FORSTEO 20 micrograms/80 microliters, injectable solution

2. What you need to know before you use FORSTEO

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

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 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 high levels of alkaline phosphatase in your blood without apparent reason, which could indicate that you have Paget's disease of the bone (a disease with abnormal bone changes). If you are not sure, 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 have continuous nausea, vomiting, constipation, low energy, or muscle weakness, tell your doctor. These may be symptoms of too much calcium in your blood.
• if you have kidney stones or a history of kidney stones.
• if you have kidney problems (moderate renal insufficiency), you should tell your doctor.

Some patients, after the first doses, may experience dizziness or an increase in heart rate. For the first doses, use FORSTEO in a place where you can sit or lie down immediately if you feel dizzy.

The recommended treatment time of 24 months should not be exceeded.

FORSTEO should not be used in growing adults.

Children and adolescents

FORSTEO should not be used in children and adolescents (under 18 years).

Other medicines and FORSTEO

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines, because occasionally interactions may occur (e.g., digoxin/digitalis, a medicine used to treat heart diseases).

Pregnancy and breastfeeding

Do not use FORSTEO if you are pregnant or breastfeeding. If you are a woman of childbearing age, you should use effective contraceptive methods during treatment with FORSTEO. If you become pregnant, treatment with FORSTEO should be discontinued. Consult your doctor or pharmacist before using any medicine.

Driving and using machines

Some patients may feel dizzy after the injection of FORSTEO. If you feel dizzy, do not drive or use machines until you feel better.

FORSTEO contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per dose; this is essentially "sodium-free".

3. How to use FORSTEO

Follow exactly the administration instructions of this medicine indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

The recommended dose is 20 micrograms administered once a day by subcutaneous injection in the thigh or abdomen. To help you remember to inject your medicine, inject it at the same time every day.

Inject FORSTEO every day for as long as your doctor prescribes it. The total duration of treatment with FORSTEO should not exceed 24 months. You should not receive more than one 24-month treatment cycle with FORSTEO in your lifetime.

FORSTEO can be injected at mealtime.

Consult the User Manual included in the package with instructions on how to use the FORSTEO pen.

No needles are included with the pen. Becton, Dickinson and Company needles can be used.

The injection of FORSTEO should be performed shortly after removing the pen from the refrigerator, as indicated in the User Manual. Return the pen to the refrigerator immediately after use. You should use a new needle for each injection and discard it after each 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 to take each day.

FORSTEO can 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.

The effects that could be expected from an overdose include nausea, vomiting, dizziness, and headache.

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

If you stop treatment with FORSTEO

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

If you have any other questions about the use of this medicine, ask your doctor or pharmacist.

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 limbs (very common, may affect more than 1 in 10 patients), discomfort, headache, and dizziness (common). If you feel dizzy after an injection, sit or lie down until you feel better. If it does 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 not, tell your doctor as soon as possible.

Some patients may have experienced allergic reactions shortly after injection, consisting of difficulty breathing, swelling of the face, rash, and chest pain (rare frequency). 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 patients

• increase in blood cholesterol levels
• depression
• neuralgic pain in the leg
• feeling of fainting
• irregular palpitations
• breathing difficulties
• increased sweating
• muscle cramps
• loss of energy
• fatigue
• chest pain
• low blood pressure
• heartburn (pain or burning sensation just below the breastbone)
• vomiting
• hiatus hernia (a condition where part of the stomach pushes up into the chest)
• 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 or involuntary loss of urine
• increased need to urinate
• weight gain
• kidney stones
• pain in the muscles and joints. Some patients have experienced severe back cramps or pain and had to be hospitalized.
• increase in blood calcium levels
• increase in blood uric acid levels
• increase in the levels of an enzyme called alkaline phosphatase.

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

• reduction in kidney function, including kidney failure
• swelling, mainly in the hands, feet, and legs.

Reporting of side effects

If you experience 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 through the national reporting system included in Appendix V. By reporting side 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 carton and pen after CAD and EXP respectively. The expiry date is the last day of the month stated.

FORSTEO should always be stored in a refrigerator (between 2°C and 8°C). You can use FORSTEO for 28 days after performing the first injection while the pen is stored in a refrigerator (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 is or has been frozen.

Each pen should be discarded after 28 days, even if it is not empty.

FORSTEO contains a clear and colorless solution. Do not use FORSTEO if it has solid particles or if the solution is cloudy or discolored.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Container Contents and Additional Information

FORSTEO Composition

• The active ingredient 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 injectable preparations. Additionally, a solution of hydrochloric acid and/or sodium hydroxide may have been added to adjust the pH.

Product Appearance and Container Contents

FORSTEO is a clear and colorless solution. It is presented in a cartridge included in a disposable pre-filled pen. Each pen contains 2.4 ml of solution sufficient for 28 doses. The pens are available in packages containing one or three pens. Only certain package sizes may be available.

Marketing Authorization Holder

Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, Netherlands

Manufacturer

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

You can request more information about this medication by contacting the local representative of the marketing authorization holder:

Date of Last Revision of this Leaflet:

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

The leaflet for this product can be found 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 injectable solution, pre-filled pen

Instructions for Use

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

Also, read the leaflet includedin the package.

Do not share your pen or needles as this may pose a risk of infection transmission.

Your pen contains medication for 28 days.

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