All About Xgeva

What is Xgeva?

If you have a certain kind of cancer or tumor, your doctor may prescribe Xgeva to help prevent serious bone problems.

Xgeva is a prescription drug that’s used in adults to:

• prevent bone fractures in people with multiple myeloma or cancer that has spread to the bones from a solid tumor
• treat hypercalcemia (high calcium levels in the blood) caused by cancer
• treat giant cell tumors (a rare type of bone tumor) that can’t be safely removed by surgery

Doctors may also prescribe Xgeva for certain children with giant cell tumors. To learn more about Xgeva’s uses, see the “What indications is Xgeva used for?” section below.

Xgeva basics

Xgeva contains the active drug denosumab. It belongs to a group of biologic drugs called RANKL inhibitors. (Biologic drugs are medications made from parts of living cells.)

Xgeva is not available in biosimilar form. (Biosimilars are like generic drugs. But unlike generics, which are made for non-biologic drugs, biosimilars are made for biologic drugs.) Instead, denosumab comes only as the brand-name drug Xgeva.

You’ll receive Xgeva as an injection under your skin at a clinic or doctor’s office.

Read on to learn about Xgeva’s side effects, uses, dosage, and more.

What are Xgeva’s side effects?

Like most drugs, Xgeva may cause mild or serious side effects. The lists below describe some of the more common side effects that Xgeva may cause. These lists don’t include all possible side effects.

Keep in mind that the side effects of a drug can depend on:

• the condition you are using it to treat
• your age
• other health conditions you have
• other medications you take

Your doctor or pharmacist can tell you more about the potential side effects of Xgeva. They can also suggest ways to help reduce side effects.

Mild side effects

Here’s a short list of some of the mild side effects that Xgeva can cause. To learn about other mild side effects, talk with your doctor or pharmacist, or read Xgeva’s prescribing information.

Mild side effects of Xgeva that have been reported include:

• fatigue (low energy) or weakness
• digestive problems, such as nausea, diarrhea, vomiting, or constipation
• pain in your back, joints, limbs, hands, or feet
• swelling in your legs or arms due to fluid buildup
• upper respiratory infection such as the common cold
• skin rash
• headache
• shortness of breath
• decreased appetite
• toothache
• low phosphate levels
• low levels of red blood cells or platelets (cells that help with blood clotting)

Mild side effects of many drugs may go away within a few days to a couple of weeks. But if they become bothersome, talk with your doctor or pharmacist.

Serious side effects

Serious side effects from Xgeva can occur, but they aren’t common. If you have serious side effects from Xgeva, call your doctor right away. But, if you think you’re having a medical emergency, you should call 911 or your local emergency number.

Serious side effects of Xgeva that have been reported include:

• pneumonia
• thigh bone fractures
• hypocalcemia (low calcium levels)*
• osteonecrosis of the jaw*
• allergic reaction*

* For more information about this side effect, see the “Side effect focus” section below.

Side effect focus

Learn more about some of the side effects Xgeva may cause.

Osteonecrosis of the jaw

In rare cases, taking Xgeva may cause osteonecrosis of the jaw (ONJ). ONJ is the breakdown or death of bone tissue in the jaw.

Symptoms of ONJ may include:

• jaw or mouth pain that doesn’t go away
• infection of the teeth, gums, or bones
• sores on your gums
• toothache
• lingering pain or slow healing after a dental procedure

In Xgeva’s studies, most people who developed ONJ also had other factors that contributed to the condition (such as a tooth removal).

Examples of other factors that may increase the risk of ONJ while taking Xgeva include:

• continuing Xgeva treatment for a long time
• smoking cigarettes
• having anemia or diabetes
• having gum infections
• taking medications that weaken your immune system, such as steroids
• taking cancer medications that stop the growth of blood vessels, such as bevacizumab (Avastin)

What might help

It’s important to practice good oral hygiene during your Xgeva treatment. This includes regular brushing, flossing, and seeing your dentist for cleanings and checkups. You’ll also have a dental checkup before starting Xgeva.

