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Acidosis Condition in which the blood has too much acid (or too little base), frequently resulting in a decrease in blood pH.

Adynamic (aplastic) bone disease Bone disease characterized by low bone turnover and low amounts of circulating parathyroid hormone. Normal amounts of mineralization occur in this type of disease, though osteoblast and osteoclast numbers are reduced.

Calcimemetic Drug that mimics calcium in order to lower parathyroid hormone levels, but does not have the adverse effects that calcium may have.

Calciphylaxis Condition in which calcification affects small arteries.

Calcitriol 1,25-dihydroxyvitamin D3, the form of vitamin D3 that is biologically active in intestinal transport of dietary calcium and calcium resorption from bone.

Calcium-phosphorus product (Ca x P) The calcium-phosphorus product is the multiple of the serum levels of calcium and phosphorus. It is also a theoretical indicator of the risk of mineral crystallization in body tissues.

Glomerular filtration rate (GFR) An indicator of kidney function calculated from the serum creatinine level using the patient’s age, weight, gender, and body size.

Hydroxyapatite Mineral component of bones and teeth, Ca₁₀(PO₄)₆(OH)₂.

Hypercalcemia High calcium blood level; defined as blood calcium concentration >10.5 mg/dL of blood.

Hypocalcemia Low calcium blood level; defined as blood calcium concentration <8.8 mg/dL of blood.

Hyperparathyroidism Excessive secretion of parathyroid hormone by 1 or more of the 4 parathyroid glands.

Hyperphosphatemia High phosphate blood level; defined as blood phosphate concentration >4.5 mg/dL of blood.

Metastatic calcification Calcium salt deposits in soft tissues.

Osteitis fibrosa Classic form of renal osteodystrophy caused by secondary hyperparathyroidism. Characteristics include high bone turnover rate, and increased number and activity of osteoclasts.

Osteoblast Cells responsible for laying down the protein matrix upon which calcium salts, particularly calcium phosphates, are deposited to form bone.

Osteoclast Cells formed from differentiated macrophages that are responsible for the breakdown of bone.

Osteodystrophy Defective bone formation.

Osteoid Uncalcified bone matrix, the product of osteoblasts.

Osteomalacia Characterized by a lowered osteoblast activity and a high unmineralized bone content that can result in considerably weakened bone.

Parathyroid hormone Hormone produced by parathyroid glands; controls bone formation and the excretion of calcium and phosphorus.

Renal osteodystrophy Generalized changes in the bone that resemble osteomalacia and rickets; occurs in those with chronic renal failure.

Uremic pruritus Skin sensation resulting from renal failure causing a desire to scratch; itchiness.

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Important Safety Information

The most common adverse events were gastrointestinal, such as nausea and vomiting, and generally abated over time with continued dosing
The most common side effects leading to discontinuation in clinical trials were gastrointestinal events (nausea, vomiting, and diarrhea)
Other side effects reported in trials included dialysis graft complications, headache, abdominal pain, and hypotension
Although studies were not designed to detect differences in risk of fracture and mortality, there were no differences demonstrated in patients treated with FOSRENOL^® compared to alternative therapy for up to 3 years
The duration of treatment exposure and time of observation in the clinical program were too short to conclude that FOSRENOL^® does not affect the risk of fracture or mortality beyond 3 years
While lanthanum has been shown to accumulate in the GI tract, liver, and bone in animals, the clinical significance in humans is unknown
Patients with acute peptic ulcer, ulcerative colitis, Crohn’s disease, or bowel obstruction were not included in FOSRENOL^® clinical studies. Caution should be used in patients with these conditions
FOSRENOL^® should not be taken by patients who are nursing or pregnant
FOSRENOL^® should not be taken by patients who are under 18 years of age

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