arising [7.5:<7 m/dL: 8%), hyperkalemia (4%) Gastrointestinal: Vomiting (9%) Immunologic: Antibody development (7%; 80% of these patients have preexisting anti-etelcalcetid antibodies) Neuromuscular & skeletal: Myalgia (2%)> <1% (Limited to important or life-threatening): Cardiac insufficiency, hypotension Warnings/Precautions Concerns related to adverse effects: Adynamic bone disease: May develop if parathyroid hormone levels are chronically suppressed; reduce dose or discontinue etelcalcetide and/or vitamin D if parathyroid hormone levels decrease below the recommended target range. Cardiovascular effects: QT prolongation and ventricular arrhythmia secondary to hypocalcemia may occur. 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 be at increased risk. Closely monitor corrected serum calcium and QT interval. Cases of hypotension, heart failure, and decreased myocardial performance have also been reported; may correlate with decreases in corrected serum calcium although a causal relationship to etelcalcetide cannot be excluded. Closely monitor for signs and symptoms of worsening heart failure during therapy. GI effects: Upper GI bleeding has been reported; relationship to etelcalcetide uncertain. Patients with risk factors for upper GI bleeding (eg, gastritis, esophagitis, ulcers, severe vomiting) may be at increased. Monitor patients for worsening of nausea and vomiting associated with etelcalcetide and for signs/symptoms of GI bleeding and ulcerations during therapy. Hypocalcemia: Severe and potentially life-threatening events associated with hypocalcemia (eg, muscle spasms, myalgias, paresthesias, seizures, QT interval prolongation, ventricular arrhythmia) may occur. Hypocalcemia may require treatment interruption, dose reduction, or initiation (or dose increases) of calcium-based phosphate binder and/or vitamin D to raise serum calcium depending on calcium levels or symptoms of hypocalcemia. Do not initiate therapy if the corrected serum calcium is less than the lower limit of normal; corrected serum calcium must be at or above the lower limit of normal prior to initiation, dose increase or re-initiation. Disease-related concerns: Heart failure: Patients with heart failure may experience worsening of their heart failure with use; additional monitoring may be required. Seizure disorder: Use with caution in patients with a history of seizure disorder; seizure threshold is lowered by significant decreases in serum calcium. Monitor corrected serum calcium levels closely. Concurrent drug therapy issues: Drug-drug interactions: Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions database for more detailed information. Monitoring Parameters Signs/symptoms of hypocalcemia, worsening of heart failure, GI bleeding/ulcerations; QT interval in patients at risk for QT interval prolongation and ventricular arrhythmia. Corrected serum calcium and PTH levels, per the following recommendations: Corrected serum calcium levels: Prior to initiation and 1 week after dose initiation or adjustment. After the maintenance dose is established, monitor every 4 weeks. PTH levels: Prior to initiation and 4 weeks after dose initiation or adjustment. After the maintenance dose is established, monitor per clinical practice. Pregnancy Considerations Adverse events were observed in animal reproduction studies at doses which also caused maternal toxicity (including hypocalcemia). Patient Education Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?) Patient may experience diarrhea or headache. Have patient report immediately to prescriber signs of low calcium (muscle cramps or spasms, numbness and tingling, or seizures); abnormal heartbeat; severe dizziness; passing out; severe nausea; vomiting; severe abdominal pain; black, tarry, or bloody stools; vomiting blood, or signs of heart problems (cough or shortness of breath that is new or worse, swelling of the ankles or legs, abnormal heartbeat, weight gain of more than five pounds in 24 hours, dizziness, or passing out) (HCAHPS). Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions. Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients. Print this page> ] Recently Approved Lonhala Magnair Lonhala Magnair (glycopyrrolate) is a long-acting muscarinic antagonist (LAMA) bronchodilator for... Ozempic Ozempic (semaglutide) is a glucagon-like peptide-1 (GLP-1) analog administered once-weekly for the... Ogivri Ogivri (trastuzumab-dkst) is a HER2 / neu receptor antagonist biosimilar to Herceptin indicated for... Sublocade Sublocade (buprenorphine) is a once-monthly injectable partial opioid agonist formulation for the... More searching for what you offer
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