Movantik

Naloxegol may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• diarrhea
• nausea
• gas
• stomach pain
• vomiting
• headache
• sweating
• chills
• anxiety
• irritability
• yawning

Some side effects can be serious. If you experience this symptom, stop taking naloxegol and call your doctor immediately :

• severe or worsening stomach pain

Naloxegol may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

Keep all appointments with your doctor.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

Oral Administration

Discontinue all maintenance laxative therapy prior to initiating naloxegol

Laxatives can be used PRN if there is suboptimal response to naloxegol after 3 days

Alteration in analgesic dosing regimen prior to initiating is not required

Naloxegol is efficacious in patients who have taken opioids for at least 4 wk; sustained opioid exposure prior to starting may increase sensitivity to naloxegol effects

Take on empty stomach at least 1 hr before first meal of the day or 2 hr after the meal

For patients who are unable to swallow tablet whole, tablet can be crushed and given orally or administered via nasogastric tube

Avoid grapefruit or grapefruit juice during treatment with naloxegol

Discontinue if treatment with opioid pain medication is also discontinued

If unable to swallow tablet whole

• Tablet can be crushed to a powder, mixed with 120 mL of water and drunk immediately; refill the glass with 120 mL of water, stir, and drink contents to assure whole tablet is consumed
• Administer by NG-tube
  • Flush the NG tube with 30 mL of water using a 60 mL syringe
  • Crush the tablet to a powder in a container and mix with ~60 mL of water
  • Draw up the mixture using the 60 mL syringe and administer the syringe contents through the NG tube
  • Add ~60 mL of water to the same container used to prepare the dose
  • Draw up the water using the same 60 mL syringe and use all the water to flush the NG tube and any remaining medicine from the NG tube into the stomach

Grapefruit and grapefruit juice may interact with Movantik and lead to potentially dangerous effects. Discuss the use of grapefruit products with your doctor.

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known if Movantik crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using Movantik.

Naloxegol blocks certain effects of opioid medication. An opioid is sometimes called a narcotic.

Naloxegol reduces constipation caused by opioid (narcotic) pain medicine used to treat severe chronic pain. Naloxegol works by treating constipation without reducing the pain-relieving effects of the narcotic.

Naloxegol is used in people who have been taking narcotic pain medicine for at least 4 weeks, to treat chronic pain that is not caused by cancer.

Naloxegol may also be used for purposes not listed in this medication guide.

Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.

Other drugs may interact with naloxegol, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.

Storage

Oral

20–25°C (may be exposed to 15–30°C).1

• Peripherally acting μ-opiate receptor antagonist; covalent conjugate of naloxone and PEG.1 2 3 5 11

• Blocks μ-opiate receptors in the GI tract, thereby reversing opiate-induced constipating effects (e.g., slowing of GI motility and transit).1 3 5 10

• Conjugation with PEG decreases passive permeability of the drug across the blood-brain barrier and renders naloxegol a substrate for P-gp, which results in increased efflux across the blood-brain barrier.1 2 3 5 10 11 CNS penetration expected to be negligible at recommended dosages, limiting the potential for interference with centrally mediated opiate analgesia.1 5 10 11

• Exhibits antagonist effects at μ- and δ-opiate receptors and weak partial agonist activity at κ-opiate receptors, but has highest affinity for μ-receptors;13 affinity for μ-receptors is approximately 20-fold lower than that of naloxone.13

Naloxegol is used to treat constipation that is caused by opioids (narcotic pain medicines), in adults with long-lasting pain that is not caused by cancer.

This medicine is available only with your doctor's prescription.

Take this medicine exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. To do so may increase the chance of side effects.

This medicine should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.

Take this medicine on an empty stomach at least 1 hour before the first meal of the day or 2 hours after a meal.

Swallow the tablet whole. Do not crush, break, or chew it.

Stop taking other laxatives before starting treatment with naloxegol. Also, stop taking naloxegol if you have stopped taking narcotic pain medicines.

Do not eat grapefruit or drink grapefruit juice while you are using this medicine.

If you have trouble swallowing the tablet, you may crush it and mix it with 120 mL of water and drink it right away. Refill the glass with water, stir, and drink right away to make sure to get full dose of this medicine.

If you have trouble swallowing the tablet, it may also be given through a nasogastric tube: Draw up 30 mL of water into a 60 mL syringe and flush the nasogastric tube. Crush the tablet to a powder and mix it with 60 mL of water in a container. Draw up the mixture using 60 mL syringe and give it through the tube. Add 60 mL of water to the container mixture and use the same 60 mL syringe to flush the tube for any remaining medicine.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (tablets):
  • For constipation caused by opioids:
    • Adults—25 milligrams (mg) once a day in the morning. Your doctor may adjust your dose as needed.
    • Children—The safety and effectiveness of Movantik has not been established in children.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

• Tell all of your health care providers that you take Movantik. This includes your doctors, nurses, pharmacists, and dentists.
• Talk with your doctor before using a laxative with this medicine.
• Avoid grapefruit and grapefruit juice.
• This medicine is only for use in patients who take pain drugs. Tell your doctor if you stop taking your pain drug.
• Signs of opioid withdrawal have happened with Movantik. Call your doctor right away if you have more sweating, chills, loose stools (diarrhea) or stomach pain that is not normal, anxiety, irritability, or yawning.
• If you are taking methadone for pain, talk with your doctor. Stomach problems like loose stools (diarrhea) and stomach pain may happen more often in people taking methadone with this medicine than in people taking other pain drugs.
• This medicine may not work as well for people who have been taking pain drugs for less than 4 weeks.
• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using Movantik while you are pregnant.
• If this medicine is used during pregnancy, it may cause withdrawal in the unborn baby. A doctor will need to check on the unborn baby after Movantik (naloxegol) is used.

