Eladynos

Package leaflet: Information for the user

Eladynos 80 micrograms/dose solution for injection in pre-filled pen

abaloparatide

This medicinal product is under additional monitoring. This will allow for rapid identification of new
safety information. You can help by reporting any side effects you experience while taking this
medicinal product. See the end of section 4 for information on how to report side effects.
Please read this leaflet carefully before using this medicinal product, 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 other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet

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

1. What Eladynos is and what it is used for

Eladynos contains the active substance abaloparatide, which is used to treat osteoporosis in postmenopausal women.
Osteoporosis is particularly common in women after menopause. It is a disease that causes bones to become thin and fragile. If you have osteoporosis, you are at increased risk of fractures, especially in the spine, hips, and wrists.
This medicine is used to make bones stronger and reduce the risk of fractures.

2. What you should know before using Eladynos

Do not use Eladynos

• if you are allergic to abaloparatide or to any of the other ingredients of this medicine (listed in section 6)
• if you are pregnant or breastfeeding
• if you could still become pregnant
• if you have high levels of calcium in your blood
• if you have severely reduced kidney function
• if you have high levels of alkaline phosphatase enzyme in your blood of unknown origin
• if you have undergone radiation therapy involving the bones
• if you have ever been diagnosed with bone tumour or other tumours that have spread to the bones

Warnings and precautions
Talk to your doctor or pharmacist before using Eladynos, or during treatment:

• if you feel dizzy when standing, which could be caused by a drop in blood pressure. Some patients may experience dizziness or a rapid heartbeat within 4 hours after injection of Eladynos. The first injection(s) must always be administered under the supervision of a healthcare professional who can monitor you during the first hour after injection. Always inject Eladynos in a place where you can sit or lie down immediately if you feel dizzy;
• if you have heart disease or suffer from high blood pressure. Your doctor may decide to monitor you more closely;
• if you continuously experience nausea, vomiting, constipation, low energy, or muscle weakness. These may be signs of too much calcium in the blood;
• if you have high levels of calcium in your urine, suffer from kidney stones, or have had kidney stones in the past. Eladynos may worsen your condition.

Before starting treatment with Eladynos, your blood pressure and heart condition will be evaluated.
The recommended treatment period of 18 months must not be exceeded.
Children and adolescents
Eladynos must not be used in children and adolescents under 18 years of age.
Other medicines and Eladynos
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
In particular, inform your doctor or pharmacist if you are taking:

• digoxin or digitalis, medicines used to treat heart weakness, because calcium levels in the blood may increase with abaloparatide use
• medicines used to control high blood pressure, as they may worsen symptoms of low blood pressure, including dizziness
  Pregnancy and breastfeeding
  Do not use Eladynos if you are a woman of childbearing potential, pregnant, or breastfeeding.

Driving and using machines
Some patients may experience dizziness after injection of the medicine. If you feel dizzy, do not drive and do not operate machinery until you feel better.
Eladynos contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e. essentially 'sodium-free'.

3. How to use Eladynos

Use this medicine exactly as your doctor has instructed you. If you have any doubts, consult your
doctor or pharmacist.
The recommended dose is one injection (80 micrograms) once daily under the skin, in the lower
abdomen (stomach area). See the grey-coloured area in the first figure at step 5 of the "Instructions for use"
at the end of this leaflet.
To help you remember to take your medicine, inject Eladynos at approximately the same time each day.
Do not inject Eladynos at the same site on the abdomen on consecutive days. Alternate the injection site
daily to reduce the risk of injection site reactions. Only inject into clean skin. Do not inject into areas
where the skin is tender, bruised, red, scaly, or hardened. Avoid areas with scars or stretch marks.
Follow carefully the "Instructions for use" at the end of this leaflet.
Your doctor may advise you to take calcium and vitamin D supplements. Your doctor will tell you how
much to take each day.
Duration of use
Inject Eladynos every day for the entire duration prescribed by your doctor. The maximum total duration
of treatment with Eladynos must not exceed 18 months.
If you use more Eladynos than you should
If you accidentally use more Eladynos than you should, contact your doctor or pharmacist. Possible
symptoms of overdose may include nausea, vomiting, dizziness (especially when standing up quickly),
rapid heartbeat, and headache.
If you forget to use Eladynos
If you miss a dose, take it as soon as possible within 12 hours of your usual injection time. Then, inject
the next dose at your usual time the following day.
If more than 12 hours have passed since you should have used Eladynos, skip the missed dose. Then,
inject the next dose as usual on the next scheduled day.
Do not use a double dose to make up for the missed dose. Do not administer more than one injection
on the same day.
If you stop using Eladynos
Do not stop treatment without first talking to your doctor. Your doctor will advise you and decide how
long you should be treated with Eladynos.
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 gets them.
Stop treatment with Eladynos and contact your doctor immediately or go to the nearest emergency
department if you experience any of the following symptoms (severe allergic reaction):
swelling of the face or tongue, wheezing and difficulty breathing, hives, itching and redness of the
skin, severe vomiting or diarrhoea, dizziness or loss of consciousness (frequency not known). These
symptoms can be serious and potentially life-threatening.

