FORSTEO

Package leaflet: Information for the user

FORSTEO 20 micrograms/80 microliters injectable solution in a pre-filled pen

teriparatide
Please 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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as yours, because it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What FORSTEO is and what it is used for
2. What you need to know before using FORSTEO
3. How to use FORSTEO
4. Possible side effects
5. How to store FORSTEO
6. Contents of the pack and other information

1. What FORSTEO is and what it is used for

FORSTEO contains the active substance teriparatide, which is used to strengthen bones and reduce the
risk of fractures by stimulating bone formation.
FORSTEO is used to treat osteoporosis in adults. Osteoporosis is a disease that causes bones to become thin and brittle.
This condition is particularly common in women after menopause, but can also occur in men. Osteoporosis is also common in patients receiving corticosteroid therapy.

2. What you need to know before using FORSTEO

Do not use FORSTEO

• If you are allergic to teriparatide or to 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 cancers that have spread (metastasized) to the bones.
• If you have other bone diseases. If you have a bone disease, inform your doctor.
• If you have elevated blood levels of alkaline phosphatase of unknown origin, which may indicate Paget's disease of the bone (a disorder characterized by abnormal bone changes). If you are unsure, ask your doctor.
• If you have undergone radiation therapy involving the bones.
• If you are pregnant or breastfeeding.

Warnings and precautions
FORSTEO may cause an increase in calcium levels in the blood or urine.
Talk to your doctor or pharmacist before or during treatment with FORSTEO:

• if you continuously experience nausea, vomiting, constipation, low energy, or muscle weakness. These may be signs of too much calcium in the blood.
• if you suffer from kidney stones or have a history of kidney stones.
• if you have kidney problems (moderate renal impairment).

Some patients may experience dizziness or rapid heartbeat after taking the first doses. During the initial doses, if you feel dizzy, administer FORSTEO in a place where you can sit or lie down.
The recommended treatment period of 24 months must not be exceeded.
FORSTEO must not be used in adults who are still growing.
Children and adolescents
FORSTEO must not be used in children and adolescents (under 18 years of age).
Other medicines and FORSTEO
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, as they may occasionally interact (e.g. digoxin/digitalis, a medicine used to treat heart conditions).
Pregnancy and breastfeeding
Do not use FORSTEO if you are pregnant or breastfeeding. If you are a woman of childbearing age, you must use effective contraceptive methods during treatment with FORSTEO. If you become pregnant, FORSTEO must be discontinued. Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Some patients may experience dizziness after injection of FORSTEO. If you feel dizzy, do not drive or operate machinery until you feel better.
FORSTEO contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per dose, i.e. essentially "sodium-free".

3. How to use FORSTEO

Use this medicine exactly as instructed by your doctor. If you have any doubts, consult your doctor or pharmacist.
The recommended dose is 20 micrograms administered once daily by subcutaneous injection (injection under the skin) in the thigh or abdomen. To help you remember to take your medicine, inject it at the same time each day.
Inject FORSTEO every day for the entire duration prescribed by your doctor. The total duration of treatment with FORSTEO must not exceed 24 months. You must not receive more than one 24-month course of treatment during your lifetime.
FORSTEO may be injected at mealtimes.
Read the user manual included in the package for instructions on how to use the pen containing FORSTEO.
Injection needles are not included in the pen package. You may use pen needles from Becton, Dickinson and Company.
You must inject FORSTEO shortly after removing the pen from the refrigerator, as described in the user manual. After use, immediately return the pen to the refrigerator.
Use a new needle for each injection and dispose of it after each use. Never store the pen with the needle attached. Never share your FORSTEO pen with other people.
Your doctor may advise you to take FORSTEO together with calcium and vitamin D. Your doctor will tell you how much calcium and vitamin D you should take each day.
FORSTEO can be taken regardless of meals.

If you use more FORSTEO than you should
If you accidentally use more FORSTEO than you should, contact your doctor or pharmacist.
Effects that might occur with overdose include nausea, vomiting, dizziness, and headache.

If you forget or are unable to take FORSTEO at your usual time, take it during the day as soon as possible. Do not take a double dose to make up for the missed dose. Do not administer more than one injection in the same day. Do not try to make up for a missed dose.

If you stop treatment with FORSTEO
If you are considering stopping treatment with FORSTEO, please discuss this with your doctor. Your doctor will advise you and decide for how long you should continue treatment with FORSTEO.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.

