Movymia 20 micrograms/80 microliters solution for injection
Spain
Table of Contents
Patient Information Leaflet
Introduction
Patient Information Leaflet
Movymia 20 micrograms/80 microliters injectable solution
teriparatide
Read the entire leaflet carefully before you start using this medicine, because it contains important information for you.
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Keep this leaflet as you may need to read it again.
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If you have any questions, ask your doctor or pharmacist.
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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 could harm them.
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If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.
Leaflet Contents
- What Movymia is and what it is used for
- What you need to know before using Movymia
- How to use Movymia
- Possible side effects
- How to store Movymia
- Contents of the pack and other information
1. What Movymia is and what it is used for
Movymia contains the active substance teriparatide, which is used to increase bone strength and reduce the risk of fractures by stimulating new bone formation.
Movymia 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 especially common in women after menopause, but it can also occur in men. Osteoporosis is also common in patients treated with medicines called corticosteroids.
2. What you need to know before using Movymia
Do not use Movymia
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if you are allergic to teriparatide or to any of the other ingredients of this medicine (listed in section 6).
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if you have high levels of calcium in your blood (pre-existing hypercalcemia).
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if you have severe kidney problems.
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if you have ever had bone cancer or if other types of cancer have spread (metastasized) to your bones.
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if you have certain bone diseases. If you have a bone disease, consult your doctor.
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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.
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if you have received radiation therapy that may have affected your bones.
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if you are pregnant or breastfeeding.
Warnings and precautions
Movymia may increase calcium levels in your blood or urine.
Consult your doctor before or during treatment with Movymia:
- 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 have kidney problems (moderate renal failure), you must inform your doctor.
Some patients may experience dizziness or increased heart rate after the first doses of Movymia. For the initial doses, use Movymia 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 inserting a cartridge into the Movymia Pen, record the batch number (Batch) of the cartridge and the date of the first injection on the cartridge box, and provide this information when reporting any adverse reactions.
Movymia must not be used in growing adults.
Children and adolescents
Movymia must not be used in children and adolescents (under 18 years of age).
Other medicines and Movymia
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/cardiac glycosides, a medicine used to treat heart conditions) may interact with teriparatide.
Pregnancy and breastfeeding
Do not use Movymia if you are pregnant or breastfeeding. If you are a woman of childbearing potential, you must use effective contraceptive methods during treatment with Movymia. If you become pregnant while using Movymia, treatment must be stopped. Consult your doctor or pharmacist before using this medicine.
Driving and using machines
Some patients may feel dizzy after receiving an injection of Movymia. If you feel dizzy, you should not drive or operate machinery until you feel better.
Movymia contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per dose, i.e., essentially “sodium-free”.
3. How to use Movymia
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 microlitres) administered once daily by subcutaneous injection (injection under the skin) in the thigh or abdomen.
To help you remember to inject your medicine, inject at approximately the same time each day.
Movymia may be injected at mealtimes. Take Movymia every day for as long as your doctor prescribes it. The total duration of treatment with Movymia must not exceed 24 months. You must not receive more than one 24-month course of treatment during your lifetime.
Your doctor may advise you to take Movymia with calcium and vitamin D. Your doctor will tell you how much you should take each day.
Movymia may be taken with or without food.
Movymia cartridges are designed for exclusive use with the reusable multidose delivery system, Movymia Pen, and compatible pen needles. The pen and injection needles are not included with Movymia. However, for initiation of treatment, a package containing a cartridge and pen must be used, which includes a Movymia cartridge case and a Movymia Pen case.
The pen may be used with injection needles meeting 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.
Before first use, insert the cartridge into the pen. For proper use of this medicine, it is very important that you carefully follow the detailed instructions for use of the pen provided with it.
Use a new injection needle for each injection to prevent contamination, and dispose of the needle safely after use.
Never store the pen with the needle attached.
Never share your pen with other people.
Do not use the Movymia Pen to inject any other medicine (e.g., insulin). The pen is designed for use with Movymia only.
Do not refill the cartridge.
Do not transfer the medicine to a syringe.
You should inject Movymia shortly after removing the pen with the cartridge inserted from the refrigerator. Return the pen with the cartridge inserted to the refrigerator immediately after use. Do not remove the cartridge from the pen after each use. Keep it in the cartridge holder throughout the entire 28-day treatment period.
Preparing the pen for use
- To ensure correct administration of Movymia, always read the Instructions for Use of the Movymia Pen, included in the pen case.
- Wash your hands before handling the cartridge or pen.
