Livogiva - patient leaflet, side effects, dosage

1. What Livogiva is and what it is used for

Livogiva contains the active substance teriparatide that is used to make the bones stronger, and to reduce the risk of fractures by stimulating bone formation.

Livogiva is used to treat osteoporosis in adults. Osteoporosis is a disease that causes your bones to become thin and fragile.This disease is especially common in women after the menopause, but it can also occur in men. Osteoporosis is also common in patients receiving corticosteroids.

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 suffer from high calcium levels (pre-existing hypercalcaemia).
• if you suffer from serious kidney problems.
• if you have ever been diagnosed with bone cancer or other cancers that have spread (metastasised) to your bones.
• if you have certain bone diseases. If you have a bone disease, tell your doctor.
• if you have unexplained high levels of alkaline phosphatase in your blood, which means you

might have Paget’s disease of bone (disease with abnormal bone changes). If you are not sure, ask your doctor.

• if you have had radiation therapy involving your bones.
• if you are pregnant or breast-feeding.

Warnings and precautions

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

Talk to your doctor or pharmacist before or while using Livogiva:

• if you have continuing nausea, vomiting, constipation, low energy, or muscle weakness. These may be signs there is 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 impairment).

Some patients get dizzy or get a fast heartbeat after the first few doses. For the first doses, inject Livogiva where you can sit or lie down right away if you get dizzy.

The recommended treatment time 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 (less than 18 years).

Other medicines and Livogiva

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, because occasionally they may interact (e.g. digoxin/digitalis, a medicine used to treat heart disease).

Pregnancy and breast-feeding

Do not use Livogiva if you are pregnant or breast-feeding. If you are a woman of child-bearing potential, you should use effective methods of contraception during use of Livogiva. If you become pregnant, Livogiva should be discontinued. Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

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

Livogiva contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium-free’.

3. How to use Livogiva

Always use this medicine exactly as your doctor has told you to. Check with your doctor or pharmacist if you are not sure.

The recommended dose is 20 micrograms given once daily by injection under the skin (subcutaneous injection) in the thigh or abdomen. To help you remember to use your medicine, inject it at about the same time each day.

Inject Livogiva each day for as long as your doctor prescribes it for you. The total duration of treatment with Livogiva should not exceed 24 months. You should not receive more than one treatment course of 24 months over your lifetime.

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

Read the user manual, which is included in the carton for instructions on how to use the Livogiva pen.

Injection needles are not included with the pen. Pen needles 29 to 31 gauge (diameter 0.25–0.33 mm) can be used.

You should use your Livogiva injection shortly after you take the pen out of the refrigerator as described in the user manual. Put the pen back into the refrigerator immediately after you have used it. Use a new injection needle for each injection and dispose of it after each use. Never store your pen with the needle attached. Never share your Livogiva pen with others.

Livogiva can be given with or without food.

If you use more Livogiva than you should

If, by mistake, you have used more Livogiva than you should, contact your doctor or pharmacist.

The effects of overdose that might be expected include nausea, vomiting, dizziness, and headache.

If you forget or cannot take Livogiva at your usual time , use it as soon as possible on that day. Do not use a double dose to make up for a forgotten dose. Do not use more than one injection in the same day. Do not try to make up for a missed dose.

If you stop taking Livogiva

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

If you have any further questions on 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 limb (frequency is very common, may affect more than 1 in 10 people) and feeling sick, headache and dizziness (frequency is common). If you become dizzy (light-headed) after your injection, you should sit or lie down until you feel better. If you do not feel better, you should call a doctor before you continue treatment. Cases of fainting have been reported in association with teriparatide use.

If you experience discomfort such as redness of the skin, pain, swelling, itching, bruising or minor bleeding around the area of the injection (frequency is common), this should clear up in a few days or weeks. Otherwise tell your doctor as soon as possible.

Some patients may have experienced allergic reactions soon after injection, consisting of breathlessness, swelling of the face, rash and chest pain (frequency is rare). In rare cases, serious and potentially life-threatening allergic reactions including anaphylaxis can occur.

