DENOSUMAB
About
DENOSUMAB belongs to a group of medicines called RANK ligand inhibitors used to treat osteoporosis in postmenopausal women and men who have an increased risk of fracture. DENOSUMAB is also used to treat bone loss due to reduced testosterone level caused by surgery, due to the treatment with medicines such as glucocorticoids and in patients with prostate cancer. DENOSUMAB may also be used to reduce the risk of fractures in people with multiple myeloma, giant cell tumour of the bone, and to treat high calcium levels caused due to cancer.
DENOSUMAB contains ‘denosumab’, which works by blocking a receptor in the body that causes bone loss, thereby treats bone loss. DENOSUMAB treats giant cell tumour of bone (GCTB) by blocking certain receptors in the tumour cells, thereby slowing the tumour growth. DENOSUMAB helps treat high calcium levels by decreasing bone breakdown as a breakdown of the bones releases calcium. DENOSUMAB makes the bones stronger and less likely to break.
DENOSUMAB will be administered by a healthcare professional; do not self-administer. In some cases, you may experience common side-effects such as bone/joint/muscle pain, arm/leg pain, abdominal discomfort, constipation, and painful/frequent urination. You are advised to talk to your doctor if the side effects persist or worsen.
DENOSUMAB might cause osteonecrosis of the jaw; therefore, maintain good dental hygiene and receive regular dental check-ups whilst on treatment with DENOSUMAB. Avoid taking DENOSUMAB if you are pregnant. Consult your doctor before taking DENOSUMAB if you are breastfeeding. DENOSUMAB is not recommended for children below 18 years as safety and effectiveness have not been established. Keep your doctor informed about your health condition and medicines to rule out any interactions.
Uses of DENOSUMAB
Medicinal Benefits
DENOSUMAB belongs to a group of medicines called RANK ligand inhibitors used to treat osteoporosis in postmenopausal women and men who have an increased risk of fracture. DENOSUMAB is also used to treat bone loss due to reduced hormone levels caused by surgery or due to treatment with medicines in patients with prostate cancer. It is also used to treat bone loss occurring due to long-term treatment with glucocorticoids in patients who are at an increased risk of fractures. DENOSUMAB may also be used to reduce the risk of fractures in people with multiple myeloma, giant cell tumours of the bone and to treat high calcium levels caused due to cancer. DENOSUMAB binds to a protein on RANK ligand on osteoclast (cells that cause bone breakdown) and inhibits their formation, functioning and survival. Thereby decreases bone breakdown, increases bone density, and strengthens the bone. DENOSUMAB treats giant cell tumour of bone (GCTB) by blocking certain receptors in the tumour cells, thereby slows the tumour growth. DENOSUMAB helps treat high calcium levels by decreasing bone breakdown as the breakdown of the bones releases calcium. DENOSUMAB makes the bones stronger and less likely to break.
Directions for Use
Storage
Side Effects of DENOSUMAB
- Bone/joint/muscle pain
- Pain in extremities (arm/leg pain)
- Abdominal discomfort
- Constipation
- Painful/frequent urination
- Upper respiratory tract infection
- Rash
- Eczema
- Hair loss
In-Depth Precautions and Warning
Drug Warnings
Do not take DENOSUMAB if you are allergic to any of its components; if you have hypocalcaemia (low levels of calcium in the blood). Inform your doctor if you have low levels of calcium, kidney dysfunction, liver problems, poor dental health, gum problems, weak immune system, hypoparathyroidism (decreased function of the parathyroid gland), malabsorption, latex allergy, undergone thyroid surgery, planned dental procedure, if you are taking glucocorticoids, or cannot take calcium and vitamin D supplements. Avoid taking DENOSUMAB if you are pregnant. Consult your doctor if you are breastfeeding. DENOSUMAB is not recommended for children below 18 years as safety and effectiveness have not been established.
Drug Interactions
Drug-Drug Interactions: DENOSUMAB may interact with kinase inhibitors (palbociclib).
Drug-Food Interactions: No interactions found/established.
Drug-Disease Interactions: Inform your doctor if you have hypocalcaemia (low levels of calcium in the blood) or immunosuppression.
