Romosozumab-aqqg

What is Romosozumab-aqqg?

Romosozumab-aqqg (EVENITY) is a sclerostin inhibitor indicated for the treatment of osteoporosis in postmenopausal women.

What are the uses of this medicine?

This medicine is used to:

• treat osteoporosis (thinning and weakening of bone) in women after menopause (“change of life”) who:
• are at high risk of fracture (broken bone), or
• cannot use another osteoporosis medicine or other osteoporosis medicines did not work well.

How does this medicine work?

• EVENITY inhibits the action of sclerostin, a regulatory factor in bone metabolism.
• EVENITY increases bone formation and, to a lesser extent, decreases bone resorption.
• Animal studies showed that romosozumab-aqqg stimulates new bone formation on trabecular and cortical bone surfaces by stimulating osteoblastic activity resulting in increases in trabecular and cortical bone mass and improvements in bone structure and strength.

Who Should Not Use this medicine ?

This medicine cannot be used in patients who:

• Hypocalcemia
• Known hypersensitivity to EVENITY

Is this medicine FDA approved?

• It was approved for use in the United States in 2019.

How should this medicine be used?

• Two separate syringes (and two separate subcutaneous injections) are needed to administer the total dose of 210 mg of EVENITY. Inject two 105 mg/1.17 mL prefilled syringes, one after the other.
• EVENITY should be administered by a healthcare provider.

Recommended Dosage

• The recommended dose of EVENITY is 210 mg administered subcutaneously in the abdomen, thigh or upper arm. Administer EVENITY once every month.
• The treatment duration for EVENITY is 12 monthly doses.
• Patients should be adequately supplemented with calcium and vitamin D during treatment with EVENITY

Administration

• EVENITY is an injection that will be given to you by your healthcare provider. EVENITY is injected under your skin (subcutaneous).
• You will receive an EVENITY dose (2 injections) 1 time every month for 12 doses.
• You should take calcium and vitamin D while you receive EVENITY.
• If you miss a dose of EVENITY, contact your healthcare provider as soon as possible to schedule your next dose. Your next dose of EVENITY should then be scheduled every month from the date of the last injection.
• You should take good care of your teeth and gums while you receive EVENITY. You should tell your dentist that you are receiving EVENITY before you have dental work.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Injection: 105 mg/1.17 mL solution in a single-use prefilled syringe. A full dose of EVENITY requires two single-use prefilled syringes.

This medicine is available in fallowing brand namesː

• EVENITY

What side effects can this medication cause?

The most common side effects of this medicine include:

• joint pain
• headache

EVENITY may cause serious side effects, including:

• Serious allergic reactions
• Low calcium levels in your blood (hypocalcemia)
• Severe jaw bone problems (osteonecrosis)
• Unusual thigh bone fractures

What special precautions should I follow?

• Monitor for symptoms of myocardial infarction and stroke and seek prompt medical attention if symptoms occur.
• This medicine may cause hypersensitivity reactions, including angioedema, erythema multiforme, dermatitis, rash, and urticaria. Discontinue EVENITY if a clinically significant allergic reaction occurs.
• This medicine may cause hypocalcemia. Adequately supplement calcium and vitamin D during treatment with EVENITY.
• Osteonecrosis of the jaw (ONJ), which can occur spontaneously, is generally associated with tooth extraction and/or local infection with delayed healing, and has been reported in patients receiving EVENITY. Monitor for symptoms. Consider discontinuation of therapy based on benefit-risk assessment.
• Evaluate new or unusual thigh, hip, or groin pain to rule out an incomplete femur fracture. During EVENITY treatment, patients should be advised to report new or unusual thigh, hip, or groin pain.

What to do in case of emergency/overdose?

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.

Can this medicine be used in pregnancy?

• EVENITY is not indicated for use in women of reproductive potential.

Can this medicine be used in children?

• Safety and effectiveness of EVENITY have not been established in pediatric patients.

What are the active and inactive ingredients in this medicine?

• Active ingredient: romosozumab-aqqg
• Inactive ingredients: acetate, calcium, polysorbate 20, sodium hydroxide, sucrose and water for injection.

Who manufactures and distributes this medicine?

• Manufactured by: Amgen Inc., One Amgen Center Drive, Thousand Oaks, CA 91320-1799

What should I know about storage and disposal of this medication?

• Keep EVENITY in a refrigerator at 36°F to 46°F (2°C to 8°C) in the original carton to protect it from light.
• Do not freeze EVENITY.
• Do not shake EVENITY.
• When you remove EVENITY from the refrigerator, EVENITY must be kept at room temperature up to 77°F (25°C) in the original carton and must be used within 30 days.
• EVENITY should be thrown away if taken out of the refrigerator and not used within 30 days.
• Do not keep EVENITY at temperatures above 77°F (25°C).
• Warm temperatures will affect how EVENITY works.

• Dailymed label info on Romosozumab-aqqg
• FDA Romosozumab-aqqg

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