Cinacalcet

In the United States, cinacalcet is indicated for the treatment of secondary hyperparathyroidism in people with chronic kidney disease on dialysis and hypercalcemia in people with parathyroid carcinoma.^[4][12] Cinacalcet can also be used to treat severe hypercalcemia in patients with primary hyperparathyroidism who are unable to undergo parathyroidectomy.^[4][13]

In the European Union cinacalcet is indicated for:

• the treatment of secondary hyperparathyroidism (HPT) in adults with end stage renal disease (ESRD) on maintenance dialysis therapy.^[5]
• the treatment of secondary hyperparathyroidism (HPT) in children aged three years and older with end stage renal disease (ESRD) on maintenance dialysis therapy in whom secondary HPT is not adequately controlled with standard of care therapy.^[5]
• part of a therapeutic regimen including phosphate binders and/or vitamin D sterols, as appropriate.^[5]
• the treatment of parathyroid carcinoma and primary hyperparathyroidism in adults.^[5]
• the reduction of hypercalcaemia in adults with:
  • parathyroid carcinoma;^[5]
  • primary HPT for whom parathyroidectomy would be indicated on the basis of serum calcium levels (as defined by relevant treatment guidelines), but in whom parathyroidectomy is not clinically appropriate or is contraindicated.^[5]

Hypocalcemia (decreased calcium levels) is a contraindication to the use of cinacalcet. Those who have serum calcium levels less than 7.5 mg/dL should not be started on cinacalcet. Hypocalcemia symptoms include paresthesias, myalgias, muscle cramping, tetany, and convulsions. Cinacalcet should not be administered until serum calcium levels are above 8.0 mg/dL and/or hypocalcemia symptoms are resolved.^[4] Cinacalcet is not approved for pediatric use in the United States.^[6][4][5]

Common side effects of cinacalcet include upset stomach, vomiting, diarrhea, dizziness, nausea, weakness, and chest pain.^[13]

Clinical trials conducted in the United States by Amgen to determine whether the drug is safe in children were halted by the U.S. Food and Drug Administration (FDA) in February 2013, following the death of a 14-year-old participant.^[6][14]

Serious side effects, including overdose symptoms, of cinacalcet include:^[13]

• burning
• tingling
• unusual feelings of the lips, tongue, fingers, or feet
• muscle aches or cramps
• sudden tightening of muscles in hands, feet, face, or throat
• seizures

Cinacalcet is a strong inhibitor of the liver enzyme CYP2D6 and is partially metabolized by CYP3A4 and CYP1A2. Dose adjustments may be necessary if people are treated with CYP3A4 and CYP1A2 inhibitors and medications that are metabolized by CYP2D6.^[4][3]