This page is for general information. Consult a doctor for personal advice. Call emergency services if symptoms are severe.

How to use OSDY 20 micrograms/80 microliters Injectable Solution in Pre-filled Pen

Introduction

Package Leaflet: Information for the User

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

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 signs of illness 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 Package Leaflet

What is Osdy and what is it used for
What you need to know before you start using Osdy
How to use Osdy
Possible side effects
Storage of Osdy
Contents of the pack and further information

1. What is Osdy and what is it used for

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

Teriparatide is used for the treatment of osteoporosis in adults. Osteoporosis is a disease that makes your bones wear out and become fragile. This disease is especially common in women after menopause, but it can also occur in men. Osteoporosis is also common in patients treated with corticosteroids.

2. What you need to know before you start using Osdy

Your healthcare professional will teach you how to use the Osdy pen.

Do not use Osdy

if you are allergicto teriparatide or 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 types of cancer that have spread (metastasized) to your bones.
if you have certain bone diseases. If you have a bone disease, consult your doctor.
if you have high levels of alkaline phosphatase in your blood without apparent explanation, which could indicate that you have Paget's disease of the bone (a disease with abnormal bone changes). If you are not sure, consult your doctor.
if you have received radiation therapy that may have affected your bones.
if you are pregnant or breastfeeding.

Warnings and Precautions

Teriparatide may cause an increase in the amount of calcium in your blood or urine.

Consult your doctor or pharmacist before starting or while using teriparatide:

if you constantly have nausea, vomiting, constipation, low energy, or muscle weakness. These may be symptoms of too much calcium in your blood.
if you have kidney stones or a history of kidney stones.
if you have kidney problems (moderate renal insufficiency).

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

The recommended treatment time of 24 months should not be exceeded.

Teriparatide should not be used in adults who are still growing.

Children and Adolescents

Teriparatide should not be used in children and adolescents (under 18 years of age).

Other Medicines and Osdy

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines, because occasionally interactions may occur (e.g., digoxin/digitalis, a medicine used to treat heart diseases).

Pregnancy and Breastfeeding

Do not use teriparatide if you are pregnant or breastfeeding. If you are a woman of childbearing age, you should use effective contraceptive methods during treatment with teriparatide. If you become pregnant, treatment with teriparatide should be discontinued. Consult your doctor or pharmacist before using any medicine.

Driving and Using Machines

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

Osdy Contains Sodium

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

3. How to Use Osdy

Follow exactly the administration instructions of this medicine indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

The recommended dose is 20 micrograms administered once a day by injection under the skin (subcutaneous injection) in the thigh or abdomen. To help you remember to inject your medicine, inject it at the same time every day.

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

Teriparatide can be injected at mealtime.

Consult the User Manual included in the package with instructions on how to use the Osdy pen.

No needles are included with the pen. The device can be used with 31G insulin pen needles.

The injection of teriparatide should be performed shortly after removing the pen from the refrigerator, as indicated in the User Manual. Return the pen to the refrigerator immediately after use. You should use a new needle for each injection and discard it after each use. Do not store the pen with the needle attached. Never share your teriparatide pen with others.

Your doctor may recommend that you take calcium and vitamin D with teriparatide. Your doctor will tell you how much to take each day.

Osdy can be used with or without food.

If You Use More Osdy Than You Should

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

The effects that could be expected from an overdose include nausea, vomiting, dizziness, and headache.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount ingested.

If You Forget or Cannot Inject Osdy at the Usual Time, do it as soon as you can that same day. Do not administer a double dose to make up for forgotten doses. Do not inject more than once on the same day. Do not try to make up for the forgotten dose.

If You Stop Treatment with Osdy

If you are thinking of stopping treatment with teriparatide, please consult your doctor. Your doctor will advise and decide how long you should be treated with teriparatide.

If you have any other questions about 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.

The most common side effects are pain in the limbs (very common, may affect more than 1 in 10 patients), discomfort, headache, and dizziness (common). If you feel dizzy after an injection, sit or lie down until you feel better. If it does not improve, consult your doctor before continuing treatment. Cases of fainting associated with the use of teriparatide have been reported.

