Naloxegol Oxalate (Movantik)

Trade Name : MOVANTIK

AstraZeneca Pharmaceuticals LP

TABLET, FILM COATED

Strength 12.5 mg/1

NALOXEGOL OXALATE Opioid Antagonist [EPC],Opioid Antagonists [MoA]

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GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Naloxegol Oxalate (Movantik) which is also known as MOVANTIK and Manufactured by AstraZeneca Pharmaceuticals LP. It is available in strength of 12.5 mg/1 per ml. Read more

Naloxegol Oxalate (Movantik) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials. Click to know price. Read less

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Warnings and Precautions u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a004/2020

MOVANTIK is indicated for the treatment of opioid-induced constipation (OIC) in adult patients with chronic non-cancer pain, including patients with chronic pain related to prior cancer or its treatment who do not require frequent (e.g., weekly) opioid dosage escalation.
MOVANTIK is an opioid antagonist indicated for the treatment of opioid-induced constipation (OIC) in adult patients with chronic non-cancer pain, including patients with chronic pain related to prior cancer or its treatment who do not require frequent (e.g., weekly) opioid dosage escalation. n

Administration
Recommended dosage

MOVANTIK (naloxegol) is available in two strengths:

u2022
(3)

MOVANTIK is contraindicated in:

(4n- 5.3
(4n- 7.1)

No data

Opioid withdrawal
Severe abdominal pain and/or diarrhea
Gastrointestinal perforation

Serious and important adverse reactions described elsewhere in labeling include:
The most common adverse reactions in clinical trials (u22653%) are: abdominal pain, diarrhea, nausea, flatulence, vomiting, and headache. n
To report SUSPECTED ADVERSE REACTIONS, contact AstraZeneca at 1-800-236-9933 or FDA at 1-800-FDA-1088 or n

Table 2 displays the effects of other drugs on MOVANTIK.

Moderate CYP3A4 inhibitors (e.g., diltiazem, erythromycin, verapamil)
Strong CYP3A4 inducers (e.g., rifampin)
Other opioid antagonists

No data

Pregnancy
Lactation
Hepatic Impairment

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.

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: (5u03b1,6u03b1)-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.

No data

Carcinogenesis
In a 104-week carcinogenicity study in CD-1 mice, naloxegol was not tumorigenic at oral doses up to 100 mg/kg/day in males and 160 mg/kg/day in females (43 and 27 times the human AUC at the maximum recommended human dose for male and female mice, respectively). In a carcinogenicity study in Sprague-Dawley rats, naloxegol was administered orally at doses of 40, 120, and 400 mg/kg/day for at least 93 weeks. Naloxegol did not cause an increase in tumors in female rats. In male rats, an increase in interstitial (Leydig) cell adenomas in testes was observed at 400 mg/kg/day (818 times the human AUC at the maximum recommended human dose). The no observed effect level for increased tumor incidence was 120 mg/kg/day in male and 400 mg/kg/day in female rats (246 and 1030 times the human AUC at the maximum recommended human dose for male and female rats, respectively). The Leydig cell neoplasms in rats are considered to be unlikely relevant to humans.
Mutagenesis
Naloxegol was not genotoxic in the bacterial reverse mutation (Ames) assay, mouse lymphoma TK mutation assay, or the mouse micronucleus assay.
Impairment of Fertility
Naloxegol was found to have no effect on fertility or reproductive performance in male and female rats at oral doses up to 1000 mg/kg/day (greater than 1000 times the human AUC at the maximum recommended human dose).

The safety and efficacy of MOVANTIK were evaluated in two replicate, randomized, double-blind placebo-controlled trials (Study 1 and Study 2) in patients with opioid-induced constipation (OIC) and non-cancer related pain.
Patients receiving an opioid morphine equivalent daily dose of between 30 mg and 1,000 mg for at least four weeks before enrollment and self-reported OIC were eligible to participate. OIC was confirmed through a two-week run-in period and was defined as <3 spontaneous bowel movements (SBMs) per week on average with at least 25% of the SBMs associated with one or more of the following conditions: (1) straining, (2) hard or lumpy stools; and (3) having a sensation of incomplete evacuation. An SBM was defined as a bowel movement (BM) without rescue laxative taken within the past 24 hours. Patients with 0 BMs over the two-week run-in period or patients with an uneven distribution of SBMs across the two-week run-in period (0 SBMs in one week with u22654 SBMs in the other week) were excluded. Throughout the studies (including the two-week run-in period), patients were prohibited from using laxatives other than bisacodyl rescue laxative (if they had not had a BM for 72 hours) and one-time use of an enema (if after 3 doses of bisacodyl, they still did not have a BM).
Patients suspected of having clinically important disruptions to the blood-brain barrier were not enrolled in these studies.
A total of 652 patients in Study 1 and 700 patients in Study 2 were randomized in a 1:1:1 ratio to receive 12.5 mg or 25 mg of MOVANTIK or placebo once daily for 12 weeks.
The mean age of the subjects in these two studies was 52 years, 10% and 13% were 65 years of age or older, 61% and 63% were women, and 78% and 80% were White in Studies 1 and 2, respectively.
Back pain was the most common reason for pain (56% and 57%); arthritis (10% and 10%) and joint pain (3% and 5%) were other prominent reasons in Studies 1 and 2, respectively. Prior to enrollment, patients had been using their current opioid for an average of 3.6 and 3.7 years. The patients who participated in Studies 1 and 2 were taking a wide range of opioids. The mean baseline opioid morphine equivalent daily dosage was 140 mg and 136 mg per day.
Use of one or more laxatives on at least one occasion within the two weeks prior to enrollment was reported by 71% of patients in both Studies 1 and 2.
The primary endpoint was response defined as: u22653 SBMs per week and a change from baseline of u22651 SBM per week for at least 9 out of the 12 study weeks and 3 out of the last 4 weeks.
There was a statistically significant difference for the 25 mg MOVANTIK treatment group versus placebo for the primary endpoint in Study 1 and Study 2 (see Table 3). Statistical significance for the 12.5 mg treatment group versus placebo was observed in Study 1 but not in Study 2 (see Table 3).
One secondary endpoint in Study 1 and Study 2 was response in laxative users with OIC symptoms. This subgroup comprised 55% and 53% of total patients in these two studies, respectively. These patients (identified using an investigator-administered questionnaire), prior to enrollment, had reported using laxative(s) at least 4 out of the past 14 days with at least one of the following OIC symptoms of moderate, severe, or very severe intensity: incomplete bowel movements, hard stool, straining, or sensation of needing to pass a bowel movement but unable to do so. In this subgroup, in Studies 1 and 2, 42% and 50% reported using laxatives on a daily basis. The most frequently reported laxatives used on a daily basis were stool softeners (18% and 24%), stimulants (16% and 18%), and polyethylene glycol (6% and 5%). Use of two laxative classes was reported in 31% and 27% anytime during the 14 days prior to enrollment. The most commonly reported combination was stimulants and stool softeners (10% and 8%). In Study 1, a statistically significantly higher percentage of patients in this subgroup responded with MOVANTIK 12.5 mg compared to placebo (43% vs. 29%; p=0.03) and with MOVANTIK 25 mg compared to placebo (49% vs. 29%; p=0.002). In Study 2, a statistically significantly higher percentage of patients in this subgroup responded with MOVANTIK 25 mg compared to placebo (47% vs. 31%; p=0.01). This secondary endpoint was not tested for MOVANTIK 12.5 mg versus placebo in Study 2 because the primary endpoint was not statistically significant.
Another secondary endpoint was time to first post-dose SBM. The time to first post-dose SBM was significantly shorter with MOVANTIK 25 mg compared to placebo in both Study 1 (p <0.001) and Study 2 (p <0.001), and for MOVANTIK 12.5 mg as compared to placebo in Study 1 (p <0.001). For Study 1, the median times to first post-dose SBM were 6, 20, and 36 hours with MOVANTIK 25 mg, MOVANTIK 12.5 mg, and placebo, respectively. For Study 2, the median times to first post-dose SBM were 12 and 37 hours with MOVANTIK 25 mg and placebo, respectively. These analyses do not include the results for MOVANTIK 12.5 mg versus placebo in Study 2 because the primary endpoint was not statistically significant. In the two studies, 61-70% and 58% of patients receiving MOVANTIK 25 mg and MOVANTIK 12.5 mg, respectively, had an SBM within 24 hours of the first dose.
A third secondary endpoint was an evaluation of change from baseline between the treatment groups for mean number of days per week with at least 1 SBM but no more than 3 SBMs. There was a significant difference in number of days per week with 1 to 3 SBMs per day on average over 12 weeks between MOVANTIK 25 mg (Study 1 and Study 2) and MOVANTIK 12.5 mg (Study 1) and placebo.

