Arikayce liposomal

Patient Information Leaflet

ARIKAYCE liposomal 590 mg nebuliser dispersion

amikacin
Please read all of this leaflet carefully before you start using this medicine, as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

1. What ARIKAYCE liposomal is and what it is used for
2. What you need to know before using ARIKAYCE liposomal
3. How to use ARIKAYCE liposomal
4. Possible side effects
5. How to store ARIKAYCE liposomal
6. Contents of the pack and other information
7. Instructions for use

1. What ARIKAYCE liposomal is and what it is used for

ARIKAYCE liposomal is an antibiotic containing the active substance amikacin. Amikacin
belongs to a group of antibiotics called aminoglycosides, which stop the growth of
certain bacteria that cause infections.
ARIKAYCE liposomal is used by inhalation for the treatment of lung infection caused by the
Mycobacterium avium complex in adults with limited treatment options who do not have
cystic fibrosis.

2. What you should know before using ARIKAYCE liposomal

Do not use ARIKAYCE liposomal

• if you are allergic to amikacin or other aminoglycosides, to soy, or to any of the other ingredients of this medicine (listed in section 6)
• if you are taking other aminoglycosides (orally or by injection)
• if you have severely impaired kidney function.

Warnings and precautions
Talk to your doctor or pharmacist before using ARIKAYCE liposomal if:

• you use a bronchodilator (“symptomatic medicine”) for breathing problems, as you will be instructed to use it before ARIKAYCE liposomal;
• you have kidney problems; you may need to have a kidney function test before starting treatment;
• you have hearing problems, ringing or buzzing in the ears (tinnitus), or balance problems, including dizziness, lack of coordination, vertigo, or feeling lightheaded. If you have hearing problems, you may need to undergo a hearing test before or during treatment;
• you suffer from other lung diseases;
• you have a condition causing muscle weakness and fatigue, such as myasthenia gravis;
• you yourself have or have a maternal family history of mitochondrial mutation disease (a genetic disorder) or hearing loss due to antibiotic use, you are advised to inform your doctor or pharmacist before taking an aminoglycoside; certain mitochondrial mutations may increase the risk of hearing loss with this product. Your doctor may recommend genetic testing before administering ARIKAYCE liposomal.

Contact your doctor immediately if, while using ARIKAYCE liposomal, you experience any of the following symptoms:

• loss of consciousness, rash, fever, worsening or new breathing problems;
• worsening kidney problems;
• ear problems such as ringing in the ears or hearing loss. See section 4.

Children and adolescents
ARIKAYCE liposomal must not be administered to children and adolescents under 18 years of age.
Other medicines and ARIKAYCE liposomal
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Particular caution is required if you are taking other medicines, as some may interact with ARIKAYCE liposomal, for example:

• diuretics such as ethacrynic acid, furosemide, or mannitol
• other medicines that may affect the kidneys, hearing, balance, or that may reduce muscle strength.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or breastfeeding, the use of ARIKAYCE liposomal should be avoided. Ask your doctor or pharmacist for advice before using this medicine.
If you become pregnant while using ARIKAYCE liposomal, inform your doctor. Your doctor will decide whether you should stop using ARIKAYCE liposomal.
It is not known whether amikacin passes into human breast milk. If you are breastfeeding, your doctor will advise you whether to stop breastfeeding or stop treatment with this medicine.
Driving and using machines
ARIKAYCE liposomal may cause dizziness and other vestibular disorders, such as vertigo and balance disturbances. Do not drive or operate machinery while inhaling ARIKAYCE liposomal. For any concerns, consult your doctor.

3. How to use ARIKAYCE liposomal

Use this medicine exactly as instructed by your doctor. If you have any doubts, consult your doctor.

The recommended dose is one vial of ARIKAYCE liposomal to be inhaled through the mouth once daily using the portable Lamira nebulizer. After 6 months of treatment, your doctor will decide whether you should continue or stop the therapy. The maximum duration of treatment is 18 months.

How to take ARIKAYCE liposomal

If you are using a bronchodilator ("reliever medicine"), use it before taking ARIKAYCE liposomal.

Each vial is for single use only.

• Use ARIKAYCE liposomal only with the portable Lamira nebulizer and Lamira aerosol head connected to a Lamira control unit. See section 7 for instructions on how to use the medicine with the Lamira nebulizing system.
• Do not use ARIKAYCE liposomal with other types of portable nebulizers or aerosol heads.
• Do not add any other medicines to the portable Lamira nebulizer.
• Do not drink the liquid contained in the vial.
• Read the instructions for use provided at the end of this leaflet.

When and how should you replace the portable Lamira nebulizer?
One portable Lamira nebulizer should be used for a 28-day treatment cycle. The aerosol head should be replaced once a week. Each box of ARIKAYCE liposomal contains 4 aerosol heads. For cleaning and storage recommendations, refer to the manufacturer's instructions for use.

If you use more ARIKAYCE liposomal than you should
Contact your doctor immediately if you are concerned that you have used too much of this medicine.

If you forget to use ARIKAYCE liposomal
If you forget to take your dose, take it as soon as possible on the same day. Do not take more than one dose in the same day to make up for a missed dose.

If you stop using ARIKAYCE liposomal
If you decide to stop using ARIKAYCE liposomal for any reason, you must inform your doctor.

