Movymia 20 micrograms /80 microliters solution for injection teriparatide
What Movymia Is And What It Is Used For
Movymia contains the active substance teriparatide which is used to make the skeleton stronger and reduce the risk of bone fractures by stimulating bone formation.
Movymia is used to treat osteoporosis in adults. Osteoporosis is a disease that causes the bones in the body to become thin and fragile. The disease is particularly common in women after menopause, but can also occur in men. Osteoporosis is also common in patients receiving medicines called corticosteroids.
What You Need To Know Before You Use Movymia
Do Not Use Movymia
- If you are allergic to teriparatide or any of the other ingredients of this medicine (listed in section 6).
- If you have high levels of calcium in your blood ( hypercalcaemia ).
- If you have severe kidney problems.
- If you have had skeletal cancer or if other cancers have spread (metastasized) to the skeleton.
- If you have a certain type of bone disease. Tell your doctor if you have a bone disease.
- If you have inexplicably high levels of alkaline phosphatase in your blood, which indicates that you may have Paget’s bone disease (disease with abnormal breakdown and bone formation). If you are not sure, talk to your doctor.
- If you have received straw treatment involving the bone structure.
- If you are pregnant or breastfeeding.
Warnings And Cautions
This medicine may increase the level of calcium in the blood or urine.
Talk to your doctor before or while you are taking this medicine:
- If you constantly have nausea, vomiting, constipation, low energy or muscle weakness. It may be a sign that you have too much calcium in your blood.
- If you suffer from kidney stones or have had kidney stones before.
- If you suffer from kidney problems (moderate renal impairment).
Some patients become dizzy or have a fast heart rate after the first doses of Movymia. Inject Movymia where you can quickly sit or lie down if you get dizzy.
The recommended treatment time of 24 months should not be exceeded.
Before inserting a cartridge into the Movymia Pen, enter the batch number (lot) of cartridge one and the date of the first injection one on the outer carton. Provide this information when reporting any side effects.
This medicine should not be used in young adults who are still growing.
Children And Young People
Movymia should not be used in children or adolescents (under 18 years of age).
Other Medicines And Movymia
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
This is important because some medicines (eg digoxin/digitalis, for the treatment of heart disease) may affect the effect of teriparatide.
Pregnancy And Breastfeeding
Do not use this medicine if you are pregnant or breastfeeding. If you are a pregnant woman, use a safe contraceptive during treatment with Movymia. If you become pregnant during treatment with Movymia, treatment with Movymia should be stopped. Talk to your doctor or pharmacist before using this medicine.
Driving And Using Machines
Some people may feel dizzy after injecting it. If you feel dizzy, do not drive or use any tools or machines until you feel better.
Movymia Contains Sodium
This medicine contains less than 1 mmol (23 mg) sodium per dose, ie essentially ‘sodium-free’.
Movymia Pen How To Use
- Always use this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.
- The recommended dose is 20 micrograms (equivalent to 80 microliters), which is injected under the skin of the thigh or abdomen, once a day.
- Take your medicine at the same time each day to make it easier to remember to take it. Movymia Movymia can be injected with meals. Inject Movymia every day for as long as your doctor prescribes it. The total duration of treatment with Movymia should not exceed 24 months. You should not receive more than one 24-month treatment regimen during your lifetime.
- Your doctor may recommend that you use it with calcium and vitamin D. Your doctor will tell you how much to take each day.
- Movymia can be taken with or without food.
- Movymia cartridges are designed to be used only with the reusable drug delivery system Movymia Pen for multiple doses and compatible pen needles. The pen and injection needles are not included with Movymia. To start treatment, however, an ampoule and pen pack must be used, containing an inner pack with a Movymia cartridge and an inner pack with a Movymia Pen.
- The pen can be used with injection needles that follow the ISO standard for pen needles only intended for injection under the skin with a thickness of 29 – 31 G (gauge) (diameter 0.25 – 0.33 mm) and length 5 – 12.7 mm.
- Insert cartridge one into the pen before first use. It is very important to carefully follow the Movymia pen instructions for use that come with the proper use of this medicine.
- 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 a pen with other people.
- Do not use your Movymia Pen to inject other medicines (eg insulin ).
- The pen is adapted for use with Movymia only.
- Do not refill the cartridge one more time.
- Do not transfer the medicine to a syringe.
- Inject this medicine shortly after removing the pen with the cartridge inserted from the refrigerator, as described in the instructions for use. Return the pan with the cartridge inserted in the refrigerator immediately after use. Do not remove cartridge one from the pen after each use. Store it in the cartridge holder for the entire 28-day treatment period.
Prepare the pen for use
- Always read the instructions for use for the Movymia Pen that comes with the carton with the pen to ensure proper administration of this medicine.
- Wash your hands before handling the cartridge or pen.
- The expiration date on the cartridge label must always be checked before inserting the cartridge into the pen. Make sure that the date when a new cartridge is used is at least 28 days before the expiry date. Insert cartridge one into the pen before the first use according to the Movymia pen instructions for use of the pen. Enter the batch number (lot) for each cartridge and the date of the first injection one in a calendar. The date of the first injection should also be indicated on Movymia’s outer carton (see the intended space on the carton: {First day of use:}).
- After inserting a new cartridge and before the first injection one from cartridge one, fill it according to the Movymia pen instructions provided. Do not refill after the first dose .
