Drug Detail:Naldemedine (Naldemedine [ nal-dem-e-deen ])
Drug Class: Peripheral opioid receptor antagonists
Usual Adult Dose for Constipation - Drug Induced
0.2 mg orally once a day
Comments:
- Opioid analgesic doses do not require adjustments when starting this drug.
- Treatment should be discontinued if opioid pain medication is discontinued.
Use: Treatment of opioid-induced constipation (OIC) in patients with chronic, non-cancer pain, including patients with chronic pain related to prior cancer or its treatment who do not require frequent (e.g., weekly) opioid dosage escalation
Renal Dose Adjustments
Data not available
Liver Dose Adjustments
Mild and moderate liver dysfunction (Child-Pugh class A and B): No adjustment recommended.
Severe liver dysfunction (Child-Pugh class C): Not recommended.
Dose Adjustments
Suspicion of obstruction/perforation in patients with severe, persistent, and/or worsening abdominal pain: This drug should be discontinued.
Precautions
CONTRAINDICATIONS:
- Hypersensitivity to the active component or to any of the ingredients
- Patients at risk of recurrent obstruction
- Patients with known/suspected gastrointestinal obstruction
Safety and efficacy have not been established in pediatric patients.
Consult WARNINGS section for additional precautions.
Dialysis
Data not available
Other Comments
Administration advice:
- This drug may be taken without regard to meals; however, the dose should be taken at the same time each day.
Storage requirements:
- Protect from light and moisture.
General:
- Patients receiving opioids for less than 4 weeks prior to starting this drug may be less responsive.
- Changes to opioid analgesics are not required prior to starting this drug.
- This drug should be discontinued if treatment with the opioid pain medication is discontinued.
Monitoring:
- GASTROINTESTINAL: Abdominal pain
- OTHER: Opioid withdrawal signs/symptoms
Patient advice:
- Patients should be instructed to stop this drug if they stop taking their opioid pain medication.
- Patients should be instructed to promptly stop this drug and seek medical attention if they develop unusually severe, persistent, or worsening abdominal pain.
- Patients should be instructed to contact their healthcare professional if they experience opioid withdrawal symptoms.
- Patients should be instructed to speak with a healthcare professional before taking any new or over-the-counter medications, or herbal supplements, as other medications may affect the way this drug works.
- Advise patients to speak to their healthcare provider if they become pregnant, intend to become pregnant, or are breastfeeding.
Frequently asked questions
- Which drugs cause opioid-induced constipation?
