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How does this medication work? What will it do for me?
Romosozumab belongs to the class of medications called bone formation agents. It is used for the treatment of osteoporosis for women who are past menopause who have a history of bone fractures as a result of osteoporosis, and those who have multiple risk factors for developing fractures. This medication works by blocking the action of a protein that is produced by the bone cells and partially controls the creation and break down of bones. It increases bone production and slows down how quickly bone is broken down by the body.
This medication may be available under multiple brand names and/or in several different forms. Any specific brand name of this medication may not be available in all of the forms or approved for all of the conditions discussed here. As well, some forms of this medication may not be used for all of the conditions discussed here.
Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are taking this medication, speak to your doctor. Do not stop taking this medication without consulting your doctor.
Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take this medication if their doctor has not prescribed it.
What form(s) does this medication come in?
Each single-use pre-filled syringe containing 1.17 mL of a sterile, preservative-free, clear-to-opalescent, colourless-to-light-yellow solution, contains 105 mg of romosozumab. Nonmedicinal ingredients: acetate, calcium, polysorbate 20, sodium hydroxide, sucrose, and water for injection.
How should I use this medication?
The recommended dose of romosozumab is 210 mg injected subcutaneously (under the skin) once a month. This dose is given as two separate injections of 105 mg. Treatment should be continued for 12 monthly doses.
Romosozumab is administered by subcutaneous injection in the thigh, abdomen, or upper outer arm. It is important to rotate the site of injection. Do not inject into an area of skin that is swollen, red, or irritated. The solution for injection should be clear and colourless-to-light-yellow. If it is cloudy or you can see particles in the solution, do not use it. Do not shake this medication before using it. Allow the medication to warm to room temperature for 30 minutes before you inject it.
If you are using this medication at home, your doctor will ensure that you understand exactly how to use it. Make sure you ask any and all questions necessary to ensure that you use it exactly as prescribed. Please refer to the appropriate package insert for details on proper injection procedures. It is important to visit your doctor regularly during therapy to ensure that the medication is working safely and effectively.
Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.
It is important to take this medication exactly as prescribed by your doctor. If you miss a dose, take it as soon as you remember. The next dose should be 1 month from the date you inject the missed dose. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice .
If you are receiving this medication at your doctor’s office and miss an appointment to receive romosozumab, contact your doctor as soon as possible to reschedule your appointment.
Store this medication in the refrigerator, protect it from light and moisture, and keep it out of the reach of children. Do not freeze or shake this medication.
Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.
Who should NOT take this medication?
Do not take this medication if you:
- are allergic to romosozumab or any ingredients of the medication
- have low levels of calcium in the blood
What side effects are possible with this medication?
Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.
The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.
The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.
Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.
- back pain
- more frequent cold symptoms (e.g., sore throat, nasal congestion)
- joint pain
- pain or redness at the injection site
Although most of the side effects listed below don’t happen very often, they could lead to serious problems if you do not seek medical attention.
Check with your doctor as soon as possible if any of the following side effects occur:
- signs of low blood calcium levels (e.g., muscle spasms, tingling or numbness of the fingers and mouth, twitching, or memory loss)
Stop taking the medication and seek immediate medical attention if any of the following occur:
- delayed healing and infection of mouth and jaw (usually after tooth extraction)
- new or unusual pain in the hip or thigh
- signs of a serious allergic reaction (e.g., abdominal cramps, difficulty breathing, nausea and vomiting, or swelling of the face and throat)
- signs of heart attack (e.g., sudden chest pain or pain radiating to back, down arm, jaw; sensation of fullness of the chest; nausea; vomiting; sweating; anxiety)
- signs of stroke (e.g., sudden or severe headache; sudden loss of coordination; vision changes; sudden slurring of speech; or unexplained weakness, numbness, or pain in arm or leg)
Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.
Are there any other precautions or warnings for this medication?
Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.
Atypical femur fracture: There have been reports from people treated with romosozumab of a rare fracture of the long bone in the thigh (femur) without any form of trauma. If you experience new or unusual pain in the groin, hip, or thigh area, contact your doctor as soon as possible.
Calcium and vitamin D: Calcium and vitamin D are important contributors to bone growth and strength. It may be necessary to take calcium or vitamin D supplements to get the best effect from romosozumab if you are not getting enough from your diet. Your doctor may test you for low calcium levels or vitamin D deficiency before you start taking romosozumab.
Heart problems: Romosozumab has been linked to non-fatal and fatal heart attack and stroke. People who have had a heart attack or stroke in the past should not use this medication. If you have heart disease such as angina, congestive heart failure, or arrhythmia, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed. Get immediate medical attention if you develop symptoms of heart attack or stroke.
Jaw problems: Rarely, romosozumab may cause severe jaw problems associated with delayed healing and infection. If you experience any pain, swelling, or infection in the jaw, contact your doctor immediately. Before starting treatment with romosozumab, your doctor may recommend that you see a dentist for an examination and any necessary dental treatment. While receiving romosozumab, it is important to maintain good dental hygiene. If possible, you should avoid invasive dental procedures such as tooth extractions.
Pregnancy: This medication should not be used during pregnancy. If you become pregnant while taking this medication, contact your doctor immediately.
Breast-feeding: It is not known if romosozumab passes into breast milk. If you are a breast-feeding mother and are taking this medication, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.
Children: The safety and effectiveness of using this medication have not been established for children.
What other drugs could interact with this medication?
Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications that you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them. Depending on your specific circumstances, your doctor may want you to:
- stop taking one of the medications,
- change one of the medications to another,
- change how you are taking one or both of the medications, or
- leave everything as is.
An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.
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