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Prolia
Glaxo SmithKline Pharmaceuticals Ltd
Generic: Denosumab
Safety Advices
বাংলা
English
CAUTION
Caution is advised when consuming alcohol with Prolia. Please consult your doctor.
UNSAFE
Prolia is highly unsafe to use during pregnancy. Seek your doctor's advice as studies on pregnant women and animals have shown significant harmful effects to the developing baby.
SAFE IF PRESCRIBED
Prolia is probably safe to use during breastfeeding. Limited human data suggests that the drug does not represent any significant risk to the baby.
SAFE
Prolia does not usually affect your ability to drive.
SAFE IF PRESCRIBED
Prolia is safe to use in patients with kidney disease. No dose adjustment of Prolia is recommended.
SAFE IF PRESCRIBED
Prolia is probably safe to use in patients with liver disease. Limited data available suggests that dose adjustment of Prolia may not be needed in these patients. Please consult your doctor.
Medicine Overview of Prolia 60mg/ml Injection
Introduction
Prolia is a medicine used in the treatment of osteoporosis in postmenopausal women and in men at increased risk of fractures. It makes the bones strong and reduce the risk of fractures. Prolia is given by a healthcare professional and should not be self-administered. You should use it regularly and at the same time each day to get maximum benefit from it. Continue using it as recommended by your doctor and complete the dose even if you feel better. To make it more effective, take adequate amount of calcium and vitamin D supplements while on treatment with this medicine. Some...
... Show moreUses of Prolia
- Osteoporosis
Side effects of Prolia
Common
- Musculoskeletal (bone, muscle or joint) pain
- Pain in extremity
- Nerve pain
- Constipation
- Rash
- Urinary tract infection
How to use Prolia
Your doctor or nurse will guide you how to use this medicine.
How Prolia works
Prolia is a monoclonal antibody. It binds to a protein that causes bone loss, thereby strengthening the bone and minimizing the risk of fractures.
What if you forget to take Prolia?
If you miss a dose of Prolia, please consult your doctor.
Quick Tips
- Xgeva Solution for Injection is a medication used to treat thinning of the bones (called osteoporosis).
- Take calcium and vitamin D to help build your bones when taking Xgeva Solution for Injection.
- Do not take if you are pregnant or plan to become pregnant.
- May cause a rare problem of the jaw (osteonecrosis), mostly seen after a dental procedure. Tell your doctor if you develop sudden jaw pain.
- Xgeva Solution for Injection may also increase the risk of infection. Avoid being close to people with cold, flu or other contagious illnesses.
- Tell your doctor if you develop a rash while taking Xgeva Solution for Injection.
Brief Description
Indication
Osteoporosis, treatment of men and postmenopausal women with osteoporosis who are at high risk for fracture; treatment to increase bone mass in men at high risk for fracture who are receiving androgen deprivation therapy for nonmetastatic prostate cancer; treatment to increase bone mass in women at high risk for fracture who are receiving adjuvant aromatase inhibitor therapy for breast cancer. Prevention of skeletal-related events (eg, pathological fracture, bone radiation, spinal cord compression or bone surgery) in adults w/ bone metastases from solid tumours. Adults & skeletally mature adolescents w/ giant cell tumor of bone that is unresectable or where surgical...
... Show moreAdministration
Administer SC in upper arm, upper thigh, or abdomen; do NOT administer intradermally, IM, or IV
Administer calcium and vitamin D as needed to treat or prevent hypocalcemia
Avoid vigorous shaking of vial/syringe
Adult Dose
Denosumab 60mg Subcutaneous Osteoporosis 60 mg SC every 6 months Supplement with calcium 1000 mg/day and vitamin D 400 IU/day Aromatase Inhibitor Induced Bone Loss Women with breast cancer: 60 mg SC every 6 months Androgen Deprivation Induced Bone Loss Men with prostate cancer: 60 mg SC every 6 months Denosumab 120mg Subcutaneous Skeletal-Related Events Prevention of skeletal-related events (SREs; eg, bone fractures and pain) in patients with bone metastases from solid tumors 120 mg (1.7 mL) SC every 4 weeks Giant Cell Tumor Treatment of adults and skeletally mature adolescents with giant cell tumor of bone in whom surgical...
... Show moreRenal Dose
Renal Impairment: Based on the available safety and efficacy data in the elderly, no dosage adjustment is required in patients with renal impairment.
Patients with severe renal impairment [creatinine clearance (CrCl) <30 mL/min] or receiving dialysis are at greater risk of developing hypocalcemia. Adequate intake of calcium and vitamin D is important in patients with severe renal impairment or receiving dialysis.
Contraindication
Clinically significant hypersensitivity to denosumab or to any of the components. Hypocalcemia.
Mode of Action
Denosumab is a human monoclonal antibody (IgG2) that targets and binds with high affinity and specificity to receptor activator of nuclear factor kappa-B ligand (RANKL) preventing RANKL from activating its only receptor, RANK, on the surface of osteoclasts and their precursors, independent of bone surface. Prevention of the RANKL/RANK interaction inhibits osteoclast formation, function and survival. Denosumab therefore reduces bone resorption and increases bone mass and strength in both cortical and trabecular bone.
Precaution
Correct hypocalcemia prior to initiation of therapy. Patients should receive Ca & vit D supplements during treatment (unless hypercalcemia is present). Skin infections predominantly cellulitis may develop. Osteonecrosis of the jaw in patients w/ advanced cancer. Atypical femoral fracture. Severe renal impairment or undergoing dialysis. Pregnancy & lactation. Childn.
Lactation: Unknown whether drug is distributed in breast milk; caution is advised
Side Effect
>10%
Back pain (34.7%),Extremity pain (11.7%)
1-10%
Musculoskeletal pain (7.6%),Hypercholesterolemia (7.2%),Cystitis (5.9%),Upper respiratory tract infection (4.9%),New malignancies (4.8%, compared with 4.3% in placebo group),Sciatica (4.6%),Nonfatal serious infection (4%),Bone pain (3.7%),Anemia (3.3%),Upper abdominal pain (3.3%),Rash (2.5%),Flatulence (2.2%),Osteonecrosis of jaw (2.2%),Pruritus (2.2%),Hypocalcemia (1.7%)
<1%
Serious infection of abdomen resulting in hospitalization (0.9%),Serious infection of urinary tract resulting in hospitalization (0.7%),Serious infection resulting in death (0.2%),Pancreatitis (0.2%),Serious infection of ear resulting in hospitalization (0.1%)
Pregnancy Category Note
Pregnancy Contraindicated Based on findings in animals and its mechanism of action, denosumab can cause fetal harm when administered to a pregnant woman In utero exposure in cynomolgus monkeys dosed monthly with denosumab throughout pregnancy at a dose 50-fold higher than the recommended human dose based on body weight resulted in increased fetal loss, stillbirths, and postnatal mortality, and absent lymph nodes, abnormal bone growth, and decreased neonatal growth Present at low concentrations (~2% of serum exposure) in seminal fluid of male subjects receiving therapy; following vaginal intercourse, maximum amount of denosumab delivered to a female partner would result in...
... Show moreInteraction
Increased risk of serious infections w/ immunosuppressive agents.Denosumab did not affect the pharmacokinetics of midazolam, a drug metabolised by cytochrome P450 3A4 (CYP3A4).
Incompatibilities:Denosumab must not be mixed with other medicinal products.
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