Xgeva is a brand-name prescription medication. It’s used to help prevent and treat several types of bone problems.

Xgeva contains denosumab. This is a kind of biologic (a drug created from parts of living organisms) called a monoclonal antibody.

A healthcare provider will give you Xgeva as an injection under your skin (subcutaneous injection). You’ll go to a clinic or your doctor’s office for the injections.

How it’s used

The Food and Drug Administration (FDA) has approved Xgeva to be used to:

  • Help prevent broken bones in people with multiple myeloma. Multiple myeloma is a form of cancer that affects your bone marrow (the tissue in your bones).
  • Help prevent broken bones in people with bone metastasis caused by solid tumors. Bone metastasis occurs when cancer spreads to your bones. And a solid tumor is a lump of tissue that forms when cells grow too quickly. It’s solid because it doesn’t contain liquid.
  • Treat giant cell tumors that can’t be completely removed by surgery or in cases where surgery would be too dangerous. A giant cell tumor is a rare type of bone tumor that isn’t cancerous.
  • Treat hypercalcemia caused by cancer. Hypercalcemia occurs when there’s too much calcium in your blood. Also, you must have already tried a type of drug called a bisphosphonate, which helps prevent the loss of bone mass.

Xgeva is approved for use in adults. However, the drug is also approved to treat giant cell tumors in adolescents whose bones have finished growing.

Effectiveness

Three clinical trials looked at people with bone metastasis from solid tumors. The people took either Xgeva or a drug called zoledronic acid (Zometa). Xgeva helped prevent people from getting fractures for 27.7 months. The zoledronic acid treatment helped prevent people from getting fractures for 19.5 months. Therefore, Xgeva helped delay the time that people got fractures by 8.2 months longer than zoledronic acid.

For more information about how effective Xgeva is in helping prevent and treat other conditions, see the “Xgeva uses” section below.

Xgeva is available only as a brand-name medication. Xgeva contains one active drug ingredient: denosumab.

Xgeva isn’t currently available in a biosimilar form.

A biosimilar is a drug that’s similar to a brand-name medication. A generic drug, on the other hand, is an exact copy of a brand-name medication. Biosimilars are based on biologic drugs, which are made from parts of living organisms. Generics are based on regular drugs, which are made from chemicals. Biosimilars and generics tend to cost less than brand-name drugs.

Xgeva can cause mild or serious side effects. The following lists contain some of the key side effects that may occur while taking Xgeva. These lists do not include all possible side effects.

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

More common side effects

The more common side effects of Xgeva can include:

Some of these side effects may go away within a few days or a couple of weeks. If they’re more severe or don’t go away, talk with your doctor or pharmacist.

Serious side effects

Serious side effects from Xgeva 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, explained in more detail below in “Side effect details,” include:

  • severe allergic reactions
  • osteonecrosis (death of bone cells) in your jaw
  • hypercalcemia (high calcium levels) after stopping treatment with Xgeva
  • hypocalcemia (low levels of calcium)
  • breaks in your femur, the bone between your hip and your knee
  • breaks in your spine after stopping treatment with Xgeva

Side effect details

You may wonder how often certain side effects occur with this drug. Here’s some detail on several of the side effects this drug may cause.

Allergic reaction

As with most drugs, some people can have an allergic reaction after taking Xgeva, but this is rare. It’s not known how often people using Xgeva have allergic reactions. Symptoms of a mild allergic reaction can include:

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

A more severe allergic reaction is also rare. 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 or talking
  • low blood pressure

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

Jaw and dental side effects

Problems with your mouth, teeth, and jaw while taking Xgeva could be early warning signs of osteonecrosis in your jaw. (This is a condition in which the cells in your jaw die.)

Symptoms of osteonecrosis can include:

  • mouth or jaw pain that lasts
  • slow healing after dental surgery
  • tooth infection
  • toothache
  • bone loss
  • bone infections
  • gums that have sores or recede (pull away from teeth)

In addition to taking Xgeva, other factors may increase your risk of developing osteonecrosis of the jaw during your treatment:

  • not brushing, flossing, or seeing your dentist on a regular basis
  • wearing dentures that don’t fit well
  • having tooth problems, such as severe tooth decay, tooth infection, or a broken tooth
  • having had a serious dental procedure, such as a tooth extraction, a dental implant, or oral surgery
  • having an infection
  • having certain conditions, such as diabetes or anemia (low level of red blood cells)

If you notice any symptoms of osteonecrosis while taking Xgeva, tell your doctor right away. They may test the bone density in your jaw to see if you have bone loss. If you do, they may recommend a drug other than Xgeva.

In clinical studies, the longer people took Xgeva, the higher their risk for osteonecrosis. The most common reason people stopped taking Xgeva during the studies was osteonecrosis of the jaw.

For information on how often jaw and dental effects occurred in Xgeva clinical studies, see the “Adverse Reactions” section of the Xgeva prescribing information.

Bone, joint, or muscle pain

Xgeva can cause pain in your bones, joints, or muscles. This pain can be severe or may greatly decrease your quality of life.

