Cinacalcet

Cinacalcet is a prescription medicine used to treat the symptoms of primary hyperparathyroidism (HPT), secondary hyperparathyroidism, and parathyroid carcinoma.

• Cinacalcet is available under the following different brand names: Sensipar

Adult dosage

Tablet

• 30mg
• 60mg
• 90mg

Primary Hyperparathyroidism (HPT)

Adult dosage

• Initial dose: 30 mg orally every 12 hours
• May increase if needed at 2-4 week intervals through sequential doses 60 mg every 12 hours, 90 mg every 12 hours, or 90 mg every 6-8 hours as necessary to normalize serum calcium levels

Secondary Hyperparathyroidism

• Initial dose: 30 mg orally once daily
• May increase if needed by titrating at 2-4 week intervals through sequential doses of 60, 90, 120, or 180 mg once daily

Parathyroid Carcinoma

• Initial dose: 30 mg orally every 12 hours
• May increase if needed at 2-4 week intervals through sequential doses 60 mg every 12 hours, 90 mg every 12 hours, or 90 mg every 6-8 hours as necessary to normalize serum calcium levels

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

Common side effects of Cinacalcet include:

• nausea,
• vomiting, 
• diarrhea, and
• myalgia.

Serious side effects of Cinacalcet include:

• hives,
• difficulty breathing,
• swelling of the face, lips, tongue, or throat,
• numbness or tingly feeling around the mouth,
• muscle pain, tightness, or contraction,
• seizure,
• shortness of breath,
• swelling,
• rapid weight gain,
• bloody or tarry stools,
• coughing up blood,
• vomit that looks like coffee grounds,
• numbness or tingly feeling around the mouth,
• fast or slow heart rate, and
• overactive reflexes.

Rare side effects of Cinacalcet include:

• none 

This is not a complete list of side effects and other serious side effects or health problems that may occur as a result of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Cinacalcet has severe interactions with the following drugs:
  • eliglustat
  • etelcalcetide
• Cinacalcet has serious interactions with the following drugs:
  • carbamazepine
  • cimetidine
  • clarithromycin
  • dacomitinib
  • erythromycin base
  • erythromycin ethylsuccinate
  • erythromycin lactobionate
  • erythromycin stearate
  • givosiran
  • ketoconazole
  • levoketoconazole
  • metoclopramide intranasal
  • nefazodone
  • rifabutin
  • rifampin
  • St John's Wort
• Cinacalcet has moderate interactions with at least 83 other drugs.
• Cinacalcet has minor interactions with no other drugs. 

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your health care professional or doctor for additional medical advice, or if you have health questions, concerns.

Contraindications

• Hypersensitivity
• Serum calcium is less than the lower limit of the normal range

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Cinacalcet?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Cinacalcet?”

Cautions

• History of seizure; seizures (primarily generalized or tonic-clonic) were observed in clinical trials (1.4% compared with 0.7% in placebo)
• Not for therapy of patients with chronic kidney disease not on dialysis due to increased risk for hypokalemia
• Drug exposure is increased in patients with moderate and severe hepatic impairment; monitor serum calcium, serum phosphorus, and intact parathyroid hormone closely
• The adynamic bone disease may develop; if PTH levels decrease below 150 pg/mL in patients receiving therapy, the dose and/or vitamin D sterols should be reduced or therapy discontinued
• Therapy is not indicated for patients with CKD, not on dialysis; long-term safety and efficacy of therapy are not established in patients with secondary HPT and CKD, not on dialysis
• Idiosyncratic cases of hypotension, worsening heart failure, and/or arrhythmia were reported in patients with impaired cardiac function, in which a causal relationship to therapy could not be completely excluded and which may be mediated by reductions in serum calcium levels
• Significant lowering of calcium by therapy can cause paresthesias, myalgias, muscle spasms, tetany, and seizures; QT interval prolongation and ventricular arrhythmia; life-threatening events and fatal outcomes associated with hypocalcemia reported, including in pediatric patients
• The threshold for seizures is lowered by significant reductions in serum calcium levels; monitor serum calcium levels in patients with seizure disorders
• Educate patients on symptoms of hypocalcemia and advise them to contact a healthcare provider if they occur; if corrected serum calcium falls below the lower limit of normal or symptoms of hypocalcemia develop, start or increase calcium supplementation (including calcium, calcium-containing phosphate binders, and/or vitamin D sterols or increases in dialysate calcium concentration)
• Gastrointestinal bleeding
  • Cases of gastrointestinal bleeding, mostly upper gastrointestinal bleeding, were reported in patients using calcimimetics
  • The exact cause of GI bleeding is unknown; patients with risk factors for upper GI bleeding (such as known gastritis, esophagitis, ulcers, or severe vomiting) may be at increased risk for GI bleeding when receiving treatment
  • Monitor patients for worsening of common GI adverse reactions of nausea and vomiting associated with therapy and for signs and symptoms of GI bleeding and ulcerations during therapy
  • Promptly evaluate and treat any suspected GI bleeding
• QT interval prolongation and ventricular arrhythmia
  • Decreases in serum calcium can prolong the QT interval, potentially resulting in ventricular arrhythmia; cases of QT prolongation and ventricular arrhythmia reported in patients receiving therapy; patients with congenital long QT syndrome
  • History of QT interval prolongation, family history of long QT syndrome or sudden cardiac death, and other conditions that predispose to QT interval prolongation and ventricular arrhythmia may increase the risk for QT interval prolongation and ventricular arrhythmias
  • In patients at risk, receiving therapy, who develop hypocalcemia, closely monitor corrected serum calcium and QT interval
• Drug interaction overview
  • Concurrent administration with calcium-lowering drugs including other calcium-sensing receptor agonists could result in severe hypocalcemia; closely monitor serum calcium in patients receiving the drug therapy and concomitant therapies known to lower serum calcium levels

Pregnancy and Lactation

• Limited case reports of use in pregnant women are insufficient to inform a drug-associated risk of adverse developmental outcomes; in animal reproduction studies, when female rats were exposed to the drug during the period of organogenesis through to weaning at 2-3 times systemic drug levels (based on AUC) at the maximum recommended human dose (MRHD) of 180 mg/day, peripartum and early postnatal pup loss and reduced pup body weight gain were observed in the presence of maternal hypocalcemia
• Lactation
  • There are no data regarding presence in human milk or effects on the breastfed infant or milk production; studies in rats showed that cinacalcet was excreted in the milk; developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for therapy and any potential adverse effects on the breastfed infant from therapy or underlying maternal condition