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Prolia
Denosumab
$550.00
60mg · 1 pre-filled syringe · 6 months supply
Brand· By Amgen
$91.67 per month
Brand or generic
Generic packs carry the same active ingredient at the same strength.
How long a supply?
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Annual cost
$1100a year at this pack size
Prescription required
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60mg
FDA boxed warningSevere hypocalcemia in patients with advanced kidney disease
Patients with advanced chronic kidney disease (eGFR < 30 mL/min/1.73 m 2 ), including dialysis-dependent patients, are at greater risk of severe hypocalcemia following Prolia administration. Severe hypocalcemia resulting in hospitalization, life-threatening events and fatal cases have been reported.
The presence of chronic kidney disease-mineral bone disorder (CKD-MBD) markedly increases the risk of hypocalcemia in these patients.
Prior to initiating Prolia in patients with advanced chronic kidney disease, evaluate for the presence of CKD-MBD. Treatment with Prolia in these patients should be supervised by a healthcare provider with expertise in the diagnosis and management of CKD-MBD.
Patients with advanced chronic kidney disease are at greater risk of severe hypocalcemia following Prolia administration. Severe hypocalcemia resulting in hospitalization, life-threatening events and fatal cases have been reported.
About Prolia
Overview
Prolia (denosumab) is a monoclonal antibody medicine given as an injection under the skin. It treats osteoporosis in postmenopausal women and increases bone mass in men with osteoporosis, and it treats osteoporosis caused by glucocorticoids in men and women at high risk of fracture. It also increases bone mass in people at high risk of fracture who are receiving androgen deprivation therapy for nonmetastatic prostate cancer or adjuvant aromatase inhibitor therapy for breast cancer. It blocks a protein called RANKL, reducing the activity of cells that break down bone and increasing bone mass and strength.
What it treats
- Osteoporosis in postmenopausal women at high risk of fracture. - Osteoporosis in men at high risk of fracture, to increase bone mass. - Glucocorticoid-induced osteoporosis in men and women at high risk of fracture. - To increase bone mass in men at high risk of fracture receiving androgen deprivation therapy for nonmetastatic prostate cancer. - To increase bone mass in women at high risk of fracture receiving adjuvant aromatase inhibitor therapy for breast cancer.
Safety information
Side effects
Common side effects vary by the condition being treated. In women with osteoporosis after menopause, they include back pain, pain in the arms or legs, muscle or bone pain, high cholesterol and bladder infection. In men with osteoporosis, they include back pain, joint pain and inflammation of the nose and throat. In people with osteoporosis caused by glucocorticoids, they include back pain, high blood pressure, bronchitis and headache. Joint pain and back pain are common in people treated for bone loss during certain hormone treatments for prostate or breast cancer. Serious risks include severely low blood calcium, severe allergic reactions including anaphylaxis, jawbone damage or death, unusual thighbone fractures, and serious infections that may require hospital treatment. Skin inflammation, rash, eczema and severe bone, joint or muscle pain can also occur. Inflammation of the pancreas has been reported in clinical trials. Seek immediate medical attention for a severe allergic reaction. Contact a doctor promptly for signs of infection, including a skin infection, thigh or groin pain, jaw symptoms, severe skin reactions, or severe bone, joint or muscle pain. Low blood calcium can worsen, especially in people with kidney impairment or those taking calcimimetic medicines. Existing low calcium must be corrected before treatment. Calcium monitoring and adequate calcium and vitamin D supplementation are needed. Multiple spinal fractures have been reported after stopping Prolia. Do not stop treatment without discussing this risk with your prescriber; the label recommends switching to another medicine that reduces bone breakdown if Prolia is stopped.
FDA boxed warning
Severe hypocalcemia in patients with advanced kidney disease
Patients with advanced chronic kidney disease (eGFR < 30 mL/min/1.73 m 2 ), including dialysis-dependent patients, are at greater risk of severe hypocalcemia following Prolia administration. Severe hypocalcemia resulting in hospitalization, life-threatening events and fatal cases have been reported.
The presence of chronic kidney disease-mineral bone disorder (CKD-MBD) markedly increases the risk of hypocalcemia in these patients.
Prior to initiating Prolia in patients with advanced chronic kidney disease, evaluate for the presence of CKD-MBD. Treatment with Prolia in these patients should be supervised by a healthcare provider with expertise in the diagnosis and management of CKD-MBD.
Patients with advanced chronic kidney disease are at greater risk of severe hypocalcemia following Prolia administration. Severe hypocalcemia resulting in hospitalization, life-threatening events and fatal cases have been reported.
A boxed warning is the strongest warning the US Food and Drug Administration requires on a medicine label. Text is taken from the official label, with internal section references removed.
When to call your doctor
If symptoms are severe or getting worse quickly, seek emergency care rather than waiting.
Before taking this medicine
Do not use Prolia if you have low blood calcium, are pregnant, or have had a serious allergic reaction to Prolia or any of its ingredients. Low calcium must be corrected before treatment begins. Allergic reactions have included anaphylaxis, facial swelling and hives. Prolia may harm an unborn baby. If you could become pregnant, a pregnancy test is needed before starting treatment. Use effective contraception during treatment and for at least 5 months after the last dose. Prolia is not approved for children. Kidney impairment requires particular caution. Advanced chronic kidney disease, including kidney disease requiring dialysis, increases the risk of severely low blood calcium. A related mineral and bone disorder increases this risk further. Your clinician should assess for this disorder, monitor blood calcium and ensure adequate calcium and vitamin D supplementation. Calcimimetic medicines can also increase the risk of low calcium. Do not receive other denosumab products while receiving Prolia. Other important risks include jawbone damage, unusual thighbone fractures, serious infections, severe skin reactions, and severe bone, joint or muscle pain. Report thigh or groin pain and jaw symptoms, and seek prompt medical attention for signs of infection. A clinically significant allergic reaction requires permanent discontinuation. Severe skin reactions or severe bone, joint or muscle pain may also require treatment to be stopped by your clinician. Prolia strongly suppresses bone turnover, so monitoring for related problems is needed. Do not stop Prolia without discussing a treatment plan with your prescriber. Multiple spinal fractures have been reported after stopping it. If treatment is discontinued, another medicine that reduces bone breakdown should be arranged.
Interactions
Tell your doctor about all medicines and supplements you take, especially: - Other medicines containing denosumab, which must not be used alongside Prolia. - Medicines that lower blood calcium, such as cinacalcet, which can increase the risk of low calcium during treatment. - Medicines that suppress the immune system, which may increase the risk of serious infections. Discuss your calcium and vitamin D supplements with your doctor, as adequate intake is important during treatment.
Using Prolia
Dosing
Dosing is set by your prescriber. Each health care professional may prescribe medication differently according to a patient's medical history and condition, so follow the directions on your prescription label and speak to your doctor or pharmacist before changing anything.
Storage
Store in the original carton to protect it from light. Check the pack for whether it must be refrigerated before first use. Keep all medicines out of the sight and reach of children.
Clinical information on this page is summarised from the US FDA label PROLIA (DENOSUMAB) INJECTION [AMGEN, INC] (DailyMed, retrieved 19 September 2026).
Patient information and references
Official and supporting information to read alongside advice from your prescriber or pharmacist.
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