Other side effects may occur with the following frequencies:

Very common (may affect more than 1 in 10 people)

• increased calcium levels observed in urine tests
• dizziness, see section 2 “Warnings and precautions”

Common (may affect up to 1 in 10 people)

• increased calcium levels observed in blood tests
• increased uric acid levels observed in blood tests
• headache
• palpitations, rapid heartbeat
• increased blood pressure
• abdominal pain
• constipation, diarrhoea
• nausea, vomiting
• weakness, fatigue, malaise
• injection site reactions such as bruising, rash, and pain
• bone, joint, hand, foot or back pain
• muscle spasms (in the back and legs)
• difficulty sleeping
• kidney stones
• itching, rash

Uncommon (may affect up to 1 in 100 people)

• allergic reactions
• sensation of swelling
• pain
• feeling dizzy or lightheaded when sitting or standing due to a drop in blood pressure

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

5. How to store Eladynos

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and on the pen after Exp.
The expiry date refers to the last day of that month.
Before first use, store in a refrigerator (2 °C–8 °C). Do not freeze. Avoid placing the pens near the
freezer compartment of the refrigerator to prevent freezing. Do not use Eladynos if it has been frozen or if freezing has occurred.
After first use, store at a temperature below 25 °C and dispose of after 30 days.
Eladynos may only be stored at room temperature (below 25 °C) for 30 days.
Record the date of day 1 in the designated space on the carton. Day 1 refers to the date of first use or the date the pen was removed from the refrigerator. This ensures that you do not use the pen for more than 30 consecutive days or store it for longer than 30 days. After 30 days, the pen must be disposed of according to local regulations, even if there is still unused medicine remaining.

• Discard the old pen before opening a new Eladynos pen to avoid any confusion.
• Do not store the pen with a needle attached.
• Do not use this medicine if the solution appears cloudy, discolored, or contains particles.

Do not dispose of any medicine or needles 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 Eladynos contains

• The active substance is abaloparatide. Each 40 microlitre dose contains 80 micrograms of abaloparatide. Each pre-filled pen contains 3 mg of abaloparatide in 1.5 mL of solution (equivalent to 2 milligrams per mL).
• The other components are:
  • phenol
  • water for injections
  • sodium acetate trihydrate (see section 2 “Eladynos contains sodium”) and acetic acid (both used for pH adjustment)

Description of the appearance of Eladynos and contents of the pack
Eladynos is a clear, colourless, injectable solution. It is supplied in a carton
containing one or three pre-filled multi-dose pens, each with 30 doses.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Theramex Ireland Limited
3rd Floor, Kilmore House,
Park Lane, Spencer Dock,
Dublin 1
D01 YE64
Ireland
Manufacturer
Theramex Poland Sp. z o. o.
Amsterdam Building,
ul. Poleczki 35,
02-822 Warszawa
Poland
Further information
More detailed information on this medicinal product is available on the website of the European Medicines Agency, https://www.ema.europa.eu/.
Instructions for use
Do not inject Eladynos until your doctor, nurse, or pharmacist has shown you, or shown your caregiver, how to use the Eladynos pen.
DO NOT start the administration procedure until you have carefully read the package leaflet and
these instructions for use included in the Eladynos carton. Follow these instructions carefully each time
you use the Eladynos pen.
If you have any doubts about how to use the Eladynos pen, contact your doctor, nurse, or pharmacist.
Important information before using the Eladynos pen

• Do not share needles with other people: there is a risk of transmitting serious infections. Never share your Eladynos pen, even if the needle has been replaced.
• Always use a new needle for each injection. Materials required for each injection with the Eladynos pen
• 1 needle. Needles are not included with the Eladynos pen. Suitable needles for use with the Eladynos pen are 8 mm, 31 G.
• 1 alcohol swab
• 1 cotton ball or gauze pad
• 1 sharps disposal container for discarding needles and Eladynos pens. See section 5 of the package leaflet for disposal information.

Components of the Eladynos pen

Green injection button
Pen cap Cartridge holder Dose display window Dose dial
Lot / Exp.
Septum Plunger
Medicinal cartridge
Components of the needle (not included with the pen) for use with the pen

Protective paper
Needle
Needle cap Inner needle shield
of needle
How to inject Eladynos
Step 1 Check the Eladynos pen
Wash your hands.
Check the label on the pen to make sure it is the correct medicine.
Check the expiry date (Exp.) on the pen to ensure it has not passed.

Record the date of day 1 to ensure you do not use the pen for more than 30 consecutive days.
Remove the cap from the pen.

Check that the pen and medicine cartridge are not damaged.
The liquid should be clear, colourless, and free from particles. If not, it must not be used.
It is normal for small air bubbles to be present in the liquid.
Step 2 Attaching a needle to the Eladynos pen
Remove the protective paper from a new needle.

Attach the needle, still with its needle cap, straight onto the pen, and screw it on firmly until it is securely fixed. Ensure the needle is straight so that it does not bend when inserted. The pen will not work if the needle is not correctly attached. Do not overtighten, as this may make it difficult to remove the needle later.
If the needle bends, refer to “Troubleshooting” below.

Remove the needle cap and keep it for reuse after the injection.

Carefully remove and discard the inner needle shield.

Step 3 Day 1 only – Checking the Eladynos pen before the first injection
The pen contains enough medicine for 30 days, plus a small amount to test each pen once to confirm it is working properly.
Caution: if you test the pen before each injection, the medicine in the pen will run out earlier than expected. Therefore, Step 3 should only be performed on day 1, before the first injection with each pen.
From day 2 to day 30, do not test the pen again. Proceed directly to Step 4 to set the dose for injection.
Holding the pen as shown, turn the dose dial forward until it stops.
In the dose display window, you will see “•80”.

Hold the pen with the needle pointing upwards.
Press the green injection button fully down.
You should see one or more drops of liquid at the needle tip.

The dose display window should now show “●0”.
Note: If no liquid appears at the needle tip, refer to “Troubleshooting”.

Step 4 Setting the dose on the Eladynos pen
Turn the white dose dial forward until it stops, and until the dose display window shows “●80”. The pen is now ready for injection.

Note: If you cannot set the pen to “●80”, refer to “Troubleshooting” below.
Step 5 Choosing and cleaning the injection site
The injection should be given in the lower abdomen, as indicated by the grey area, avoiding a 5 cm zone around the navel.

Choose a different injection site on the abdomen each day. Only inject into clean skin.
Do not inject into areas where the skin is tender, bruised, red, scaly, or hardened.
Avoid areas with scars or stretch marks.
Clean the injection site with an alcohol swab and let it dry.
Do not touch, blow on, or fan the injection site after cleaning.

Note: Your doctor, nurse, or pharmacist may advise you to pinch a fold of skin at the injection site.
After inserting the needle, you may release the skin.
Step 6 Administering the injection with the Eladynos pen
Insert the needle perpendicularly into the skin.

Press and HOLD DOWN the green button until ALL of the following steps are completed:

• “●0” appears in the display
• hold for 10 seconds to deliver the full dose
• lift the pen from the skin and THEN release the button.

Do not press the green injection button if a needle has not been attached.

Note: Do not move the pen after insertion. If the green injection button cannot be pressed fully, or stops before “●0” appears, refer to “Troubleshooting” below.
Slowly remove the pen from the injection site, withdrawing the needle straight out.
Slight bleeding is normal. Do not rub the injection site. If slight bleeding occurs, press a cotton ball or gauze pad over the site as needed. You may also cover the area with a small plaster.
Step 7 Removing the needle from the pen
Caution: To avoid needle-stick injuries, follow this step carefully.
Carefully replace the needle cap onto the needle. Then press gently on the needle cap to snap it into place.

After replacing the needle cap, unscrew the needle. To unscrew, grip the cap at the base near the needle and rotate it at least 8 times before gently pulling to remove the needle with the cap attached.
Note: Do not press on the needle cap while unscrewing the needle.

Note: The distance between the needle cap and the pen should increase as you unscrew the needle.

Step 8 After the injection
Replace the pen cap firmly on the Eladynos pen.
Between injections, keep the pen cap on the pen.

Troubleshooting
What should I do if the needle is bent?

• Carefully remove the bent needle and attach a new needle to the pen following Step 2. The pen needle consists of a visible part that enters the skin and a hidden part that enters the pen septum.
• Examine the needle components carefully, paying particular attention to the hidden part of the needle.

Even if the visible part of the needle appears straight, the internal part may bend when the needle is attached to the pen.

• Make sure to keep the entire needle straight when attaching it to the pen to avoid bending the internal part.

What should I do if no liquid comes out of the needle tip during pen check on day 1?

• If no liquid comes out of the needle, the pen preparation is incomplete. The needle may be blocked, bent, or not properly attached.
• Attach a new needle to the pen following Step 2, then repeat Step 3 “Checking the Eladynos pen before the first injection”.
• If you still do not see a drop of liquid, contact your pharmacist, doctor, or nurse.

What should I do if I cannot turn the white dose dial to set “●80” on the Eladynos pen?

• The pen does not contain enough medicine to deliver a full dose. You will need to obtain a new pen.

What should I do if the green injection button is difficult to press?

• If the green injection button cannot be pressed fully, or stops before the dose display window shows “●0”, the new pen test is incomplete. The needle may be blocked or not properly attached.
• Attach a new needle to the pen following Step 2.
• If the green injection button still cannot be pressed fully, or continues to stop before the dose display window shows “●0”, contact your pharmacist, doctor, or nurse.