Tobi

Generic name: tobramycin (inhalation)
Brand names: Bethkis, Kitabis Pak, Tobi, Tobi Podhaler
Drug classes: Aminoglycosides, Inhaled anti-infectives

Medically reviewed by  A Ras MD.

What is Tobi?

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

It is not known if Tobi is safe and effective:

• in children under 6 years of age
• in people who have an FEV₁ less than 25% or greater than 75% predicted
• in people who are colonized with a bacterium called Burkholderia cepacia

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 C18H37N5O9. Tobramycin is a white to almost white powder; visually free from any foreign contaminants. Tobramycin is freely soluble in water, very slightly soluble in ethanol, and practically insoluble in chloroform and ether.

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

 

Who should not take Tobi?

Do not take Tobi it you are allergic to tobramycin, any of the ingredients in Tobi, or to any other aminoglycoside antibacterial.

See “What are the ingredients in Tobi?” for a complete list of ingredients.

What should I tell my healthcare provider before taking Tobi?

Before you take Tobi, 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)
• 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
• are pregnant or plan to become pregnant. Tobi is in a class of drugs that can harm your unborn baby.
• are breastfeeding or plan to breastfeed. It is not known if Tobi passes into your breast milk.
• are receiving aminoglycoside therapy by injection or through a vein (intravenous) while taking Tobi. Your blood levels of tobramycin will be checked.

Tell your healthcare provider about all the medicines you take, including prescription medicines, over-the-counter medicines, vitamins, and herbal supplements.

How should I take Tobi?

• Take Tobi exactly as your healthcare provider tells you. Do not change your dose or stop taking Tobi unless your healthcare provider tells you to.
• The usual dose for adults and children over 6 years of age is:
  • 1 single-use ampule of Tobi inhaled 2 times each day using a hand-held PARI LC PLUS Reusable Nebulizer ana DeVilbiss Pulmo-Aide air compressor.
• Each dose of Tobi should be taken as close to 12 hours apart as possible.
• You should not take your dose less than 6 hours apart.
• Tobi is taken as a breathing treatment (inhalation) with a hand-held PARI LC PLUS Reusable Nebulizer with a DeVilbiss Pulmo-Aide compressor. Do not use any other nebulizer for your Tobi treatment.
• Do not mix or dilute Tobi with dornase alfa or other medicines in your nebulizer system.
• Each treatment should take about 15 minutes.
• Tobi should be inhaled while you are sitting or standing upright and breathing normally through the mouthpiece of the nebulizer. Nose clips may help you to breathe through your mouth.
• If you forget to take Tobi and there are at least 6 hours to your next dose, take your dose as soon as you can. Otherwise, wait for your next dose. Do not double the dose to make up for the missed dose.
• After using Tobi for 28 days, you should stop using it and wait 28 days. After you have stopped using Tobi for 28 days, you should start using Tobi again for 28 days. Complete the full 28-day course even if you are feeling better. It is important that you keep to the 28-day on, 28-day off cycle.

If you are taking several medicines or treatments to treat your cystic fibrosis, you should take your medicines or other treatments before inhaling Tobi or as directed by your healthcare provider. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter prescription medicines, vitamins, and herbal supplements.

Using Tobi with certain other medicines can cause serious side effects.

If you are using Tobi, 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 ethacrynic acid, furosemide, or intravenous mannitol
• urea

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.

What are the possible side effects of Tobi?

Tobi may cause serious side effects, including:

• Severe breathing problems (bronchospasm). Tell your healthcare provider right away if you get any of these symptoms of bronchospasm with using Tobi:
  • shortness of breath with wheezing
  • coughing and chest tightness
• Hearing loss or ringing in the ears (ototoxicity). Tell your healthcare provider right away if you have hearing loss or you hear noises in your ears such as ringing or hissing. Tell your healthcare provider if you develop vertigo, difficulty with balance or dizziness.
• Worsening kidney problems (nephrotoxicity). Tobi is in a class of drugs which may cause worsening kidney problems, especially in people with known or suspected kidney problems. Your healthcare provider may do a blood test to check how your kidneys are working while you are using Tobi.
• Worsening muscle weakness (neuromuscular disorder). Tobi is in a class of drugs which can cause muscle weakness to get worse in people who already have problems with muscle weakness (myasthenia gravis or Parkinson’s disease).

The most common side effects of Tobi include:

• increased cough
• sore throat
• increased sputum
• coughing up blood
• voice changes
• decreased lung function
• loss or change in taste t
• rouble breathing
• rash

These are not all of the possible side effects of Tobi. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800- FDA-1088.

