Etelcalcetide Hydrochloride and Oramorph SR

• Generic Name: etelcalcetide
• Dosage Forms: n.a.
• Other Brand Names: Parsabiv

Treatment of secondary hyperparathyroidism associated with chronic renal disease in patients undergoing hemodialysis.

Additional studies needed to determine effects on clinical outcomes, including cardiovascular morbidity and mortality.

Safety and efficacy not established in patients with chronic renal disease who are not undergoing hemodialysis; use not recommended in these patients.

Safety and efficacy not established in patients with parathyroid carcinoma or primary hyperparathyroidism; use not recommended in these patients.

• Generic Name: morphine
• Dosage Forms: sustained release tablets
• Other Brand Names: Arymo ER, Kadian, MorphaBond ER, Avinza, MS Contin, Duramorph PF, Infumorph, Mitigo, RMS, Roxanol

Morphine tablet is used to relieve short-term (acute) or long-term (chronic) moderate to severe pain. The extended-release capsule and extended-release tablet are used to treat pain severe enough to require daily, around-the-clock, long-term opioid treatment and when other pain medicines did not work well enough or cannot be tolerated. Morphine belongs to the group of medicines called narcotic analgesics (pain medicines). It acts on the central nervous system (CNS) to relieve pain.

Morphine extended-release capsules and extended-release tablets should not be used if you need pain medicine for just a short time, such as when recovering from surgery. Do not use this medicine to relieve mild pain, or in situations when non-narcotic medication is effective. This medicine should not be used to treat pain that you only have once in a while or "as needed".

When morphine 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.