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Written By Santoshini Reddy G , M Pharmacy
Reviewed By Dr Aneela Siddabathuni , MPharma., PhD
Last Updated Dec 7, 2024 | 2:22 PM IST
Denolite Injection 1 ml is used to treat osteoporosis, bone loss, giant cell tumours of the bone, high calcium levels and reduce the risk of fractures. It contains denosumab, which blocks a receptor that causes bone loss; thereby increasing bone density, and strengthening the bone. It slows the tumour growth by blocking certain receptors in the tumour cells. In some cases, this medicine may cause side effects such as bone/joint/muscle pain, arm/leg pain, abdominal discomfort, constipation, and painful/frequent urination. Before taking this medicine, inform the doctor if you are pregnant or breastfeeding, taking any other medication, or have any pre-existing medical conditions.
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Prescription drug

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Composition

DENOSUMAB-60MG

Manufacturer/Marketer

Bioelite Lifesciences Pvt Ltd

Consume Type

PARENTERAL

Return Policy

Not Returnable

Expires on or after

Apr-26

for this medicine

About Denolite Injection 1 ml

Denolite Injection 1 ml 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. Denolite Injection 1 ml 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. Denolite Injection 1 ml 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.
 
Denolite Injection 1 ml contains ‘denosumab’, which works by blocking a receptor in the body that causes bone loss, thereby treats bone loss. Denolite Injection 1 ml treats giant cell tumour of bone (GCTB) by blocking certain receptors in the tumour cells, thereby slowing the tumour growth. Denolite Injection 1 ml helps treat high calcium levels by decreasing bone breakdown as a breakdown of the bones releases calcium. Denolite Injection 1 ml makes the bones stronger and less likely to break.
 
Denolite Injection 1 ml 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.
 
Denolite Injection 1 ml might cause osteonecrosis of the jaw; therefore, maintain good dental hygiene and receive regular dental check-ups whilst on treatment with Denolite Injection 1 ml. Avoid taking Denolite Injection 1 ml if you are pregnant. Consult your doctor before taking Denolite Injection 1 ml if you are breastfeeding. Denolite Injection 1 ml 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 Denolite Injection 1 ml

Treatment of Osteoporosis, bone loss, giant cell tumour of the bone, high calcium levels.

Medicinal Benefits

Denolite Injection 1 ml 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. Denolite Injection 1 ml 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. Denolite Injection 1 ml 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. Denolite Injection 1 ml 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. Denolite Injection 1 ml treats giant cell tumour of bone (GCTB) by blocking certain receptors in the tumour cells, thereby slows the tumour growth. Denolite Injection 1 ml helps treat high calcium levels by decreasing bone breakdown as the breakdown of the bones releases calcium. Denolite Injection 1 ml makes the bones stronger and less likely to break.

Directions for Use

Denolite Injection 1 ml will be administered by a healthcare professional; do not self-administer.

Storage

Store in a cool and dry place away from sunlight

Side Effects of Denolite Injection 1 ml

  • Bone/joint/muscle pain
  • Pain in extremities (arm/leg pain)
  • Abdominal discomfort
  • Constipation
  • Painful/frequent urination
  • Upper respiratory tract infection
  • Rash
  • Eczema
  • Hair loss

Drug Warnings

Do not take Denolite Injection 1 ml 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 Denolite Injection 1 ml if you are pregnant. Consult your doctor if you are breastfeeding. Denolite Injection 1 ml is not recommended for children below 18 years as safety and effectiveness have not been established.

Drug Interactions

Drug-Drug Interactions: Denolite Injection 1 ml 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

  • PALBOCICLIB

Habit Forming

No

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 Denolite Injection 1 ml and for 5 months after discontinuation. 
  • Your doctor might prescribe calcium and vitamin D supplements whilst on treatment with Denolite Injection 1 ml.

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.

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Alcohol

Caution

It is not known if alcohol interacts with Denolite Injection 1 ml, so please consult a doctor.

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Pregnancy

Unsafe

Denolite Injection 1 ml 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 Denolite Injection 1 ml and for 5 months after discontinuation. Inform your doctor if you are pregnant, think you are pregnant or planning for pregnancy.

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Breast Feeding

Caution

Consult your doctor if you are breastfeeding; your doctor will decide if breastfeeding mothers can take Denolite Injection 1 ml or not.

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Driving

Safe if prescribed

Denolite Injection 1 ml generally does not affect your ability to drive. However, drive or operate machinery only if you are alert.

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Liver

Caution

Please consult your doctor if you have a liver impairment or any concerns regarding this.

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Kidney

Caution

Please consult your doctor if you have kidney impairment or any concerns regarding this.

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Children

Unsafe

Denolite Injection 1 ml is not recommended for children below 18 years as safety and effectiveness were not established.

Country of origin

India
Other Info - DEN0403

Author Details

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FAQs

Denolite Injection 1 ml 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.
Denolite Injection 1 ml 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. Denolite Injection 1 ml makes the bones stronger and less likely to break.
Osteonecrosis of the jaw (bone damage in the jaw) might be a side-effect of Denolite Injection 1 ml. The risk increases in people taking Denolite Injection 1 ml 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 Denolite Injection 1 ml. 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). Denolite Injection 1 ml helps treat high calcium levels by decreasing bone breakdown.
Unusual thigh bone fractures might occur whilst on treatment with Denolite Injection 1 ml. Consult your doctor if you experience new or unusual pain in the thigh, hip, or groin.
Denolite Injection 1 ml 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.
Denolite Injection 1 ml 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.
Denolite Injection 1 ml has been used safely for up to 8 years, showing substantial increases in bone density during that time. However, the optimal duration of therapy varies depending on individual health conditions and needs. Long-term use should be closely monitored by your healthcare provider to assess benefits, risks, and the need for continued therapy. Always consult the doctor for personalized guidance.
Some people may experience hair loss while using Denolite Injection 1 ml. However, individual reactions to medications can vary. If you experience hair loss or any unusual symptoms while taking Denolite Injection 1 ml, consult the doctor to determine the cause and discuss appropriate management options.
No, Denolite Injection 1 ml is not a chemotherapy medication. It is a monoclonal antibody which is used to treat conditions like osteoporosis, and bone loss associated with certain cancers, and to prevent bone fractures in patients with metastatic bone disease. It targets a protein called RANKL to inhibit bone breakdown, thereby increasing bone strength and density.
Denolite Injection 1 ml is administered subcutaneously (under the skin) in your upper arm, upper thigh, or stomach area by the doctor or nurse, usually given once every 6 months for osteoporosis. Your doctor will determine the exact schedule based on your condition. Always follow the doctor's instructions regarding dosage and scheduling, as it may vary based on your specific medical condition.
You should inform your doctor before receiving Denolite Injection 1 ml, as it is not recommended during pregnancy due to the potential risk of harm to the foetus.
Denolite Injection 1 ml should be stored in a refrigerator at a temperature between 2°C and 8°C. Do not freeze it. Keep the vial in its outer carton to protect it from light.
The side effects of Denolite Injection 1 ml include abdominal discomfort, bone/joint/muscle pain, arm/leg pain, constipation, and painful/frequent urination. Consult the doctor if any of these side effects persist or worsen.

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