Drug-Drug Interactions Checker List:
Safety Advice
Alcohol
cautionIt is not known if alcohol interacts with DENOSUMAB, so please consult a doctor.
Pregnancy
unsafeDENOSUMAB is not recommended during pregnancy as it might cause foetal harm. If you are a woman of child-bearing potential, use effective contraception during the treatment with DENOSUMAB and for 5 months after discontinuation. Inform your doctor if you are pregnant, think you are pregnant or planning for pregnancy.
Breast Feeding
cautionConsult your doctor if you are breastfeeding; your doctor will decide if breastfeeding mothers can take DENOSUMAB or not.
Driving
safe if prescribedDENOSUMAB generally does not affect your ability to drive. However, drive or operate machinery only if you are alert.
Liver
cautionPlease consult your doctor if you have a liver impairment or any concerns regarding this.
Kidney
cautionPlease consult your doctor if you have kidney impairment or any concerns regarding this.
Children
unsafeDENOSUMAB is not recommended for children below 18 years as safety and effectiveness were not established.
Habit Forming
Diet & Lifestyle Advise
- Include dairy products like milk, yoghurt, cheese, or milk-based custard in your diet.
- Eat daily a serving of broccoli, cabbage, bok choy (Chinese white cabbage), spinach, and other green leafy vegetables.
- Snack on calcium-rich nuts like Brazil nuts or almonds.
- Sprinkle sesame seeds over your food, vegetables, and salads. Sesame seeds are high in calcium.
- Avoid or reduce the intake of caffeine, soft drinks, and alcohol as they may inhibit calcium absorption.
- Replace the meat with tofu or tempeh for extra calcium in your food.
Special Advise
- If you are a woman of child-bearing potential, use effective contraception during the treatment with DENOSUMAB and for 5 months after discontinuation.
- Your doctor might prescribe calcium and vitamin D supplements whilst on treatment with DENOSUMAB.
Patients Concern
Disease/Condition Glossary
Osteoporosis: It is a bone disease that weakens and thins the bones by decreasing bone density. As the density of bones decreases, they weaken and are more likely to break. Postmenopausal women are more likely to develop osteoporosis than men because, at menopause, women’s ovaries stop producing oestrogen (a female hormone) that is essential to keep bones healthy. Following menopause, bone loss occurs, making bones weak and more likely to break. Osteoporosis can also occur in men due to ageing and/or low levels of testosterone hormone. Signs and symptoms include back pain caused by a fractured or collapsed vertebra, loss of height over time, a stooped posture, bones that break much more easily than expected.
FAQs
DENOSUMAB is used to treat osteoporosis in postmenopausal women and men who have an increased risk of fracture. It is also used to treat bone loss and reduce the risk of fractures.
DENOSUMAB binds to a protein on RANK ligand on osteoclast (cells that cause bone breakdown) and inhibits their formation, functioning and survival. Thereby decreases bone breakdown, increases bone density, and strengthens the bone. DENOSUMAB makes the bones stronger and less likely to break.
Osteonecrosis of the jaw (bone damage in the jaw) might be a side-effect of DENOSUMAB. The risk increases in people taking DENOSUMAB for longer durations. It might also occur upon discontinuation of the treatment. Maintain good dental hygiene and receive regular dental check-ups whilst on treatment with DENOSUMAB. Inform your doctor if you have dental problems, gum disease, planned tooth extractions, cancer, if you smoke, or are taking bisphosphonates or corticosteroids.
Breakdown of bones releases calcium and causes hypercalcemia (high calcium levels in the blood). DENOSUMAB helps treat high calcium levels by decreasing bone breakdown.
Unusual thigh bone fractures might occur whilst on treatment with DENOSUMAB. Consult your doctor if you experience new or unusual pain in the thigh, hip, or groin.
DENOSUMAB treats giant cell tumour of bone (GCTB) by blocking certain receptors in the tumour cells, thereby slows the tumour growth. Giant cell tumour of the bone is a non-cancerous tumour that typically grows at the ends of long bones.
DENOSUMAB might cause skin infections. Consult your doctor immediately if you notice symptoms such as swollen skin, redness, cellulitis (hot and tender skin), commonly in the lower leg with feverish symptoms.
