Introduction

Label: information for the user

Livogiva 20 micrograms/80 microliters injectable solution in preloaded pen

teriparatida

This medicine is subject to additional monitoring, which will speed up the detection of new information about its safety. You can contribute by reporting any adverse effects you may experience. The final part of section 4 includes information on how to report these adverse effects.

Read this label carefully before starting to use this medicine, as it contains important information for you.

Keep this label, as you may need to read it again.
If you have any questions, consult your doctor or pharmacist.
This medicine has been prescribed only for you, and you should not give it to others even if they have the same symptoms as you, as it may harm them.
If you experience adverse effects, consult your doctor or pharmacist, even if they do not appear in this label. See section 4.

1. What is Livogiva and how is it used

Livogiva contains the active ingredient teriparatida, which is used to increase bone strength and reduce the risk of fractures by stimulating bone formation.

Livogiva is used for the treatment of osteoporosis in adults. Osteoporosis is a disease that causes bones to wear away and become fragile. This disease is especially common in women after menopause, but it can also occur in men. Osteoporosis is also common in patients treated with corticosteroids.

2. What you need to know before starting to use Livogiva

No use Livogiva

If you are allergic to teriparatide or any of the other components of this medication (listed in section 6).
If you have high levels of calcium in your blood (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 a clear explanation, which could indicate that you have Paget's disease of the bone (a disease with 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

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

Consult your doctor or pharmacist before starting to use or while using Livogiva:

If you have persistent 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), tell your doctor.

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

The recommended treatment duration of 24 months should not be exceeded. Livogiva should not be used in growing adults.

Children and adolescents

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

Other medications and Livogiva

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication, as occasional interactions may occur (e.g., digoxin/digitals, a medication used to treat heart diseases).

Pregnancy and breastfeeding

Do not use Livogiva if you are pregnant or breastfeeding. If you are a fertile woman, you should use effective contraceptive methods during treatment with Livogiva. If you become pregnant, treatment with Livogiva should be discontinued. Consult your doctor or pharmacist before using any medication.

Driving and operating machines

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

Livogiva contains sodium

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

3. How to use Livogiva

Follow exactly the administration instructions for this medication as indicated by your doctor.

If in doubt, consult your doctor or pharmacist again.

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

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

Your doctor may recommend using Livogiva with calcium and vitamin D. Your doctor will tell you how much to take each day.

Refer to the User Manual included in the package with instructions on how to use the Livogiva pen.

Needles are not included with the pen. You can use needles for pens with a gauge of 29-31 (diameter: 0.25-0.33 mm).

The Livogiva 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. 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 Livogiva pen with others.

Livogiva can be used with or without food.

If you use more Livogiva than you should

If you accidentally administer more Livogiva than prescribed, consult your doctor or pharmacist.

Expected effects of an overdose may include nausea, vomiting, dizziness, and headache.

If you forget or are unable to inject Livogiva at the usual time, do it as soon as possible thatsame day. Do not administer a double dose to compensate for missed doses. Do not inject more than once in the same day. Do not attempt to compensate for the missed dose.

If you interrupt treatment with Livogiva

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

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

4. Possible Adverse Effects

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

The most common side effects are pain in the extremities (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 you 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 skin redness, pain, swelling, itching, bruises, or light 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 just after the injection, which consist of difficulty breathing, facial swelling, skin 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
nerve pain in the leg
sensation of fainting
irregular heart palpitations
difficulty breathing
increased sweating
muscle cramps
loss of energy
fatigue
chest pain
low blood pressure
heartburn (pain or burning sensation just below the sternum)
vomiting
hernia of the tube that carries food to the stomach
low hemoglobin or low red blood cell count (anemia)

Uncommon: may affect up to 1 in 100 patients

increased heart rate
abnormal heart sound
shortness of breath
hemorrhoids (piles)
accidental loss or leakage 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 levels of an enzyme called alkaline phosphatase.

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

kidney function reduction, including renal insufficiency
swelling, mainly in the hands, feet, and legs.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the national notification system included in thescheme in theAppendix V.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

5. Livogiva Storage

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging and the pen after CAD and EXP respectively. The expiration date is the last day of the month indicated.

Livogiva must be stored always in the refrigerator (between 2°C and 8°C). Livogiva can be used for 28 days after the first injection while the pen is stored in the refrigerator (between 2°C and 8°C).

