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LIVOGIVA 20 micrograms/80 microliters Injectable Solution in Pre-filled Pen

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About the medicine

How to use LIVOGIVA 20 micrograms/80 microliters Injectable Solution in Pre-filled Pen

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This page provides general information and does not replace a doctor’s consultation. Always consult a doctor before taking any medication. Seek urgent medical care if symptoms are severe.

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Contents of the leaflet

  1. Introduction
  2. What is Livogiva and what is it used for
  3. What you need to know before you use Livogiva
  4. How to use Livogiva
  5. Possible side effects
  6. Storage of Livogiva
  7. Container Contents and Additional Information

Introduction

Package Leaflet: Information for the User

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

teriparatide

This medicinal product is subject to additional monitoring, which will allow for quick identification of new safety information. You can help by reporting any side effects you may get. The last section of this leaflet includes information on how to report side effects.

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 further questions, ask your doctor or pharmacist.
  • This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
  • If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

1. What is Livogiva and what is it 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 makes your bones waste 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.

Doctor consultation

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2. What you need to know before you use Livogiva

Do not use Livogiva

  • 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 in your blood (pre-existing hypercalcaemia).
  • if you have severe kidney problems.
  • if you have been diagnosed with bone cancer or other types of cancer that have spread 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 any 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

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 have 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 have 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 feel dizzy or have an increased heart rate. For the first doses, use Livogiva in a place where you can sit or lie down immediately if you feel dizzy.

The recommended treatment period 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 of age).

Other medicines and Livogiva

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 Livogiva if you are pregnant or breastfeeding. If you are a woman of childbearing age, 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 medicine.

Driving and using machines

Some patients may feel dizzy after injecting Livogiva. If you feel dizzy, do not drive or use machines until you feel better.

Livogiva contains sodium

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

3. How to use Livogiva

Follow exactly the administration instructions of this medicine as 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 use your medicine, inject yourself at the same time every day.

Inject Livogiva every day for as long as your doctor prescribes it. 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 in your lifetime.

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

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

No needles are included with the pen. Needles for pens of 29-31 gauge (diameter: 0.25-0.33 mm) can be used.

The injection of Livogiva should be performed shortly after removing the pen from the refrigerator, as indicated in the User Manual. Put the pen back in 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 have accidentally administered more Livogiva 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 Livogiva at the usual time, do it as soon as you can that 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 Livogiva

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

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

Medicine questions

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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 immediately 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
  • difficulty breathing
  • 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 sound
  • 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 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 pack and the pen after CAD and EXP respectively. The expiry date is the last day of the month stated.

Livogiva should be stored in a refrigerator (between 2°C and 8°C). You can use Livogiva for 28 days after the first injection, while the pen is stored in a 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.

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

Livogiva contains a clear and colorless solution. Do not use Livogiva 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

Livogiva Composition

  • The active ingredient is teriparatide. Each milliliter 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 milliliter).
  • The other components are glacial acetic acid, sodium acetate trihydrate, mannitol, metacresol, and water for injectable preparations. See section 2.

Product Appearance and Container Contents

Livogiva is a clear and colorless solution. It is presented in a cartridge included in a pre-filled disposable 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 some pack 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

Date of Last Revision of this Leaflet

Other Sources of Information

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

INSTRUCTIONS FOR USE

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

IMPORTANT INFORMATION

DO NOTstart administration until you have carefully read the leaflet and this instructions manual contained in the Livogiva box. Whenever you use the Livogiva pen, follow the instructions carefully.

Livogiva Pen and its Parts

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

Needles are not included.

Injector device with transparent medication cartridge, blue-green body, and yellow indicator window, showing parts such as caps and needle

Instructions for Use

Preparing the Injection

Step 1

Prepare the injection site and remove the white cap.

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

Hand holding an auto-injector with exposed needle and black arrow indicating injection direction

Step 2

Check the pen, pen label, and medication

  1. Check the pen.

DO NOTuse the Livogiva pen if it is damaged.

