Romosozumab-aqqg (Subcutaneous)

Romosozumab-aqqg injection is used to treat osteoporosis (thinning and weakening of the bones) in postmenopausal women who are at high risk of fracture (history of osteoporotic fracture) or have used another osteoporosis medicine that did not work well.

This medicine must be given only by or under the direct supervision of your doctor.

It is very important that your doctor checks your progress at regular visits to ensure this medicine is working properly. Blood tests may be needed to check for unwanted effects.

This medicine may raise your risk of having a heart attack or stroke. Check with your doctor right away if you are experiencing chest pain or discomfort, nausea or vomiting, pain or discomfort in the arms, jaw, back, or neck, slurred speech, or weakness.

This medicine may cause serious allergic reactions, including anaphylaxis and angioedema, which can be life-threatening and require immediate medical attention. Tell your doctor right away if you have a rash, itching, hoarseness, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth after receiving this medicine.

This medicine may cause hypocalcemia (low calcium levels in the blood). Low blood calcium must be corrected before you receive this medicine. Check with your doctor right away if you have stomach cramps, confusion, seizures, difficulty breathing, irregular heartbeat, mood or mental changes, muscle cramps, numbness and tingling around the mouth, fingertips, or feet, or tremors.

It is important that you inform all of your doctors that you are receiving romosozumab-aqqg injection, including your dentist. If you are having dental procedures while receiving this medicine, you may have an increased chance of having a severe problem with your jaw. Make sure you tell your doctor or dentist about any new problems, such as pain or swelling, with your teeth or jaw.

Make sure you tell your doctor about any new medical issues, especially with your teeth or jaws. Tell your doctor if you have severe muscle, bone, or joint pain after receiving this medicine.

This medicine may increase your risk of developing fractures of the thigh bone. This may be more common if you use it for a long time. Check with your doctor right away if you have a dull or aching pain in the thighs, groin, or hips.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription (e.g., other medicines that also contain zoledronic acid) or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

In deciding to use a medicine, it is important to consider the risks of taking the medicine compared to the benefits it may provide. This is a choice you and your doctor will make together. For this medicine, the following factors should be taken into account:

Allergies

Inform your doctor if you have ever had any unusual or allergic reactions to this medicine or any other medicines. Also, let your healthcare professional know if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, carefully read the label or package ingredients.

Pediatric

There have not been appropriate studies on how age affects the results of romosozumab-aqqg injection in children. Safety and effectiveness have not been confirmed.

Geriatric

Current studies have not found specific problems related to older adults that would limit the usefulness of romosozumab-aqqg injection in elderly patients. However, older patients may be more sensitive to the effects of this medicine than younger adults.

Breast Feeding

There are no sufficient studies in women to determine the risk to infants when using this medicine while breastfeeding. Consider the potential benefits and risks before using this medicine while breastfeeding.

Interactions with Medicines

Some medicines should not be taken together. In other cases, two different medicines may be used together even if there is a chance of interaction. In such cases, your doctor may want to adjust the dose, or other precautions may be needed. Inform your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used around mealtime or with certain foods due to possible interactions. Using alcohol or tobacco with specific medicines may also lead to interactions. Discuss with your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical issues may affect how this medicine is used. Be sure to tell your doctor if you have any other medical problems, especially:

• Anemia or
• Blood clotting problems or
• Cancer or
• Dental disease or infection or
• Poor oral hygiene—Use with caution. May increase risk for serious jaw problems (e.g., osteonecrosis of the jaw).

• Heart attack within the last year or
• Hypocalcemia (low calcium levels in the blood) or
• Stroke within the last year—Should not be used in patients with these conditions.

• Severe kidney disease or
• Patients receiving dialysis—Use with caution. The effects may be heightened due to slower removal of the medicine from the body.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do happen, they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

More common

• Fast heartbeat
• fever
• hives, itching, skin rash
• hoarseness
• irritation
• joint pain, stiffness, or swelling
• redness of the skin
• swelling of the eyelids, face, lips, hands, or feet
• tightness in the chest
• troubled breathing or swallowing

Less common

• Large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or genitals
• rapid weight gain
• tingling of the hands or feet
• unusual weight gain or loss

Rare

• Chest pain or discomfort
• confusion
• difficulty in breathing
• difficulty in speaking
• double vision
• headache
• heavy jaw feeling
• inability to move the arms, legs, or facial muscles
• inability to speak
• irregular heartbeat
• limp
• loosening of a tooth
• mood or mental changes
• muscle cramps in the hands, arms, feet, legs, or face
• nausea
• numbness and tingling around the mouth, fingertips, or feet
• pain or discomfort in the arms, jaw, back, or neck
• pain, swelling, or numbness in the mouth or jaw
• pain, swelling, tenderness, and bruising in your thigh
• seizures
• slow speech
• stomach cramps
• sweating
• tremor
• vomiting

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Difficulty in moving
• muscle pain or stiffness

Less common

• Bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site
• lack or loss of strength
• trouble sleeping

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

In the U.S.

• Evenity

Available Dosage Forms:

• Solution

Therapeutic Class: Calcium Regulator

Pharmacologic Class: Romosozumab

Find detailed information on biosimilars for this medication.

A nurse or other trained health professional will give you this medicine in a medical facility. It is given as a shot under the skin of your stomach, thighs, or outer area of the upper arms.

This medicine comes with a Medication Guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.

Your doctor will give you calcium and vitamin D supplements while you are receiving this medicine to prevent unwanted effects.