Denosumab Injection (Osteoporosis)

What is this medication?

DENOSUMAB (den oh SUE mab) prevents and treats osteoporosis. It works by making your bones stronger and less likely to break (fracture). It is a monoclonal antibody.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): JUBBONTI, Prolia

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• Dental or gum disease
• Had thyroid or parathyroid (glands located in neck) surgery
• Having dental surgery or a tooth pulled
• Kidney disease
• Low levels of calcium in the blood
• On dialysis
• Poor nutrition
• Thyroid disease
• Trouble absorbing nutrients from your food
• An unusual or allergic reaction to denosumab, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breastfeeding

How should I use this medication?

This medication is injected under the skin. It is given by your care team in a hospital or clinic setting.

A special MedGuide will be given to you before each treatment. Be sure to read this information carefully each time.

Talk to your care team about the use of this medication in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

Keep appointments for follow-up doses. It is important not to miss your dose. Call your care team if you are unable to keep an appointment.

What may interact with this medication?

Do not take this medication with any of the following:

• Other medications that contain denosumab

This medication may also interact with the following:

• Medications that lower your chance of fighting infection
• Steroid medications, such as prednisone or cortisone

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Your condition will be monitored carefully while you are receiving this medication.

You may need blood work done while taking this medication.

This medication may increase your risk of getting an infection. Call your care team for advice if you get a fever, chills, sore throat, or other symptoms of a cold or flu. Do not treat yourself. Try to avoid being around people who are sick.

Tell your dentist and dental surgeon that you are taking this medication. You should not have major dental surgery while on this medication. See your dentist to have a dental exam and fix any dental problems before starting this medication. Take good care of your teeth while on this medication. Make sure you see your dentist for regular follow-up appointments.

This medication may cause low levels of calcium in your body. The risk of severe side effects is increased in people with kidney disease. Your care team may prescribe calcium and vitamin D to help prevent low calcium levels while you take this medication. It is important to take calcium and vitamin D as directed by your care team.

Talk to your care team if you may be pregnant. Serious birth defects may occur if you take this medication during pregnancy and for 5 months after the last dose. You will need a negative pregnancy test before starting this medication. Contraception is recommended while taking this medication and for 5 months after the last dose. Your care team can help you find the option that works for you.

Talk to your care team before breastfeeding. Changes to your treatment plan may be needed.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible:

• Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
• Infection—fever, chills, cough, sore throat, wounds that don't heal, pain or trouble when passing urine, general feeling of discomfort or being unwell
• Low calcium level—muscle pain or cramps, confusion, tingling, or numbness in the hands or feet
• Osteonecrosis of the jaw—pain, swelling, or redness in the mouth, numbness of the jaw, poor healing after dental work, unusual discharge from the mouth, visible bones in the mouth
• Severe bone, joint, or muscle pain
• Skin infection—skin redness, swelling, warmth, or pain

Side effects that usually do not require medical attention (report these to your care team if they continue or are bothersome):

• Back pain
• Headache
• Joint pain
• Muscle pain
• Pain in the hands, arms, legs, or feet
• Runny or stuffy nose
• Sore throat

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

This medication is given in a hospital or clinic. It will not be stored at home.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.