Consumer Information for: TOBRAMYCIN INHALATION SOLUTION USP

• TOBRAMYCIN INHALATION SOLUTION USP is used to treat people (six years and older) with cystic fibrosis who have a bacterial lung infection with Pseudomonasaeruginosa (see “What is Pseudomonas aeruginosa?” section below).

Antibacterial drugs like TOBRAMYCIN INHALATION SOLUTION USP treat only bacterial infections. They do not treat viral infections such as the common cold. Although you may feel better early in treatment, TOBRAMYCIN INHALATION SOLUTION USP should be used exactly as directed. Misuse or overuse of TOBRAMYCIN INHALATION SOLUTION USP could lead to the growth of bacteria that will not be killed by TOBRAMYCIN INHALATION SOLUTION USP (resistance). This means that TOBRAMYCIN INHALATION

SOLUTION USP may not work for you in the future. Do not share your medicine.

TOBRAMYCIN INHALATION SOLUTION USP contains a medicine called tobramycin. Tobramycin belongs to the aminoglycoside class of antibiotics. TOBRAMYCIN INHALATION SOLUTION USP is inhaled (breathe) directly into the lungs so that the antibiotic can kill the Pseudomonas aeruginosa bacteria causing the infection. This helps to fight lung infections and improve breathing in people with cystic fibrosis.

What is Pseudomonas aeruginosa?

It is a very common bacterium that infects the lung of nearly everyone with cystic fibrosis at some time during their lives. Some people do not get this infection until later on in their lives, while others get it very young. It is one of the most damaging bacteria for people with cystic fibrosis. If the infection is not properly fought, it will continue to damage your lungs causing further problems to your breathing.

Medicinal ingredient: Tobramycin

Non-medicinal ingredients: Nitrogen, sodium chloride, sodium hydroxide, sulfuric acid and water for injection.

Solution: 300 mg / 5 mL ampoule

• you are allergic to tobramycin, or to any other aminoglycoside antibiotic such as amikacin, gentamycin, kanamycin, paromomycin, streptomycin,

• you are allergic to any of the other ingredients in TOBRAMYCIN INHALATION SOLUTION USP (see What are the ingredients in TOBRAMYCIN INHALATION SOLUTION USP?)

If this applies to you, tell your healthcare professional without taking TOBRAMYCIN INHALATION SOLUTION USP.

If you think you may be allergic, ask your healthcare professional for advice.

• Have or have had hearing problems (including noises in the ears such as ringing or hissing, dizziness, or any changes in hearing).

• Your mother has had hearing problems after taking an antibiotic called an aminoglycoside.

• Have been told you have a certain genetic change related to hearing problems.

• Have vestibular problems (problems with your inner ear and brain) that can cause vertigo (loss of balance) and dizziness.

• Have kidney problems.

• Have unusual difficulty in breathing with wheezing or coughing and chest tightness.

• Have blood in your sputum (the substance you cough up).

• Have Parkinson’s disease.

• Have a condition called myasthenia gravis which is a chronic disease that causes muscle weakness.

• Are breastfeeding or planning to breastfeed.

• Are receiving an antibiotic called an aminoglycoside by injection since this can cause hearing loss, kidney problems or dizziness.

• Are taking any other medicines.

Pregnancy: Before taking TOBRAMYCIN INHALATION SOLUTION USP, talk to your healthcare professional if you are pregnant or want to become pregnant. It is not known whether inhaling this medicine can harm an unborn baby. When given by injection, the medicine in TOBRAMYCIN INHALATION SOLUTION USP can harm an unborn baby and cause deafness. Your healthcare professional will talk to you about whether you can take TOBRAMYCIN INHALATION SOLUTION USP if you are pregnant.

Breastfeeding: When given by injection, the medicine in TOBRAMYCIN INHALATION SOLUTION USP can be found in the breast milk. The quantity found in the breast milk after inhaling TOBRAMYCIN INHALATION SOLUTION USP is not known. TOBRAMYCIN INHALATION SOLUTION USP may cause

problems to your baby’s hearing or kidneys. Talk to your healthcare professional about whether you

should stop breastfeeding or stop taking TOBRAMYCIN INHALATION SOLUTION USP.

TOBRAMYCIN INHALATION SOLUTION USP is in a class of antibiotics that may cause hearing loss, dizziness, or kidney problems. While you are using TOBRAMYCIN INHALATION SOLUTION USP and if you have or are at risk of hearing or kidney problems, your healthcare professional may do bloodwork to check how your kidneys are working. You may also take a hearing test to check whether or not TOBRAMYCIN INHALATION SOLUTION USP is affecting your hearing.

