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compositionComposition:DENOSUMAB-60MG
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Prescription Medicine
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Gennodeb 60 mg PFS 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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Written By Santoshini Reddy G , M Pharmacy
Reviewed By Dr Aneela Siddabathuni , MPharma., PhD
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More about the Product

Composition :

DENOSUMAB-60MG

Manufacturer/Marketer :

Gennova Biopharmaceuticals Ltd

Consume Type :

Parenteral

Return Policy :

Not Returnable

About Gennodeb 60 mg PFS Injection 1 ml

Gennodeb 60 mg PFS Injection 1 ml is an injection used to treat osteoporosis and strengthen thinning bones. It is prescribed to help reduce the risk of fractures in people who have a high chance of breaking bones. This medicine helps maintain bone density, especially in postmenopausal women and men undergoing certain cancer treatments.

This medicine is typically injected at regular intervals as decided by your healthcare provider. Because it is given as an injection, it does not need to be taken with meals, meaning food does not affect how it works in your body. To support your bones while using this treatment, your doctor may suggest adding calcium and vitamin D supplements to your daily routine, alongside light weight-bearing exercises.

While using Gennodeb 60 mg PFS Injection 1 ml, some people may experience mild side effects like back pain, muscle stiffness, or joint discomfort. However, you must contact your doctor immediately if you notice serious symptoms, such as severe jaw pain, unusual pain in your thigh or groin, or signs of low blood calcium levels like muscle twitching or numbness.

Do not take this if you have untreated low levels of calcium in your blood. Before starting treatment, tell your doctor if you have severe kidney disease, a weak immune system, or are scheduled for any dental procedures. This medicine is not suitable for individuals who have unresolved dental or jawbone issues.

This injection may interact with other bone therapies or medicines that suppress your immune system, which can increase your risk of infections. If you are pregnant, planning to become pregnant, or breastfeeding, you should not use this medicine as it can harm the developing baby. Elderly individuals should consult their doctor to ensure their kidney function is monitored during treatment.

Uses of Gennodeb 60 mg PFS Injection 1 ml

Your doctor may prescribe Gennodeb 60 mg PFS Injection 1 ml to help manage the following conditions:

  • Osteoporosis in postmenopausal women: Gennodeb 60 mg PFS Injection 1 ml helps increase bone strength and reduces the risk of spine, hip, and other bone fractures.
  • Bone loss from cancer treatments: It protects bones from weakening in men receiving hormone therapy for prostate cancer and women receiving certain therapies for breast cancer.
  • Osteoporosis in men: It strengthens bones in men who have a high risk of bone fractures.
  • Glucocorticoid-induced osteoporosis: It treats bone loss caused by long-term use of steroid medications.

Key Benefits

Gennodeb 60 mg PFS Injection 1 ml is used to strengthen bones and reduce the risk of fractures in people with osteoporosis and certain bone-related conditions. It works by slowing bone breakdown, helping maintain bone strength and density over time.

  • Strengthens Bones: Helps increase bone density and improve bone strength, reducing the likelihood of fractures.
  • Reduces Fracture Risk: Helps lower the risk of fractures of the spine, hip, and other bones in people at high risk of bone loss.
  • Slows Bone Loss: Reduces bone breakdown, helping preserve healthy bone structure and support long-term skeletal health.
  • Supports Bone Health During Certain Treatments: Helps prevent bone loss associated with some cancer treatments and hormone therapies, as advised by your doctor.
  • Convenient Long-Term Treatment: Given as a periodic injection, it provides effective bone protection without the need for daily medication.

Directions for Use

  • Your doctor will determine the dosage and timing of Gennodeb 60 mg PFS Injection 1 ml based on your health condition. Usually, it is given once every 6 months.
  • Gennodeb 60 mg PFS Injection 1 ml is administered subcutaneously (under the skin) in your upper arm, upper thigh, or stomach area by the doctor or nurse in a hospital setting.
  • Do not self-administer it.

How Gennodeb 60 mg PFS Injection 1 ml Works

Your bones are constantly undergoing a natural process of being broken down and rebuilt by specialised cells. In osteoporosis and other bone-weakening conditions, the cells that break down bone become overly active, leading to thin, fragile bones that break easily. Gennodeb 60 mg PFS Injection 1 ml contains denosumab, which works by targeting and blocking a specific protein in the body that signals these bone-breaking cells to grow and activate. By turning down this signal, this medicine slows down the rate of bone loss, allowing your bones to rebuild their strength and density over time.
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Alcohol

Caution

It is not known if alcohol interacts with Gennodeb 60 mg PFS Injection 1 ml, so please consult a doctor.

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Pregnancy

Unsafe

Gennodeb 60 mg PFS 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 Gennodeb 60 mg PFS 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 Gennodeb 60 mg PFS Injection 1 ml or not.

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Driving

Safe if prescribed

Gennodeb 60 mg PFS 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

Gennodeb 60 mg PFS Injection 1 ml is not recommended for children below 18 years as safety and effectiveness were not established.

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Heart

Caution

Gennodeb 60 mg PFS Injection 1 ml should be administered with caution in patients with heart problems. Therefore, please talk to your doctor before receiving Gennodeb 60 mg PFS Injection 1 ml.

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Geriatrics

Caution

Gennodeb 60 mg PFS Injection 1 ml should be administered with caution in older adults. Always seek medical advice before receiving it.

