Denosumab (Subcutaneous Route)

1 Denosumab (Subcutaneous Route): A Summary

Brand Name:

Prolia, Xgeva

Denosumab injection is a monoclonal antibody used for the treatment of osteoporosis in women who have an increased risk for fractures after menopause, and osteoporosis in men. This drug is also used for the treatment of bone loss in men with prostate cancer and women with breast cancer who are receiving cancer treatment. 

Bone problems in patients with bone metastases from tumors can also be prevented by this drug. Giant cell tumor of the bone that cannot be resected can also be treated by this drug. Hypercalcemia of malignancy can also be treated by this drug. This drug is to be given only by or under the supervision of your healthcare professional.

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2 What to Know Before Using

Before taking this drug, the risks and benefits for your body should be discussed with your healthcare provider. Inform your healthcare provider for any allergic reactions to these drugs or any other drugs, foods, dyes, preservatives, or animals. 

Carefully read the label of non-prescription drugs for any possible allergic reaction or contraindications. This drug is not recommended for use 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. Studies in the elderly have not demonstrated any geriatric-specific problems that would limit the utility of denosumab injection. 

Fetal abnormalities have been reported in studies of pregnant women and animals. This drug is contraindicated in women who are or may become pregnant because the risk clearly outweighs any possible benefit. Infant risk is still undetermined when using this drug during breastfeeding. Discuss with your healthcare professional about the potential risks and benefits before taking this drug while breastfeeding. 

Drugs should not be taken together to prevent any interactions but in necessary cases inquire your healthcare provider regarding the adjustments in dosage or any other necessary precautions to prevent any unwanted side effects. Inform your healthcare professional if you are taking any other prescription and nonprescription drugs. 

Intake of specific food or using alcohol or tobacco with this drug is associated with an increased risk of certain side effects. Your healthcare professional can give you special instructions about the use of food, alcohol, or tobacco. Inform your healthcare provider for any other medical problems such as:

3 Proper Usage

A trained healthcare professional will be the only to give you this drug. This drug is injected under your skin, usually on the upper arm, upper thigh, or stomach. ProliaВ® is usually given once every 6 months, and XgevaВ® is usually given once every 4 weeks. 

You will also be prescribed with vitamin D and calcium supplements. This drug needs to be given on a fixed schedule. Call your healthcare professional for instructions if you miss a dose.

4 Precautions to Take

Regular visits should be made to your healthcare provider to track your progress and to monitor the effectiveness of the drug. Unwanted effects can be screened by blood tests. ProliaВ® contains denosumab which can also be found in XgevaВ®. Patients using ProliaВ® should not receive XgevaВ®. 

This drug has teratogenic potential and it is recommended to use an effective form of birth control to prevent any chance of pregnancy during treatment and for at least 5 months after the last dose. Birth defects can also happen if the father is taking this drug when his sexual partner becomes pregnant. Inform your healthcare professional immediately if a pregnancy occurs while you are receiving this drug. 

Check with your healthcare professional immediately if you have symptoms of anaphylaxis such as rash, lightheadedness, dizziness, or fainting, itching, swelling of the face, tongue, and throat, trouble breathing, or chest pain after you get the injection. Call your healthcare professional immediately if you have symptoms of hypocalcemia muscle spasms or twitching, or numbness or tingling in your fingers, toes, or around your mouth. ProliaВ® may increase your risk of developing infections and it is recommended to limit any form of contact with people who are sick or have infections while you are using this drug. 

Check with your healthcare professional immediately if you have a fever or chills, red, swollen skin, severe abdominal or stomach pain, or burning or painful urination. Check with your healthcare professional if you have any symptoms of skin problems that persist or worsen such blistering, crusting, irritation, itching, or reddening of the skin, cracked, dry, or scaly skin, rash, or swollen skin. 

Inform all healthcare professionals that treat you that you are receiving denosumab injection. The chance of having a severe problem with your jaw may be increased if you are having dental procedures while receiving this drug. Inform your healthcare professional about any new problems, such as pain or swelling, with your teeth or jaw. 

The needle cover of the prefilled ProliaВ® syringe contains dry natural rubber which may cause allergic reactions in people who are sensitive to latex. Inform your healthcare professional if you have a latex allergy before you start using this drug. 

Prolonged use of this drug may increase your risk of developing fractures of the thigh bone. Check with your healthcare professional immediately if you have a dull or aching pain in the thigh, groin, or hips, severe muscle, bone, or joint pain after receiving ProliaВ®.

5 Potential Side Effects

Side effects may vary for each individual and prompt medical attention should be given if they occur. Seek advice from your healthcare professional immediately if you experience any unusual symptoms such as

  • 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, abdominal or stomach cramps
  • 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
  • confusion
  • congestion
  • convulsions
  • cough
  • difficulty with breathing
  • difficulty with moving
  • dryness or soreness of the throat
  • ear congestion
  • fast or irregular heartbeat
  • fever or chills
  • 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, or hips
  • pain in the upper leg
  • painful blisters on the trunk of the body
  • pale skin
  • rapid weight gain
  • runny or stuffy nose
  • sneezing
  • swollen joints
  • tender, swollen glands in the neck
  • tremor
  • trouble swallowing
  • troubled breathing with exertion
  • unusual bleeding or bruising
  • unusual tiredness or weakness
  • unusual weight gain or loss
  • voice changes
  • abdominal or stomach discomfort
  • blood in the stool
  • change in bowel habits
  • clear or bloody discharge from the nipple
  • constipation
  • darkened urine
  • difficulty with swallowing or eatin
  •  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
  • nausea
  • 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
  • unexplained weight loss
  • vomiting
  • yellow eyes 
  • skin, 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. As your body adjusts to the drug, the side effects will slowly disappear. Ask your healthcare professional about ways to prevent or reduce some of these side effects. 

f any of the following side effects persists, or are inconvenient, or if you notice any other effects, or if you have any questions about them, consult with your health care professional. Report any side effects to the FDA hotline at 1-800-FDA-1088.

6 Related Clinical Trials