If you need to have an invasive dental procedure while receiving Xgeva, your doctor may have to pause your treatment. Examples of these procedures include tooth extractions and dental implant procedures.

Tell your doctor right away if you have a toothache or other possible symptoms of ONJ during your treatment with Xgeva. If you develop ONJ, your doctor or dentist will discuss the treatment options for ONJ with you. They may prescribe medications to ease your symptoms or recommend surgical treatments. They may also have you stop your Xgeva treatment.

If you have concerns about your dental health while using Xgeva, talk with your doctor or dentist.

Hypocalcemia

Xgeva may cause hypocalcemia (low calcium levels). This was a common side effect in studies of the drug. In some cases, hypocalcemia can be severe.

Symptoms of hypocalcemia may include:

• muscle spasms or cramps
• numbness and tingling in the face, hands, or feet
• confusion or memory problems
• depression
• hallucinations (seeing or hearing things that aren’t really there)
• brittle nails

Fatal cases of hypocalcemia have also been reported in people who took Xgeva. But it isn’t known if the drug was the cause or if other factors were involved. If you’re concerned about the risk of life threatening hypocalcemia with Xgeva, talk with your doctor.

You may have a higher risk of this side effect if you have severe kidney problems or take medications that lower your calcium levels.

What might help

Before prescribing Xgeva, your doctor will check your calcium levels. If you have hypocalcemia, they’ll treat it before prescribing Xgeva.

You’ll have blood tests during Xgeva treatment to check for low calcium levels. You may have these tests more frequently in the first few weeks of treatment or if you have other risk factors for developing this side effect.

Your doctor may have you take dietary supplements to help prevent low calcium levels during your Xgeva treatment. These supplements include calcium, vitamin D, and possibly magnesium. These products are available without a prescription, but your doctor will tell you the type and dosage of these supplements to take.

Allergic reaction

Some people may have an allergic reaction to Xgeva. Allergic reactions have been reported in people taking Xgeva but weren’t seen in the drug’s studies.

Symptoms of a mild allergic reaction can include:

• skin rash
• itchiness
• flushing (temporary warmth, redness, or deepening of skin color)

A more severe allergic reaction is rare but possible. Symptoms of a severe allergic reaction can include swelling under your skin, usually in your eyelids, lips, hands, or feet. They can also include swelling of your tongue, mouth, or throat, which can cause breathing problems.

Call your doctor right away if you have an allergic reaction to Xgeva. But if you think you’re having a medical emergency, call 911 or your local emergency number.

What should I know about Xgeva vs. alternative drug Prolia?

Xgeva and Prolia contain the same active drug, denosumab. But these drugs are used to treat or prevent different conditions related to the bones.

For an in-depth comparison of Xgeva and Prolia, see this article.

What does Xgeva cost?

Costs of prescription drugs can vary depending on many factors. These factors include what your insurance plan covers and which pharmacy you use.

If you have questions about how to pay for your prescription, talk with your doctor or pharmacist. The Xgeva website also has information about financial assistance options.

You can also check out this article to learn more about saving money on prescriptions.

What is Xgeva’s dosage?

Your doctor will recommend the dosage of Xgeva that’s right for you. Below are commonly used dosages, but your doctor will determine the dosage you receive.

Form and strength

Xgeva comes as a liquid solution in a vial. Each vial contains 120 milligrams (mg) of the drug in 1.7 milliliters (mL) of solution.

You’ll receive Xgeva as an injection under your skin at a clinic or doctor’s office.

Recommended dosages

You’ll receive Xgeva doses every 4 weeks.

If you’re taking Xgeva to treat giant cell tumors or hypercalcemia caused by cancer, you’ll likely receive two extra doses during your first month of treatment.

Your doctor will go over your dosing schedule for Xgeva.

Questions about Xgeva’s dosage

Below are some common questions about Xgeva’s dosage.

• What if I miss a dose of Xgeva? If you miss an appointment to receive a dose of Xgeva, call your doctor’s office right away. They’ll work with you to reschedule your appointment as soon as possible.
• Will I need to use Xgeva long term? If Xgeva is working to improve your condition, your treatment may be long term. Talk with your doctor about the benefits of long-term use and the risks of stopping your treatment.
• How long does Xgeva take to work? Xgeva should slow down your body’s breakdown of bone within a few weeks of starting treatment. During your treatment, your doctor will monitor you to make sure the drug is still working for your condition.

What indications is Xgeva used for?

Xgeva has several indications, which are listed below. (Indications are the specific uses or conditions for which a medication is taken.)

Xgeva is used in certain adults to:

• prevent bone fractures in people with multiple myeloma or cancer that has spread to the bones from a solid tumor
• treat hypercalcemia (high calcium levels in the blood) due to cancer
• treat giant cell tumors (a rare type of bone tumor) that can’t be safely removed by surgery (Xgeva may also be used in certain children with this condition)

These uses are described in more detail below.

Xgeva for preventing fractures in people with cancer

Xgeva is used to prevent bone fractures in adults who have one of the following forms of cancer:

• multiple myeloma, a cancer that affects the bone marrow
• cancer that has spread to the bones (also called bone metastases) from a solid tumor. A few examples of solid tumors are prostate cancer, breast cancer, and lung cancer.

Your body naturally maintains your bones by continually breaking down bone tissue, then rebuilding it. With multiple myeloma or bone metastases, the cancer can interfere with the body’s natural bone maintenance. This may cause bones to break down more quickly than usual. This, along with the effects of certain cancer treatments such as radiation, can lead to weak bones. Weak bones are more likely to fracture (break).

Xgeva works to prevent bone fractures by slowing bone breakdown. When the drug attaches to a specific protein in your body, it stops certain bone cells from breaking down bone tissue. This helps strengthen your bones.

Xgeva for hypercalcemia

Xgeva is also used in certain adults to treat hypercalcemia due to cancer. For this use, doctors prescribe Xgeva for adults who have already tried a bisphosphonate drug, but it didn’t work effectively. Examples of bisphosphonates are alendronate (Fosamax), pamidronate (Aredia), and zoledronic acid (Zometa).

Some people with cancer may have high calcium levels. This is because cancer can cause your bones to break down more quickly than usual. When bones break down, calcium is released into the blood. Xgeva works to treat high calcium levels by slowing bone breakdown.

Xgeva for giant cell tumors

Xgeva is also used in adults and some children to treat giant cell tumors that can’t be safely removed by surgery. A giant cell tumor is a rare type of bone tumor that’s usually benign (noncancerous). When used in children, doctors typically prescribe Xgeva only to older children whose bones have stopped growing. This generally happens around 12 years of age.

Xgeva works to treat giant cell tumors by attaching to certain proteins within the tumors. This can help prevent the tumors from growing. This may also help shrink the tumors.

What should I know about Xgeva vs. alternative drug Zometa?

Xgeva and Zometa are used to treat certain conditions that affect your bones.

Xgeva contains the active drug denosumab, while Zometa contains the active drug zoledronic acid.

For more information about how these drugs compare, see this article.

What are some frequently asked questions about Xgeva?

Find answers to some commonly asked questions about Xgeva.

Does Xgeva cause dental side effects?

It’s possible. Teeth problems have been reported in people taking Xgeva. In studies of people receiving Xgeva for giant cell tumors (a rare type of bone tumor), toothache was a common side effect.

In rare cases, Xgeva may cause osteonecrosis of the jaw (ONJ). This refers to the breakdown or death of bone tissue in the jaw. For more information, see “Side effect focus” in the “What are Xgeva’s side effects?” section above.

It’s important to practice good oral hygiene during your Xgeva treatment. This includes regular brushing, flossing, and seeing your dentist for cleanings and checkups. You’ll also have a dental checkup before starting Xgeva. Tell your doctor or dentist right away if you have a toothache during treatment, as this could be a sign of ONJ.

Is Xgeva a chemotherapy drug?

No, Xgeva isn’t a chemotherapy drug. Chemotherapy drugs treat cancer by killing fast-growing cells in your body, including healthy cells.

Xgeva is a kind of targeted therapy. Although the drug is used in people with certain types of cancer, the drug doesn’t kill cancer cells (or any fast-growing cells). Instead, Xgeva helps prevent and treat serious bone problems, such as bone fractures. It’s used in people with multiple myeloma, cancer that has spread to the bones, hypercalcemia (high calcium levels in the blood) due to cancer, and bone tumors. Xgeva works to slow bone breakdown. It also works to keep bone tumors from growing.

If you have questions about how Xgeva works to treat your condition, talk with your doctor.

Can Xgeva cause long-term side effects?

It’s possible. People who take Xgeva for a long time may have an increased risk of the following side effects:

• osteonecrosis of the jaw (breakdown or death of bone tissue in the jaw)
• thigh bone fractures

Additionally, long-term side effects have been reported in people after their Xgeva treatment ended. Examples of these side effects included hypercalcemia (high calcium levels in the blood). For more information about the possible side effects of stopping Xgeva, see “Side effect focus” in the “What are Xgeva’s side effects?” section above.

Your doctor will monitor you for side effects during and after your Xgeva treatment.

Will I experience side effects after stopping Xgeva treatment?

Possibly.

Stopping Xgeva treatment may lead to certain side effects. These side effects may include:

• hypercalcemia (high calcium level in your blood)
• spine fractures

Severely high calcium levels have occurred in certain people within the first year after stopping Xgeva treatment. Specifically, this side effect happened in people with giant cell tumors whose bones were still growing. For this reason, doctors typically only prescribe Xgeva for this condition in adults and in children whose bones have stopped growing.

Additionally, spine fractures have occurred in some people after stopping Xgeva. This risk may be higher in people with osteoporosis (bone loss) or who have had bone fractures.

When considering Xgeva treatment, it’s important to talk with your doctor about the risks and benefits of not only starting the drug but also stopping it.

You and your doctor will determine how long your Xgeva treatment will last. You should not decide on your own to stop going to your Xgeva injection appointments. If you’re interested in stopping the drug, talk with your doctor. They can help you weigh the risks and benefits of stopping treatment.

If you and your doctor decide you’ll stop Xgeva, they’ll monitor you closely for side effects. This may include getting blood tests and bone mineral density tests.

How is Xgeva given?

Your doctor will explain how Xgeva will be given to you. They will also explain how much you’ll be given and how often.

Taking Xgeva

You’ll receive Xgeva as an injection under your skin at a clinic or doctor’s office. Xgeva injections are given in the upper arm, upper thigh, or abdomen (belly).

Taking Xgeva with other drugs

You may take certain dietary supplements while taking Xgeva. These include calcium and vitamin D.

Calcium and vitamin D supplements are available without a prescription. Talk with your doctor about the type and dosage of calcium and vitamin D you should take.

Taking these supplements can help prevent or manage hypocalcemia (low calcium levels), which is a serious side effect of Xgeva. (For more information, see “Side effect focus” in the “What are Xgeva’s side effects?” section above.)

Questions for your doctor

You may have questions about Xgeva and your treatment plan. It’s important to discuss all your concerns with your doctor.

Here are a few tips that might help guide your discussion:

• Before your appointment, write down questions such as:
  • How will Xgeva affect my body, mood, or lifestyle?
• Bring someone with you to your appointment if doing so will help you feel more comfortable.
• If you don’t understand something related to your condition or treatment, ask your doctor to explain it to you.

Remember, your doctor and other healthcare professionals are available to help you. And they want you to get the best care possible. So, don’t be afraid to ask questions or offer feedback on your treatment.

What should be considered before taking Xgeva?

Interactions

Taking a medication with certain vaccines, foods, and other things can affect how the medication works. These effects are called interactions.

Before taking Xgeva, you should tell your doctor about all medications you take, including prescription and over-the-counter types. Also, describe any vitamins, herbs, or supplements you use. Your doctor or pharmacist can tell you about any increased risks that may occur with Xgeva.

Interactions with drugs or supplements

Xgeva should not be given to people who’re receiving Prolia. This is because Prolia and Xgeva contain the same active drug, denosumab.

No other medications are specifically known to interact with Xgeva, but taking certain drugs with Xgeva may increase the risk of side effects. Examples of these drugs include:

• cinacalcet (Sensipar), a drug used in certain people with chronic kidney disease
• immunosuppressive drugs, such as tacrolimus (Prograf) and etanercept (Enbrel)
• anti-angiogenic drugs (drugs that keep new blood vessels from forming) such as bevacizumab (Avastin)
• steroids, such as prednisone and methylprednisolone (Medrol)

Warnings

Xgeva may not be right for you if you have certain medical conditions or other factors that affect your health. Talk with your doctor about your health history before you take Xgeva. Factors to consider include:

• Allergic reaction. If you’ve had an allergic reaction to Xgeva, Prolia, or any of their ingredients, your doctor will likely not prescribe Xgeva. Ask them what other medications are better options for you.
• Low calcium level. Xgeva may cause hypocalcemia (low calcium levels). If you’ve been told you have low calcium levels, or if you take a medication that lowers calcium levels, talk with your doctor. They’ll treat your hypocalcemia before considering Xgeva for you. If they prescribe Xgeva, they’ll also have you take calcium and vitamin D supplements to help maintain healthy calcium levels. And they’ll monitor your calcium levels closely during treatment.
• Kidney problems. Xgeva may cause low calcium levels. If you have kidney problems, this side effect is more likely to occur. Because of this risk, doctors typically recommend calcium and vitamin D supplements for people who take Xgeva and have kidney problems. Your doctor will also monitor your calcium levels closely during treatment.
• Osteoporosis. Before starting Xgeva treatment, tell your doctor if you have osteoporosis. (This condition causes weak and brittle bones.) Xgeva can cause certain fractures during treatment and after stopping it. You may have a greater risk for this side effect if you have osteoporosis. Your doctor can recommend whether it’s safe for you to use Xgeva.

Xgeva and alcohol

It should be safe to drink alcohol during your Xgeva treatment.

If you drink alcohol, talk with your doctor about the amount that’s safe for you to drink alcohol during your Xgeva treatment.

Pregnancy and breastfeeding

Xgeva is not safe to use during pregnancy. This drug may cause harmful effects in a fetus.

If you are able to become pregnant, your doctor will have you take a pregnancy test before they prescribe Xgeva. They’ll need to confirm you aren’t pregnant before you start this treatment. Your doctor will also prescribe birth control to prevent pregnancy while you’re receiving Xgeva and for at least 5 months after your last dose.

It isn’t known if Xgeva is safe to use while breastfeeding. If you’re breastfeeding or planning to, talk with your doctor before starting treatment with Xgeva.

What to ask your doctor

Xgeva can help prevent or treat serious bone problems in certain people.

Your doctor can provide more information about the pros and cons of using Xgeva for your condition. They can also tell you about other treatment options for multiple myeloma, cancer that’s spread to the bones, hypercalcemia (high calcium levels in the blood), and bone tumors.

You may have questions or concerns about using Xgeva. Be sure to discuss these with your doctor. A few questions you may want to ask include:

• How long will my Xgeva treatment last?
• Should I take any dietary supplements, such as calcium or vitamin D, with Xgeva?
• Is it safe to keep taking my other medications during my Xgeva treatment?
• Can I drive myself to my Xgeva injection appointments?