Romosozumab - Subcutaneous

Romosozumab treats osteoporosis (thinning and weakening of bones) in postmenopausal women who are at high risk of fracture (broken bone). This medicine slows down bone loss and helps build new bone, making the bones stronger and reducing the risk of fracture.

Romosozumab is to be injected subcutaneously (into the fatty layer under the skin, usually in the thigh, upper arm, or abdomen area).

Your doctor or nurse will administer the injection for you. If you or your caregiver had been given the proper training on the preparation and injection techniques of this medicine, you or your caregiver may do the administration.

Use Romosozumab exactly as directed by your doctor or according to the instructions on the label. Do not use more or less than instructed by your doctor.

This medicine is available as a pre-filled pen or syringe. Make sure you know how to use the specific device you have been given. If you have problems or do not understand the instructions, ask your doctor or pharmacist.

Remember to rotate the injection sites. Do not inject into the same area all the time. New injection sites should be at least a few inches away from the previous injection site. Do not inject near the navel (belly button), and into areas where the skin is tender, bruised, red, hard, scarred or with stretch marks.

The dose of this medicine will be decided by your doctor. Your doctor will advise you on the treatment timeframe depending on your condition and response to the medication.

Romosozumab must be administered regularly for it to be effective. Continue using this medicine even when you feel better. Do not stop using it unless instructed by the doctor.

Ensure that you keep all appointments with your doctor so that you do not miss any doses. Your doctor also needs to regularly monitor your response to Romosozumab.

If you miss an appointment or miss an injection, alert your doctor or nurse. A replacement appointment or injection should be given as soon as possible.

If you or a caregiver had been trained to administer this medicine and missed a dose, inject the missed dose as soon as possible, and the next dose should be scheduled every month from the date of the last injection.

DO NOT double a dose under any circumstances.

Inform your doctor or pharmacist immediately if you forgot to administer your dose.

Do not use Romosozumab if you ever had an allergic reaction (e.g. rashes, breathlessness, swollen eyes) to this medicine or any of its ingredients.

Alert your doctor if you have the following conditions:

• untreated hypocalcaemia (low calcium level in the blood)
• history of heart attack or stroke

as Romosozumab may not be suitable for you.

Inform your doctor if you have the following conditions:

• risk factors for heart or blood vessel problems e.g. high blood pressure, high fat level in the blood, diabetes
• dental or gum disease
• poor dental health
• smoker
• cancer
• anaemia (low red blood cell count in the body)
• blood clotting problems
• infection
• severe kidney disease or receiving dialysis (a procedure that helps individuals with kidney failure to filter toxic substances from the blood)

Let your doctor know if you are pregnant or breastfeeding.

Ensure that you take enough calcium and vitamin D while being treated with Romosozumab. Your doctor will advise you about how much of these supplements to take.

Maintain good oral hygiene while being treated with this medicine.

If you are undergoing chemotherapy (treatment for cancer) or radiotherapy (use of radiation to treat cancer) or going to have an operation, including minor surgery and dental work (e.g. tooth extraction), inform your doctor or dentist that you are using this medicine.

Why is it important to keep my appointments with the doctor?

Keep your appointments with your doctor. Your doctor needs to monitor your condition and check your response to the medication regularly.

• Dental examination may be done before starting treatment.
• Routine tests (e.g. blood calcium levels, bone mineral density [a test that measures the amount of calcium and other minerals in the bone]) may be done while you are being treated with this medicine. Your doctor will advise you about how often you need to have these tests.
• Regular monitoring of signs and symptoms of allergic reactions, hypocalcaemia, heart-related problems, jaw pain or swelling, and new or unusual pain in the hip, thigh, or groin may also be needed.

Romosozumab may cause any of the following side effects: headache, common colds, stuffy nose, cough, joint or neck pain, and pain or redness at the injection site.

Some side effects may need immediate medical help. Alert your doctor quickly if you experience any of the following:

• signs and symptoms of allergic reaction e.g. rashes, breathlessness, swelling of the face, eyes or mouth
• signs and symptoms of heart attack e.g. chest pain, tightness or pressure, pain that may spread to the arms, jaw, neck, shoulder or back, shortness of breath, lightheadedness
• weakness or numbness on one side of the body, trouble speaking, vision problems, changes in balance or coordination
• muscle cramps or spasms, numbness and tingling sensation in the fingers, toes, or around the mouth, fits or seizures
• mouth sores that do not heal, loose teeth, jaw pain or swelling
• new or unusual pain in the hip, thigh, or groin

Inform your doctor if any of these side effects do not go away or are severe, or if you experience other side effects.

Always notify your doctor and pharmacist if you are taking any other medicines, including herbal tonics such as traditional Chinese medicines, supplements, and medicines that you buy without a prescription.

Avoid alcohol.

Store in the refrigerator, between 2-8°C.

Do not freeze Romosozumab otherwise, it will no longer be effective and should not be used.

Keep the pre-filled pen or syringe in their original package to protect from light. Do not shake.

Once you remove this medicine from the refrigerator, you must store it at room temperature (up to 25°C) in its original package for up to 30 days. If stored at room temperature, throw away any remaining injection solution, even if the injection pen or syringe is not empty or has not been used within 30 days.

If you notice that the injection has changed colour or has become cloudy, do not use it. Throw it away and use a new injection.

Keep away from extreme heat or cold and from the reach of children.

Medicines must not be used past the expiry date.