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

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 C34H53NO11.C2H2O4 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.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Movantik can interact with other medications, vitamins, or herbs you may be taking. An interaction is when a substance changes the way a drug works. This can be harmful or prevent the drug from working well.

To help avoid interactions, your doctor should manage all of your medications carefully. Be sure to tell your doctor about all medications, vitamins, or herbs you’re taking. To find out how this drug might interact with something else you’re taking, talk to your doctor or pharmacist.

Food interactions

You shouldn’t eat grapefruit or drink grapefruit juice during your treatment with this drug. Doing so can increase the levels of Movantik in your blood. This raises your risk of side effects.

Medications that might interact with this drug

Don’t take these drugs with Movantik. When used with Movantik, these drugs can cause dangerous effects in the body. Examples of these drugs include:

• Opioid antagonists, such as naloxone, naltrexone, and buprenorphine. Taking these drugs with Movantik increases your risk of opioid withdrawal.

Increased side effects from Movantik: Taking Movantik with certain medications raises your risk of side effects from Movantik. This is because the amount of Movantik in your body is increased. Examples of these drugs include:

• Erythromycin, clarithromycin, diltiazem, verapamil, ketoconazole, itraconazole, posaconazole, voriconazole, ritonavir, and indinavir. Taking these drugs with Movantik increases your risk of opioid withdrawal. Your doctor may reduce your dose of Movantik and watch you closely if you take these drugs together.

When Movantik is less effective: When Movantik is used with certain drugs, it may not work as well to treat your condition. This is because the amount of Movantik in your body may be decreased. Examples of these drugs include:

• Rifampin, carbamazepine, and St. John’s wort. Your doctor may switch you to another drug if you’re taking one of these medications.

People with stomach or intestinal wall disease

This drug can increase your risk of a tear in your stomach or intestinal wall if you have certain conditions. These conditions include Crohn’s disease, peptic ulcer disease, Ogilvie’s syndrome, diverticular disease, infiltrative gastrointestinal tract malignancies, or peritoneal metastases. If you have severe stomach pain or pain that gets worse or doesn’t go away, stop taking this drug and call your doctor.

People with kidney disease

If you have kidney problems or a history of kidney disease, you may not be able to clear this drug from your body well. Decreased kidney function may increase the levels of this drug in your body. This can cause more side effects. If your kidney problems are moderate or severe, your doctor may start you on a lower dose.

Pregnant women

This drug is a category C pregnancy drug. That means two things:

1. Research in animals has shown adverse effects to the fetus when the mother takes the drug.
2. There haven’t been enough studies done in humans to be certain how the drug might affect the fetus.

Talk to your doctor if you’re pregnant or planning to become pregnant. This drug should only be used if the potential benefit justifies the potential risk to the fetus.

Women who are breast-feeding

It isn’t known if this drug passes into breast milk. If it does, it may cause side effects in a child who is breastfed.

Talk to your doctor if you breastfeed your child. You may need to decide whether to stop breastfeeding or stop taking this medication.

For seniors

The kidneys of older adults may not work as well as they used to. This can cause your body to process drugs more slowly. As a result, more of a drug stays in your body for a longer time. This raises your risk of side effects.

For children

This drug hasn’t been studied in children. It shouldn’t be used in people younger than 18 years.

When to call the doctor

Call your doctor right away if you become pregnant while taking this drug.

Tell your doctor if you stop taking your opioid pain medication. If you stop taking your pain drug, you should also stop taking naloxegol.

Allergies

This drug can cause a severe allergic reaction. Symptoms can include:

• trouble breathing
• swelling of your throat or tongue 

If you have an allergic reaction, call your doctor or local poison control center right away. If your symptoms are severe, call 9-1-1 or go to the nearest emergency room.

Don’t take this drug again if you’ve ever had an allergic reaction to it. Taking it again could be fatal (cause death).

All possible dosages and drug forms may not be included here. Your dosage, drug form, and how often you take the drug will depend on:

• your age
• the condition being treated
• how severe your condition is
• other medical conditions you have
• how you react to the first dose

What are you taking this medication for?

Brand: Movantik

• Typical starting dose: 25 mg taken once per day in the morning
• Dose adjustment: If you can’t tolerate this drug, your doctor may decrease your dose to 12.5 mg per day.

This drug hasn’t been studied in children. It shouldn’t be used in people younger than 18 years.

The kidneys of older adults may not work as well as they used to. This can cause your body to process drugs more slowly. As a result, more of a drug stays in your body for a longer time. This raises your risk of side effects.

Your doctor may start you on a lowered dose or a different dosing schedule. This can help keep levels of this drug from building up too much in your body.

People with kidney disease: Your doctor may start you on 12.5 mg taken once per day. If you can tolerate this dose, but your symptoms continue, your doctor may increase your dose to 25 mg taken once per day.

People taking diltiazem, erythromycin, verapamil, or similar drugs: If you need to take one of these drugs at the same time as Movantik, your doctor will lower your dose to 12.5 mg taken once per day. Your doctor will watch you closely to see if you have any side effects.

Warnings

You should stop taking laxatives (drugs used to loosen stools and increase bowel movements) before you start taking this drug. You can use laxatives after you’ve been using Movantik for 3 days if you still have constipation.

If you’ve been using opioids for a long time, you may be more sensitive to the effects of this drug. If you stop taking your opioid pain drug, you should also stop taking Movantik.

You should take this drug on an empty stomach

Take this drug one time per day, in the morning

Don't cut or crush the tablet

Store this drug carefully

A prescription for this medication is refillable

Travel

Not every pharmacy stocks this drug. When filling your prescription, be sure to call ahead.

Insurance

Are there any alternatives?