EVENITY 105 mg solution for injection in pre-filled pen – Summary of product characteristics (SmPC) – (emc)

EVENITY 105 mg is a key therapeutic option for managing severe osteoporosis in postmenopausal women at high risk of fractures. This medication is administered via a pre-filled pen, allowing for convenient subcutaneous injections that enhance patient compliance. Understanding the characteristics of EVENITY is essential for both healthcare providers and patients alike.

This article delves into the essential aspects of EVENITY, including its administration, effectiveness, contraindications, and comparisons with other osteoporosis treatments.

What is EVENITY 105 mg solution for injection in pre-filled pen?

EVENITY is a monoclonal antibody designed specifically for treating severe osteoporosis, particularly in postmenopausal women who are at an elevated risk of fractures. This treatment works by inhibiting the activity of osteoclasts, which are responsible for bone resorption, thereby enhancing bone formation.

Each pre-filled pen contains 105 mg of romosozumab, administered through two subcutaneous injections once a month. This method of administration is particularly beneficial for patients who may have difficulty with oral medications.

It is important for patients on EVENITY to maintain sufficient levels of calcium and vitamin D in their diets. This supplementation supports the overall effectiveness of the treatment and helps in achieving optimal bone health.

How is EVENITY administered to patients?

EVENITY is administered as two subcutaneous injections of 105 mg each, typically given once a month. The injections can be self-administered or performed by a healthcare professional, making it a flexible option for many patients.

  • The injections should be given in areas of the body such as the abdomen, thigh, or upper arm.
  • Patients should rotate injection sites with each administration to minimize discomfort.
  • Before administering the injection, it is recommended to allow the pen to reach room temperature for about 30 minutes.

Proper training on injection techniques enhances patient confidence and ensures effective delivery of the medication. Healthcare providers must also educate patients on managing any potential side effects.

What are the key clinical studies on EVENITY?

Clinical trials have significantly demonstrated the efficacy of EVENITY in reducing fracture risks among postmenopausal women with osteoporosis. One pivotal study included 7,180 participants and showed that those receiving EVENITY for 12 months experienced fewer spinal fractures compared to those on a placebo.

Another clinical trial involving 4,093 women highlighted EVENITY’s superiority over alendronate, showing significant reductions in new spinal fractures within the first year of treatment. The continued benefits of EVENITY were observed even after transitioning to denosumab therapy after the initial treatment period.

Overall, these studies confirm the clinical efficacy of romosozumab in preventing osteoporotic fractures and maintaining bone health in high-risk populations.

What are the contraindications for EVENITY treatment?

While EVENITY offers substantial benefits, it is crucial to be aware of its contraindications. Patients with a history of hypersensitivity to any component of EVENITY should not use this treatment. Additionally, individuals with hypocalcemia or a prior history of myocardial infarction or stroke must avoid this medication.

Special considerations are necessary for elderly patients and those with renal impairment. Although typically no dosage adjustments are required, monitoring calcium levels is important for those with severe renal issues.

Prior to starting EVENITY, healthcare providers should conduct a thorough assessment of the patient’s medical history to mitigate any potential cardiovascular risks associated with the treatment.

What are the recommended dosages for EVENITY?

The standard dosage for EVENITY is two subcutaneous injections of 105 mg each, administered once a month for a total duration of 12 months. This regimen is designed to provide optimal therapeutic effects in preventing fractures.

  • Patients must maintain adequate calcium and vitamin D intake throughout the treatment.
  • Following the 12-month period of EVENITY, transitioning to an antiresorptive therapy is recommended to sustain the benefits achieved during the treatment.

Healthcare providers should evaluate individual patient needs and adjust treatment plans accordingly, ensuring patients receive the most effective osteoporosis management strategies.

What are the potential side effects of EVENITY?

As with any medication, EVENITY is associated with potential side effects. Some common adverse reactions include injection site reactions, headaches, and musculoskeletal pain. These side effects are generally mild and often resolve on their own over time.

More serious side effects may involve cardiovascular events; hence, patients with a history of heart disease should be closely monitored during treatment. Regular check-ups are essential for assessing any adverse effects and ensuring patient safety.

It is also crucial for patients to report any unusual symptoms or concerns to their healthcare provider promptly. Early intervention can help manage side effects effectively.

How does EVENITY compare to other osteoporosis treatments?

When compared to traditional osteoporosis treatments like alendronate, EVENITY has shown superior effectiveness in reducing spinal fractures. Clinical studies indicate that women treated with EVENITY experienced fewer clinical fractures post-treatment compared to those on alendronate.

The unique mechanism of action of EVENITY, which both inhibits bone resorption and promotes bone formation, sets it apart from other therapies. This dual action can offer significant advantages for women at high risk of fractures.

Moreover, the convenience of subcutaneous administration in a pre-filled pen format enhances patient compliance, making EVENITY a compelling option for osteoporosis management.

Questions related to EVENITY treatment

Where is the best place to inject evenity?

The recommended injection sites for EVENITY include the abdomen, thigh, or upper arm. Patients should rotate their injection sites to minimize discomfort and skin irritation. It is important to avoid areas with bruising, scarring, or any other skin conditions.

What is the active ingredient in evenity?

The active ingredient in EVENITY is romosozumab, a monoclonal antibody specifically designed to treat osteoporosis. Romosozumab works by inhibiting bone resorption while simultaneously stimulating bone formation, which is critical for improving bone density and reducing fracture risk.

What are the cons of evenity?

Despite its advantages, some cons of EVENITY include the potential for serious cardiovascular events and the necessity for regular monitoring. Some patients may also experience mild side effects such as injection site reactions or headaches. Furthermore, the requirement for calcium and vitamin D supplementation can be seen as an additional burden.

What is the price of evenity?

The price of EVENITY can vary significantly based on factors such as insurance coverage, location, and pharmacy. Typically, the cost may range from $1,500 to $2,000 per month without insurance. Patients are encouraged to consult their healthcare providers and insurance companies for detailed information regarding coverage and costs.

Leave a Comment