Terrosa 20 micrograms/80 microliters solution for injection in pre-filled pen

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Terrosa 20 micrograms/80 microliters injectable solution in a pre-filled pen

teriparatide

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

• Keep this leaflet, as 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, and you should not give it to other people even if they have the same symptoms as you, because it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

1. What Terrosa is and what it is used for

Terrosa contains the active substance teriparatide, which is used to increase bone strength and reduce the risk of fractures by stimulating bone formation.

Terrosa is used for the treatment of osteoporosis in adults. Osteoporosis is a disease that causes your bones to weaken and become fragile. This condition is particularly common in women after menopause, but can also occur in men. Osteoporosis is also common in patients treated with medicines called corticosteroids.

2. What you need to know before using Terrosa

Do not use Terrosa

• if you are allergic to teriparatide or to any of the other ingredients of this medicine (listed in section 6).
• if you have high levels of calcium in your blood (pre-existing hypercalcemia).
• if you have severe kidney problems.
• if you have ever had bone cancer or if other types of cancer have spread (metastasized) to your bones.
• if you have certain bone diseases. If you have a bone disease, consult your doctor.
• if you have unexplained high levels of alkaline phosphatase in your blood, which could indicate Paget's disease of the bone (a condition involving abnormal bone changes). If you are unsure, consult your doctor.
• if you have received radiation therapy that may have affected your bones.
• if you are pregnant or breastfeeding.

Warnings and precautions

Terrosa may increase calcium levels in your blood or urine.

Consult your doctor before or while using Terrosa:

• If you continuously experience nausea, vomiting, constipation, low energy, or muscle weakness, inform your doctor. These may be symptoms of too much calcium in your blood.
• If you suffer from kidney stones or have had kidney stones in the past.
• If you suffer from kidney problems (moderate renal failure).

Some patients, after the first doses of Terrosa, may experience dizziness or increased heart rate. For the first doses, use Terrosa in a place where you can sit or lie down immediately if you feel dizzy.

The recommended treatment duration of 24 months must not be exceeded.

Before starting to use a new pre-filled pen, record the batch number (Batch) of the medicine and the date of the first injection on the pre-filled pen’s carton and in a calendar, and provide this information when reporting any adverse reactions.

Terrosa must not be used in growing adults.

Children and adolescents

Terrosa must not be used in children and adolescents (under 18 years of age).

Other medicines and Terrosa

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

This is important because some medicines (e.g., digoxin/digitalis, a medicine used to treat heart conditions) may interact with teriparatide.

Pregnancy and breastfeeding

Do not use Terrosa if you are pregnant or breastfeeding. If you are a woman of childbearing potential, you must use effective contraception during treatment with Terrosa. If you become pregnant while using Terrosa, treatment with Terrosa must be stopped. Consult your doctor or pharmacist before using this medicine.

Driving and using machines

Some patients may feel dizzy after receiving a Terrosa injection. If you feel dizzy, do not drive or operate machinery until you feel better.

Terrosa contains sodium

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

3. How to use Terrosa

Follow exactly the administration instructions for this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.

The recommended dose is 20 micrograms (corresponding to 80 microliters), administered once daily by subcutaneous injection (under the skin) in the thigh or abdomen.

To help you remember to inject your medicine, inject it around the same time each day. Terrosa may be injected at mealtimes.

Inject Terrosa every day for as long as your doctor prescribes it. The total duration of treatment with Terrosa must not exceed 24 months. You must not receive more than one 24-month treatment cycle in your lifetime.

Your doctor may advise you to take Terrosa with calcium and vitamin D. Your doctor will tell you how much you should take each day.

Terrosa may be taken with or without food.

Compatible injection needles are not supplied with Terrosa.

The pre-filled pen can be used with injection needles developed according to the ISO standard for pen needles, with a gauge between 29 G and 31 G (diameter 0.25 – 0.33 mm) and a length between 5 mm and 12.7 mm, for subcutaneous injection only.

For correct use of this medicine, it is very important to strictly follow the detailed instructions for use of the pre-filled pen provided with the medicine.

Use a new injection needle for each injection to prevent contamination, and safely dispose of the needle after use.

Never store the pen with the needle attached.

Do not transfer the medicine to a syringe.

You should inject Terrosa shortly after removing the pre-filled pen from the refrigerator. Replace the pen cap on the pre-filled pen and return the pen to the refrigerator immediately after use. Store it in the refrigerator before and throughout the entire 28-day treatment period.