Other side effects include:

Common: may affect up to 1 in 10 people

• increase in blood cholesterol levels
• depression
• neuralgic pain in the leg
• feeling faint
• irregular heart beats
• breathlessness
• increased sweating
• muscle cramps
• loss of energy
• tiredness
• chest pain
• low blood pressure
• heartburn (painful or burning sensation just below the breast bone)
• being sick (vomiting)
• a hernia of the tube that carries food to your stomach

low haemoglobin or red blood cell count (anaemia)

Uncommon: may affect up to 1 in 100 people

• increased heart rate
• abnormal heart sound
• shortness of breath
• haemorrhoids (piles)
• accidental loss or leakage of urine
• increased need to pass water
• weight increase
• kidney stones
• pain in the muscles and pain in the joints. Some patients have experienced severe back cramps or pain which lead to hospitalization.
• increase in blood calcium level
• increase in blood uric acid level
• increase in an enzyme called alkaline phosphatase.

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

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

Reporting of side effects

If you get 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 via the national reporting system listed in By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store 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 after EXP. The expiry date refers to the last day of that month.

Livogiva should be stored in a refrigerator (2°C to 8°C) at all times. You can use Livogiva for up to 28 days after the first injection, as long as the pen is stored in a refrigerator (2°C to 8°C).

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

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

Livogiva contains a clear and colourless solution. Do not use Livogiva if solid particles appear or if the solution is cloudy or coloured.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.

6. Contents of the pack and other information

What Livogiva contains

• – The active substance is teriparatide. Each milliliter of the solution for injection contains 250 micrograms of teriparatide. Each pre-filled pen of 2.7 mL contains 675 micrograms of teriparatide (corresponding to 250 micrograms per mL).

• – The other ingredients are glacial acetic acid, sodium acetate trihydrate, mannitol, metacresol, and water for injections. See section 2.

What Livogiva looks like and contents of the pack

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

Not all 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

Netherlands

This leaflet was last revised in

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site:.

USER MANUAL

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

IMPORTANT INFORMATION

DO NOT start the administration procedure until you have read the Package leaflet and this User Manual contained in your Livogiva carton thoroughly. Follow the instructions carefully whenever using the Livogiva pen.

Instructions for use

Prepare for injection

• A) Wash your hands before every injection.

• B) Prepare the injection site (thigh or abdomen) as recommended by your doctor or pharmacist.

• C) Remove the white cap by pulling it straight off the device (Figure B).

  
  

  Step 2	A)	Check the pen.
  Check pen, pen label and medicine	B)	DO NOT use the Livogiva pen if it is damaged.  Check the label on the pen.
  	C)	DO NOT use if the pen ^'11111 ■iQfl contains the incorrect medicine or if the medicine has expired Figure c (Figure C). Check the medicine cartridge. The liquid medication should be clear and colourless. DO NOT use the medicine if it is cloudy, coloured, or has floating particles. (Figure C).

  Step 3 Attach new needle	A)	Peel off the paper tab (Figure D).	i J\ FigureD
  	B)	Push needle straight onto medicine cartridge (Figure E).	^~lm 11 ■ T zpTr Figure E
  		Screw on needle clockwise until firmly attached (Figure F). z Do not over-tighten the needle.	mil’
  			Figure F

  Step 4 Remove outer needle cover	Pull off large outer needle cover (Figure G) and save it for later (see Step 9).	!
  		□
  		Figure G

  Step 5 Set dose

  
  

Pull out the black injection button until it stops. (Figure H).

Check to make sure red stripe shows. Additionally, the instruction window will show an arrow pointing towards the needle end of the pen (Figure I).

Troubleshooting when setting the dose

If the pen does not set fully or if you cannot pull back on the black injection button refer to Troubleshooting Problem E.

Administer injection

Step 6 Pull off small inner needle protector and

Remove inner throw it away (Figure J). The needle will needle cover be exposed.

• A) Gently hold a fold of skin on your thigh or abdomen and insert the needle straight into the folded skin (Figure K).

  
  

• B) Press the black injection button down until it stops and hold (Figure L).

  Figure L

  
  

• C) Hold it in and count to 5 s-l-o-w-l-y to make sure the full dose has been delivered (Figure M). You may not see the black injection button moving. To confirm that your dose has been delivered, see step 8 “Confirm dose”.

  Figure IV1

  
  

• D) Remove the needle from the skin (Figure N). Once needle is removed from skin, take your thumb off the black injection button.

