Prolia Injection for Bone Loss: Pros & Cons

Prolia is a brand name medication that contains the active drug denosumab. It is given by injection to reduce bone loss and treat osteoporosis in people with low bone mineral density; bone density or bone mineral density (BMD) is the amount of calcium and other minerals in your bones. Low BMD indicates that your bones are not getting enough minerals, which causes a loss of bone strength. Please continue reading to learn more about the pros and cons of taking Prolia.

What is Prolia? How does it increase bone density?

Prolia (denosumab injection) belongs to a group of medications called monoclonal antibodies, which is one of the biologic drugs. These medications interact with the immune system. Specifically, Prolia destroys certain proteins in the body that signal the breakdown of healthy bones. By blocking this signal, Prolia decreases bone breakdown, helping to increase bone strength. In other words, Prolia reduces bone turnover, prevents bone loss, and increases bone density.

Who can take Prolia?

Prolia is a prescription medication that is used to treat men and women with metabolic bone disease who have an increased risk of bone fractures, such as:

Postmenopausal women with osteoporosis
Men with osteoporosis
Men and women receiving steroid treatment
Men receiving androgen deprivation therapy for non-metastatic prostate cancer
Women receiving cancer treatment with an adjuvant aromatase inhibitor for breast cancer

Denosumab injection is also sold under the brand name Xgeva. It is used to treat people with a high risk of bone fracture due to:

Certain types of cancers, such as giant cell tumor of bone (GCTB) that cannot be treated surgically
Prevent bone fractures in those with multiple myeloma or metastatic cancers that have spread to bone tissue
Hypercalcemia (high calcium levels) caused by cancer that is unresponsive to other treatments

How to take Prolia?

Dose and Administration

Prolia (denosumab) comes in the form of an injection solution that is injected subcutaneously (under the skin) of your upper arm, upper thigh, or abdomen. You will receive an injection of 60 milligrams (mg) Prolia in your doctor’s office every 6 months for osteoporosis.

Your provider may ask you to take at least 1,000 mg calcium supplements and 400 international units (IU) of vitamin D supplements during Prolia treatment. Follow these directions carefully to get the maximum benefit from the medicine. The denosumab treatment regimen for reasons other than treating osteoporosis is different.

Allergic Reactions

Before starting denosumab treatment, tell your doctor if you have ever had an allergic reaction to denosumab (Prolia, Xgeva), any of the active or inactive ingredients in denosumab injections, latex, or any other medications.

Drug Interactions

Give your doctor and pharmacist a complete list of your medications, including prescription drugs, over-the-counter medications, dietary supplements, and herbal products. This will help prevent potentially dangerous drug interactions between Prolia and your other drugs. Prolia and Xgeva contain the same active ingredient, and you should not receive these two medications at the same time.

Medical Conditions

Talk with your doctor about the pros and cons of taking Prolia if you have certain health conditions such as hypocalcemia (low blood calcium levels), cancer, diabetes, kidney disease (or if you are receiving dialysis), immune system conditions, parathyroid surgery or thyroid conditions, a history of dental work or dental surgery (tooth extractions or dental implants), surgery on the stomach or intestines affecting your body’s ability to absorb nutrients.

Pregnancy

Prolia can be harmful to an unborn baby. You will need a negative pregnancy test before starting treatment with this medicine. Your healthcare provider will advise you to use an effective method of birth control while you are on Prolia and for five months after your last dose.

What are the benefits of Prolia for bone health?

The main benefit of taking Prolia for bone health is that it can prevent bone loss, increase bone mass, and lower your risk of a bone fracture if you have osteoporosis.

What is the downside of Prolia?

Just like other medications, the downside of Prolia is that it can cause side effects. Common side effects of Prolia include headache, back pain, joint pain, muscle pain, high cholesterol, elevated blood pressure, common cold symptoms (sore throat, sneezing, runny nose, stuffy nose), cough, wheezing, swelling in the hands or feet, and bladder infections.

In addition, one of the possible side effects of Prolia is the increased risk of developing an infection. Let your doctor know if you experience the following signs and symptoms:

Digestive system symptoms such as unusual, severe stomach pain, flatulence, or heartburn.
Fever, chills, feeling malaise, pain
Painful urination or urinary urgency

More serious adverse effects of Prolia are listed below. You should call your doctor immediately or seek emergency medical attention if you develop:

Serious allergic reaction: swelling of the face, tongue, or throat, shortness of breath, hives, rash, and itchiness
Low calcium levels: Numbness or tingling in the fingers, toes, or around the mouth
Muscle cramps, spasms, twitching, or stiffness
Unusual skin problems: Redness, dryness, itching, peeling, oozing, blistering, warmth, swelling, or tenderness of the skin
Newly developed pain in the hip and thigh area

Has anyone had bad side effects from Prolia?

Yes, rarely, Prolia (denosumab) can cause bad side effects such as:

Serious allergic reactions with low blood pressure, throat tightness, trouble breathing, swelling of the face, eyes, lips, tongue or throat, skin rash, hives, and itching. Seek emergency medical care if this happens.
Osteonecrosis of the jaw (a serious condition in which the bone cells in the jaw bone die). Go to your dentist before starting Prolia treatment for a professional cleaning and to ensure any appliances, such as dentures, fit well. Practice good oral hygiene while you are taking Prolia.
Severe and potentially fatal hypocalcemia (low blood calcium levels). Your doctor will check blood calcium levels before starting Prolia.
Unusual bone fracture in the thigh bone. Tell your doctor if you develop severe pain in your thigh, hip, or groin.
Increased risk of spinal fractures after stopping Prolia treatment or missing Prolia doses. Do not stop Prolia therapy without talking to your provider.
Serious infections, such as dermatitis, cellulitis, and eczema, can occur after taking Prolia, which may require hospitalization. You may need to stop taking Prolia if this happens.
A mild allergic reaction or a more severe allergic reaction that may be life-threatening.

What percentage of people have bad side effects from Prolia?

Studies have shown the following:

Osteonecrosis of the jaw was reported during clinical trials of Prolia.
Hypocalcemia (decreased blood calcium levels) was reported in 1.7% of women who took Prolia compared to 0.4% of women who took a placebo (inactive or fake medicine).
Serious fatal infections occurred in 0.2% in both placebo and Prolia groups. However, serious nonfatal infections occurred in 4.0% of the Prolia group and 3.3% in the placebo group.
Skin infections, such as cellulitis, requiring hospitalization were reported by 0.4% in the Prolia group compared to less than 0.1% in the placebo group.
Skin adverse events such as eczema, dermatitis, and rashes were reported in 10.8% of the Prolia group compared to 8.2% of the placebo group.
A new spinal fracture was reported by 6% of women with postmenopausal osteoporosis who discontinued Prolia and remained in the study. Multiple spinal fractures were reported in 3% of women who discontinued Prolia and remained in the study.

What are the pros and cons of Prolia?

Pros

Prolia injections work well to lower your risk of bone fractures due to low bone mass.
You only need to take Prolia once every 6 months.
It is a good option for people who have failed or cannot take first-choice medications for osteoporosis, such as Fosamax (active drug alendronate sodium), Boniva (active drug ibandronate), or Zometa (active drug zoledronic acid).

Cons

Prolia is a prescription drug that is given by injection. A healthcare professional will inject Prolia in a doctor’s office. You cannot take this medicine at home.
Rarely, taking Prolia can cause serious adverse effects, including severe infection, osteonecrosis of the jaw, hypocalcemia, or a severe allergic reaction.
Prolia is not safe during pregnancy.
There is no generic version of Prolia at this time. Therefore, Prolia can be costly.

Is Prolia worth the risk?

If you have postmenopausal osteoporosis, Prolia can significantly lower your fracture risk, including your risk of hip fracture, spinal fracture, and other bone fractures. All of these medical problems can lead to serious complications. However, there are several side effects that may not be ideal for certain groups of people, for example, those with a weakened immune system. Your healthcare professional will discuss how Prolia compares to other osteoporosis medications and help you choose the best one.

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