If you have any questions about how to use this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
Immediately inform your doctor if:

• you experience hypersensitivity or severe allergic reactions while taking ARIKAYCE liposomal (e.g. with low blood pressure, loss of consciousness, severe rash or severe wheezing and shortness of breath). The frequency of these side effects is unknown;
• your usual lung problems worsen or new breathing problems occur (e.g. shortness of breath or wheezing). This may be a sign of severe lung inflammation requiring treatment and may lead to discontinuation of ARIKAYCE liposomal. The frequency of these serious side effects is common to very common.

Other side effects
Inform your doctor or pharmacist if you experience any of the following symptoms.
Very common side effects (may affect more than 1 in 10 people)

• Difficulty speaking
• Difficulty breathing
• Cough
• Coughing up blood

Common side effects (may affect up to 1 in 10 people)

• Infection causing worsening of lung condition
• Increased mucus production from the lungs when coughing
• Productive cough
• Wheezing
• Throat irritation
• Sore throat
• Loss of voice
• Oral thrush (fungal infection of the mouth)
• Mouth pain
• Taste disturbances
• Lung inflammation
• Headache
• Dizziness
• Feeling of unsteadiness
• Diarrhea
• Nausea
• Vomiting
• Dry mouth
• Reduced appetite
• Itchy skin
• Deafness
• Ringing in the ears
• Kidney problems, including impaired kidney function
• Joint pain
• Muscle pain
• Rash
• Fatigue
• Chest discomfort
• Fever
• Weight loss

Uncommon side effects (may affect up to 1 in 100 people)

• Anxiety

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please consult your doctor or pharmacist. You can also report side effects directly via the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store ARIKAYCE liposomal

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and on the label of the
vial after Exp. The expiry date refers to the last day of that month.
Store in a refrigerator (2 °C – 8 °C). Do not freeze; discard vials that have been frozen.
Alternatively, ARIKAYCE liposomal may be stored at room temperature below 25 °C, but only for a maximum of 4 weeks. Once it has reached room temperature, any unused medicine must be discarded after 4 weeks.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What ARIKAYCE liposomal contains

• The active substance is amikacin. Each vial contains amikacin sulfate equivalent to 590 mg of amikacin in liposomal formulation. The average dose delivered from each vial is approximately 312 mg of amikacin.
• The other components are cholesterol, dipalmitoylphosphatidylcholine (DPPC), sodium chloride, sodium hydroxide, and water for injectable preparations.

Description of the appearance of ARIKAYCE liposomal and contents of the pack
ARIKAYCE liposomal is a milky white to off-white dispersion for nebulizer, contained in a glass vial with a rubber stopper and metal seal, and a plastic snap-off cap.
The 28 vials are supplied in a box for 28 days of use; one vial per day. One box of ARIKAYCE liposomal contains 4 inner boxes, each containing 7 vials, and one aerosol head. The 28-day pack also includes 1 Lamira portable nebulizer.
Marketing Authorization Holder
Insmed Netherlands B.V.
Stadsplateau 7
3521 AZ Utrecht
The Netherlands
Manufacturer
Almac Pharma Services (Ireland) Ltd.
Finnabair Industrial Estate,
Dundalk, Co. Louth, A91 P9KD,
Ireland
Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines Agency, https://www.ema.europa.eu. In addition, links to other websites on rare diseases and related therapeutic treatments are provided.

7. Instructions for use

ARIKAYCE liposomal is for oral inhalation use with the Lamira nebulizer system.

Before using the Lamira nebulizer system, ensure that you have read and understood the detailed information provided in the complete Instructions for Use supplied with the Lamira nebulizer system.
These instructions contain more comprehensive information on how to assemble, prepare, use, clean, and disinfect the Lamira nebulizer system.
Wash your hands with soap and water and dry them thoroughly.
Assemble the portable Lamira nebulizer and connect it to the control unit as illustrated in the complete Instructions for Use.
This medicine is a white, milky liquid in a transparent vial. Do not use if you notice any change in color or floating particles in the vial.

Preparation of the medicine for use

1. It is recommended to remove the vial from the refrigerator at least 45 minutes before use to allow it to reach room temperature. Do not use any other medicines with the portable Lamira nebulizer.
2. Shake the ARIKAYCE liposomal vial vigorously until the medicine appears uniform and well mixed.
3. Lift the orange closure cap from the vial and set it aside (Figure 1).

Figure 1

4. Grasp the metal ring at the top of the vial and gently pull it downward until one side detaches from the vial (Figure 2).

Figure 2

5. Remove the metal band from the top of the vial with a twisting motion until it completely detaches from the vial (Figure 3).

Figure 3

6. After removal, set the metal ring aside. Carefully remove the rubber stopper (Figure 4).

Figure 4

7. Pour the contents of the ARIKAYCE liposomal vial into the medication reservoir of the portable Lamira nebulizer (Figure 5).

Figure 5

8. Close the medication reservoir. (Figure 6).

Figure 6

9. Sit in a relaxed position with your shoulders upright. This will make inhalation easier and help the medicine reach your lungs more effectively.
10. Place the mouthpiece in your mouth and breathe slowly and deeply. Then inhale and exhale normally through the mouthpiece until the treatment is complete. The treatment should last approximately 14 minutes, but may last up to 20 minutes. Make sure to keep the portable Lamira nebulizer upright throughout the entire treatment (Figure 7).

Figure 7