- Check the expiry date on the cartridge label before inserting it into the pen.
Ensure that at least 28 days remain until the expiry date. Insert the cartridge into the pen before first use, as detailed in the pen instructions. Record the batch number (Lot) of each cartridge and the date of first injection on a calendar.
You should also record the date of first injection on the Movymia case (see the space provided on the box: {First use:}).
- After inserting a new cartridge and before the first injection from that cartridge, prepare the pen according to the provided instructions. Do not repeat this preparation step after the first dose.
Injecting Movymia
- Before injecting Movymia, 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 to the skin. Press and hold the button until the dose indicator returns to the starting position.
- After the injection, leave the needle in the skin for six seconds to ensure you receive the full dose.
- Immediately after the injection, place the needle protection cap over the needle; unscrew the cap counterclockwise to remove the needle from the pen. This will maintain the sterility of the remaining Movymia and prevent leakage from the pen. It will also prevent air from re-entering the cartridge and avoid needle blockage.
- Replace the cap on the pen. Leave the cartridge in the pen.
If you use more Movymia than you should
If you accidentally administer more Movymia than prescribed, consult your doctor or pharmacist.
Effects that may occur with an overdose include nausea, vomiting, dizziness, and headache.
If you forget to use Movymia
If you miss an injection or are unable to inject your medicine at the usual time, do so as soon as possible on the same day. Do not use a double dose to make up for missed doses. Do not inject more than once in the same day.
If you stop treatment with Movymia
If you are considering stopping treatment with Movymia, please consult your doctor. Your doctor will advise you and decide how long your treatment with Movymia should last.
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 patients). Other common adverse effects (affecting up to 1 in 10 patients) include malaise, headache, and dizziness. If you feel dizzy after an injection, sit or lie down until you feel better. If symptoms do not improve, consult your doctor before continuing treatment. Cases of fainting after use of teriparatide have been reported.
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.
Rare (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 acid (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 type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Movymia
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the container and cartridge, indicated as CAD and EXP respectively. The expiry date refers to the last day of the month shown.
Store in a refrigerator (between 2 °C and 8 °C). Do not freeze. Keep the cartridge in its carton to protect it from light.
You may use Movymia for up to 28 days after the first injection, provided the cartridge / pen with the cartridge inserted is stored in the refrigerator (between 2 °C and 8 °C).
Avoid placing the cartridge near the freezer compartment of the refrigerator to prevent freezing. Do not use Movymia if it has been frozen or shows signs of freezing.
Each cartridge must be properly discarded 28 days after first use, even if it is not completely empty.
Movymia contains a clear, colourless solution. Do not use Movymia if it contains solid particles or if the solution is cloudy or discoloured.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.
6. Contents of the pack and other information
Composition of Movymia
- The active substance is teriparatide. Each 80 microlitre dose contains 20 micrograms of teriparatide. A 2.4 ml cartridge contains 600 micrograms of teriparatide (equivalent to 250 micrograms per ml).
- The other components are: glacial acetic acid, mannitol, metacresol, sodium acetate trihydrate, hydrochloric acid (to adjust pH), sodium hydroxide (to adjust pH) and water for injections (see section 2 “Movymia contains sodium”).
Appearance of the product and contents of the pack
Movymia is a clear, colourless injectable solution. It is supplied in a cartridge. Each cartridge contains 2.4 ml of solution, sufficient for 28 doses.
Pack sizes: 1 cartridge or 3 cartridges packed in a sealed plastic tray with lid and contained in a carton.
Pack containing cartridge and pen: 1 Movymia cartridge packed in a sealed plastic tray with lid and contained in a carton and 1 Movymia Pen packed in a carton.
Only certain pack sizes may be marketed.
Marketing Authorisation Holder
STADA Arzneimittel AG
Stadastrasse 2-18
61118 Bad Vilbel
Germany
Manufacturer
Gedeon Richter Plc.
Gyömroi út 19-21
1103 Budapest
Hungary
For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
Laboratorio STADA, S.L.
Tel: +34 934738889
Date of the most recent revision of this leaflet: September 2021
Other sources of information
Detailed information on this medicinal product is available on the European Medicines Agency website: http://www.ema.europa.eu/
Detailed information on this product is also available by scanning the QR code shown below or on the carton with a smartphone. The same information is also available at the following URL: movymiapatients.com
Instructions for use
Movymia Pen
Reusable injection pen designed for use with Movymia cartridges, for subcutaneous injection
When using the Movymia Pen, always follow the instructions given below and on the reverse side.
