Forsteo (teriparatide)

How does it work?

Forsteo injection contains the active ingredient teriparatide, which is a type of medicine called a bone formation agent.

Teriparatide is a synthetic version of human parathyroid hormone, which is produced by the parathyroid glands. This hormone is involved in the metabolism of calcium and phosphorous. Teriparatide mimics the effects of the natural human hormone and is used to increase bone formation.

Bone is not a static structure. There is a continual turnover over of bone in the body; bone is formed by cells called osteoblasts, and is broken down by cells called osteoclasts.

In women at the menopause, blood levels of the female hormone oestrogen start to decrease. This results in an increase in bone breakdown, which can lead to a loss of bone density. Bone loss is particularly rapid for the first ten years after the menopause and it may lead to the development of osteoporosis - a condition in which the bones become weak and brittle and break more easily. Osteoporosis is more common in women after menopause but can also occur in men.

Teriparatide is used to treat osteoporosis in women who have passed the menopause and in men with an increased risk of fracture. It works by increasing the action of the bone formation cells, osteoblasts. This increases the formation of bone and therefore helps keep the bones strong. Teriparatide also increases the absorption of calcium from the intestine into the blood and the reabsorption of calcium from the kidneys into the blood. Calcium is deposited in the bone by the osteoblasts and this helps strengthen the bones.

Teriparatide has been shown to significantly reduce the risk of spinal factures, but not hip fractures, in postmenopausal women; and has been shown to increase bone density in men with osteoporosis. It is given as a daily injection under the skin of the thigh or abdomen, using an injection pen similar to those used by people with diabetes for injecting insulin.

What is it used for?

Osteoporosis in women who have passed the menopause and for men who are at increased risk of suffering from fracture.

Warning!

Your doctor or pharmacist will teach you how to use the injection pen. Always use the pen exactly as instructed; make sure you read the user manual that comes with the medicine and ask your doctor or pharmacist if you are unclear on anything.

The injection pen should be kept in a fridge at 2-8°C. Don't put it next to the ice compartment as it may freeze and cannot then be used. Make sure it is kept out of the reach of children. Use a new injection needle for each injection and dispose of the needle carefully after use, as directed. Never store the pen with a needle attached. The pen should be carefully disposed of 28 days after opening, even if it is not empty; you may find it helpful to write the date of opening on it. Do not use the pen if the solution inside is cloudy, coloured or contains particles.

This medicine may cause dizziness and so may affect your ability to drive or operate machinery safely. Do not drive or operate machinery until you know how this medicine affects you and you are sure it won't affect your performance.

This medicine can occasionally cause your blood pressure to drop when you move from a lying down or sitting position to sitting or standing, especially when you first start taking the medicine. This may make you feel dizzy or unsteady. To avoid this try getting up slowly. If you do feel dizzy, sit or lie down until the symptoms pass.

This medicine has not been studied in people with decreased liver function.

This medicine must not be used for longer than a total of 18 months, as the safety of long-term use has not yet been established.

Use with caution in

Moderately decreased kidney function.

People who have or have recently had stones in the urinary tract (urolithiasis).

Not to be used in

Severely decreased kidney function.

Children and growing adolescents.

Metabolic bone diseases other than osteoporosis, eg Paget's disease of bone, hyperparathyroidism.

High levels of calcium in the blood (hypercalcaemia).

Bone cancer.

People who have had previous radiotherapy to the bones.

Unexplained raised levels of alkaline phosphatase.

Pregnancy.

Breastfeeding.

This medicine should not be used if you are allergic to one or any of its ingredients. Please inform your doctor or pharmacist if you have previously experienced such an allergy. If you feel you have experienced an allergic reaction, stop using this medicine and inform your doctor or pharmacist immediately.

Pregnancy and breastfeeding

Certain medicines should not be used during pregnancy or breastfeeding. However, other medicines may be safely used in pregnancy or breastfeeding providing the benefits to the mother outweigh the risks to the unborn baby. Always inform your doctor if you are pregnant or planning a pregnancy, before using any medicine.

This medicine should not be used during pregnancy or breastfeeding. Seek medical advice from your doctor.

Side effects

Medicines and their possible side effects can affect individual people in different ways. The following are some of the side effects that are known to be associated with this medicine. Because a side effect is stated here, it does not mean that all people using this medicine will experience that or any side effect.

Pain, swelling, redness, bruising or itching around injection site.

Limb pain.

Nausea and vomiting.

Dizziness.

Headache.

Fatigue.

Depression.

Chest pain.

Muscle cramps.

Balance problems involving the inner ear (vertigo).

Shortness of breath (dyspnoea).

Raised cholesterol levels.

Increased sweating.

Low red blood cell count (anaemia).

Weakness or loss of strength (asthenia).

Awareness of your heartbeat (palpitations).

Sciatica.

Low blood pressure (hypotension).

Reflux of stomach acid into the foodpipe, causing heartburn (gastro-oesophageal reflux).

Increased production of and urge to pass urine (polyuria).

Weight gain.

The side effects listed above may not include all of the side effects reported by the drug's manufacturer. For more information about any other possible risks associated with this medicine, please read the information provided with the medicine or consult your doctor or pharmacist.

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