"The US Food and Drug Administration (FDA) today approved a drug for children and adults with hemophilia B called albutrepenonacog alfa (Idelvion, CSL Behring), which combines albumin with factor IX to reduce injection frequency."...
The following serious adverse reactions are discussed elsewhere in the labeling:
- Precipitation of Severe Opioid Withdrawal [see WARNINGS AND PRECAUTIONS]
Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to the rates in the clinical studies of another drug and may not reflect the rates observed in practice.
The following adverse reactions were observed in EVZIO clinical studies. In two pharmacokinetic studies with a total of 54 healthy adult subjects exposed to 0.4 mg EVZIO, 0.8 mg EVZIO (two 0.4 mg EVZIOs) or 2 mg EVZIO, adverse reactions occurring in more than one subject were dizziness and injection site erythema.
The following adverse reactions have been identified during post-approval use of naloxone hydrochloride in the post-operative setting. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure: Hypotension, hypertension, ventricular tachycardia and fibrillation, dyspnea, pulmonary edema, and cardiac arrest. Death, coma, and encephalopathy have been reported as sequelae of these events. Excessive doses of naloxone hydrochloride in post-operative patients have resulted in significant reversal of analgesia and have caused agitation [see WARNINGS AND PRECAUTIONS].
Other events that have been reported in post-marketing use of EVZIO include agitation, disorientation, confusion, and anger.
Abrupt reversal of opioid effects in persons who were physically dependent on opioids has precipitated an acute withdrawal syndrome. Signs and symptoms have included: body aches, fever, sweating, runny nose, sneezing, piloerection, yawning, weakness, shivering or trembling, nervousness, restlessness or irritability, diarrhea, nausea or vomiting, abdominal cramps, increased blood pressure, tachycardia. In the neonate, opioid withdrawal signs and symptoms also included: convulsions, excessive crying, hyperactive reflexes [see WARNINGS AND PRECAUTIONS].
Read the Evzio (naloxone hydrochloride auto-injector for injection) Side Effects Center for a complete guide to possible side effects
No Information ProvidedThis monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 10/31/2016
Additional Evzio Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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