Prolia

Generic Name: denosumab (Subcutaneous route)

den-OSE-ue-mab

Commonly used brand name(s)

In the U.S.

• Prolia


• Xgeva

Available Dosage Forms:

• Solution

Pharmacologic Class: Monoclonal Antibody

Uses For Prolia

Denosumab injection is used to treat osteoporosis (thinning of the bones) in women after menopause who have an increased risk for fractures. This medicine is used when women cannot use other medicines for osteoporosis or after other medicines did not work well.

Denosumab injection is also used to treat bone loss in men and women who are receiving treatments for prostate and breast cancers.

Denosumab injection is also used to prevent bone problems in patients with bone metastases (cancer that has spread) from certain types of tumors.

This medicine is available only with your doctor's prescription.

Before Using Prolia

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. Safety and efficacy 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

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

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 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)—Prolia® should not be given in patients with this condition.

Proper Use of denosumab

This section provides information on the proper use of a number of products that contain denosumab. It may not be specific to Prolia. Please read with care.

A nurse 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.

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.

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 your doctor's 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 While Using Prolia

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™.

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 using 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.

It is important to tell your doctor if you become pregnant. Your doctor may want you to join a pregnancy surveillance program for patients receiving this medicine.

Prolia 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

• 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

• Abdominal or stomach cramps


• arm, back, 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


• mood or mental changes


• 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


• shortness of breath


• sneezing


• swollen joints


• tender, swollen glands in the neck


• tremor


• trouble with swallowing


• troubled breathing with exertion


• unusual bleeding or bruising


• unusual tiredness or weakness


• unusual weight gain or loss


• voice changes


• wheezing

Rare

• 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 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


• 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 intestines


• feeling of constant movement of self or surroundings


• full feeling


• 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


• sleeplessness


• trouble sleeping


• unable to sleep


• 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.

See also: Prolia side effects (in more detail)

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More Prolia resources

• Prolia Side Effects (in more detail)
• Prolia Use in Pregnancy & Breastfeeding
• Prolia Drug Interactions
• Prolia Support Group
• 0 Reviews for Prolia - Add your own review/rating

• Prolia Monograph (AHFS DI)


• Prolia Consumer Overview


• Prolia MedFacts Consumer Leaflet (Wolters Kluwer)


• Prolia Prescribing Information (FDA)


• Denosumab Professional Patient Advice (Wolters Kluwer)


• Xgeva Prescribing Information (FDA)


• Xgeva MedFacts Consumer Leaflet (Wolters Kluwer)


• Xgeva Consumer Overview

Compare Prolia with other medications

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