MOVANTIK (naloxegol) tablets are supplied as:
Storage
Store MOVANTIK at 20-25u00b0C (68-77u00b0F). Excursions permitted to 15-30u00b0C (59-86u00b0F) [see USP Controlled Room Temperature].

Advise the patient to read the FDA-approved patient labeling (Medication Guide).
Administration
Advise patients to:
If patients are unable to swallow the MOVANTIK tablet whole
Drug Interactions
Advise patients to tell their healthcare provider when they start or stop taking any concomitant medications. Strong CYP3A4 inhibitors (e.g., clarithromycin, ketoconazole) are contraindicated with MOVANTIK, and other CYP3A4 enzyme modulating drugs can alter MOVANTIK exposure n .
Opioid Withdrawal
Advise patients that clusters of symptoms consistent with opioid withdrawal may occur while taking MOVANTIK, including sweating, chills, diarrhea, abdominal pain, anxiety, irritability, and yawning. Inform patients taking methadone as therapy for their pain condition that they may be more likely to have gastrointestinal adverse reactions such as abdominal pain and diarrhea that may be related to opioid withdrawal, than patients receiving other opioids n n
Severe Abdominal Pain and/or Diarrhea
Advise patients that symptoms may occur after starting treatment. The patient should discontinue MOVANTIK and contact their healthcare provider if they develop severe abdominal pain and/or diarrhea n .
Gastrointestinal Perforation
Advise patients to discontinue MOVANTIK and promptly seek medical attention if they develop unusually severe, persistent or worsening abdominal pain n .
Pregnancy
Advise females of reproductive potential, who become pregnant or are planning to become pregnant that the use of MOVANTIK during pregnancy may precipitate opioid withdrawal in the pregnant women and the fetus .
Lactation
Advise females that breastfeeding is not recommended during treatment with MOVANTIK n n .
MOVANTIK is a registered trademark of the AstraZeneca group of companies.
Distributed by: AstraZeneca Pharmaceuticals LP, Wilmington, DE 19850
u00a9 AstraZeneca 2020

This Medication Guide has been approved by the U.S. Food and Drug Administration.u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0Revised: 04/2020

NDC 0310-1969-30u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0n
movantikn
(naloxegol) Tablets
12.5 mg*
*Each tablet contains 14.2 mg
naloxegol oxalate
Dispense the accompanying
Medication Guide to each patient.
Rx only
AstraZeneca

NDC 0310-1970-30u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0n
movantikn
(naloxegol) Tablets
25 mg*
*Each tablet contains 28.5 mg
naloxegol oxalate
Dispense the accompanying
Medication Guide to each patient.
Rx only
AstraZeneca

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Naloxegol Oxalate (Movantik)

Trade Name : MOVANTIK

TABLET, FILM COATED

Delivery Process

Product information is meant for

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

Packaging and Delivery

About GNH

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Naloxegol Oxalate (Movantik)

Trade Name : MOVANTIK

TABLET, FILM COATED

Delivery Process

Product information is meant for

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

Packaging and Delivery

About GNH

Similar Products

Desogestrel And Ethinyl Estradiol (Emoquette)

Diphenoxylate Hydrochloride And Atropine Sulfate (Diphenoxylate Hydrochloride And Atropine Sulfate)

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Metoprolol Succinate (Metoprolol Succinate)

Losartan Potassium (Losartan Potassium)

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NZ Drugs

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