Xgeva Dosage, forms & strengths
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Xgeva (denosumab) is a monoclonal antibody that is manufactured by Amgen Inc. It is indicated by the U.S. Food and Drug Administration (FDA) for:
- Prevention of skeletal-related events (SREs) in patients with multiple myeloma and patients with bone metastases and solid tumors from prostate cancer, breast cancer, and lung cancer.
- Adults and skeletally mature adolescents with giant cell tumor of bone.
- Hypercalcemia of malignancy that didn’t respond to bisphosphonate therapy.
How does Xgeva work?
RANKL is a protein that helps regulates bone breakdown and bone resorption. When cancer cells attack bones, RANKL can become too active and cause an increased breakdown of bone. This can lead to weakened bones which are more likely to fracture or break. When bone is broken down, it can also increase your blood calcium levels.
Xgeva is a RANK ligand (RANKL) inhibitor that prevents RANKL from binding to its receptor. This slows osteoclasts from breaking down the bone and increasing calcium levels. This also prevents the growth of giant cell tumors. This leads to a reduced risk of broken bones, radiation therapy, and spinal cord compression.
Xgeva dosage forms and strengths
- 120 mg/1.7 mL (70 mg/mL) solution in a single-dose vial for subcutaneous injection
The recommended dose of Xgeva will depend on the condition being treated:
- Multiple myeloma and metastatic cancer that has spread to your bones from solid tumors: Inject 120mg under the skin every 4 weeks.
- Giant cell tumor of bone: Inject 120mg under the skin every 4 weeks with added doses of 120mg on days 8 and 15 of the first month of therapy. Take calcium and vitamin D as needed to treat or prevent low calcium levels.
- High calcium levels due to cancer: Inject 120mg under the skin every 4 weeks with added doses of 120mg on days 8 and 15 of the first month of therapy.
Xgeva dosage restrictions
- There are no dose adjustments recommended in patients with hepatic impairment.
- Patients with renal impairment (creatinine clearance < 30 ml/min) or on dialysis are at an increased risk of hypocalcemia. You should take calcium and vitamin D supplements if needed.
How to take Xgeva
- Read the Full Prescribing Information including the Boxed Warning, Instructions for Use, and Medication Guide that comes with this medication.
- Xgeva is injected under the skin in your upper arm, thigh, or stomach area by your doctor. Xgeva should not be injected into your vein or muscle.
- You should take calcium and vitamin D supplements as needed to treat or prevent low blood calcium levels.
- Make sure your dentist is aware you are taking Xgeva. You may have to stop taking Xgeva before having invasive dental procedures or dental surgery.
- Pay close attention to your oral hygiene while on this medication. Make sure to brush and floss your teeth regularly while on Xgeva.
Xgeva dosage FAQs
What are the most common side effects of Xgeva?
The most common adverse effects of Xgeva in clinical trials (incidence greater than 1%) include:
- Back pain
- Low serum calcium levels
- Upper respiratory tract infection
- Decreased appetite
- Musculoskeletal pain
Xgeva can sometimes cause more serious side effects, including:
- Severe, life-threatening allergic reactions (hives, angioedema, and dyspnea)
- Osteonecrosis of the jaw (ONJ)
- Atypical femoral fractures
- Multiple vertebral fractures (MVF) following treatment discontinuation
- Hypercalcemia after stopping Xgeva in patients with giant cell tumor of bone and patients with growing skeletons
Contact your healthcare professional for medical advice about any side effects you experience while taking Xgeva. You can report your adverse reactions to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
What drug interactions occur with Xgeva?
When Xgeva is taken with other medications, it may change the way they work or increase the frequency and severity of side effects. Discuss with your doctor whether any of the prescription drugs, over-the-counter medications, vitamins, and herbal supplements you take may interact with this medication, including immunosuppressants.
Are there any contraindications or precautions with Xgeva?
Xgeva should not be taken if you have the following conditions:
- Severe hypersensitivity to any ingredients in Xgeva
- Low calcium levels (hypocalcemia)
Xgeva should be used with caution in the following:
- People who cannot take calcium or vitamin D supplements
- Previous thyroid or parathyroid surgery
- Malabsorption syndrome
- Decreased renal function or are on dialysis
- Have scheduled dental surgery
- Breastfeeding or plan to breastfeed
Can you take Xgeva while you are pregnant or breastfeeding?
Based on data from animal studies and its mechanism of action, Xgeva can cause fetal toxicity when given to pregnant women. You should notify your healthcare provider if you become pregnant or think you may be pregnant. Females who can get pregnant should use an effective form of contraception while taking Xgeva and for at least 5 months after their last dose of Xgeva. There is no data on whether Xgeva is found in breast milk during lactation or the effects it may have on the infant. You should always discuss the risks and benefits of any medication with your healthcare provider if you are pregnant, plan on becoming pregnant, or are breastfeeding.
Is Xgeva the same as Prolia?
Although Xgeva and Prolia contain the same active ingredient, they are used to treat different medical conditions. Prolia is indicated to treat osteoporosis and drug-related bone loss. Xgeva is used to treat or prevent bone problems and high calcium levels that are due to certain types of cancer.
How much does a vial of Xgeva cost?
The cost for a vial of Xgeva subcutaneous solution (120 mg/1.7 mL) is approximately $3000.
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