由1000多位接受透析治疗的慢性肾功能患者参与的为期6个月的Cinacalcet临床试验中,最常见的不良反应是恶心、呕吐,发生率分别是31%和27%,而接受安慰剂的恶心、呕吐的发生率分别是19%和15%。大多数的慢性肾功能患者还出现了低钙血症。因此在标签中有监测患者血钙水平的提示。
Generic Name for SENSIPAR
Cinacalcet 30mg, 60mg, 90mg, tabs.
Legal Classification:
Rx
Pharmacological Class for SENSIPAR
Calcimimetic.
Manufacturer of SENSIPAR
Amgen, Inc.
Indications for SENSIPAR
Secondary hyperparathyroidism in patients with chronic kidney disease on dialysis.
Adult dose for SENSIPAR
Swallow whole; take with food. Individualize. ≥18yrs: initially 30mg once daily. May titrate dose every 2–4 weeks through sequential doses of 60mg, 90mg, 120mg, and 180mg once daily until target iPTH levels of 150–300pg/mL. May take with Vit.D sterols and/or phosphate binders.
Children's dosing for SENSIPAR
<18yrs: not recommended.
Warnings/Precautions for SENSIPAR
Do not initiate if serum calcium <8.4mg/dL. Obtain serum calcium and serum phosphorus within 1 week of therapy, then monthly. Obtain iPTH within 1–4 weeks after start of therapy, during dose adjustment, then every 1–3 months. Suspend if serum calcium <7.5mg/dL or persistent hypocalcemia symptoms occur; may restart at next lowest dose if resolved. Monitor for adynamic bone disease; if iPTH levels decrease below target range (150–300pg/mL), reduce dose or discontinue. History of seizures. Cardiovascular disorders. Moderate and severe hepatic impairment. Pregnancy (Cat.C). Nursing mothers: not recommended.
Interactions for SENSIPAR
Potentiates CYP2D6 substrates (eg, metoprolol, carvedilol, flecainide, vinblastine, thioridazine, and TCAs). Potentiated by CYP3A4 inhibitors (eg, ketoconazole, itraconazole, erythromycin); may need to adjust dose.
Adverse Reactions for SENSIPAR
GI upset, myalgia, dizziness, hypo- or hypertension, asthenia, anorexia, chest pain, hypocalcemia.
How is SENSIPAR supplied?
Tabs—30
Related Disease:
Hyperparathyroidism
