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MOVANTIK
Overview
What is MOVANTIK?
MOVANTIK (naloxegol), an opioid antagonist, contains naloxegol oxalate as the active ingredient. (Naloxegol is a PEGylated derivative of naloxone.)
The chemical name for naloxegol oxalate is: (5α,6α)-17-allyl-6-(2,5,8,11,14,17,20-heptaoxadocosan-22-yloxy)-4,5-epoxymorphinan-3,14-diol oxalate. The structural formula is:
The empirical formula for naloxegol oxalate is CHNO.CHO and the molecular weight is 742.
Naloxegol oxalate is a white to off-white powder, with high aqueous solubility across the physiologic pH range.
MOVANTIK (naloxegol) tablets for oral use contain 14.2 mg and 28.5 mg of naloxegol oxalate, respectively equivalent to 12.5 mg and 25 mg of naloxegol.
Excipients in tablet core are: mannitol, cellulose microcrystalline, croscarmellose sodium, magnesium stearate, and propyl gallate.
Excipients in tablet coat are: hypromellose, titanium dioxide, polyethylene glycol, iron oxide red, and iron oxide black.
What does MOVANTIK look like?
What are the available doses of MOVANTIK?
MOVANTIK (naloxegol) is available in two strengths:
What should I talk to my health care provider before I take MOVANTIK?
How should I use MOVANTIK?
MOVANTIK (naloxegol) is indicated for the treatment of opioid-induced constipation (OIC) in adult patients with chronic non-cancer pain, .
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What interacts with MOVANTIK?
Sorry No Records found
What are the warnings of MOVANTIK?
Sorry No Records found
What are the precautions of MOVANTIK?
Sorry No Records found
What are the side effects of MOVANTIK?
Sorry No records found
What should I look out for while using MOVANTIK?
MOVANTIK is contraindicated in:
What might happen if I take too much MOVANTIK?
In a clinical study of patients with OIC a daily dose of 50 mg (twice the recommended dosage), administered over 4 weeks, was associated with an increased incidence of GI adverse reactions, such as abdominal pain, diarrhea and nausea. These adverse reactions frequently occurred within 1-2 days after dosing.
No antidote is known for naloxegol. Dialysis was noted to be ineffective as a means of elimination in a clinical study in patients with renal failure.
If a patient on opioid therapy receives an overdose of naloxegol, the patient should be monitored closely for potential evidence of opioid withdrawal symptoms such as chills, rhinorrhea, diaphoresis or reversal of central analgesic effect. Base treatment on the degree of opioid withdrawal symptoms, including changes in blood pressure and heart rate, and on the need for analgesia.
How should I store and handle MOVANTIK?
Store between 20 to 25°C (68 to 77°F) [see USP Controlled Room Temperature].MOVANTIK (naloxegol) tablets are supplied as:StorageStore MOVANTIK at 20-25°C (68-77°F). Excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].MOVANTIK (naloxegol) tablets are supplied as:StorageStore MOVANTIK at 20-25°C (68-77°F). Excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].MOVANTIK (naloxegol) tablets are supplied as:StorageStore MOVANTIK at 20-25°C (68-77°F). Excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Naloxegol is an antagonist of opioid binding at the mu-opioid receptor. When administered at the recommended dose levels, naloxegol functions as a peripherally-acting mu-opioid receptor antagonist in tissues such as the gastrointestinal tract, thereby decreasing the constipating effects of opioids.
Naloxegol is a PEGylated derivative of naloxone, and is a substrate for the P-glycoprotein transporter (P-gp). Also, the presence of the PEG moiety in naloxegol reduces its passive permeability as compared with naloxone. Due to the reduced permeability and increased efflux of naloxegol across the blood-brain barrier, related to P-gp substrate properties, the CNS penetration of naloxegol is expected to be negligible at the recommended dose levels limiting the potential for interference with centrally mediated opioid analgesia.
Non-Clinical Toxicology
MOVANTIK is contraindicated in:Many drugs affect thyroid hormone pharmacokinetics and metabolism (e.g., absorption, synthesis, secretion, catabolism, protein binding, and target tissue response) and may alter the therapeutic response to Levothyroxine Sodium Tablets, USP. In addition, thyroid hormones and thyroid status have varied effects on the pharmacokinetics and action of other drugs. A listing of drug-thyroidal axis interactions is contained in Table 2.
The list of drug-thyroidal axis interactions in Table 2 may not be comprehensive due to the introduction of new drugs that interact with the thyroidal axis or the discovery of previously unknown interactions. The prescriber should be aware of this fact and should consult appropriate reference sources (e.g., package inserts of newly approved drugs, medical literature) for additional information if a drug-drug interaction with levothyroxine is suspected.
Clusters of symptoms consistent with opioid withdrawal, including hyperhidrosis, chills, diarrhea, abdominal pain, anxiety, irritability, and yawning have occurred in patients treated with MOVANTIK []. In addition, patients receiving methadone as therapy for their pain condition were observed in clinical trials to have a higher frequency of gastrointestinal adverse reactions that may have been related to opioid withdrawal than patients receiving other opioids []. Patients having disruptions to the blood-brain barrier may be at increased risk for opioid withdrawal or reduced analgesia. Take into account the overall risk-benefit profile when using MOVANTIK in such patients. Monitor for symptoms of opioid withdrawal in such patients.
Serious and important adverse reactions described elsewhere in labeling include:
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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Interactions
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