Avoid placing the pens near the freezer of the refrigerator to prevent their freezing. Do not use Livogiva if it is or has been frozen.

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

Livogiva contains a transparent and colorless solution. Do not use Livogiva if it has solid particles or if the solution is cloudy or colored.

Medicines should not be thrown down the drain or in the trash. Ask your pharmacist how to dispose of the packaging and the medications that you no longer need. This way, you will help protect the environment.

6. Contents of the packaging and additional information

Composition of Livogiva

The active principle is teriparatide. Each milliliter of injectable solution contains 250 micrograms of teriparatide. Each preloaded pen of 2.7 ml contains 675 micrograms of teriparatide (equivalent to 250 micrograms per milliliter).
The other components are glacial acetic acid, sodium trihydrate acetate, mannitol, metacresol, and water for injectable preparations. See Section 2.

Appearance of the product and contents of the package

Livogiva is a transparent and colorless solution. It is presented in a cartridge included in a disposable preloaded pen. Each pen contains 2.7 ml of solution sufficient for 28 doses. Livogiva is available in packages containing one or three preloaded pens.

Only some package sizes may be available.

Marketing Authorization Holder

Theramex Ireland Limited

3rd Floor Kilmore House, Park Lane, Spencer Dock

DO1 YE64 Dublin 1

Ireland

Manufacturer

Eurofins PROXY Laboratories (PRX)

Archimedesweg 25 2333 CM Leiden

Netherlands

Last review date of this leaflet

Other sources of information

The detailed information on this medicine is available on the website of the European Medicines Agencyhttp://www.ema.europa.eu/.

USER MANUAL

Livogiva 20 micrograms/80 microliters injectable solution in preloaded pen

IMPORTANT INFORMATION

DO NOTstart administering until you have read this leaflet and the user manual contained in the Livogiva box. Always use the Livogiva pen carefully following the instructions.

Livogiva pen and its parts

Needles for the pen of caliber 29-31 (diameter: 0.25-0.33 mm) can be used.

The needles are not included.

Instructions for use

Preparation of the injection

Step 1

Prepare the injection site and remove the white cap.

Wash your hands before each injection.
Prepare the injection site (thigh or abdomen) as instructed by your doctor or pharmacist.
Remove the white cap, pulling it straight off the device (Figure B).

Step 2

Check the pen, the pen label, and the medicine

Check the pen.

DO NOTuse the Livogiva pen if it is damaged.

Check the pen label.

If the pen does not contain the correct medicine or the medicine has expired,DO NOTuse it (Figure C).

Check the medicine cartridge. The liquid medicine must be transparent and colorless.

If the medicine is cloudy, colored, or contains particles in suspension,DO NOTuse it (Figure C).

Step 3

Place a new needle

Remove the paper wiper (Figure D).

Place the needle by pressing itdirectlyinto the medicine cartridge (Figure E).

Twist the needle clockwise until it is securely fixed (Figure F).Do notover-tighten the needle.

Step 4

Remove the outer needle cap

Remove the large outer needle cap, pulling it straight off the needle (Figure G) andsave it for later(see Step 9).

Step 5

Adjust the dose

Pullthe black injection button until it stops (Figure H).

Make sureyou see the red band.

The dose indicator window will show an arrow pointing towards the end of the needle (Figure I).

Resolving issues with dose adjustment

If the pen cannot be fully adjusted or the black injection button cannot be pulled, see theProblem Resolution Esection.

Administration of the injection

Step 6

Remove the inner needle shield

Removethe small inner needle shield and dispose of it (Figure J). The needle will be exposed.

Step 7 Inject the dose	Pinch the skin of the thigh or abdomen and insert the needle directly under the pinched skin (Figure K).
	Press the black injection button until it stops and keep it pressed (Figure L).
	Keep it pressed andcount slowly to 5to ensure that the entire dose is administered (Figure M). You may not see the black injection button move. To confirm that you have administered the dose, see the Step 8 "Confirm the dose" section.
	Remove the needle from the skin (Figure N). Once the needle is removed from the skin, remove your finger from the black injection button.

After the injection

Step 8

Confirm the dose

Make surethe black injection button has been fully inserted. The dose indicator window will show an arrow pointing towards the black injection button.

If you do not see the yellow cylinder, you have completed the injection steps correctly (Figure O).

Important

DO NOTsee any part of the yellow cylinder. In this case, and if you have already administered the medicine,DO NOTinject a second dose on the same day.

Instead,YOU MUST re-adjust the pen.See theProblem Resolution Asection.

Step 9 Remove the needle and dispose of it	Place the large outer needle cap on the needle and press (Figures P and Q). Do not try to put the needle cap back on with your hands.
	Twist the needle off completely by giving it 3-5 full turns in the opposite direction of the clock (Figure R).
	Remove the needle (Figure S).
	Dispose of the needle in a puncture-proof container according to local regulations (Figure T). DO NOTre-use the needle.
Needle disposal For more information on the proper disposal of the needle, see theNeedle Disposal Informationsection.

Step 10

Cover the pen again and store it

Replace the white cap (Figure U).

Always store the pen in the refrigerator with the white cap on after use (Figure V).

DO NOTstore the pen with a needle attached.

Problem Resolution
Problem	Solution
The yellow cylinder is still visible after pressing the black injection button. How do I re-adjust my Livogiva pen?	To re-adjust the Livogiva pen, follow these steps: 1)If you have already administered the medicine,DO NOTinject a second dose on the same day. The next day, use a new needle for the injection. 2)Remove the needle. 3)Fix a new needle, remove the large outer needle cap, and save it. 4)Remove the inner needle shield and dispose of it. 5)Point the needle downwards in an empty container. Press the black injection button until it stops. Keep it pressed and count slowly to 5. You may observe a small bubble or drop of liquid.When you are finished, the black injection button should be fully inserted. 6)If you still see the yellow cylinder, do not use this pen and contact your doctor or pharmacist. 7)Place the large outer needle cap on the needle. Twist the needle off completely by giving it 3-5 full turns in the opposite direction of the clock. Remove the needle cap and dispose of it as instructed by your doctor or pharmacist. Replace the white cap and store the Livogiva pen in the refrigerator. You can avoid this problemby always using a new needle for each injection and pressing the black injection button until it stops and counting slowly to 5.
How can I know if my Livogiva pen is working?	The Livogiva pen is designed to deliver the full dose each time it is used, following the instructions in theInstructions for Usesection. The black injection button must be fully inserted to confirm that the Livogiva pen has delivered the full dose of medicine. Remember to use a new needle each time you inject to ensure that your Livogiva pen is working correctly.
I see a bubble of air in my Livogiva pen.	A small bubble of air will not affect your dose or harm you. You can continue with your usual dose administration.
I cannot remove the needle.	1)Place the large outer needle cap on the needle. 2)Use the large outer needle cap to twist the needle off. 3)Twist the needle off completely by giving it 3-5 full turns in the opposite direction of the clock. 4)If you still cannot remove the needle, ask someone to help you. See the Step 9 "Remove the needle and dispose of it" section.
What should I do if I cannot pull the black injection button?	Change to a new Livogiva pen to administer the dose as instructed by your doctor or pharmacist. When it is difficult to pull the black injection button, it means that there is not enough medicine in the Livogiva pen for another dose. You may still see some medicine in the cartridge.

Cleaning and Storage

Cleaning the Livogiva pen

Clean the exterior of the Livogiva pen with a damp cloth.
Do not submerge the pen in water or clean it with any liquid.

Storage of the Livogiva pen

Read and follow the storage instructions for the pen in theLeaflet: Information for the User.
DO NOTstore the device with a needle attached, as this may affect the sterility of the medicine during subsequent injections.
Store the Livogiva pen with the white cap on.

If you have left the Livogiva pen outside the refrigerator, do not dispose of it. Put it back in the refrigerator and contact your doctor or pharmacist.

Needle Disposal Information

Disposal of needles from the pen and the Livogiva pen

Before disposing of the Livogiva pen, make sure you have removed the needle from the pen.
Deposit used needles in a puncture-proof container or a hard plastic container with a secure closure. Do not throw the needles directly in the household trash.
Do not recycle the container filled with sharp objects.

Other points of interest

DO NOTtransfer the medicine to a syringe.
During the injection, you may hear one or more clicks; this is the normal functioning of the pen.
It is not recommended to use the Livogiva pen by people who are blind or have vision difficulties without the help of a trained person in the proper use of the pen.

This user manual has been revised in: