Romosozumab injection

What is this medication?

ROMOSOZUMAB (roe moe SOZ ue mab) increases bone formation. It is used to treat osteoporosis in women.

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

COMMON BRAND NAME(S): EVENITY

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

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

• dental disease or wear dentures
• heart disease
• history of stroke
• kidney disease
• low levels of calcium in the blood
• an unusual or allergic reaction to romosozumab, other medicines, foods, dyes or preservatives
• pregnant or trying to get pregnant
• breast-feeding

How should I use this medication?

This medicine is for injection under the skin. It is given by a healthcare professional in a hospital or clinic setting.

Talk to your pediatrician about the use of this medicine 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 doctor or healthcare professional if you are unable to keep an appointment.

What may interact with this medication?

Interactions are not expected.

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 medicine.

You may need blood work done while you are taking this medicine.

Some people who take this medicine have severe bone, joint, or muscle pain. This medicine may also increase your risk for jaw problems or a broken thigh bone. Tell your healthcare professional right away if you have severe pain in your jaw, bones, joints, or muscles. Tell your healthcare professional if you have any pain that does not go away or that gets worse.

You should make sure you get enough calcium and vitamin D while you are taking this medicine. Discuss the foods you eat and the vitamins you take with your healthcare professional.

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

What side effects may I notice from receiving this medication?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue
• bone pain
• chest pain or chest tightness
• jaw pain, especially after dental work
• signs and symptoms of a stroke like changes in vision; confusion; trouble speaking or understanding; severe headaches; sudden numbness or weakness of the face, arm or leg; trouble walking; dizziness; loss of balance or coordination
• signs and symptoms of low calcium like fast heartbeat; muscle cramps; muscle pain; pain, tingling, numbness in the hands or feet; seizures

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

• headache
• joint pain
• pain, redness, or irritation at site where injected
• pain, tingling, numbness in the hands or feet
• swelling of ankles, feet, hands
• trouble sleeping

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 medicine is given in a hospital or clinic and 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.