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Denub 60 mg/ml PFS Injection 2x1 ml

Denub 60 mg/ml PFS Injection 2x1 ml

Prescription drug
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Composition

DENOSUMAB-60MG

Manufacturer/Marketer

Alkem Laboratories Ltd

Consume Type

PARENTERAL

Return Policy

Not Returnable

for this medicine

About Denub 60 mg/ml PFS Injection 2x1 ml

Denub 60 mg/ml PFS Injection 2x1 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. Denub 60 mg/ml PFS Injection 2x1 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. Denub 60 mg/ml PFS Injection 2x1 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.
 
Denub 60 mg/ml PFS Injection 2x1 ml contains ‘denosumab’, which works by blocking a receptor in the body that causes bone loss, thereby treats bone loss. Denub 60 mg/ml PFS Injection 2x1 ml treats giant cell tumour of bone (GCTB) by blocking certain receptors in the tumour cells, thereby slowing the tumour growth. Denub 60 mg/ml PFS Injection 2x1 ml helps treat high calcium levels by decreasing bone breakdown as a breakdown of the bones releases calcium. Denub 60 mg/ml PFS Injection 2x1 ml makes the bones stronger and less likely to break.
 
Denub 60 mg/ml PFS Injection 2x1 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.
 
Denub 60 mg/ml PFS Injection 2x1 ml might cause osteonecrosis of the jaw; therefore, maintain good dental hygiene and receive regular dental check-ups whilst on treatment with Denub 60 mg/ml PFS Injection 2x1 ml. Avoid taking Denub 60 mg/ml PFS Injection 2x1 ml if you are pregnant. Consult your doctor before taking Denub 60 mg/ml PFS Injection 2x1 ml if you are breastfeeding. Denub 60 mg/ml PFS Injection 2x1 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 Denub 60 mg/ml PFS Injection 2x1 ml

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

Medicinal Benefits

Denub 60 mg/ml PFS Injection 2x1 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. Denub 60 mg/ml PFS Injection 2x1 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. Denub 60 mg/ml PFS Injection 2x1 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. Denub 60 mg/ml PFS Injection 2x1 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. Denub 60 mg/ml PFS Injection 2x1 ml treats giant cell tumour of bone (GCTB) by blocking certain receptors in the tumour cells, thereby slows the tumour growth. Denub 60 mg/ml PFS Injection 2x1 ml helps treat high calcium levels by decreasing bone breakdown as the breakdown of the bones releases calcium. Denub 60 mg/ml PFS Injection 2x1 ml makes the bones stronger and less likely to break.

Directions for Use

Denub 60 mg/ml PFS Injection 2x1 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 Denub 60 mg/ml PFS Injection 2x1 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 Denub 60 mg/ml PFS Injection 2x1 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 Denub 60 mg/ml PFS Injection 2x1 ml if you are pregnant. Consult your doctor if you are breastfeeding. Denub 60 mg/ml PFS Injection 2x1 ml is not recommended for children below 18 years as safety and effectiveness have not been established.

Drug Interactions

Drug-Drug Interactions: Denub 60 mg/ml PFS Injection 2x1 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 Denub 60 mg/ml PFS Injection 2x1 ml and for 5 months after discontinuation. 
  • Your doctor might prescribe calcium and vitamin D supplements whilst on treatment with Denub 60 mg/ml PFS Injection 2x1 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 Denub 60 mg/ml PFS Injection 2x1 ml, so please consult a doctor.

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Pregnancy

Unsafe

Denub 60 mg/ml PFS Injection 2x1 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 Denub 60 mg/ml PFS Injection 2x1 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 Denub 60 mg/ml PFS Injection 2x1 ml or not.

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Driving

Safe if prescribed

Denub 60 mg/ml PFS Injection 2x1 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

Denub 60 mg/ml PFS Injection 2x1 ml is not recommended for children below 18 years as safety and effectiveness were not established.

Country of origin

India

Manufacturer/Marketer address

Alkem Laboratories Limited, Devashish Building, Alkem House, Senapati Bapat Road, Lower Parel, Mumbai - 400 013.
Other Info - DEN0499

Author Details

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FAQs

Denub 60 mg/ml PFS Injection 2x1 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.
Denub 60 mg/ml PFS Injection 2x1 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. Denub 60 mg/ml PFS Injection 2x1 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 Denub 60 mg/ml PFS Injection 2x1 ml. The risk increases in people taking Denub 60 mg/ml PFS Injection 2x1 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 Denub 60 mg/ml PFS Injection 2x1 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). Denub 60 mg/ml PFS Injection 2x1 ml helps treat high calcium levels by decreasing bone breakdown.
Unusual thigh bone fractures might occur whilst on treatment with Denub 60 mg/ml PFS Injection 2x1 ml. Consult your doctor if you experience new or unusual pain in the thigh, hip, or groin.
Denub 60 mg/ml PFS Injection 2x1 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.
Denub 60 mg/ml PFS Injection 2x1 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.

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