Adult Dosing

Postmenopausal osteoporosis

• 70 mg alendronate/2800 IU vitamin D3 or 70 mg alendronate/5600 IU vitamin D3 PO qwk
• Appropriate dose for most osteoporotic women: 70 mg alendronate/5600 IU vitamin D3 PO qwk

Osteoporosis in male

• 70 mg alendronate/2800 IU vitamin D3 or 70 mg alendronate/5600 IU vitamin D3 PO qwk
• Appropriate dose for most osteoporotic men: 70 mg alendronate/5600 IU vitamin D3 PO qwk

• Consume with only plain water (6-8 oz) at least 30 minutes before the first food/beverage/medication
• Avoid lying down for at least 30 minutes and until after the first food of the day
• Avoid taking at bedtime or before rising
• Do not cut/crush/chew
• Calcium and additional vitamin D supplementation are recommended if inadequate dietary intake

Pediatric Dosing

• Safety and effectiveness in pediatric patients have not been established

[Outline]

• Adult Dosing
• Pediatric Dosing

• Osteoporosis in postmenopausal women
• To increase bone mass in men with osteoporosis

Note:

• Patient on bisphosphonate therapy should periodically re-evaluate the need for continued therapy
• Consider discontinuation after 3-5 yrs of use in patients at low-risk for fracture; periodically assess risk for fracture in patients who discontinue therapy

• Hypersensitivity to any of the ingredients of the product
• Abnormal esophageal peristalsis
• Esophageal stricture
• Achalasia
• Inability to stand/sit upright for at least 30 minutes
• Hypocalcemia
• Hypercalcemia
• Hypervitaminosis D
• CrCl <35

• N/A

Renal Dose Adjustment (Based on CrCl)

• <35 mL/min: Avoid use

Hepatic Dose Adjustment

• Hepatic impairment: No dose adjustments

See Supplemental Patient Information

• Severe irritation of upper gastrointestinal mucosa may occur. Carefully follow dosing instructions in patients with active upper GI disease. Esophagitis, esophageal ulcers and esophageal erosions, occasionally with bleeding and rarely followed by esophageal stricture or perforation have occurred; hospitalize patients in severe cases; discontinue therapy on occurrence of new or worsening of symptoms
• To avoid risk of severe esophageal adverse experiences, provide full dosing instructions, and see that instructions are understood by the patients
• Worsening of hypocalcemia may occur; correct hypocalcemia and other disorders affecting mineral metabolism prior to initiation of therapy; Monitor serum calcium and symptoms of hypocalcemia during therapy in patients with above disorders. Small, asymptomatic decreases in serum calcium and phosphate can occur
• Avoid alendronate/cholecalciferol alone to treat vitamin D deficiency
• Severe incapacitating bone, joint, muscle pain have occurred; discontinue therapy on worsening of symptoms
• Rare occasions of osteonecrosis of the jaw associated with tooth extraction and/or local infection with delayed healing have occurred, Consider discontinuation of therapy based on individual benefit/risk assessment
• Avoid use in patients with renal insufficiency (creatinine clearance <35 mL/min)
• Monitor Cr at baseline, urine/serum Ca if history of mineral metabolism disorder or associated disease with unregulated overproduction of 1,25 dihydroxyvitamin D, 25-dihydroxyvitamin D oR presence of GI malabsorption syndrome
• Anticonvulsants, cimetidine, and thiazides may increase the catabolism of vitamin D ; consider additional vitamin D supplementation

Cautions: Use cautiously in

• Active upper gastrointestinal problems
• Barrett's esophagus
• Dysphagia
• Esophageal diseases
• Gastritis
• Duodenitis
• Ulcers
• Malabsorption syndrome
• Hyperphosphatemia
• Leukemia
• Lymphoma
• Sarcoidosis
• Concurrent therapies (chemotherapy, corticosteroids)
• Invasive dental procedures
• Poor oral hygiene
• Co-morbid disorders
• NSAID use

Supplemental Patient Information

• Instruct patients to follow dosing instructions strictly to make sure dosage works and helps to lower the chance of adverse effects in esophagus
• Inform patients to stop taking the drug and report to clinician on chest pain or occurrence of new or worsening of heartburn
• Inform patients to stop taking the drug and report to the clinician on occurrence of chest pain or new or worsening heartburn
• Patients at increased risk for vitamin D insufficiency (e.g., over the age of 70 years, nursing home bound, or chronically ill, GI malabsorption) should be instructed to take additional vitamin D supplementation

Pregnancy Category:C

Breastfeeding: Absorption of alendronate by a breastfed infant is unlikely as alendronate is poorly absorbed. Literature unavailable on use of alendronate during breastfeeding. Prefer an alternate drug while nursing a newborn or preterm infant. This information is based upon LactMed database. (available at http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT last accessed 8 December 2010). Cholecalciferol and some of its active metabolites are excreted into breast milk. Manufacturer advises caution on administering to nursing women.

• GI: Abdominal pain, nausea, dyspepsia, constipation, acid regurgitation, esophageal ulcer, vomiting, abdominal distention, dysphagia, gastritis, flatulence, diarrhea, taste perversion, esophagitis, esophageal erosion, esophageal stricture, esophageal perforation
• MUSC: Bone, muscle or joint pain, muscle cramp
• CNS: Headache, dizziness
• METABOLIC: Hypocalcemia, hypercalcemia
• EENT: Uveitis, scleritis
• DERM: Severe skin reactions, urticaria, angioedema
• MISC: Osteonecrosis of jaw, atypical femur fractures, photosensitivity

Alendronate

• Anti-osteoporosis agent; inhibits osteoclast activity, reducing bone resorption and increases bone mineral density
• Mean relative bioavailability: 0.64% (women) for 5-70 mg doses; Bioavailability: 0.59% (men) for 10mg tab
• Metabolism: Unknown
• Excreted in urine (50%) on IV use
• Half-life: >10yrs; accumulates in bone which reflects release of alendronate from the skeleton

Cholecalciferol

• Prohormone; stimulates intestinal absorption of both calcium and phosphate, regulates serum calcium, renal calcium and phosphate excretion, bone formation and bone resorption
• Absorption: Unknown
• Metabolized by liver, kidney; CYP450: Unknown
• Excreted primarily in bile; urine
• Half-life: 14hrs (cholecalciferol), 10-21 days (25-hydroxyvitamin D3)

US Trade Name(s)

• Fosamax plus D

US Availability

Fosamax plus D (alendronate/cholecalciferol)

• TABS:
• 70 mg/2800 IU
• 70 mg/5600 IU

Canadian Trade Name(s)

• Fosavance

Canadian Availability

Fosavance (alendronate/cholecalciferol)

• TABS:
• 70 mg/2800 IU
• 70 mg/5600 IU

UK Trade Name(s)

• Fosavance

UK Availability

Fosavance (alendronate/cholecalciferol)

• TABS: 70 mg/2800 IU

Australian Trade Name(s)

• Dronalen plus
• Fosamax Plus Once Weekly

Australian Availability

Dronalen plus (alendronate/cholecalciferol)

• TABS: 70 mg/140 mcg

Fosamax Plus Once Weekly (alendronate/cholecalciferol)

• TABS:
• 70 mg/70 mcg
• 70 mg/140 mcg

[Outline]

Endocrine/Metabolic

Bisphosphonates

Pricing data from www.DrugStore.com in U.S.A.

• Fosamax Plus D 70-2800 MG-UNIT TABS [Disp Pack] (MERCK SHARP & DOHME)
  4 mg-unit = $117
  12 mg-unit = $323.98
• Fosamax Plus D 70-5600 MG-UNIT TABS [Disp Pack] (MERCK SHARP & DOHME)
  4 mg-unit = $115.99
  12 mg-unit = $329.96

Warning: This pricing information is subject to change at the sole discretion of DS Pharmacy. For the most current and up-to-date pricing information, please visit drugstore.com.