Viberzi

Drug overview for VIBERZI (eluxadoline):

Generic name: eluxadoline (EL-ux-AD-oh-leen)
Drug class: Irritable Bowel Syndrome Agents
Therapeutic class: Gastrointestinal Therapy Agents

Eluxadoline is a mixed micro-opiate receptor agonist and delta-opiate receptor antagonist; eluxadoline has poor oral bioavailability and is used for its local effects at opiate receptors in the GI tract.

No enhanced Uses information available for this drug.

DRUG IMAGES

VIBERZI 100 MG TABLET
VIBERZI 75 MG TABLET

The following indications for VIBERZI (eluxadoline) have been approved by the FDA:

Indications:
Diarrhea predominant irritable bowel syndrome

Professional Synonyms:
Diarrhea predominant IBS
Diarrhea predominant spastic colon

Dosing information for VIBERZI
DRUG LABEL	DOSING TYPE	DOSING INSTRUCTIONS
VIBERZI 75 MG TABLET	Maintenance	Adults take 1 tablet (75 mg) by oral route 2 times per day
VIBERZI 100 MG TABLET	Maintenance	Adults take 1 tablet (100 mg) by oral route 2 times per day

The following drug interaction information is available for VIBERZI (eluxadoline):

Contraindicated
Severe
Moderate

There are 0 contraindications.

There are 2 severe interactions. These drug interactions can produce serious consequences in most patients. Actions required for severe interactions include, but are not limited to, discontinuing one or both agents, adjusting dosage, altering administration scheduling, and providing additional patient monitoring. Review the full interaction monograph for more information.

Drug Interaction	Drug Names
Eluxadoline/OATP1B1 Inhibitors SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction. MECHANISM OF ACTION: OATP1B1 inhibitors may decrease the hepatic uptake of eluxadoline.(1) CLINICAL EFFECTS: Concurrent use of OATP1B1 inhibitors may result in elevated levels of and side effects from eluxadoline, including constipation, nausea, abdominal pain, and impaired mental and physical abilities.(1) PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: Patients receiving concurrent OATP1B1 inhibitors should receive a dose of eluxadoline of 75 mg twice daily. Monitor patients for impaired mental or physical abilities, abdominal pain, nausea, and constipation.(1) DISCUSSION: Concurrent administration of a single dose (600 mg) of cyclosporine, an OATP1B1 inhibitor, increased the maximum concentration (Cmax) and area-under-curve (AUC) of a single dose of eluxadoline (100 mg) by 4.4-fold and 6.2-fold, respectively.(1) OATP1B1 inhibitors include asciminib, atazanavir, belumosudil, boceprevir, cyclosporine, darunavir, encorafenib, eltrombopag, erythromycin, gemfibrozil, leflunomide, letermovir, lopinavir, paritaprevir, resmetirom, rifampin, ritonavir, roxadustat, saquinavir, simeprevir, telaprevir, teriflunomide, tipranavir, vadadustat, and voclosporin.(1,2)	ALVAIZ, APTIVUS, ARAVA, ATAZANAVIR SULFATE, AUBAGIO, BRAFTOVI, CYCLOSPORINE, CYCLOSPORINE MODIFIED, DARUNAVIR, E.E.S. 200, E.E.S. 400, ELTROMBOPAG OLAMINE, ERY-TAB, ERYPED 200, ERYPED 400, ERYTHROCIN LACTOBIONATE, ERYTHROCIN STEARATE, ERYTHROMYCIN, ERYTHROMYCIN ESTOLATE, ERYTHROMYCIN ETHYLSUCCINATE, ERYTHROMYCIN LACTOBIONATE, EVOTAZ, GEMFIBROZIL, GENGRAF, KALETRA, LEFLUNICLO, LEFLUNOMIDE, LOPID, LOPINAVIR-RITONAVIR, LUPKYNIS, NEORAL, NORVIR, PAXLOVID, PREVYMIS, PREZCOBIX, PREZISTA, PROMACTA, REYATAZ, REZDIFFRA, REZUROCK, RIFADIN, RIFAMPIN, RITONAVIR, SANDIMMUNE, SCEMBLIX, SYMTUZA, TERIFLUNOMIDE, VAFSEO
Eluxadoline/Anticholinergics; Opioids SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction. MECHANISM OF ACTION: Eluxadoline is a mixed mu-opioid and kappa-opioid agonist and delta-opioid antagonist and may alter or slow down gastrointestinal transit.(1) CLINICAL EFFECTS: Constipation related adverse events that sometimes required hospitalization have been reported, including the development of intestinal obstruction, intestinal perforation, and fecal impaction.(1) PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: Avoid use with other drugs that may cause constipation. If concurrent use is necessary, evaluate the patient's bowel function regularly. Monitor for symptoms of constipation and GI hypomotility, including having bowel movements less than three times weekly or less than usual, difficulty having a bowel movement or passing gas, nausea, vomiting, and abdominal pain or distention.(1) Instruct patients to stop eluxadoline and immediately contact their healthcare provider if they experience severe constipation. Loperamide may be used occasionally for acute management of severe diarrhea, but must be discontinued if constipation develops.(1) DISCUSSION: In phase 3 clinical trials, constipation was the most commonly reported adverse reaction (8%). Approximately 50% of constipation events occurred within the first 2 weeks of treatment while the majority occurred within the first 3 months of therapy. Rates of severe constipation were less than 1% in patients receiving eluxadoline doses of 75 mg and 100 mg.