Qutavina - patient leaflet, side effects, dosage

- 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.

What is in this leaflet

• 1. What Qutavina is and what it is used for

• 2. What you need to know before you use Qutavina

• 3. How to use Qutavina

• 4. Possible side effects

• 5. How to store Qutavina

• 6. Contents of the pack and other information

1. What Qutavina is and what it is used for

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

Qutavina 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 Qutavina

Do not use Qutavina

• 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

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

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

• 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 Qutavina where you can sit or lie down right away if you get dizzy.

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

Qutavina should not be used in growing adults.

Children and adolescents

Qutavina should not be used in children and adolescents (less than 18 years).

Other medicines and Qutavina

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 Qutavina if you are pregnant or breast-feeding. If y potential, you should use effective methods of contraception pregnant, Qutavina should be discontinued. Ask your doc any medicine.

Driving and using machines

Some patients may feel dizzy after machines until you feel better

Qutavina contains sodium

This medicine contains less than 1 free’.

3. How to use Qut

e exactly as your doctor has told you to. Check with your doctor or pharmacist

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 Qutavina each day for as long as your doctor prescribes it for you. The total duration of treatment with Qutavina 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 Qutavina 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 Qutavina 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 Qutavina 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 Qutavina pen with others.

Qutavina can be given with or without food.

If you use more Qutavina than you should

If, by mistake, you have used more Qutavina 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 Qutavina 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 Qutavina

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

If you have any further questions on the use of this medicine, ask y

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 Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Qutavina

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.

Qutavina should be stored in a refrigerator (2°C to 8°C) at all times. You can use Qutavina 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 Qutavina if it is, or has been, frozen.

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

Qutavina contains a clear and colourless solution. Do not use Qutavina 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 Qutavina 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 Qutavina looks like and contents of the pack

Qutavina 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. Qutavina is available in packs containing one or three pre-filled pens.

Not all pack sizes may be available.

Marketing Authorisation Holder

EuroGenerics Holdings BV

Locatellikade 1, 1076AZ Amsterdam Netherlands

Manufacturer

Eurofins PROXY Laboratories (PRX)

Archimedesweg 25 2333 CM Leiden

Netherlands

This leaflet was last revised in

Other sources of information ZAJ

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

USER MANUAL

Qutavina 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 Qutavina carton thoroughly. Follow the instructions carefully whenever using the Qutavina pen.

Qutavina pen and parts

Pen needles 29 to 31 gauge (diameter 0.25–0.33 mm) can be used.

Needles not included .

Instructions for use

Prepare for injection

Instruction Window

Black 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

  Check pen, pen label and medicine

  
  

  A)

  
  

  B)

  
  

  C)

  
  

  Check the pen.

  DO NOT use the Qutavina pen if it is damaged.

  Check the label on the pen.

  DO NOT use if the pen contains the incorrect medicine or if the medicine has expired (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).

  
  

  B) Push needle straight onto medicine cartridge. (Figure E)

  
  

  Screw on needle clockwise unti firmly attached (Figure F).

  Do not over-tighten the needle.

  
  
  
  

  Figure E

  
  

  Figure F

  
  

  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 .

Pull off small inner needle protector and throw it away (Figure J). The needle will be exposed.

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

	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 Qutavina 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 Qutavina pen for another dose. You may still see some medicine left in the cartridge.

_____________­______________________ Cleaning and storage ____

Cleaning your Qutavina pen

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

Storing your Qutavina pen

• Read and follow the instructions in the Information for the Patient leaflet on how to store your pen.
• DO NOT store the Qutavina with a needle attached. Doing this may affect the sterility of the medicine during subsequent injections.
• Store the Qutavina with the white cap on.

If the Qutavina 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 Qutavina pen

• Before disposing of the Qutavina 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.

^f^^ 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 Qutavina 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.___________­__________________