Prolia
Prolia (denosumab) is a convenient option for treating osteoporosis because you only need one dose of the medication every 6 months. It's given as an injection under the skin by a healthcare professional (HCP), typically at their clinic or office. Prolia (denosumab) works well to strengthen your bones. But it can cause some common side effects, such as back or muscle pain. Prolia (denosumab) can also cause your blood calcium levels to drop dangerously low, so your HCP will order blood work regularly during treatment.
What is Prolia (denosumab)?
What is Prolia (denosumab) used for?
Osteoporosis in females who've gone through menopause
Osteoporosis in males
Osteoporosis caused by certain steroid medications
Bone loss in males taking certain medications for prostate cancer
Bone loss in females taking certain breast cancer medications
How Prolia (denosumab) works
Prolia (denosumab) is a monoclonal antibody. It blocks a protein in your body that sends signals to break down your bones. This prevents bone loss and helps strengthen your bones.
Drug Facts
More on Prolia (denosumab) essentials
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What are the side effects of Prolia (denosumab)?
Common Side Effects
- Back pain (35%)
- Pain in your arms and legs (12%)
- Pain in your muscles, bones, joints, or nerves (up to 8%)
- High cholesterol levels (8%)
- Pain or discomfort while urinating and other symptoms of a bladder infection (6%)
- Sensation that the room is spinning (5%)
- Swelling in the hands and feet (5%)
- Cough, sore throat, and other symptoms of an upper respiratory tract infection (5%)
Other Side Effects
- Chest pain
- Stomach pain
- Passing gas
- Heartburn
- Feeling weak
- Trouble sleeping
- Rash, itching
Serious Side Effects
- Serious allergic reactions: dizziness, trouble, tightness in your throat, swelling in your face and throat, itchiness, rash
Source: DailyMed
More on Prolia (denosumab) side effects
The following side effects have also been reported
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor or nurse immediately if any of the following side effects occur:
More common
Back pain
blistering, crusting, irritation, itching, or reddening of the skin
bloody or cloudy urine
cracked, dry, or scaly skin
difficult, burning, or painful urination
frequent urge to urinate
muscle or bone pain
pain in the arms or legs
rash
skin rash, encrusted, scaly, and oozing
swelling
Less common
Arm or jaw pain
bloating or swelling of the face, arms, hands, lower legs, or feet
body aches or pain
chest pain or discomfort
chest tightness or heaviness
chills
confusion
congestion
difficulty with breathing
difficulty with moving
dryness or soreness of the throat
ear congestion
fast or irregular heartbeat
headache
hoarseness
joint pain
loss of voice
muscle cramps in the hands, arms, feet, legs, or face
muscle stiffness
numbness and tingling around the mouth, fingertips, hands, or feet
pain in the lower back, bottom, upper leg, or hips
painful blisters on the trunk of the body
pale skin
rapid weight gain
runny or stuffy nose
seizures
stomach cramps
swollen joints
tender, swollen glands in the neck
trouble swallowing
troubled breathing with exertion
unusual bleeding or bruising
unusual tiredness or weakness
unusual weight gain or loss
voice changes
Rare
Blood in the stool
change in bowel habits
clear or bloody discharge from the nipple
darkened urine
difficulty with eating
dimpling of the breast skin
indigestion
inverted nipple
itching, pain, redness, swelling, tenderness, or warmth on the skin
loss of appetite
lower back or side pain
lump in the breast or under the arm
lump or swelling in the abdomen or stomach
pains in the stomach, side, or abdomen, possibly radiating to the back
persistent crusting or scaling of the nipple
raised, firm, and bright red patches of the skin on the arm or leg
redness or swelling of the breast
sore on the skin of the breast that does not heal
stomach discomfort
unexplained weight loss
vomiting
yellow eyes or skin
Incidence not known
Heavy feeling in the jaw
loose teeth
pain, swelling, or numbness in the mouth or jaw
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
Less common
Dizziness or lightheadedness
excess air or gas in the stomach or bowels
feeling of constant movement of self or surroundings
feeling of fullness
lack or loss of strength
passing gas
redness, pain, itching, burning, swelling, or a lump under your skin where the shot was given
sensation of spinning
trouble sleeping
upper abdominal or stomach pain
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
Pros and cons of Prolia (denosumab)
Pros
Works well at preventing bone loss, which lowers your risk of broken bones
Only given once every 6 months, which is less often than most other osteoporosis treatments)
A possible option for people who can't take first-choice medications for osteoporosis
Cons
Must be taken with calcium and vitamin D supplements
Not safe during pregnancy
Can cause bone and muscle pain
Pharmacist tips for Prolia (denosumab)
It's important that you take calcium and vitamin D supplements every day while you're taking Prolia (denosumab). This will help keep your bones healthy and strong. Most people will need to take at least 1,000 mg of calcium and 400 IU (international units) of vitamin D every day. Talk with your provider if you're not such how much calcium and vitamin D you need.
