Description and Brand Names

Drug information provided by: Micromedex

US Brand Name

  1. Prolia
  2. Xgeva

Descriptions


Denosumab injection is used to treat osteoporosis (thinning of the bones) in women who have an increased risk for fractures after menopause, and osteoporosis in men. It is given when other medicines cannot be used or after other medicines did not work well.

Denosumab injection is also used to treat bone loss in men with prostate cancer and women with breast cancer who are receiving cancer treatment. It is used to prevent bone problems in patients with bone metastases (cancer that has spread) from tumors. Denosumab is used to treat giant cell tumor of the bone that cannot be removed by surgery.

This medicine is to be given only by or under the supervision of your doctor.

This product is available in the following dosage forms:

  • Solution

Before Using

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Use of denosumab injection is not recommended in the pediatric population, except for teenagers with giant cell tumor of the bone. The safety and efficacy of denosumab for other conditions have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of denosumab injection in the elderly.

Pregnancy

Information about this denosumab-subcutaneous-route
Pregnancy Category Explanation
All Trimesters X Studies in animals or pregnant women have demonstrated positive evidence of fetal abnormalities. This drug should not be used in women who are or may become pregnant because the risk clearly outweighs any possible benefit.

Breastfeeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Drug Interactions

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. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Other Interactions

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

  • Anemia or
  • Blood clotting problems or
  • Cancer or
  • Dental disease, history of or
  • Dental implants, history of or
  • Dentures that don't fit well or
  • Gum disease or
  • Hypoparathyroidism (underactive parathyroid gland), history of or
  • Kidney problems, severe and may require dialysis or
  • Malabsorption syndrome (trouble absorbing food), history of or
  • Mouth surgery, history of or
  • Parathyroid surgery, history of or
  • Thyroid surgery, history of or
  • Tooth extraction, history of—May cause side effects to become worse.
  • Ear infection or
  • Eczema or
  • Endocarditis (heart infection) or
  • Skin infections or
  • Skin rashes or
  • Stomach infection or
  • Urinary tract infection—Use with caution. May make these conditions worse.
  • Hypocalcemia (low calcium in the blood)—Should not be given to patients with this condition.

Proper Use

A doctor or other trained health professional will give you this medicine. This medicine is given as a shot under your skin, usually on the upper arm, upper thigh, or stomach.

Prolia® is usually given once every 6 months, and Xgeva® is usually given once every 4 weeks. Your doctor may also give you vitamin D and calcium supplements. Follow the instructions about how to take these medicines.

This medicine comes with a Medication Guide. Read the information carefully. Ask your doctor if you have any questions.

Missed Dose

This medicine needs to be given on a fixed schedule. If you miss a dose or forget to use your medicine, call your doctor or pharmacist for instructions.

Precautions

It is important that your doctor check your progress at regular visits to make sure this medicine is working properly. Blood tests may be needed to check for unwanted effects.

Prolia® contains denosumab which can also be found in Xgeva®. Patients using Prolia® should not receive Xgeva®.

Your unborn baby could be harmed if you use this medicine while you are pregnant. Women receiving Xgeva® should use an effective form of birth control to keep from getting pregnant during treatment and for at least 5 months after the last dose. There is also a potential for this medicine to cause birth defects if the father is using it when his sexual partner becomes pregnant. If a pregnancy occurs while you are receiving this medicine, tell your doctor right away.

Xgeva® may cause serious allergic reactions, including anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Tell your doctor or nurse right away if you have a rash, lightheadedness, dizziness, or fainting, itching, swelling of the face, tongue, and throat, trouble breathing, or chest pain after you get the injection.

This medicine may cause hypocalcemia (low calcium in the blood). A low blood calcium must be treated before you receive this medicine. Call your doctor right away if you have muscle spasms or twitching, or numbness or tingling in your fingers, toes, or around your mouth.

Prolia® may increase your risk of developing infections. Avoid being near people who are sick or have infections while you are using this medicine. Check with your doctor right away if you have a fever or chills, red, swollen skin, severe abdominal or stomach pain, or burning or painful urination.

Skin problems may occur after receiving Prolia®. Check with your doctor right away if you have any of the following symptoms that do not go away or get worse: blistering, crusting, irritation, itching, or reddening of the skin, cracked, dry, or scaly skin, rash, or swollen skin.

It is important that you tell all of your doctors that you are receiving denosumab injection, including your dentist. If you are having dental procedures while receiving this medicine, you may have an increased chance of having a severe problem with your jaw. Make sure you tell your doctor or dentist about any new problems, such as pain or swelling, with your teeth or jaw.

The needle cover of the prefilled Prolia® syringe contains dry natural rubber (a derivative of latex), which may cause allergic reactions in people who are sensitive to latex. Tell your doctor if you have a latex allergy before you start using this medicine.

This medicine may increase your risk of developing fractures of the thigh bone. This may be more common if you use it for a long time. Check with your doctor right away if you have a dull or aching pain in the thigh, groin, or hips.

Side Effects

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

  1. Back pain
  2. blistering, crusting, irritation, itching, or reddening of the skin
  3. bloody or cloudy urine
  4. cracked, dry, or scaly skin
  5. difficult, burning, or painful urination
  6. frequent urge to urinate
  7. muscle or bone pain
  8. pain in the arms or legs
  9. rash
  10. skin rash, encrusted, scaly, and oozing
  11. swelling

Less common

  1. Abdominal or stomach cramps
  2. arm or jaw pain
  3. bloating or swelling of the face, arms, hands, lower legs, or feet
  4. body aches or pain
  5. chest pain or discomfort
  6. chest tightness or heaviness
  7. confusion
  8. congestion
  9. convulsions
  10. cough
  11. difficulty with breathing
  12. difficulty with moving
  13. dryness or soreness of the throat
  14. ear congestion
  15. fast or irregular heartbeat
  16. fever or chills
  17. headache
  18. hoarseness
  19. joint pain
  20. loss of voice
  21. muscle cramps in the hands, arms, feet, legs, or face
  22. muscle stiffness
  23. numbness and tingling around the mouth, fingertips, hands, or feet
  24. pain in the lower back, bottom, or hips
  25. pain in the upper leg
  26. painful blisters on the trunk of the body
  27. pale skin
  28. rapid weight gain
  29. runny or stuffy nose
  30. sneezing
  31. swollen joints
  32. tender, swollen glands in the neck
  33. tremor
  34. trouble swallowing
  35. troubled breathing with exertion
  36. unusual bleeding or bruising
  37. unusual tiredness or weakness
  38. unusual weight gain or loss
  39. voice changes

Rare

  1. Abdominal or stomach discomfort
  2. blood in the stool
  3. change in bowel habits
  4. clear or bloody discharge from the nipple
  5. constipation
  6. darkened urine
  7. difficulty with swallowing or eating
  8. dimpling of the breast skin
  9. indigestion
  10. inverted nipple
  11. itching, pain, redness, swelling, tenderness, or warmth on the skin
  12. loss of appetite
  13. lower back or side pain
  14. lump in the breast or under the arm
  15. lump or swelling in the abdomen or stomach
  16. nausea
  17. pains in the stomach, side, or abdomen, possibly radiating to the back
  18. persistent crusting or scaling of the nipple
  19. raised, firm, and bright red patches of the skin on the arm or leg
  20. redness or swelling of the breast
  21. sore on the skin of the breast that does not heal
  22. unexplained weight loss
  23. vomiting
  24. yellow eyes or skin

Incidence not known

  1. Heavy feeling in the jaw
  2. loose teeth
  3. 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

  1. Dizziness or lightheadedness
  2. excess air or gas in the stomach or intestines
  3. feeling of constant movement of self or surroundings
  4. full feeling
  5. heartburn
  6. lack or loss of strength
  7. passing gas
  8. redness, pain, itching, burning, swelling, or a lump under your skin where the shot was given
  9. sensation of spinning
  10. trouble sleeping
  11. 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.