Oseffyl

PACKAGE LEAFLET

Package leaflet: information for the user

OSEFFYL

20 micrograms/80 microliters injectable solution in a pre-filled pen
Teriparatide
Please read this leaflet carefully before 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 other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any adverse reactions, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What OSEFFYL is and what it is used for

OSEFFYL contains the active substance teriparatide, which is used to strengthen bones and reduce the risk of fractures by stimulating bone formation.
OSEFFYL is used to treat osteoporosis in adults. Osteoporosis is a disease that causes bones to become thin and fragile. This condition is particularly common in women after menopause, but can also occur in men. Osteoporosis is also common in patients being treated with corticosteroids.

2. What you need to know before taking OSEFFYL

Do not take OSEFFYL

• 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 (pre-existing hypercalcemia).
• If you have severe kidney problems.
• If you have ever been diagnosed with bone cancer or other tumours that have spread (metastasized) to the bones.
• If you have other bone diseases. If you have a bone disease, inform your doctor.
• If you have elevated blood levels of alkaline phosphatase of unknown origin, which may indicate Paget's disease of the bone (a disorder causing abnormal bone changes). If you are unsure, ask your doctor.
• If you have undergone radiation therapy involving the bones.
• If you are pregnant or breastfeeding.

Warnings and precautions
OSEFFYL may cause an increase in calcium levels in the blood or urine.
Contact your doctor or pharmacist before or during treatment with OSEFFYL:

• 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 suffer from kidney stones or have a history of kidney stones.
• if you have kidney problems (moderate renal impairment).

Some patients may experience dizziness or a rapid heartbeat after taking the first doses. During the initial doses, if you feel dizzy, inject OSEFFYL in a place where you can sit or lie down.
The recommended treatment period of 24 months must not be exceeded.
OSEFFYL must not be used in young adults who are still growing.
Children and adolescents
OSEFFYL must not be used in children and adolescents (under 18 years of age).
Other medicines and OSEFFYL
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, as they may occasionally interact (e.g. digoxin/digitalis, a medicine used to treat heart conditions).
Pregnancy and breastfeeding
Do not take OSEFFYL if you are pregnant or breastfeeding. If you are a woman of childbearing potential, you must use effective contraceptive methods during treatment with OSEFFYL. If you become pregnant, OSEFFYL must be discontinued. Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Some patients may experience dizziness after an OSEFFYL injection. If you feel dizzy, do not drive and do not operate machinery until you feel better.
OSEFFYL contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per dose, i.e. essentially "sodium-free".

3. How to take OSEFFYL

Take this medicine exactly as your doctor has instructed you. If you have any doubts, consult your doctor or pharmacist.
The recommended dose is 20 micrograms administered once daily by subcutaneous injection (injection under the skin) in the thigh or abdomen. To help you remember to take the medicine, inject it at the same time each day.
Inject OSEFFYL every day for the entire duration prescribed by your doctor. The total duration of treatment with OSEFFYL must not exceed 24 months. You must not receive more than one 24-month course of treatment in your lifetime.
Read the user manual included in the package for instructions on how to use the OSEFFYL pen. Injection needles are not included in the pen package. You may use pen needles from Becton, Dickinson and Company (29 to 31 gauge [diameter 0.25–0.33 mm, length 12.7, 8, or 5 mm]).
You should inject OSEFFYL shortly after removing the pen from the refrigerator, as described in the user manual. After use, immediately return the pen to the refrigerator. Use a new needle for each injection and dispose of it immediately after use. Never store the pen with the needle attached. Never share your OSEFFYL pen with other people.
Your doctor may advise you to take OSEFFYL together with calcium and vitamin D. Your doctor will tell you how much calcium and vitamin D you should take each day.
OSEFFYL may be injected regardless of meals.

If you take more OSEFFYL than you should
If you accidentally take more OSEFFYL than you should, contact your doctor or pharmacist.
Effects that may occur with overdose include nausea, vomiting, dizziness, and headache.

If you forget or are unable to take OSEFFYL at your usual time, take it during the day as soon as possible. Do not take a double dose to make up for a forgotten dose. Do not administer more than one injection on the same day. Do not try to make up for a missed dose.

If you stop treatment with OSEFFYL
If you are considering stopping treatment with OSEFFYL, please discuss this with your doctor.
Your doctor will advise you and decide for how long you should continue treatment with OSEFFYL.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
The most common side effects are limb pain (frequency is very common, may affect more than 1 in 10 people) and nausea, headache, and dizziness (frequency is common).
If you feel dizzy after the injection, you should sit or lie down until you feel better. If you do not feel better, you must contact a doctor before continuing treatment. Cases of fainting have been reported in association with the use of teriparatide.
If you experience discomfort, as well as redness of the skin, pain, swelling, itching, a small localized bruise, or minor bleeding at the injection site (frequency is common), these symptoms should resolve within a few days or weeks. Otherwise, inform your doctor as soon as possible.
Some patients have experienced allergic reactions shortly after injection, including shortness of breath, facial swelling, rash, and chest pain (frequency is rare). In rare cases, serious and potentially life-threatening allergic reactions including anaphylaxis may occur.
Other side effects include:
Common: may affect up to 1 in 10 people

• increased cholesterol levels in the blood
• depression
• neuralgic leg pain
• feeling of weakness
• irregular heartbeat
• shortness of breath
• increased sweating
• muscle cramps
• loss of energy
• fatigue
• chest pain
• decrease in blood pressure
• heartburn (a sensation of pain or burning felt just below the breastbone)
• general feeling of discomfort (vomiting)
• presence of hernia in the tube carrying food to the stomach
• decrease in haemoglobin or number of red blood cells (anaemia)

Uncommon: may affect up to 1 in 100 people

• increased heart rate
• abnormal heart sounds
• laboured breathing
• haemorrhoids
• involuntary loss or leakage of urine
• increased need to pass fluids
• weight gain
• kidney stones
• muscle pain and joint pain. Some patients have experienced severe cramps or
• back pain requiring hospitalization.
• increased calcium levels in the blood
• increased uric acid levels in the blood
• increase in an enzyme called alkaline phosphatase

Rare: may affect up to 1 in 1,000 people

• reduced kidney function, including kidney impairment
• development of swelling, particularly in the hands, feet, and legs

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. You can also report side effects directly via the national reporting system at www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store OSEFFYL

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.
Close the pen with the pen cap after use (due to the sensitivity of the injectable solution to light).
OSEFFYL must always be stored in the refrigerator (2 °C - 8 °C). You may use OSEFFYL for up to 28 days after the first injection, provided the pen is stored in the refrigerator (2 °C - 8 °C).
Do not freeze OSEFFYL. Avoid placing the pens near the freezer compartment of the refrigerator to prevent freezing. Do not use OSEFFYL if it has been frozen.
After 28 days, each pen must be properly disposed of, even if it is not completely empty.
OSEFFYL contains a clear, colourless solution. Do not use OSEFFYL if you notice the presence of solid particles or if the solution appears cloudy or discoloured.
Do not dispose of medicines 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 OSEFFYL contains

• The active substance is teriparatide. Each millilitre of injectable solution contains 250 micrograms of teriparatide.
• The other excipients are glacial acetic acid, sodium acetate (anhydrous), mannitol, metacresol, and water for injections. Additionally, hydrochloric acid solution and/or sodium hydroxide solution may have been added to adjust the pH.

Description of the appearance of OSEFFYL and contents of the pack
OSEFFYL is a clear, colourless solution. It is supplied in a cartridge contained within a pre-filled pen. Each pen contains 2.4 ml of solution, sufficient for 28 doses. Pens are available in packs containing 1 or 3 pens. Not all pack sizes may be available.
Marketing Authorisation Holder and Manufacturer
Italfarmaco S.p.A
Viale Fulvio Testi 330-20126 Milan
Manufacturer
GP-PHARM, S.A.
Polígono Industrial Els Vinyets-Els Fogars, Sector 2, Carretera Comarcal C-244, Km 22
08777 Sant Quintí de Mediona
Spain
This medicinal product is authorised in the European Economic Area Member States under the following
names:
Germany Teriparatid Welding 20 Micrograms / 80 Microliters Solution for Injection in Pre-filled Pen
Italy OSEFFYL 20 micrograms/80 microlitres solution for injection in pre-filled pen
USER INSTRUCTION MANUAL FOR THE PEN
USER INSTRUCTION MANUAL FOR THE PEN
Overview of pen parts
OSEFFYL is a medicine supplied in a pen. The pen contains enough medicine for one daily injection for 28 consecutive days.
Use a new needle for each injection. Needles are not supplied with the pen.

1. Pen cap
2. Cartridge with medicine
3. Label
4. Dose window
5. Dose selector button
6. Dose activator
7. Large outer cap
8. Small inner cap
9. Needle
10. Seal film

For your safety
Important information

• Read the instructions for use completely. Follow all instructions carefully.
• Read the package leaflet supplied with the pen.
• If you have any questions, contact your doctor, pharmacist, or healthcare provider.

Prevention of infectious diseases

• Do not share the pen, as this could risk transmitting infectious diseases.
• Use a new sterile needle for each injection. Used needles pose a risk of transmitting infectious diseases.

Using the pen

• Check the pen label when removing it from the refrigerator. Make sure you are using the correct medicine.
• Check the expiry date; do not use the pen if the expiry date has passed.
• Check the medicine: it should be clear, colourless, and free from particles. Do not transfer the medicine into a syringe. OSEFFYL must be administered using only this pen.
• Do not use the pen for more than 28 injections. Record the first day of injection in the injection diary on the back of these instructions for use. Calculate the date of the 28th injection using a calendar and record this date in the injection diary as well.
• The pen is not recommended for use by blind or visually impaired individuals without the assistance of a support person.

Storage

• Store the pen in the refrigerator, preferably in the door compartment.
• Keep the pen and needles out of the reach of children.

Troubleshooting

• If a problem occurs during injection, do not administer a second injection on the same day.
• Read the section "What to do if ..." in these Instructions for Use.
• Do not use the pen if it is damaged.
• Use the pen only if the medicine is clear, colourless, and free from particles.
• If you cannot resolve the problem yourself or are unsure whether it is safe, contact your doctor, pharmacist, or healthcare provider.

Preparing the pen before the first injection
Before the FIRST injection, you must prepare the pen as described here.
You need to perform this step only once. This procedure does NOT need to be repeated for the second or any subsequent injections.
Attaching the needle

1. Remove the pen cap.
2. Take a new needle and remove the protective film from the needle cap.

3. Attach the needle with the large outer cap to the pen. Screw the large outer cap clockwise until it stops.

4. Remove the large outer cap from the needle and keep it for later use.

Selecting the dose

5. Rotate the dose selector button until it stops. Ensure that the number "80" is fully visible and centred in the dose window, with the white mark aligned in the notch of the window.

6. Remove the small inner cap from the needle and discard it.

7. Hold the pen with the needle pointing upwards. Push the dose activator fully down and hold for 5 seconds (see figure on the next page). Collect any expelled liquid with a tissue.

8. Confirm the dose. Ensure that the number "0" is fully visible and centred in the dose window, that the white mark is aligned in the notch of the window, and that the raised marks on the dose selector button and pen body are aligned.

Removing the needle
Remove the needle after preparing the pen, as it could become contaminated.

9. Carefully push the needle into the large outer cap saved earlier (see figure on the next page). Do not touch the needle to avoid accidental needlestick injury.

10. Unscrew the needle by rotating the large outer cap counterclockwise and pull the needle off the pen.

11. Dispose of the needle with its cap in a safe sharps container available from your pharmacy or healthcare provider.

Keeping the injection diary

12. Record the current date and the date of the 28th injection in the injection diary on the back of these instructions for use. The pen is now ready for the first and all subsequent injections as described in the following section.

Injecting OSEFFYL
Prepare for injection
Wash your hands before each injection.
Prepare the injection site (on the thigh or abdomen) as instructed by your doctor, pharmacist, or nurse.
Use a new needle for each injection, as a new needle is sharp and allows for an almost painless injection. A used needle may be blocked or contaminated.
Attaching the needle

1. Remove the pen cap.
2. Take a new needle and remove the protective film from the needle cap.

3. Attach the needle with the large outer cap to the pen. Screw the large outer cap clockwise until it stops.

4. Remove the large outer cap from the needle and keep it for later use.

Selecting the dose

5. Rotate the dose selector button until it stops. Ensure that the number "80" is fully visible and centred in the dose window, with the white mark aligned in the notch of the window.

6. Remove the small inner cap from the needle and discard it.

7. Gently pinch a fold of skin on the thigh or abdomen.
8. Insert the needle into the prepared injection site at an angle of approximately 90 degrees. Push the dose activator fully down and hold for 5 seconds. Count slowly to 5.

9. Remove the needle from the skin.

10. Confirm the dose. Ensure that the number "0" is fully visible and centred in the dose window, that the white mark is aligned in the notch of the window, and that the raised marks on the dose selector button and pen body are aligned.

Removing the needle
Remove the needle after preparing the pen.
11. Carefully push the needle into the large outer cap saved earlier (see figure on the next page). Do not touch the needle to avoid accidental needlestick injury.

12. Unscrew the needle by rotating the large outer cap counterclockwise and pull the needle off the pen.

13. Dispose of the needle with the large outer cap in a safe sharps container available from your pharmacy or nurse.
14. Reattach the pen cap to the pen.

Storing the pen
Do not store the pen with a needle attached. This could cause air bubbles to form in the medicine cartridge. Always close the pen with the pen cap.
Remove the pen from the refrigerator only when needed for use. Store the pen in the refrigerator, preferably in the door compartment. Do not store the pen near the back wall of the refrigerator or in the freezer. The medicine becomes unusable if frozen.
If the pen has been kept outside the refrigerator for an extended period, do not discard it. Return the pen to the refrigerator and contact your doctor, pharmacist, or caregiver.
Disposal of the pen
The pen must be disposed of on the day of the last injection (see the injection diary). Discard the pen even if there is medicine remaining in the cartridge. Dispose of the pen as instructed by your doctor or pharmacist.
Apply the pen cap before disposal. Do not discard the pen with the needle attached.
What to do if…
Air bubble in the cartridge: You may use the pen without problems.
During preparation of the pen for first use, no medicine comes out: Repeat the steps described under "Selecting the dose" (page 5).
The dose activator is blocked or you think you did not inject the full dose: Do not administer a second injection on the same day. Continue with the normal injection the next day. Make sure to rotate the dose selector button fully until it stops and that the number "80" is fully visible and centred in the dose window, with the white mark aligned in the notch of the window.

This user manual was last updated on