  1. Check the pen label.

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

  1. Check the medication cartridge. The liquid medication should be transparent and colorless.

If the medication is cloudy, has color, or contains particles in suspension, DO NOTuse it (Figure C).

Blue and white auto-injector device in hand holding injection on the side of the abdomen with arrow indicating direction

Step 3

Attach a new needle

  1. Remove the paper tab (Figure D).

Hands holding a medication vial with inserted needle and arrow indicating direction of withdrawal

  1. Attach the needle by pressing it directlyonto the medication cartridge (Figure E).

Hand holding an auto-injector with visible transparent needle and arrow indicating injection direction

Screw the needle clockwise until it is securely attached (Figure F). Do notovertighten the needle.

Hand holding a white auto-injector with dosing marks and arrow indicating injection direction on light skin

Step 4

Remove the outer needle cap

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

Hand holding an auto-injector with visible needle and shadow indicating injection point on skin

Step 5

Adjust the dose

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

Hands holding a device applicator with yellow button and arrow indicating injection direction

Make surethe red band is visible.

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

Auto-injector device with yellow cylinder and triangular indicator window inside a green and black body

Troubleshooting when adjusting the dose

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

Administering the Injection

Step 6

Remove the inner needle cap.

Removethe small inner needle cap and discard it (Figure J). The needle will be exposed.

Syringe with connected needle and purple adapter, showing insertion into skin with arrow indicating direction

Step 7

Inject the dose

  1. Gently pinch the skin of your thigh or abdomen and insert the needle directly under the pinched skin (Figure K).

Hand holding a green and white auto-injector pressed against the arm with arrow indicating injection direction

  1. Press the black injection button until it stops and hold it (Figure L).

Hand pressing a green and white auto-injector against the arm skin with arrow indicating direction

  1. Hold it and slowly count to 5to ensure the full dose is administered (Figure M). You may not see the black injection button move. To confirm you have administered the dose, refer to Step 8 «Confirm the dose».

Hand holding a green and white auto-injector against the arm skin with ascending numeric marks in a brown oval

  1. Remove the needle from the skin (Figure N). Once the needle is removed from the skin, release the black injection button.

Hand holding a green and white auto-injector with black arrow pointing up and human skin below

After the Injection

Step 8

Confirm the dose.

Make surethe black injection button has been pushed in all the way. The indicator window will show an arrow pointing TOWARDSthe black button.

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

Important

DO NOTsee any part of the yellow cylinder. If you do and you have already injected the medication, DO NOTinject a second dose on the same day.

Instead, YOU MUST re-adjust the pen. Refer to the Troubleshooting A section.

Auto-injector device with yellow triangular button inside a green square and green checkmark

Step 9

Remove the needle and discard it.

  1. Place the large outer needle cap onto the needle and press (Figures P and Q). Do not attempt to replace the needle cap with your hands.

Hand holding a pre-filled syringe with connected needle and arrow indicating direction of plunger withdrawal

  1. Completely unscrew the needle by giving the large needle cap 3-5 full turns in the counter-clockwise direction (Figure R).

Hands holding a pre-filled injection device with arrows indicating rotation and plunger push

Remove the needle (Figure S).

Hand holding a syringe with connected needle, showing injection and dosing graduation on the transparent cylinder

  1. Discard the needle in a puncture-resistant container for sharp objects according to local regulations (Figure T).

DO NOT reuse the needle.

Finger pressing a used needle towards a red container for sharp objects with biohazard symbol and SHARPS CONTAINER label

Needle Disposal

If you need more information on proper needle disposal, refer to the Information on Needle Disposal section.

Step 10

Cover the pen and store it.

  1. Replace the white cap (Figure U).

Hand holding a white auto-injector with black arrow indicating injection direction and viewing window

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

DO NOTstore the Livogiva pen with a needle attached, as this could affect the sterility of the medication during subsequent injections.

