Xgeva
Xgeva (denosumab) is a RANKL inhibitor that helps prevent the breakdown of bones. It's used to prevent bone problems in adults with certain types of cancer, like breast cancer and prostate cancer, that have spread to the bones. It's also used to lower calcium levels in people who have cancer (hypercalcemia of malignancy). Xgeva (denosumab) is given as an injection under the skin, typically once per month by a healthcare professional (HCP). Common side effects of this medication include fatigue and nausea.
What is Xgeva (denosumab)?
What is Xgeva (denosumab) used for?
- Prevention of broken bones in adults with multiple myeloma (MM) or cancer that has spread to the bones
- Giant cell tumor of bone in adults and children ages 12 years and older who can't receive surgery
- High calcium levels caused by cancer (hypercalcemia of malignancy) in adults
How Xgeva (denosumab) works
Xgeva (denosumab) is a monoclonal antibody that's classified as a RANKL inhibitor. By blocking the protein RANKL, Xgeva (denosumab) stops bones from being broken down by preventing cells called osteoclasts from working.
Drug facts
More on Xgeva (denosumab) essentials
Side effects of Xgeva (denosumab)
The following side effects may get better over time as your body gets used to the medication. Let your healthcare provider know immediately if you continue to experience these symptoms or if they worsen over time.
Common Side Effects
- Fatigue (45%)
- Low blood phosphorus levels (32%)
- Nausea (31%)
- Shortness of breath (21%)
- Diarrhea (20%)
- Low blood calcium levels (18%)
- Cough (15%)
- Headache (13%)
Less Common Side Effects
- Osteonecrosis of the jaw
- Skin rash
- Hair loss
- Muscle pain
Xgeva (denosumab) serious side effects
Contact your healthcare provider immediately if you experience any of the following.
- Serious allergic reactions: dizziness, trouble, tightness in your throat, swelling in your face and throat, itchiness, rash
- Dangerously low calcium levels: tingling, numbness, muscle cramps, irregular heart rhythm, seizures, confusion
- Osteonecrosis of the jaw: pain, swelling, exposed bone, bad breath, loose teeth, gum infection
The following Xgeva (denosumab) side effects have also been reported
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor or nurse immediately if any of the following side effects occur:
More common
Back pain
blistering, crusting, irritation, itching, or reddening of the skin
bloody or cloudy urine
cracked, dry, or scaly skin
difficult, burning, or painful urination
frequent urge to urinate
muscle or bone pain
pain in the arms or legs
rash
skin rash, encrusted, scaly, and oozing
swelling
Less common
Arm or jaw pain
bloating or swelling of the face, arms, hands, lower legs, or feet
body aches or pain
chest pain or discomfort
chest tightness or heaviness
chills
confusion
congestion
difficulty with breathing
difficulty with moving
dryness or soreness of the throat
ear congestion
fast or irregular heartbeat
headache
hoarseness
joint pain
loss of voice
muscle cramps in the hands, arms, feet, legs, or face
muscle stiffness
numbness and tingling around the mouth, fingertips, hands, or feet
pain in the lower back, bottom, upper leg, or hips
painful blisters on the trunk of the body
pale skin
rapid weight gain
runny or stuffy nose
seizures
stomach cramps
swollen joints
tender, swollen glands in the neck
trouble swallowing
troubled breathing with exertion
unusual bleeding or bruising
unusual tiredness or weakness
unusual weight gain or loss
voice changes
Rare
Blood in the stool
change in bowel habits
clear or bloody discharge from the nipple
darkened urine
difficulty with eating
dimpling of the breast skin
indigestion
inverted nipple
itching, pain, redness, swelling, tenderness, or warmth on the skin
loss of appetite
lower back or side pain
lump in the breast or under the arm
lump or swelling in the abdomen or stomach
pains in the stomach, side, or abdomen, possibly radiating to the back
persistent crusting or scaling of the nipple
raised, firm, and bright red patches of the skin on the arm or leg
redness or swelling of the breast
sore on the skin of the breast that does not heal
stomach discomfort
unexplained weight loss
vomiting
yellow eyes or skin
Incidence not known
Heavy feeling in the jaw
loose teeth
pain, swelling, or numbness in the mouth or jaw
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
Less common
Dizziness or lightheadedness
excess air or gas in the stomach or bowels
feeling of constant movement of self or surroundings
feeling of fullness
lack or loss of strength
passing gas
redness, pain, itching, burning, swelling, or a lump under your skin where the shot was given
sensation of spinning
trouble sleeping
upper abdominal or stomach pain
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
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Pros and cons of Xgeva (denosumab)
Pros
- Works well at preventing bone loss, which prevents serious bone problems
- Only need to get once a month (after the first month)
Cons
- Injected by healthcare professional at their office
- Can't be used if you’re pregnant or planning to become pregnant
Pharmacist tips for Xgeva (denosumab)
- Xgeva (denosumab) is injected under your skin once a month by a healthcare professional (HCP) in either your upper arm, upper thigh, or stomach area.
- Mark your appointments on your calendar to get your Xgeva (denosumab) injections from your HCP or to get any blood tests (e.g., calcium and phosphate levels) done. It's important to get your injections on time so you don't miss any doses. Be sure to follow up regularly with your care team to discuss how treatment is going for you.
- Your prescriber might recommend incorporating bone-healthy foods into your diet, exercising, and taking calcium and vitamin D supplements to help prevent your bones from weakening. Work with your prescriber on a plan that works best for you.
- If you're having any dental procedures done, make sure to let your dentist or oral surgeon know you're taking Xgeva (denosumab) because it can cause jaw bone problems (called osteonecrosis of the jaw).
- Tell your prescriber if you're taking Prolia (denosumab) for osteoporosis before starting Xgeva (denosumab). Both Prolia and Xgeva have the same active ingredient, denosumab. So you shouldn't be on both medications.
- If you're pregnant, let your prescriber know right away. Xgeva (denosumab) can cause serious harm to your unborn baby. If you're able to get pregnant, make sure to use a reliable form of birth control during treatment with Xgeva (denosumab) and for at least 5 months after you stop the medication.
- Ask your healthcare team about possible risks and benefits of receiving Xgeva (denosumab) while breastfeeding. There isn't much information about how this medication might affect a nursing child, but research shows low amounts of it can pass into breastmilk.
Common questions about Xgeva
No, Xgeva isn't a bisphosphonate; it's a RANKL inhibitor, which is a type of monoclonal antibody. Both bisphosphonates and Xgeva work by stopping osteoclasts (cells that break down bone) from working, but they do so in different ways. Bisphosphonates are typically first-choice medications for osteoporosis. Xgeva isn't FDA-approved for osteoporosis, but it treats other bone-related problems. Note that there's another brand-name medication containing denosumab called Prolia, which is used to treat osteoporosis.
No, Xgeva isn't a chemotherapy. Chemotherapy is a type of treatment that kills fast-growing cells and is typically used to treat cancer. Instead, Xgeva is a RANKL inhibitor that prevents the breakdown of bones. Xgeva helps to treat bone problems, including those caused by cancer, but it doesn't treat the cancer itself.
Xgeva can cause low calcium levels through several ways. One way it does so is by slowing the breakdown of bones, which causes less calcium to be released from bones into the blood. Another way it does so is by lowering the amount of calcitriol (the active form of vitamin D) made by the kidneys. Because your body needs vitamin D to absorb calcium, having lower levels of calcitriol means that the body isn't able to absorb calcium as well. If you have low calcium levels after starting Xgeva, your prescriber might recommend that you take vitamin D or calcium supplement.
How long Xgeva takes to work can depend on the condition you're taking it to treat. And since this medication is sometimes used to prevent bone problems, you might not feel any noticeable change after starting treatment or only see benefits through lab results. For example, in a study that looked at people who had high calcium levels caused by cancer, results showed that denosumab was able to lower calcium levels within target range after about 9 days. When you start Xgeva, your prescriber will monitor you regularly throughout treatment to see how well this medication is treating your condition. Talk with your healthcare team to see what you might expect after starting this medication.
Hair loss wasn't a reported side effect from people taking Xgeva in clinical trials. There has been a report of one person experiencing hair loss after taking a different medication containing denosumab for osteoporosis; their hair grew back after stopping treatment. Talk with your prescriber if you have concerns about Xgeva and hair loss.
Yes, Xgeva can cause osteonecrosis of the jaw (ONJ), which is the breakdown of the jawbone. In clinical studies, up to about 7% of people receiving Xgeva experienced ONJ. Your healthcare team will recommend that you schedule dental exams before starting and regularly while receiving this medication to monitor for signs of ONJ. You can lower your risk of this side effect by regularly brushing and flossing your teeth. Let your care team know right away if you experience pain and swelling in the jaw.
Xgeva is typically taken long-term for most conditions. In clinical studies, people who received this medication to prevent serious bone-related problems typically continued treatment for at least a year. Before you start Xgeva, your healthcare team will let you know what you can expect during treatment. Your care team might ask you to take this medication as long as it's helping your condition and you're not having any serious side effects.
No, Xgeva isn't the same as Prolia (denosumab). While both medications contain denosumab, they aren't FDA-approved to treat the same medical conditions. Prolia (denosumab) is prescribed to treat conditions related to osteoporosis. It's given as an injection under the skin by a healthcare professional (HCP), typically once every 6 months. Xgeva is prescribed to strengthen bones weakened by cancer. It's also injected under the skin by a HCP. But Xgeva is given monthly. If you're already taking Prolia (denosumab), you should not receive Xgeva. Ask your healthcare team if you have questions about either medications.
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Risks and warnings for Xgeva (denosumab)
Xgeva (denosumab) can cause some serious health issues. This risk may be even higher for certain groups. If this worries you, talk to your doctor or pharmacist about other options.
Low calcium levels
- Risk factors: Serious kidney problems | Not taking calcium supplements | Taking other medications that can lower calcium blood levels | Conditions that affect how well your body absorbs minerals | Surgery to remove your small intestine | History of hypoparathyroidism (low levels of parathyroid hormone) or thyroid surgery
Xgeva (denosumab) can case dangerously low blood calcium levels, especially in people who have kidney problems and are taking medications for high parathyroid levels, such as cinacalcet (Sensipar) and Parsabiv (etelcalcetide).
Signs of low calcium include memory loss, muscle spasms or cramps, numbness and tingling in the hands, feet, and face. Your prescriber will monitor your calcium, phosphorus, and magnesium levels regularly during treatment, especially during the first weeks after you start Xgeva (denosumab). If needed, your healthcare team will prescribe calcium and vitamin D supplements to keep your calcium level within a safe range.
High calcium levels after stopping treatment
- Risk factors: History of giant cell tumor of bone | Being at an age where your bones are still growing
Xgeva (denosumab) can cause dangerously high calcium levels for people who stop taking Xgeva (denosumab) for giant cell tumor of bone and in people whose bones are still growing. The risk is highest during the first year after you stop the medication. Let your prescriber know right away if you experience loss of appetite, stomach upset or pain, nausea, vomiting, and constipation.
Problems in the jaw bone (osteonecrosis)
- Risk factors: Having oral or dental procedures done while taking Xgeva (denosumab) | Using dental devices | Taking steroid medications, certain medications that stop tumors from growing, or chemotherapy | Poor mouth hygiene | History of gum infections | History of diabetes
Although rare, Xgeva (denosumab) can cause osteonecrosis of the jaw, a condition where the jaw bone breaks down. This can cause symptoms like jaw pain, infection or inflammation in your jawbone, tooth or gum infection, or slow healing after a dental procedure. The risk of ONJ might be higher the longer you take Xgeva (denosumab).
To lower your risk of this side effect, practice good mouth hygiene, such as brushing and flossing your teeth multiple times per day and rinsing with fluoride. You might need a dental exam before you start Xgeva (denosumab) and occasionally while you're taking the medication. If you notice pain or swelling in your jaw, talk to your prescriber right away. If you have a dental procedure planned while you're taking this medication, let your prescriber know so you can discuss the risks and benefits of continuing this medication or having the procedure done.
Thigh bone fractures
- Risk factors: Taking steroid medications
People taking Xgeva (denosumab) have experienced unusual thigh fractures, even without any falls or injuries occurring to the area. If you experience any new or unusual hip, thigh, or groin pain, let your healthcare team know so they can check you for any fractures.
Spine fractures after stopping treatment
- Risk factors: Stopping Xgeva (denosumab) treatment or skipping doses | History of fractures | History of osteoporosis
When you stop taking Xgeva (denosumab) or skip doses, your risk of broken bones rises, including the risk of spine fractures. Before you start taking Xgeva (denosumab), let your prescriber know if you've ever fractured your spine so you can discuss the risks and benefits of taking this medication. To lower your risk of spine fractures, your prescriber might suggest you start another medication for osteoporosis after you stop taking Xgeva (denosumab).
Harm to your unborn baby
- Risk factors: Currently pregnant
Xgeva (denosumab) can cause serious and life-threatening harm to an unborn baby. Don't use Xgeva (denosumab) if you're pregnant. Before you start treatment, your healthcare team might ask you to take a pregnancy test to make sure you're not pregnant. It's important to use a reliable form of birth control while you're taking Xgeva (denosumab) and for at least 5 months after you stop the medication.
Serious allergic reactions
Some people who received Xgeva (denosumab) have reported serious allergic reactions, including trouble breathing, swelling of the throat and lips, and hives. Get medical help right away if you experience these symptoms. Also, let your healthcare team know about the reaction after you receive treatment; they'll ask you to stop Xgeva (denosumab) and consider other options.
Xgeva (denosumab) dosage
Vial| Dosage | Quantity | Price as low as | Price per unit |
|---|---|---|---|
| 1.7ml of 120mg/1.7ml | 1 vial | $3,309.64 | $3,309.64 |
Typical dosage for Xgeva (denosumab)
Xgeva (denosumab) is given as an injection under the skin in the upper arm, upper thigh, or stomach.
-
Prevention of broken bones in people with MM or cancer that has spread to the bones: The typical dose is 120 mg injected under the skin every 4 weeks.
-
Giant cell tumor of bone and high calcium levels caused by cancer: The typical dose is 120 mg injected under the skin every 4 weeks. In the first month of treatment, you'll receive an additional 120 mg on Day 8 and 15.
More on Xgeva (denosumab) dosage
Interactions between Xgeva (denosumab) and other drugs
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Tofacitinib
How much does Xgeva (denosumab) cost?
$467.05
Xgeva (denosumab) contraindications
Contraindications are specific health conditions or situations in which a person should not take a medication due to safety concerns. If you have any of the following conditions or if any of the following apply to you, let your healthcare provider know because Xgeva (denosumab) will not be safe for you to take.
- Low calcium levels that are untreated
- Currently pregnant
What are alternatives to Xgeva (denosumab)?
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