What is Prolia® (denosumab) used for?
Prolia® is a monoclonal antibody. Monoclonal antibodies are made to target and destroy only certain cells in the body. This may help to protect healthy cells from damage.
Prolia® is used to treat osteoporosis in postmenopausal women who have a high risk of bone fracture.
Prolia® is also used to increase bone mass in women and men with a high risk of bone fracture caused by receiving treatments for certain types of cancer.
How should I take Prolia® (denosumab)?
Prolia® is injected under the skin of your stomach, upper thigh, or upper arm. A healthcare provider will give you this injection.
Prolia® is usually given once every 6 months.
Your doctor may have you take extra calcium and vitamin D while you are being treated with Prolia®. Take only the amount of calcium and vitamin D that your doctor has prescribed.
If you need to have any dental work (especially surgery), tell the dentist ahead of time that you are receiving Prolia®.
Pay special attention to your dental hygiene. Brush and floss your teeth regularly while receiving this medication. You may need to have a dental exam before you begin treatment with Prolia®. Follow your doctor’s instructions.
Your risk of bone fractures can increase when you stop using Prolia®. Do not stop using this medicine without first talking to your doctor.
You may take Prolia® syringe out of the refrigerator and allow it to reach room temperature before the injection is given. Do not heat the medicine before using.
Do not shake the prefilled syringe or you may ruin the medicine. Do not use the medicine if it looks cloudy or has particles in it. Call your pharmacist for a new prescription.
Each prefilled syringe of this medicine is for one use only. Throw away after one use, even if there is still some medicine left in it after injecting your dose.
Use a disposable needle and syringe only once. Follow any state or local laws about throwing away used needles and syringes. Use a puncture-proof “sharps” disposal container (ask your pharmacist where to get one and how to throw it away). Keep this container out of the reach of children and pets.
Do not share this medicine with another person, even if they have the same symptoms you have.
How do I store Prolia® (denosumab)?
Prolia® is best stored in the refrigerator. To prevent drug damage, do not freeze. There may be different brands of Prolia® that may have different storage needs. It is important to always check the product package for instructions on storage, or ask your pharmacist. For safety, you should keep all medicines away from children and pets.
You should not flush Prolia® down the toilet or pour them into a drain unless instructed to do so. It is important to properly discard this product when it is expired or no longer needed. Consult your pharmacist for more details about how to safely discard your product.
After you have taken Prolia® out of the refrigerator, you may keep it at room temperature for up to 14 days. Store in the original container away from heat and light.
Precautions & warnings
What should I know before using Prolia® (denosumab)?
Before using this drug, tell your doctor if:
- You are pregnant or breastfeeding. This is because, while you are expecting or feeding a baby, you should only take medicines on the recommendation of a doctor.
- You are taking any other medicines. This includes any medicines you are taking which are available to buy without a prescription, such as herbal and complementary medicines.
- You have allergy with any of active or inactive ingredients of Prolia® or other medications.
- You have any other illnesses, disorders, or medical conditions.
You should not receive Prolia® if you have low levels of calcium in your blood (hypocalcemia).
To make sure Prolia® is safe for you, tell your doctor if you have:
- Kidney disease (or if you are on dialysis)
- A weak immune system (caused by disease or by using certain medicines)
- A history of hypoparathyroidism (decreased functioning of the parathyroid glands)
- A history of thyroid surgery
- A history of surgery to remove part of your intestine
- Any condition that makes it hard for your body to absorb nutrients from food (malabsorption)
- If you are allergic to latex
Prolia® may cause bone loss (osteonecrosis) in the jaw. Symptoms include jaw pain or numbness, red or swollen gums, loose teeth, gum infection, or slow healing after dental work.
Osteonecrosis of the jaw may be more likely if you have cancer or received chemotherapy, radiation, or steroids. Other risk factors include blood clotting disorders, anemia (low red blood cells), and a pre-existing dental problem.
Is it safe during pregnancy or breastfeeding?
There are no adequate studies in women for determining risk when using Prolia® during pregnancy or while breastfeeding. Please always consult with your doctor to weigh the potential benefits and risks before taking Prolia®. Prolia® is pregnancy risk category X, according to the US Food and Drug Administration (FDA).
FDA pregnancy risk category reference below:
- A=No risk
- B=No risk in some studies
- C=There may be some risk
- D=Positive evidence of risk
What side effects can occur from Prolia® (denosumab)?
Get emergency medical help if you have any signs of an allergic reaction to Prolia®: hives, itching, rash; difficult breathing, feeling light-headed; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have:
- New or unusual pain in your thigh, hip, or groin
- Severe pain in your joints, muscles, or bones
- Skin problems such as dryness, peeling, redness, itching, blisters, bumps, oozing, or crusting
- Low levels of calcium in your blood (hypocalcemia) – numbness or tingly feeling around your mouth or in your fingers or toes, muscle tightness or contraction, overactive reflexes
Serious infections may occur during treatment with Prolia®. Call your doctor right away if you have signs of infection such as:
- Fever, chills, night sweats
- Swelling, pain, tenderness, warmth, or redness anywhere on your body
- Pain or burning when you urinate
- Increased or urgent need to urinate
- Severe stomach pain
- Cough, feeling short of breath
Common side effects may include:
- Bladder infection (painful or difficult urination)
- Back pain, muscle pain
- Pain in your arms or legs
Not everyone experiences these side effects. There may be some side effects not listed above. If you have any concerns about a side-effect, please consult your doctor or pharmacist.
What drugs may interact with Prolia® (denosumab)?
Prolia® may interact with other drugs that you are currently taking, which can change how your drug works or increase your risk for serious side effects. To avoid any potential drug interactions, you should keep a list of all the drugs you are using (including prescription drugs, nonprescription drugs, and herbal products) and share it with your doctor and pharmacist. For your safety, do not start, stop, or change the dosage of any drugs without your doctor’s approval.
Does food or alcohol interact with Prolia® (denosumab)?
Prolia® may interact with food or alcohol by altering the way the drug works or increase the risk for serious side effects. Please discuss with your doctor or pharmacist any potential food or alcohol interactions before using this drug.
What health conditions may interact with Prolia® (denosumab)?
Prolia® may interact with your health condition. This interaction may worsen your health condition or alter the way the drug works. It is important to always let your doctor and pharmacist know all the health conditions you currently have.
The information provided is not a substitute for any medical advice. You should ALWAYS consult with your doctor or pharmacist before using Prolia® (denosumab).
What is the dose of Prolia® (denosumab) for an adult?
Prolia® should be administered by a healthcare professional.
The recommended dose of Prolia® is 60 mg administered as a single subcutaneous injection once every 6 months. Administer Prolia® via subcutaneous injection in the upper arm, the upper thigh, or the abdomen. All patients should receive calcium 1000 mg daily and at least 400 IU vitamin D daily.
What is the dose of Prolia® (denosumab) for a child?
The dosage has not been established in pediatric patients. It may be unsafe for your child. It is always important to fully understand the safety of the drug before using. Please consult with your doctor or pharmacist for more information.
How is Prolia® (denosumab) available?
Prolia® is available in the following dosage forms and strengths:
- Injection: denosumab 60mg in 1mL
What should I do in case of an emergency or overdose?
In case of an emergency or an overdose, call your local emergency services or go to your nearest emergency room.
What should I do if I miss a dose?
If you miss a dose of Prolia®, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and take your regular dose as scheduled. Do not take a double dose
Hello Health Group does not provide medical advice, diagnosis or treatment.
Review Date: August 8, 2017 | Last Modified: September 13, 2019