Injectable pen with arrow pointing towards the inside of a double-door stainless steel refrigerator

Troubleshooting

Problem

Solution

  1. 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 injected the medication, do not inject a second dose on the same day. The next day, use a new needle for the injection.
  2. Remove the needle.
  3. Attach a new needle, remove the large outer needle cap, and save it.
  4. Remove the small inner needle cap and discard it.
  5. Point the needle downwards into an empty container. Press the black injection button until it stops. Hold it and count slowly to 5. You may observe a small spurt or drop of liquid. When you are finished, the black injection button should be pushed in all the way.
  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 onto the needle. Completely unscrew the needle by giving the needle cap 3-5 full turns in the counter-clockwise direction. Remove the needle cap and discard it as your doctor or pharmacist has instructed. Replace the white cap and store the Livogiva pen in the refrigerator.

You can avoid this problem by always using a NEW needle for each injection and pressing the black injection button all the way and counting slowly to 5.

  1. How can I tell if my Livogiva pen is working?

The Livogiva pen is designed to inject the full dose each time it is used by following the instructions in the Instructions for Usesection.

The black injection button must be pushed in all the way to confirm that the Livogiva pen has injected the full dose of medication. Remember to use a new needle each time you inject to ensure your Livogiva pen is working correctly.

  1. I see an air bubble in my Livogiva pen.

A small air bubble will not affect your dose or harm you. You can proceed with administering your dose as usual.

  1. I cannot remove the needle.
  1. Place the large needle cap onto the needle.
  2. Use the large needle cap to unscrew the needle.
  3. Completely unscrew the needle by giving the large needle cap 3-5 full turns in the counter-clockwise direction.
  4. If you still cannot remove the needle, ask someone for help.

Refer to Step 9 «Remove the needle and discard it».

  1. 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.

When it is hard to pull the black injection button, it means there is not enough medication left in the Livogiva pen for another dose. You may still see some medication in the cartridge.

Cleaning and Storage

Cleaning the Livogiva Pen

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

Storing the Livogiva Pen

  • Read and follow the storage instructions for the pen in the Patient Information Leaflet.
  • DO NOTstore the Livogiva device with a needle attached, as this could affect the sterility of the medication during subsequent injections.
  • Store the Livogiva pen with the white cap on.

If you have left the Livogiva pen out of the refrigerator, do not discard it. Return it to the refrigerator and contact your doctor or pharmacist.

Information on Needle Disposal

Disposal of the Pen Needle and Livogiva Pen

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

Other Points of Interest

  • DO NOTtransfer the medication to a syringe.
  • During injection, you may hear one or more clicks; this is the normal operation of the pen.
  • The use of the Livogiva pen by blind or visually impaired individuals without the assistance of a trained person in the proper use of the pen is not recommended.

This user manual was revised on:

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Dermatology 21 years exp.

Dr Tomasz Grzelewski is an MD, PhD specialist in allergy, paediatrics, general practice and sports medicine, with a clinical focus on dermatology, endocrinology, allergology and sports-related health. He has more than 20 years of clinical experience and completed his medical training at the Medical University of Łódź, where he defended his PhD thesis with distinction. His doctoral research was recognised by the Polish Society of Allergology for its innovative contribution to the field. Throughout his career, he has gained extensive expertise in diagnosing and managing a wide range of allergic and paediatric conditions, including modern allergen desensitisation techniques.

For five years, Dr Grzelewski served as the Head of two paediatric departments in Poland, managing complex clinical cases and leading multidisciplinary teams. He also worked in medical centres in the United Kingdom, gaining experience across both primary care and specialist environments. With over a decade of telemedicine experience, he has provided online consultations across Europe and is valued for his clear, structured and evidence-based medical guidance.

Dr Grzelewski is actively involved in clinical programmes focused on modern anti-allergic therapies. As a Principal Investigator, he leads research projects on sublingual and oral allergen desensitisation, supporting evidence-based progress in allergy treatment for both children and adults.