(1)	ACETAMIN-CAFF-DIHYDROCODEINE, ACETAMINOPHEN-CODEINE, ADASUVE, AMITRIPTYLINE HCL, AMOXAPINE, ANAFRANIL, ANASPAZ, ANTIVERT, APADAZ, ASA-BUTALB-CAFFEINE-CODEINE, ASCOMP WITH CODEINE, ATROPEN, ATROPINE SULFATE, ATROVENT HFA, BELBUCA, BELLADONNA, BELLADONNA LEAF POWDER, BELLADONNA-OPIUM, BENZHYDROCODONE-ACETAMINOPHEN, BENZTROPINE MESYLATE, BEVESPI AEROSPHERE, BONJESTA, BREZTRI AEROSPHERE, BRIXADI, BROMFED DM, BROMPHENIRAMINE MALEATE, BROMPHENIRAMINE-PSEUDOEPHED-DM, BUPRENORPHINE, BUPRENORPHINE HCL, BUPRENORPHINE-NALOXONE, BUTALB-ACETAMINOPH-CAFF-CODEIN, BUTORPHANOL TARTRATE, BUTRANS, CARBINOXAMINE MALEATE, CARBINOXAMINE MALEATE ER, CARISOPRODOL-ASPIRIN-CODEINE, CHLORDIAZEPOXIDE-AMITRIPTYLINE, CHLORDIAZEPOXIDE-CLIDINIUM, CHLORPHENIRAMINE MALEATE, CHLORPROMAZINE HCL, CIMETIDINE, CLEMASTINE FUMARATE, CLEMASZ, CLIDINIUM BROMIDE, CLOMIPRAMINE HCL, COBENFY, COBENFY STARTER PACK, CODEINE PHOSPHATE, CODEINE SULFATE, COMBIVENT RESPIMAT, CONZIP, CUVPOSA, CYCLOPENTOLATE HCL, CYPROHEPTADINE HCL, DARIFENACIN ER, DARTISLA, DEMEROL, DESIPRAMINE HCL, DEXCHLORPHENIRAMINE MALEATE, DICLEGIS, DICYCLOMINE HCL, DIHYDROCODEINE BITARTRATE, DILAUDID, DIMENHYDRINATE, DIPHEN, DIPHENHYDRAMINE HCL, DIPHENHYDRAMINE-0.9% NACL, DIPHENOXYLATE-ATROPINE, DISKETS, DISOPYRAMIDE PHOSPHATE, DONNATAL, DOXEPIN HCL, DOXYLAMINE SUCC-PYRIDOXINE HCL, DOXYLAMINE SUCCINATE, DSUVIA, DUODOTE, DURAMORPH, ED-SPAZ, ENDOCET, FENTANYL, FENTANYL CITRATE, FENTANYL CITRATE-0.9% NACL, FENTANYL CITRATE-D5W, FENTANYL CITRATE-STERILE WATER, FENTANYL CITRATE-WATER, FENTANYL-BUPIVACAINE-0.9% NACL, FENTANYL-BUPIVACAINE-NACL, FENTANYL-ROPIVACAINE-0.9% NACL, FENTANYL-ROPIVACAINE-NACL, FESOTERODINE FUMARATE ER, FIORICET WITH CODEINE, FLAVOXATE HCL, GLYCATE, GLYCOPYRROLATE, GLYCOPYRROLATE-STERILE WATER, GLYCOPYRROLATE-WATER, GLYRX-PF, HOMATROPINE METHYLBROMIDE, HYCODAN, HYDROCODONE BITARTRATE, HYDROCODONE BITARTRATE ER, HYDROCODONE-ACETAMINOPHEN, HYDROCODONE-CHLORPHENIRAMNE ER, HYDROCODONE-HOMATROPINE MBR, HYDROCODONE-IBUPROFEN, HYDROMET, HYDROMORPHONE ER, HYDROMORPHONE HCL, HYDROMORPHONE HCL-0.9% NACL, HYDROMORPHONE HCL-D5W, HYDROMORPHONE HCL-NACL, HYDROMORPHONE HCL-WATER, HYDROXYZINE HCL, HYDROXYZINE PAMOATE, HYOSCYAMINE SULFATE, HYOSCYAMINE SULFATE ER, HYOSCYAMINE SULFATE SR, HYOSYNE, HYSINGLA ER, IMIPRAMINE HCL, IMIPRAMINE PAMOATE, INFUMORPH, IPRATROPIUM BROMIDE, IPRATROPIUM-ALBUTEROL, ISOPROPAMIDE IODIDE, KARBINAL ER, LEVBID, LEVORPHANOL TARTRATE, LEVSIN, LEVSIN-SL, LIBRAX, LOMOTIL, LOXAPINE, MB CAPS, ME-NAPHOS-MB-HYO 1, MECLIZINE HCL, MEPERIDINE HCL, MEPERIDINE HCL-0.9% NACL, METHADONE HCL, METHADONE HCL-0.9% NACL, METHADONE HCL-NACL, METHADONE INTENSOL, METHADOSE, METHSCOPOLAMINE BROMIDE, MITIGO, MORPHINE SULFATE, MORPHINE SULFATE ER, MORPHINE SULFATE-0.9% NACL, MORPHINE SULFATE-NACL, MOTOFEN, MS CONTIN, NALOCET, NORGESIC, NORGESIC FORTE, NORPACE, NORPACE CR, NORPRAMIN, NORTRIPTYLINE HCL, NUCYNTA, NUCYNTA ER, NULEV, OLINVYK, OPIUM TINCTURE, ORPHENADRINE CITRATE, ORPHENADRINE CITRATE ER, ORPHENADRINE-ASPIRIN-CAFFEINE, ORPHENGESIC FORTE, OSCIMIN, OSCIMIN SL, OXCARBAZEPINE, OXCARBAZEPINE ER, OXTELLAR XR, OXYBUTYNIN CHLORIDE, OXYBUTYNIN CHLORIDE ER, OXYCODONE HCL, OXYCODONE HCL ER, OXYCODONE HYDROCHLORIDE, OXYCODONE-ACETAMINOPHEN, OXYCONTIN, OXYMORPHONE HCL, OXYMORPHONE HCL ER, OXYTROL, PAMELOR, PENTAZOCINE-NALOXONE HCL, PERCOCET, PERPHENAZINE-AMITRIPTYLINE, PHENERGAN, PHENOBARBITAL-BELLADONNA, PHENOBARBITAL-HYOSC-ATROP-SCOP, PHENOHYTRO, PREVDUO, PRIMLEV, PROLATE, PROMETHAZINE HCL, PROMETHAZINE HCL-0.9% NACL, PROMETHAZINE VC, PROMETHAZINE-CODEINE, PROMETHAZINE-DM, PROMETHAZINE-PHENYLEPHRINE HCL, PROMETHEGAN, PROPANTHELINE BROMIDE, PROTRIPTYLINE HCL, PYRILAMINE MALEATE, QDOLO, REMIFENTANIL HCL, RESPA A.R., ROBINUL, ROBINUL FORTE, ROXICODONE, ROXYBOND, RYCLORA, RYVENT, SCOPOLAMINE, SCOPOLAMINE HYDROBROMIDE, SCOPOLAMINE METHYL NITRATE, SILENOR, SOLIFENACIN SUCCINATE, SPIRIVA HANDIHALER, SPIRIVA RESPIMAT, STIOLTO RESPIMAT, SUBLOCADE, SUBOXONE, SUFENTANIL CITRATE, SYMAX, SYMAX DUOTAB, SYMAX-SL, SYMAX-SR, THIORIDAZINE HCL, THIORIDAZINE HYDROCHLORIDE, TIOTROPIUM BROMIDE, TOLTERODINE TARTRATE, TOLTERODINE TARTRATE ER, TOVIAZ, TRAMADOL HCL, TRAMADOL HCL ER, TRAMADOL HCL-ACETAMINOPHEN, TRANSDERM-SCOP, TREZIX, TRIFLUOPERAZINE HCL, TRIHEXYPHENIDYL HCL, TRILEPTAL, TRIMIPRAMINE MALEATE, TRIPROLIDINE HCL, TROPICAMIDE, TROSPIUM CHLORIDE, TROSPIUM CHLORIDE ER, TUXARIN ER, ULTIVA, URELLE, URETRON D-S, URIBEL TABS, URIMAR-T, URNEVA, URO-MP, URO-SP, UROGESIC-BLUE, URYL, VESICARE, VESICARE LS, XTAMPZA ER, ZUBSOLV