If you experience discomfort such as redness of the skin, pain, swelling, itching, bruising, or slight bleeding around the injection site (common), these should disappear within a few days or weeks. If not, tell your doctor as soon as possible.

Some patients may have experienced allergic reactions just after the injection, consisting of difficulty breathing, swelling of the face, skin rash, and chest pain (rare frequency). In rare cases, severe and potentially life-threatening allergic reactions, including anaphylaxis, may occur.

Other side effects are:

Common: may affect up to 1 in 10 patients

increase in blood cholesterol levels
depression
neuralgic pain in the leg
feeling of fainting
irregular palpitations
difficulty breathing
increased sweating
muscle cramps
loss of energy
fatigue
chest pain
low blood pressure
stomach acid (pain or burning sensation just below the sternum)
vomiting
hernia of the tube that carries food to the stomach
low hemoglobin or low red blood cell count (anemia)

Uncommon: may affect up to 1 in 100 patients

increased heart rate
abnormal heart sound
shortness of breath
hemorrhoids (piles)
accidental loss or leakage of urine
increased need to urinate
weight gain
kidney stones
pain in the muscles and joints. Some patients have experienced severe back cramps or pain and had to be hospitalized.
increase in blood calcium levels
increase in blood uric acid levels
increase in levels of an enzyme called alkaline phosphatase.

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

reduction of kidney function, including renal failure
swelling, mainly in the hands, feet, and legs.

Reporting of Side Effects

If you experience any side effects, talk to your doctor, even if it is possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Medicines Monitoring System for Human Use: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Osdy

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

Teriparatide should always be stored in a refrigerator (between 2°C and 8°C). You can use teriparatide for 28 days after performing the first injection while the pen is stored in a refrigerator (between 2°C and 8°C).

Do not freeze teriparatide. Avoid placing the pens near the freezer compartment of the refrigerator to prevent freezing. Do not use teriparatide if it has been frozen.

Each pen should be discarded after 28 days, even if it is not completely empty.

Teriparatide contains a clear and colorless solution. Do not use teriparatide if it has solid particles or if the solution is cloudy or discolored.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicines in the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Contents of the Pack and Further Information

Composition of Osdy
The active substance is teriparatide. Each milliliter of solution for injection contains 250 micrograms of teriparatide.
The other ingredients are glacial acetic acid, sodium acetate, mannitol, metacresol, and water for injections. Additionally, a solution of hydrochloric acid and/or sodium hydroxide may have been added to adjust the pH.

Appearance of the Product and Contents of the Pack

Osdy is a clear and colorless solution. It is presented in a cartridge included in a pre-filled disposable pen. Each pen contains 2.4 ml of solution sufficient for 28 doses. The pens are available in packs containing one or three pens. Not all pack sizes may be marketed.

Marketing Authorization Holder

Reddy Pharma Iberia, S.A.

Avda. Josep Tarradellas nº 38

08029 Barcelona

Spain

Manufacturer

betapharm Arzneimittel GmbH,

Kobelweg 95,

86156 Augsburg

Germany

Pharmadox Healthcare Ltd.,

KW20A Kordin Industrial Park

Paola PLA 3000

Malta

Rual Laboratories SRL

313, Splaiul Unirii, Building H

1st floor, sector 3

030138 Bucuresti

Romania

Dr. Reddy's Laboratories Romania S.R.L.

Space 1 Sector 1 30-32 Strada Daniel Danielopolu 5th Floor,

Bucharest, 014134

Romania

This medicine is authorized in the Member States of the European Economic Area under the following names:

Country	Name
Germany	Teriparatid beta 20 Mikrogramm/80 Mikroliter Injektionslösung im Fertigpen
Spain	Osdy 20 microgramos/80 microlitros solución inyectable en pluma precargada EFG

Date of the Last Revision of this Leaflet:May 2025

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/

USER MANUAL FOR THE PEN

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

teriparatide

Instructions for Use

Before using your new pen, please read the entireInstructions for Usesection. Carefully follow the instructions when using the pen.

Also, readthe leaflet included in the packaging.

Do not share your pen or needles as it may pose a risk of infection transmission.

