Denuril Inj

DENURIL INJ

Name

• Brand Name: DENURIL INJ by ALKEM BERGEN - ASTA (also marketed by Alkem Laboratories Ltd.)
• Common Name: Denosumab Injection

Composition

• Active Ingredient: Denosumab 60 mg/mL

Uses

DENURIL INJ, a RANK ligand inhibitor, is prescribed for various bone-related conditions:

• Osteoporosis: Treatment of osteoporosis in postmenopausal women and men with an increased risk of fractures.
• Bone Loss:
  • Due to hormonal therapy in breast or prostate cancer.
  • Occurring due to long-term treatment with glucocorticoids in patients at increased fracture risk.
• Giant Cell Tumors of Bone (GCTB): To slow tumor growth by blocking specific receptors in tumor cells.
• Cancer-Related Bone Complications:
  • To reduce the risk of fractures in people with multiple myeloma.
  • To treat bone metastases (cancer that has spread to the bones).
  • To treat high calcium levels (hypercalcemia of malignancy) caused by cancer.

Dosage and Administration

DENURIL INJ is administered subcutaneously (under the skin) in the upper arm, upper thigh, or stomach area by a healthcare professional. It should not be self-administered. The typical dosage is usually once every 6 months. The specific dosage and duration of treatment are determined by the healthcare provider based on the individual's medical condition and response. Adequate calcium and vitamin D supplementation are often advised during treatment.

Side Effects

Common Side Effects:

• Bone, joint, or muscle pain
• Arm or leg pain
• Abdominal discomfort or pain
• Constipation
• Painful or frequent urination
• Injection site reactions (redness, swelling, bruising)
• Headache
• Rash or eczema
• Upper respiratory tract infection
• Hair loss
• Nerve pain/Sciatica

Serious Side Effects:

• Osteonecrosis of the jaw (ONJ)
• Atypical femoral fractures
• Hypocalcemia (very low blood calcium levels), which may cause muscle cramps, spasms, or numbness.
• Increased risk of infection

Precautions

• Pregnancy and Breastfeeding: DENURIL INJ is highly unsafe during pregnancy and must be avoided. Women of child-bearing potential should use effective contraception during treatment and for at least 5 months after the last dose. Consultation with a doctor is crucial if breastfeeding.
• Dental Health: Due to the risk of osteonecrosis of the jaw, patients should maintain good oral hygiene and have regular dental check-ups. Report any jaw pain, loose teeth, discharge, swelling, or non-healing sores to your doctor and dentist immediately.
• Pre-existing Conditions: Inform your doctor if you have low calcium levels, kidney dysfunction, liver problems, poor dental health, gum problems, a weak immune system, hypoparathyroidism, malabsorption, latex allergy, a history of thyroid surgery, or a planned dental procedure.
• Drug Interactions: Inform your doctor about all other medicines you are taking, especially glucocorticoids.
• Pediatric Use: DENURIL INJ is not recommended for children and adolescents under 18 years of age.
• Alcohol Consumption: Caution is advised when consuming alcohol.
• Kidney Function: Close monitoring of renal function may be necessary for patients with moderate kidney impairment.

Storage

DENURIL INJ should be stored in a refrigerator at 2°C to 8°C (36°F to 46°F) in its original carton to protect it from light, moisture, and heat. Do not freeze the medicine. If removed from the refrigerator, it can be kept at room temperature (up to 25°C or 77°F) in its original carton and must be used within 14 days. Keep out of reach and sight of children and pets.

DENURIL INJ (Denosumab) FAQs

Denuril Injection, with the active ingredient Denosumab, is a medication primarily used to manage various bone conditions. It is manufactured by ALKEM BERGEN - ASTA.

What is Denuril Injection used for?

Denuril Injection is used to treat several conditions related to bone health. It is prescribed for osteoporosis, which is characterized by weakened bones, in postmenopausal women and men who have an increased risk of fractures. It also helps prevent bone complications in patients with certain types of cancer, such as multiple myeloma and bone metastases (cancer that has spread to the bones). Additionally, it treats bone loss resulting from reduced testosterone levels due to surgery or hormone therapy for prostate cancer, as well as bone loss caused by glucocorticoid treatment. It can also be used for giant cell tumors of the bone (GCTB) and to manage high calcium levels in the blood caused by cancer.