Children and adolescents: Caregivers should provide assistance to children when starting TOBRAMYCIN INHALATION SOLUTION USP treatment, particularly those aged 10 years or younger, and should continue to supervise them throughout treatment.

TOBRAMYCIN INHALATION SOLUTION USP can be taken by children and adolescents aged 6 years and older. TOBRAMYCIN INHALATION SOLUTION USP should not be given to children less than 6 years old.

Driving and Operating Machinery: Give yourself time after taking TOBRAMYCIN INHALATION SOLUTION USP to see how you feel before driving a vehicle or using machinery.

Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.

You should not take the following medicines while you are taking TOBRAMYCIN INHALATION SOLUTION USP:

• Furosemide or ethacrynic acid, a diuretic (“water pills”)

• Urea or intravenous mannitol

You should not take the following medicines while you are taking TOBRAMYCIN INHALATION SOLUTION USP, or soon after finishing TOBRAMYCIN INHALATION SOLUTION USP treatment:

• Medicines (including tobramycin or another aminoglycoside antibiotic given by injection) that may harm your nervous system, kidneys or hearing. This interaction may cause hearing loss, dizziness, or kidney problems.

The following medicines can increase the chances of harmful effects occurring if they are given to you while receiving infusions of tobramycin or other aminoglycoside antibiotic. Talk to your healthcare professional if you are taking these medications:

• Amphotericin C, cefalotin, cyclosporine, tacrolimus, polymixins: these medicines may harm your kidneys.

• Platinum compounds (such as carboplastin and cisplatin): these medicines may harm your kidneys or hearing.

• Anticholinesterases (such as neostigmine and pyridostigmine) or botulinum toxin: these medicines may cause muscle weakness to appear or become worse.

Many other medications may also harm your nervous system, kidneys or hearing. Tell your healthcare professional about all the medications you are taking, even those that do not appear on this list.

• TOBRAMYCIN INHALATION SOLUTION USP is a solution specifically formulated for inhalation using a PARI LC PLUS™ reusable nebulizer and a DeVilbiss Pulmo-Aide^® air compressor (see the step-by-step Instructions in the “How To Administer TOBRAMYCIN INHALATION SOLUTION USP” section below).

• Take TOBRAMYCIN INHALATION SOLUTION USP exactly as your healthcare professional tells you to. Ask your healthcare professional if you are not sure.

• Take TOBRAMYCIN INHALATION SOLUTION USP at the same time each day. This will help you remember when to take TOBRAMYCIN INHALATION SOLUTION USP.

• Do NOT mix TOBRAMYCIN INHALATION SOLUTION USP with dornase alfa in the nebulizer.

• Please check the order of medications with your doctor. If you are taking several medications and have other therapies for cystic fibrosis, TOBRAMYCIN INHALATION SOLUTION USP should always be taken last. Take your medicines in the following order:

  • 1^st bronchodilator

  • 2^nd chest physiotherapy

  • 3^rd other inhaled medications

  • 4^th TOBRAMYCIN INHALATION SOLUTION USP.

• Continue taking TOBRAMYCIN INHALATION SOLUTION USP as your healthcare professional tells you.

• If you have questions about how long to take TOBRAMYCIN INHALATION SOLUTION USP, talk to your doctor or your pharmacist.

How To Administer TOBRAMYCIN INHALATION SOLUTION USP:

This information is not intended to replace consultation with your healthcare professional, and cystic fibrosis care team about properly taking medication or using inhalation equipment.

TOBRAMYCIN INHALATION SOLUTION USP is specifically formulated for inhalation using a PARI LC PLUS™ reusable nebulizer and a DeVilbiss Pulmo-Aide^® air compressor. You can take TOBRAMYCIN INHALATION SOLUTION USP at home, school, or at work. The following are instructions on how to use the DeVilbiss Pulmo-Aide^® Compressor and PARI LC PLUS^TM reusable nebulizer to administer TOBRAMYCIN INHALATION SOLUTION USP.

You will need the following supplies:

• TOBRAMYCIN INHALATION SOLUTION USP plastic ampoule (vial)

• DeVilbiss Pulmo-Aide^® Compressor

• PARI LC PLUS^TM Reusable Nebulizer

• Tubing to connect the nebulizer and compressor

• Clean paper or cloth towels

• Nose clips (optional)

It is important that your nebulizer and compressor function properly before starting your TOBRAMYCIN INHALATION SOLUTION USP therapy.

Note: Please refer to the manufacturers’ care and use instructions for important information.