Preparation for injection

• To ensure correct administration of Terrosa, always read the Instructions for Use of the Terrosa pre-filled pen included in the medicine pack.
• Wash your hands before handling the pre-filled pen.
• Check the expiry date on the label of the pre-filled pen before starting to use the medicine. Make sure that at least 28 days remain until the expiry date. Record the batch number (Batch) and the date of the first injection of the pre-filled pen in use on a calendar. You should also record the date of the first injection on the Terrosa carton (see the space provided on the box: {First use:}).
• Attach a new injection needle to the pre-filled pen and set the dose in the display window by rotating the dose selector knob.

Injection of Terrosa

• Before injecting Terrosa, clean the skin at the injection site (thigh or abdomen) as instructed by your doctor.
• Gently pinch the cleaned skin and insert the needle perpendicularly into the skin. Press the dose selector button and hold it down for at least 6 seconds to ensure you receive the full dose.
• Immediately after completing the injection, place the needle protection cap over the needle; unscrew the cap by turning it counterclockwise to remove the needle from the pen. This will maintain the sterility of the remaining Terrosa and prevent leakage from the pen. It will also prevent air from re-entering the pre-filled pen and needle blockage.
• Replace the cap on the pen.
• Safely dispose of used pen needles using a sharps container or as directed by your doctor.

If you use more Terrosa than you should

If you have accidentally administered more Terrosa than prescribed, consult your doctor or pharmacist.

Effects that may occur following an overdose include nausea, vomiting, dizziness, and headache.

If you forget to use Terrosa

If you miss an injection or cannot inject your medicine at the usual time, do it as soon as possible on the same day. Do not use a double dose to make up for a missed dose. Do not inject more than once on the same day.

If you stop using Terrosa

If you are considering stopping treatment with Terrosa, please consult your doctor. Your doctor will advise you and decide on how long you should be treated with Terrosa.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

The most common adverse effects are limb pain (very common, may affect more than 1 in 10 people). Other common adverse effects (affecting up to 1 in 10 people) are malaise, headache, and dizziness. If you feel dizzy after an injection, sit or lie down until you feel better. If you do not improve, consult your doctor before continuing treatment. Fainting has been reported after the use of teriparatide.

If you experience discomfort around the injection site such as redness of the skin, pain, swelling, itching, bruising, or slight bleeding (which may occur frequently), these should disappear within a few days or weeks. If they do not, inform your doctor.

Rarely (may affect up to 1 in 1,000 patients), some patients may experience allergic reactions, consisting of difficulty breathing, facial swelling, skin rash, and chest pain. These reactions usually occur immediately after the injection. In rare cases, severe and potentially life-threatening allergic reactions, including anaphylaxis, may occur.

Other adverse effects are:

Common (may affect up to 1 in 10 patients):

• increased blood cholesterol levels
• depression
• neuropathic leg pain
• feeling faint
• sensation of spinning (vertigo)
• irregular palpitations
• difficulty breathing
• increased sweating
• muscle cramps
• loss of energy
• fatigue
• chest pain
• low blood pressure
• stomach acidity (pain or burning sensation just below the sternum)
• vomiting
• hernia of the tube carrying food to the stomach (hiatal hernia)
• low hemoglobin or low red blood cell count (anemia)

Uncommon (may affect up to 1 in 100 patients):

• increased heart rate
• abnormal heart sounds
• shortness of breath
• hemorrhoids
• urinary incontinence
• increased need to urinate
• weight gain
• kidney stones
• muscle and joint pain. Some patients have experienced severe back cramps or pain and required hospitalization.
• increased blood calcium levels
• increased blood uric acid levels
• increased levels of an enzyme called alkaline phosphatase

Rare (may affect up to 1 in 1,000 patients):

• reduced kidney function, including renal failure
• swelling, mainly in the hands, feet, and legs

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly through the national reporting system included in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Terrosa

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging and on the prefilled pen, listed as CAD and EXP respectively. The expiry date refers to the last day of the month indicated.

Store in a refrigerator (between 2 °C and 8 °C). The prefilled pen must be returned to the refrigerator immediately after use. Do not freeze.

Keep the pen cap on the prefilled pen to protect it from light.

Terrosa may be used for 28 days after the first injection, provided the prefilled pen is stored in the refrigerator (between 2 °C and 8 °C).

Avoid placing the prefilled pen near the freezer compartment of the refrigerator to prevent freezing. Do not use Terrosa if it has been frozen or shows signs of having been frozen.

Each prefilled pen must be properly discarded 28 days after first use, even if it is not completely empty.

Terrosa contains a clear, colourless solution. Do not use Terrosa if it contains solid particles or if the solution is cloudy or discoloured.

Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging you no longer need. This helps protect the environment.

6. Package contents and other information

Composition of Terrosa

• The active substance is teriparatide. Each 80 microliter dose contains 20 micrograms of teriparatide. A pre-filled pen containing 2.4 ml contains 600 micrograms of teriparatide (corresponding to 250 micrograms per ml).
• The other components are: glacial acetic acid, mannitol, metacresol, sodium acetate trihydrate, hydrochloric acid (for pH adjustment), sodium hydroxide (for pH adjustment), and water for injections (see section 2 “Terrosa contains sodium”).

Appearance of the product and contents of the pack

Terrosa is a clear, colourless, injectable solution. It is supplied in a pre-filled pen. Each pre-filled pen contains 2.4 ml of solution, sufficient for 28 doses.

Pack sizes: cartons containing 1 or 3 pre-filled pens.

Only certain pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Gedeon Richter Plc.
Gyömroi út 19-21.
1103 Budapest
Hungary

Date of the most recent revision of this leaflet:

Other sources of information

Detailed information about this product is also available by scanning the QR code below or on the carton with a smartphone. The same information is also available at the following URL: www.terrosapatient.com

The QR code should be included.

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

User Manual

Terrosa 20 micrograms (µg)/80 microliters injectable solution in pre-filled pen

Instructions for Use

Important Information

This Terrosa pre-filled pen is for daily administration of a fixed dose of 80 microliters of Terrosa solution for injection for the treatment of osteoporosis.

Your pre-filled pen contains 28 doses.

It is not possible to set a dose other than 80 microliters.

If you are unable to set the 80 microliter dose, your pen is nearly empty.

The Terrosa Pen is not rechargeable; do not use it after administering 28 doses.

Parts of the pen

1. Pen cap

2. Needle connector

3. Cartridge holder

4. Cartridge plunger

5. Viewing window/screen

6. Dose-setting button

7. Pen needle

8. Inner needle cap

9. Outer needle cap

10. Removable seal

The pen needle is not supplied with the pen. It must be attached before using the pen (see step 1c).

Before you start

Before starting to use a new pen, please read these instructions completely. Follow the instructions carefully when using the pen. Also read the package leaflet.

Record the date of your first injection on a calendar.

Do not share your pen or needles, as you may risk transmitting infectious agents.

Wash your hands before each injection.

Do not use your Terrosa pen if it is damaged or if you have any doubts about its proper functioning.

Prepare everything you will need:
• Alcohol swab
• Pre-filled pen
• Pen needle

1. Preparing the pen

1/a Remove the pen cap

• Remove the pen cap (1) by pulling it off.

1/b Check the medicine

• Check the pen label to ensure you have the correct medicine and that it has not expired.

• Do not use the Terrosa pen if:

• the pen is damaged.

• the solution is cloudy, discoloured, or contains particles.

1/c Attach the needle

• Use a new needle for each injection. Use only needles recommended in the section “Compatible needles” on the last page of these instructions for use.
• Do not use the pen needle if the removable seal is damaged or missing – discard it and use a new one.

• Remove the removable seal (10).

• Press the needle onto the end of the pen and screw it on firmly until securely attached.

• Remove the outer needle cap (9) and keep it in a safe place, as you will need it to remove the needle later. Leave the inner needle cap (8) on the needle to prevent accidental needlestick injuries.

1. Injection

2/a Setting the dose

Your pen contains 28 fixed doses of 80 microliters. This fixed dose must be set for each daily injection.

• Turn the dose-setting button (6) until the viewing window (5) shows an arrow symbol and the button locks. You should hear a click when the dose is correctly set.
• The arrow symbol means the fixed daily dose is set and the pen is ready for injection.
• If you cannot set the dose, the pen is nearly empty. Use a new pen.

2/b Choose the injection site

• Use your abdomen or upper thigh for the injection. Prepare your skin as recommended by your doctor.
• Clean the selected area with an alcohol wipe.

• Carefully remove the inner needle cap (8) and immediately discard it.

2/c Delivering the dose

• Gently pinch a fold of skin between your thumb and index finger.

Insert the needle straight and gently into the skin.

• Press the dose-setting button (6) fully and keep it pressed for at least 6 seconds to ensure complete dose delivery – you will hear a "click" when you start pressing the button; this is normal.

• Remove the pen slowly. Important: Check that the screen displays '0'.

1. After the injection

3/a Remove the needle

• Carefully replace the outer needle cap (9) over the needle (7).

• Hold the outer needle cap (9) and unscrew the needle (7).
• Always dispose of needles safely using a sharps container or as directed by your doctor.

3/b How to store the pen

• Replace the cap (1) on the pen.
• Return the pen to the refrigerator immediately after use, storing it between 2 and 8 °C.

3/c How to dispose of the pen

When disposing of the pen after 28 days of use, do so carefully and as described in the section "How to dispose of the used Terrosa Pen and needles" on the last page of these Instructions for Use.

Troubleshooting

If you have any questions regarding the use of the Terrosa Pen, follow the instructions provided in the table on the following page:

Problem	Solution
Visible small air bubbles in the cartridge.	A small air bubble will not affect the dose or cause harm.
Needle cannot be attached.	Use another needle. If the second needle also cannot be attached, contact the patient support service.
The needle is broken/bent/twisted.	Use another needle.
If you accidentally try to inject without the needle attached.	Attach the needle. You will see a few drops come out. The pen is ready for use again. Set the dose and inject.
The dose button cannot be turned up to the arrow mark.	The amount of medication in the Terrosa pen is less than 80 microliters. Use a new Terrosa pen.
If the display does not return to the '0' position after injection.	Do not repeat the injection on the same day. Use a new needle for the injection the following day. If the display still does not return to the '0' position after injection, do not use this pen; contact the patient support service.
The pen is leaking.	Do not use this pen; contact the patient support service.

Important additional information

• The Terrosa pre-filled pen contains 28 fixed daily doses of 80 microliters of Terrosa injectable solution for the treatment of osteoporosis.
• Do not transfer the medication to a syringe.
• Use the Terrosa pen only as directed by your doctor and according to the information in these Instructions for Use and the Terrosa package leaflet.
• Use a new needle for each injection.
• The Terrosa pen may be used by patients aged 18 years and older, healthcare professionals, or third parties such as adult family members.
• The Terrosa pen must not be used by blind patients or those with visual impairment without the assistance of a trained person without disability. Please consult your doctor if you have hearing or manual dexterity problems.

If you have any questions regarding the use of the Terrosa pen, please contact the patient support service.

Telephone: XXXXXXXXXX
Email: XXXXXXXX

Compatible needles

• Clickfine needle, gauge 29 to 31 (diameter 0.25 – 0.33 mm), length 12, 10, 8, or 6 mm.
• BD Micro-Fine needle, gauge 29 to 31 (diameter 0.25 – 0.33 mm), length 12.7, 8, or 5 mm.

Storage and care of the Terrosa pen

• Do not store the Terrosa pen with the needle attached, as this may cause air bubbles to form in the cartridge.
• Transport and store the Terrosa pen at temperatures between 2 and 8 °C.
• Do not store the Terrosa pen in the freezer. If the medication has frozen, discard the device and use a new Terrosa pen.
• Keep the Terrosa pen and needles out of the reach of children.
• Handle the pen carefully. Do not drop the pen and avoid impact against hard surfaces. Protect it from water, dust, and moisture.
• You may use a damp cloth to clean the Terrosa pen. Do not use alcohol, solvents, or cleaning agents. Do not immerse the Terrosa pen in water, as this may damage it.
• Do not use the Terrosa pen if it is damaged or if you have any doubts about its proper functioning.

How to dispose of the Terrosa pen and used needles

• Discard the Terrosa pen 28 days after first use.
• Always remove the needle before discarding the Terrosa pen.
• Place used needles in a sharps container or in a hard plastic container with a secure lid. Do not dispose of needles directly into household waste.
• Do not recycle a full sharps container.
• Ask your doctor or pharmacist about the appropriate disposal options for the pen and the sharps container.
• The instructions regarding needle handling are not intended to replace local, healthcare professional, or institutional policies.

Marketing Authorization Holder: Gedeon Richter Plc., Hungary
Manufactured by Gedeon Richter Plc., Hungary

This user manual was last reviewed on