Generic Name: Naloxegol Brand Name(s): Generics only. No brands available. Avability: Rx Pregnancy Category: C

Uses

What is Naloxegol used for?

Naloxegol is used to treat constipation caused by narcotic (opiate-type) medications in people with ongoing pain that is not caused by cancer. It blocks the effect of narcotics on the gut without blocking the effect on pain. Naloxegol belongs to a class of drugs known as narcotic antagonists.

How should I take Naloxegol?

Take this medication by mouth on an empty stomach at least 1 hour before or 2 hours after a meal, as directed by your doctor, usually once daily in the morning.

If you are unable to swallow this medication whole, you may crush the tablets to a powder, mix in 120 milliliters of water and drink immediately. Refill the glass with another 120 milliliters of water, stir the contents and drink it.

If you are giving this medication through a tube into the stomach (nasogastric tube), ask you health care professional for detailed instructions on how to properly mix and give it.

The dosage is based on your medical condition, response to treatment, and other medications you may be taking. Be sure to tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Use this medication regularly to get the most benefit from it. To help you remember, take it at the same time each day.

Do not increase your dose or use this drug more often or for longer than prescribed. Your condition will not improve any faster, and your risk of side effects will increase.

Naloxegol is used only for constipation caused by narcotics. Stop using this medication when you stop taking narcotic pain medication unless otherwise directed by your doctor.

Stop taking other laxatives before you start treatment with naloxegol. Your doctor may direct you to take other laxatives if your condition does not improve after 3 days of treatment with naloxegol. Ask your doctor for more details and follow your doctor’s instructions carefully.

Tell your doctor if your constipation persists or worsens.

How do I store Naloxegol?

Naloxegol is best stored at room temperature away from direct light and moisture. To prevent drug damage, you should not store Naloxegol in the bathroom or the freezer. There may be different brands of Naloxegol that may have different storage needs. It is important to always check the product package for instructions on storage, or ask your pharmacist. For safety, you should keep all medicines away from children and pets.

You should not flush Naloxegol down the toilet or pour them into a drain unless instructed to do so. It is important to properly discard this product when it is expired or no longer needed. Consult your pharmacist for more details about how to safely discard your product.

Precautions & warnings

What should I know before using Naloxegol?

Before taking naloxegol, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: stomach/intestinal blockage, stomach/intestinal ulcers or tumors, bowel disease (such as Crohn’s, diverticulitis), kidney disease.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

During pregnancy, naloxegol should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is unknown if this medication passes into breast milk. Consult your doctor before breast-feeding.

Is it safe during pregnancy or breast-feeding?

There are no adequate studies in women for determining risk when using this Naloxegol during pregnancy or while breastfeeding. Please always consult with your doctor to weigh the potential benefits and risks before taking Naloxegol. Naloxegol is pregnancy risk category C according to the US Food and Drug Administration (FDA).

FDA pregnancy risk category reference below:

  • A=No risk,
  • B=No risk in some studies,
  • C=There may be some risk,
  • D=Positive evidence of risk,
  • X=Contraindicated,
  • N=Unknown

Side effects

What side effects can occur from Naloxegol?

Pain in the stomach/abdomen, diarrhea, or gas may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Opiate withdrawal symptoms may occur in some people. Tell your doctor right away if any of these withdrawal symptoms occur: sweating, chills, pain in the stomach/abdomen, diarrhea, yawning, mental/mood changes (such as anxiety/irritability).

This drug may rarely cause a serious tear in the stomach or intestinal wall (perforation). If you notice any of the following unlikely but serious side effects, get medical help right away: severe/persistent/worsening pain in the stomach/abdomen, fever, dizziness/fainting, nausea/vomiting.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

Not everyone experiences these side effects. There may be some side effects not listed above. If you have any concerns about a side-effect, please consult your doctor or pharmacist.

Interactions

What drugs may interact with Naloxegol?

Other medications can affect the removal of naloxegol from your body, which may affect how naloxegol works. Examples include azole antifungals (such as ketoconazole, itraconazole), boceprevir, clarithromycin, cobicistat, indinavir, nefazodone, nelfinavir, rifamycins (such as rifampin, rifabutin), ritonavir, tipranavir, among others.

Naloxegol may interact with other drugs that you are currently taking, which can change how your drug works or increase your risk for serious side effects. To avoid any potential drug interactions, you should keep a list of all the drugs you are using (including prescription drugs, nonprescription drugs and herbal products) and share it with your doctor and pharmacist. For your safety, do not start, stop, or change the dosage of any drugs without your doctor’s approval.

Does food or alcohol interact with Naloxegol?

Naloxegol may interact with food or alcohol by altering the way the drug works or increase the risk for serious side effects. Please discuss with your doctor or pharmacist any potential food or alcohol interactions before using this drug.

Avoid eating grapefruit or drinking grapefruit juice while using this medication unless your doctor or pharmacist says you may do so safely. Grapefruit can increase the chance of side effects with this medicine. Ask your doctor or pharmacist for more details.

What health conditions may interact with Naloxegol?

Naloxegol may interact with your health condition. This interaction may worsen your health condition or alter the way the drug works. It is important to always let your doctor and pharmacist know all the health conditions you currently have.

Dosage

The information provided is not a substitute for any medical advice. You should ALWAYS consult with your doctor or pharmacist before using this Naloxegol.

What is the dose of Naloxegol for an adult?

Usual Adult Dose for Constipation – Drug Induced

Opioid-Induced Constipation – Chronic:

Initial dose: 25 mg orally once a day

Maintenance dose: 25 mg orally once a day; dose may be reduced to 12.5 mg orally once a day for patients unable to tolerate higher dose

Comments: Prior to initiation, discontinue all maintenance laxative therapy; laxatives can be used as needed for suboptimal response after 3 days.

Use: For the treatment of opioid-induced constipation in adult patients with chronic non-cancer pain.

Renal Dose Adjustments

-CrCl less than 60 mL/min: Reduce starting dose to 12.5 mg orally once a day; may increase to 25 mg orally once a day as needed for symptoms, if tolerated.

-Use caution in patients with renal impairment as there is a potential for markedly increased exposures in some patients with renal impairment.

Liver Dose Adjustments

Mild or moderate hepatic impairment: No adjustment recommended

Severe hepatic impairment: Avoid use

Dose Adjustments

Dose Adjustments due to Drug Interactions:

-Concomitant use with strong CYP450 3A4 inhibitors is contraindicated.

-Concomitant use with moderate CYP450 3A4 inhibitors should be avoided; if unavoidable, reduce dose of naloxegol to 12.5 mg orally once a day and monitor for adverse reactions.

-Discontinue use of this drug if treatment with the opioid pain medication is discontinued.

Other Comments

Administration advice:

-Take on an empty stomach, 1 hour before the first meal of the day or 2 hours after the meal

-Swallow tablets whole, do not crush or chew

-If unable to swallow tablets whole, may crush to a powder and mix with 4 ounces of water; drink immediately, then rinse glass with an additional 4 ounces of water and drink again.

-Avoid grapefruit (juice and fruit) during treatment

NASOGASTRIC (NG) Administration:

-Flush NG tube with 30 mL of water using a 60 mL syringe

-Crush tablet and mix with 60 mL of water; draw mixture into 60 mL syringe and administer contents through NG tube

-Rinse container used to mix crushed tablet with water with an additional 60 mL of water; use all the water to flush the NG tube.

General:

-If treatment with opioid pain medication is discontinued, this drug should be discontinued.

-In patients with chronic non-cancer pain, all maintenance laxative therapy should be discontinued prior to initiating therapy; laxatives can be used as needed after 3 days.

-This drug has been shown to be efficacious in patients who have taken opioids for at least 4 weeks; sustained exposure to opioids prior to starting this drug may increase the patient’s sensitivity.

Monitoring:

-Monitor for the development of severe, persistent, or worsening abdominal pain

Patient advice:

-If unusually severe, persistent, or worsening abdominal pain develops, promptly seek medical attention.

-If severe or persistent diarrhea occurs, patients should be advised to stop therapy and consult their healthcare provider.

-If symptoms of opioid withdrawal such as sweating, chills, anxiety, irritability, and yawning occur, patients should be instructed to let their healthcare provider know.

-Speak to your physician or health care professional if you become pregnant, intend to become pregnant, or are breastfeeding.

What is the dose of Naloxegol for a child?

The dosage has not been established in pediatric patients. It may be unsafe for your child. It is always important to fully understand the safety of the drug before using. Please consult with your doctor or pharmacist for more information.

How is Naloxegol available?

Naloxegol is available in the following dosage forms and strengths:

  • Oral tablet

What should I do in case of an emergency or overdose?

In case of an emergency or an overdose, call your local emergency services or go to your nearest emergency room.

What should I do if I miss a dose?

If you miss a dose of Naloxegol, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and take your regular dose as scheduled. Do not take a double dose.

 

Hello Health Group does not provide medical advice, diagnosis or treatment.

Sources

Review Date: August 10, 2018 | Last Modified: August 10, 2018

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