Naldemedine

Naldemedine Brand Name– SYMPROIC

What is Naldemedine

Naldemedine is an opioid antagonist indicated for the treatment of opioid-induced constipation (OIC) in adult patients with chronic non-cancer pain.

Naldemedine has been shown to be efficacious in patients who have taken opioids for at least 4 weeks.

At recommended doses, naldemedine functions peripherally in GI tissues with limited CNS penetration. 

Naldemedine was approved by the FDA in March 2017.

Indications

  • opiate agonist-induced constipation

For the treatment of opiate agonist-induced constipation 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

Side Effects

  1. abdominal pain
  2. agitation
  3. anxiety
  4. bronchospasm
  5. chills
  6. diarrhea
  7. fever
  8. flushing
  9. GI perforation
  10. hyperhidrosis
  11. irritability
  12. lacrimation
  13. nausea
  14. rash
  15. rhinorrhea
  16. sinus tachycardia
  17. sneezing
  18. tremor
  19. vomiting
  20. yawning

Monitoring Parameters

  • laboratory monitoring not necessary

Contraindications

  • abdominal pain
  • acute opioid withdrawal
  • breast-feeding
  • cholelithiasis
  • Crohn’s disease
  • diarrhea
  • diverticulitis
  • fecal impaction
  • gastric cancer
  • GI disease
  • GI obstruction
  • GI perforation
  • hepatic disease
  • inflammatory bowel disease
  • peptic ulcer disease
  • pregnancy

Interactions

  • Alvimopan
  • Amiodarone
  • Amoxicillin; Clarithromycin; Lansoprazole
  • Amoxicillin; Clarithromycin; Omeprazole
  • Apalutamide
  • Aprepitant, Fosaprepitant
  • Atazanavir
  • Atazanavir; Cobicistat
  • Atropine; Hyoscyamine; Phenobarbital; Scopolamine
  • Belladonna Alkaloids; Ergotamine; Phenobarbital
  • Brigatinib
  • Buprenorphine; Naloxone
  • Bupropion; Naltrexone
  • Cabozantinib
  • Capmatinib
  • Carbamazepine
  • Ceritinib
  • Chloramphenicol
  • Ciprofloxacin
  • Clarithromycin
  • Cobicistat
  • Crizotinib
  • Cyclosporine
  • Daclatasvir
  • Danazol
  • Darunavir
  • Darunavir; Cobicistat
  • Darunavir; Cobicistat; Emtricitabine; Tenofovir alafenamide
  • Dasabuvir; Ombitasvir; Paritaprevir; Ritonavir
  • Delavirdine
  • Diltiazem
  • Dronedarone
  • Duvelisib
  • Eliglustat
  • Elvitegravir; Cobicistat; Emtricitabine; Tenofovir Alafenamide
  • Elvitegravir; Cobicistat; Emtricitabine; Tenofovir Disoproxil Fumarate
  • Enzalutamide
  • Erythromycin
  • Erythromycin; Sulfisoxazole
  • Ethotoin
  • Fedratinib
  • Fluconazole
  • Fluvoxamine
  • Fosamprenavir
  • Fosphenytoin
  • Fostamatinib
  • Glecaprevir; Pibrentasvir
  • grapefruit juice
  • Hydantoins
  • Idelalisib
  • Indinavir
  • Isavuconazonium
  • Isoniazid, INH; Pyrazinamide, PZA; Rifampin
  • Isoniazid, INH; Rifampin
  • Istradefylline
  • Itraconazole
  • Ketoconazole
  • Lapatinib
  • Lefamulin
  • Letermovir
  • Lomitapide
  • Lopinavir; Ritonavir
  • Lumacaftor; Ivacaftor
  • Lumacaftor; Ivacaftor
  • Mefloquine
  • Methylnaltrexone
  • Mitotane
  • Nalmefene
  • Naloxone
  • Naltrexone
  • Nefazodone
  • Nelfinavir
  • Netupitant, Fosnetupitant; Palonosetron
  • Nicardipine
  • Nilotinib
  • Ombitasvir; Paritaprevir; Ritonavir
  • Opiate Antagonists
  • Osimertinib
  • Pentazocine; Naloxone
  • Phenobarbital
  • Phenytoin
  • Posaconazole
  • Primidone
  • Quinine
  • Ranolazine
  • Ribociclib
  • Ribociclib; Letrozole
  • Rifampin
  • Ritonavir
  • Sapropterin
  • Saquinavir
  • Simeprevir
  • Sofosbuvir; Velpatasvir
  • Sofosbuvir; Velpatasvir; Voxilaprevir
  • Sorafenib
  • St. John’s Wort, Hypericum perforatum
  • Temsirolimus
  • Tipranavir
  • Trandolapril; Verapamil
  • Tucatinib
  • Verapamil
  • Voriconazole
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