Movantik: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

WHAT THE MEDICATION IS USED FOR:

MOVANTIK (naloxegol oxalate) is used to treat constipation that is specifically caused by pain medications, called opioids, taken on a regular basis. It is used in non-cancer pain patients when laxative(s) have not provided acceptable relief of constipation.

Constipation related to opioids can result in symptoms such as:

• stomach pain;
• rectal straining (having to push very hard to move the stool out, which can also cause pain in the anus during pushing);
• hard stools (stools which are hard “like a rock”);
• incomplete emptying of the rectum (after having bowel movement, the feeling as if a stool is still in the rectum which needs to come out).

WHAT IT DOES:

Opioids can slow down the movement of the bowel and cause constipation. MOVANTIK is a peripherally acting opioid receptor antagonist. This means that MOVANTIK blocks the constipating effects of opioids in the bowel without affecting the pain relief provided by the opioid that you are taking. About one-half of patients can expect a bowel movement within 12 hours after taking MOVANTIK for the first time.

WHEN IT SHOULD NOT BE USED:

You should not take MOVANTIK if:

• You are allergic to naloxegol oxalate or other medications in this class or to any of the ingredients of MOVANTIK (see WHAT THE IMPORTANT NONMEDICINAL INGREDIENTS ARE).

  • Your bowels are, or may be, blocked or you have been warned that your bowels are at risk of becoming blocked.
  • You are taking certain other medications such as ketoconazole or voriconazole (to treat fungal infections), clarithromycin (an antibiotic) or ritonavir (for HIV).

WHAT THE MEDICINAL INGREDIENT IS:

Naloxegol (as naloxegol oxalate)

WHAT THE IMPORTANT NONMEDICINAL INGREDIENTS ARE:

MOVANTIK tablets contain the following non-medicinal ingredients: croscarmellose sodium, hypromellose, iron oxide black, iron oxide red, macrogol 400, magnesium stearate, mannitol, microcrystalline cellulose, propyl gallate, titanium dioxide.

WHAT DOSAGE FORMS IT COMES IN:

MOVANTIK comes in 12.5 mg and 25 mg tablet strengths. The 12.5 mg tablets are oval, biconvex, mauve, film-coated, engraved with “12.5” on one side and “nGL” on the other side. The 25 mg tablets are oval, biconvex, mauve, film-coated, engraved with “25” on one side and “nGL” on the other side.

WARNINGS AND PRECAUTIONS

BEFORE you use MOVANTIK, talk to your healthcare professional if:

• You have severe stomach ulcers, Crohn’s Disease or diverticulitis (illness where your gut is inflamed), cancer in your gut or ‘peritoneum’ (the lining of your stomach area), or any condition that might damage the wall of your bowel.
• You currently have severe or persistent stomach pain and/or diarrhea.
• Your blood brain barrier has been damaged, such as after a recent brain injury, or if you have a disease of the central nervous system like multiple sclerosis or Alzheimer’s Disease.
• You experience a lack of pain relief from your opioid medicine or symptoms of opioid withdrawal syndrome;
• You have kidney problems.
• You have severe liver problems (as MOVANTIK use is not recommended).
• You are taking methadone.
• You have had a heart attack within the last 6 months, have had heart failure or other severe problems with your heart.
• You are taking any other medications, including those obtained without a prescription, or natural health products (see INTERACTIONS WITH THIS MEDICATION).

If you are pregnant or planning to become pregnant, MOVANTIK use is not recommended.

If you are breastfeeding or planning to breastfeed, MOVANTIK use is not recommended. Taking MOVANTIK while you are breastfeeding may cause opioid withdrawal in your baby.

If your opioid medication is to be stopped for more than 24 hours while taking MOVANTIK you should talk to your doctor.

If you develop severe or persistent stomach pain and/or diarrhea you should stop taking MOVANTIK and tell your doctor immediately.

INTERACTIONS WITH THIS MEDICATION

Tell your healthcare professional if you are taking, or have recently taken, any other medications, including laxatives. This includes medications obtained without a prescription and herbal medications.

Tell your healthcare professional if you are taking the following medications or remedies that may interact with MOVANTIK:

• Certain medications such as ketoconazole or voriconazole (to treat fungal infections) clarithromycin (an antibiotic) or ritonavir (for HIV);
• Certain medications such as rifampin (an antibiotic), carbamazepine or phenytoin (for epilepsy);
• Certain medications such as diltiazem or verapamil (for high blood pressure or chest pain) or erythromycin (an antibiotic);
• Methadone;
• Herbal remedy St. John’s wort (Hypericum perforatum);
• Grapefruit or grapefruit juice;
• Medications called “opioid antagonists” such as naltrexone and naloxone (used to counteract the effects of opioids).

