Forsteo
teriparatide
teriparatide
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.
What FORSTEO is and what it is used for
What you need to know before you use FORSTEO
How to use FORSTEO
Possible side effects
5 How to store FORSTEO
6. Content of the pack and other information
FORSTEO contains the active substance teriparatide that is used to make the bones stronger, and to reduce the risk of fractures by stimulating bone formation.
FORSTEO is used to treat osteoporosis in adults. Osteoporosis is a disease that causes your bones to become thin and fragile. This disease is especially common in women after the menopause, but it can also occur in men. Osteoporosis is also common in patients receiving corticosteroids.
if you are allergic to teriparatide or any of the other ingredients of this medicine (listed in section 6).
if you suffer from high calcium levels (pre-existing hypercalcaemia).
if you suffer from serious kidney problems.
if you have ever been diagnosed with bone cancer or other cancers that have spread (metastasised) to your bones.
if you have certain bone diseases. If you have a bone disease, tell your doctor.
if you have unexplained high levels of alkaline phosphatase in your blood, which means you might have Paget’s disease of bone (disease with abnormal bone changes). If you are not sure, ask your doctor.
if you have had radiation therapy involving your bones.
if you are pregnant or breast-feeding.
FORSTEO may cause an increase in the amount of calcium in your blood or urine.
Talk to your doctor or pharmacist before or while using FORSTEO:
if you have continuing nausea, vomiting, constipation, low energy, or muscle weakness. These may be signs there is too much calcium in your blood.
if you suffer from kidney stones or have a history of kidney stones.
if you suffer from kidney problems (moderate renal impairment).
Some patients get dizzy or get a fast heartbeat after the first few doses. For the first doses, inject FORSTEO where you can sit or lie down right away if you get dizzy.
The recommended treatment time of 24 months should not be exceeded. FORSTEO should not be used in growing adults.
FORSTEO should not be used in children and adolescents (less than 18 years).
Please tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, because occasionally they may interact (e.g. digoxin/digitalis, a medicine used to treat heart disease).
Do not use FORSTEO if you are pregnant or breast-feeding. If you are a woman of child-bearing potential, you should use effective methods of contraception during use of FORSTEO. If you become pregnant, FORSTEO should be discontinued. Ask your doctor or pharmacist for advice before taking any medicine.
Some patients may feel dizzy after injecting FORSTEO. If you feel dizzy you should not drive or use machines until you feel better.
This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially “sodium- free”.
Always use this medicine exactly as your doctor has told you to. Check with your doctor or pharmacist if you are not sure.
The recommended dose is 20 micrograms given once daily by injection under the skin (subcutaneous injection) in the thigh or abdomen. To help you remember to take your medicine, inject it at about the same time each day.
Inject FORSTEO each day for as long as your doctor prescribes it for you. The total duration of treatment with FORSTEO should not exceed 24 months. You should not receive more than one treatment course of 24 months over your lifetime.
FORSTEO can be injected at meal times.
Read the user manual booklet, which is included in the carton for instructions on how to use the FORSTEO pen.
Injection needles are not included with the pen. Becton, Dickinson and Company pen needles can be used.
You should take your FORSTEO injection shortly after you take the pen out of the refrigerator as described in the user manual. Put the pen back into the refrigerator immediately after you have used it. Use a new injection needle for each injection and dispose of it after each use. Never store your pen with the needle attached. Never share your FORSTEO pen with others.
Your doctor may advise you to take FORSTEO with calcium and vitamin D. Your doctor will tell you how much you should take each day.
FORSTEO can be given with or without food.
If, by mistake, you have used more FORSTEO than you should, contact your doctor or pharmacist.
The effects of overdose that might be expected include nausea, vomiting, dizziness, and headache.
If you are considering stopping FORSTEO treatment, please discuss this with your doctor. Your doctor will advise you and decide how long you should be treated with FORSTEO.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The most common side effects are pain in limb (frequency is very common, may affect more than 1 in 10 people) and feeling sick, headache and dizziness (frequency is common). If you become dizzy (light-headed) after your injection, you should sit or lie down until you feel better. If you do not feel better, you should call a doctor before you continue treatment. Cases of fainting have been reported in association with teriparatide use.
If you experience discomfort such as redness of the skin, pain, swelling, itching, bruising or minor bleeding around the area of the injection (frequency is common), this should clear up in a few days or weeks. Otherwise tell your doctor as soon as possible.
Some patients may have experienced allergic reactions soon after injection, consisting of breathlessness, swelling of the face, rash and chest pain (frequency is rare). In rare cases, serious and potentially life-threatening allergic reactions including anaphylaxis can occur.