Your pen contains medication for 28 days.

Osdy injection device with white cylinder, purple body, and red bands, showing parts such as button, cartridge, and gray cap

Always wash your hands before each injection. Prepare the injection site as your doctor or pharmacist has indicated.

Remove the gray cap.

Hands holding an auto-injector with a transparent window showing the liquid level inside

Place the needle

Remove the paper tab. Hands holding a medical device with a pointed end and a transparent cylinder

Place the needle by pressing it directlyonto the medication cartridge

Hand holding an auto-injector with the needle pointing towards the skin, black arrow indicating the direction of injection

Screw the needle until it is perfectly fixed.

Hands holding an auto-injector with a red arrow indicating the rotation movement of the device

Remove the outer needle cap and keep it.

Hand holding a syringe with a needle, a blue circle highlighting the base of the needle just before insertion into the skin

Dose adjustment

Pullthe black injection button until it stops.

If you cannot pull the black injection button, see the Troubleshooting, Problem Esection on the back.

Hand holding a purple auto-injector pressing against the thigh with a black arrow indicating the direction of injection

Make sureyou see the red band.

Hand holding a syringe with a red band at the base and a needle marked with a blue circle

Removethe inner needle protector and discard it.

Hand holding a syringe with the needle inserted, blue circle highlighting the inner needle protector and the injection point

Clean the administration area with an alcohol swab and inject the dose.

Hand holding a purple auto-injector inserting the needle into the thigh skin with an arrow indicating the direction

Pinch your thigh or abdomen skin gently and insert the needle directly under your skin.

Hand holding a purple auto-injector inserting the needle into the abdomen skin with an arrow indicating the direction

Pressthe black injection button until it stops. Keep it pressed and count slowly to 5. Then, remove the needle from the skin.

Confirm the dose

IMPORTANT

After completing the injection: Once the needle is removed from the skin, make surethe black injection button has been inserted all the way. If the white cylinder is not visible, you have completed the injection steps correctly.

Hand holding a pre-filled purple injection device highlighted with a blue circle

DO NOTsee any part of the white cylinder. If you have already injected and see it, do not inject a second time on the same day. Instead, YOU MUST readjust the Osdy pen(see Troubleshooting, Problem Asection).

Hand holding a purple vial with a black cap crossed out by a red circle with a diagonal red line

Remove the needle

Hand holding a purple auto-injector with the needle exposed and pointing downwards, close-up of the needle

Place the outer needle cap.

Hands holding an auto-injector with an orange needle visible inserted into the skin

Completely unscrew the needle by giving the outer needle cap 3 to 5 full turns. Remove the needle and discard it as your doctor or pharmacist has indicated.

Hand holding an auto-injector with the tip pointing towards the skin and an arrow indicating the direction of injection

Remove the needle and discard it as your doctor or pharmacist has indicated.

Hands holding an auto-injector with a visible needle protector and an arrow indicating the direction of insertion

Put the gray cap back on. Store the Osdy pen in the refrigerator immediately after use.

The instructions for handling needles do not intend to replace local, institutional, or healthcare professional guidelines.

To obtain more information or if you have any questions, consult the back of this page.

	Troubleshooting
PROBLEM		SOLUTION
The white cylinder is still visible after pressing the black injection button. How do I readjust my pen?		Follow these steps to readjust the pen: If you have already injected, DO NOT inject a second time on the same day. Remove the needle. Attach a new needle, remove the outer needle cap, and keep it. Pull the black injection button until it stops. Make sure you see the red band. Remove the inner needle protector and discard it. Point the needle downwards into an empty container. Press the black injection button until it stops. Keep it pressed and count slowly to 5. You may see a small jet or drop of fluid. When finished, the black injection button should be inserted all the way. If you still see the white cylinder, please contact your doctor or pharmacist. Place the outer needle cap on the needle. Completely unscrew the needle by giving the outer needle cap 3 to 5 full turns. Remove the needle and discard it as your doctor or pharmacist has indicated. Put the gray cap back on and store the Osdy pen in the refrigerator.
	You can avoid this problem by always using a NEW needle for each injection and pressing the black injection button all the way while counting slowly to 5.
How can I know if my pen is working?		The pen is designed to inject a complete dose each time it is used, following the instructions in the Instructions for Usesection. The black injection button should be inserted all the way to confirm that the pen has injected the complete dose. Remember to use a new needle for each injection to ensure your pen works correctly.
I see an air bubble in my pen.		A small air bubble will not affect your dose or harm you. You can proceed with the administration of your dose as usual.
I cannot remove the needle.		Place the outer needle cap on the needle. Use the outer needle cap to unscrew the needle. Completely unscrew the needle by giving the outer needle cap 3 to 5 full turns. If you still cannot remove the needle, ask someone for help.
What should I do if I cannot pull the black injection button?		Switch to a new pen to administer your dose as indicated by your doctor or pharmacist. This means you have already used all the medication that could be injected accurately, even if you can see that some medication is still left in the cartridge.

