Evenity (Romosozumab) – Osteoporosis Injection Information, Dosing, Side Effects, and Canadian Access

Evenity is a prescription medication used to treat osteoporosis in postmenopausal women who are at high risk for fracture. The active ingredient is romosozumab, a monoclonal antibody that targets sclerostin, a protein involved in bone metabolism. By blocking sclerostin, Evenity has a dual effect on bone: it increases bone formation and also decreases bone breakdown. This can improve bone strength and lower the risk of fractures when used appropriately and followed by ongoing osteoporosis therapy.

Evenity is supplied as a single-use prefilled syringe and is given by subcutaneous injection once per month for a limited course of therapy. Because the medication has important safety warnings and requires monthly injections and calcium/vitamin D supplementation, it should be used under the guidance of a healthcare provider experienced in osteoporosis care.

What Evenity Is Used For

Evenity is indicated for the treatment of osteoporosis in postmenopausal women at high risk for fracture, defined as:

• A history of osteoporotic fracture, or
• Multiple risk factors for fracture

Evenity is not authorized for pediatric use and is not intended for women of reproductive potential.

How Evenity Works

Romosozumab is a humanized monoclonal antibody that binds to and inhibits sclerostin. Sclerostin normally limits bone formation. By inhibiting sclerostin, Evenity:

• Promotes new bone formation, and
• Decreases bone resorption (breakdown) to a lesser extent

This “dual action” is one reason Evenity is often described as a bone-building therapy rather than a purely anti-resorptive therapy.

Strength, Form, and What Comes in the Box

• Single-use prefilled syringe: 105 mg/1.17 mL solution for subcutaneous injection
• Monthly dose requires two syringes per visit (total monthly dose 210 mg)

The needle shield is latex-free. The solution should appear clear to opalescent and colorless to light yellow. Do not use if it is cloudy, discolored, or contains particles.

Serious Warning: Heart Attack and Stroke Risk

Evenity may increase the risk of myocardial infarction (heart attack), stroke, and cardiovascular death. Treatment is not recommended in patients with a history of heart attack or stroke. In patients with other cardiovascular or cerebrovascular disease or risk factors, the benefits and risks should be weighed carefully.

If a patient experiences a heart attack or stroke while receiving Evenity, Evenity should be discontinued and prompt medical evaluation is required.

Who Should Not Use Evenity (Contraindications)

Do not use Evenity if:

• You have low blood calcium (hypocalcemia). Low calcium must be corrected before starting Evenity.
• You are allergic to romosozumab or any ingredient in the formulation.

Evenity Dosing and Duration

The recommended dose is 210 mg once monthly, given as two consecutive subcutaneous injections of 105 mg each. Treatment is limited to 12 monthly doses (12 months).

After completing 12 months of Evenity, if osteoporosis therapy is still needed, a follow-on anti-resorptive agent is commonly considered. Without follow-on anti-resorptive therapy, bone mineral density gains trend toward pre-treatment levels after stopping Evenity.

Calcium and vitamin D supplementation

Patients should be adequately supplemented with calcium and vitamin D during treatment. This is especially important because Evenity can cause low blood calcium, and risk is higher in certain patients (including those with severe renal impairment or on dialysis).

Missed dose

• If a dose is missed, it should be administered as soon as it can be rescheduled.
• After that, continue monthly dosing based on the date of the last dose.

How Evenity Is Given

Evenity is injected under the skin (subcutaneous injection). It may be administered by a healthcare professional or by an individual trained by a healthcare professional. After proper training, some patients may self-inject if their clinician determines it is appropriate and medical follow-up is maintained.

Injection sites include:

• Abdomen
• Thigh
• Upper arm

If you use the same general injection area, do not inject in the exact same spot used previously. Avoid areas where the skin is tender, bruised, red, or hard.

Common Side Effects

In clinical studies, the most commonly reported side effects included:

• Joint pain (arthralgia)
• Headache

Other side effects seen in studies included injection site reactions (such as pain or redness), muscle spasms, and other general symptoms depending on the individual.

Injection Site Reactions

Injection site reactions can occur and may include pain, redness, swelling, bruising, itching, or rash at the injection site. If injection site reactions are severe or persistent, contact a healthcare professional.

Important Precautions and Serious Risks

Low blood calcium (hypocalcemia)

Evenity can cause low calcium levels. This is why existing hypocalcemia must be corrected before starting therapy and why calcium/vitamin D supplementation is important. Symptoms of low calcium can include muscle spasms, twitches, cramps, and numbness or tingling (especially around the mouth or in fingers/toes).

Osteonecrosis of the jaw (ONJ)

ONJ has occurred in patients treated with Evenity. Risk may be higher in people with poor oral hygiene, dental disease, invasive dental procedures, cancer, older age, smoking, or certain concomitant therapies (including corticosteroids, chemotherapy, and radiotherapy to the head/neck).

• Consider a dental exam and preventive dentistry before starting in higher-risk patients.
• Maintain good oral hygiene and routine dental care during treatment.
• Report oral symptoms such as tooth mobility, pain, swelling, or non-healing sores promptly.

Atypical femoral fractures

Atypical low-trauma femur fractures have been reported. New or unusual thigh, hip, or groin pain should be evaluated promptly.

Hypersensitivity reactions

Clinically significant allergic reactions (including angioedema, rash, urticaria, and dermatitis) have been reported. If a serious allergic reaction occurs, appropriate treatment should be initiated and Evenity should be discontinued.

Renal impairment

Patients with severe renal impairment or those receiving dialysis are at greater risk of developing hypocalcemia. Monitoring of calcium and ensuring supplementation is especially important in these patients.

Drug Interactions

No specific drug interaction studies have been conducted with Evenity, and established drug-drug interactions are not listed. Even so, patients should provide a complete medication and supplement list to their clinician, especially if they are on therapies that may affect calcium levels or overall fracture risk.

How Evenity Compares to Other Osteoporosis Treatments

Osteoporosis therapies generally fall into two broad categories:

• Bone-building (anabolic) therapies: designed to build new bone
• Anti-resorptive therapies: designed to slow bone breakdown

Evenity is often considered a bone-building option because of its strong effect on bone formation (and additional effect on reducing resorption). Compared with common alternatives:

• Bisphosphonates (for example, alendronate) are anti-resorptives often used first-line for many patients.
• Denosumab is also an anti-resorptive option, typically given every 6 months by injection.
• Other bone-building agents (such as teriparatide) work through different pathways and have different dosing schedules.

Evenity is time-limited to 12 months and is often followed by an anti-resorptive medication to help preserve bone density gains. The best choice depends on fracture history, bone density results, cardiovascular history, renal function, other medications, and overall risk profile.

Storage and Handling

• Refrigerate at 2°C to 8°C in the original carton.
• Protect from direct light.
• Do not freeze.
• Do not shake.
• If removed from the refrigerator, keep at room temperature (up to 25°C) in the original carton and use within 30 days.

Before injecting, allow the syringe to sit at room temperature for at least 30 minutes for comfort. Do not warm it in any other way.

Accessing Evenity from Canada

Evenity is a monthly injectable therapy, and the total cost of osteoporosis treatment can vary widely depending on insurance coverage, pharmacy pricing, and clinical follow-up needs. Some Americans explore Canadian access options for maintenance and specialty medications when affordability becomes a barrier to staying on treatment.

Over The Border Meds is a Canadian prescription referral service that helps eligible U.S. patients access medications from Canada with a valid prescription. For Evenity, prescriptions and treatment plans should clearly reflect:

• The monthly dose (210 mg total, given as two 105 mg injections)
• The planned 12-month course
• Calcium and vitamin D supplementation instructions
• Follow-up plan after month 12 (often including an anti-resorptive therapy)

Learn more: Over The Border Meds

Disclaimer

This information is for educational purposes only and does not replace medical advice. Evenity should only be used under medical supervision. Seek emergency care for symptoms of heart attack or stroke, severe allergic reaction, severe jaw symptoms, or signs of low calcium.

Reference: Evenity Product Monograph (Canada)

Evenity is given as two consecutive subcutaneous injections once monthly, typically administered by a healthcare professional. Treatment usually continues for 12 months, after which another osteoporosis medication may be recommended. Always follow your doctor’s instructions and attend scheduled appointments to ensure proper dosing and monitoring.