The most common side effects are limb pain (frequency: very common, may affect more than 1 in 10 people) and nausea, headache, and dizziness (frequency: common).

If you feel dizzy after an injection, you should sit or lie down until you feel better. If you do not feel better, contact your doctor before continuing treatment. Cases of fainting have been reported in association with the use of teriparatide.

If you experience discomfort, redness of the skin, pain, swelling, itching, a small localized bruise, or slight bleeding around the injection site (frequency: common), these symptoms should resolve within a few days or weeks. Otherwise, inform your doctor as soon as possible.

Some patients have experienced allergic reactions shortly after injection, including shortness of breath, facial swelling, rash, and chest pain (frequency: rare). In rare cases, serious and potentially life-threatening allergic reactions, including anaphylaxis, may occur.

Other side effects include:

Common: may affect up to 1 in 10 people

• increased blood cholesterol levels
• depression
• neuralgic leg pain
• feeling of weakness
• irregular heartbeat
• shortness of breath
• increased sweating
• muscle cramps
• loss of energy
• fatigue
• chest pain
• decrease in blood pressure
• heartburn (a sensation of pain or burning felt just below the breastbone)
• general feeling of malaise (vomiting)
• presence of a hernia in the duct carrying food to the stomach (hiatal hernia)
• decrease in haemoglobin or in the number of red blood cells in the blood (anaemia)

Uncommon: may affect up to 1 in 100 people

• increased heart rate
• abnormal heart sounds
• laboured breathing
• haemorrhoids
• involuntary loss or leakage of urine
• increased need to eliminate fluids
• weight gain
• kidney stones
• muscle pain and joint pain. Some patients have experienced severe cramps or back pain requiring hospitalization.
• increased calcium levels in the blood
• increased uric acid levels in the blood
• increase in an enzyme called alkaline phosphatase

Rare: may affect up to 1 in 1,000 people

• reduced kidney function, including renal impairment
• development of swelling, particularly in the hands, feet, and legs

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system listed in Annex V.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store FORSTEO

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and on the pen after
Exp.. The expiry date refers to the last day of that month.
FORSTEO must always be stored in the refrigerator (2°C to 8°C). You may use FORSTEO for up to
28 days after the first injection; during this period, the pen should be kept in the refrigerator (2°C–
8°C).
Do not freeze FORSTEO. Avoid placing the pens near the freezer compartment of the refrigerator
to prevent freezing. Do not use FORSTEO if it has been frozen or is frozen.
After 28 days, each pen must be properly disposed of, even if it is not completely empty.
FORSTEO contains a clear, colourless solution. Do not use FORSTEO if you notice solid particles or if the solution appears cloudy or coloured.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What FORSTEO contains

• The active substance is teriparatide. Each millilitre of injectable solution contains 250 micrograms of teriparatide.
• The excipients are glacial acetic acid, sodium acetate (anhydrous), mannitol, metacresol, and water for injections. Additionally, hydrochloric acid solution and/or sodium hydroxide solution may have been added to adjust the pH.

Description of the appearance of FORSTEO and contents of the pack
FORSTEO is a clear, colourless solution. FORSTEO is supplied in a cartridge contained in a pre-filled pen. Each pen contains 2.4 mL of solution, sufficient for 28 doses. Pens are available in packs containing one or three pens. Not all pack sizes may be available.

Marketing Authorisation Holder
Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, The Netherlands

Manufacturer
Lilly France S.A.S., Rue du Colonel Lilly, F-67640 Fegersheim, France

For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder.

België/Belgique/Belgien Lietuva
Eli Lilly Benelux S.A./N.V. Eli Lilly Lietuva
Tél/Tel: + 32 (0) 2 548 84 84 Tel: + 370 (5) 2649600

България Luxembourg/Luxemburg
ТП "Ели Лили Недерланд" Б.В. - България Eli Lilly Benelux S.A./N.V.
Тел: + 359 2 491 41 40 Tél/Tel: + 32 (0) 2 548 84 84

Česká republika Magyarország
Eli Lilly R, s.r.o. Lilly Hungária Kft.
Tel: + 420 234 664 111 Tel: + 36 1 328 5100

Danmark Malta
Eli Lilly Danmark A/S Charles de Giorgio Ltd.
Tlf: + 45 45 26 60 00 Tel: + 356 25600 500

