Romosozumab-aqqg (roe-moe-SOZ-ue-mab - aqqg)

Treats osteoporosis in postmenopausal women.

Brand Name(s):

Evenity

When This Medicine Should Not Be Used:

How to Use This Medicine:

Injectable

• Your doctor will prescribe your exact dose and tell you how often it should be given. This medicine is given as a shot under your skin.
• A nurse or other health provider will give you this medicine.
• Your doctor may give you calcium and vitamin D supplements while you are receiving this medicine to prevent unwanted effects.
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Some medicines can affect how romosozumab-aqqg works. Tell your doctor if you are using denosumab, bisphosphonate medicine, cancer medicine, or steroids.

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant or breastfeeding, or if you have kidney disease, cancer, anemia, blood clotting problems, dental problems, or if you had a heart attack or stroke within the last year.
• This medicine may cause the following problems:
  • Increased risk of heart attack or stroke
  • Increased risk for a thigh bone fracture
• Tell any doctor or dentist who treats you that you are using this medicine. This medicine may cause jaw problems, especially if you have a tooth pulled or have other dental work.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Chest pain that may spread to your arms, jaw, back, or neck, trouble breathing, nausea, unusual sweating, fainting
• Confusion, seizures, uneven heartbeat, muscle cramps or spasms, numbness and tingling around the mouth, fingertips, or feet
• New or unusual thigh, hip, or groin pain
• Numbness or weakness in your arm or leg, or on one side of your body
• Pain in your lower leg (calf)
• Sudden or severe headache, problems with vision, speech, or walking

If you notice these less serious side effects, talk with your doctor:

• Headache
• Joint or muscle pain
• Pain, itching, burning, swelling, or a lump under your skin where the shot was given

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088