Other side effects include:
Common: may affect up to 1 in 10 people
increase in blood cholesterol levels
depression
neuralgic pain in the leg
feeling faint
irregular heart beats
breathlessness
increased sweating
muscle cramps
loss of energy
tiredness
chest pain
low blood pressure
heartburn (painful or burning sensation just below the breast bone)
being sick(vomiting)
a hernia of the tube that carries food to your stomach
low haemoglobin or red blood cell count (anaemia)
Uncommon: may affect up to 1 in 100 people
increased heart rate
abnormal heart sound
shortness of breath
haemorrhoids (piles)
accidental loss or leakage of urine
increased need to pass water
weight increase
kidney stones
pain in the muscles and pain in the joints. Some patients have experienced severe back cramps or pain which lead to hospitalisation.
increase in blood calcium level
increase in blood uric acid level
increase in an enzyme called alkaline phosphatase.
Rare: may affect up to 1 in 1,000 people
reduced kidney function, including renal failure
swelling, mainly in the hands, feet and legs.
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
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 refers to the last day of that month.
FORSTEO should be stored in a refrigerator (2°C to 8°C) at all times. You can use FORSTEO for up to 28 days after the first injection, as long as the pen is stored in a refrigerator (2°C to 8°C).
Do not freeze FORSTEO. Avoid placing the pens close to the ice compartment of the refrigerator to prevent freezing. Do not use FORSTEO if it is, or has been, frozen.
Each pen should be properly disposed of after 28 days, even if it is not completely empty.
FORSTEO contains a clear and colourless solution. Do not use FORSTEO if solid particles appear or if the solution is cloudy or coloured.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use These measures will help to protect the environment.
The active substance is teriparatide. Each millilitre of the solution for injection contains 250 micrograms of teriparatide.
The other ingredients are glacial acetic acid, sodium acetate (anhydrous), mannitol, metacresol,
and water for injections. In addition, hydrochloric acid and/or sodium hydroxide solution may have been added for pH adjustment.
FORSTEO is a colourless and clear solution. It is supplied in a cartridge contained in a pre-filled disposable pen. Each pen contains 2.4 mL of solution enough for 28 doses. The pens are available in
cartons containing one or three pens. Not all pack sizes may be available.
Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, The Netherlands
Lilly France S.A.S, Rue du Colonel Lilly, F-67640 Fegersheim, France.
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
Eli Lilly Benelux S.A./N.V. Tél/Tel: + 32 (0) 2 548 84 84
ТП "Ели Лили Недерланд" Б.В. - България Тел: + 359 2 491 41 40
Eli Lilly ČR, s.r.o.
Tel: + 420 234 664 111
Eli Lilly Danmark A/S
Tlf: + 45 45 26 60 00
Lilly Deutschland GmbH Tel: + 49 (0) 6172 273 2222
Eli Lilly Nederland B.V. Tel: +372 6 817 280
ΦΑΡΜΑΣΕΡΒ-ΛΙΛΛΥ Α.Ε.Β.Ε. Τηλ: + 30 210 629 4600
Valquifarma, S.A.U. Tel: + 34-91 623 1732
Lilly France
Tél: + 33 (0) 1 55 49 34 34
Eli Lilly Hrvatska d.o.o. Tel: +385 1 2350 999
Eli Lilly and Company (Ireland) Limited Tel: + 353 (0) 1 661 4377
Eli Lilly Lietuva
Tel: + 370 (5) 2649600
Lilly Hungária Kft. Tel: + 36 1 328 5100
Charles de Giorgio Ltd. Tel: + 356 25600 500
Eli Lilly Nederland B.V. Tel: + 31(0) 30 6025800
Eli Lilly Norge A.S Tlf: + 47 22 88 18 00
Eli Lilly Ges. m.b.H. Tel: + 43 (0) 1 711 780
Eli Lilly Polska Sp. z o.o. Tel: + 48 22 440 33 00
Lilly Portugal Produtos Farmacêuticos, Lda Tel: + 351 21 412 66 00
Eli Lilly România S.R.L. Tel: + 40 21 4023000
Eli Lilly farmacevtska družba, d.o.o.
Tel: + 386 (0) 1 580 00 10
Icepharma hf.
Sími: + 354 540 8000
Eli Lilly Italia S.p.A. Tel: + 39 055 42571
Phadisco Ltd
Τηλ: + 357 22 715000
Eli Lilly (Suisse) S.A Pārstāvniecība Latvijā
Tel: + 371 67364000
Oy Eli Lilly Finland Ab Puh/Tel: + 358 (0) 9 8545 250
Eli Lilly Sweden AB Tel: + 46 (0) 8 7378800
Eli Lilly and Company (Ireland) Limited Tel: + 353-(0) 1 661 4377
This leaflet is available in all EU/EEA languages on the European Medicines Agency web site.
Instructions for use
Your pen contains 28 days of medicine.
Forsteo parts*
Black Injection button
Yellow Shaft
Red Stripe Blue Body Medicine Cartridge White Cap Paper Tab Needle Large Needle Cover
Small Needle Protector
* Needles not included. Becton, Dickinson and Company pen needles can be used. Ask your doctor or pharmacist which needle gauge and length are best for you.
