What are the necessary steps before prescribing Fosamax (alendronate) to a patient?

Pre-Prescribing Checklist for Fosamax (Alendronate)

Before prescribing Fosamax, you must verify the patient does not have contraindications, assess renal function, correct any calcium/vitamin D deficiency, ensure proper administration capability, and provide specific dosing instructions. 1, 2

Absolute Contraindications to Verify

• Esophageal abnormalities that delay esophageal emptying 1, 2
• Inability to stand or sit upright for at least 30 minutes after taking the medication 1, 2
• Hypocalcemia (low serum calcium levels) - must be corrected before initiating therapy 1, 2
• Hypersensitivity to alendronate or any component of the product 1, 2
• Increased risk of aspiration (for alendronate solution formulation) 3

Renal Function Assessment

• Check creatinine clearance or GFR before prescribing 1
• Do not use alendronate if GFR < 35 mL/min/1.73 m² in patients with chronic kidney disease 1
• Age-related decline in renal function necessitates assessment, particularly in elderly patients 1

Calcium and Vitamin D Status

• Check serum 25(OH)D levels before starting bisphosphonates 1
• Target serum 25(OH)D level ≥30 ng/mL for optimal bone health 1
• If 25(OH)D levels <30 ng/mL: Give ergocalciferol 50,000 IU weekly for 8 weeks, then recheck levels 1
• Alternative for levels 20-30 ng/mL: Add 1,000 IU daily vitamin D2 or D3, recheck in 3 months 1
• Correct hypocalcemia before initiating therapy to prevent treatment-related hypocalcemia 1

Concurrent Supplementation Requirements

• Prescribe calcium 1,000-1,200 mg daily (if dietary intake inadequate) 1, 3, 2
• Prescribe vitamin D 800-1,000 IU daily (if dietary intake inadequate) 1, 3, 2
• Inadequate supplementation reduces treatment efficacy 1

Patient Capability Assessment

• Verify patient can swallow tablets whole without chewing or sucking 2
• Confirm patient can remain upright for 30 minutes after taking medication 2
• Ensure patient can take medication first thing in the morning on an empty stomach 2
• Confirm patient can wait 30 minutes before eating, drinking (except plain water), or taking other medications 2

Medication Review

• Review current medications for potential interactions 2
• Specifically note use of:
  • Antacids 2
  • Aspirin 2
  • NSAIDs 2
• Timing is critical: All other medications must be taken at least 30 minutes after alendronate 2

Dental Assessment

• Assess for planned dental surgery or tooth extractions 1
• Osteonecrosis of the jaw is a rare but serious risk (incidence <1 to 28 cases per 100,000 person-years), with risk increasing after 2 years of therapy 1

Patient Education Requirements

Provide explicit instructions on administration 2:

• Take immediately upon arising for the day, before any food, beverage, or other medication 2
• Swallow tablet whole with full glass (6-8 oz) of plain water only - not mineral water, coffee, tea, soda, or juice 2
• Do not chew or suck on the tablet (risk of oropharyngeal ulceration) 2
• Remain upright (sitting, standing, or walking) for at least 30 minutes after taking 2
• Wait at least 30 minutes before first food of the day 2
• Never take at bedtime 2

Warn about symptoms requiring immediate discontinuation 2:

• Difficulty or pain upon swallowing 2
• Retrosternal pain 2
• New or worsening heartburn 2

Lifestyle Modification Counseling

• Recommend weight-bearing exercise 3, 2
• Advise smoking cessation 3
• Limit alcohol to ≤2 units daily 3

Dosing Selection

For osteoporosis treatment 1:

• Alendronate 70 mg once weekly (preferred for convenience) 1, 4
• Alternative: 10 mg daily 1

For osteoporosis prevention 1:

• 35 mg once weekly 1
• Alternative: 5 mg daily 1

For glucocorticoid-induced osteoporosis (adults ≥40 years with moderate-to-high fracture risk) 1:

• 5 mg daily 1

Common Pitfalls to Avoid

• Do not prescribe if patient cannot follow strict administration instructions - improper administration significantly increases risk of esophageal adverse events 2
• Do not assume adequate calcium/vitamin D status - most clinical trials included supplementation of 500-1,000 mg calcium and 400-800 IU vitamin D daily 1
• Do not overlook renal function - oral bisphosphonates have better renal safety than IV formulations, but still contraindicated if GFR <35 1
• Do not prescribe for indefinite duration without reassessment - consider drug holidays or dose reduction after 5 years due to rare adverse effects (atypical femoral fractures: 3.0-9.8 cases per 100,000 patient-years) 1, 3

Monitoring Plan

• Bone mineral density with vertebral fracture assessment or spinal x-ray every 1-2 years for patients on long-term therapy 3
• Reassess need for continued therapy after 5 years - fracture protection may persist for up to 5 years after stopping 1