FORSTEO 20 MICROGRAMS/80 MICROLITERS, SOLUTION FOR INJECTION

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

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

teriparatide

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 pass it on to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Contents of the 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 increase bone strength and reduce the risk of fractures by stimulating bone formation.

FORSTEO is used for the treatment of osteoporosis in adults. Osteoporosis is a disease that causes your bones to become thin and fragile. This condition is particularly common in women after menopause, but it can also occur in men. Osteoporosis is also common in patients being treated with corticosteroids.

2. What you need to know before using FORSTEO

Your healthcare professional will teach you how to use the FORSTEO pen.

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 types of cancer that have spread (metastasized) to your bones.
• if you have certain bone diseases. If you have a bone disease, consult your doctor.
• if you have elevated levels of alkaline phosphatase in the blood without apparent cause, which could indicate Paget's disease of the bone (a condition involving abnormal bone changes). If you are unsure, consult your doctor.
• if you have received radiation therapy that may have affected your bones.
• if you are pregnant or breastfeeding.

Warnings and precautions

FORSTEO may cause an increase in the amount of calcium in your blood or urine.

Consult your doctor or pharmacist before starting or while using FORSTEO:

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

Some patients may experience dizziness or increased heart rate after the first doses. For the initial doses, use FORSTEO 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.

FORSTEO must not be used in growing adults.

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 need to take any other medicines, as interactions may occasionally occur (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 treatment must be stopped. Consult your doctor or pharmacist before using any medicine.

Driving and using machines

Some patients may feel dizzy after injection of FORSTEO. If you feel dizzy, you must 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; essentially "sodium-free".

3. How to use FORSTEO

Follow exactly the instructions given by your doctor for administering this medicine. If you are unsure, consult your doctor or pharmacist again.

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 around the same time each day.

Use FORSTEO every day for as long as your doctor prescribes. The total duration of treatment with FORSTEO must not exceed 24 months. You must not receive more than one 24-month course of treatment with FORSTEO during your lifetime.

FORSTEO may be injected with meals.

Refer to the User Manual included in the pack for instructions on how to use the FORSTEO pen.

Needles are not included with the pen. Becton, Dickinson and Company needles may be used.

The FORSTEO injection should be administered shortly after removing the pen from the refrigerator, as indicated in the User Manual. Return the pen to the refrigerator immediately after use. A new needle must be used for each injection and discarded after use. Do not store the pen with the needle attached. Never share your FORSTEO pen with others.

Your doctor may recommend that you take calcium and vitamin D with FORSTEO. Your doctor will tell you how much you should take each day.

FORSTEO may be used with or without food.

If you use more FORSTEO than you should

If you have accidentally administered more FORSTEO than prescribed, consult your doctor or pharmacist.

Effects that might be expected following an overdose include nausea, vomiting, dizziness, and headache.

If you forget or are unable to inject FORSTEO at your usual time, do so as soon as possible on the same day. Do not administer a double dose to make up for a missed dose. Do not inject more than once in the same day. Do not attempt to make up for a missed dose.

If you stop using FORSTEO

If you are considering stopping treatment with FORSTEO, please consult your doctor. Your doctor will advise you and decide how long you should be treated with FORSTEO.

If you have any further questions about using this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone experiences them.

The most common adverse effects are limb pain (very common, may affect more than 1 in 10 people), malaise, headache, and dizziness (common). 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 associated with the use of teriparatide have been reported.

If you experience discomfort such as redness of the skin, pain, swelling, itching, bruising, or slight bleeding around the injection site (common), these should disappear within a few days or weeks. If they do not, inform your doctor as soon as possible.

Some patients may have experienced allergic reactions immediately after injection, consisting of difficulty breathing, facial swelling, skin rash, and chest pain (rare frequency). Rarely, severe and potentially life-threatening allergic reactions may occur, including anaphylaxis.

Other adverse effects include:

Common: may affect up to 1 in 10 patients

• increased blood cholesterol levels
• depression
• neuralgic leg pain
• feeling faint
• irregular palpitations
• difficulty breathing
• increased sweating
• muscle cramps
• loss of energy
• fatigue
• chest pain
• low blood pressure
• acid reflux (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 (piles)
• accidental urine leakage or 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 adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly through the national reporting system detailed in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of FORSTEO

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 packaging and on the pen, as CAD and EXP respectively. The expiry date refers to the last day of the month indicated.

FORSTEO must always be stored in a refrigerator (between 2°C and 8°C). You may use FORSTEO for 28 days after the first injection, provided the pen is kept refrigerated (between 2°C and 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.

Each pen must be properly discarded after 28 days, even if it is not completely empty.

FORSTEO contains a clear, colourless solution. Do not use FORSTEO 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 that you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of FORSTEO

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

Appearance of the product and contents of the pack

FORSTEO is a clear, colourless solution. It is supplied in a cartridge contained within a disposable 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. Some pack sizes may not be available.

Marketing Authorization 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 more information about this medicinal product, you may contact the local representative of the Marketing Authorization Holder:

Date of the most recent review of this leaflet:

Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu/

This leaflet is available on the European Medicines Agency website in all languages of the European Union/European Economic Area.

USER MANUAL FOR THE PEN

Forsteo

FORSTEO 20 micrograms (μg)/80 microliters solution for injection in pre-filled pen

Instructions for Use

Before using your new pen, please read the entire Instructions for Use section. Follow the instructions carefully when using the pen.

Also read the package leaflet included in the package.

Do not share your pen or needles, as this may pose a risk of transmitting infections.

Your pen contains enough medication for 28 days.

Always wash your hands before each injection. Prepare the injection site as instructed by your doctor or pharmacist.