OSDY 20 micrograms/80 microliters Injectable Solution in Pre-filled Pen
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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
or
Pharmadox Healthcare Ltd.,
KW20A Kordin Industrial Park
Paola PLA 3000
Malta
or
Rual Laboratories SRL
313, Splaiul Unirii, Building H
1st floor, sector 3
030138 Bucuresti
Romania
or
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.
Always wash your hands before each injection. Prepare the injection site as your doctor or pharmacist has indicated.
- Remove the gray cap.
|
- Place the needle
Remove the paper tab. | Place the needle by pressing it directlyonto the medication cartridge
| Screw the needle until it is perfectly fixed.
| Remove the outer needle cap and keep it.
|
- 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.
| Make sureyou see the red band.
| Removethe inner needle protector and discard it.
|
- Clean the administration area with an alcohol swab and inject the dose.
Pinch your thigh or abdomen skin gently and insert the needle directly under your skin. |
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.
| 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).
|
- Remove the needle
Place the outer needle cap. |
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. |
Remove the needle and discard it as your doctor or pharmacist has indicated. |
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 | |
| Follow these steps to readjust the pen:
| |
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. | ||
| 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. | |
| A small air bubble will not affect your dose or harm you. You can proceed with the administration of your dose as usual. | |
|
| |
| 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
Storing yourpen
|
Disposal of Needles and Pen |
Disposal of Needles and Pen
|
Other Points of Interest | |
|
Manufactured by: betapharm Arzneimittel GmbH, Kobelweg 95, 86156 Augsburg Germany or Pharmadox Healthcare Ltd., KW20A Kordin Industrial Park Paola PLA 3000 Malta or Rual Laboratories SRL 313, Splaiul Unirii, Building H 1st floor, sector 3 030138 Bucuresti Romania or 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 |
- Country of registration
- Active substance
- Prescription requiredYes
- Manufacturer
- This information is for reference only and does not constitute medical advice. Always consult a licensed doctor before taking any medication. Oladoctor is not responsible for medical decisions based on this content.
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