Cinacalcet Hydrochloride and Duragesic Mat

• Generic Name: cinacalcet
• Dosage Forms: n.a.
• Other Brand Names: Sensipar

Treatment of secondary hyperparathyroidism associated with chronic renal disease in patients who are undergoing hemodialysis or peritoneal dialysis.

Safety and efficacy in patients who are not undergoing dialysis have not been established.

May be used alone or in conjunction with vitamin D analogs and/or phosphate binders.

Effects on clinical outcomes remain to be fully determined. The primary finding of the EVOLVE trial (a lack of effect on mortality or major cardiovascular events ) is controversial because of study limitations.

Management of hypercalcemia associated with parathyroid carcinoma; designated an orphan drug by FDA for this use.

Treatment of hypercalcemia associated with primary hyperparathyroidism in patients who would be candidates for parathyroidectomy based on serum calcium concentrations but who are unable to undergo the surgery; designated an orphan drug by FDA for this use.

• Generic Name: fentanyl
• Dosage Forms: n.a.
• Other Brand Names: Duragesic, Abstral, Fentora, Subsys, Actiq, Ionsys, Lazanda, Onsolis, Sublimaze

Fentanyl skin patch is used to treat severe pain, including acute pain following surgery. Ionsys® is applied by your healthcare provider in a hospital setting after surgery for the short-term management of acute pain. Duragesic® is used for pain severe enough to require around-the-clock pain relief for a long period of time. Fentanyl is a strong narcotic analgesic (pain medicine). It acts on the central nervous system (CNS) to relieve pain.

The Duragesic® skin patch should not be used if you need pain medicine for just a short time, such as after dental surgery or tonsil surgery. Do not use the patch for mild pain or pain that occurs only once in a while.

When a narcotic medicine is used for a long time, it may become habit-forming, causing mental or physical dependence. However, people who have continuing pain should not let the fear of dependence keep them from using narcotics to relieve their pain. Mental dependence (addiction) is not likely to occur when narcotics are used for this purpose. Physical dependence may lead to withdrawal side effects if treatment is stopped suddenly. However, severe withdrawal side effects can usually be prevented by gradually reducing the dose over a period of time before treatment is stopped completely.

This medicine is available only under a restricted distribution program called the Opioid Analgesic REMS (Risk Evaluation and Mitigation Strategy) program.