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Pharmacist resources

You may be the first to know when adult patients with chronic non-cancer pain experience OIC

 

Getting Started with MOVANTIK

Dosage1

  • The recommended dose of MOVANTIK is 25 mg once daily in the morning
  • Reduce the dosage to 12.5 mg once daily for patients who are not able to tolerate the 25-mg dose
  • The starting dosage for patients with creatinine clearance (CLcr) <60 mL/min (ie, patients with moderate, severe, or end-stage renal impairment) is 12.5 mg once daily. If this dosage is well tolerated but OIC symptoms continue, the dosage may be increased to 25 mg once daily taking into consideration the potential for markedly increased exposures in some patients with renal impairment and the increased risk of adverse reactions with higher exposures
  • Avoid concomitant use of MOVANTIK with moderate CYP3A4 inhibitor drugs (eg, diltiazem, erythromycin, verapamil). If concurrent use is unavoidable, reduce the MOVANTIK dosage to 12.5 mg once daily and monitor for adverse reactions
 

Administration1

  • Discontinue all maintenance laxative therapy prior to initiation of MOVANTIK. Laxative(s) can be used as needed if there is a suboptimal response to MOVANTIK after three days
  • Alteration in analgesic dosing regimen prior to initiating MOVANTIK is not required
  • Patients receiving opioids for less than 4 weeks may be less responsive to MOVANTIK
  • Take MOVANTIK on an empty stomach at least 1 hour prior to the first meal of the day or 2 hours after the meal
  • For patients who are unable to swallow the MOVANTIK tablet whole, the tablet can be crushed to a powder, mixed with 4 ounces (120 mL) of water and drunk immediately. The glass should be refilled with 4 ounces (120 mL) of water, stirred and the contents drunk
  • MOVANTIK can also be administered via a nasogastric (NG) tube, please see the Prescribing Information for full details
  • Avoid consumption of grapefruit or grapefruit juice during treatment with MOVANTIK
  • Discontinue MOVANTIK if treatment with the opioid pain medication is also discontinued
 

MOVANTIK Adverse Reactions1

The safety of MOVANTIK was investigated in 1497 patients across four clinical studies.

The safety and efficacy of MOVANTIK was evaluated in two 12-week, replicate, randomized, double-blind, placebo-controlled trials (KODIAC-04 and KODIAC-05) in patients with opioid-induced constipation (OIC) and non-cancer related pain (n=1352). In KODIAC-04 and KODIAC-05, the most common adverse reactions (≥3%) for MOVANTIK 25 mg vs placebo were: abdominal pain (21% vs 7%), diarrhea (9% vs 5%), nausea (8% vs 5%), flatulence (6% vs 3%), vomiting (5% vs 4%), headache (4% vs 3%), and hyperhidrosis (3% vs <1%).

Results from two safety and tolerability trials (one 12-week extension study, KODIAC-07 [n=302], and a 52-week, open-label safety and tolerability study of MOVANTIK vs usual care treatment, KODIAC-08 [n=844]) were similar to the KODIAC-04 and KODIAC-05 trials.

The majority of commercially covered patients* nationwide now have unrestricted access to MOVANTIK2

  • The MOVANTIK Pharmacy savings card enables eligible commercially covered patients* to obtain MOVANTIK for as little as $0 per month, a cost less than OTC laxatives‡§

MOVANTIK Savings Card

FULL ELIGIBILITY AND USE INFORMATION  
 

*Subject to eligibility. Restrictions apply.

* “Patients” means covered lives (Commercial, Commercial [BCBS], Employer, Municipal Plan, PBM, Union) at Tiers 1-7 in the region, as calculated by Fingertip Formulary® as of February 10, 2015.

“Unrestricted access” is defined as unrestricted coverage with the absence of prior authorization, step edits/therapy, quantity/supply limitations, or other restrictions in a specific plan, geographic region, or population.

OTC laxatives include Colace®, Dulcolax®, ex-lax®, MiraLAX®, Peri-Colace®,  Senokot®, and Senokot-S®.3

§Pricing comparisons do not imply comparable efficacy, safety, or FDA-approved indications.