General information about the safe and effective use of Tobi

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use Tobi for a condition for which it was not prescribed. Do not give it to other people, even if they have the same symptoms you have. It may harm them. You can ask your pharmacist or healthcare provider for more information about Tobi that is written for health professionals

How should I store Tobi?

• Tobi should be stored under refrigeration at 2ºC–8ºC/36ºF–46ºF.
• Upon removal from the refrigerator, or if refrigeration is unavailable, Tobi pouches (opened or unopened) may be stored at room temperature (up to 25ºC/77ºF) for up to 28 days.
• Tobi should not be used beyond the expiration date stamped on the ampoule when stored under refrigeration (2ºC–8ºC/36ºF–46ºF) or beyond 28 days when stored at room temperature (25ºC/77ºF).
• Tobi ampoules should not be exposed to intense light.
• The solution in the ampoule is slightly yellow, but may darken with age if not stored in the refrigerator; however, the color change does not indicate any change in the quality of the product as long as it is stored within the recommended storage conditions.
• Keep out of sight and reach of children.

What are the ingredients in Tobi?

Active ingredient: tobramycin

Inactive ingredients: sodium chloride in sterile water for injection, sulfuric acid, sodium hydroxide, and nitrogen

Instructions for USE

TOBI (TOH-bee) Podhaler (POD-hay-ler)
(tobramycin inhalation powder)

 

• 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):

  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

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

• Or:

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

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

  1 Podhaler device and its storage case.

• Or:

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

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

  1 Podhaler device and its storage case.

Note:

• Do not swallow TOBI Podhaler capsules. The powder in the capsule is for you to inhale using the Podhaler device.
• Only use the Podhaler device that comes in the pack. Do not use TOBI Podhaler capsules with any other device, and do not use the Podhaler device to take any other medicine.
• When you start a new weekly (7-day) pack of capsules, use the new Podhaler device that is supplied in the pack and throw away (discard) the user device and its storage case. Each Podhaler device is only used for 1 week (7 days).
• Always keep the TOBI Podhaler capsules in the blister card. Only remove 1 capsule at a time just before you are going to use it.
• Doses should be inhaled as close to 12 hours apart as possible and not less than 6 hours apart.
• Small pieces of the capsules can get into your mouth and you may be able to feel these pieces on your tongue. These small pieces will not hurt you if you swallow or inhale them.
• The extra (reserve) Podhaler device provided in the 28-day supply package may be used if the Podhaler device:
  • is wet, dirty, or broken
  • has been dropped
  • does not seem to be piercing the capsule properly (see Step 17)

Getting ready:

• Wash and dry your hands (See Figure B).

Preparing your TOBI Podhaler dose

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

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

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

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

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

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

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

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

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

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

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

Taking your TOBI Podhaler dose

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

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

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

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

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

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

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

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

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

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

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

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

• If the capsule is pierced but still contains more than just a fine coating of powder (See Figure T) you must inhale from it again 2 times:
  • Put the capsule back into the Podhaler device capsule chamber with the pierced side of the capsule pointing down.
  • Screw the mouthpiece back on the Podhaler device by turning it to the right (clockwise) until it is tight.
  • Repeat Step 10 to Step 17.

• If the capsule is not pierced (See Figure U) you must pierce it again and inhale from it 2 times:
  • Put the capsule back into the Podhaler device capsule chamber.
  • Screw the mouthpiece back on the Podhaler device by turning it to the right (clockwise) until it is tight.
• Repeat Step 9 to Step 17 making sure to press the blue button all the way down.

Note:

If you have tried to pierce the capsule 2 times and it is still not pierced, use the extra (reserve) Podhaler device provided in the TOBI Podhaler package instead (only available in the 28-day supply package). If you need a new device, ask your healthcare provider.
• • Prepare the extra (reserve) Podhaler device by following Step 1 to Step 3.
  • Then using the same capsule, repeat Step 7 to Step 17.

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

After your TOBI Podhaler dose:

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

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

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

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

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

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

How should I store TOBI Podhaler?

 

• Store your Podhaler device and blister-packaged capsules at room temperature between 68°F to 77°F (20°C to 25°C).
• Keep the TOBI Podhaler capsules and Podhaler device in a dry place.
• Store the Podhaler device tightly closed in its storage case when you are not using it.
• Keep TOBI Podhaler capsules, Podhaler device, and all medicines out of the reach of children.

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

Label

PRINCIPAL DISPLAY PANEL – 28 M