What if I have taken an overdose of Gennodeb 60 mg PFS Injection 1 ml

Since this injection is given by a healthcare professional, receiving an overdose is highly unlikely. However, if you suspect you have received too much or experience severe symptoms, seek immediate medical attention or visit the nearest emergency room.

Diet & Lifestyle Advise

  • Maintain Adequate Calcium and Vitamin D Intake: Consume calcium- and vitamin D-rich foods or supplements as recommended by your healthcare provider to support healthy bones.
  • Stay Physically Active: Engage in regular weight-bearing and muscle-strengthening exercises, such as walking or light resistance training, to help maintain bone strength and balance.
  • Avoid Smoking and Limit Alcohol: Smoking and excessive alcohol intake can weaken bones and increase the risk of fractures.
  • Maintain Good Oral Hygiene: Brush and floss regularly, and attend routine dental check-ups to help reduce the risk of jaw-related complications during treatment.
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Have a query?

How Soon It Starts Working

The time required for Gennodeb 60 mg PFS Injection 1 ml to start to work: The time required for Gennodeb 60 mg PFS Injection 1 ml to show its action is unknown. The time for which the effects of Gennodeb 60 mg PFS Injection 1 ml last: The duration of action for Gennodeb 60 mg PFS Injection 1 ml is clinically unknown.

What if you forget to take Gennodeb 60 mg PFS Injection 1 ml

If you miss a scheduled injection, contact your doctor or healthcare provider as soon as possible to reschedule. It is important to receive this medicine on a regular schedule to maintain its bone-strengthening benefits.

Storage

• Store this medicine in a refrigerator between 2°C and 8°C (36°F to 46°F) in its original carton to protect it from light.

Drug Warnings

  • Inspect the Injection Before Use: Do not use the medicine if the solution is cloudy, discoloured, contains particles, or if the syringe or vial is damaged.
  • Monitor Calcium Levels: Your doctor may check your blood calcium levels before and during treatment, particularly if you have kidney disease or are at risk of low calcium.
  • Inform Your Dentist: Tell your dentist that you are receiving Gennodeb 60 mg PFS Injection 1 ml before undergoing any invasive dental procedures.
  • Do Not Stop Treatment Without Medical Advice: Stopping Gennodeb 60 mg PFS Injection 1 ml suddenly may increase the risk of fractures. Always consult your doctor before discontinuing treatment.
  • Rotate Injection Sites: If self-administering under medical guidance, rotate injection sites with each dose to help reduce local skin reactions.

verifiedApollotooltip

Inform your doctor if you are taking any of the following medicines before using Gennodeb 60 mg PFS Injection 1 ml:

  • Immunosuppressive Medicines: Medicines that suppress the immune system, including certain biologic therapies and chemotherapy, may increase the risk of infections when used with Gennodeb 60 mg PFS Injection 1 ml.
  • Other Bone-Modifying Medicines: Using Gennodeb 60 mg PFS Injection 1 ml with other medicines that affect bone metabolism may require careful monitoring to avoid excessive effects on bone turnover.

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verifiedApollotooltip
  • No clinically significant food interactions are known with Gennodeb 60 mg PFS Injection 1 ml when used as directed.

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All Substitutes & Brand Comparisons

Habit Forming

No

Therapeutic Class

[MONOCLONAL ANTIBODIES]

FAQs

Gennodeb 60 mg PFS 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.
Gennodeb 60 mg PFS 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. Gennodeb 60 mg PFS 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 Gennodeb 60 mg PFS Injection 1 ml. The risk increases in people taking Gennodeb 60 mg PFS 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 Gennodeb 60 mg PFS 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). Gennodeb 60 mg PFS Injection 1 ml helps treat high calcium levels by decreasing bone breakdown.
Unusual thigh bone fractures might occur whilst on treatment with Gennodeb 60 mg PFS Injection 1 ml. Consult your doctor if you experience new or unusual pain in the thigh, hip, or groin.
Gennodeb 60 mg PFS 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.
Gennodeb 60 mg PFS 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.
Gennodeb 60 mg PFS 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 Gennodeb 60 mg PFS Injection 1 ml. However, individual reactions to medications can vary. If you experience hair loss or any unusual symptoms while taking Gennodeb 60 mg PFS Injection 1 ml, consult the doctor to determine the cause and discuss appropriate management options.
No, Gennodeb 60 mg PFS 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.
Gennodeb 60 mg PFS 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 Gennodeb 60 mg PFS Injection 1 ml, as it is not recommended during pregnancy due to the potential risk of harm to the foetus.
Gennodeb 60 mg PFS 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 Gennodeb 60 mg PFS 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.
Yes, most patients are advised to take calcium and vitamin D daily to prevent low blood calcium levels during treatment. Your doctor will recommend the right daily amount for you. Talk to your doctor before starting any new supplements.
Yes, it is highly recommended to have a dental exam and complete any major dental work before starting this medicine. This helps reduce the rare risk of developing serious jawbone problems. Talk to your doctor and dentist for personalised advice.
If you stop this treatment, your bone density can decrease rapidly, and your risk of bone fractures may return to what it was before starting. Never stop your treatment without a detailed discussion with your healthcare provider. Talk to your doctor about alternative options.
Yes, this medicine does not generally affect your ability to drive or operate machinery. However, if you feel dizzy or unwell after your injection, avoid driving until you feel better. Talk to your doctor if you experience unusual symptoms.

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Country of origin

India

Manufacturer/Marketer address

T-184, Midc, Bhosari, Pune 411 026, Maharashtra, India
Other Info - GEN0731
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