Know all of the medications you take. Keep a list of them with you to show your healthcare professional.

PROPER USE OF THIS MEDICATION

MOVANTIK is not indicated for use in patients below 18 years of age, as it has not been studied in this age group.

MOVANTIK should be taken in the morning on an empty stomach at least 1 hour before the first meal of the day or 2 hours after. You should not consume grapefruit or grapefruit juice whilst taking MOVANTIK.

Tablets should be swallowed whole with water.

If you have trouble swallowing the tablet whole, you can crush it and mix with water in the following way:

• Crush the tablet to a powder.
• Pour the powder into half of a glass of room temperature non-carbonated water (120 mL or 4 oz).
• Stir and drink immediately.
• To make sure there is no medicine left, rinse the empty glass with another half glass of room temperature non-carbonated water (120 mL or 4 oz) and drink it.

If you cannot swallow MOVANTIK tablets and have a nasogastric (NG) tube, MOVANTIK may be given as follows:

1. 1. Flush the NG tube with 1 ounce (30mL) of water using a 60 mL syringe.
2. 2. Crush the tablet to a powder in a container and mix with approximately 2 ounces (60mL) of water.
3. 3. Draw up the mixture using the 60 mL syringe and administer the syringe contents through the NG tube.
4. 4. Add approximately 2 ounces (60mL) of water to the same container used to prepare the dose of MOVANTIK.

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.

You could have a bowel movement within 12 hours after taking your first dose of MOVANTIK.

USUAL DOSE:

Always take this medication exactly as your healthcare professional had told you. Check with your healthcare professional if you are not sure.

Adults: The recommended dose is 25 mg orally once daily.

When you start taking MOVANTIK, stop using all other laxatives. You can start your laxatives again once your doctor tells you to.

OVERDOSE:

MISSED DOSE:

What you should do if you forget to take a tablet depends on the length of time until your next dose.

• If it is 12 hours or more until your next dose: Take the missed tablet as soon as you remember. Then, take the next dose as normal.
• If it is less than 12 hours until your next dose: Skip the missed dose. Then, take the next dose at the normal time.

Do not take a double dose (two doses at the same time) to make up for a forgotten tablet.

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

Like all medications MOVANTIK can cause side effects, although not everybody gets them.

The following side effects may happen with MOVANTIK:

• Very common (may affect more than 1 in 10 patients): stomach pain, diarrhea (passing of frequent, watery stools).
• Common (may affect more than 1 in 100 but less than 1 in 10 patients): passing wind, nausea, vomiting, runny or stuffy nose, headache, excessive sweating.
• Uncommon (may affect up to 1 in 100 people): opioid withdrawal symptoms (may include nausea, vomiting, diarrhea, excess sweating, muscle aches, increased tearing, insomnia, yawning, goosebumps, runny nose, dilation of the pupil, feeling depressed, fever).
• Not known: hypersensitivity, gastrointestinal perforation.

Stop taking MOVANTIK and tell your doctor immediately if:

• You have severe or persistent stomach pain, as cases of gastrointestinal perforation (a hole in your intestine or stomach) have occurred.

  or

• You have severe diarrhea (watery, bloody or persistent).

Other side effects may occur when using MOVANTIK.

If any of the side effects persist or worsen, or if you notice any side effects not listed in this leaflet, contact your healthcare professional.

HOW TO STORE IT

MOVANTIK should be kept out of the reach and sight of children.

Store your MOVANTIK tablets at room temperature (15-30°C).

The expiry date of this medication is printed on the package label. Do not use the medication after this date.

REPORTING SUSPECTED SIDE EFFECTS

MORE INFORMATION

NOTE: This INFORMATION FOR THE CONSUMER leaflet provides you with the most current information at the time of printing.

The most current information, the Consumer Information Leaflet plus the full Product Monograph, prepared for health professionals can be found at the Health Canada website (http://hc-sc.gc.ca/index-eng.php);

or by contacting the sponsor, Knight Therapeutics Inc. at medinfo@gudknight.com, or by calling 1-844-483-5636.

Knight Therapeutics Inc., Montreal, Quebec, H3Z 3B8

MOVANTIK^® is a registered trademark of AstraZeneca AB, used under license to Knight Therapeutics Inc.

Last revised: December 11, 2019