Prolia (Denosumab) - Subcutaneous: Uses, Side Effects, Dosages - Verywell Health
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What Is Prolia?
Prolia (denosumab) is used to treat and slow down bone loss to help maintain strong bones and reduce the risk of fractures, usually due to osteoporosis (weak and brittle bones). Prolia is also used to increase bone mass in people receiving specific breast cancer or prostate cancer treatments.
Prolia interferes with the interaction between the RANKL and RANK proteins. Specifically, Prolia is a RANKL inhibitor that prevents RANKL's ability to attach with RANK. This is thought to block osteoclast activity. Osteoclasts are bone cells that play a role in breaking down bones.
Prolia is available as a prescription subcutaneous (under the skin) injection.
Drug Facts
Generic Name: Denosumab
Brand Name(s): Prolia
Drug Availability: Prescription
Therapeutic Classification: RANKL inhibitor
Available Generically: Prolia doesn't currently have a generic version, which is called an interchangeable biosimilar for biologic medications.
Controlled Substance: N/A
Administration Route: Subcutaneous (under the skin)
Active Ingredient: Denosumab
Dosage Form(s): Prefilled subcutaneous injection
What Is Prolia Used For?
Prolia is used as a medication option for osteoporosis. It's also used to improve bone mass in people receiving specific breast or prostate cancer treatments.
Osteoporosis is a medical condition of low bone mass. Millions of people in the United States (U.S.) have this condition. Many people with osteoporosis might not experience symptoms until they experience fractures (breaks) from their brittle and weak bones.
Osteoporosis has several risk factors, which may include:
- Postmenopausal people assigned female at birth: This population experiences low estrogen levels, which raise the likelihood of osteoporosis.
- Corticosteroid (steroid) use: Steroids typically decrease inflammation (swelling). Long-term steroid use, however, can cause bone loss, which raises your osteoporosis risk.
- Certain cancer medications: Specific treatments in breast or prostate cancers affect hormone levels. This may lower your bone mass and increase your risk of osteoporosis.
How to Take Prolia
To receive Prolia, you'll need to see your healthcare provider every six months. During your office visits, your healthcare provider will inject Prolia as a subcutaneous (under the skin) injection in one of the following body areas:
- Upper arm
- Upper thigh
- Stomach
If you're using Prolia to improve your bone mass, you'll also need to take 1,000 milligrams (mg) of calcium and vitamin 400 international units (IU) daily.
Storage
You can only receive Prolia during office visits with your healthcare provider. As a result, you won't usually need to worry about how to store Prolia or travel with this medication.
If you're going to pick Prolia up from the pharmacy before your office visit, place the medication in your refrigerator between 36 degrees to 46 degrees Fahrenheit (F). You can also keep it at room temperature, but make sure the temperature is not more than 77 degrees F. Once it's at room temperature, Prolia will only be good for 14 days. When storing this medication, try to protect it from light and heat. Also, handle this medication with care. Avoid vigorous shaking, and don't freeze it.
If you plan to travel with Prolia, get familiar with your final destination's regulations. Checking with the U.S. embassy or consulate might be a helpful resource. In general, however, make a copy of your Prolia prescription. It's also a good idea to keep your medication in its original container from your pharmacy with your name on the label. Keep this medication with you, and do not place it in the checked luggage. Ask your pharmacist or healthcare provider if you have any questions about traveling with your medicine.
You can also ask your pharmacist or healthcare provider about the best ways to dispose of medications, such as in disposal boxes in your area. The FDA's website is another potentially helpful resource for where and how to discard all unused and expired drugs.
How Long Does Prolia Take to Work?
Within three days of receiving Prolia, you'll likely begin to break down less bone. Maximum effectiveness, however, might require up to one month.
Off-Label Uses
Based on a 2008 clinical study, you might see Prolia used along with methotrexate to treat the bone damage caused by rheumatoid arthritis (RA).
