Evenity 105 mg/1.17 mL subcutaneous syringe

Generic name:
Romosozumab - injection

Pronunciation
(ROE-moe-SOZ-ue-mab)

Brand name(s)
Evenity

This medication may rarely increase the risk for a heart attack, stroke, or sudden death. Before starting treatment with romosozumab, tell your doctor if you had a heart attack or stroke within the past year. Get medical help right away if you have symptoms of a heart attack (such as chest/jaw/left arm pain, shortness of breath, unusual sweating) or signs of a stroke (such as weakness on one side of the body, trouble speaking, sudden vision changes, confusion).

Romosozumab is used to treat bone loss (osteoporosis) for women after menopause who are at high risk of having broken bones (fractures). It works by increasing bone density and strength. This effect helps to decrease the risk of having a fracture.

Read the Medication Guide provided by your pharmacist before you start using romosozumab and each time you get another dose. If you have any questions, ask your doctor or pharmacist.

This medication is given by injection under the skin by a health care professional. It is given as directed by your doctor, usually once a month.

Use this medication regularly to get the most benefit from it. Keep receiving this medication even if you feel well. Most people with osteoporosis do not have symptoms. To help you remember, mark your calendar with a reminder.

According to the manufacturer, you should not use this drug for longer than 12 months.

See also Warning section.

Joint pain may occur. If this effect lasts or gets worse, tell your doctor or pharmacist promptly.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including:

• signs of low level of calcium in the blood (such as muscle spasms, numbness/tingling of the hands/feet)
• new or unusual hip/thigh/groin pain

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

• rash
• itching/swelling (especially of the face/tongue/throat)
• severe dizziness
• trouble breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

See also Warning section.

Before using romosozumab, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of:

• low level of calcium in the blood
• heart problems (such as slow/irregular heartbeat, heart failure, previous heart attack, chest pain)
• stroke or "mini-stroke"/transient ischemic attack (TIA)
• kidney disease

Some people using romosozumab may have serious jawbone problems. Your doctor should check your mouth before you start this medication. Tell your dentist that you are using this medication before you have any dental work done. To help prevent jawbone problems, have regular dental exams and learn how to keep your teeth and gums healthy. If you have jaw pain, tell your doctor and dentist right away.

Before having surgery (especially dental procedures), tell your doctor and dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). Your doctor or dentist may tell you to stop using romosozumab before your surgery. Ask for specific instructions about stopping or starting this medication.

This medication is not usually used by women of childbearing age. It is unlikely to be used during pregnancy or breastfeeding. Consult your doctor if you have any questions about this medication.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669.

Do not share this medication with others.

Lab and/or medical tests (such as blood calcium level, bone density) should be done while you are using this medication. Keep all medical and lab appointments.

Lifestyle changes that help promote healthy bones include increasing weight-bearing exercise, stopping smoking, limiting alcohol, and eating well-balanced meals that contain adequate calcium and vitamin D. You may also need to take calcium and vitamin D supplements. Consult your doctor for specific advice.

It is important to get each dose of this medication as scheduled. If you miss a dose, ask your doctor or pharmacist right away for a new dosing schedule.

Not applicable. This medication is given in a doctor's office and will not be stored at home.

HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.