This pain can occur right after you start treatment with Xgeva or months later. The pain usually develops within the first year of taking Xgeva, if it occurs at all. It’s not known how often people using Xgeva have bone, joint, or muscle pain.

If you have pain in your bones, joints, or muscles while taking Xgeva, tell your doctor. They may pause your Xgeva treatment or suggest a change in medication.

Hypercalcemia

High levels of calcium, called hypercalcemia, can occur after treatment with Xgeva. In clinical studies, hypercalcemia was reported in people with growing skeletons and those with giant cell tumors within 1 year after they stopped taking Xgeva. (Xgeva is not approved for use in children whose skeletons are still growing.)

Symptoms of hypercalcemia can include:

  • headache
  • fatigue (lack of energy)
  • extreme thirst
  • urinating much more often than usual
  • back pain
  • nausea
  • belly pain
  • feeling less hungry than usual
  • constipation
  • vomiting

If you notice symptoms of hypercalcemia while taking Xgeva or after you stop taking the drug, tell your doctor. They may pause your Xgeva use to treat the hypercalcemia or recommend a drug other than Xgeva.

Hypocalcemia

Taking Xgeva can lead you to have hypocalcemia (low levels of calcium). And if you have hypocalcemia before you start taking Xgeva, the drug can lower your calcium levels even further.

Before you start taking Xgeva, it’s important that your doctor checks your calcium level. If it’s too low, they may prescribe calcium and vitamin D supplements to help raise your calcium level.

Symptoms of hypocalcemia can include:

  • confusion or memory loss
  • hallucinations (seeing or hearing things that aren’t really there)
  • depression
  • muscle spasms (twitches)
  • muscle cramps
  • numbness and tingling in your hands, feet, or face
  • weak and brittle nails
  • bones that break easily

If you notice symptoms of hypocalcemia while taking Xgeva, tell your doctor. They may test you for low calcium levels. Depending on the results, your doctor may recommend a drug other than Xgeva.

For information on how often hypocalcemia occurred in Xgeva clinical studies, see the “Adverse Reactions” section of the Xgeva prescribing information.

Bone fractures

Bone fracture (broken bone) can be a side effect during and after Xgeva treatment. This can occur in bones such as your femur or in your spine. Symptoms of a fracture in your femur include unusual pain in your thigh, hip, or groin. Symptoms of a fracture in your spine include back or neck pain.

Weeks to months before people had a complete fracture in their femur, they reported feeling dull, aching pain in their thigh. And before people had a fracture in their spine, they reported head, neck, or back pain.

If you notice symptoms of a bone fracture while taking Xgeva, tell your doctor right away. Your doctor may recommend a drug other than Xgeva.

For information on how often bone fractures occurred in Xgeva clinical studies, see the “Clinical Trials” section of the Xgeva prescribing information.

Side effects in children

Xgeva is approved to treat giant cell tumors in adolescents whose bones have finished growing. Side effects of the drug in adolescents are the same as in adults. To learn more, please see the “Xgeva side effects” section above.

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

The actual price you’ll pay depends on your insurance plan and your location.

Financial and insurance assistance

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

Amgen Inc., the manufacturer of Xgeva, offers a program called Xgeva First Step for people who have health insurance coverage. For more information about this program, and to find out if you’re eligible for support, call 888-65-STEP1 (888-657-8371) or visit the program website.

For people without health insurance, a program called Amgen Safety Net Foundation is available to help with treatment costs. For more information about this program, and to find out if you’re eligible for support, call 888-762-6436 or visit the program website.

The Xgeva dosage your doctor prescribes will depend on several factors. These include:

  • the type and severity of the condition you’re using Xgeva to treat
  • your age
  • other medical conditions you may have

The following information describes dosages that are commonly used or recommended. However, be sure to take the dosage your doctor prescribes for you. Your doctor will determine the best dosage to suit your needs.

Drug forms and strengths

Xgeva comes in a single-dose vial with 120 mg/1.7mL of solution (liquid mixture).

Dosage for multiple myeloma

The recommended dose of Xgeva for multiple myeloma is 120 mg once every 4 weeks.

A healthcare provider will give you Xgeva as an injection under your skin (subcutaneous injection). Possible injection spots are your upper arm, upper thigh, or belly. You’ll go to a clinic or your doctor’s office for an injection once every 4 weeks.

Your doctor may also prescribe calcium and vitamin D supplements to help prevent or treat low calcium levels.

Dosage for bone metastasis from solid tumors

The recommended dose of Xgeva for bone metastasis from solid tumors is 120 mg once every 4 weeks.

A healthcare provider will give you Xgeva as an injection under your skin. Possible injection spots are your upper arm, upper thigh, or belly. You’ll go to a clinic or your doctor’s office for an injection once every 4 weeks.

Your doctor may also prescribe calcium and vitamin D supplements to help prevent or treat low calcium levels.

Dosage for giant cell tumors

The recommended dose of Xgeva for certain giant cell tumors is 120 mg once every 4 weeks.

A healthcare provider will give you Xgeva as an injection under your skin. Possible injection spots are your upper arm, upper thigh, or belly. You’ll go to a clinic or your doctor’s office for an injection once every 4 weeks.

