Denomab 60 Pre-Filled Syringe

✔️ Side Effects

• Musculoskeletal (bone, muscle, or joint) pain
• Pain in the extremities
• Nerve pain
• Constipation
• Rash
• Urinary tract infection

✔️ Denomab® 60 is indicated for:

Treatment of osteoporosis in postmenopausal women and in men at high risk of fracture

Increase in bone mass in men receiving androgen deprivation therapy for non-metastatic prostate cancer who are at high fracture risk

Increase in bone mass in women receiving adjuvant aromatase inhibitor therapy for breast cancer who are at high fracture risk

Prevention of skeletal-related events (such as pathological fractures, spinal cord compression, need for bone radiation or surgery) in adults with bone metastases from solid tumors

Treatment of giant cell tumor of bone in adults and skeletally mature adolescents, when the tumor is unresectable or surgical resection would result in severe morbidity

✔️ Therapeutic Benefits

• Strengthens bone structure
• Reduces the risk of fractures
• Improves bone density and mass
• Helps prevent complications related to bone metastases

✔️ Route of Administration

• It should not be self-administered
• Administer subcutaneously (SC) in the upper arm, upper thigh, or abdomen
• Do NOT administer intradermally, intramuscularly, or intravenously
• Avoid vigorous shaking of the vial or prefilled syringe
• Use regularly as prescribed by the doctor for maximum benefit
• Continue treatment for the full duration recommended, even if symptoms improve
• Adequate calcium and vitamin D supplementation is essential during therapy

✔️ Dosage | Denosumab Injection

Adult Dosage

Osteoporosis

Denosumab 60 mg SC every 6 months

Supplement with:

Calcium 1000 mg/day

Vitamin D 400 IU/day

Aromatase Inhibitor–Induced Bone Loss

Women with breast cancer:

60 mg SC every 6 months

Androgen Deprivation Therapy–Induced Bone Loss

Men with prostate cancer:

60 mg SC every 6 months

Prevention of Skeletal-Related Events (SREs)

Patients with bone metastases from solid tumors:

Denosumab 120 mg (1.7 mL) SC every 4 weeks

Giant Cell Tumor of Bone

Adults and skeletally mature adolescents where surgery is not feasible or would result in severe morbidity:

120 mg SC every 4 weeks

Additional 120 mg doses on Days 8 and 15 during the first month of treatment

Hypercalcemia of Malignancy

Refractory to bisphosphonate therapy:

120 mg SC every 4 weeks

Additional 120 mg doses on Days 8 and 15 during the first month

Special Populations

Elderly

No dosage adjustment required based on current safety and efficacy data

Hepatic Impairment

Safety and efficacy have not been established

Renal Impairment

No dosage adjustment is required in patients with renal impairment

Patients with severe renal dysfunction (CrCl <30 mL/min) or those on dialysis have a higher risk of hypocalcemia

Adequate calcium and vitamin D intake is essential in these patients

✔️ Drug Interactions

Increased risk of serious infections when used concomitantly with immunosuppressive agents

Denosumab does not affect CYP3A4 metabolism and does not alter the pharmacokinetics of midazolam

Incompatibility: Denosumab must not be mixed with other medicinal products

✔️ Important Warnings & Precautions

• Skin infections, particularly cellulitis, may occur during therapy
• Osteonecrosis of the jaw (ONJ) has been reported, especially in patients with advanced malignancy
• Atypical femoral fractures have been observed with long-term use
• Patients with severe renal impairment or those undergoing dialysis are at increased risk of hypocalcemia and require close monitoring
• Use during lactation is not recommended due to lack of safety data

✔️ Denosumab is contraindicated in patients with:

• Clinically significant hypersensitivity to denosumab or any formulation component
• Hypocalcemia (must be corrected before initiating therapy)
• Pregnancy and breastfeeding
• Children and adolescents

Patients should receive adequate calcium and vitamin D supplementation during treatment unless hypercalcemia is present.

✔️ Adverse Effects

Very Common (>10%)

• Back pain (34.7%)
• Pain in extremities (11.7%)

Common (1–10%)

• Musculoskeletal pain (7.6%)
• Hypercholesterolemia (7.2%)
• Cystitis (5.9%)
• Upper respiratory tract infection (4.9%)
• New malignancies (4.8%; placebo: 4.3%)
• Sciatica (4.6%)
• Nonfatal serious infections (4%)
• Bone pain (3.7%)
• Anemia (3.3%)
• Upper abdominal pain (3.3%)
• Rash (2.5%)
• Flatulence (2.2%)
• Osteonecrosis of the jaw (2.2%)
• Pruritus (2.2%)
• Hypocalcemia (1.7%)

Rare (<1%)

• Serious abdominal infection requiring hospitalization (0.9%)
• Serious urinary tract infection requiring hospitalization (0.7%)
• Serious infection leading to death (0.2%)
• Pancreatitis (0.2%)
• Serious ear infection requiring hospitalization (0.1%)

✔️ Pregnancy & Lactation Risk

Pregnancy

Contraindicated

Animal studies demonstrate fetal harm, including increased fetal loss, stillbirths, postnatal mortality, lymph node absence, abnormal bone development, and reduced neonatal growth

Findings were observed in cynomolgus monkeys receiving doses up to 50 times the recommended human dose

Contraception Recommendations

Females of reproductive potential should use effective contraception during treatment and for at least 5 months after the final dose

Denosumab is present at very low levels (~2% of serum concentration) in seminal fluid; exposure to female partners is negligible, and condom use is not required

Lactation

It is unknown whether denosumab is excreted in human milk

Effects on breastfed infants and milk production are unknown

Caution is advised; breastfeeding is generally not recommended during therapy

✔️ Storage:

Storage Conditions Store Denomab in a refrigerator at 2°C to 8°C in the original carton. Do not freeze. Once removed from the refrigerator, Denomab must not be exposed to temperatures above 25°C or direct light and must be used within 14 days. Discard Denomab if not used within 14 days. Protect Denomab from direct light and heat. Avoid vigorous shaking of Denomab.