Cleaning and Storage

Cleaning your pen

Clean the outside of your pen with a damp cloth.
Do not submerge your pen in water, or wash or clean it with any liquid.

Storing yourpen

Store your pen in the refrigerator immediately after each use. Read and follow the instructions for storing your pen in the Patient Information Leaflet.
Do not store your pen with the needle attached, as this may cause air bubbles to form in the cartridge.
Store the pen with the gray cap on.
Never store the pen in the freezer.
If the medication has been frozen, discard the device and use a new pen.
If the pen has been left out of the refrigerator, do not discard it. Return it to the refrigerator and contact your doctor or pharmacist.

Disposal of Needles and Pen

Before disposing of the Osdy pen, make sure you have removed the needle from the pen.
Place used needles in a puncture-proof container or a hard plastic container with a secure lid. Do not throw needles directly into the household trash.
Do not recycle the filled puncture-proof container.
Consult your healthcare professional about the available options for properly disposing of the pen and the puncture-proof container.
The instructions for handling needles do not intend to replace local, institutional, or healthcare professional guidelines.
Discard your pen 28 days after the first use.

Other Points of Interest

The Osdy pen contains medication for 28 days.
Do not transfer the medication to a syringe.
Write down the date of your first injection on a calendar.
Read and follow the instructions in the Patient Information Leafleton how to use the medication.
Check the pen label to ensure you have the correct medication and that it has not expired.
Contact your doctor or pharmacist if you have observed any of the following:
The pen appears to be damaged
The solution is NOT transparent and colorless and particle-free

Use a new needle for each injection.
During injection, you may hear one or more clicks, which is the normal operation of the device.
It is not recommended that blind or visually impaired individuals use the pen without the help of a trained person in the proper use of the device.

Manufactured by:

betapharm Arzneimittel GmbH,

Kobelweg 95,

86156 Augsburg

Germany

Pharmadox Healthcare Ltd.,

KW20A Kordin Industrial Park

Paola PLA 3000

Malta

Rual Laboratories SRL

313, Splaiul Unirii, Building H

1st floor, sector 3

030138 Bucuresti

Romania

Dr. Reddy's Laboratories Romania S.R.L.

Space 1 Sector 1 30-32 Strada Daniel Danielopolu 5th Floor,

Bucharest, 014134

Romania

This user manual was revised in May 2024

OSDY 20 micrograms/80 microliters Injectable Solution in Pre-filled Pen

How to use OSDY 20 micrograms/80 microliters Injectable Solution in Pre-filled Pen

Introduction

Package Leaflet: Information for the User

Contents of the Package Leaflet

1. What is Osdy and what is it used for

2. What you need to know before you start using Osdy

Do not use Osdy

Warnings and Precautions

Children and Adolescents

Other Medicines and Osdy

Pregnancy and Breastfeeding

Driving and Using Machines

Osdy Contains Sodium

3. How to Use Osdy

If You Use More Osdy Than You Should

If You Stop Treatment with Osdy

4. Possible Side Effects

Reporting of Side Effects

5. Storage of Osdy

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

6. Contents of the Pack and Further Information

Appearance of the Product and Contents of the Pack

Marketing Authorization Holder

USER MANUAL FOR THE PEN

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