Movantik 25mg Tablets
It is used to treat constipation caused by some pain drugs.
Drug Class
Opioid-induced constipation (OIC) treatment
Pharmacologic Class
Peripherally acting mu-opioid receptor antagonist (PAMORA)
Pregnancy Category
Not assigned (Risk Summary)
FDA Approved
Sep 2014
DEA Schedule
Not Controlled
Overview
What is this medicine?
Movantik is a medication used to treat constipation caused by opioid pain medicines. It works by blocking the effects of opioids in your gut, helping you have bowel movements more easily, without affecting the pain relief from your opioid medication.
How to Use This Medicine
Taking Your Medication Correctly
To ensure you get the most benefit from your medication, follow these steps:
Take your medication exactly as directed by your doctor.
Read all the information provided with your medication and follow the instructions carefully.
Take your medication on an empty stomach, either at least 1 hour before or 2 hours after your first meal of the day.
If you have difficulty swallowing the medication whole, you can crush it and mix it with 4 ounces (120 mL) of water. To do this:
Crush the medication and mix it with 4 ounces (120 mL) of water.
Drink the mixture immediately.
Refill the glass with 4 ounces (120 mL) of water, stir, and drink to ensure you get the full dose.
If you have a feeding tube, you can still use this medication. Follow the instructions provided by your doctor or healthcare provider, and be sure to flush the feeding tube after administering the medication.
Storing and Disposing of Your Medication
To keep your medication safe and effective:
Store it at room temperature in a dry place, away from the bathroom.
Keep all medications in a secure location, out of the reach of children and pets.
Dispose of any unused or expired medication properly. Do not flush it down the toilet or pour it down the drain unless instructed to do so by your pharmacist or healthcare provider.
Check with your pharmacist to see if there are any drug take-back programs in your area.
What to Do If You Miss a Dose
If you miss a dose of your medication:
Take it as soon as you remember.
If it's close to the time for your next dose, skip the missed dose and return to your regular schedule.
* Do not take two doses at the same time or take extra doses.
To ensure you get the most benefit from your medication, follow these steps:
Take your medication exactly as directed by your doctor.
Read all the information provided with your medication and follow the instructions carefully.
Take your medication on an empty stomach, either at least 1 hour before or 2 hours after your first meal of the day.
If you have difficulty swallowing the medication whole, you can crush it and mix it with 4 ounces (120 mL) of water. To do this:
Crush the medication and mix it with 4 ounces (120 mL) of water.
Drink the mixture immediately.
Refill the glass with 4 ounces (120 mL) of water, stir, and drink to ensure you get the full dose.
If you have a feeding tube, you can still use this medication. Follow the instructions provided by your doctor or healthcare provider, and be sure to flush the feeding tube after administering the medication.
Storing and Disposing of Your Medication
To keep your medication safe and effective:
Store it at room temperature in a dry place, away from the bathroom.
Keep all medications in a secure location, out of the reach of children and pets.
Dispose of any unused or expired medication properly. Do not flush it down the toilet or pour it down the drain unless instructed to do so by your pharmacist or healthcare provider.
Check with your pharmacist to see if there are any drug take-back programs in your area.
What to Do If You Miss a Dose
If you miss a dose of your medication:
Take it as soon as you remember.
If it's close to the time for your next dose, skip the missed dose and return to your regular schedule.
* Do not take two doses at the same time or take extra doses.
Lifestyle & Tips
- Take Movantik on an empty stomach, at least 1 hour before your first meal of the day or 2 hours after your first meal.
- Do not crush, chew, or break the tablet. Swallow it whole.
- If you have trouble swallowing, you can crush the tablet and mix it with 4 ounces (120 mL) of water. Drink immediately. Rinse the glass with 4 ounces (120 mL) of water and drink that as well.
- Maintain adequate hydration and fiber intake as recommended by your healthcare provider.
- Continue to take your opioid pain medication as prescribed.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
25 mg orally once daily
Dose Range:
12.5 - 25 mg
Condition-Specific Dosing:
intolerance:
Reduce to 12.5 mg once daily if 25 mg is not tolerated.
concomitant_moderate_CYP3A4_inhibitors:
Reduce to 12.5 mg once daily.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Not established
Dose Adjustments
Renal Impairment:
Mild:
No dose adjustment needed (CrCl ≥60 mL/min)
Moderate:
No dose adjustment needed (CrCl 30 to <60 mL/min)
Severe:
Reduce to 12.5 mg once daily (CrCl <30 mL/min)
Dialysis:
Not studied in patients with ESRD on dialysis; consider 12.5 mg once daily with caution.
Hepatic Impairment:
Mild:
No dose adjustment needed (Child-Pugh A)
Moderate:
No dose adjustment needed (Child-Pugh B)
Severe:
Reduce to 12.5 mg once daily (Child-Pugh C)
Pharmacology
Mechanism of Action
Naloxegol is a PEGylated derivative of naloxone. It acts as a selective, peripherally acting mu-opioid receptor antagonist. Due to its PEGylation, it has limited ability to cross the blood-brain barrier, thereby antagonizing opioid effects in the gastrointestinal tract (reducing constipation) without reversing central opioid analgesia.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 6%
Tmax:
0.5 to 2 hours
FoodEffect:
Food significantly decreases the rate and extent of absorption (AUC and Cmax reduced by 30-50%). Should be taken on an empty stomach.
Distribution:
Vd:
Approximately 100 L
ProteinBinding:
Approximately 4-6%
CnssPenetration:
Limited
Elimination:
HalfLife:
6 to 11 hours
Clearance:
Not available
ExcretionRoute:
Fecal (approximately 55%), Renal (approximately 16% unchanged)
Unchanged:
Approximately 16% (renal)
Pharmacodynamics
OnsetOfAction:
Within 24-48 hours for first spontaneous bowel movement
PeakEffect:
Not precisely defined for constipation relief, but related to Tmax for systemic exposure.
DurationOfAction:
Once daily dosing suggests 24-hour effect.
Safety & Warnings
Side Effects
Serious Side Effects: Seek Medical Help Immediately
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical attention right away:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Severe stomach pain and diarrhea, which can occur within a few days of starting this medication. These problems may require hospitalization.
Tears in the stomach or bowel wall, which can be life-threatening. If you take bevacizumab or have a history of stomach or bowel problems (such as cancer, recent surgery, diverticulitis, or colitis), inform your doctor. Seek medical help immediately if you experience:
+ Severe stomach pain or swelling that worsens or persists
+ Vomiting blood or coffee ground-like material
+ Persistent upset stomach or vomiting
+ Black, tarry, or bloody stools
Other Possible Side Effects
Most people do not experience significant side effects, but some may occur. If you are bothered by any of the following side effects or if they persist, contact your doctor:
Stomach pain or diarrhea
Gas
Headache
* Upset stomach or vomiting
This is not an exhaustive list of potential side effects. If you have questions or concerns about side effects, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical attention right away:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Severe stomach pain and diarrhea, which can occur within a few days of starting this medication. These problems may require hospitalization.
Tears in the stomach or bowel wall, which can be life-threatening. If you take bevacizumab or have a history of stomach or bowel problems (such as cancer, recent surgery, diverticulitis, or colitis), inform your doctor. Seek medical help immediately if you experience:
+ Severe stomach pain or swelling that worsens or persists
+ Vomiting blood or coffee ground-like material
+ Persistent upset stomach or vomiting
+ Black, tarry, or bloody stools
Other Possible Side Effects
Most people do not experience significant side effects, but some may occur. If you are bothered by any of the following side effects or if they persist, contact your doctor:
Stomach pain or diarrhea
Gas
Headache
* Upset stomach or vomiting
This is not an exhaustive list of potential side effects. If you have questions or concerns about side effects, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Severe, persistent, or worsening abdominal pain (could indicate gastrointestinal perforation)
- Nausea, vomiting, or diarrhea that is severe or persistent
- Symptoms of opioid withdrawal (e.g., sweating, chills, anxiety, irritability, yawning, body aches, runny nose, watery eyes, goosebumps)
- Allergic reaction symptoms (e.g., rash, itching, swelling, severe dizziness, trouble breathing)
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances. Be sure to describe the allergic reaction you experienced.
If you have liver disease, as this may affect how your body processes the medication.
If you have a history of bowel blockage, as this may increase the risk of complications.
Any medications you are currently taking, including prescription and over-the-counter drugs, natural products, and vitamins. Certain medications, such as those used to treat HIV, infections, seizures, and other conditions, may interact with this medication and should be avoided.
If you are taking St. John's wort, as it may reduce the effectiveness of this medication. Do not take St. John's wort while using this drug.
If you are using another medication similar to this one, as this may increase the risk of adverse effects. If you are unsure, consult your doctor or pharmacist.
* If you are breastfeeding, as this medication is not recommended for use during breastfeeding.
This list is not exhaustive, and it is crucial to discuss all your medications, health problems, and concerns with your doctor and pharmacist to ensure safe use. Do not start, stop, or change the dose of any medication without consulting your doctor first.
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances. Be sure to describe the allergic reaction you experienced.
If you have liver disease, as this may affect how your body processes the medication.
If you have a history of bowel blockage, as this may increase the risk of complications.
Any medications you are currently taking, including prescription and over-the-counter drugs, natural products, and vitamins. Certain medications, such as those used to treat HIV, infections, seizures, and other conditions, may interact with this medication and should be avoided.
If you are taking St. John's wort, as it may reduce the effectiveness of this medication. Do not take St. John's wort while using this drug.
If you are using another medication similar to this one, as this may increase the risk of adverse effects. If you are unsure, consult your doctor or pharmacist.
* If you are breastfeeding, as this medication is not recommended for use during breastfeeding.
This list is not exhaustive, and it is crucial to discuss all your medications, health problems, and concerns with your doctor and pharmacist to ensure safe use. Do not start, stop, or change the dose of any medication without consulting your doctor first.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. Before using a laxative, consult with your doctor to discuss potential interactions. Additionally, avoid consuming grapefruit and grapefruit juice while taking this drug.
This medication is specifically designed for patients who are currently taking opioid pain medications. If you stop taking your opioid pain medication, notify your doctor immediately. Be aware that this drug may cause symptoms of opioid withdrawal, such as excessive sweating, chills, diarrhea, stomach pain, anxiety, irritability, or yawning. If you experience any of these symptoms, contact your doctor right away.
If you are taking methadone for pain management, discuss the potential risks with your doctor, as the combination of methadone and this drug may increase the likelihood of stomach problems, including diarrhea and stomach pain, compared to other pain medications.
Note that this medication may be less effective for individuals who have been taking pain medications for less than 4 weeks. If you are pregnant or planning to become pregnant, consult with your doctor to weigh the benefits and risks of using this medication during pregnancy. If this drug is used during pregnancy, it may cause withdrawal symptoms in the unborn baby, and your doctor will need to monitor the baby's health after the medication is administered.
This medication is specifically designed for patients who are currently taking opioid pain medications. If you stop taking your opioid pain medication, notify your doctor immediately. Be aware that this drug may cause symptoms of opioid withdrawal, such as excessive sweating, chills, diarrhea, stomach pain, anxiety, irritability, or yawning. If you experience any of these symptoms, contact your doctor right away.
If you are taking methadone for pain management, discuss the potential risks with your doctor, as the combination of methadone and this drug may increase the likelihood of stomach problems, including diarrhea and stomach pain, compared to other pain medications.
Note that this medication may be less effective for individuals who have been taking pain medications for less than 4 weeks. If you are pregnant or planning to become pregnant, consult with your doctor to weigh the benefits and risks of using this medication during pregnancy. If this drug is used during pregnancy, it may cause withdrawal symptoms in the unborn baby, and your doctor will need to monitor the baby's health after the medication is administered.
Overdose Information
Overdose Symptoms:
- Exaggerated adverse effects (e.g., severe abdominal pain, diarrhea)
- Potential for opioid withdrawal symptoms if blood-brain barrier is compromised or at very high doses.
What to Do:
Seek immediate medical attention or call a poison control center (1-800-222-1222). Treatment is supportive.
Drug Interactions
Contraindicated Interactions
- Strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, clarithromycin, ritonavir, indinavir, saquinavir, telithromycin, nefazodone)
Major Interactions
- Moderate CYP3A4 inhibitors (e.g., diltiazem, erythromycin, verapamil, fluconazole, grapefruit juice): Reduce Movantik dose to 12.5 mg once daily.
- Other opioid antagonists (e.g., naltrexone): May precipitate opioid withdrawal.
Moderate Interactions
- P-glycoprotein (P-gp) inhibitors: May increase naloxegol exposure.
Minor Interactions
- Opioid agonists: May reduce analgesic effect if significant systemic absorption occurs, though unlikely with PAMORA.
Monitoring
Baseline Monitoring
Renal function (CrCl)
Rationale: To determine appropriate starting dose in patients with severe renal impairment.
Timing: Prior to initiation of therapy.
Hepatic function (Child-Pugh score)
Rationale: To determine appropriate starting dose in patients with severe hepatic impairment.
Timing: Prior to initiation of therapy.
Bowel habits and constipation severity
Rationale: To establish baseline for assessing treatment efficacy.
Timing: Prior to initiation of therapy.
Routine Monitoring
Frequency and consistency of bowel movements
Frequency: Daily
Target: Regular, spontaneous bowel movements
Action Threshold: Lack of response after several days, or worsening constipation.
Abdominal pain/discomfort
Frequency: Daily
Target: Minimal to no pain
Action Threshold: Severe or persistent abdominal pain, especially with nausea/vomiting (may indicate GI perforation).
Signs/symptoms of opioid withdrawal
Frequency: Daily, especially early in therapy
Target: Absence of withdrawal symptoms
Action Threshold: Symptoms like sweating, chills, abdominal pain, diarrhea, anxiety, irritability (may indicate blood-brain barrier disruption).
Symptom Monitoring
- Abdominal pain (especially severe or persistent)
- Nausea
- Vomiting
- Diarrhea
- Signs of opioid withdrawal (e.g., sweating, chills, piloerection, abdominal pain, diarrhea, anxiety, irritability, yawning, rhinorrhea, sneezing, myalgia, arthralgia)
Special Patient Groups
Pregnancy
Limited human data on naloxegol use in pregnant women are insufficient to inform a drug-associated risk for major birth defects and miscarriage. Animal studies have shown adverse developmental effects at doses higher than clinical exposure. Use only if the potential benefit justifies the potential risk to the fetus.
Trimester-Specific Risks:
First Trimester:
Limited data, potential for fetal harm based on animal studies at high doses.
Second Trimester:
Limited data, potential for fetal harm based on animal studies at high doses.
Third Trimester:
Limited data. Risk of opioid withdrawal in the neonate if the mother is opioid-dependent and naloxegol crosses the placenta.
Lactation
Naloxegol and its active metabolite are present in human milk. There are no data on the effects of naloxegol on the breastfed infant or on milk production. Monitor breastfed infants for signs of opioid withdrawal (e.g., irritability, vomiting, diarrhea) or decreased analgesia if the mother is taking an opioid. Consider the developmental and health benefits of breastfeeding along with the mother’s clinical need for Movantik and any potential adverse effects on the breastfed infant from Movantik or from the underlying maternal condition.
Infant Risk:
Moderate risk (L3). Potential for opioid withdrawal or decreased analgesia in breastfed infant.
Pediatric Use
Safety and effectiveness in pediatric patients have not been established.
Geriatric Use
No overall differences in safety or effectiveness were observed between elderly patients and younger patients, but greater sensitivity of some older individuals cannot be ruled out. No specific dose adjustment is required based on age alone, but consider age-related decline in renal function.
Clinical Information
Clinical Pearls
- Movantik is specifically for opioid-induced constipation (OIC) and should not be used for other types of constipation.
- Ensure patients are on stable opioid therapy before initiating Movantik.
- Advise patients to discontinue all laxatives prior to starting Movantik, then reintroduce laxatives as needed if response to Movantik is insufficient.
- Patients should be monitored for symptoms of opioid withdrawal, especially if the blood-brain barrier is compromised (e.g., active disruption of the blood-brain barrier, such as in patients with primary brain tumors, CNS metastases, or other inflammatory conditions, or patients receiving radiation therapy to the brain).
- Severe abdominal pain should prompt evaluation for gastrointestinal perforation, especially in patients with underlying GI conditions (e.g., diverticulitis, inflammatory bowel disease, GI malignancy).
Alternative Therapies
- Other peripherally acting mu-opioid receptor antagonists (PAMORAs): Methylnaltrexone (Relistor), Naldemedine (Symproic)
- Chloride channel activators: Lubiprostone (Amitiza)
- Guanylate cyclase-C agonists: Linaclotide (Linzess), Plecanatide (Trulance)
- Serotonin-4 (5-HT4) receptor agonists: Prucalopride (Motegrity)
- Osmotic laxatives (e.g., polyethylene glycol, lactulose)
- Stimulant laxatives (e.g., senna, bisacodyl)
Cost & Coverage
Average Cost:
Typically high, check current pricing per 30 tablets
Insurance Coverage:
Tier 2 or 3 (Specialty/Non-preferred Brand)
General Drug Facts
If your symptoms or health issues persist or worsen, it's essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication.
This medication is accompanied by a Medication Guide, which provides crucial information about its use. Please read this guide carefully and review it again whenever you receive a refill. If you have any questions or concerns about this medication, don't hesitate to consult with your doctor, pharmacist, or other healthcare provider.
In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When reporting the incident, be prepared to provide details about the medication taken, the amount, and the time it occurred.
This medication is accompanied by a Medication Guide, which provides crucial information about its use. Please read this guide carefully and review it again whenever you receive a refill. If you have any questions or concerns about this medication, don't hesitate to consult with your doctor, pharmacist, or other healthcare provider.
In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When reporting the incident, be prepared to provide details about the medication taken, the amount, and the time it occurred.