Preparing Your TOBRAMYCIN INHALATION SOLUTION USP For Inhalation:

1. Wash your hands thoroughly with soap and water.

2a. TOBRAMYCIN INHALATION SOLUTION USP is packaged with four ampoules per foil pouch.

2b. Separate one ampoule by gently bending it backwards and forwards while holding the middle of the ampoule. Carefully separate the ampoule from the strip, starting from the top, being careful not to tear off the top flap, to the bottom. Leave the remaining ampoules in the foil envelope. Store all remaining ampoules in the refrigerator as directed.

3. Lay out the contents of a PARI LC PLUS^TM Reusable Nebulizer package on a clean, dry paper or cloth towel. You should have the following parts: nebulizer top (a), nebulizer bottom (b), inspiratory valve cap (c), mouthpiece with valve (d) and tubing (e) on a clean, dry paper or cloth towel.

4. Remove the Nebulizer Top from the Nebulizer Cup by twisting the Nebulizer Top counter-clockwise, and then lifting off. Place the Nebulizer Top on the clean paper or cloth towel. Stand the Nebulizer Cup upright on the towel.

5. Connect one end of the tubing to the compressor air outlet. The tubing should fit snugly. Plug in your compressor to an electrical outlet.

6. Open the TOBRAMYCIN INHALATION SOLUTION USP ampoule by holding the bottom tab with one hand and twisting off the top of the ampoule with the other hand. Be careful not to squeeze the ampoule until you are ready to empty its contents into the Nebulizer Cup.

7. Squeeze all the contents of the ampoule into the Nebulizer Cup.

8. Replace the Nebulizer Top (a).

Note: In order to insert the Nebulizer Top into the Nebulizer Cup, the Semi-Circle halfway down the stem of the Nebulizer Top should face the Nebulizer Outlet (see illustration). Turn the Nebulizer Top clockwise until securely fastened to the Nebulizer Cup.

9. Attach the Mouthpiece (d) to the Nebulizer Outlet. Then firmly push the Inspiratory Valve Cap (c) in place on the Nebulizer Top. Note: the Inspiratory Valve Cap will fit snugly.

10. Connect the free end of the tubing (e) from the compressor to the Air Intake on the bottom of the nebulizer, making sure to keep the nebulizer upright. Press the tubing on the

Air Intake firmly.

TOBRAMYCIN INHALATION SOLUTION USP Treatment:

1. Turn on the compressor.

2. Check for a steady mist from the Mouthpiece. If there is no mist, check all tubing connections and confirm that the compressor is working properly.

3. Sit or stand in an upright position that will allow you to breathe normally.

4. Place mouthpiece between your teeth and on top of your tongue and breathe normally only through your mouth. Nose clips may help you breathe through your mouth and not through your nose. Do not block airflow with your

tongue.

5. Continue treatment until all of your TOBRAMYCIN INHALATION SOLUTION USP is gone and there is no longer any mist being produced. You may hear a sputtering sound when the Nebulizer Cup is empty. The entire TOBRAMYCIN INHALATION SOLUTION USP treatment should take approximately 15 minutes to complete. Note: if you are interrupted, need to cough or rest during your TOBRAMYCIN INHALATION SOLUTION USP treatment, turn off the compressor to save your medication. Turn the compressor back on when you are ready to resume your therapy.

6. Follow the nebulizer cleaning and disinfecting instructions after completing therapy.

Cleaning Your Nebulizer:

To reduce the risk of infection, illness or injury from contamination, you must thoroughly clean all parts of the nebulizer as instructed after each treatment. Never use a nebulizer with a clogged nozzle. If the nozzle is clogged, no aerosol mist is produced which will alter the effectiveness off the treatment.

Replace the nebulizer if clogging occurs.

1. Remove tubing from nebulizer and disassemble nebulizer parts.

2. Wash all parts (except tubing) with warm water and liquid dish soap.

3. Rinse thoroughly with warm water and shake out water.

4. Air dry or hand dry nebulizer parts on a clean, lint-free cloth. Reassemble nebulizer when dry and store.

5. You can also wash all parts of the nebulizer in a dishwasher (except tubing). Place the nebulizer parts in a dishwasher basket, then place on the top rack of the dishwasher. Remove and dry the parts when the cycle is complete.

Disinfecting Your Nebulizer:

Your nebulizer is for your use only - Do not share your nebulizer with other people. You must regularly disinfect the nebulizer. Failure to do so could lead to serious or fatal illness.

Clean the nebulizer as described above. Every other treatment day, disinfect the nebulizer parts (except tubing) by boiling them in water for a full 10 minutes.

Dry parts on a clean, lint-free cloth.

Care And Use Of Your Pulmo-Aide Compressor:

Follow the manufacturer’s instructions for care and use of your compressor.

Filter Change:

1. DeVilbiss Compressor filters should be changed every six months or sooner if filter turns completely grey in colour.

Compressor Cleaning:

1. With power switch in the “Off” position, unplug power cord from wall outlet.

2. Wipe outside of the compressor cabinet with a clean, damp cloth every few days to keep dust free. Caution: Do not submerge in water; doing so will result in compressor damage.

• Usual dose of TOBRAMYCIN INHALATION SOLUTION USP in adults and children 6 years of age and older:

  • Inhale the content of one ampoule (with 300 milligrams (mg) of tobramycin) in the morning and one in the evening for 28 days using the nebulizer and a suitable compressor. Space the morning and evening doses as close as possible to 12 hours and not less than 6 hours apart.

• After taking TOBRAMYCIN INHALATION SOLUTION USP for 28 days, stop using it and wait 28 days before starting another 28-days treatment cycle again.

• It is important that you keep using TOBRAMYCIN INHALATION SOLUTION USP two times per day during your 28 days on treatment and that you keep to the 28-day on, 28-day off cycle (see picture below).

Repeat cycle

If you forget to take TOBRAMYCIN INHALATION SOLUTION USP 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.

These are not all the possible side effects you may have when taking TOBRAMYCIN INHALATION SOLUTION USP. If you experience any side effects not listed here, tell your healthcare professional.

Some side effects are very common (these side effects may affect more than 1 in 10 patients):

• Runny or stuffy nose, sneezing

• Changes in your voice (hoarseness)

• Discoloration of the substance you cough up (sputum)

• Decreased results for the tests of lung function

Some side effects are common (these side effects may affect between 1 and 10 in every 100 patients):

• Generally feeling unwell

• Muscle pain

• Voice alteration with sore throat and difficulty swallowing (laryngitis)

The frequency of some side effects is not known (the frequency cannot be estimated from the available data):

• Increased quantity of the substance you cough up (sputum)

• Chest pain

• Reduced appetite

• Itching

• Itchy rash

• Rash

• Loss of voice

• Disturbed sense of taste

• Sore throat

If you experience symptoms such as severe diarrhea (bloody or watery) with or without fever, abdominal pain, or tenderness, you may have Clostridium difficile colitis (bowel inflammation). If this occurs, stop taking TOBRAMYCIN INHALATION SOLUTION USP and contact your healthcare professional immediately.

Talk to your healthcare professional if the following occurs while taking TOBRAMYCIN INHALATION SOLUTION USP:

• If you are not getting better. Strains of Pseudomonas can become resistant to treatment with the antibiotic over time. This can mean TOBRAMYCIN INHALATION SOLUTION USP may not work as well over time.

If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.

TOBRAMYCIN INHALATION SOLUTION USP ampoules are for single use only. Once opened, use immediately. Discard any unused solution. Store TOBRAMYCIN INHALATION SOLUTION USP ampoules in a refrigerator (2-8°C).

If you can't keep TOBRAMYCIN INHALATION SOLUTION USP ampoules in the refrigerator store them in the foil pouches (opened or unopened) at room temperature (up to 25°C) for up to 28 days.

Store TOBRAMYCIN INHALATION SOLUTION USP ampoules in the original package away from heat or direct light.

The solution in TOBRAMYCIN INHALATION SOLUTION USP ampoule is normally slightly yellow. However unrefrigerated TOBRAMYCIN INHALATION SOLUTION USP solution may darken with time. The colour change of unrefrigerated TOBRAMYCIN INHALATION SOLUTION USP solution does not mean a change in the quality of TOBRAMYCIN INHALATION SOLUTION USP provided that the foil pouches (opened or unopened) are stored at room temperature (up to 25°C) for a maximum of 28 days.

Do not use the unrefrigerated TOBRAMYCIN INHALATION SOLUTION USP after 28 days. Do not use TOBRAMYCIN INHALATION SOLUTION USP:

• if the solution is cloudy or if there are particles in the solution,

• beyond the expiration date stamped on the ampoule. Keep out of reach and sight of children.

• Talk to your healthcare professional.

• Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website: (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug- products/drug-product-database.html); the manufacturer’s website (www.labriva.com), or by calling 1-800-363-7988.

This leaflet was prepared by:

Laboratoire Riva Inc. 660 Boul. Industriel Blainville, Quebec J7C 3V4

Last Revised: AUG 08, 2024