Denosumab is also available as another brand-name product called Xgeva. Compared to Prolia, Xgeva has the following uses:
- Lower bone fracture (break) risk in people with multiple myeloma (a type of blood cancer).
- Treat people with giant cell tumor of bone (GCTB) that can't be safely removed with surgery.
- Treat cancer-related hypercalcemia (high calcium) that didn't improve with a bisphosphonate, such as zoledronic acid (Reclast).
What Are the Side Effects of Prolia?
This is not a complete list of side effects and others may occur. A healthcare provider can advise you on side effects. If you experience other effects, contact your pharmacist or a healthcare provider. You may report side effects to the FDA at fda.gov/medwatch or 800-FDA-1088.
Common Side Effects
Common side effects with Prolia for postmenopausal osteoporosis may include:
For osteoporosis in people assigned male at birth, common side effects with Prolia may include:
If you developed osteoporosis from steroids, Prolia is linked to the following common side effects:
If you're using Prolia for osteoporosis due to specific cancer treatments, typical side effects might include:
- Back pain
- Joint pain
- Pain affecting muscles and bones
- Pain in extremities
Severe Side Effects
Get medical help right away if you develop the following serious side effects:
- Severe allergic reaction: If you have a severe allergic reaction to Prolia, you'll likely experience symptoms of swelling, itchiness, rash, and breathing difficulties.
- Severe infections: Prolia might increase your risk of serious infections, including the skin, ear, stomach, and urinary tract. Be on the lookout for symptoms of an infection.
- Severe bone, joint, or muscle pain: While bone, joint, or muscle pain is common with Prolia, the pain can become excessive and severe.
- Skin-related side effects: People who take Prolia are more likely to have skin-related side effects, which may include skin irritation, itchiness, or rash. Some people might also develop eczema, a dry, red, itchy, and scaly skin condition.
Prolia is also linked to hypocalcemia (low calcium) and low bone turnover. Since Prolia interferes with the activity of osteoclasts (a type of bone cell), osteoclasts are not turning over (breaking down) bone and releasing calcium as much.
While breaking down bone might sound like a bad thing, a certain amount of turnover is normal and necessary. Excessive osteoclast inhibition will likely result in low calcium blood levels and low bone turnover.
Symptoms of low calcium levels in your blood may include:
Low bone turnover, on the other hand, is thought to raise your risk of the following serious side effects:
- Abnormal femoral fractures: Prolia raises your risk of abnormal femoral fractures. These fractures happen with little to no trauma. You might experience a dull and aching pain in your thigh, hip, or groin area for months before a complete fracture happens.
- Osteonecrosis of the jaw: Prolia raises your risk for osteonecrosis of the jaw (ONJ). ONJ is a rare but serious complication where your gums no longer cover your jawbone, and the cells in your jawbone start to die slowly.
Call 911 if your symptoms feel life-threatening.
Long-Term Side Effects
You might develop severe bone, joint, or muscle pain months after starting Prolia. Many of Prolia's other long-term side effects are thought to be caused by its influence on osteoclast activity. Excessively preventing osteoclasts from turning over (breaking down) bone is believed to contribute to:
- Abnormal fractures of the femoral bone that runs from the hip and groin areas to your knee
- Osteonecrosis ("bone death") of the jaw (ONJ)
- Slow healing of broken bones
Stopping Prolia, on the other hand, is linked to multiple fractures in your vertebrae (bones of your back or spine). When you discontinue Prolia, the inactive osteoclasts will eventually break down bone at the same levels before you started Prolia. This and other risk factors may increase your chance of vertebral fractures. To prevent this, your healthcare provider will typically switch you to another osteoporosis medication.
Report Side Effects
Prolia may cause other side effects. Call your healthcare provider if you have any unusual problems while taking this medication.
If you experience a serious side effect, you or your healthcare provider may send a report to the FDA's MedWatch Adverse Event Reporting Program or by phone (800-332-1088).
Dosage: How Much Prolia Should I Take?
At your twice-yearly office visits, your healthcare provider will typically administer Prolia as a subcutaneous injection.
Modifications
The following modifications (changes) should be kept in mind when using Prolia (denosumab):
Severe allergic reaction: Avoid using Prolia if you have a known allergy to it or its ingredients. Ask your pharmacist or healthcare provider for a complete list of the ingredients if you're unsure.
Pregnancy: Prolia negatively affected the fetus in monkey animal studies. However. we don't know enough about the safety and effects of Prolia on pregnant people and their unborn fetuses. Since Prolia may cause harm to the fetus, however, this medication isn't recommended while pregnant. Discuss with your healthcare provider if you plan to become pregnant or are pregnant. They will help you weigh the benefits and risks of Prolia during pregnancy.
People assigned female at birth with childbearing or reproductive potential: Prolia may cause harm to the unborn fetus. Therefore, effective birth control should be used during Prolia treatment and for a minimum of five months after your last dose.
Breastfeeding: In animal studies, Prolia was present in the breastmilk of cynomolgus monkeys for one month after the last dose—with no negative effects on milk production. Prolia in rats, however, was linked to trouble with making milk.
In humans, the large size of the denosumab protein makes it unlikely for high Prolia levels to be present in breastmilk. If small amounts are present, the nursing baby's digestive system will likely destroy it before absorbing it into the bloodstream. Since we don't know enough about the safety of Prolia in human breastmilk and nursing babies, however, caution should be used, especially in newborns and preterm infants.
Talk with your healthcare provider if you plan to breastfeed. Your healthcare provider will help you weigh the benefits and harms of taking Prolia while nursing. They can also discuss the different ways available to feed your baby.
Older adults over 65: Based on available data for Prolia, there are no safety and effectiveness differences between older and younger adults. Older adults, however, might be more sensitive to Prolia's effects.
Children: Prolia in children with osteogenesis imperfecta (OI) resulted in severe hypercalcemia (high calcium levels in the blood). OI is a brittle bone condition that runs through families. Currently, the FDA hasn't approved Prolia for use in children.
Kidney problems: If you have severe kidney impairment or are on dialysis, Prolia is linked to a higher risk of hypocalcemia (low calcium levels in the blood). Therefore, your healthcare provider will want to monitor your calcium levels closely, especially when you start Prolia.
Conditions that affect calcium levels: In addition to kidney problems, other conditions may also affect your calcium levels. As a result, you'll be at a higher risk of calcium imbalances, such as low calcium. If you have these conditions, your healthcare provider will closely monitor your calcium levels, particularly at the beginning of your Prolia treatment.
Many of these medical conditions include problems with the glands in your neck or throat, like hypoparathyroidism, thyroid surgery, or parathyroid surgery. Other conditions may include issues with your digestive system, such as having a part of your small intestine removed or having trouble absorbing nutrients from your food.
Serious Prolia-related side effects: If you experience any severe side effects with Prolia, your healthcare provider may advise holding or stopping this medication.
Missed Dose
To receive Prolia every six months, you'll need to see your healthcare provider during office visits. If you miss any appointments, reach out to your healthcare provider as soon as possible to reschedule. Once you receive this rescheduled dose, you can receive the next dose six months later.
Try to find ways that work for you to help yourself remember to keep your appointments and receive your medication routinely. If you miss too many doses, Prolia might be less effective. Missing too many doses might also increase your likelihood of vertebral (back or spinal) fractures.
Overdose: What Happens If I Take Too Much Prolia?
There is limited information available about Prolia overdose.
If you think you're experiencing an overdose or life-threatening symptoms, seek immediate medical attention.
What Happens If I Overdose on Prolia?
If you think you or someone else may have overdosed on Prolia, call a healthcare provider or the Poison Control Center (800-222-1222).
If someone collapses or isn't breathing after taking Prolia, call 911 immediately.
Precautions
It is important that your doctor check your progress at regular visits to make sure this medicine is working properly. Blood tests may be needed to check for unwanted effects.
Prolia® contains denosumab which can also be found in Xgeva® . Patients receiving Prolia® should not receive Xgeva® .
Your unborn baby could be harmed if you use this medicine while you are pregnant. Women should use a highly effective form of birth control to keep from getting pregnant during treatment with this medicine and for at least 5 months after the last dose. There is also a potential for this medicine to cause birth defects if the father is using it when his sexual partner becomes pregnant. If a pregnancy occurs while you are receiving this medicine, tell your doctor right away.
This medicine may cause serious allergic reactions, including anaphylaxis, which can be life-threatening and requires immediate medical attention. Tell your doctor or nurse right away if you have a rash, lightheadedness, dizziness, or fainting, itching, swelling of the face, tongue, and throat, trouble breathing, or chest pain after you get the injection.
This medicine may cause hypocalcemia (low calcium in the blood). A low blood calcium must be treated before you receive this medicine. Call your doctor right away if you have muscle spasms or twitching, or numbness or tingling in your fingers, toes, or around your mouth.
Prolia® may increase your risk of developing infections. Avoid being near people who are sick or have infections while you are receiving this medicine. Check with your doctor right away if you have a fever or chills, red, swollen skin, severe abdominal or stomach pain, or burning or painful urination.
Skin problems may occur after receiving Prolia® . Check with your doctor right away if you have any of the following symptoms that do not go away or get worse: blistering, crusting, irritation, itching, or reddening of the skin, cracked, dry, or scaly skin, rash, or swollen skin.
It is important that you tell all of your doctors that you are receiving denosumab injection, including your dentist. If you are having dental procedures while receiving this medicine, you may have an increased chance of having a severe problem with your jaw. Make sure you tell your doctor or dentist about any new problems, such as pain or swelling, with your teeth or jaw.
The needle cover of the prefilled Prolia® syringe contains dry natural rubber (a derivative of latex), which may cause allergic reactions in people who are sensitive to latex. Tell your doctor if you have a latex allergy before you start receiving this medicine.
This medicine may increase your risk of developing fractures of the thigh bone. This may be more common if you use it for a long time. Check with your doctor right away if you have a dull or aching pain in the thigh, groin, or hips.
Check with your doctor right away if you have severe muscle, bone, or joint pain after receiving Prolia® .
Do not suddenly stop receiving this medicine without checking first with your doctor. Doing so may increase your risk for more fractures. Talk to your doctor about other medicines that you can take.
Hypercalcemia may occur after stopping Xgeva® treatment in patients with growing bones. Tell your doctor right away if you have nausea, vomiting, headache, or decreased alertness.
What Are Reasons I Shouldn't Take Prolia?
Before taking Prolia, talk with your healthcare provider if any of the following applies to you:
- Severe allergic reaction: If you're allergic to Prolia or its components (ingredients), this medication isn't a viable option for you.
- Pregnancy: Prolia might cause harm to the unborn fetus. Therefore, it isn't typically recommended while pregnant. Talk with your healthcare provider to weigh the benefits and risks of Prolia during your pregnancy.
- Breastfeeding: High levels of Prolia are unlikely to be present in human breastmilk. If small amounts are in breastmilk, the nursing infant's digestive system will likely destroy Prolia before absorbing it into the bloodstream. Since little is known about the effects and safety of Prolia in nursing babies, use Prolia with caution, especially in newborns and preterm infants. Discuss with your healthcare provider the benefits and harms of Prolia while nursing.
- Children: The FDA hasn't approved Prolia for children. Furthermore, Prolia was linked to severely high calcium levels in children with a brittle bone condition that runs in families.
- Older adults over 65: Based on available data for Prolia, there are no safety and effectiveness differences between older and younger adults. Older adults, however, might be more sensitive to Prolia's effects.
- Hypocalcemia: Hypocalcemia is low levels of calcium in the blood. Prolia may worsen this condition. Therefore, your hypocalcemia will need to be corrected before you can start Prolia treatment.
What Other Medications Interact With Prolia?
Use caution when taking Prolia with the following medications:
- Xgeva: Xgeva is another medication that also contains denosumab. As a result, Xgeva and Prolia shouldn't be used together.
- Specific cancer treatments: Long-term use of Prolia raises your risk of a serious side effect called ONJ. In ONJ, your gums are no longer covering your jawbone, which is slowly dying. Taking Prolia with certain cancer treatments may further increase your risk of ONJ. Some examples of these cancer treatments include cisplatin (Platinol) chemotherapy and bevacizumab (Avastin) for lung cancer.
- Immunosuppressants: Immunosuppressants are medications that calm down the immune system for people with certain medical conditions, such as rheumatoid arthritis (RA) and organ transplants. These immunosuppressants, however, may increase your risk of serious infections, which is also a severe side effect of Prolia.
- Medications that affect calcium levels: Hypocalcemia (low calcium levels) is a potentially serious side effect of Prolia. Medications that also cause low calcium might worsen this effect. An example medication is cinacalcet (Sensipar) for high parathyroid hormone (PTH) levels in people with chronic kidney disease (CKD).
- Steroids: Potentially severe side effects of Prolia include abnormal femoral bone fractures, which run from your hip and groin areas to your knee. Another possible severe side effect is ONJ. These side effects seemed to happen in people taking Prolia and steroids together.
Talk with your pharmacist or healthcare provider for more detailed information about medication interactions with Prolia.
And be sure to talk with your healthcare provider about any other medicines you take or plan to take, including over-the-counter (OTC), nonprescription products, vitamins, herbs, or plant-based medicines.
What Medications Are Similar?
Prolia is a RANKL inhibitor. Presently, there are no other RANKL inhibitors used for osteoporosis.
Prolia, however, is also a biologic (non-chemical-based) medication. A biologic medication is made from naturally occurring sources, such as proteins and tissues. Of all the available treatment options for osteoporosis, there is another biologic option called romosozumab-aqqg (Evenity). The following is some interesting information about Prolia and Evenity:
- Evenity is given as two injections every month, instead of a twice-yearly injection like Prolia.
- Prolia and Evenity need to be given by your healthcare provider during office visits.
- Both Prolia and Evenity lower bone fractures in the vertebral (back or spine) and nonvertebral areas. Evenity also has evidence that it can lower your risk of hip fractures.
- Prolia can be considered as a go-to choice to treat osteoporosis in high-risk people with no previous fractures.
- Either Prolia or Evenity are go-to options to treat osteoporosis in very high-risk people with prior fractures.
- While Prolia can be used until you're no longer at a high risk of fractures, Evenity should only be used for one year.
- After stopping Evenity or Prolia, your healthcare provider will switch you to another medication for osteoporosis.
- The FDA assigned black box warnings to Evenity—but not Prolia.
These two medications are not typically used together.
How Can I Stay Healthy While Taking Prolia?
If you're taking Prolia, chances are osteoporosis has been negatively affecting your quality of life. Living with osteoporosis does have its challenges. You may have tried different approaches or treatments. Below are some general tips to support your health:
- Take osteoporosis-related medications as recommended by your healthcare provider.
- People who can be pregnant should use effective birth control measures to prevent pregnancy during treatment and for at least five months after the last dose of Prolia.
- Make sure you're getting enough calcium and vitamin D. If you're not getting enough calcium and vitamin D through your diet, ask your healthcare provider whether you'll benefit from supplements.
- Limit your alcohol intake.
- Quit smoking if you smoke.
- Participate in weight-bearing and balancing exercises.
- Prevent falls and fractures.
- Consider support groups or working with a mental health professional to help you find coping strategies to change the way you think, feel, or respond to living with osteoporosis.
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