Remember to schedule your appointment to get your injection every 6 months from your provider. If you miss a dose of Prolia (denosumab), make an appointment with your provider to get the injection as soon as possible. For the following injections, schedule your appointment every 6 months from the date of your last injection.
Typically, you need to receive Prolia (denosumab) at your provider's office. If you're not able to come in for your appointment, let your provider know as soon as possible; they can talk with you about other options.
Don't stop taking Prolia (denosumab) or skip doses without talking to your provider. Your risk of broken bones, including in your spine, is higher if you stop taking the medication or skip doses.
If you're pregnant, don't take Prolia (denosumab). The medication can harm your unborn baby. Let your provider know right away if you become pregnant while you're taking this medication. Make sure to use a reliable form of birth control while you're taking Prolia (denosumab) and for at least 5 months after you stop the medication.
If you're having any dental procedures done, make sure to let your dentist or oral surgeon know you're taking Prolia (denosumab) because it can cause jaw bone problems.
Prolia (denosumab) can cause a rash or eczema. If you experience redness, itching, small bumps, dryness, oozing or crusty blisters, or peeling skin that doesn't go away, let your provider know.
If you're taking Xgeva (denosumab) for bone health or high calcium levels, don't take Prolia (denosumab) because they have the same active ingredient. If they are both taken together, your risk of side effects will be higher.
Frequently asked questions about Prolia (denosumab)
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What are the risks and warnings for Prolia (denosumab)?
Prolia (denosumab) can cause some serious health issues. This risk may be even higher for certain groups. If this worries you, talk to your doctor or pharmacist about other options.
Dangerously low calcium levels
Risk factors: Serious kidney problems | Receiving dialysis | Not taking calcium supplements | Taking other medications that can lower calcium blood levels | Conditions that affect how well your body absorbs minerals | Surgery to remove your small intestine | History of hypoparathyroidism (low levels of parathyroid hormone) or thyroid surgery
Prolia (denosumab) can cause calcium levels to drop dangerously low. Your risk of this side effect is higher if you have serious kidney problems, have a condition called mineral and bone disorder (CKD-MBD), or are taking other medications that can lower calcium levels, such as cinacalcet (Sensipar).
Your provider will monitor your calcium and other mineral levels within 2 weeks after your Prolia (denosumab) injection. They'll continue to monitor your calcium levels weekly for the first month after your injection, then monthly after that.
It's important that you take calcium and vitamin D supplements while you're taking Prolia (denosumab) in order to keep your calcium level within a safe range. Let your provider know if you experience symptoms of very low calcium levels, such as confusion, muscle spasms or cramps, and numbness and tingling in the hands, feet, and face.
Thigh bone fractures
Risk factors: Taking steroid medications
People taking Prolia (denosumab) have experienced unusual thigh fractures, sometimes without any falls or injuries occurring to the area. It's unclear if Prolia (denosumab) is the cause of the fractures. If you experience any new or unusual hip, thigh, or groin pain, let your provider know so they can monitor you for any fractures.
Spine fractures after stopping Prolia (denosumab) treatment
Risk factors: Stopping Prolia (denosumab) treatment or skipping doses | History of fractures | History of osteoporosis
When you stop taking Prolia (denosumab) or skip doses, your risk of broken bones rises, including the risk of spine fractures. Spine fractures can occur as early as 7 months after you stop taking Prolia (denosumab). Before you start taking Prolia (denosumab), let your provider know if you've ever fractured your spine so you can discuss the risks and benefits of taking this medication. To lower your risk of spine fractures, your provider might suggest you start taking another medication for osteoporosis after you stop taking Prolia (denosumab).
