Safety

For full information, please ensure you read the patient information leaflet – this can be found in your pack or downloaded here.

Side effects

Like all medicines, Movymia^® (teriparatide) can cause side effects, although not everybody gets them.

The most common side effects are pain in limb (which may affect more than 1 in 10 people). Other common side effects (affecting up to 1 in 10 people) include feeling sick, headache and dizziness. 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 occured after teriparatide use.

If you have discomfort around the area of the injection such as redness of the skin, pain, swelling, itching, bruising or minor bleeding (which can occur in up to 1 in 10 people), this should clear up in a few days or weeks. Otherwise tell your doctor.

Rarely, patients may suffer allergic reactions consisting of breathlessness, swelling of the face, rash and chest pain. These reactions usually occur soon after injection. 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
• nerve pain in the leg
• feeling faint
• spinning sensation
• irregular heartbeats
• breathlessness
• increased sweating
• muscle cramps
• loss of energy
• tiredness
• chest pain
• low blood pressure
• heartburn (painful or burning sensation just below the breast bone)
• vomiting
• a hernia of the tube that carries food to your stomach (hiatus hernia)
• 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
• piles (haemorrhoids)
• leakage of urine
• increased need to pass water
• weight increase
• kidney stones
• pain in the muscles and pain in the joints. Some patients have had severe back cramps or pain which led to admission into hospital.
• 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 Yellow Card Scheme web site or by searching for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

Do not use Movymia^® (teriparatide):

• 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 (hypercalcaemia).
• if you suffer from serious kidney problems.
• if you have ever had bone cancer or if other cancers 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.

Warning and precautions

Movymia^® (teriparatide) may increase calcium in your blood or urine. Talk to your doctor before or while using Movymia^® (teriparatide):

• 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 had 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 of Movymia^® (teriparatide). For the first doses, inject Movymia^® (teriparatide) in a place where you can sit or lie down right away if you get dizzy.

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

Before inserting a cartridge in Movymia^® (teriparatide) Pen write down the batch (Lot) number of the cartridge and its first injection date on a calendar. The date of first injection should also be recorded on the outer carton of Movymia^® (teriparatide) (see the provided space on the box: {First use:}).

Movymia^® (teriparatide) should not be used in growing adults.

Children and adolescents

Movymia^® (teriparatide) should not be used in children and adolescents (aged less than 18 years).

Other medicines and Movymia^® (teriparatide)

Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.
This is important, because some medicines (e.g. digoxin/digitalis, a medicine used to treat heart disease) may interact with teriparatide.

Pregnancy and breast-feeding

Do not use Movymia^® (teriparatide) 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 Movymia^® (teriparatide). If you become pregnant while using Movymia^® (teriparatide), Movymia^® (teriparatide) 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 Movymia^® (teriparatide). If you feel dizzy you should not drive or use machines until you feel better.

Movymia^® (teriparatide) contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per dosage unit, that is to say essentially “sodium-free”.

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