Romosozumab

Romosozumab

Romosozumab

What is romosozumab?

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

Side effects of romosozumab

If necessary, get emergency medical helpSigns of an allergic reaction(hives, difficulty breathing, swelling of the face or throat)or a severe skin reaction(Fever, sore throat, burning eyes, skin pain, red or purple rash with blistering and peeling).

Seek emergency medical attention if you have symptoms of a heart attack or stroke: chest pain or pressure, shortness of breath, lightheadedness, sudden numbness or weakness, vision or speech problems, or loss of balance.

Romosozumab can cause serious side effects. Call your doctor immediately 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 levels – muscle cramps or contractions, numbness or tingling (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 can report side effects to FDA at 1-800-FDA-1088.

Warnings

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

Romosozumab may increase your risk of having a heart attack or stroke, or dying from heart or blood vessel disease.Seek emergency medical attention if you have symptoms such as:Chest pain or pressure, shortness of breath, lightheadedness, sudden numbness or weakness, vision or speech problems, or loss of balance.

Before you take this medicine

You should not be treated with romosozumab if you are allergic to it or if your blood calcium levels are low (hypocalcaemia).

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

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

Tell your doctor if you have ever had:

• heart problems;

• a disease of the blood vessels;

• 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 being treated with steroids, chemotherapy or radiation. Ask your doctor about your own risk.

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

Romosozumab can only be used in women who can no longer become pregnant.This medicine must also not be used during breastfeeding.

How is romosozumab administered?

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

Romosozumab is usually given in two injections once a month for a year.

Romosozumab is just one part of a complete treatment program, which may include daily calcium and vitamin D supplements. Only take the amount prescribed by your doctor.

Pay particular attention to your dental hygiene. Brush and floss your teeth regularly while receiving romosozumab. If you need dental treatment (especially surgery), tell the dentist in advance that you are receiving romosozumab.

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

Take the medicine out of the refrigerator and let it come to room temperature for 30 minutes before your doctor injects you with the dose. Do not heat romosozumab in the microwave or with hot water.

Do not shake the pre-filled syringe as this may destroy the medicine. Do not use the medicine if it looks cloudy or contains particles. Call your pharmacist for a new prescription.

Each pre-filled syringe is for single use only. Throw it away after one use, even if it still contains medicine.

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

Place used needles and syringes in a puncture-proof sharps container. Follow state or local laws regarding disposal of this container. Keep it out of the reach of children and pets.

Romosozumab dosage information

Usual Adult Dose for Osteoporosis:

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

This medication should be administered by a healthcare provider. The dose is administered as 2 separate injections of 105 mg each (sequentially).

Comments:
– Patients should receive adequate calcium and vitamin D supplementation during therapy.
-The anabolic effect of this drug wears off after 12 months and therefore the duration of therapy should be limited to 12 monthly doses; Consider the use of antiresorptive agents if continued therapy for osteoporosis is necessary.

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

What happens if I miss a dose?

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.

What happens if I overdose?

Because the romosozumab prefilled syringe contains a certain amount of the medicine, it is unlikely that you will get an overdose.

What should I avoid when using romosozumab?

Follow your doctor's instructions regarding any food, drink, or activity restrictions.

What other drugs affect romosozumab?

Other medications may affect romosozumab, including prescription and over-the-counter medications, vitamins, and herbal products. Tell your doctor about all medications you are currently taking and any medications you are taking or stopping.

More information

Remember to keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medicine only for the prescribed indication.