0 micrograms / 80 microliters injection, in pre-filled pen (teriparatide)
1. What FORSTEO is and what it is used for
FORSTEO contains the active substance teriparatide which is used to make the skeleton stronger and reduce the risk of bone fractures by stimulating bone formation.
FORSTEO 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 especially common in women after menopause, but can also occur in men. Osteoporosis is also common in patients receiving corticosteroids.
2. What you need to know before using FORSTEO
Do not use FORSTEO
Do not use FORSTEO
- if you are allergic to teriparatide or any of the other ingredients of this medicine (listed in section 6).
- if you have increased levels of calcium in your blood (hypercalcemia).
- if you have severe kidney problems.
- if you have ever been diagnosed with skeletal cancer or other cancer that has 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 (a disease with abnormal breakdown and bone formation). If you are not sure, talk to your doctor.
- if you have received radiation therapy involving the bone structure.
- if you are pregnant or breastfeeding.
Warnings and cautions
FORSTEO may increase the amount of calcium in the blood or urine.
Talk to your doctor or pharmacist before or while you are using FORSTEO:
- if you constantly have nausea, vomiting, constipation, low energy, or muscle weakness. This 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 rapid heart rate after the first doses. Inject FORSTEO where you can quickly sit or lie down if you get dizzy.
The recommended treatment time of 24 months should not be exceeded.
FORSTEO should not be used in young adults.
Other medicines and FORSTEO
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, as they may in some cases affect the effect of each other (eg digoxin/digitalis, for the treatment of heart disease).
Children and young people
FORSTEO should not be used in children or adolescents (under 18 years of age).
Pregnancy and breastfeeding
Do not use FORSTEO if you are pregnant or breast-feeding. If you are a fertile woman, use a safe contraceptive during treatment with FORSTEO. If you become pregnant, your treatment with FORSTEO should be stopped. Consult your doctor or pharmacist before taking any medicine.
Driving and using machines
Some people may feel dizzy after injecting FORSTEO. If you feel dizzy, do not drive or use any tools or machines until you feel better.
Important information about some of the ingredients of FORSTEO
This medicine contains less than 1 mmol sodium (23 mg) per dose. This means that it is almost “sodium-free”.
3. How to use FORSTEO
Always use this medicine exactly as your doctor has told you. If you are not sure, talk to your doctor or pharmacist.
The recommended dose is one of 20 micrograms, 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.
Inject FORSTEO every day for as long as your doctor prescribes it. The total treatment time with FORSTEO should not exceed 24 months. You should not receive more than 24 months of treatment during your lifetime.
FORSTEO can be taken with a meal.
Read the instructions for use in the package, how to use the pen.
Needles are not included in the package. Becton Dickinson pen needles can be used.
Inject FORSTEO shortly after removing the pan from the refrigerator, as described in the instructions for use. Put the pen back in the refrigerator immediately after use. Use a new needle for each injection and discard it after use. Do not store the pen with the needle attached. Never share your FORSTEO pen with others.
Your doctor may prescribe calcium and vitamin D supplements. How many of these medicines you should take each day is determined by your doctor.
FORSTEO can be taken regardless of the meal.
If you use more FORSTEO than you should
If you have accidentally used more FORSTEO than you should, contact your doctor or pharmacist.
Too large a dose can cause nausea, vomiting, dizziness, and headaches.
If you forget to take FORSTEO
If you forget to take FORSTEO or can not take it at the usual time, take an injection as soon as possible on the same day. Do not take 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. Do not try to compensate for the missed dose.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
If you stop using FORSTEO
If you are considering stopping FORSTEO treatment, you should talk to your doctor. Your doctor will consult with you and decide how long you should continue with FORSTEO.
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 arms and legs (frequency is very common, may affect more than 1 in 10 people) and nausea, headache, and dizziness (frequency are common).
If you get dizzy after injection one, sit or lie down until you feel better. If you do not get better, call a doctor before continuing treatment. Cases of fainting have been reported with the use of teriparatide.
If you experience discomfort such as reddening of the skin, pain, swelling, itching, bruising or minor bleeding at the injection site (frequency is common). This usually disappears within a few days or weeks. Otherwise, a doctor should be contacted as soon as possible.
Some patients have had allergic reactions shortly after injection, such as shortness of breath, swelling of the face, rash, and chest pain (frequency is rare). 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
- neuralgic (nerve) pain in the legs
- feeling weak
- 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)
- nausea (vomiting)
- hernia in the esophagus
- 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 are
- 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 the hands, feet, and legs.
5. How to store FORSTEO
Keep out of sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton after EXP. and on the pen after EXP. The expiration date is the last day of the specified month.
Store in a refrigerator (2 ° C – 8 ° C) both before and during use. FORSTEO can be used for up to 28 days after the first injection, as long as the pen is stored in a refrigerator (2 ° C to 8 ° C).
FORSTEO must not be frozen. Avoid placing the pens near the freezer compartment of the refrigerator to prevent them from freezing. Do not use FORSTEO if it is or has been frozen.
After 28 days, the pen should be discarded, even if it is not empty.
FORSTEO contains a clear and colorless solution. Do not use FORSTEO if solid particles have formed 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.
6. Contents of the packaging and other information
Content declaration
– The active substance is teriparatide. One ml of solution for injection contains 250 micrograms of teriparatide.
The other ingredients are concentrated acetic acid, sodium acetate (anhydrous), mannitol, metacresol, and water for injections. Besides, hydrochloric acid and/or sodium hydroxide may have been added for pH adjustment.
Marketing Authorization Holder and Manufacturer
Eli Lilly Nederland BV, Papendorpseweg 83, 3528 BJ Utrecht, The Netherlands
Lilly France SAS, Rue du Colonel Lilly, F-67640 Fegersheim, France
What the medicine looks like and the contents of the pack
FORSTEO is a colorless and clear solution. It is supplied in an ampoule enclosed in a disposable pre-filled pen. Each pen contains 2.4 ml of solution that is sufficient for 28 doses. The package contains either one pen or three pencils. Not all pack sizes may be available.
Contact the representative of the marketing authorization holder to find out more about this medicine.
Tel: + 46- (0) 8 7378800
Further information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu/.
This leaflet is available in all EU / EEA languages on the European Medicines Agency’s website.