Parts of the Movymia Pen
Preparing the pen – First use / cartridge change
Follow these instructions each time you insert a new Movymia cartridge into the Movymia Pen. Do not repeat this step before each daily injection, as otherwise there will not be enough Movymia for 28 days.
Read the separate leaflet provided with the Movymia cartridge.
A: Remove the pen cap.
B: Unscrew the cartridge holder to remove it (bayonet fitting).
C: If replacing the cartridge, remove the empty cartridge. Insert a new Movymia cartridge into the cartridge holder with the foldable metal cap of the cartridge facing forward.
Record the date of the first injection of each new cartridge. This will help you track when the 28 daily doses per cartridge are used up.
D: Carefully press the threaded rod straight down until it stops. This step is not necessary if the threaded rod is already in its initial position, as when the pen is used for the first time. The threaded rod cannot be fully inserted into the pen housing.
E: Attach the cartridge holder to the housing by turning it 90 degrees until it stops.
F: Attach a new pen needle as follows:
- Remove the peel-off seal.
- Screw the pen needle clockwise onto the cartridge holder. Ensure the pen needle is properly placed and firmly seated on the cartridge holder.
- Remove the outer needle cap and keep it.
- Remove and discard the inner needle cap.
A few drops may escape when attaching the needle; this is normal.
G: Priming
The pen must be primed and tested before inserting a new cartridge and before the first injection from each cartridge.
- Turn the dose button clockwise until the drop symbol appears in the dose window. Ensure both indicator lines are aligned. During dose setting, the pen clicks and offers noticeable resistance.
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Hold the pen with the needle pointing upwards.
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Press the push-button fully down. Keep it pressed until the dose indicator returns to its initial position. A few drops of the medicine should appear at the needle tip.
If not, repeat step G until drops appear. Do not repeat step G more than four times; if necessary, follow the instructions in the Troubleshooting section on the reverse.
Administration using the Movymia Pen
Wash your hands thoroughly with soap to reduce the risk of infection.
Ensure you have the following items ready:
- Movymia Pen with cartridge inserted
- A compatible pen needle
- A puncture-resistant sharps container for used needles
Do not use the pen if the cartridge is cloudy or discoloured or contains particles.
Read the separate leaflet provided with the Movymia cartridge.
- Attach the pen needle
Use a new needle for each injection. Do not use the pen needle if the packaging is damaged or has been opened.
Note: It is not necessary to change the needle if used immediately after pen preparation. In this case, proceed directly to step “2. Dose setting and injection”.
- Remove the peel-off seal.
- Screw the pen needle clockwise onto the cartridge holder. Ensure the pen needle is properly placed and firmly seated on the cartridge holder.
- Remove the outer needle cap and keep it.
- Remove and discard the inner needle cap.
A few drops may escape when attaching the needle; this is normal.
- Dose setting and injection
Warning: Ensure you are using the correct drug solution. Check the cartridge label before inserting it into the cartridge holder.
- To set the fixed daily dose of 80 microlitres, turn the dose button clockwise until it stops and cannot be turned further. Ensure the arrow symbol appears in the dose window and is aligned with the indicator line. During dose setting, the pen clicks and offers noticeable resistance. Do not attempt to force the dose button.
Note: If the cartridge contains less than 80 microlitres, the dose button cannot be turned clockwise to the arrow symbol. In this case, remove the pen cap, change the cartridge, and prime the pen following the pen preparation steps.
- Select an appropriate injection site and prepare the skin as recommended by your doctor. Gently pinch a fold of skin between your index and thumb fingers. Insert the needle straight and carefully into the skin as shown in the illustration.
Warning: Avoid bending or breaking the pen needle. Do not tilt the pen after inserting the needle into the skin. Tilting the pen may bend or break the needle. Broken needles may remain embedded in the skin. If a broken needle remains in the skin, consult your doctor immediately.
- Press the push-button until the dose indicator returns to its initial position. Leave the needle in the skin fold for an additional 6 seconds.
- Remove the pen slowly. Check that the dose window shows the initial position to ensure the full dose has been injected.
- Remove the pen needle
- Carefully place the outer needle cap back onto the pen needle.
- Unscrew the needle cap counterclockwise to remove the needle from the pen. Dispose of it properly, for example, in a puncture-resistant sharps container.
- Replace the pen cap
- Do not remove the cartridge from the Movymia Pen before it is empty.
- Replace the pen cap after each use.
- Immediately after use, store the Movymia Pen with the cartridge in the refrigerator at a temperature of 2 to 8 °C.