IMPORTANT SAFETY INFORMATION ABOUT MOVANTIK

  • MOVANTIK® (naloxegol) is contraindicated in:
    • Patients with known or suspected gastrointestinal (GI) obstruction and patients at increased risk of recurrent obstruction, due to the potential for GI perforation
    • Patients receiving strong CYP3A4 inhibitors (eg, clarithromycin, ketoconazole) because these medications can significantly increase exposure to naloxegol which may precipitate opioid withdrawal symptoms
    • Patients with a known serious or severe hypersensitivity reaction to MOVANTIK or any of its excipients
  • Symptoms consistent with opioid withdrawal, including hyperhidrosis, chills, diarrhea, abdominal pain, anxiety, irritability, and yawning, occurred in patients treated with MOVANTIK. Patients receiving methadone as therapy for their pain condition were observed in the clinical trials to have a higher frequency of GI adverse reactions that may have been related to opioid withdrawal than patients receiving other opioids. Patients with disruptions to the blood-brain barrier may be at increased risk for opioid withdrawal or reduced analgesia. These patients (eg, multiple sclerosis, recent brain injury, Alzheimer’s disease, and uncontrolled epilepsy) were not enrolled in the clinical studies. Take into account the overall risk-benefit profile when using MOVANTIK in such patients. Monitor for symptoms of opioid withdrawal when using MOVANTIK in such patients
  • Severe abdominal pain and/or diarrhea have been reported, generally within a few days of initiation of MOVANTIK. Monitor and discontinue if severe symptoms occur. Consider restarting MOVANTIK at 12.5 mg once daily
  • Cases of GI perforation have been reported with the use of another peripherally acting opioid antagonist in patients with conditions that may be associated with localized or diffuse reduction of structural integrity in the wall of the GI tract. Monitor for severe, persistent, or worsening abdominal pain; discontinue if this symptom develops
  • Avoid concomitant use of moderate CYP3A4 inhibitors (eg, diltiazem, erythromycin, verapamil) because they may increase the risk of adverse reactions. Use of strong CYP3A4 inducers (eg, rifampin, carbamazepine, St. John’s Wort) is not recommended because they may decrease the efficacy of MOVANTIK. Avoid concomitant use of MOVANTIK with another opioid antagonist due to the increased risk of opioid withdrawal
  • The use of MOVANTIK during pregnancy may precipitate opioid withdrawal in a fetus due to the immature fetal blood-brain barrier. MOVANTIK should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Due to the potential for serious adverse reactions, including opioid withdrawal, in nursing infants, a decision should be made to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother
  • The most common adverse reactions with MOVANTIK as compared to placebo in clinical trials were: abdominal pain (21% vs 7%), diarrhea (9% vs 5%), nausea (8% vs 5%), flatulence (6% vs 3%), vomiting (5% vs 4%), headache (4% vs 3%), and hyperhidrosis (3% vs <1%)

INDICATION

MOVANTIK is indicated for the treatment of opioid-induced constipation (OIC) in adult patients with chronic non-cancer pain.

Please click here for full Prescribing Information and Medication Guide.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.FDA.gov/medwatch or call 1‑800‑FDA‑1088.

References: 1. Prescribing Information for MOVANTIK. AstraZeneca Pharmaceuticals LP, Wilmington, DE. 2. Fingertip Formulary®. 02/10/2015. 3. Data on file, 3103900. AstraZeneca Pharmaceuticals, LP.

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Full Eligibility Language for MOVANTIK Savings Card Offer:

ELIGIBILITY:

You may be eligible for this offer if you are insured by commercial insurance and your insurance does not cover the full cost of your prescription, or you are not insured and are responsible for the cost of your prescriptions.

Patients who are enrolled in a state or federally funded prescription insurance program are not eligible for this offer. This includes patients enrolled in Medicare Part D, Medicaid, Medigap, Veterans Affairs (VA), Department of Defense (DOD) programs or TriCare, and patients who are Medicare eligible and enrolled in an employer-sponsored group waiver health plan or government-subsidized prescription drug benefit program for retirees.

If you are enrolled in a state or federally funded prescription insurance program, you may not use this Savings Card even if you elect to be processed as an uninsured (cash-paying) patient.

This offer is not insurance and is restricted to residents of the United States and Puerto Rico and patients over 18 years of age. This offer is valid for retail prescriptions only.

TERMS OF USE:

Eligible commercially insured patients with a valid prescription for MOVANTIK® (naloxegol) Tablets who present this Savings Card at participating pharmacies will pay $0 per 30-day supply, subject to a maximum savings of $100 per 30-day supply. Cash-paying patients will receive up to $100 in savings on out-of-pocket costs that exceed $0 per 30-day supply. This offer is good for 12 uses and each 30-day supply counts as 1 use. Other restrictions may apply. Patient is responsible for applicable taxes, if any. If you have any questions regarding this offer, please call 1-844-327-1955. Offer expires 12/31/2018.

Non-transferable, limited to one per person, cannot be combined with any other offer. Void where prohibited by law, taxed, or restricted. Patients, pharmacists, and prescribers cannot seek reimbursement from health insurance or any third party for any part of the benefit received by the patient through this offer. AstraZeneca reserves the right to rescind, revoke, or amend this offer, eligibility, and terms of use at any time without notice. This offer is not conditioned on any past, present, or future purchase, including refills. Offer must be presented along with a valid prescription for MOVANTIK® (naloxegol) Tablets at the time of purchase. BY USING THIS CARD, YOU AND YOUR PHARMACIST UNDERSTAND AND AGREE TO COMPLY WITH THESE ELIGIBILITY REQUIREMENTS AND TERMS OF USE.

Program managed by PSKW, LLC, on behalf of AstraZeneca.