During your first month of treatment, you’ll need extra injections of 120 mg on days 8 and 15.

Your doctor may also prescribe calcium and vitamin D supplements to help prevent or treat low calcium levels.

Dosage for hypercalcemia caused by cancer

The recommended dose of Xgeva for hypercalcemia caused by cancer is 120 mg once every 4 weeks.

A healthcare provider will give you Xgeva as an injection under your skin. Possible injection spots are your upper arm, upper thigh, or belly. You’ll go to a clinic or your doctor’s office for an injection once every 4 weeks.

During your first month of treatment, you’ll need extra injections of 120 mg on days 8 and 15.

Pediatric dosage

Xgeva is approved to treat giant cell tumors in adolescents whose bones have finished growing. The recommended dose for these adolescents is 120 mg once every 4 weeks.

A healthcare provider will give your adolescent Xgeva as an injection under their skin. Possible injection spots are their upper arm, upper thigh, or belly. They’ll need to go to a clinic or their doctor’s office for an injection once every 4 weeks.

During their first month of treatment, your adolescent will need extra injections of 120 mg on days 8 and 15.

What do I do if I miss a dose?

If you miss an appointment to receive a dose of Xgeva, call your doctor. The office staff can make a new appointment and adjust the timing of future visits, if needed.

To help you remember your appointments, write your Xgeva treatment schedule in a calendar. You can also set a reminder on your phone.

Will I need to use this drug long term?

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

Other drugs are available that can treat your condition. Some may be better suited for you than others. If you’re interested in finding an alternative to Xgeva, talk with your doctor. They can tell you about other medications that may work well for you.

Note: Some of the drugs listed here are used off-label to treat these specific conditions. Off-label use is when a drug that’s approved to treat one condition is used to treat a different condition.

Alternatives for multiple myeloma

Examples of other drugs that may be used to treat multiple myeloma include:

  • Alkylating agents, such as:
    • melphalan (Alkeran, Evomela)
    • cyclophosphamide
  • Bisphosphonates, such as:
    • pamidronate disodium (Aredia)
    • zoledronic acid (Zometa)
  • Bone resorption inhibitors, such as:
    • pamidronate disodium (Aredia)
  • Cytolytic antibodies such as:
    • daratumumab (Darzalex)
  • Cytotoxic antibiotics, such as:
    • doxorubicin hydrochloride liposome (Doxil)
  • Hematopoietic stem cell mobilizers, such as:
    • plerixafor (Mozobil)
  • Histone deacetylase inhibitors, such as:
    • panobinostat (Farydak)
  • Immunomodulatory agents, such as:
    • thalidomide (Thalomid)
    • lenalidomide (Revlimid)
    • pomalidomide (Pomalyst)
  • Immunostimulatory antibodies, such as:
    • elotuzumab (Empliciti)
  • Nitrosoureas, such as:
    • carmustine (BiCNU)
  • Proteasome inhibitors, such as:
    • bortezomib (Velcade)
    • carfilzomib (Kyprolis)
    • ixazomib citrate (Ninlaro)

Alternatives for bone metastasis from solid tumors

Examples of other drugs that may be used to treat bone metastasis from solid tumors include:

  • Bisphosphonates, such as:
    • alendronate (Fosamax)
    • risedronate (Actonel)
    • ibandronate (Boniva)
    • zoledronic acid (Zometa)
  • Radiopharmaceuticals, such as:
    • strontium-89 (Metastron)
    • samarium-153 (Quadramet)
    • radium-223 (Xofigo)

Alternatives for giant cell tumors

Chemotherapy drugs are an example of another type of drug that may be used to treat giant cell tumors.

Alternatives for hypercalcemia caused by cancer

Examples of other drugs that may be used to treat hypercalcemia caused by cancer include:

  • Bisphosphonates, such as:
    • pamidronate (Aredia)
    • zoledronic acid (Zometa)
  • Hormones, such as:
    • calcitonin (Miacalcin)
  • Glucocorticoids, such as:
    • hydrocortisone (Cortef)
    • prednisone (Deltasone)
  • Calcimimetics, such as:
    • cinacalcet (Sensipar)

You may wonder how Xgeva compares to other medications that are prescribed for similar uses. Here we look at how Xgeva and Zometa are alike and different.

Uses

The Food and Drug Administration (FDA) has approved Xgeva and Zometa to treat certain conditions that affect your skeleton and involve bone tumors.

Multiple myeloma

Xgeva is approved to help prevent broken bones in people with multiple myeloma. This is a form of cancer that affects your bone marrow (the tissue in your bones).

Zometa is approved to treat bone metastases in multiple myeloma when used with a type of anticancer drug called an antineoplastic. (Bone metastases are cancer cells that have moved from another part of the body into the bones.)

Bone metastasis from solid tumors

Xgeva is approved to help prevent broken bones in people with bone metastasis from solid tumors. Bone metastasis occurs when cancer spreads to your bones. And a solid tumor is a lump of tissue that forms when cells grow too quickly. It’s solid because it doesn’t contain liquid.

Zometa is approved to treat bone metastasis from solid tumors when used with a type of anticancer drug called an antineoplastic. In some cases, Zometa may be used to treat prostate cancer. However, the cancer must have gotten worse after you tried at least one type of hormone therapy.

Giant cell tumors

Xgeva is approved to treat giant cell tumors that can’t be completely removed by surgery or in cases where surgery would be too dangerous. A giant cell tumor is a rare type of bone tumor that isn’t cancerous.

Xgeva is also approved to treat giant cell tumors in adolescents whose bones have finished growing.

Zometa isn’t approved to treat giant cell tumors.

Hypercalcemia caused by cancer

Both Xgeva and Zometa are approved to treat hypercalcemia caused by cancer. Hypercalcemia occurs when there’s too much calcium in your blood.

To use Xgeva, you must have already tried a type of drug called a bisphosphonate, which helps prevent the loss of bone mass. Zometa is a bisphosphonate.

Drug forms and administration

Xgeva contains the drug denosumab. Zometa contains the drug zoledronic acid.

For Xgeva

A healthcare provider will give you Xgeva as an injection under your skin (subcutaneous injection). You’ll go to a clinic or your doctor’s office for your injections. The drug comes in a single-dose vial with 120 mg/1.7 mL of solution (liquid mixture).

Xgeva is given once every 4 weeks. For giant cell tumors and hypercalcemia caused by cancer, you’ll need extra doses on days 8 and 15.

For Zometa

Zometa is given as an intravenous (IV) infusion in a clinic or your doctor’s office. This is an injection into your vein that’s given over a period of time. This infusion should last at least 15 minutes. The drug comes in two forms:

  • a single-use bottle that contains 4 mg/100 mL of the drug
  • a single-use vial that contains 4 mg/5 mL of the drug

For hypercalcemia related to cancer, Zometa is given as a single dose of 4 mg. If needed, a second dose can be given after at least 7 days.

For multiple myeloma and bone metastasis from solid tumors, Zometa is given at a dose of 4 mg every 3 to 4 weeks.

Side effects and risks

Xgeva and Zometa are both approved to treat some of the same conditions. Therefore, both medications can cause very similar and very different side effects. Below are examples of these side effects.

More common side effects

These lists contain examples of more common side effects that can occur with Xgeva, with Zometa, or with both drugs (when taken individually).

  • Can occur with Xgeva:
  • Can occur with Zometa:
    • body aches
    • fever that’s usually mild and lasts a short time
    • anemia (low level of red blood cells)
    • vomiting
    • constipation
    • flu-like symptoms, including chills and feeling unwell
  • Can occur with Xgeva and Zometa
    • tiredness
    • nausea
    • mild allergic reactions

Serious side effects

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

  • Can occur with Xgeva:
    • osteonecrosis (death of bone cells) in your jaw
    • hypocalcemia, also known as low calcium levels
    • breaks in your femur, the bone between your hip and knee
    • multiple breaks in the bones in your spine after stopping treatment with Xgeva
    • hypercalcemia, also known as high calcium levels, after stopping treatment with Xgeva
  • Can occur with Zometa:
    • new or unusual pain in your hips, thighs, groin, jaw, or ears
    • eye problems, such as redness, itching, swelling, or sensitivity to light
    • irregular heartbeat
    • sores in your jaw or mouth
    • kidney problems, such as urinating more or less often than usual
    • seizures
    • severe dizziness
    • trouble breathing
  • Can occur with both Xgeva and Zometa:
    • severe allergic reactions
    • increased or severe pain in your bones, joints, or muscles

Effectiveness

Xgeva and Zometa are both FDA-approved to treat certain bone conditions. These include certain forms of multiple myeloma, bone metastasis from solid tumors, and hypercalcemia caused by cancer. The use of the two drugs in treating these conditions has been directly compared in several clinical studies.

One study looked at people who had multiple myeloma or solid tumors that were metastatic (spread to other parts of the body). These people took either Xgeva or Zometa. In the Xgeva group, 43.8% of people had bone problems while 44.6% of the Zometa group did.

A second study looked at people with metastatic breast cancer who took either Xgeva or Zometa. Xgeva was found to be more effective than Zometa in preventing bone problems. Of the people who took Xgeva, 31% of them had a broken bone. This was compared to 36% of people who took Zometa.

In a third study, researchers looked at people with hypercalcemia caused by cancer. Xgeva was able to lower high levels of calcium by 64% in the first 10 days of treatment. Xgeva wasn’t compared to a placebo (no treatment) or a different drug.

Costs

Xgeva and Zometa are both brand-name drugs. Neither drug is available in biosimilar form.

A biosimilar is a drug that’s similar to a brand-name medication. A generic drug, on the other hand, is an exact copy of a brand-name medication. Biosimilars are based on biologic drugs, which are made from parts of living organisms. Generics are based on regular drugs, which are made from chemicals. Biosimilars and generics tend to cost less than brand-name drugs.

Xgeva costs more than Zometa. The actual price you’ll pay for either drug depends on your insurance plan and your location.

You may wonder how Xgeva compares to other medications that contain the same active ingredient, denosumab. Here we look at how Xgeva and Prolia are alike and different.

Uses

The Food and Drug Administration (FDA) has approved Xgeva and Prolia to treat certain bone conditions.

Xgeva is FDA-approved to:

  • Help prevent broken bones in people with multiple myeloma. Multiple myeloma is a form of cancer that affects your bone marrow (the tissue in your bones).
  • Help prevent broken bones in people with bone metastasis caused by solid tumors. Bone metastasis occurs when cancer spreads to your bones. And a solid tumor is a lump of tissue that forms when cells grow too quickly. It’s solid because it doesn’t contain liquid.
  • Treat giant cell tumors that can’t be completely removed by surgery or in cases where surgery would be too dangerous. A giant cell tumor is a rare type of bone tumor that isn’t cancerous.
  • Treat hypercalcemia caused by cancer. Hypercalcemia occurs when there’s too much calcium in your blood. Also, you must have already tried a type of drug called a bisphosphonate, which helps prevent the loss of bone mass.

Xgeva is approved for use in adults. However, the drug is also approved to treat giant cell tumors in adolescents whose bones have finished growing.

Prolia is FDA-approved to treat people who have a high risk of breaking their bones, including:

  • women who have gone through menopause and have osteoporosis
  • men with osteoporosis
  • men and women with glucocorticoid-induced osteoporosis
  • men who are receiving androgen deprivation therapy for nonmetastatic prostate cancer
  • women who are receiving adjuvant aromatase inhibitor therapy for breast cancer

Drug forms and administration

Both Xgeva and Prolia are given by your healthcare provider as an injection under your skin (subcutaneous injection).

Xgeva comes in a single-dose vial with 120 mg/1.7 mL of solution (liquid mixture). Prolia comes in a single-dose prefilled syringe with 60 mg/mL of solution.

Xgeva is given once every 4 weeks. For giant cell tumors and hypercalcemia caused by cancer, you’ll need extra doses on days 8 and 15. Prolia injections are given every 6 months.

Side effects and risks

Xgeva and Prolia both contain the drug denosumab. Therefore, both medications can cause very similar side effects. Below are examples of these side effects.

More common side effects

This list contains examples of more common side effects that can occur with both Xgeva and Prolia:

Serious side effects

This list contains examples of serious side effects that can occur with Xgeva and Prolia:

  • severe allergic reactions
  • osteonecrosis (death of bone cells) in your jaw
  • hypocalcemia, also known as low calcium levels
  • breaks in your femur, the bone between your hip and knee
  • multiple breaks in the bones in your spine after stopping treatment with Xgeva
  • hypercalcemia, also known as high calcium levels, after stopping treatment with Xgeva

Effectiveness

Xgeva and Prolia are similar in that they have the same active ingredient, denosumab. However, each has different FDA-approved uses.

These drugs haven’t been compared to each other in clinical studies. However, studies have found that both Xgeva and Prolia are effective in treating their approved uses.

Costs

Xgeva and Prolia are both brand-name drugs. Neither drug is available in biosimilar form.

A biosimilar is a drug that’s similar to a brand-name medication. A generic drug, on the other hand, is an exact copy of a brand-name medication. Biosimilars are based on biologic drugs, which are made from parts of living organisms. Generics are based on regular drugs, which are made from chemicals. Biosimilars and generics tend to cost less than brand-name drugs.

Xgeva costs more than Prolia. The actual price you’ll pay for either drug depends on your insurance plan and your location.

The Food and Drug Administration (FDA) approves prescription drugs such as Xgeva to treat certain conditions. Xgeva 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.

Xgeva for prostate cancer complications

Prostate cancer usually affects men older than age 50 years. The older you get, the more your risk increases.

Sometimes prostate cancer can spread from the prostate to other parts of the body. The disease usually spreads to bones first. Xgeva may help prevent or delay serious complications from prostate cancer spreading to bones.

One study looked at how Xgeva compared to a drug called zoledronic acid (Zometa) in people with bone metastasis from prostate cancer. (The people had prostate cancer that spread to their bones.) People who took Xgeva didn’t have any broken bones for about 20.7 months. This was compared to people who took zoledronic acid, who didn’t have any broken bones for about 17.1 months.

Xgeva for multiple myeloma

Multiple myeloma is a form of cancer that affects your bone marrow (the tissue in your bones). The disease changes plasma cells, which are a kind of white blood cell that helps fight infections.

These changed cells crowd out healthy cells. When your body doesn’t make enough healthy bone cells, your bones may become weak and break. Xgeva is used to help prevent broken bones in people with multiple myeloma.

One study looked people with multiple myeloma or cancer that spread to their bones. Researchers studied how long it was until people had a fracture. People who took Xgeva didn’t have a fracture for 625 days. People who took zoledronic acid didn’t have a fracture for 496 days.

A second study reported that the zoledronic acid group had a fracture at 521 days. The Xgeva group lasted to 629 days before a fracture occurred.

Xgeva for breast cancer complications

Breast cancer affects cells in the breast and causes them to divide and multiply. When breast cancer spreads to other body parts, it’s called metastatic breast cancer. In some cases, the cancer can reach your bones.

Xgeva is used to help prevent or delay bone problems in people with breast cancer that’s spread to their bones. The drug is also used to treat other complications of cancer such as hypercalcemia of malignancy (high levels of calcium).

One study compared Xgeva to a drug called zoledronic acid (Zometa) in people with bone metastasis from breast cancer. (The people had breast cancer that spread to their bones.) Of the people who took Xgeva, 30.7% developed bone problems. This was compared to 36.5% of people who took zoledronic and developed bone problems.

Another study that lasted 6 years also looked at people with bone metastasis from breast cancer. They took either Xgeva or zoledronic acid. People who took Xgeva had 315 fractures, while people who took zoledronic acid had 372 fractures.

Xgeva for bone metastasis

Xgeva is approved to help prevent broken bones in people with bone metastasis from solid tumors. Bone metastasis occurs when cancer spreads to your bones. And a solid tumor is a lump of tissue that forms when cells grow too quickly. It’s solid because it doesn’t contain liquid.

Three clinical trials looked at people with bone metastasis from solid tumors. The people took either Xgeva or a drug called zoledronic acid (Zometa). Xgeva helped prevent people from getting fractures for 27.7 months. The zoledronic acid treatment helped prevent people from getting fractures for 19.5 months. Therefore, Xgeva helped delay the time that people got fractures by 8.2 months longer than zoledronic acid.

Xgeva for hypercalcemia

When cancer moves from a part of your body to your bones, the cancer cells can crowd out healthy bone cells. These bone cells release calcium, which moves into your bloodstream. Too much calcium in your blood is called hypercalcemia.

Xgeva is approved to treat hypercalcemia of malignancy. This is hypercalcemia that’s related to cancer. You must have already tried a type of drug called a bisphosphonate, which helps prevent the loss of bone mass.

Some types of cancer have higher rates of hypercalcemia, including:

One clinical trial looked at people with hypercalcemia who took Xgeva. For 64% of people treated with Xgeva, calcium levels returned to normal within 10 days of first taking the drug. Xgeva wasn’t compared to a placebo (no treatment) or a different drug.

Xgeva and children

In some cases, Xgeva is approved to treat certain tumors in adolescents whose bones have finished growing. Xgeva is used to treat giant cell tumors that can’t be completely removed by surgery or in cases where surgery would be too dangerous. A giant cell tumor is a rare type of bone tumor that isn’t cancerous.

In studies, adolescents who took Xgeva while their bones were still growing developed hypercalcemia after they stopped treatment. (Hypercalcemia refers to high levels of calcium in your blood.) Adolescents also developed hypercalcemia if they took Xgeva for off-label uses.

Alcohol hasn’t been shown to interact with Xgeva.

If you drink alcohol, ask your doctor how much is safe for you to consume while you take Xgeva.

Xgeva can interact with several other medications. It can also interact with certain supplements as well as certain foods.

Different interactions can cause different effects. For instance, some interactions can interfere with how well a drug works. Other interactions can increase the number of side effects or make them more severe.

Xgeva and other medications

Below is a list of medications that can interact with Xgeva. This list does not contain all drugs that may interact with Xgeva.

Before taking Xgeva, 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 drug interactions that may affect you, ask your doctor or pharmacist.

Xgeva and immunosuppressants

Taking Xgeva and immunosuppressants together can weaken your immune system (your body’s defense against disease). This can increase your risk for serious infections, especially if your immune system is already weak.

Examples of immunosuppressant drugs that may increase your risk for serious infections include:

  • Corticosteroids, such as:
    • prednisone (Deltasone, Orasone)
    • budesonide (Entocort EC)
    • prednisolone (Millipred)
  • Biologics, such as:
    • abatacept (Orencia)
    • adalimumab (Humira)
    • anakinra (Kineret)
    • certolizumab (Cimzia)
    • etanercept (Enbrel)
    • golimumab (Simponi)
    • infliximab (Remicade)
    • ixekizumab (Taltz)
    • natalizumab (Tysabri)
    • rituximab (Rituxan)
    • secukinumab (Cosentyx)
    • tocilizumab (Actemra)
    • ustekinumab (Stelara)
    • vedolizumab (Entyvio)
  • Monoclonal antibodies, such as:
    • basiliximab (Simulect)
    • daclizumab (Zinbryta)

If your immune system is weak or if you’re taking an immunosuppressant, talk with your doctor before using Xgeva. They may recommend different medications for you.

Xgeva and etelcalcetide

Taking Xgeva and etelcalcetide can decrease the level of calcium in your blood. This can lead to hypocalcemia (low level of calcium).

For symptoms of hypocalcemia, see the “Side effect details” section above. If you have any symptoms of hypocalcemia while taking Xgeva, call your doctor right away.

Xgeva and siponimod

Taking Xgeva and siponimod together can weaken your immune system (your body’s defense against disease). This can increase your risk for serious infections.

If you’re taking siponimod, talk with your doctor before using Xgeva. They may choose a different medication that does not interact with siponimod.

Xgeva and Prolia

Xgeva and Prolia both contain the same active ingredient, denosumab. So if you use Xgeva and Prolia, you’d be taking more than the amount of denosumab that’s safe for you. This may cause an increased risk in side effects and more severe side effects such as hypercalcemia.

If you’re taking Prolia, talk with your doctor before using Xgeva. They may have you use one or the other drug, but not both.

Xgeva and Faslodex (not an interaction)

Xgeva and fulvestrant (Faslodex) don’t interact with one another. The two drugs are often used together to help treat some forms of breast cancer.

You should take Xgeva according to your doctor or healthcare provider’s instructions.

A healthcare provider will give you Xgeva as an injection under your skin (subcutaneous injection). Possible injection spots are your upper arm, upper thigh, or belly. You’ll go to a clinic or your doctor’s office for your injections.

When to take

You’ll have an injection of Xgeva once every 4 weeks. For giant cell tumors and hypercalcemia caused by cancer, you’ll need extra doses on days 8 and 15.

To help you remember your appointments, write your Xgeva treatment schedule in a calendar. You can also set a reminder on your phone.

Although the tissue in your bones is constantly breaking down, your body builds the tissue back up, which helps keep your bones strong.

When you have cancer that started in or spread to your bones, this breakdown/buildup process can be out of balance. A protein called RANKL usually help keep the process of breaking down bone and rebuilding bone in balance. But when cancer cells invade bones, RANKL can become too active. This can cause the cancer cells to increase the breakdown of the bone, leaving bones weak and more likely to break.

Xgeva binds to RANKL and prevents RANKL from attaching to its receptor. Receptors are proteins on the outside of cells that act like docking stations. By blocking RANKL from binding to its receptor, Xgeva helps decrease the level of bone breakdown. This is the way Xgeva works in helping prevent bone fractures and breaks in multiple myeloma and bone metastasis. (Bone metastasis occurs when cancer spreads to your bones.)

Xgeva also works to treat giant cell tumors, which are a rare type of bone tumor that isn’t cancerous. Giant cell tumors have a high level of RANKL in their cells. Xgeva binds to RANKL in the tumor cells and helps prevent the tumors from growing. The drug can also shrink the tumors.

In addition, Xgeva helps treat hypercalcemia caused by cancer. Hypercalcemia occurs when there’s too much calcium in your blood. When bone is broken down and reabsorbed into the body, calcium levels rise. Xgeva binds to the RANKL protein, preventing RANKL from attaching to its receptor. This prevents bone breakdown, which in turn decreases the amount of calcium that’s released into the bloodstream. The end result is reduced calcium levels.

How long does it take to work?

In clinical studies, within 1 week of starting treatment, most people who took Xgeva had a meaningful reduction in bone turnover markers in their blood. (This is a sign that the drug is strengthening your bones). Each person’s response to Xgeva will be unique, though.

Xgeva hasn’t been tested in pregnant women. In animal studies, Xgeva harmed the baby when the drug was given to the pregnant mother. Xgeva also harmed the baby when the mother was given the drug within the 5 months before they became pregnant. However, animal studies don’t always predict what happens in humans.

If you’re pregnant or are planning to become pregnant, you shouldn’t take Xgeva. Talk with your doctor about other treatment options.

Results from animal studies show that Xgeva isn’t safe to take during pregnancy. Because of possible risks to the baby, women should use birth control (contraception) while they’re pregnant. Women should also use birth control for at least 5 months after they stop taking Xgeva. This is in case they become pregnant during this time.

If you’re taking Xgeva and have any questions about birth control, talk with your doctor.

There’s no information about Xgeva in human breast milk. In animal studies, Xgeva was found in breast milk. However, studies in animals don’t always reflect what will happen in humans.

If you’re taking Xgeva and are thinking about breastfeeding your child, talk with your doctor. They can help you find the best way to feed your child.

Here are answers to some frequently asked questions about Xgeva.

Is Xgeva chemotherapy?

No, Xgeva isn’t chemotherapy. Xgeva is a targeted therapy. This type of treatment targets cancer cells and tends to leave healthy cells alone.

Chemotherapy is a drug treatment that uses powerful chemicals to kill fast-growing cells in your body. It’s most often used to treat cancer because cancer cells grow and multiply quickly. Chemotherapy drugs act on all cells in your body that are growing rapidly, not just cancer cells.

Is Xgeva the same as Prolia?

No, but it’s easy to see why there may be some confusion. The Food and Drug Administration (FDA) has approved the drugs Xgeva and Prolia to treat certain bone conditions. And both drugs contain the active ingredient denosumab. Drugs with the same active ingredient can be used for different things based on how much and how often you take them.

Because Xgeva and Prolia both contain denosumab, you shouldn’t take these medications together. If you did, you’d be taking more than the amount of denosumab that’s safe for you. And this could increase your risk for side effects such as osteonecrosis (death of bone cells) and hypocalcemia (low levels of calcium). See the “Xgeva side effects” section above for more information.

To learn more about how these two drugs compare, see the “Xgeva vs. Prolia” section above. And if you have questions about Xgeva or Prolia, talk with your doctor or pharmacist.

Do I need to take calcium supplements with Xgeva?

You might. Taking Xgeva can lead you to have hypocalcemia (low levels of calcium). And if you have hypocalcemia before you start taking Xgeva, the drug can lower your calcium levels even further.

To help prevent or treat low calcium levels, your doctor may prescribe calcium supplements if you’re taking Xgeva for:

Along with the calcium supplements, your doctor may also prescribe vitamin D supplements. Vitamin D helps your bones absorb calcium.

While you’re taking Xgeva, it’s a good idea to know the symptoms of hypocalcemia. See the “Serious side effects” section above for a list of symptoms. Tell your doctor if you notice any of them while taking the drug.

And if you have questions about hypocalcemia during your Xgeva treatment, talk with your doctor.

Can I use either Xgeva or Prolia to treat osteoporosis?

Of the two drugs, only Prolia is approved to treat osteoporosis in certain cases. Prolia is used for people who have a high risk of breaking their bones, including:

  • women who have gone through menopause and have osteoporosis
  • men with osteoporosis
  • men and women with glucocorticoid-induced osteoporosis

Although Xgeva is used to treat certain bone conditions, the drug isn’t approved to treat osteoporosis.

For more about these two drugs, see the “Xgeva vs. Prolia” section above. And if you have questions about Xgeva, Prolia, or how to treat osteoporosis, talk with your doctor.

How can I prevent jaw bone problems?

To help prevent jaw problems, it’s important to keep your mouth healthy. You can help do this by brushing and flossing every day, and seeing your dentist on a regular basis.

Problems with your mouth, teeth, and jaw while taking Xgeva are often early warning signs of osteonecrosis in your jaw. This is a condition in which the cells in your jaw die. (For more about osteonecrosis, see the “Side effect details” section above.)

Keep in mind that certain dental procedures can put you at risk for problems such as slow healing or infection in your jaw. These procedures include tooth extraction, root canal, and dental implant surgery. If you need minor dental surgery during Xgeva treatment, watch for any symptoms you have afterward. Tell your dentist if you have any pain or wounds in your mouth or jaw that are slow to heal.

If you have questions about mouth and jaw problems while taking Xgeva, ask your dentist or doctor.

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

  • Hypocalcemia. If you have hypocalcemia (low levels of calcium), your doctor will need to treat the condition before you start taking Xgeva. Your doctor may prescribe calcium and vitamin D supplements to help raise your calcium level.
  • Allergic reactions. If you’ve had an allergic reaction to Xgeva or any of its ingredients, you shouldn’t take the drug. Talk with your doctor about other treatments that are a better choice for you.
  • Pregnancy. If you’re pregnant or are planning to become pregnant, you shouldn’t take Xgeva. For more information, please see the “Xgeva and pregnancy” section above.
  • Breastfeeding. If you’re taking Xgeva and are thinking about breastfeeding your child, talk with your doctor. For more information, please see the “Xgeva and breastfeeding” section above.

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

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

Indications

Xgeva is indicated for:

  • the prevention of fractures in adults with multiple myeloma and adults with bone metastasis from solid tumors
  • giant cell tumors of the bone that are unable to be completely removed or unsafe to remove without causing harm to the patient in adults and skeletally mature adolescents
  • the treatment of hypercalcemia of malignancy in people who are not helped by bisphosphonate treatment

Mechanism of action

Xgeva binds to the receptor activator of nuclear factor kappa-B ligand (RANKL), a required protein for the formation of osteoclasts. Increased osteoclast activity increases the risk of bone loss in people with solid tumors with metastasis. This binding results in the prevention of RANKL from binding with its receptor and doing its job of breaking down bone, thereby decreasing the risk of bone loss. The final result is decreased bone loss and increased bone density.

Pharmacokinetics and metabolism

Subcutaneous administration results in a bioavailability of 62%.

Doses of 120 mg once every 4 weeks reach steady state by 6 months. In patients with giant cell tumor of bone and hypercalcemia of malignancy, doses of 120 mg are needed on days 8 and 15 doses in addition to 120 mg once every 4 weeks, and reach steady state in 3 months.

The mean elimination half-life of Xgeva is 28 days.

Contraindications

Xgeva is contraindicated in people:

  • With hypersensitivity to any component of the product.
  • With hypocalcemia, which must be corrected with supplemental calcium and vitamin D before therapy with Xgeva is begun.
  • Who are pregnant. Taking Xgeva during pregnancy may cause fetal harm. Perform a pregnancy test prior to initiation of therapy. Adequate contraception is required in women of reproductive potential while on therapy and for at least 5 months after discontinuation.

Storage

Store Xgeva in its original carton. Keep in the refrigerator at 36°F to 46°F (2°C to 8°C). Do not let the product freeze. Following removal from the refrigerator, Xgeva must remain at or below 77°F (25°C) and protected from direct light or heat. Xgeva must be discarded if not used within 14 days of removal from refrigerator.

Do not use after the expiration date. Avoid the vigorous shaking of Xgeva.

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.

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