DENOSUMAB

The U.S. FDA granted its initial approval to Denosumab on 1 June 2010 for treatment of osteoporosis in postmenopausal women at high risk of fracture.

Osteoporosis in women postmenopause who are at high risk of fracture Men with osteoporosis who are at increased risk of fracture Bone loss in men due to reduced levels of testosterone caused as a result of prostate cancer surgery or treatment with medications Osteoporosis in patients with a high risk of fracture due to long-term treatment with glucocorticoids. And increase bone mass in women at high risk of fracture due to adjuvant aromatase inhibitor therapy for breast cancer.

Denosumab is to be administered by a healthcare provider. It is injected subcutaneously under the skin of stomach, upper thigh or upper arm. Denosumab is to be given once every six months.

Bone, joint or muscle pain that might become severe sometimes, severe pain in arm or leg, frequent or painful urination, blood in urine, inability to hold urine, infections in the upper respiratory tract, loss of hair, pain in the abdomen, constipation, itchy, red or dry skin, Tingling, pain, or numbness that moves down the leg are some common side effects of Denosumab.

Denosumab should not be used in children and adolescents below 18 years of age. Denosumab may be unsafe during pregnancy and is not recommended while being pregnant. Inform your doctor if you think you might be pregnant or are planning to get pregnant. Denosumab may be unsafe during breastfeeding and hence it is essential to inform doctor if you are breastfeeding before starting treatment with this medication. Do not take Denosumab if you have hypocalcemia (low levels of calcium in your blood). Inform your doctor about the same. Hypersensitivity might occur in some patients, in such case discontinue the use of denosumab and contact your doctor immediately.

Before starting treatment with denosumab, inform your doctor: About any medication you are taking or if you are using any other medication containing denosumab. If you have a kidney disease or if you are on dialysis If you have hypocalcaemia In case your immune system is weak If you have hypoparathyroidism If you’ve had a thyroid surgery In case you have malabsorption If you have any problems in the mouth or teeth like gum disease, poor oral health, a planned tooth extraction or if you have nit visited a dentist in a long time In case you smoke as it might cause dental problems Osteonecrosis of the jaw may occur in some patients. Hence regular oral examination must be done by the doctor before starting treatment with Denosumab.

Effective contraception should be used during Denosumab treatment. Contraception must be continued for at least 5 months after stopping this medication. Adequate calcium and vitamin D intake is necessary while using Denosumab. Oral and dental hygiene should be maintained throughout treatment with this medication.

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