Denosis 120

Indications

Denosumab is used to treat osteoporosis (thin, fragile bones) in women after menopause and in men at high risk of fractures, and bone loss caused by hormone-blocking cancer treatment or long-term steroid use. A higher-strength form is used to prevent fractures and other bone problems in people whose cancer has spread to the bone, and to treat giant cell tumour of bone.

How It Works

Denosumab is a monoclonal antibody (a laboratory-made protein) that blocks a protein called RANKL. RANKL switches on osteoclasts, the cells that break down bone. By blocking it, Denosumab slows bone breakdown, so bones become denser and stronger and the risk of fractures falls.

Dosage and Administration

Denosumab is given as an injection under the skin by a doctor or nurse, or by a trained patient, as prescribed. For osteoporosis it is usually given once every 6 months. For bone problems caused by cancer, a higher dose is usually given every 4 weeks. Most people should also take calcium and vitamin D supplements as advised. Do not miss doses: stopping or delaying treatment can cause rapid bone loss and multiple spinal fractures, so another bone medicine is usually started if Denosumab is stopped.

Interactions

• No major drug interactions are known.
• Other medicines that lower calcium, such as Cinacalcet or some diuretics, may add to the risk of low calcium.
• Do not use two Denosumab products together.

Contraindications

• Allergy to Denosumab or any ingredient (some pens contain latex).
• Low blood calcium (hypocalcaemia) that has not been corrected.
• Pregnancy.
• Unhealed wounds from dental or mouth surgery (for the cancer dose).

Side Effects

Common side effects include pain in the arms, legs, back or muscles, skin rash or eczema, urinary or chest infections, constipation and low blood calcium. Rare but serious effects include osteonecrosis of the jaw (death of jaw bone, often after a tooth extraction), unusual thigh bone fractures and serious skin infections.

Get urgent medical help if you have muscle spasms, cramps, numbness or tingling around the mouth or in the fingers (signs of low calcium), jaw pain or a loose tooth, new pain in the thigh, hip or groin, a red, swollen, hot area of skin with fever, or signs of a severe allergic reaction.

Pregnancy and Lactation

Denosumab must not be used in pregnancy as it may harm the baby. Women who could become pregnant should use effective contraception during treatment and for at least 5 months after the last dose. Breastfeeding is not recommended during treatment.

Precautions and Warnings

• Have a dental check before starting, keep good mouth hygiene and tell your dentist you receive Denosumab.
• Calcium levels are checked, especially in people with kidney disease.
• Do not stop treatment without talking to your doctor.

Overdose

No cases of harmful overdose are reported. As it is given by health professionals on a schedule, overdose is unlikely.

Therapeutic Class

Bone resorption inhibitor, RANKL monoclonal antibody.

Storage

Store in a refrigerator at 2 to 8°C, do not freeze. Keep in the outer carton to protect from light, and out of the reach of children.