Risk of serious infections
Risk factors: Weak immune system | Taking medications that affect your immune system (such as transplant medications or steroids)
People taking Prolia (denosumab) have reported serious infections. This includes infections that affect the skin, stomach, bladder, ear, and lining of their heart (endocarditis). Your risk of infection is higher if you have a weakened immune system or if you take other medications that affect your immune system. Let your provider know if you experience any symptoms of infection, such as fever, cough, trouble breathing, skin redness or swelling, serious stomach pain, or frequent or painful urination.
Problems in the jaw bone (osteonecrosis)
Risk factors: Oral or dental procedures | Cancer diagnosis | Taking steroid medications or chemotherapy | Poor oral hygiene | History of dental diseases | Low red blood cell counts or clotting disorders | Infection | Wearing dentures that don't fit well
Although it's rare, Prolia (denosumab) can cause your jawbone to break down. This is more likely to happen if you've had dental procedures done while you're taking the medication, if you have cancer, poor mouth hygiene, certain dental diseases, low red blood cell counts, blood clotting disorders, some sort of infection, if you wear dentures that don't fit, if you take steroid medications, or if you're getting chemotherapy. To lower your risk, practice good mouth hygiene, such as brushing and flossing your teeth multiple times per day. Your provider might suggest you have a dental exam before you start taking Prolia (denosumab). If you notice pain or swelling in your jaw, talk to your provider right away. If you have a dental procedure planned while you're taking this medication, let your provider know so you can discuss the risks and benefits of continuing this medication or having the procedure done.
Serious allergic and skin reactions
Some people reported serious allergic or skin reactions after starting Prolia (denosumab). Let your provider know right away if you experience serious rash, swelling, itching, trouble breathing, or tightening of your throat. Your provider will likely ask you to stop Prolia (denosumab) and consider other options.
Bone or muscle pain
Though not common, people have reported severe bone, joint or muscle pain after starting Prolia (denosumab). This might happen anytime from a day to several months after you've begun treatment. Let your provider know if you experience severe pain because they might consider other treatment options for you.
Prolia (denosumab) dosage forms
Typical dosing for Prolia (denosumab)
Prolia (denosumab) is an injection that's typically given to you by your healthcare provider.
The typical recommended dose is 60 mg injected under the skin of your upper arm, upper thigh, or stomach once every 6 months.
More on Prolia (denosumab) dosage forms
Interactions between Prolia (denosumab) and other drugs
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Tofacitinib
How much does Prolia (denosumab) cost?
Prolia (denosumab) contraindications
Low calcium levels
Currently pregnant
What are alternatives to Prolia (denosumab)?
Osteoporosis in females who've gone through menopause
Osteoporosis in males
Osteoporosis caused by certain steroid medications
Bone loss in males taking certain medications for prostate cancer
Bone loss in females taking certain breast cancer medications
Prevention and treatment of osteoporosis in females
Treatment of osteoporosis in males
Osteoporosis in females who've gone through menopause (postmenopause)
Osteoporosis in males
Osteoporosis caused by long-term use of corticosteroids
What is the latest news about Prolia (denosumab)?
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References
Best studies we foundAmerican Cancer Society. (2021). Aromatase inhibitors for lowering breast cancer risk.
Amgen Inc. (2020). At-home nurse injection program.
Amgen Inc. (2023). Prolia-denosumab injection [package insert]. DailyMed.
Amgen Inc. (n.d.). Compared to other osteoporosis treatments, only Prolia® is 1 shot every 6 months.
Dourra, M., et al. (2021). Denosumab-induced alopecia areata with lichenoid eruption. JAAD Case Reports.
Fang, D., et al. (2019). Androgen deprivation therapy in nonmetastatic prostate cancer patients: Indications, treatment effects, and new predictive biomarkers. Asia-Pacific Journal of Clinical Oncology.
Ganesan, K., et al. (2023). Biphosphonate. StatPearls.
Goyal, A., et al. (2023). Hypocalcemia. StatPearls.
Lyakhovitsky, A., et al. (2016). Alopecia areata after denosumab treatment for osteoporosis. JAAD Case Reports.
National Institute of Diabetes and Digestive and Kidney Diseases. (2021). Mineral & bone disorder in chronic kidney disease.
Song, M. (2019). Dental care for patients taking antiresorptive drugs: A literature review. Restorative Dentistry & Endodontics.
U.S. Food and Drug Administration. (2024). Prolia (denosumab): Drug safety communication - FDA adds boxed warning for increased risk of severe hypocalcemia in patients with advanced chronic kidney disease.
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