Prolia is a brand-name prescription medication. It’s FDA-approved to reduce bone loss and to treat osteoporosis (a condition that causes weakened bones).

Specifically, Prolia is approved for use in the following people when they’re at high risk of bone fracture:

  • women with osteoporosis who’ve gone through menopause
  • men with osteoporosis
  • men or women with osteoporosis that’s caused by taking certain corticosteroids
  • men with nonmetastatic prostate cancer* who are taking medications to decrease levels of male hormones (such as testosterone)
  • women who are receiving adjuvant treatment** for breast cancer with certain drugs that decrease estrogen levels

* With nonmetastatic prostate cancer, the cancer hasn’t spread from your prostate to other areas of your body.

** Adjuvant treatment is used to prevent cancer from coming back after it’s been treated in the past.

Details

Prolia contains the drug denosumab. It belongs to a class of medications called monoclonal antibodies. (These drugs are made from immune system cells.) Prolia works by decreasing bone breakdown in your body. This leads to reduced bone loss and helps to treat osteoporosis.

Prolia is given by healthcare providers as an injection under your skin (called a subcutaneous injection). You’ll get Prolia injections at your doctor’s office once every 6 months.

Prolia is meant to be used in combination with calcium and vitamin D supplements.

It’s not known if Prolia is safe or effective for use in children.

Effectiveness

In clinical trials, Prolia was effective in treating osteoporosis and reducing bone loss. For information about Prolia’s effectiveness, see the “Prolia Uses” section below.

Prolia is available only as a brand-name medication. It’s not currently available in generic form. (A generic drug is an exact copy of the active drug in a brand-name medication.)

Prolia contains the active drug denosumab.

Prolia can cause mild or serious side effects. The following lists contain some of the key side effects that may occur while taking Prolia. These lists don’t include all possible side effects.

For more information on the possible side effects of Prolia, talk with your doctor or pharmacist. They can give you tips on how to deal with any side effects that may be bothersome.

Note: The Food and Drug Administration (FDA) tracks side effects of drugs they have approved. If you would like to report to the FDA a side effect you’ve had with Prolia, you can do so through MedWatch.

Your side effects may vary from those listed below, depending on the condition you’re using Prolia to treat.

Mild side effects

Mild side effects of Prolia can include:*

Most of these side effects may go away within a few days or a couple of weeks. But if they become more severe or don’t go away, talk with your doctor or pharmacist.

* This is a partial list of mild side effects from Prolia. To learn about other mild side effects, talk with your doctor or pharmacist, or visit Prolia’s Medication Guide.

Serious side effects

Serious side effects from Prolia aren’t common, but they can occur. Call your doctor right away if you have serious side effects. Call 911 if your symptoms feel life threatening or if you think you’re having a medical emergency.

Serious side effects and their symptoms can include:

  • Atypical femur fractures (unusual fractures of your thigh bone). Symptoms can include:
    • pain in your hip, thigh, or groin area
    • trouble walking
    • swelling in your thigh
  • Multiple fractures in your spine after stopping Prolia treatment. Symptoms can include:
    • pain in your back
    • trouble walking
  • Serious infections, such as urinary tract infections (UTIs) or skin infections. Symptoms will vary, depending on the type of infection you have. But they may include:
    • rash
    • swelling
    • pain in your pelvis or belly
    • fever
  • Severe pain in your joints, bones, or muscles. In addition to the severe pain, symptoms can also include:
    • having trouble moving around
  • Decreased bone production (when it takes longer for your bones to make new bone tissue). Symptoms can include:
    • long healing time after fractures
    • atypical (unusual) bone fractures

Other serious side effects, which are discussed in detail below, include:

  • severe allergic reaction
  • dental and jaw-related side effects
  • skin side effects

How long do side effects of Prolia last?

Some side effects from Prolia may last only a few days, while others may last several months. Because the drug can stay in your body for up to 6 months, some side effects can still occur months after your last dose of Prolia. This includes side effects that affect your teeth.

If you’re having side effects from Prolia that are bothersome and aren’t getting better, talk with your doctor. They may be able to recommend ways to reduce your side effects. Or your doctor may recommend a medication other than Prolia to treat your condition.

Side effect details

You may wonder how often certain side effects occur with this drug, or whether certain side effects pertain to it. Here’s some detail on some of the side effects this drug may or may not cause.

Allergic reaction

As with most drugs, some people can have an allergic reaction after taking Prolia. Symptoms of a mild allergic reaction can include:

  • skin rash
  • itchiness
  • flushing (warmth and redness in your skin)

A more severe allergic reaction is rare but possible. Symptoms of a severe allergic reaction can include:

  • swelling under your skin, typically in your eyelids, lips, hands, or feet
  • swelling of your tongue, mouth, or throat
  • trouble breathing
  • low blood pressure

Symptoms of serious allergic reaction, such as decreased blood pressure and trouble breathing, have been reported in people taking Prolia. However, it’s not known how many people taking Prolia during clinical trials had an allergic reaction to the drug.

Call your doctor right away if you have a severe allergic reaction to Prolia. But call 911 if your symptoms feel life threatening, or if you think you’re having a medical emergency.

Dental and jaw-related side effects

Dental and jaw-related side effects are rare with Prolia, but they can occur. Symptoms of dental and jaw-related side effects can include:

  • pain or numbness in your jaw
  • infections in your mouth
  • loosening of your teeth

It wasn’t reported exactly how many people had dental and jaw-related side effects during clinical trials. But it was reported that no one taking Prolia for steroid-induced osteoporosis had jaw necrosis (death of tissue in the jawbone). With steroid-induced osteoporosis, your bones become thin and weak from using certain corticosteroids.

With jaw necrosis, your teeth may become loose and need to be removed. This condition may also be painful. The risk of jaw necrosis may be increased the longer that you take Prolia.

The risk of jaw necrosis may also be increased if you’ve had recent dental work. This could include having dental surgery, tooth extractions, or dental implants, such as implants with dental crowns. Having an infection in your mouth can also increase your risk of jaw necrosis.

What to do for dental and jaw-related side effects

Before you start taking Prolia, your doctor will examine your mouth and teeth. They’ll recommend whether Prolia is a good option for you based on this exam.

Good oral hygiene habits, such as brushing and flossing your teeth, should be followed while you’re taking Prolia. These habits can help decrease your risk of oral infections and the need for dental surgery.

If you have any dental or jaw-related side effects, such as mouth pain or loosening of your teeth, see your dentist or doctor right away. Treatment for jaw necrosis should be started as soon as possible. (Treatment may include antibiotics or oral surgery.) If you develop certain dental or jaw-related side effects, your doctor may recommend that you stop taking Prolia.

If you have questions or concerns about dental and jaw-related side effects, talk with your doctor.

Weight gain

Weight gain itself wasn’t reported as a side effect during clinical trials of Prolia. However, some people taking Prolia did have swelling in their arms or legs. And with swelling, your body weight can be quickly increased.

In clinical trials of women who’d gone through menopause and who were taking Prolia for osteoporosis, 4.9% had swelling in their arms or legs. In comparison, 4% of the women taking a placebo (no active drug) had swelling. During studies, people taking Prolia for other conditions didn’t report any swelling in their arms or legs.

If you have weight gain or swelling of your arms or legs while you’re taking Prolia, talk with your doctor. They may be able to recommend ways to help reduce this side effect.

Hair loss

During initial clinical trials of Prolia, hair loss wasn’t reported as a side effect. However, hair loss was reported in postmarketing studies of the drug. (Postmarketing studies are done after a drug is approved and has been released on the market.)

It’s not known for sure how many people have hair loss when taking Prolia. But keep in mind that hair loss may be a side effect of certain cancer treatments. And because Prolia can be used to decrease bone loss in people with either prostate cancer or breast cancer, their hair loss may be due to cancer treatments rather than Prolia.

If you have hair loss while you’re taking Prolia, talk with your doctor. They may be able to recommend ways to decrease this side effect.

Side effects of stopping Prolia

After you stop taking Prolia, you may have certain side effects, such as bone loss. But you likely won’t have withdrawal symptoms when you stop taking Prolia. Withdrawal symptoms happen when you stop taking a drug that your body has become dependent on. (With dependence, your body needs the drug in order to feel normal.)

Bone loss can happen very quickly after stopping Prolia. With bone loss, you have an increased risk of fractures. Even if you stop using Prolia after just one shot, or you skip one dose of Prolia, your risk of fracture may be increased. This includes the risk of spinal fractures. And if you’ve already had a fracture in your spine, your risk of having more than one broken bone in your spine is also increased.

In clinical trials, new fractures in people’s spines happened on average around 17 months after their last injection of Prolia. But in some cases, the fractures happened as soon as 7 months after Prolia was stopped.

Also in clinical trials, in women who’d gone through menopause and were using Prolia, 6% developed a new spinal fracture when stopping the drug. In addition, 3% of the women had multiple new spinal fractures after they stopped taking Prolia. It wasn’t reported how often fractures occurred in people taking Prolia for other uses.

Before starting Prolia, talk with your doctor about the risks of stopping the drug if you need to. Your doctor may recommend other treatment options that you can use if Prolia doesn’t work for you or if you decide to stop using the drug.

Hip pain

It’s possible to have hip pain while you’re taking Prolia. In fact, in postmarketing studies of Prolia, some people reported having severe bone, joint, or muscle pain, which may have occurred in their hip. (Postmarketing studies are done after a drug is approved and has been released on the market.)

In clinical trials of people receiving cancer treatment who took Prolia for osteoporosis, 14.3% had joint pain. In comparison, 13% of people taking a placebo also had joint pain. (A placebo is a treatment with no active drug.)

Also in the trials, in women who’d gone through menopause who took Prolia for osteoporosis, 7.6% had muscle or bone pain. In comparison, 7.5% of the women taking a placebo also had this type of pain.

And in trials of people taking cancer treatments that affect certain hormones (such as testosterone and estrogen), 6% of people who took Prolia had muscle or bone pain. In comparison, 3.8% of people who took a placebo had this type of pain.

Hip pain that’s caused by fractures

It’s important to note that during clinical trials, one of the rare but serious side effects of Prolia was atypical femur fractures. Femur fractures can cause pain to your hip, groin, or thigh. Atypical femur fractures are unusual fractures in your thigh. They’re usually not caused by major trauma to the area. And it’s even possible to have atypical femur fractures in both of your thighs at the same time.

In fact, in clinical trials, one person out of 394 men and women who took Prolia for steroid-induced osteoporosis had an unusual femur fracture. (With steroid-induced osteoporosis, your bones become thin and weak from using certain corticosteroids.) But the number of people taking Prolia for other uses who had femur fractures during clinical trials wasn’t reported.

If you have hip pain while you’re taking Prolia, it’s important that you talk with your doctor right away. They’ll check to see if you have a fracture that’s causing your hip pain. If you do have a fracture, your doctor may switch you from Prolia to a different medication.

Skin side effects, such as rash

Skin side effects, such as rash or dermatitis (inflammation in your skin) may happen while you’re taking Prolia. Symptoms of skin problems may include:

  • redness
  • itching
  • peeling or oozing
  • blisters
  • very dry, leathery skin

Skin side effects in clinical trials

In clinical trials of women who’d gone through menopause, 10.8% of women taking Prolia had a skin side effect. In comparison, only 8.2% of women taking a placebo had the same. (A placebo is a treatment with no active drug.)

Clinical trials also showed that 2.5% of the women taking Prolia reported a rash. In comparison, 2% of women taking a placebo developed a rash. (In these cases, the women’s rash wasn’t necessarily located at the site of their drug injections. It could have been anywhere on their body.)

The trials also showed that 2.2% of the women developed itchy skin. In comparison, 2.1% of the women taking a placebo had itching.

Skin side effects were also seen in men with osteoporosis who took Prolia. In clinical trials, 4.2% of men taking Prolia had skin side effects, such as a rash. In comparison, 3.3% of men taking a placebo had skin side effects.

Another trial compared Prolia to a drug called risedronate. This trial looked at treating osteoporosis caused by certain corticosteroids. In this trial, 3.8% of people taking Prolia reported skin side effects, such as a rash. In comparison, 4.2% of people taking risedronate reported skin side effects.

What to do for skin side effects

If you have a rash or any skin changes while you’re using Prolia, see your doctor right away. Your skin changes may be a side effect from the drug. And keep in mind that some skin changes may be signs of an allergic reaction, which can become serious. (For more information about this, see the section “Allergic reaction” above.)

Your doctor will check to see what’s causing your skin problems, and they’ll recommend if any treatment is needed. If you have severe skin side effects from Prolia, your doctor may switch you to a medication other than Prolia.

Headache

Headaches are a possible side effect of Prolia. However, in studies, this side effect was only reported in people taking Prolia for steroid-induced osteoporosis. (With steroid-induced osteoporosis, your bones become thin and weak from using certain corticosteroids.)

In clinical trials, 3.6% of women and men taking Prolia for steroid-induced osteoporosis had headaches. In comparison, only 1.8% of the people taking a placebo (no active drug) had headaches.

If you have new or worsening headaches while you’re taking Prolia, talk with your doctor. They can recommend ways to reduce how severe your headaches are. And they may also be able to suggest ways to help prevent headaches.

Other drugs are available that can improve bone strength. Some may be a better fit for you than others. If you’re interested in finding an alternative to Prolia, talk with your doctor. They can tell you about other medications that may work well for you.

Examples of drugs that may be used to improve bone strength include:

  • alendronate (Fosamax)
  • risedronate (Actonel)
  • ibandronate (Boniva)
  • zoledronic acid (Reclast, Zometa)
  • denosumab (Xgeva)
  • teriparatide (Forteo)
  • abaloparatide (Tymlos)
  • raloxifene (Evista)

Talk with your doctor about your bone health needs. They’ll recommend the treatment that’s right for you, based on your specific health needs.

You may wonder how Prolia compares with other medications that are prescribed for similar uses. Here we look at how Prolia and Reclast are alike and different.

Ingredients

Prolia contains the active drug denosumab, while Reclast contains the active drug zoledronic acid.

Uses

Prolia is used to treat bone loss and certain types of osteoporosis (a condition that causes weakened bone). Specifically, Prolia is approved for use in the following people when they’re at high risk of bone fracture:

  • women with osteoporosis who’ve gone through menopause
  • men with osteoporosis
  • men or women with osteoporosis that’s caused by taking certain corticosteroids
  • men with nonmetastatic prostate cancer* who are taking medications to decrease levels of male hormones (such as testosterone)
  • women who are receiving adjuvant treatment** for breast cancer with certain drugs that decrease estrogen levels

* With nonmetastatic prostate cancer, the cancer hasn’t spread from your prostate to other areas of your body.

** Adjuvant treatment is used to prevent cancer from coming back after it’s been treated in the past.

Reclast is also approved to treat osteoporosis in men and in women who’ve gone through menopause. Like Prolia, Reclast is also approved to treat osteoporosis that’s caused by using certain corticosteroids.

In addition, Reclast is approved to prevent osteoporosis in women who’ve gone through menopause. The drug is also approved to treat Paget’s disease of the bone. (With this condition, you have enlarged but weakened bones.)

Unlike Prolia, Reclast isn’t approved to increase bone mass in either men with prostate cancer or women with breast cancer who are using certain cancer treatments.

Drug forms and administration

Prolia is given by healthcare providers as an injection under your skin (called a subcutaneous injection). You’ll get Prolia injections in your doctor’s office once every 6 months.

Reclast is given as an intravenous (IV) infusion. With an IV infusion, the drug is injected into your vein over a period of time. You’ll get Reclast infusions at your doctor’s office once every 1 to 2 years.

Side effects and risks

Prolia and Reclast both contain drugs used to treat osteoporosis. Therefore, these medications can cause very similar side effects. Below are examples of these side effects. Your side effects may vary from those listed below, depending on the condition you’re using Prolia to treat.

Mild side effects

These lists contain up to 10 of the most common mild side effects that can occur with Prolia, with Reclast, or with both Prolia and Reclast (when taken individually).

  • Can occur with Prolia:
    • back pain
    • swelling in your arms or legs, which may cause weight gain
    • stomach problems, such as upper belly pain
  • Can occur with Reclast:
    • fever
    • flu-like symptoms, such as fatigue or sore throat
    • nausea or vomiting
    • vomiting
    • diarrhea
    • swelling in your eye
  • Can occur with both Prolia and Reclast:
    • muscle pain
    • headache
    • joint pain
    • pain in your arms or legs

Serious side effects

These lists contain examples of serious side effects that can occur with Prolia, with Reclast, or with both drugs (when taken individually).

  • Can occur with Prolia:
    • serious infections, such as UTIs and skin infections
    • skin side effects, such rash or blisters
    • multiple fractures in your spine after stopping Prolia
    • decreased bone production (when it takes longer for your bones to make new bone tissue)
  • Can occur with Reclast:
    • kidney problems, such as decreased kidney function
  • Can occur with both Prolia and Reclast:
    • dental and jaw-related side effects
    • atypical femur fractures (unusual fractures in your thigh bone)
    • severe allergic reaction
    • severe pain in your joints, bones, or muscles

Effectiveness

Prolia and Reclast have different approved uses, but they’re both used to treat osteoporosis in men and in women who’ve gone through menopause. These drugs are also both approved to treat osteoporosis that’s caused by steroids.

The use of Prolia and Reclast in treating osteoporosis in women who’ve gone through menopause has been directly compared in a clinical study. In this study, people’s bone mineral density (BMD) was measured. (BMD is a measurement that shows how strong your bones are.)

Women taking Reclast had a 0.6% increase in BMD in their hip bone after 12 months of treatment. In comparison, women taking Prolia had an increase of 1.9% in the BMD in their hip bone after 12 months.

The women’s spinal BMD was also measured in this study. For women taking Reclast, their spinal BMD was increased by 1.1% after 12 months of treatment. In comparison, for women taking Prolia, their spinal BMD was increased by 3.2% after 12 months.

Prolia and Reclast haven’t been directly compared in clinical studies as treatment options for men with osteoporosis or for people with osteoporosis that’s caused by steroids. However, separate studies have found both Prolia and Reclast to be effective for treating this condition.

Costs

Prolia and Reclast are both brand-name drugs. There is currently no generic form of Prolia. However, there is a generic form of Reclast available called zoledronic acid. (A generic drug is an exact copy of the active drug in a brand-name medication. Generics usually cost less than brand-name medications do.)

According to estimates on GoodRx.com, Prolia costs significantly more than Reclast. The actual price you’ll pay for either drug depends on your insurance plan, your location, and the medical office where you receive each drug.

You may wonder how Prolia compares with other medications that are prescribed for similar uses. Here we look at how Prolia and Fosamax are alike and different.

Ingredients

Prolia contains the active drug denosumab, while Fosamax contains the active drug alendronate.

Uses

Prolia is used to treat bone loss and certain types of osteoporosis (a condition that causes weakened bone). Specifically, Prolia is approved for use in the following people when they’re at high risk of bone fracture:

  • women with osteoporosis who’ve gone through menopause
  • men with osteoporosis
  • men or women with osteoporosis that’s caused by taking certain corticosteroids
  • men with nonmetastatic prostate cancer* who are taking medications to decrease levels of male hormones (such as testosterone)
  • women who are receiving adjuvant treatment** for breast cancer with certain drugs that decrease estrogen levels

* With nonmetastatic prostate cancer, the cancer hasn’t spread from your prostate to other areas of your body.

** Adjuvant treatment is used to prevent cancer from coming back after it’s been treated in the past.

Fosamax is also approved to treat osteoporosis in men and in women who’ve gone through menopause. The drug is also approved to treat osteoporosis that’s caused by using certain corticosteroids.

Unlike Prolia, Fosamax is approved to prevent osteoporosis in women who’ve gone through menopause. And Fosamax isn’t approved to increase bone mass in men with prostate cancer or in women with breast cancer who are using certain cancer treatments.

In addition, Fosamax is approved to treat Paget’s disease of the bone. (With this condition, you have enlarged but weakened bones.)

Drug forms and administration

Prolia is given by healthcare providers as an injection under your skin (called a subcutaneous injection). You’ll get Prolia injections in your doctor’s office once every 6 months.

Fosamax comes as a tablet that’s taken by mouth once a week.

There are also generic forms of Fosamax available that have different dosages than brand-name Fosamax does. For example, some of the generic forms come as tablets that are taken by mouth once daily instead of once weekly. A generic drug is an exact copy of the active drug in a brand-name medication. Generics usually cost less than brand-name medications do.

Side effects and risks

Prolia and Fosamax both contain drugs to treat osteoporosis. Therefore, these medications can cause very similar side effects. Below are examples of these side effects. Your side effects may vary from those listed below, depending on the condition you’re using Prolia to treat.

Mild side effects

These lists contain up to 10 of the most common mild side effects that can occur with Prolia, with Fosamax, or with both Prolia and Fosamax (when taken individually).

Serious side effects

These lists contain examples of serious side effects that can occur with Prolia, with Fosamax, or with both drugs (when taken individually).

  • Can occur with Prolia:
    • serious infections, such as UTIs and skin infections
    • skin side effects, such rash or blisters
    • multiple fractures in your spine after stopping Prolia
    • decreased bone production (when it takes longer for your bones to make new bone tissue)
  • Can occur with Fosamax:
    • irritation in your stomach or intestines, which may lead to ulcers
  • Can occur with both Prolia and Fosamax:
    • severe pain in your joints, bones, or muscles
    • severe allergic reaction
    • dental and jaw-related side effects
    • atypical femur fractures (unusual fractures in your thigh bone)

Effectiveness

Prolia and Fosamax have different approved uses, but they’re both used to treat osteoporosis in men and in women who’ve gone through menopause. These drugs are also both approved to treat osteoporosis that’s caused by steroids.

The use of Prolia and Fosamax in treating osteoporosis has been directly compared in a clinical study. (This study didn’t specify people’s results based on the specific condition they were using either Prolia or Fosamax to treat.)

This study showed that over 3 years of treatment, 3.7% of people taking Prolia had a hip fracture. In comparison, 3.1% of people taking Fosamax had a hip fracture over the same period of time.

In this study, 9% of people taking either Prolia or Fosamax had any type of bone fracture over the course of the 3-year study. And there was no significant difference in people’s risk of fracture depending on which of the two drugs they took.

Another study, done in 2009, compared Prolia and Fosamax in treating osteoporosis in women who’d gone through menopause. In this study, the women’s bone mineral density (BMD) was measured. (BMD is a measurement that shows how strong your bones are.) After 12 months of treatment, BMD measured at the hip was increased by 3.5% in women taking Prolia. And this BMD was increased by 2.6% in women taking Fosamax.

Costs

Prolia and Fosamax are both brand-name drugs. Fosamax is available as a generic medication, alendronate. There is currently no generic form of Prolia. Brand-name medications usually cost more than generics.

According to estimates on GoodRx.com, Prolia costs significantly more than either brand-name Fosamax or its generic drug alendronate.

The actual price you’ll pay for either drug depends on your insurance plan, your location, and whether you receive the drug from a pharmacy or medical office.

The Prolia dosage your doctor prescribes is usually the same for everyone taking the drug. However, your doctor will ultimately prescribe the smallest dosage that provides the desired effect.

The following information describes dosages that are commonly used or recommended. Your doctor will determine the best dosage to fit your needs.

Drug forms and strengths

Prolia comes as a solution inside prefilled syringes that each hold 60 mg of the drug. Prolia is given as an injection under your skin (called a subcutaneous injection). The drug can be injected into your upper thigh, upper arm, or abdomen (belly). You’ll get Prolia injections from a healthcare provider at your doctor’s office.

Dosage of Prolia to improve bone strength

The usual dosage of Prolia is one 60-mg injection given once every 6 months.

How long can I take Prolia?

You can use Prolia over a long period of time. In fact, if your osteoporosis is under control while you’re taking Prolia, and you’re not having severe or bothersome side effects, you should continue taking the drug for as long as your doctor recommends.

Clinical trials have shown that the drug is effective when it’s used over a 3-year period. But it may be effective when used for longer periods of time as well.

If you have severe or bothersome side effects from Prolia, or you’d like to stop using Prolia for other reasons, talk with your doctor. They can discuss with you other treatment options to help increase your bone density.

What if I miss a dose?

If you miss an appointment to get your Prolia injection, call your doctor’s office and reschedule the appointment as soon as possible. The medical staff will help you determine when you should receive your next dose of Prolia.

To help make sure that you don’t miss an appointment for your injection, try setting a reminder on your phone.

Will I need to use this drug long term?

Prolia is meant to be used as a long-term treatment. If you and your doctor determine that Prolia is safe and effective for you, you’ll likely take it long term.

The Food and Drug Administration (FDA) approves prescription drugs such as Prolia to treat certain conditions. Prolia may also be used off-label for other conditions. Off-label use is when a drug that’s approved to treat one condition is used to treat a different condition.

For each of the uses described below, Prolia is given to people who are at high risk of a bone fracture.

Prolia for postmenopausal women with osteoporosis

Prolia is approved to treat osteoporosis in women who’ve gone through menopause. With osteoporosis, your bones become weak and brittle. Osteoporosis that happens after menopause is due to the decrease in your body’s estrogen level that occurs with menopause. As women become older, their risk of osteoporosis increases.

Effectiveness in postmenopausal women with osteoporosis

Prolia has been effective in treating osteoporosis during clinical trials. For example, one study looked at women with osteoporosis who’d gone through menopause and who had a high risk of fracture. Some women took injections of Prolia, while other women took injections of a placebo (no active drug).

Women taking Prolia reduced their risk of fractures in their spine by 68% compared with women taking a placebo. The women taking Prolia also reduced their risk of fractures that didn’t affect their spine by 20% compared with women who took the placebo. (Examples of these fractures include those affecting the hip or leg.)

In clinical trials, Prolia also increased bone mineral density (BMD) in women with osteoporosis who’d gone through menopause. (BMD is a measurement that shows how strong your bones are.) When compared with women taking the placebo, women taking Prolia had an increased BMD of:

  • 8.8% in their spine
  • 6.4% in their hip
  • 5.2% in their femoral neck (the upper part of the thigh bone that connects into the hip)

Prolia for men with osteoporosis

Prolia is approved to treat osteoporosis in men. With osteoporosis, your bones become weak and brittle. In men, osteoporosis can be caused by decreased production of hormones, such as testosterone. The condition can also be genetic. And as men age, their risk of osteoporosis increases.

Effectiveness in men with osteoporosis

In clinical trials, Prolia was effective in treating osteoporosis in men. In one trial, the men’s bone mineral density (BMD) was measured. (BMD is a measurement that shows how strong your bones are.) Some men were given injections of Prolia, while other men were given injections of a placebo (no active drug).

After 1 year of treatment, when compared with men taking the placebo, men taking Prolia had an increased BMD of:

  • 4.8% in their spine
  • 2% in their hip
  • 2.2% in their femoral neck (the upper part of the thigh bone that connects into the hip)

Prolia for people with osteoporosis that’s caused by steroid treatment

Prolia is approved to treat osteoporosis that’s caused by using certain corticosteroids. With osteoporosis, your bones become weak and brittle.

Taking certain steroids over a long period of time can cause osteoporosis. This is because some steroids, such as prednisone, can decrease the density of your bones. So if you’re taking certain steroids long term, your bones may become weaker, and you may have a higher risk of fractures.

But some people need to take steroids on a daily basis to decrease inflammation in their body. For example, people with rheumatoid arthritis (RA) or multiple sclerosis (MS) may need to do this. (People with these conditions have swelling in their joints or other areas of their body that is eased by taking steroids.)

However, taking an equivalent of 2.5 mg of prednisone for 3 months or longer can put you at risk for fractures. If you need to take steroids long term, talk with your doctor about ways to lower your risk of fracture. They may suggest that you exercise or take supplements such as calcium or vitamin D. Or they may recommend a prescription medication, such as Prolia.

Effectiveness in people with osteoporosis that’s caused by steroid treatment

In clinical trials, Prolia was effective in treating osteoporosis that’s caused by taking certain corticosteroids, such as prednisone. Trials looked at both people taking steroids for less than 3 months and people taking steroids for 3 months or longer.

People were given either Prolia or risedronate. (Risedronate is drug that’s also approved to treat osteoporosis that’s caused by steroids. But unlike Prolia, it comes as a tablet that’s taken by mouth either once daily or once weekly.)

In one trial, bone mineral density (BMD) was measured in people’s spines. (BMD is a measurement that shows how strong your bones are.) For people taking steroids for less than 3 months, Prolia increased their spinal BMD by 3.8%. In comparison, people taking risedronate had increased their spinal BMD by 0.8%.

People taking steroids for 3 months or longer who used Prolia also had a larger increase in their spinal BMD compared with people using risedronate. For example, in this group of people, those taking Prolia had their spinal BMD increased by 4.4%. But for those taking risedronate, their spinal BMD was only increased by 2.3%.

Prolia for men using androgen deprivation therapy for nonmetastatic prostate cancer

Prolia is approved to increase bone mass in men with nonmetastatic prostate cancer who are using androgen deprivation therapy. (With nonmetastatic prostate cancer, the cancer hasn’t spread out of the prostate to other parts of the body.)

Androgen deprivation therapy (ADT) is a treatment option for prostate cancer. It works by blocking androgens (male hormones), such as testosterone. Androgens encourage prostate cancer to grow and spread in your body. By blocking androgens, these therapies can help treat prostate cancer.

However, certain hormones help to keep you bones strong and healthy. Because ADT affects your hormones, it can also affect your bone density. One study showed that after only 6 to 12 months of ADT, men lost bone mineral density (BMD)* at a rate that was 17.3% faster than men who weren’t taking these treatments.

* BMD is a measurement that shows how strong your bones are.

Effectiveness in men using androgen deprivation therapy

In clinical trials, Prolia was an effective treatment to increase bone mass in men taking certain medications that decrease androgen levels. Some men were given injections of Prolia, while other men were given injections of a placebo (no active drug). In this study, BMD was measured to evaluate how strong the men’s bones were.

Compared with men taking the placebo, after 36 months of treatment, men taking Prolia had BMD that was increased by:

  • 7.9% in their spine
  • 5.7% higher in their hip
  • 4.9% higher in their femoral neck (the upper part of the thigh bone that connects into the hip)

In addition, Prolia also decreased the risk of spinal fractures in men taking ADT. For example, over a 3-year period, men taking Prolia had their risk of spinal fractures reduced by 62% compared with men who took the placebo.

Prolia for women using adjuvant aromatase inhibitor therapy for breast cancer

Prolia is approved to increase bone mass in women taking adjuvant therapy for breast cancer with an aromatase inhibitor. (Adjuvant therapy used to prevent the cancer from coming back after it’s already been treated in the past.)

Aromatase inhibitors are a class of drugs that are often used for adjuvant treatment of breast cancer. This class of drugs includes medications such as anastrozole (Arimidex) and exemestane (Aromasin).

Studies have looked at women who’ve gone through menopause who are taking aromatase inhibitors. The studies found that the women taking these drugs have 2 to 4 times more bone loss than do women who aren’t taking these medications. Increased bone loss raises the risk of bone fracture in women taking aromatase inhibitors.

Effectiveness in women using adjuvant aromatase inhibitor therapy

In clinical trials, Prolia was effective in increasing bone mass in women with breast cancer who were taking adjuvant aromatase inhibitor treatment. Some women were given injections of Prolia, while other women were given injections of a placebo (no active drug).

In one study, the women’s bone mineral density (BMD) was measured. (BMD is a measurement that shows how strong your bones are.)

After 1 year of treatment with Prolia, women taking Prolia had a spinal BMD that was 5.5% higher than women taking the placebo.

In the study, about 81% of the women were treated for 2 years. After 2 years of treatment, when compared with women taking the placebo, women taking Prolia had BMD that was increased by:

  • 7.6% in their spine
  • 4.7% in their hip
  • 3.6% in their femoral neck (the upper part of the thigh bone that connects into the hip)

Off-label uses for Prolia

In addition to the uses listed above, Prolia may be used off-label. Off-label drug use is when a drug that’s approved for one use is used for a different use that’s not approved. Below are examples of off-label uses for Prolia.

Prolia for rheumatoid arthritis

Prolia isn’t approved to treat rheumatoid arthritis (RA). But sometimes it’s used off-label for this condition.

With RA, your immune system attacks your joints. This causes inflammation and pain, especially in your feet, hands, wrists, and ankles. This inflammation can eventually lead to joint damage.

Studies have looked at using Prolia to treat RA. Some of the findings of these studies are reviewed below:

  • One study showed that Prolia may be especially helpful in people with RA who are also taking other medications, such as methotrexate, to treat their RA. This is because while methotrexate helps to decrease swelling in your joints, Prolia helps to decrease joint damage from RA.
  • Another study also showed that Prolia may help reduce damage in bones and joints in people with RA. This may help people with RA to continue doing their normal physical activities. In this particular study, Prolia was used by people who were already taking the drug methotrexate for their RA. And the people continued to use methotrexate along with Prolia.

There’s even a current ongoing study looking at whether Prolia may be effective in reversing bone damage that’s already happened due to RA.

If you’d like to know more about using Prolia for RA, talk with your doctor.

Prolia for metabolic bone disease

Metabolic bone disease is a group of conditions that cause decreased bone density. A common example of metabolic bone disease is osteoporosis, which Prolia is approved to treat. However, there are other metabolic bone diseases that Prolia isn’t approved to treat. For these other conditions, the drug is sometimes used off-label.

These conditions include:

  • Juvenile Paget’s disease, which is a metabolic bone disease that’s caused by a genetic problem. With this condition, you have weak and abnormally formed bones. People with Juvenile Paget’s disease have bone fractures more often than people without the condition.
  • Hajdu-Cheney syndrome, which is also metabolic bone disease that’s caused by a genetic problem. This condition causes decreased bone production, especially in your hands and feet.

If you have questions about using Prolia to treat a certain metabolic bone disease, talk with your doctor.

While you’re taking Prolia, your doctor may recommend other treatments to use with Prolia. These other treatments are described below.

Prolia with calcium and vitamin D

It’s recommended that you take calcium and vitamin D during Prolia treatment. Doing this will help to promote healthy and strong bones.

The typical recommended dosages for these supplements are as follows:

  • Calcium: You should take 1000 mg by mouth daily.
  • Vitamin D: You should take at least 400 IU by mouth daily.

Prolia with other prescription drugs to improve bone strength

In some cases, your doctor may recommend that you take another prescription drug with Prolia to help improve your bone strength. These other prescription drugs could include:

  • romosozumab-aqqg (Evenity)
  • raloxifene (Evista)
  • alendronate (Fosamax)
  • teriparatide (Forteo)

Your doctor will let you know whether you’ll need to take any other prescription medications with Prolia.

You should receive Prolia according to your doctor’s or healthcare provider’s instructions.

Prolia is given as an injection under your skin (called a subcutaneous injection). You’ll get Prolia injections once every 6 months at your doctor’s office.

Prolia injection sites

Prolia can be injected under the skin of your:

  • upper arm
  • upper thigh
  • abdomen (belly)

When to take

Prolia injections should be given once every 6 months. They’re given in your doctor’s office, so be sure to schedule your appointments ahead of time.

To help make sure that you don’t miss a dose, try setting an appointment reminder on your phone.

Prolia is approved to treat certain types of osteoporosis and to increase bone mass. For more information about Prolia’s approved uses, see the section “Prolia uses” above.

With osteoporosis, your bones are brittle and weak, and they may fracture more easily than usual. Many different things can cause osteoporosis, including:

  • changing hormone levels
  • medications, such as certain corticosteroids
  • unhealthy diet and exercise habits

In addition to treating osteoporosis, Prolia is also approved to increase bone mass in people using certain cancer treatments. These treatments affect hormone levels in your body, which can lead to bone loss.

Prolia works by stopping the action of cells (called osteoclasts) that break down your bone. By blocking these cells from working, Prolia causes an increase in your bone density and strength. This reduces your risk of fractures.

How long does it take to work?

Prolia can begin working right after your first dose. In fact, within only a few days after your Prolia dose, your body decreases its breakdown of bone.

And after about 1 month following your dose, Prolia is working at its maximum level to reduce bone loss and help increase your bone density.

You may not be able to tell that Prolia is working in your body. But during treatment, your doctor will order a test that measures your bone mineral density (BMD). This measurement shows how strong and dense your bones are. Your doctor will monitor your BMD to know whether or not Prolia is working for you.

How long does Prolia stay in your system?

Prolia stays in your body for about 6 months after you’ve received your dose. Over these 6 months, the drug works to block bone breakdown in your body, which strengthens your bones overall. After 6 months, you’ll need to get another dose of Prolia so that the medication can continue to work.

Here are answers to some frequently asked questions about Prolia.

Is Prolia safe to use?

Yes, Prolia is safe and effective to treat osteoporosis and to prevent bone loss in certain people.

In fact, before Prolia was approved by the Food and Drug Administration (FDA), the drug’s safety was tested. For all of Prolia’s approved uses, the drug was shown to be a safe medication.

During clinical studies, serious side effects were seen in some people using Prolia. But serious side effects occurred in some people using a placebo (no active drug). For example, of people taking Prolia, serious (but not deadly) side effects were seen in:

  • 25% of women with osteoporosis who’d already gone through menopause. In comparison, for women taking a placebo, 24.2% had serious side effects.
  • 8.3% of men with osteoporosis. In comparison, for men taking a placebo, 7.5% had serious side effects.
  • 16% of people with osteoporosis that was caused by certain corticosteroids. In comparison, for people taking a different drug called risedronate, 17% had serious side effects.
  • 34.6% of men using certain prostate cancer drugs who took Prolia to prevent bone loss. In comparison, for men taking a placebo, 30.6% had serious side effects.
  • 14.7% of women using certain breast cancer drugs who took Prolia to prevent bone loss. In comparison, in women taking a placebo, 9.2% had serious side effects.

For information about the serious side effects that Prolia may cause, see the section “Prolia side effects” above.

If you have questions about Prolia’s safety, talk with your doctor.

Can older people use Prolia?

Yes, in general, Prolia is a safe and effective medication for older people to use. In fact, many people who have osteoporosis are older adults. This is because as we age, our hormones change. And these changes can increase our risk of osteoporosis.

In clinical trials, 76% of people taking Prolia were ages 65 years or older. The trials showed no increased risk or any difference in safety for older people taking Prolia compared with younger people taking the drug.

It’s possible that older people’s bodies may be more sensitive to the medication. This is because their bodies may break down the medication more slowly. However, that hasn’t been shown for sure in clinical trials.

If you have concerns about whether it’s safe for you to use Prolia, talk with your doctor.

Is Prolia used to treat osteopenia?

No, not usually. With osteopenia, your bones are weaker than usual. But your bones aren’t as weak and brittle as they would be with osteoporosis.

People with osteopenia don’t have osteoporosis. And not everyone who has osteopenia will develop osteoporosis. In addition, people with osteopenia have a lower risk of bone fractures than do people with osteoporosis.

Usually, you don’t need medical treatment for osteopenia. Instead, your doctor may recommend that you exercise more, or that you add more calcium and vitamin D to your diet.

However, in some cases, if you have a high risk of fractures, your doctor may recommend treating your osteopenia with Prolia. But keep in mind that this isn’t an approved use of Prolia, so the drug would be used off-label for this purpose. (With off-label use, a drug is used to treat a condition that it’s not approved to treat.)

If you have questions about whether Prolia would be a good choice for osteopenia treatment, talk with your doctor.

Does Prolia cause any eye-related side effects?

No, in clinical trials of Prolia there weren’t any eye-related side effects reported. However, certain other medications used to treat osteoporosis may cause eye-related side effects. This includes medications such as risedronate (Actonel) and alendronate (Fosamax).

The eye-related side effects that certain drugs other than Prolia may cause include:

  • swelling in your eye
  • blurry vision
  • eye infections
  • long-term vision problems, in some cases

However, there haven’t been reports of Prolia causing these eye-related side effects.

If you have any issues with your eyes during Prolia treatment, talk with your doctor. They can check to see what’s causing your eye issues, and they’ll recommend whether you need medical treatment.

Can Prolia cause kidney stones?

No, kidney stones weren’t reported as a side effect of Prolia in clinical trials.

However, some studies show that calcium and vitamin D supplements can increase your risk of kidney stones. (This is especially true if the supplements are taken long term.) In some cases, the benefit of taking calcium and vitamin D supplements may outweigh the risk of kidney stones.

Keep in mind that it’s recommended that you take both calcium and vitamin D while you’re taking Prolia.

If you’re concerned about getting kidney stones during Prolia treatment, talk with your doctor. They’ll be able to help you weigh the risks and benefits of treatment.

How are Prolia and Xgeva different from each other?

Prolia and Xgeva both contain the same active drug called denosumab. But these medications have different approved uses.

Prolia is approved to treat osteoporosis and to increase bone mass in certain people. However, Xgeva is approved for the following uses:

  • preventing certain bone problems in people with multiple myeloma*
  • preventing certain bone problems in people with cancer that has spread to their bones
  • treating high blood calcium levels that are caused by cancer
  • treating a certain type of bone cancer that can’t be treated with surgery

Prolia and Xgeva are each given as injections under your skin (called subcutaneous injections). However, Prolia is given once every 6 months, while Xgeva is given once every 4 weeks. The doses of these drugs also differ. If you’re taking Prolia, you’ll receive a 60-mg dose with each injection. But if you’re taking Xgeva, you’ll receive a 120-mg dose with each injection.

You shouldn’t take Prolia and Xgeva at the same time. If you have questions about which medication is right for you, talk with your doctor.

* Multiple myeloma is type of cancer that affects your white blood cells.

Can Prolia be taken with other medications, supplements, and foods?

Prolia isn’t known to interact with any other medications. It’s also not known to interact with any herbs, supplements, or foods.

However, before taking Prolia, talk with your doctor and pharmacist. Tell them about all prescription, over-the-counter, and other drugs you take. Also tell them about any vitamins, herbs, and supplements you use. Sharing this information can help you avoid potential interactions.

If you have questions about interactions that may affect you, ask your doctor or pharmacist.

As with all medications, the cost of Prolia can vary.

The actual price you’ll pay depends on your insurance plan, your location, and the pharmacy you use.

Your insurance plan may require you to get prior authorization before approving coverage for Prolia. This means that your doctor and insurance company will need to communicate about your prescription before the insurance company will cover the drug. The insurance company will review the request and let you and your doctor know if your plan will cover Prolia.

If you’re not sure if you’ll need to get prior authorization for Prolia, contact your insurance company.

Financial and insurance assistance

If you need financial support to pay for Prolia, or if you need help understanding your insurance coverage, help is available.

Amgen, the manufacturer of Prolia, offers ways to help lower the cost of Prolia. For example, if you have commercial insurance, the Prolia Co-pay Program may help reduce the cost of your prescription. And if you don’t have insurance coverage, you may find cost assistance through the Amgen Safety Net Foundation.

For more information on these programs, and to find out if you’re eligible for support, visit the manufacturer’s website.

You shouldn’t take Prolia if you’re pregnant or planning to become pregnant. Prolia can be harmful to a developing fetus. In fact, the drug can increase the risk of abnormal bone development and decreased growth. Prolia can also increase the risk of stillbirth, as well as infant death following birth.

If you’re a female who’s able to become pregnant, your doctor will have you take a pregnancy test before you start using Prolia. This allows your doctor to make sure you aren’t pregnant before you start taking the drug.

To help prevent pregnancy, it’s recommended that you use contraception while you’re taking Prolia. For more information about this, see the next section, “Prolia and birth control.”

If you’re pregnant or planning to become pregnant, talk with your doctor before starting Prolia. They’ll recommend a medication other than Prolia for you.

Prolia isn’t safe to take during pregnancy. Because of this, it’s recommended that you use birth control while taking this drug. If you’re sexually active and you or your partner can become pregnant, talk with your doctor about your birth control needs while you’re using Prolia.

For women using Prolia

If you’re a woman who’s able to become pregnant, your doctor will have you take a pregnancy test before you start using Prolia. This allows your doctor to make sure that you aren’t pregnant before starting treatment.

You should also use birth control while you’re taking Prolia. And you should continue to use birth control for at least 5 months after your last dose of the drug.

For men using Prolia

For drugs that can cause birth defects, men who are sexually active with females who can become pregnant should use birth control such as condoms to avoid pregnancy. However, the manufacturer of Prolia has stated that men taking this drug don’t need to use contraception during treatment.

If you have questions about your birth control needs, talk with your doctor.

It’s not known if Prolia is safe to take while you’re breastfeeding. However, the manufacturer of Prolia recommends that you don’t breastfeed while using the drug.

There haven’t been any studies done in breastfeeding women using the drug. And it’s not known if Prolia is passed into the breast milk of lactating women using the drug.

However, in animal studies, Prolia was passed into the breast milk of lactating animals for up to 1 month after their last dose of Prolia. Keep in mind that animal studies don’t always predict what will happen in people.

If you’re breastfeeding, talk with your doctor before starting Prolia. They can suggest safe and healthy ways to feed your child while you’re using this drug.

Before taking Prolia, talk with your doctor about your health history. Prolia may not be right for you if you have certain medical conditions or other factors affecting your health. These include:

  • Low calcium level in your blood. You shouldn’t take Prolia if you have a low blood calcium level. This is because Prolia can lower your blood calcium level even further, which could become dangerous. (Having a low calcium level can increase your risk of heart problems and may worsen heart disease if you already have the condition.) If your blood calcium level is low, it will have to be increased before you can start taking Prolia. (The level can be increased by taking calcium supplements.) If you have a low calcium level, talk with your doctor about the best way to increase the level before starting Prolia.
  • Allergic reaction to Prolia. If you have a history of an allergic reaction to Prolia or to any of the ingredients in Prolia, don’t take this medication. Talk with your doctor about medications other than Prolia that you can take to treat osteoporosis or bone loss.
  • Parathyroid or thyroid surgery. If you’ve had surgery on either your parathyroid or thyroid, you may have an increased risk of low blood calcium. Prolia can lower your blood calcium level even further, which could become dangerous. Talk with your doctor before taking Prolia if you’ve had surgery on your parathyroid or thyroid.
  • Trouble absorbing minerals. If you have trouble absorbing minerals (called malabsorption syndrome), you aren’t able to absorb calcium into your blood like usual. With this condition, you have an increased risk of low blood calcium levels, which can become dangerous. If you have a history of malabsorption syndrome, talk with your doctor before taking Prolia.
  • Kidney problems, including chronic kidney disease (CKD) or the need for kidney dialysis. If you have kidney problems or you are on dialysis treatment, talk with your doctor before starting Prolia. Prolia can cause decreased levels of calcium in your blood. Kidney problems can also cause a decrease in your calcium levels. They can also cause high parathyroid hormone (PTH) levels, which can affect your blood calcium levels. If you’re taking Prolia and you have kidney problems, you are at an increased risk of having a low calcium level, which can become dangerous.
  • Immunosuppression. With immunosuppression, your immune system is impaired, and it doesn’t work as well as it should. This condition can increase your risk of infection. Prolia can also increase your risk of serious infection. People who are immunosuppressed, including people taking drugs that suppress their immune system, may have a higher risk of serious infections while using Prolia. If you have an impaired immune system, or you take drugs that affect the activity of your immune system, talk with your doctor before taking Prolia.
  • Need for dental surgery or tooth extraction. Prolia can increase your risk of jaw necrosis. (With jaw necrosis, your jawbone begins to die.) This risk is increased if you’re having dental surgery or any teeth extracted (pulled). Talk with your doctor if you’re planning on having any dental procedures done while you’re taking Prolia.
  • Pregnancy. You shouldn’t take Prolia if you’re pregnant. Prolia can cause serious problems, including stillbirth and infant death. For more information, please see the “Prolia and pregnancy” section above.
  • Breastfeeding. It’s not known if Prolia is safe to take while you’re breastfeeding. For more information, please see the “Prolia and breastfeeding” section above.

Note: For more information about the potential negative effects of Prolia, see the “Prolia side effects” section above.

Prolia and alcohol

There aren’t any known interactions between Prolia and alcohol. However, alcohol can increase your risk of both osteoporosis and bone fractures. This is because alcohol can affect how your body absorbs calcium, which your body needs in order to have strong, healthy bones.

In addition, alcohol consumption can also make you fall more easily, which can increase your risk of fractures.

If you drink alcohol, talk with your doctor to see if there’s a safe amount of alcohol you can drink while you’re taking Prolia.

The following information is provided for clinicians and other healthcare professionals.

Indications

Prolia is indicated for use in people with high risk of fracture to:

  • treat osteoporosis in postmenopausal women
  • treat steroid-induced osteoporosis in men or women
  • treat osteoporosis in men
  • increase bone mass in men with nonmetastatic prostate cancer who are taking androgen deprivation therapy
  • increase bone mass in women with breast cancer who are taking aromatase inhibitors

Mechanism of action

Prolia works by inhibiting the RANK ligand (RANKL), which is a protein involved in the formation and action of osteoclasts. Prolia inhibits both osteoclast production and their role in bone destruction. This decreases bone breakdown and also strengthens bones.

Pharmacokinetics and metabolism

Prolia reaches a maximum concentration (Cmax) at about 10 days post-dose. However, individuals may have different responses to the drug, as Tmax ranges from 3 days to 21 days post-dose (with a median of 10 days). Drug concentration decreases over 4 to 5 months post-dose. The average half-life of the drug is 25.4 days.

There were no differences in pharmacokinetics with regard to age, weight, or race.

Contraindications

Due to the risk of fetal harm, Prolia is contraindicated in people who are pregnant. It is also contraindicated for use in people with hypocalcemia and in people with a past hypersensitivity to Prolia or to any of the ingredients in Prolia.

Storage

Prolia should be stored in a refrigerator, between 36°F and 46°F (2°C and 8°C).

Once Prolia is taken out of the refrigerator, it should be kept at or below 77°F (25°C). It can be stored out of the refrigerator at this temperature for up to 14 days. However, after a 14-day period, if the medication is not used, it needs to be discarded.

Prolia should be kept in its original carton until it is ready for use. Do not freeze Prolia. The medication should come to room temperature before it is administered, which usually takes 15 to 30 minutes. Prolia should not be heated or warmed in any other manner.

Disclaimer: Medical News Today has made every effort to make certain that all information is factually correct, comprehensive, and up to date. However, this article should not be used as a substitute for the knowledge and expertise of a licensed healthcare professional. You should always consult your doctor or other healthcare professional before taking any medication. The drug information contained herein is subject to change and is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. The absence of warnings or other information for a given drug does not indicate that the drug or drug combination is safe, effective, or appropriate for all patients or all specific uses.