Prolia (Denosumab)
Complete patient guide for uses, dosage, side effects, and safety information
Prescription RequiredQuick Facts
What Is Prolia Used For?
Prolia contains denosumab, a protein that helps strengthen bones by preventing bone-removing cells from damaging your bones. It’s specifically designed to improve bone density and reduce your risk of fractures.
Primary Uses
Prolia is used to treat osteoporosis in women after menopause, men with osteoporosis, and men with prostate cancer who have reduced testosterone levels from surgery or treatment. It’s also used to improve bone density in patients taking corticosteroids.
How It Works
Denosumab is a protein (monoclonal antibody) that attaches specifically to another protein in your body to stop the development of bone-removing cells before they reach your bones and cause damage. This makes your bones stronger and less likely to break.
Good to know: Continued treatment with Prolia makes your bone stronger and less likely to break over time.
How to Take Prolia
Prolia is given as an injection under the skin (subcutaneous injection) by a healthcare professional. It’s important to stay on schedule with your injections for the best results.
Dosage Instructions
The recommended dose is 60 mg given once every 6 months as a single injection under the skin. You should also take calcium and vitamin D supplements as recommended by your doctor while receiving Prolia.
What If You Miss a Dose?
If you miss a dose, Prolia should be given as soon as possible. From then on, schedule your next injection 6 months from the date of the last injection. Use the reminder card provided to keep track of your next injection date.
Important: Do not stop or delay Prolia treatment without talking to your doctor. Stopping treatment may worsen your condition or increase your chance of breaking bones.
Side Effects
Like all medications, this medicine can cause side effects. Most are mild and temporary, but some require medical attention.
Common Side Effects
These side effects occur relatively frequently and usually don’t require emergency care:
- Back, muscle or joint pain or stiffness (especially hips, knees, spine)
- Pain in arms or legs
- Aching muscles, muscle tenderness or weakness
- Unusual hair loss or thinning
- Itchy, red or dry skin
- Ear pain, discharge or infection
- Blurred or cloudy vision
- High cholesterol levels
Seek immediate medical attention if you experience:
- Signs of allergic reaction (shortness of breath, wheezing, swelling, rash, hives)
- Low blood calcium symptoms (muscle spasms, twitches, numbness, tingling, seizures)
- Mouth or jaw problems (persistent pain, swelling, non-healing sores, loose teeth)
- Bone fractures (severe pain in hip, groin, thigh, or spine)
- Skin infection (swollen, red, hot, tender skin with fever and chills)
- Upper abdominal pain with back pain, nausea, vomiting, fever
- Pain in hands and feet
- Severe allergic reaction with skin rash, blisters or fever
- Purple or brownish-red spots, hives or skin sores
Important Warnings
Before starting Prolia, it’s crucial to discuss your medical history and current health conditions with your doctor to ensure this medication is safe for you.
Who Should Not Take Prolia
Do not use Prolia if you have low calcium levels in your blood, are pregnant or breastfeeding, are allergic to denosumab or medicines produced using Chinese Hamster Ovary cells, are under 18 years old, are taking another medicine containing denosumab, or if the medication is expired or damaged.
Medical Conditions to Discuss
Tell your doctor if you have calcium or vitamin D deficiency, severe kidney problems or kidney failure, dental problems or jaw pain, sugar intolerance, or if you’re unable to take daily calcium or vitamin D supplements. You may have higher risk of jaw problems if you’re undergoing chemotherapy, taking steroids, having dental procedures, or have poor dental care.
Pregnancy and Breastfeeding
Do not use Prolia if you are pregnant, think you may be pregnant, or trying to get pregnant, as it may harm your unborn baby. Do not use if breastfeeding, as it’s unknown if denosumab passes into breast milk. Females who are menstruating should ensure adequate contraception while taking Prolia.
Severe calcium deficiency: Severe low blood calcium levels may lead to hospitalization, life-threatening events and death. Your doctor will monitor your blood calcium levels, especially in the first few weeks.
Drug Interactions
Tell your doctor about all medicines you’re taking, including prescription drugs, over-the-counter medications, vitamins, and supplements.
- Another medicine containing denosumab (Xgeva) – do not take together
- Medicines, vitamins or supplements from pharmacy, supermarket or health food shop
Alcohol & Driving
While Prolia has no known effects on your ability to drive or use machines, take general precautions, especially soon after receiving an injection.
Alcohol
No specific alcohol interactions are mentioned, but drinking alcohol is listed as a risk factor that can increase fracture risk.
Driving and Operating Machinery
Be careful before you drive or use any machines or tools until you know how Prolia affects you. As a general precaution, if you’re driving soon after an injection, arrange to have someone else drive.
Storage
Store Prolia in the refrigerator between 2°C and 8°C in the original carton to protect from light. Do not freeze or shake the pre-filled syringe. The medicine may be left at room temperature (up to 25°C) for up to 30 minutes before injection to make it more comfortable, but must be used within 30 days if left at room temperature. Keep out of reach of children.
Overdose Information
If you think you or anyone else has received too much Prolia, immediately phone the Poisons Information Centre (13 11 26), contact your doctor, or go to the Emergency Department at your nearest hospital. Do this even if there are no signs of discomfort or poisoning.
Frequently Asked Questions
Prolia helps control your condition but does not cure it. You must continue treatment every 6 months for as long as your doctor tells you to. Your doctor may recommend tests, X-rays, and bone density scans from time to time to make sure the medicine is working.
No, do not stop or delay Prolia treatment without talking to your doctor. Stopping, skipping or delaying treatment may worsen your condition or increase your chance of breaking bones, especially in your spine if you have a history of spinal fractures.
Practice good dental hygiene including brushing teeth and tongue after every meal and gentle flossing daily. Use a mirror to check for changes like sores or bleeding gums. Tell your doctor and dentist immediately if you notice any problems. Your doctor may ask for a dental examination before starting Prolia.
Yes, you should take calcium and vitamin D supplements as recommended by your doctor while receiving Prolia. Most people don’t get enough calcium and vitamin D in their diet, and supplements are needed to help strengthen bones and prevent low calcium levels.
If you miss a dose, Prolia should be given as soon as possible. From then on, schedule your injections every 6 months from the date of the last injection. Use the reminder card provided to keep track of your next injection date.
No, do not use Prolia in children or adolescents under 18 years of age. Prolia is not indicated for use in patients under 18.
Tell any doctor, dentist, nurse, or pharmacist you visit that you are using Prolia. If you’re about to start any other medicine, remind your healthcare provider that you’re being treated with Prolia.
Important Disclaimer
This information is intended for general educational purposes only and should not be considered medical advice. Always consult your healthcare provider or pharmacist before starting, stopping, or changing any medication.
If you think you may have a medical emergency, call your doctor or emergency services immediately.