Always wash your hands before every injection. Prepare the injection site as directed by your doctor or pharmacist.
Pull off paper tab.
Push needle straight
onto medicine cartridge.
Screw on needle until firmly attached.
Pull off large needle cover and save it.
Red stripe
Small needle protector
button until it stops.
If you cannot pull out the black injection button see Troubleshooting, Problem E.
protector and throw away.
Gently hold a fold of skin from thigh or abdomen and insert needle straight
into skin.
IMPORTANT
Once the needle is removed from the skin, check to make sure the black injection button is all the way in. If the yellow shaft does not show, you have completed the injection steps correctly.
You should NOT see any of the yellow shaft. If you do and have already injected, do not inject yourself a second time on the same day. Instead, you MUST reset FORSTEO (see
Troubleshooting Problem A).
Put large needle cover on needle.
Unscrew the needle all the way by giving the large needle cover 3 to 5 complete turns.
Pull off needle and throw away as directed by your doctor or pharmacist.
Push white cap back on. Place FORSTEO in the refrigerator immediately after use.
The directions regarding needle handling are not intended to replace local, healthcare professional or institutional policies.
Troubleshooting
To reset the FORSTEO, follow the steps below.
If you have already injected, DO NOT inject yourself a second time on the same
day.
Remove the needle.
Attach a new needle, pull off the large needle cover and save it.
Pull out the black injection button until it stops. Check to make sure the red stripe
shows.
Pull off the small needle protector and throw away.
Point the needle down into an empty container. Push in the black injection button
until it stops. Hold it in and count to 5 s-l-o- w-l-y. You may see a small stream or drop of
fluid. When you have finished, the black injection button should be all the way in.
If you still see the yellow shaft showing,
please contact your doctor or pharmacist
Put the large needle cover on needle.
Unscrew the needle all the way by giving the needle cover 3 to 5 complete turns. Pull off needle cover and throw away as directed by your doctor or pharmacist. Push the white cap back on, and place FORSTEO in the refrigerator.
You can prevent this problem by always using a NEW needle for each injection, and by pushing the black injection button all the way in and counting to 5 s-l-o-w-l-y.
The FORSTEO is designed to inject the full dose every time it is used according to the directions in the
section Instructions for Use. The black injection button will be all the way in to show that the full dose has been injected from the FORSTEO.
Remember to use a new needle every time you inject to be sure your FORSTEO will work properly.
A small air bubble will not affect your dose nor will it harm you. You can continue to take your dose as usual.
Put the large needle cover on the needle.
Use the large needle cover to unscrew the needle.
Unscrew the needle all the way by giving the
large needle cover 3 to 5 complete turns.
If you still cannot get the needle off, ask someone to help you.
This indicates that you have now used all the medicine that can be injected accurately even though you may still see some medicine left in the cartridge.
Cleaning and Storage
Wipe the outside of the FORSTEO with a damp cloth.
Do not place the FORSTEO in water, or wash or clean it with any liquid.
Refrigerate the FORSTEO immediately after every use. Read and follow the instructions in the Information for the Patient leaflet on how to store your pen.
Do not store the FORSTEO with a needle attached as this may cause air bubbles to form in the cartridge.
Store the FORSTEO with the white cap on.
Never store the FORSTEO in the freezer.
If the medicine has been frozen, throw the device away and use a new FORSTEO.
If the FORSTEO has been left out of the refrigerator, do not throw the pen away. Place the pen back in the refrigerator and contact your doctor or pharmacist.
Disposal of Pen Needles and Device
Before disposing of the FORSTEO device, be sure to remove the pen needle.
Put used needles in a sharps container or a hard plastic container with a secure lid. Do not throw needles directly into your household waste.
Do not recycle the filled sharps container.
Ask your healthcare professional about options to dispose of the pen and the sharps container properly.
The directions regarding needle handling are not intended to replace local, healthcare professional or institutional policies.
Dispose of the device 28 days after first use.
Other Important Notes
The FORSTEO contains 28 days of medicine.
Do not transfer the medicine into a syringe.
Write down your first injection date on a calendar.
Read and follow the instructions in the Information for the Patient leaflet for using the product.
Check the FORSTEO label to make sure you have the correct medicine, and that it has not expired.
Contact your doctor or pharmacist if you notice any of the following:
The FORSTEO appears damaged
The solution is NOT clear, colourless and free of particles
Use a new needle for each injection.
During injection, you may hear one or more clicks – this is a normal device operation.
The FORSTEO is not recommended for use by the blind or visually impaired persons without the assistance of a person trained in the proper use of the device.
Keep the FORSTEO out of the sight and reach of children.
Manufactured by Lilly France, F-67640 Fegersheim, France for Eli Lilly and Company.
This user manual was last revised in {MM/YYYY}