  
  

  After injection

  
  

  Step 8

  Confirm dose

  
  

Check to make sure the black injection button is all the way down. The instruction window will show an arrow pointing TOWARDS the black button.

If the yellow shaft does not show, you have finished the injection steps the right way. (Figure O)

Important

You should NOT see any of the yellow shaft. If you do and have already

injected the medicine, DO NOT inject yourself a second time in the same day.

Instead, you MUST reset the pen. Go to Troubleshooting Problem A

• A) Put the large outer needle cover on the needle by scooping it up and pressing it on (Figure P and Q). Do not try to put the needle cover back on with your hands.

• B) Unscrew the covered needle all the way by giving the large needle cover 3–5 counterclockwise turns. (Figure R)

Pull the needle straight off. (Figure S)

• C) Dispose of the needle into a puncture resistant container according to local regulations (Figure T).

DO NOT reuse needle.

Disposal of needles

For more information about how to correctly dispose of the needle refer to the Disposal information section

• A) Push white cap back on (Figure U).

• B) 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.

Troubleshooting
Problem		Solution
A	The yellow shaft is still showing after pushing in the black injection button. How do I reset my Livogiva?	To reset the Livogiva pen follow the steps below: 1) If you have already injected, DO NOT inject yourself a second time on the same day. Use a new needle for your injection on the following day. 2) Remove the needle. 3) Attach a new needle, pull off the large needle cover and save it. 4) Pull off the inner needle cover and throw away. 5) Point the needle down into an empty container. Push in the black injection button until it stops. Hold it in and slowly count to 5 s-l-o-w-l-y. You may see a small stream or drop of fluid. When you have finished, the black injection button should be all the way in. 6) If you still see the yellow shaft showing, do not use this pen; contact your doctor or pharmacist. 7) Put the large needle cover on needle. Unscrew the needle all the way by giving the needle cover 3 to 5 complete turns. Pull off needle cover and throw away as directed by your doctor or pharmacist. Push the white cap back on, and put your Livogiva in the refrigerator. You can prevent this problem by always using a NEW needle for each injection, and by pushing the black injection button all the way in and slowly counting to 5 s-l-o-w-l-y.
B	How can I tell if my Livogiva works?	The Livogiva is designed to inject the full dose every time it is used according to the directions in the section Instructions for Use. The black injection button should be all the way in to show that the full dose of medicine has been injected from the Livogiva. Use a new needle every time you inject to be sure your Livogiva will work properly.
C	I see an air bubble in my Livogiva.	A small air bubble will not affect your dose and it will not harm you. You can continue to use your dose as usual.
D	I cannot get the needle off.	1) Put the large needle cover on the needle. 2) Use the large needle cover to unscrew the needle. 3) Unscrew the needle all the way by giving the large needle cover 3 to 5 counter-clockwise turns. 4) If you still cannot get the needle off, ask someone to help you. See step 9 “Remove needle and dispose”.
E	What should I do if I cannot pull out the black injection button?	Change to a new Livogiva pen to use your dose as instructed by your doctor or pharmacist. When the black injection button becomes hard to pull out, this means there is not enough medicine in your Livogiva pen for another dose. You may still see some medicine left in the cartridge.

_____________­_____________________ Cleaning and storage _____________­____________________ Cleaning your Livogiva pen

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

Storing your Livogiva pen

• Read and follow the instructions in the Information for the Patient leaflet on how to store your pen.
• DO NOT store the Livogiva with a needle attached. Doing this may affect the sterility of the medicine during subsequent injections.
• Store the Livogiva with the white cap on. If the Livogiva has been left out of the refrigerator, do not throw the pen away. Place the pen back in the refrigerator and contact your doctor or pharmacist.

_____________­______________________Dis­posal information__________­________________________

Disposal of pen needles and Livogiva pen

• Before disposing of the Livogiva pen, be sure to remove the pen needle.
• Put used needles in a sharps container or a hard-plastic container with a secure lid. Do not

throw needles directly into your household waste.

• Do not recycle the filled sharps container.

_____________­_____________________Ot­her important notes_________­________________________

• DO NOT transfer the medicine into a syringe.
• During injection, you may hear one or more clicks – this is normal pen operation
• The Livogiva is not recommended for use by the blind or visually impaired persons without the assistance from a person trained in the proper use of the pen.