and should continue to supervise them until they are able to use the Podhaler device properly without help.

TOBI Podhaler capsules must not be swallowed. Each TOBI Podhaler capsule should be inhaled with two breath-hold manoeuvres and checked to ensure it is empty.

Where patients are receiving several different inhaled medicinal products and chest physiotherapy, it is recommended that TOBI Podhaler is taken last.

Adverse reactions specifically associated with overdose of TOBI Podhaler have not been identified. The maximum tolerated daily dose of TOBI Podhaler has not been established. Tobramycin serum concentrations may be helpful in monitoring overdosage. In case of signs of acute toxicity, immediate withdrawal of TOBI Podhaler and testing of renal function are recommended. In the event of accidental oral ingestion of TOBI Podhaler capsules, toxicity is unlikely as tobramycin is poorly absorbed from an intact gastrointestinal tract. Haemodialysis may be helpful in removing tobramycin from the body.

Shelf life: 3 years.

Discard the Podhaler device and its case 1 week after first use.

TOBI Podhaler capsules must always be stored in the blister to protect from moisture and only removed immediately before use.

The hard capsules are supplied in PVC/PA/Alu/PVC- PET/Alu blisters.

The Podhaler inhalation device and its storage case are made from plastic materials (polypropylene).

TOBI Podhaler is supplied in monthly packs containing 4 weekly cartons and a reserve Podhaler device in its storage case. Each weekly carton contains 56 × 28mg capsules (7 blisters with 8 capsules per blister), and a Podhaler device in its storage case.

Pack sizes:

56 capsules and 1 inhaler
224 (4 × 56) capsules and 5 inhalers (monthly multipack)
448 (8 × 56) capsules and 10 inhalers (2 x monthly multipack wrapped in foil)

Not all pack sizes may be marketed.

Only TOBI Podhaler capsules are to be used in the Podhaler device. No other inhaler may be used. TOBI Podhaler capsules must always be stored in the blister (capsule card), and only removed immediately before use. Each Podhaler device and its case are used for seven days and then discarded and replaced. Store the Podhaler device in its tightly closed case when not in use.

Basic instructions for use are given below, more detailed instructions are available from the patient leaflet.

Wash and fully dry hands.

1. Just before use, remove the Podhaler device from its case. Briefly inspect the inhaler to make sure it is not damaged or dirty.
2. Holding the body of the inhaler, unscrew and remove the mouthpiece from the inhaler body. Set the mouthpiece aside on a clean, dry surface.
3. Separate the morning and evening doses from the capsule card.
4. Peel back the foil from the capsule card to reveal one TOBI Podhaler capsule and remove it from the card.
5. Immediately insert the capsule into the inhaler chamber. Replace the mouthpiece and screw it on firmly until it stops. Do not overtighten.
6. To puncture capsule, hold the inhaler with the mouthpiece down, press the button firmly with your thumb as far as it will go, then release the button.
7. Fully exhale away from the inhaler.
8. Place mouth over the mouthpiece creating a tight seal. Inhale the powder deeply with a single continuous inhalation.
9. Remove inhaler from mouth, and hold breath for approximately 5 seconds, then exhale normally away from the inhaler.
10. After a few normal breaths away from the inhaler, perform a second inhalation from the same capsule.
11. Unscrew mouthpiece and remove the capsule from the chamber.
12. Inspect the used capsule. It should appear punctured and empty.
    • If the capsule is punctured but still contains some powder, place it back into the inhaler and take another two inhalations from the capsule. Reinspect capsule.
    • If the capsule appears to be unpunctured, place it back into the inhaler, press the button firmly as far as it goes and take another two inhalations from the capsule. After this if the capsule is still full and appears to be unpunctured, replace the inhaler with the reserve inhaler and try again.
13. Discard the empty capsule.
14. Repeat, starting at step 5, for the remaining three capsules of the dose.
15. Replace the mouthpiece and screw it on firmly until it stops. When the full dose (4 capsules) has been inhaled, wipe mouthpiece with a clean dry cloth.
16. Place inhaler back in storage case and close tightly. The inhaler should never be washed with water.

See also section 4.2.

Any unused product or waste material should be disposed of in accordance with local requirements.