In addition to his background in allergology and paediatrics, he completed dermatology studies through the Cambridge Education Group (Royal College of Physicians of Ireland) and a Clinical Endocrinology course at Harvard Medical School. This advanced training enhances his ability to manage skin manifestations of allergies, atopic conditions, urticaria, endocrine-related symptoms and complex immunological reactions.

Patients commonly seek his care for:

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Dr Tomasz Grzelewski is known for his clear communication style, structured medical approach and ability to explain treatment options in a concise and accessible way. His multidisciplinary background across allergy, paediatrics, dermatology and endocrinology allows him to provide safe, up-to-date and comprehensive care for patients of all ages.
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Dr Reznychenko offers a clear, attentive and professional approach. Her consultations help prevent minor discomforts from developing into more serious concerns – all in a convenient online format.
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Dr. Mar Tabeshadze is a licensed endocrinologist and general practitioner in Spain. She provides online consultations for adults, offering medical support for a wide range of endocrine conditions and related health concerns.

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Dr Anna Biriukova is an internal medicine doctor with clinical experience in cardiology, endocrinology, and gastroenterology. She provides online consultations for adults, offering expert medical support for heart health, hormonal balance, digestive issues, and general internal medicine.

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Dr. Horobets combines evidence-based medicine with a patient-centred approach. He carefully evaluates each patient’s medical history and symptoms, offering clear explanations and structured treatment plans adapted to individual needs.

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Dr Neshta applies current clinical guidelines and diagnostic tools, offering medical support adapted to each patient’s individual needs — all in an accessible online format.
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Frequently Asked Questions

Is a prescription required for LIVOGIVA 20 micrograms/80 microliters Injectable Solution in Pre-filled Pen?
LIVOGIVA 20 micrograms/80 microliters Injectable Solution in Pre-filled Pen requires a prescription in Spain. You can check with a doctor online whether this medicine may be appropriate for your situation.
What is the active substance in LIVOGIVA 20 micrograms/80 microliters Injectable Solution in Pre-filled Pen?
The active ingredient in LIVOGIVA 20 micrograms/80 microliters Injectable Solution in Pre-filled Pen is teriparatide. This information helps identify medicines with the same composition but different brand names.
How much does LIVOGIVA 20 micrograms/80 microliters Injectable Solution in Pre-filled Pen cost in pharmacies?
The average pharmacy price for LIVOGIVA 20 micrograms/80 microliters Injectable Solution in Pre-filled Pen is around 252.16 EUR. Prices may vary depending on the manufacturer and dosage form.
Who manufactures LIVOGIVA 20 micrograms/80 microliters Injectable Solution in Pre-filled Pen?
LIVOGIVA 20 micrograms/80 microliters Injectable Solution in Pre-filled Pen is manufactured by Theramex Ireland Limited. Pharmacy brands and packaging may differ depending on the distributor.
Which doctors can assess the use of LIVOGIVA 20 micrograms/80 microliters Injectable Solution in Pre-filled Pen online?
Doctors such as Family doctors, Psychiatrists, Dermatologists, Cardiologists, Endocrinologists, Gastroenterologists, Pulmonologists, Nephrologists, Rheumatologists, Hematologists, Infectious disease physicians, Allergists, Geriatricians, Paediatricians, Oncologists may assess whether LIVOGIVA 20 micrograms/80 microliters Injectable Solution in Pre-filled Pen is appropriate, depending on your situation and local regulations. You can book an online consultation to discuss your symptoms and possible next steps.
What are the alternatives to LIVOGIVA 20 micrograms/80 microliters Injectable Solution in Pre-filled Pen?
Other medicines with the same active substance (teriparatide) include DURATIL 20 micrograms/80 microliters Injectable Solution in Pre-filled Pen, FORSTEO 20 micrograms/80 microliters, injectable solution, MOVYMIA 20 micrograms/80 microliters Injectable Solution. These may have different brand names or formulations but contain the same therapeutic ingredient. Always consult a doctor before switching or starting a new medicine.
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