Pronunciation:

den-OSE-ue-mab - bbdz

Brand Names:

• Jubbonti
• Wyost

Classifications:

Pharmacologic—

Denosumab

Uses of This Medicine:

Denosumab-bbdz 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-bbdz injection is also used to treat bone loss in males with nonmetastatic (has not spread) prostate cancer and females with nonmetastatic breast cancer who are at high risk for fracture after receiving cancer treatment.

Denosumab-bbdz injection is also used to prevent bone problems in patients with multiple myeloma and bone metastases (cancer that has spread) from solid tumors. This medicine is also used to treat giant cell tumor of the bone that cannot be removed by surgery or when surgery is too risky. It is also used to treat hypercalcemia (high calcium in the blood) associated with cancer that did not respond to bisphosphonate treatment.

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-bbdz 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-bbdz 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-bbdz injection in the elderly. However, some elderly patients may be 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
• 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.

Jubbonti®: Given once every 6 months.

Wyost®: 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.

Receiving this medicine while you are pregnant can harm your unborn baby. If you 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 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.

Do not use this medicine together with other denosumab products (eg, Prolia®, Xgeva®).

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.

It is important that you tell all of your doctors that you are receiving denosumab-bbdz injection, including your dentist. If you are having dental procedures while receiving this medicine, you may have an increased risk 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.

This medicine 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 this medicine. 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.

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

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 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

Arm or leg pain

back pain

bone or muscle pain

bloody or cloudy urine

difficult, burning, or painful urination

dizziness or lightheadedness

feeling of constant movement of self or surroundings

frequent urge to urinate

large amount of cholesterol in the blood

loss of appetite

seizures

sensation of spinning

trouble breathing

unusual tiredness or weakness

Less common

Arm, back, or jaw pain

bloating or swelling of the face, arms, hands, lower legs, or feet

blurred vision

body aches or pain

chest pain, discomfort, tightness, or heaviness

chills

cough

difficulty in moving

ear congestion

fainting

fall

fast or irregular heartbeat

fever

headache

joint pain

lack or loss of strength

loss of voice

muscle aches, cramps, pains, or stiffness

nausea

nervousness

pain in the lower back, bottom, or hips

pale skin

pounding in the ears

rapid weight gain

slow or fast heartbeat

sneezing

sore throat

stuffy or runny nose

sweating

swollen joints

tingling of the hands or feet

unusual bleeding or bruising

unusual weight gain or loss

upper leg pain

Rare

Bloating

constipation

dark urine

indigestion

loss of indigestion

pains in the stomach, side, or abdomen, possibly radiating to the back

vomiting

yellow eyes or skin

Incidence not known

Difficulty swallowing

heavy jaw feeling

hives, itching, skin rash

loosening of a tooth

lower back or side pain

mood or mental changes

numbness and tingling around the mouth, fingertips, or feet

pain, swelling, or numbness in the mouth or jaw

puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue

stomach cramps

tremor

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:

More common

Diarrhea

Less common

Acid or sour stomach

belching

bloated

excess air or gas in the stomach or intestines

full feeling

heartburn

passing gas

stomach discomfort or upset

trouble sleeping

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.