Pronunciation:

den-OSE-ue-mab

Brand Names:

• Jubbonti
• Prolia
• Wyost
• Xgeva

Dosage Forms:

• Solution

Warnings:

Patients with advanced chronic kidney disease (eGFR less than 30 mL/min/1.73 m2), including dialysis-dependent patients, are at greater risk of severe hypocalcemia following denosumab administration. Severe hypocalcemia resulting in hospitalization, life-threatening events and fatal cases have been reported. The presence of chronic kidney disease-mineral bone disorder (CKD-MBD) markedly increases the risk of hypocalcemia in these patients. Prior to initiating denosumab in patients with advanced chronic kidney disease, evaluate for the presence of CKD-MBD. Treatment with denosumab in these patients should be supervised by a healthcare provider with expertise in the diagnosis and management of CKD-MBD .

Classifications:

Therapeutic—

Immunological Agent

Pharmacologic—

Monoclonal Antibody

Uses of This Medicine:

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 This Medicine:

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.

Children—

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.

Older adults—

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.

Other 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.

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 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 This Medicine:

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 This Medicine:

It is important that your doctor check your progress at regular visits to make sure this medicine is working properly. Blood and urine 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.

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 This Medicine:

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.