Uses for denosumab

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. It is also used to treat osteoporosis in patients using steroid medicines for at least 6 months.

Denosumab injection is also used to treat bone loss in men with prostate cancer and women with breast cancer who are at high risk for fracture receiving treatment for their cancer that has not spread throughout the body.

It is used to prevent bone problems in patients with multiple myeloma and bone metastases (cancer that has spread) from tumors. Denosumab is also used to treat giant cell tumor of the bone that cannot be removed by surgery. This medicine is also used to treat hypercalcemia of malignancy that has been treated with bisphosphonates (eg, alendronate, ibandronate, risedronate, Fosamax®) but did not work well.

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

Before using denosumab

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. This medicine may cause hypercalcemia (high calcium in the blood) in children with bone problems (eg, osteogenesis imperfecta). The safety and efficacy of denosumab for other conditions has 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. However, elderly patients are more sensitive to the effects of this medicine than younger adults.

Breast Feeding

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.

Interactions with Medicines

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.

Interactions with Food/Tobacco/Alcohol

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 do not fit well or
• Diabetes or
• Fractures, history of 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 (skin problem) 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 of denosumab

A doctor or other trained health professional will give you this medicine. It 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 to prevent unwanted effects. Follow the instructions about how to take these medicines.

This medicine comes with a Medication Guide. Read and follow the instructions 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 while using denosumab

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 receiving Prolia® should not receive Xgeva®.

Receiving this medicine while you are pregnant can harm your unborn baby. If you are a woman who can get pregnant, your doctor may do tests to make sure you are not pregnant before receiving this medicine. Use an effective form of birth control to keep from getting pregnant during treatment with this medicine and for 5 months after the last dose. If you think you have become pregnant while receiving this medicine, tell your doctor right away.

This medicine may cause serious allergic reactions, including anaphylaxis, which 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 receiving 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 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 receiving 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.

Check with your doctor right away if you have severe muscle, bone, or joint pain after receiving Prolia®.

Do not suddenly stop receiving this medicine without checking first with your doctor. Doing so may increase your risk for more fractures. Talk to your doctor about other medicines that you can take.

Hypercalcemia may occur after stopping Xgeva® treatment in patients with growing bones. Tell your doctor right away if you have confusion, constipation, depression, dry mouth, headache, incoherent speech, increased urination, loss of appetite, metallic taste, muscle weakness, nausea, stomach pain, thirst, unusual tiredness, or vomiting.

Side Effects of denosumab

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, discomfort, heaviness, or tightness
• chills
• confusion
• congestion
• cough
• difficulty with breathing
• difficulty with moving
• dryness or soreness of the throat
• ear congestion
• fast or irregular heartbeat
• fever
• 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
• sneezing
• stomach cramps
• swollen joints
• tender, swollen glands in the neck
• tremor
• trouble swallowing
• trouble breathing
• 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
• constipation
• 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
• 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
• stomach discomfort
• unexplained weight loss
• vomiting
• yellow eyes or skin

Incidence not known

• Black, tarry stools
• heavy feeling in the jaw
• loose teeth
• mood or mental changes
• pain, swelling, or numbness in the mouth or jaw
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• sore throat
• sores, ulcers, or white spots on the lips or in the mouth

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
• heartburn
• 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

Incidence not known

• Loss or thinning of the hair

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.

Frequently asked questions

• How many years should you take Prolia?
• How long should you take Xgeva for?
• Is Xgeva a chemotherapy drug?
• Does Xgeva cause bone pain?
• Does Xgeva cause low blood pressure?

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