Romosozumab-aqqg injection is used to treat osteoporosis (condition in which the bones become thin and weak and break easily) in postmenopausal women (women who have experienced a change of life; end of menstrual periods) who have a high risk of a fracture or when other osteoporosis treatments did not help or could not be tolerated. Romosozumab-aqqg injection is in a class of medications called monoclonal antibodies. It works by increasing bone formation and decreasing bone breakdown.

Romosozumab-aqqg injection may cause serious or life-threatening heart problems such as a heart attack or stroke. Tell your doctor if you have or have ever had a heart attack or stroke, especially if it has happened within the past year. If you experience any of the following symptoms during your treatment, call your doctor immediately: chest pain or pressure, shortness of breath, feeling light-headed, dizziness, headache, numbness or weakness in face, arm, or legs, difficulty talking, vision changes, or a loss of balance.

Keep all appointments with your doctor and the laboratory. Your doctor will order certain tests to check your body's response to romosozumab-aqqg injection.

Your doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with romosozumab-aqqg injection and each time you refill your prescription. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website (http://www.fda.gov/Drugs/DrugSafety/ucm085729.htm) or the manufacturer's website to obtain the Medication Guide.

Romosozumab-aqqg injection comes as a solution to be injected subcutaneously (under the skin) into in your stomach area, upper arm, or thigh. It is usually injected once a month by a healthcare provider for 12 doses.

Before receiving romosozumab-aqqg injection,

• tell your doctor and pharmacist if you are allergic to romosozumab-aqqg, any other medications, or any of the ingredients in romosozumab-aqqg injection. Ask your pharmacist or check the Medication Guide for a list of the ingredients.
• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: angiogenesis inhibitors such as axitinib (Inlyta), bevacizumab (Avastin), everolimus (Afinitor, Zortress), pazopanib (Votrient), sorafenib (Nexavar), or sunitinib (Sutent); bisphosphonates such as alendronate (Binosto, Fosamax), etidronate, or ibandronate (Boniva); cancer chemotherapy medications; denosumab (Prolia); or a steroid medication such as dexamethasone, methylprednisolone (Medrol), and prednisone (Rayos). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• tell your doctor if you have low levels of calcium. Your doctor will probably tell you not to receive romosozumab-aqqg injection.
• tell your doctor if you have or have ever had kidney disease or are being treated with hemodialysis (treatment to remove waste from the blood when the kidneys are not working).
• tell your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. Romosozumab-aqqg injection is only approved for treatment of postmenopausal women. If you become pregnant while receiving romosozumab-aqqg injection, call your doctor immediately.
• you should know that romosozumab-aqqg injection may cause osteonecrosis of the jaw (ONJ, a serious condition of the jaw bone), especially if you need to have dental surgery or treatment while you are using the medication. A dentist should examine your teeth and perform any needed treatments, including cleaning, before you start to use romosozumab-aqqg injection. Be sure to brush your teeth and clean your mouth properly while you are using romosozumab-aqqg injection. Talk to your doctor before having any dental treatments while you are using this medication.

If you miss an appointment to receive a dose, make another appointment as soon as possible. Your next dose of romosozumab-aqqg injection should be scheduled one month from the date of the last injection.

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

While you are receiving romosozumab-aqqg injection, it is important that you get enough calcium and vitamin D. Your doctor may prescribe supplements if your dietary intake is not enough.

Romosozumab-aqqg injection may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• joint pain
• pain and redness at the injection site

Some side effects can be serious. If you experience any of these symptoms or those listed in the IMPORTANT WARNING section, call your doctor immediately or get emergency medical treatment:

• swelling of the face, lips, mouth, tongue, or throat
• difficulty swallowing or breathing
• hives
• redness, scaling, or rash
• new or unusual thigh, hip, or groin pain
• muscle spasms, twitches, or cramps
• numbness or tingling in fingers, toes, or mouth

Romosozumab-aqqg injection may cause other side effects. Call your doctor if you have any unusual problems while receiving this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

Ask your pharmacist any questions you have about romosozumab-aqqg injection.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

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