Deutschland Nederland
Lilly Deutschland GmbH Eli Lilly Nederland B.V.
Tel: + 49 (0) 6172 273 2222 Tel: + 31(0) 30 6025800

Eesti Norge
Eli Lilly Nederland B.V. Eli Lilly Norge A.S
Tel: + 372 6817 280 Tlf: + 47 22 88 18 00

Ελλάδa Österreich
ΦΑΡΜΑΣΕΡΒ-ΛΙΛΛΥ Α.Ε.Β.Ε. Eli Lilly Ges. m.b.H.
Τηλ: + 30 210 629 4600 Tel: + 43 (0) 1 711 780

España Polska
Valquifarma, S.A.U. Eli Lilly Polska Sp. z o.o.
Tel: + 34-91 623 1732 Tel: + 48 22 440 33 00

France Portugal
Lilly France Lilly Portugal Produtos Farmacêuticos, Lda
Tél: + 33 (0) 1 55 49 34 34 Tel: + 351 21 412 66 00

Hrvatska România
Eli Lilly Hrvatska d.o.o. Eli Lilly România S.R.L.
Tel: +385 1 2350 999 Tel: + 40 21 4023000

Ireland Slovenija
Eli Lilly and Company (Ireland) Limited Eli Lilly farmacevtska družba, d.o.o.
Tel: + 353 (0) 1 661 4377 Tel: + 386 (0) 1 580 00 10

Ísland Slovenská republika
Icepharma hf. Eli Lilly Slovakia s.r.o.
Sími: + 354 540 8000 Tel: + 421 220 663 111

Italia Suomi/Finland
Eli Lilly Italia S.p.A. Oy Eli Lilly Finland Ab
Tel: + 39 055 42571 Puh/Tel: + 358 (0) 9 8545 250

Κύπρος Sverige
Phadisco Ltd Eli Lilly Sweden AB
Τηλ: + 357 22 715000 Tel: + 46 (0) 8 7378800

Latvija United Kingdom
Eli Lilly (Suisse) S.A. Pārstāvniecība Latvijā Eli Lilly and Company Limited
Tel: + 371 67364000 Tel: +44 (0) 1256 315000

More detailed information on this medicinal product is available on the European Medicines Agency website: http://www.ema.europa.eu.
This leaflet is available in all languages of the European Union/European Economic Area on the European Medicines Agency website.

USER MANUAL FOR THE PEN
Forsteo
FORSTEO 20 micrograms (mcg)/80 microlitres, pre-filled pen injectable solution

Instructions for use

Before using the new pen, read the entire section Instructions for use carefully. Follow
the instructions closely when using the pen.
Also, read the package leaflet provided.
Do not share the pen or needles, as there is a risk of transmitting infectious agents.
The pen contains enough medicine for 28 days.
Components of FORSTEO*
Yellow band * Needles not included. Needles from
Button Pen body Cartridge with White cap
red blue medicine white
Becton, Dickinson and Company may be used
Tab
Ask your doctor or
paper Needle Large needle
pharmacist which gauge
and length of needle
are most suitable for you.
are most suitable for you.
Small needle
protection

Large needle
protection

Always wash your hands before each injection. Prepare the injection site according to your
doctor’s or pharmacist’s instructions.
1

Remove the white cap
2

Insert the
new needle
Remove the paper tab. Insert the needle straight onto the cartridge with medicine. Screw the needle on until firmly tight. Remove the large needle protection and keep it.

3 Red strip

Set the dose Small needle
protection
Pull out the black injection button until it stops and the red strip becomes visible. If you cannot pull out the black injection button, refer to Troubleshooting, Problem E.

4

Inject the dose
Gently pinch a section of skin on the thigh or abdomen and insert the needle perpendicularly into the skin. Press the black injection button all the way down until it stops. Keep it pressed and count slowly to 5. Then remove the needle from the skin.
IMPORTANT

5 After completing NO yellow band
the injection: should be visible.
Once the needle is If visible, you have
removed from the already administered
skin, make sure the injection, do not
that the black repeat the injection
injection button is a second time on the
fully pressed in. If same day. Instead,
the yellow band is you MUST reset the
not visible, the steps FORSTEO pen (see
of the injection have Troubleshooting,
been completed Problem A).
correctly.

