Can I prescribe Evenity (romosozumab‑aqqg) at the standard dose for a patient with an estimated glomerular filtration rate of 49 mL/min/1.73 m², and what monitoring and contraindications should I be aware of?

Can I Prescribe Evenity at Standard Dose with GFR 49?

Yes, you can prescribe Evenity (romosozumab) at the standard dose of 210 mg subcutaneously once monthly for a patient with eGFR 49 mL/min/1.73 m², as no dose adjustment is required for renal impairment at this level. 1

Dosing in Renal Impairment

• No dose adjustment is necessary for patients with mild to moderate renal impairment (eGFR 30–59 mL/min/1.73 m²). 1
• The standard dose remains 210 mg administered as two separate 105 mg subcutaneous injections once monthly for 12 doses. 1
• Clinical trial data from FRAME and ARCH studies demonstrated that romosozumab was effective and well-tolerated in patients with eGFR 30–59 mL/min/1.73 m², showing significant BMD increases and vertebral fracture risk reduction of 72% and 51% respectively in this kidney function category. 2

Critical Contraindications to Screen For

Absolute contraindications that would prevent prescribing Evenity include:

• Myocardial infarction or stroke within the preceding year – this is a black box warning and represents an absolute contraindication. 1
• Hypocalcemia – must be corrected before initiating therapy. 1
• Known hypersensitivity to romosozumab including prior angioedema, erythema multiforme, or severe allergic reactions. 1

Mandatory Pre-Treatment and Monitoring Requirements

Before Initiating Therapy:

• Verify and correct hypocalcemia – check serum calcium and ensure normal levels before the first dose. 1
• Ensure adequate calcium and vitamin D supplementation throughout the 12-month treatment course. 1
• Screen cardiovascular history carefully – document absence of MI or stroke in the past 12 months and assess overall cardiovascular risk factors. 1

During Treatment:

• Monitor serum calcium concentrations more closely in patients with eGFR 30–59 mL/min/1.73 m², as they have moderately increased risk of hypocalcemia compared to those with normal kidney function. 1
• Supplement with calcium and vitamin D adequately – this is particularly important given the eGFR of 49 mL/min/1.73 m². 1
• Educate the patient to seek immediate medical attention if symptoms of MI (chest pain, shortness of breath) or stroke (sudden weakness, vision changes, speech difficulty) occur, as Evenity must be discontinued immediately if these events happen. 1

Special Considerations at This GFR Level

• Your patient with eGFR 49 mL/min/1.73 m² falls into the CKD Stage 3a category, where romosozumab has been specifically studied and shown to be both safe and effective. 2
• The safety profile regarding adverse events and asymptomatic calcium decreases was similar across all baseline kidney function groups in clinical trials, including those with eGFR 30–59 mL/min/1.73 m². 2
• Evolution of kidney function during treatment was similar across kidney function categories, indicating romosozumab does not adversely affect renal function at this level. 2

Common Pitfalls to Avoid

• Do not reduce the dose based on kidney function alone – the 210 mg monthly dose is appropriate for eGFR ≥30 mL/min/1.73 m². 1
• Do not overlook cardiovascular screening – the black box warning for cardiovascular events is the most critical safety concern, not the renal impairment itself. 1
• Do not forget calcium/vitamin D supplementation – hypocalcemia risk is modestly elevated with reduced kidney function, making supplementation essential. 1
• Do not continue beyond 12 months – Evenity is limited to 12 monthly doses, after which patients should transition to an antiresorptive agent like alendronate or denosumab. 1

Administration Details

• Evenity must be administered by a healthcare provider – it is not for patient self-injection. 1
• Inject two 105 mg syringes consecutively (one after the other) in the abdomen, thigh, or upper arm to deliver the full 210 mg dose. 1
• Each monthly dose should be given approximately 30 days apart. 1