Pronunciation:

roe-moe-SOZ-ue-mab - aqqg

Brand Names:

• Evenity

Dosage Forms:

• Solution

Warnings:

Warning: Potential Risk of Myocardial Infarction, Stroke and Cardiovascular DeathRomosozumab-aqqg may increase the risk of myocardial infarction, stroke, and cardiovascular death.Romosozumab-aqqg should not be initiated in patients who have had a myocardial infarction or stroke within the preceding year. Consider whether the benefits outweigh the risks in patients with other cardiovascular risk factors.If a patient experiences a myocardial infarction or stroke during therapy, romosozumab-aqqg should be discontinued .

Classifications:

Therapeutic—

Calcium Regulator

Pharmacologic—

Romosozumab

Uses of This Medicine:

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 to be given only by or under the direct supervision of your doctor.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

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

Children—

Appropriate studies have not been performed on the relationship of age to the effects of romosozumab-aqqg injection in the pediatric population. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of romosozumab-aqqg injection in the elderly. However, elderly patients are more sensitive to the effects of this medicine than younger adults.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you 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 (eg, 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.

• Kidney disease, severe or
• Patients receiving dialysis—Use with caution. The effects may be increased because of the slower removal of the medicine from the body.

Proper Use of This Medicine:

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.

Precautions While Using This Medicine:

It is very important that your doctor check your progress at regular visits to make sure 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 having 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 in 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 tell 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 problems, 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 (eg, other medicines that also contain zoledronic acid) or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects of This Medicine:

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