Romosozumab is used to treat osteoporosis in postmenopausal women with a high risk of bone fracture who cannot use other osteoporosis medications (or when other medications did not work).

Romosozumab may also be used for purposes not listed in this medication guide.

You should not use romosozumab if you have low levels of calcium in your blood (hypocalcemia). You may not be able to use romosozumab if you have had a heart attack or stroke within the past 12 months.

Romosozumab can increase your risk of having a heart attack or stroke, or dying from a heart or blood vessel problem. Seek emergency medical help if you have symptoms such as: chest pain or pressure, shortness of breath, feeling light-headed, sudden numbness or weakness, problems with vision or speech, or loss of balance.

Romosozumab is injected under the skin of your stomach, upper thigh, or upper arm. A healthcare provider will give you this injection.

Romosozumab is usually given as 2 injections once per month for 1 year.

Romosozumab is only part of a complete treatment program that may include taking daily calcium and vitamin D supplements. Take only the amount your doctor has prescribed.

Pay special attention to your dental hygiene. Brush and floss your teeth regularly while receiving romosozumab. If you need to have any dental work (especially surgery), tell the dentist ahead of time that you are receiving romosozumab.

If you keep romosozumab at home, store it in the original container in a refrigerator. Protect from light and do not freeze.

Take the medicine out of the refrigerator and let it reach room temperature for 30 minutes before your healthcare provider injects your dose. Do not heat romosozumab in a microwave or with hot water.

Do not shake the prefilled syringe or you may ruin the medicine. Do not use the medicine if it looks cloudy or has particles in it. Call your pharmacist for a new prescription.

Each prefilled syringe is for one use only. Throw it away after one use, even if there is still medicine left inside.

After a prefilled syringe has reached room temperature, it must be used within 30 days or thrown away. Store in the original container away from heat and light.

Place used needles and syringes in a puncture-proof "sharps" container. Follow state or local laws about how to dispose of this container. Keep it out of the reach of children and pets.

Usual Adult Dose for Osteoporosis:

210 mg subcutaneously once a month
Duration of therapy: 12 months

This drug should be administered by a healthcare provider; dose is administered as 2 separate injections of 105 mg each (one after the other)

Comments:
-Patients should receive adequate calcium and vitamin D supplementation during therapy.
-The anabolic effect of this drug wanes after 12 months and therefore the duration of therapy should be limited to 12 monthly doses; consider use of anti-resorptive agents if continued therapy for osteoporosis is needed.

Use: For the treatment of osteoporosis in postmenopausal women at high risk for fracture, defined as a history of osteoporotic fracture, or multiple risk factors for fracture, or patients who have failed or are intolerant to other available osteoporosis therapy.

You should not be treated with romosozumab if you are allergic to it, or if you have low levels of calcium in your blood (hypocalcemia).

You may not be able to receive romosozumab if you have had a heart attack or stroke within the past 12 months.

This medicine can increase your risk of having a heart attack or stroke, or dying from a heart or blood vessel problem. Ask your doctor about your specific risk.

Tell your doctor if you have ever had:

• heart problems;

• a blood vessel disorder;

• a stroke or heart attack;

• hypocalcemia (low levels of calcium in your blood);

• kidney disease (or if you are on dialysis); or

• if you cannot take calcium and vitamin D supplements every day.

This medicine may cause jaw bone problems (osteonecrosis). The risk is highest in people with cancer, blood cell disorders, pre-existing dental problems, or people treated with steroids, chemotherapy, or radiation. Ask your doctor about your own risk.

You may need to have a dental exam before you start treatment with romosozumab. Follow your doctor's instructions.

Romosozumab is for use only in women who can no longer get pregnant. This medicine is also not for use while breastfeeding.

Call your doctor for instructions if you miss a dose, or if you miss an appointment for your romosozumab injection. You should receive your missed injection as soon as possible.

Since the romosozumab prefilled syringe contains a specific amount of the medicine, you are not likely to receive an overdose.

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Get emergency medical help if you have signs of an allergic reaction (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

Seek emergency medical help if you have symptoms of a heart attack or stroke: chest pain or pressure, shortness of breath, feeling light-headed, sudden numbness or weakness, problems with vision or speech, or loss of balance.

Romosozumab may cause serious side effects. Call your doctor at once if you have:

• new or unusual pain in your thigh, hip, or groin;

• jaw pain or numbness;

• red or swollen gums, loose teeth, infected gums; or

• low calcium level--muscle spasms or contractions, numbness or tingly feeling (around your mouth, or in your fingers and toes).

Common side effects of romosozumab may include:

• headache; or

• joint pain.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Other drugs may affect romosozumab, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.