ELADYNOS 80 micrograms/dose Injectable solution in pre-filled pen

Introduction

Package Leaflet: Information for the User

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

abaloparatide

This medicinal product is subject to additional monitoring, which will allow for the quick identification of new safety information. You can help by reporting any side effects you may get. The last section of the leaflet contains information on how to report side effects.

Read all of this leaflet carefully before you start using this medicine, because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

1. What is Eladynos and what is it used for

Eladynos contains the active substance abaloparatide. It is used to treat osteoporosis in women after menopause.

Osteoporosis is especially common in women after menopause. This disease causes thinning and fragility of the bones. If you have osteoporosis, you have a higher risk of bone fractures, especially in the spine, hips, and wrists.

This medicine is used to strengthen bones and reduce the risk of bone fractures.

2. What you need to know before you use Eladynos

Do not use Eladynos if

• you are allergic to abaloparatide or any of the other ingredients of this medicine (listed in section 6)
• you are pregnant or breastfeeding
• you may become pregnant
• you have high levels of calcium in the blood
• your kidney function is severely reduced
• you have high levels of the enzyme alkaline phosphatase in the blood without any apparent cause
• you have received radiation therapy to the bones
• you have been diagnosed with bone cancer or other cancers that have spread to the bones

Warnings and precautions

Consult your doctor or pharmacist before starting treatment with Eladynos or during treatment if:

• you feel dizzy when standing up, which may be due to a drop in blood pressure. Some patients may feel dizzy or have a rapid heartbeat in the 4 hours following the injection of Eladynos. The first injection(s) should be performed under the guidance of a healthcare professional, who may keep you under observation for the first hour after the injection. Always inject Eladynos in a place where you can sit or lie down if you feel dizzy.
• you have heart disease or high blood pressure. Your doctor may want to monitor you more closely.
• you have nausea, vomiting, constipation, low energy, or muscle weakness on a continuous basis. These may be signs of high levels of calcium in the blood.
• you have high levels of calcium in the urine or have had kidney stones. Eladynos may worsen your condition.

Before starting treatment with Eladynos, you will undergo blood pressure and heart checks.

The recommended treatment duration with Eladynos should not exceed 18 months.

Children and adolescents

Abaloparatide should not be used in children and adolescents under 18 years of age.

Other medicines and Eladynos

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

In particular, tell your doctor or pharmacist if you are taking:

• digoxin or digitalis: medicines used to treat heart weakness, as calcium levels in the blood may increase with the use of abaloparatide;
• medicines to control high blood pressure, as they may worsen symptoms of low blood pressure, such as dizziness.

Pregnancy and breastfeeding

Do not use Eladynos if you are pregnant, may become pregnant, or are breastfeeding.

Driving and using machines

Some patients may feel dizzy after the injection of this medicine. If you feel dizzy, do not drive or use machines until you feel better.

Eladynos contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per dose; this is essentially 'sodium-free'.

3. How to use Eladynos

Follow the instructions for administration of this medicine exactly as prescribed by your doctor. If you are unsure, consult your doctor or pharmacist again.

The recommended dose is one injection (80 µg) once a dayunder the skin in the lower abdomen (belly). See the shaded area in gray in the first figure in step 5 of the 'Instructions for use' section at the end of the leaflet.

Preferably, inject Eladynos at the same time every day to help you remember to use the medicine.

Do not inject Eladynos in the same place on the abdomen on consecutive days. Change the injection site every day to reduce the risk of injection site reactions. Administer the injection only in normal skin. Do not administer the injection in areas where the skin is painful to the touch, has a bruise, or is red, scaly, or hardened. Avoid areas with scars or stretch marks.

Follow the 'Instructions for use'carefully at the end of the leaflet.

Your doctor may advise you to take calcium and vitamin D supplements. Your doctor will tell you how much to take per day.

Duration of use

Inject Eladynos daily for the period prescribed by your doctor. The maximum total treatment duration with Eladynos should not exceed 18 months.

If you use more Eladynos than you should

If you accidentally use more Eladynos than you should, inform your doctor or pharmacist. The effects that can be expected from an overdose are, among others, nausea, vomiting, dizziness (especially when standing up quickly), rapid heartbeat, and headache.

If you forget to use Eladynos

If you forget a dose, administer it as soon as possible within 12 hours of the scheduled time. Then, inject the next dose the following day at the usual time.

If more than 12 hours have passed since the time you should have used Eladynos, omit the missed dose. Then, inject the next dose the following day as usual.

Do not use a double dose to make up for missed doses. Do not use more than one injection on the same day.

If you stop treatment with Eladynos

Consult your doctor before stopping treatment. Your doctor will advise you and decide how long you should receive treatment with Eladynos.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Stop treatment with Eladynos and contact your doctor immediately or go to the emergency department if you experience the following symptoms (severe allergic reaction):

Swelling of the face or tongue, wheezing, and difficulty breathing, hives, itching, and red skin, severe vomiting or diarrhea, and dizziness or loss of consciousness (frequency not known). These symptoms can be severe 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 in urine tests
• dizziness; see section 2 'Warnings and precautions'

Common(may affect up to 1 in 10 people)

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

Uncommon(may affect up to 1 in 100 people)

• allergic reactions
• feeling of abdominal distension
• pain
• feeling of dizziness or lightheadedness when standing up or sitting down due to a drop in blood pressure

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. You can also report side effects directly through the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Eladynos

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 pen after EXP. The expiry date is the last day of the month shown.

Before first use, store in a refrigerator (between 2°C and 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.

After first use, store below 25°C and discard after 30 days.

Eladynos should only be stored at room temperature (below 25°C) for 30 days. Write the date of day 1 in the space provided on the carton. Day 1 is the date of the first use or the date the pen was removed from the refrigerator. The purpose is to ensure that you do not use the pen for more than 30 consecutive days or store the pen for more than 30 days. After 30 days, dispose of the pen according to local requirements, even if it still contains unused medicine.

• Dispose of the used pen before opening a new Eladynos pen to avoid possible confusion.
• Do not store the pen with the needle attached.
• Do not use this medicine if the solution is cloudy, has color, or contains visible particles.

Medicines and needles should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and needles no longer required. This will help protect the environment.

6. Container Contents and Additional Information

Eladynos Composition

• The active ingredient is abaloparatide.

Each 40 microliter dose contains 80 micrograms of abaloparatide.

Each pre-filled pen contains 3 mg of abaloparatide in 1.5 ml of solution (which is equivalent to 2 mg per milliliter).

• The other components are:

• phenol
• water for injectable preparations
• sodium acetate trihydrate (see section 2 "Eladynos contains sodium") and acetic acid (both for pH adjustment)

Product Appearance and Container Contents

Eladynos is a clear and transparent injectable solution (injection). It is supplied in a cardboard box containing a multi-dose pre-filled pen with 30 doses.

Marketing Authorization Holder and Responsible for

Theramex Ireland Limited

3rd Floor, Kilmore House,

Park Lane, Spencer Dock,

Dublin 1

D01 YE64

Ireland

Manufacturing

Cilatus Manufacturing Services Ltd

Pembroke House, 28-32 Pembroke Street

Dublin, D02 EK84, Ireland

Date of Last Revision of this Leaflet:

Other Source of Information

Detailed information on this medicinal product is available on the European Medicines Agency website: https://www.ema.europa.eu/.

----------------------------------------------------------------------------------------------------------------------------

Instructions for Use

Do not inject Eladynos until you or your caregiver have been trained by a doctor, nurse, or pharmacist on how to use the Eladynos pen.

DO NOT start the administration procedure until you have carefully read the leaflet and these instructions for use included in the Eladynos box. Always follow the instructions carefully when using the Eladynos pen.

Contact your doctor, nurse, or pharmacist if you have any questions about using the Eladynos pen.

Important Information Before Using the Eladynos Pen

• Do not share needles with other people. They can transmit a serious infection. Never share the Eladynos pen, even if you have changed the needle.
• Use a new needle for each injection.

Materials Needed for Each Injection with the Eladynos Pen

• 1 needle

Needles are not included with the Eladynos pen. The correct needles to be used with the Eladynos pen are 8 mm and 31 gauge needles.

• 1 alcohol swab
• 1 cotton ball or 1 gauze
• 1 sharps container for disposing of needles and Eladynos pens. See section 5 of the leaflet for information on disposal.

Components of the Eladynos Pen

Components of the Needle (not included with the pen) to be used with the pen

How to Inject Eladynos

Troubleshooting

What should I do if the needle bends?

• Remove the bent needle carefully and follow step 2 to attach a new needle to the pen. The pen needle has a visible part that enters the skin and an internal part that enters the pen membrane.
• Check the parts of the pen needle, paying special attention to the internal part of the needle. The visible part of the needle may appear straight, but the internal part of the needle may bend when attaching the needle to the pen.
• Make sure to keep the entire pen needle straight when attaching it to the pen to avoid bending the internal part of the needle.

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

• If you do not see liquid coming out of the needle, the pen preparation is not complete. The needle may be clogged, bent, or improperly attached.
• Follow step 2 to attach a new needle to the pen and repeat step 3 "Checking the Eladynos Pen Before the First Injection".
• If you still do not see a drop of liquid, contact your pharmacist, nurse, or doctor.

What should I do if I cannot turn the white dose button to adjust the Eladynos Pen to "80"?

• There is not enough medication in the pen to administer a full dose. You will need a new pen.

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

• If you cannot press the green injection button or it stops before "0" appears in the dose indicator window, the new pen test is not complete. The needle may be clogged or improperly attached.
• Follow step 2 to attach a new needle to the pen.
• If you still cannot press the green injection button or it stops before "0" appears in the dose indicator window, contact your pharmacist, nurse, or doctor.