What is Romosozumab?
Romosozumab can be used to treat osteoporosis among postmenopausal women with a high risk of bone fracture who are unable to use other osteoporosis medications (or if other medications have not worked). Romosozumab can be used in other ways not mentioned in this guide.
Side effects of Romosozumab
If you experience symptoms of an allergic reaction, such as hives, difficulty breathing, swelling on your face or in your throat, or a severe reaction to the skin (fever or sore throat with burning eyes, skin irritation, blistering or peeling skin, or red or purple rash), seek emergency medical attention. If you experience any of the following symptoms, seek emergency medical attention: chest pain, shortness of breath, feeling lightheaded, sudden numbness, weakness or vision problems, or loss of balance.
Romosozumab may cause serious side effects. If you experience:
- Unusual pain in your groin, hips or thighs;
- Jaw pain or numbness
- Infection of the gums or red or swollen gingivae;
- Low calcium level—muscle contractions, numbness, or tingling feeling (around the mouth or fingers and toes)
Some of the common side effects associated with romosozumab include:
- Headache
- Joint pain.
There may be other side effects. Call your physician if experiencing side effects; for reporting side effects to the FDA please dial: 1-800-FDA-1088
Warnings
If you have low calcium levels in your blood (hypocalcemia), then you should not take romosozumab. If you've had a stroke or heart attack within the last 12 months, you may not be eligible to use romosozumab. Romosozumab increases your risk of a stroke, heart attack, or death from a blood vessel or heart problem. If you experience symptoms like chest pressure or pain, feeling lightheaded, sudden numbness, weakness, or vision problems, seek emergency medical attention.
Before you take this drug
If you are allergic or have low calcium levels in your blood, you should not receive romosozumab treatment. If you've had a stroke or heart attack within the last 12 months, romosozumab may not be available to you. This medication can increase your chances of dying from heart disease, stroke, or a cardiac or blood vessel issue. Your doctor can tell you more about your risk.
Be sure to notify your physician of any of the following issues:
- Heart problems
- A blood vessel disorder;
- A stroke or heart attack
- Hypocalcemia (low calcium levels in the blood)
- If you have kidney disease or are currently on dialysis,
- If you are unable to take calcium and vitamin D supplements daily,
This medicine can cause jaw bone problems. ( Osteonecrosis). People with blood cell disorders, pre-existing issues, or those treated with steroids, chemotherapy, or radiation are at the highest risk. You can ask your doctor for more information about your risk. Before you begin treatment with romosozumab, you may be required to undergo a dental examination. You should follow your doctor's advice. Romosozumab should only be used by women who are no longer able to get pregnant. The medicine cannot be taken while breastfeeding.
How to take Romosozumab?
Romosozumab can be injected into the upper arm, upper leg, stomach, or upper thigh. This injection will be given to you by a healthcare provider. Romosozumab can be given in 2 injections, once a month for a year. Romosozumab may be part of an overall treatment plan that includes daily calcium and vitamin-D supplements. Do not exceed the dosage prescribed by your doctor. Dental hygiene is important. While receiving romosozumab, you should brush and floss your teeth. Tell your dentist that you will be receiving romosozumab if you require any dental work, especially surgery. Store romosozumab in its original container inside a fridge if you have it at home. Do not expose yourself to light. Before your healthcare provider administers your injection, take the medicine from the refrigerator. Wait at least 30 minutes for it to come back up to room temperature before refrigerating or freezing again. Romosozumab should not be heated in the microwave or by using hot water. You can ruin the medicine by shaking the prefilled syringe. If the medicine appears cloudy or contains particles, do not use it. For a new prescription, call your pharmacist. Each prefilled syringe can only be used once. After one use, throw it out, even if the medicine is still inside. The prefilled syringe must be used or thrown out within 30 days after it reaches room temperature. Keep the syringes in their original containers away from heat, light, and air. Put used needles, syringes, and sharps into a "sharps container" that is puncture-proof. Be sure to follow local or state laws on how to dispose of the container. Keep the container out of reach of pets and children.
Details on dosage
Adult dose for osteoporosis:
Subcutaneously, 210 mg once a month
Duration of treatment: 12 months
This medication should only be administered by healthcare providers. The dose is given as two separate injections, each 105mg (one after another).
Comments:
Patients should receive adequate vitamin D and calcium during treatment.
If osteoporosis treatment is required, consider using anti-resorptive drugs.
Use: To treat osteoporosis among postmenopausal women at high fracture risk, as defined by a history or multiple fracture risk factors, or in patients who are intolerant or have failed to respond to other osteoporosis therapies.
What happens if I miss the dose?
If you forget to take a dose or miss your appointment for romosozumab, call your doctor. Your missed injection should be received as soon as possible.
What happens if I overdose?
You are unlikely to get an overdose of romosozumab because the prefilled syringe only contains a certain amount.
What should be avoided?
If your doctor prescribes any restrictions regarding food, beverage, or activity, follow their instructions.
Interaction with other drug
Other drugs, such as vitamins and herbal remedies, may also affect romosozumab. Inform your doctor of all the medicines you are taking and those that you stop or start using.