How does Denuril Injection work?

Denuril Injection contains Denosumab, which is a monoclonal antibody. It works by targeting and inhibiting a protein called RANK ligand (RANKL). RANKL is a key protein involved in the formation, function, and survival of osteoclasts, which are cells responsible for breaking down bone tissue. By blocking RANKL, Denosumab reduces the activity of these bone-resorbing cells, leading to increased bone density and reduced risk of fractures. In cases of giant cell tumors of the bone, it also helps slow tumor growth by blocking specific receptors in the tumor cells.

What is the usual dosage for Denuril Injection?

Denuril Injection is administered as a subcutaneous injection (under the skin) in the upper arm, upper thigh, or stomach area by a healthcare professional; it should not be self-administered. The specific dosage and duration of treatment are determined by the individual's medical condition and response to the medication. For the treatment of osteoporosis, it is typically given once every six months. For the prevention of skeletal-related events in multiple myeloma, a common dosage is 60mg given subcutaneously every four weeks. It is crucial to take adequate calcium and vitamin D supplements throughout the treatment period to help build bones and prevent low calcium levels.

What are the possible side effects of Denuril Injection?

Like all medications, Denuril Injection can cause side effects, though not everyone experiences them. Serious side effects can include osteonecrosis of the jaw (severe jaw bone decay), atypical femoral fractures, and hypocalcemia (low blood calcium levels). Common side effects may include injection site reactions, back pain, musculoskeletal (bone, muscle, or joint) pain, pain in extremities (arms or legs), infections (such as urinary tract infections or upper respiratory tract infections), abdominal pain or discomfort, headache, hypophosphatemia (low blood phosphate levels), constipation, rash, eczema, nerve pain, hair loss, hypercholesterolemia, cystitis, and sciatica. It is important to inform your doctor if any side effects persist or worsen.

Is Denuril Injection safe during pregnancy or breastfeeding?

Denuril Injection is considered highly unsafe for use during pregnancy, as studies have shown significant harmful effects to the developing baby. Women of child-bearing potential must use effective contraception during treatment and for at least five months after the last dose. For breastfeeding mothers, Denuril Injection is probably unsafe, as limited human data suggests the drug may pass into breast milk and potentially harm the baby. It is essential to consult your doctor before using this medication if you are pregnant or breastfeeding.

Can Denuril Injection be taken with other medications?

It is crucial to inform your healthcare provider about all prescription, over-the-counter, and herbal medications you are currently taking to avoid potential drug interactions. Specific interactions noted include an increased severity of adverse effects when taken with Beclomethasone dipropionate, increased thrombogenic activity with Ethinylestradiol, increased immunosuppressive activity with Roflumilast, and increased serum concentration with Lopinavir. It is also advised to avoid taking any vaccines during treatment with Denuril Injection. Caution is recommended if you are taking glucocorticoids.

What precautions should be taken with Denuril Injection?

Before starting Denuril Injection, inform your doctor about any allergies or hypersensitivity reactions. Adequate calcium and vitamin D supplementation is vital during treatment. The medication is not approved for use in children and adolescents under 18 years of age. Individuals with pre-existing hypoparathyroidism should use it with caution, as it can affect calcium levels, which require careful monitoring. Regular dental examinations and maintaining good oral hygiene are recommended to minimize the risk of osteonecrosis of the jaw. Caution is advised for patients with moderate renal impairment, requiring close monitoring of kidney function. It is also advisable to avoid alcohol consumption and being close to people with contagious illnesses due to an increased risk of infection. Inform your doctor if you have conditions such as low calcium levels, liver issues, gum problems, a weak immune system, latex allergy, or planned dental procedures.

What happens if a dose of Denuril Injection is missed?

If you miss a dose of Denuril Injection, you should contact your healthcare provider for guidance. It is important to avoid taking double doses to make up for a missed one.

How should Denuril Injection be stored?

Denuril Injection should be stored in the refrigerator at a temperature between 2°C to 8°C (36°F to 46°F). It must not be frozen. Keep the injection in its original package to protect it from light and moisture. It should be kept out of reach and sight of children and pets. Do not store the medication after a single use.