Note for healthcare professionals
Local policies, healthcare professional guidelines, or institutional regulations may override the instructions regarding handling and disposal of needles.
Additional information
The reusable fixed-dose pen is designed for easy administration of Movymia for the treatment of osteoporosis. Each Movymia cartridge contains 28 fixed doses of 80 microlitres of Movymia.
Use the Movymia Pen only as directed by your doctor and according to the information in these instructions for use and the Movymia package leaflet.
The Movymia Pen may be used by patients who self-inject and are over 18 years of age, healthcare professionals, or third parties such as adult family members.
The Movymia Pen should not be used by blind or visually impaired patients without the assistance of a physically capable and properly trained person. Consult your doctor if you have hearing or manual dexterity difficulties.
If you have any questions regarding the use of the Movymia Pen, contact our customer support service at any time.
Telephone number: XXXXXXXXXXX
Email: XXXXXXXXXXX
Compatible pen needles
- Ypsomed mylife™ Clickfine®, gauge 29 to 31 (diameter 0.25 – 0.33 mm) and length 12, 10, 8 or 6 mm
- BD Micro-Fine Ultra™ needles, gauge 29 to 31 (diameter 0.25 – 0.33 mm) and length 12.7, 8 or 5 mm
Pen needles from other manufacturers may be used according to compatibility specifications provided.
Pen needles must be used only once, and only one person should use the Movymia cartridge.
Storage and care of the Movymia Pen
- Handle the pen carefully. Do not drop the pen and avoid knocking it against hard surfaces. Protect it from water, dust, and moisture.
- You may clean the Movymia Pen with a damp cloth. Do not use alcohol, solvents, or cleaning agents. Do not immerse the Movymia Pen in water, as this may damage it.
- Do not use the Movymia Pen if it is damaged or if you have doubts about its proper function.
- Transport and store the Movymia Pen with the cartridge inserted at the temperature specified in the separate Movymia package leaflet.
- Keep the Movymia Pen, cartridges, and needles out of reach of children.
- Do not store the Movymia Pen with the needle attached, as this may cause air bubbles to form in the cartridge.
How to dispose of the Movymia Pen and used accessories
The Movymia Pen has a two-year service life. Before disposing of the Movymia Pen, remove the needle and the cartridge. Used needles and cartridges must be safely and separately discarded. The Movymia Pen may be disposed of in accordance with local authority instructions.
Warnings
Follow the instructions provided in these instructions for use. Failure to follow these instructions may result in medication errors, incorrect dosing, transmission of disease, or infection. If you experience any health problems, seek medical attention immediately.
Warranty
The warranty covers material and manufacturing defects of the Movymia Pen for two years from the date of purchase. It is limited to pen replacement. The warranty does not cover damage caused by:
- Use of cartridges other than Movymia cartridges
- Incorrect, negligent, or improper use, handling, or cleaning
- Use contrary to that specified in the instructions for use
- Use of the pen with medical devices, accessories, or consumables not mentioned in these instructions for use
- Drops, impacts, application of force, contact with liquids
- Other cases of exposure and wear not in accordance with the instructions for use.
Troubleshooting
If you have any questions regarding the use of the Movymia Pen, follow the instructions in the table on the following page:
Question | Answer |
| A small air bubble will not affect the dose or cause harm. |
| Use another needle. If the second needle cannot be attached, contact customer service. |
| Use another needle. |
| Do not use that pen; contact customer service. |
| Change the needle and repeat priming as described in pen preparation sections “F” and “G”. If medication still does not come out, do not use that pen; contact customer service. |
| The remaining amount of Movymia in the cartridge is less than 80 microliters. Replace the cartridge and needle, and perform priming according to the pen preparation steps. |
| Do not repeat the injection on the same day. Use a new needle for the next day's injection. Set the dose and administer the injection as described in section “2. Dose Setting and Injection”. If the dose window still does not return to the starting position after injection, do not use that pen; contact customer service. |
| Do not use that pen; contact customer service. |
How can I reset the dose button to the starting position? | Do not press the plunger. To reset the pen, simply turn the dose button counterclockwise to the starting position. |
Distributor:
XXXXXXXXXX
Importer:
Gedeon Richter Plc.
Gyömroi út 19-21
1103 Budapest
Hungary
Authorized Representative in the European Community:
Ypsomed Distribution GmbH
Warmbacher Strasse 80
79618 Rheinfelden
Germany
Legal Manufacturer:
Ypsomed AG
Brunnmattstrasse 6
3401 Burgdorf
Switzerland
CE 0123
Date of text revision: