Livogiva 20 micrograms/80 microliters solution for injection in pre-filled pen: detailed information

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

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

teriparatide

Read the entire leaflet carefully before you start using this medicine, because it contains important information for you.

Keep this leaflet, as 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, and you should not give it to other people, even if they have the same symptoms as you, because it could harm them.
If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Contents of the leaflet

What Livogiva is and what it is used for
What you need to know before using Livogiva
How to use Livogiva
Possible adverse effects
How to store Livogiva
Contents of the pack and other information

1. What Livogiva is and what it is used for

Livogiva contains the active substance teriparatide, 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 your bones to weaken and become 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 Livogiva

Do not use Livogiva

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 your blood without apparent cause, which could indicate Paget's disease of the bone (a disease 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

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

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

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 suffer from 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 Livogiva in a place where you can immediately sit or lie down if you feel dizzy.

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

Children and adolescents

Livogiva must not be used in children and adolescents (under 18 years of age).

Other medicines and Livogiva

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 Livogiva if you are pregnant or breastfeeding. If you are a woman of childbearing age, you must use effective contraceptive methods during treatment with Livogiva. If you become pregnant, treatment with Livogiva must be discontinued. Consult your doctor or pharmacist before using any medicine.

Driving and using machines

Some patients may feel dizzy after injection of Livogiva. If you feel dizzy, you must not drive or operate machinery until you feel better.

Livogiva contains sodium

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

3. How to use Livogiva

Follow exactly the instructions for administration of this medicine as given by your doctor.

If in doubt, 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 use your medicine, inject it at around the same time each day.

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

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

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

Needles are not included with the pen. Pen needles of gauge 29–31 (diameter: 0.25–0.33 mm) may be used.

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 must use a new needle for each injection and dispose of it after each use. Do not store the pen with the needle attached. Never share your Livogiva pen with others.

Livogiva may be used with or without food.

If you use more Livogiva than you should

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

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

If you forget or are unable to inject Livogiva at the usual time, do so as soon as you can 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 compensate for a missed dose.

If you stop treatment with Livogiva

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

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience 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 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, 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 (uncommon frequency). Rarely, severe and potentially life-threatening allergic reactions may occur, including anaphylaxis.

Other adverse effects are:

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 indigestion (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
haemorrhoids (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 levels of calcium in the blood
increased levels of uric acid in the blood
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 type of adverse effect, consult 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 included in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Livogiva

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 under CAD and EXP respectively. The expiry date refers to the last day of the month indicated.

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

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

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

Livogiva contains a clear, colourless solution. Do not use Livogiva if it contains solid particles, or if the solution is cloudy or discoloured.

Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of any unused containers and medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Livogiva

The active substance is teriparatide. Each millilitre of injectable solution contains 250 micrograms of teriparatide. Each 2.7 ml pre-filled pen contains 675 micrograms of teriparatide (equivalent to 250 micrograms per millilitre).
The other components are glacial acetic acid, sodium acetate trihydrate, mannitol, metacresol, and water for injections. See section 2.

Appearance of the product and contents of the pack

Livogiva is a clear, colourless solution. It is supplied in a cartridge contained within a disposable pre-filled pen. Each pen contains 2.7 ml of solution, sufficient for 28 doses. Livogiva is available in packs containing one or three pre-filled pens.

Only certain pack sizes may be available.

Marketing Authorisation 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
The Netherlands

Date of the most recent revision of this leaflet

Other sources of information

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

INSTRUCTION MANUAL

Livogiva 20 micrograms/80 microlitres solution for injection in pre-filled pen

IMPORTANT INFORMATION

DO NOT start administration until you have carefully read the package leaflet and this instruction manual included in the Livogiva pack. Always follow the instructions carefully when using the Livogiva pen.

Livogiva Pen and its Parts

Pen needles of gauge 29-31 (diameter: 0.25-0.33 mm) may be used.

Needles are not included.

Medical diagram showing parts of an auto-injector: outer cap, white cap, inner cap, needle, tab, cartridge, label, body, and button

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 by pulling it straight off the device (Figure B).

A hand lifts a white protective cap off a pre-filled syringe following the direction of a black arrow pointing upward

Step 2

Check the pen, the pen label, and the medicine

Check the pen.

DO NOT use 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 NOT use it (Figure C).

Check the medicine cartridge. The liquid medicine should be clear and colourless.

If the medicine is cloudy, discoloured, or contains particles, DO NOT use it (Figure C).

Illustration showing an eye looking toward an injection pen held between thumb and index finger to verify correct positioning

Step 3

Attach a

new needle

Remove the paper tab (Figure D).

A hand holds a tilted glass vial while a

Attach the needle by pressing it directly onto the medication cartridge (Figure E).

Two hands hold a white injection pen with a gray arrow indicating sliding the cap to the left

Screw the needle on clockwise until firmly secured (Figure F). Do not overtighten the needle.

Two hands hold a white injection pen with a curved black arrow indicating rotating the cap counterclockwise

Step 4

Remove the

outer needle

cover

Remove the large outer needle cover (Figure G) and keep it for later (see Step 9).

Two hands bring together and connect the two parts of a medical injection pen for treatment with the drug indicated in Figure G

Step 5

Set the dose

Pull the black injection button until it stops

(Figure H).

Two hands hold a white and green cylindrical device with a black arrow indicating rotation to the right

Make sure the red band is visible.

In addition, the indicator window will show an arrow pointing toward the end of the pen needle (Figure I).

Technical diagram showing a green section with a triangular indicator window, a red band, and a yellow cylinder on a white background

Troubleshooting dose setting

If the pen cannot be fully set or you cannot pull the black injection button, refer to section Troubleshooting Problem E.

Administration of the injection

Step 6

Remove the

inner needle

cap.

Remove the small inner cap

from the needle and discard it (Figure J). The

needle will be exposed.

Two hands handling a syringe and a cap for the

Step 7 Inject the dose	Gently pinch the skin of the thigh or abdomen and insert the needle directly under the pinched skin (Figure K).
	Press the black-colored injection button until it stops and hold it down (Figure L).
	Keep holding it down and count slowly to 5 to ensure the full dose is administered (Figure M). You may not see the black injection button moving. To confirm the dose has been delivered, see step 8, "Confirm the dose".
	Remove the needle from the skin (Figure N). After removing the needle from the skin, remove your thumb from the black injection button.

After the injection

Step 8

Confirm the

dose.

Ensure that the black injection button has been fully depressed. The indicator window will display an arrow pointing TOWARDS the black button. If the yellow cylinder is not visible, you have successfully completed the injection steps (Figure O).

Important

DO NOT see any part of the yellow cylinder. If you do, and the medicine has already been injected, DO NOT inject a second dose on the same day.

Instead, YOU MUST re-prime the pen. See section Troubleshooting A.

Stylized icon of a cyan video camera with a yellow play button and a green checkmark positioned above the top part

Step 9 Remove the needle and dispose of it.	Place the large outer cap onto the needle and press (Figures P and Q). Do not attempt to recap the needle by hand.
Unscrew the needle completely by turning the large needle cap 3–5 full turns counterclockwise (Figure R).
Remove the needle (Figure S).
	Dispose of the needle in a puncture-resistant sharps container according to local regulations (Figure T). DO NOT reuse the needle.
Needle Disposal If you would like more information about proper needle disposal, refer to the section Information on Needle Disposal.

Step 10

Cover the

pen again and

store it.

Replace the white cap

(Figure U).

Two hands grip a white cylindrical medical device and separate it by pulling to the left as indicated by a black arrow

Always store the pen in the

refrigerator with the white cap

on after use (Figure V).

DO NOT store the pen with a

needle attached.

An injection pen with a green base is placed into an open refrigerator indicated by a gray arrow for storage

Troubleshooting
Problem	Solution
The yellow cylinder is still visible after pressing the black injection button. How do I reset my Livogiva pen?	To reset the Livogiva pen, follow the steps below: If you have already injected the medication, DO NOT inject a second dose on the same day. The next day, use a new needle for the injection. Remove the needle. Attach a new needle, remove the large outer cap from the needle and keep it. Remove the inner needle protector and discard it. Point the needle downward into an empty container. Press the black injection button until it stops. Hold it down and count slowly to 5. You may see a small spray or drop of liquid. When finished, the black injection button must be fully depressed. If you still see the yellow cylinder, do not use this pen and contact your doctor or pharmacist. Place the large outer needle cap back onto the needle. Unscrew the needle completely by turning the needle cap 3–5 full turns counterclockwise. 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 issue by always using a NEW needle for each injection and by pressing the black injection button fully and counting slowly to 5.
How can I tell if my Livogiva pen is working?	The Livogiva pen is designed to deliver the full dose each time it is used according to the instructions in the Instructions for Use section. The black injection button must be fully depressed to confirm that the Livogiva pen has delivered the complete dose of medication. Remember to use a new needle each time you inject to ensure your Livogiva pen functions properly.
I see an air bubble in my Livogiva pen.	A small air bubble will not affect your dose or harm you. You may continue administering your dose as usual.
I cannot remove the needle.	Place the large needle cap onto the needle. Use the large needle cap to unscrew the needle. Unscrew the needle completely by turning the large needle cap 3–5 full turns counterclockwise. If you still cannot remove the needle, ask someone to help you. Refer to step 9, "Remove and dispose of the needle."
What should I do if I cannot pull the black injection button?	Switch to a new Livogiva pen to administer your dose as instructed by your doctor or pharmacist. Difficulty pulling the black injection button indicates that there is no longer enough medication in the Livogiva pen for another dose. You may still see a small amount of medication in the cartridge.

Cleaning and storage

Cleaning of the Livogiva pen

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

Storage of the Livogiva pen

Read and follow the storage instructions for the pen provided in the Package Leaflet: Information for the user.

DO NOT store the Livogiva device with a needle attached, as this could compromise the sterility of the medicine during subsequent injections.
Store the Livogiva pen with the white cap in place.

If the Livogiva pen has been left outside the refrigerator, do not discard it. Return it to the refrigerator and contact your doctor or pharmacist.

Information on needle removal

Removing needles from the pen and the Livogiva pen

Before disposing of the Livogiva pen, make sure you have removed the needle from the pen.
Place used needles in a sharps container or a hard plastic container with a secure lid. Do not throw needles directly into the household waste container.
Do not recycle a sharps container once it is full.

Other points of interest

DO NOT transfer the medicine to a syringe.
During injection, you may hear one or more clicks; this is the normal functioning of the pen.
Use of the Livogiva pen by people who are blind or have visual impairments is not recommended unless they are assisted by someone trained in the proper use of the pen.

This user manual has been reviewed on: