The sNDA proposed changes including: information regarding the administration of crushed tablets mixed in water given orally or via nasogastric (NG) tube, the addition of severe abdominal pain and/or severe diarrhea to the Warnings and Precautions and Adverse Reactions sections, and a clarification to the effects of race on pharmacokinetics.
The updated labeling for Movantik now states that for patients who are unable to swallow the Movantik tablet whole, the pill can be crushed to a powder, mixed with 4oz (120mL) of water and consumed immediately. The glass should be refilled with 4oz (120mL) of water, stirred and the contents consumed. Also, Movantik can be administered via a NG tube with specific instructions listed under Dosage and Administration.
The Warnings and Precautions section has been updated with information regarding reports of severe abdominal pain and/or diarrhea, some of which resulted in hospitalization. Most of the cases of severe abdominal pain were reported in patients taking the 25mg dosage. Patients should be monitored for the development of abdominal pain and/or diarrhea with Movantik, and therapy should be discontinued if severe symptoms occur. If appropriate, restarting Movantik at 12.5mg once daily may be considered. Severe abdominal pain and/or diarrhea have also been included in the Adverse Reactions section.
An update to the Pharmacokinetics section states that when compared to Caucasian subjects, naloxegol AUC was approximately 20% lower in Blacks. In addition, Cmax was approximately 10% lower in Blacks and 30% higher in Asians.
Movantik, an opioid antagonist (peripheral), is indicated to treat opioid-induced constipation in adults with chronic non-cancer pain. It is supplied as 12.5mg and 25mg strength tablets in 30- and 90-count bottles.
For more information call (800) 236-9933 or visit Movantik.com.