Inject Movymia
- Clean the skin where you are going to inject (thigh or abdomen) according to your doctor’s instructions before injecting it.
- Gently grasp and squeeze the cleansed skin and insert the needle straight into the skin. Press and hold the button until the dose indicator returns to the start position.
- Leave the needle in the skin for six seconds after injection one to ensure that you received the full dose one.
- Attach the outer needle cover to the pen needle and screw the cover counterclockwise to remove the pen needle. This keeps the remaining Movymia sterile and does not leak from the pen. It also means that air does not return to the cartridge and that the needle does not become clogged.
- Put the cap on the pen. Leave one cartridge in the pen.
If You Use More Movymia Injection Than You Should
If you have accidentally taken more Movymia injection than you should, contact your doctor or pharmacist.
Expected effects of an overdose may include
- Nausea
- Vomiting
- Dizziness
- Headache
If You Forget To Use Movymia
If you miss an injection or can not take the medicine at the usual time, inject as soon as possible the same day. Do not use a double dose to make up for a missed dose. Do not take more than one injection on the same day, even if you miss a dose.
If You Stop Using Movymia
If you are considering stopping treatment, you should talk to your doctor. Your doctor will consult with you and determine how long you should continue with Movymia.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Possible Movymia Side Effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The most common side effects are a pain in the arms and legs (which can affect more than 1 in 10 people). Other common Movymia side effects (very common, may affect up to 1 in 10 people) include
- Nausea
- Headache
- Dizziness
If you become dizzy after the injection, sit down or lie down until you feel better. If you do not get better, call a doctor before continuing treatment. Cases of fainting have occurred after the use of teriparatide.
If you feel discomfort around the injection site such as
- Skin redness
- Pain
- Swelling
- Itching
- Bruising
- Minor bleeding (which may be common), it should go away within a few days or weeks. Otherwise, a doctor should be consulted.
In rare cases (may affect up to 1 in 1,000 people), patients have had allergic reactions, such as
- Shortness of breath
- Swelling of the face
- Rash
- Chest pain
These reactions usually occur immediately after injection. 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 people)
- Increased cholesterol levels in the blood
- Depression
- Nerve pain in the legs
- Feeling weak
- Feeling dizzy
- Irregular heartbeats
- Shortness of breath
- Increased sweating
- Muscle cramps
- Reduced energy
- Fatigue
- Chest pain
- Low blood pressure
- Heartburn (pain or burning sensation below the sternum)
- Vomiting
- Hernia in the esophagus ( hiatus hernia )
- Low hemoglobin or low red blood cell count ( anemia )
Uncommon (may affect up to 1 in 100 people)
- Increased heart rate
- Abnormal heart sound
- Shortness of breath
- Hemorrhoids
- Urine leakage
- Increased need to empty the bladder
- Weight gain
- Kidney stones ar
- Pain in muscles and pain in joints. Some patients have had such severe cramps or back pain that they have been treated in hospital.
- Increase in the amount of calcium in the blood
- Increase in the amount of uric acid in the blood
- Increase in an enzyme called alkaline phosphatase
Rare (may affect up to 1 in 1,000 people)
- Renal impairment
- Including renal failure
- Swelling, mainly in hands, feet and legs.
How To Store Movymia
- 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 the cartridge one after EXP. The expiration date is the last day of the specified month.
- Store in a refrigerator (2 ° C – 8 ° C). Do not freeze.
- Store cartridge one in the outer carton. Sensitive to light.
- This medicine can be used up to 28 days after the first injection, as long as the cartridge/pen with the inserted cartridge is stored in a refrigerator (2 ° C to 8 ° C).
- Avoid placing the cartridges near the freezer compartment of the refrigerator to prevent them from freezing. Do not use Movymia if it is or has been frozen.
- Each cartridge should be discarded after 28 days from first use, even if it is not empty.
- It contains a clear and colorless solution. Do not use Movymia if solid particles are visible in the solution or if the solution is cloudy or colored.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Contents Of The Pack And Other Information
Content Declaration
- The active substance is teriparatide. Each 80 microliter dose contains 20 micrograms of teriparatide. One 2.4 ml cartridge contains 600 micrograms teriparatide (equivalent to 250 micrograms per ml).
- The other ingredients are:
- Concentrated acetic acid
- Mannitol
- Metacresol
- Sodium acetate trihydrate
- Hydrochloric acid (for pH adjustment)
- Sodium hydroxide (for pH adjustment)
- Water for injections (see section 2 “Movymia contains sodium”).
What The Medicine Looks Like And Contents Of The Pack
- This is a colorless and clear solution for injection ( solution for injection ). 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 are packed on a plastic tray sealed with a foil lid and packed in a carton.
- Movymia ampoule and pen pack: 1 Movymia cartridge packaged on a plastic tray sealed with a foil lid and packed in an inner pack, and 1 Movymia Pen packaged in an inner pack.
- Not all pack sizes may be marketed.
Marketing Authorization Holder And Manufacturer
STADA Arzneimittel AG
Stadastrasse 2-18
61118 Bad Vilbel
Germany
Manufacturer:
Gedeon Richter Plc.
Gyömrői out 19-21.
1103 Budapest
Hungary
Contact the representative of the marketing authorization holder to find out more about this medicine:
STADA Nordic ApS
Tel: + 45 44859999