6

Remove the needle
Place the large needle protection over the needle. Unscrew the needle completely by turning the large needle protection 3 to 5 full turns. Remove the needle and dispose of it according to your doctor’s or pharmacist’s instructions. Replace the white cap on the pen. Immediately after use, store FORSTEO in the refrigerator.
The instructions regarding needle handling do not replace local institutional procedures or those indicated by healthcare professionals.

Forsteo

FORSTEO 20 micrograms (mcg)/80 microliters,
injectable solution in a prefilled pen

Troubleshooting
Problem Solution
A. The yellow band is
To reset the FORSTEO pen, follow the steps below.

still visible after I
pressed the black
injection button. How
can I reset the FORSTEO
pen?

1. If you have already administered the injection, DO NOT repeat the injection a second time on the same day.
2. Remove the needle.
3. Insert a new needle, remove the large needle protection, and keep it.
4. Pull out the black injection button until it stops. Make sure the red strip is visible.
5. Remove the small needle protection and discard it.
6. Point the needle downward into an empty container. Press the black injection button until it stops. Keep it pressed and count slowly to 5. A small stream or drop of liquid should appear. When finished, the black injection button must be fully pressed in.
7. If the yellow band is still visible, contact your doctor or pharmacist.
8. Place the large needle protection over the needle. Unscrew the needle completely by turning the large needle protection 3 to 5 full turns. Remove and dispose of the needle according to your doctor’s or pharmacist’s instructions. Replace the white cap on the pen and store FORSTEO in the refrigerator.
   You can avoid this problem by always using a NEW needle for each injection, pressing the black injection button fully down, and counting slowly to 5.

B. How can I tell if The FORSTEO pen is designed to deliver the full dose

FORSTEO is working? each time it is used according to the instructions in the Instructions for use section. The black injection button will appear fully pressed in, indicating that the full dose of FORSTEO has been administered.
Remember to use a new needle each time you inject to ensure FORSTEO works properly.

C. I can see air bubbles A small air bubble will not affect the dose or be

in FORSTEO. harmful. You may continue to take your dose as usual.

D. I cannot remove the 1) Place the large needle protection over the needle.

needle. 2) Use the large needle protection to unscrew the needle.
3) Unscrew the needle completely by turning the large needle protection 3 to 5 full turns.
4) If you still cannot remove the needle, ask someone to help you.

E. What should I do if Use a new FORSTEO pen to take your dose according

I cannot pull out the to your doctor’s or pharmacist’s instructions.
black injection button?
This means you have used all the medicine that can be accurately delivered, even if you can still see some medicine remaining in the cartridge.

Cleaning and storage
Cleaning of FORSTEO

• Clean the outside of FORSTEO with a damp cloth.
• Do not immerse FORSTEO in water or wash or clean it with any liquid.

Storage of FORSTEO

• Store FORSTEO in the refrigerator immediately after use. Read and follow the instructions in the Package Leaflet: Patient Information on how to store the pen.
• Do not store FORSTEO with the needle attached, as this may cause air bubbles to form in the cartridge.
• Store FORSTEO with the white cap in place.
• Never store FORSTEO in the freezer.
• If the medicine has been frozen, discard the FORSTEO pen and use a new one.
• If FORSTEO has been kept outside the refrigerator, do not discard the pen. Return it to the refrigerator and contact your doctor or pharmacist.

Disposal of needles and the pen
Disposal of needles and the FORSTEO pen

• Before disposing of the FORSTEO pen, make sure the needle has been removed.
• Place used needles in a closable, dedicated sharps container or in a hard plastic container with a secure lid. Do not dispose of needles directly into household waste.
• Do not recycle the container once filled with needles.
• Ask healthcare personnel about available options for proper disposal of this container.
• The instructions for needle handling do not replace local institutional regulations or those provided by healthcare professionals.
• Discard the FORSTEO pen 28 days after first use.

Other important notes

• The FORSTEO pen contains 28 days’ supply of medicine.
• Do not transfer the medicine into a syringe.
• Write the date of your first injection on a calendar.
• Read and follow the instructions in the Package Leaflet: Patient Information to use 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:
  • 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 part of the normal functioning of the FORSTEO pen.
• The FORSTEO pen is not recommended for use by blind or visually impaired individuals without the assistance of someone trained in its proper use.
• Keep FORSTEO out of sight and reach of children.

Manufactured by: Lilly France, F-67640 Fegersheim, France
for Eli Lilly and Company.
This user manual was last reviewed MM/YYYY