Drug Interaction

Drug Names

Eluxadoline/OATP1B1 Inhibitors

SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction.

MECHANISM OF ACTION: OATP1B1 inhibitors may decrease the hepatic uptake of eluxadoline.(1)

CLINICAL EFFECTS: Concurrent use of OATP1B1 inhibitors may result in elevated levels of and side effects from eluxadoline, including constipation, nausea, abdominal pain, and impaired mental and physical abilities.(1)

PREDISPOSING FACTORS: None determined.

PATIENT MANAGEMENT: Patients receiving concurrent OATP1B1 inhibitors should receive a dose of eluxadoline of 75 mg twice daily. Monitor patients for impaired mental or physical abilities, abdominal pain, nausea, and constipation.(1)

DISCUSSION: Concurrent administration of a single dose (600 mg) of cyclosporine, an OATP1B1 inhibitor, increased the maximum concentration (Cmax) and area-under-curve (AUC) of a single dose of eluxadoline (100 mg) by 4.4-fold and 6.2-fold, respectively.(1) OATP1B1 inhibitors include asciminib, atazanavir, belumosudil, boceprevir, cyclosporine, darunavir, encorafenib, eltrombopag, erythromycin, gemfibrozil, leflunomide, letermovir, lopinavir, paritaprevir, resmetirom, rifampin, ritonavir, roxadustat, saquinavir, simeprevir, telaprevir, teriflunomide, tipranavir, vadadustat, and voclosporin.(1,2)

ALVAIZ, APTIVUS, ARAVA, ATAZANAVIR SULFATE, AUBAGIO, BRAFTOVI, CYCLOSPORINE, CYCLOSPORINE MODIFIED, DARUNAVIR, E.E.S. 200, E.E.S. 400, ELTROMBOPAG OLAMINE, ERY-TAB, ERYPED 200, ERYPED 400, ERYTHROCIN LACTOBIONATE, ERYTHROCIN STEARATE, ERYTHROMYCIN, ERYTHROMYCIN ESTOLATE, ERYTHROMYCIN ETHYLSUCCINATE, ERYTHROMYCIN LACTOBIONATE, EVOTAZ, GEMFIBROZIL, GENGRAF, KALETRA, LEFLUNICLO, LEFLUNOMIDE, LOPID, LOPINAVIR-RITONAVIR, LUPKYNIS, NEORAL, NORVIR, PAXLOVID, PREVYMIS, PREZCOBIX, PREZISTA, PROMACTA, REYATAZ, REZDIFFRA, REZUROCK, RIFADIN, RIFAMPIN, RITONAVIR, SANDIMMUNE, SCEMBLIX, SYMTUZA, TERIFLUNOMIDE, VAFSEO

Eluxadoline/Anticholinergics; Opioids

SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction.

MECHANISM OF ACTION: Eluxadoline is a mixed mu-opioid and kappa-opioid agonist and delta-opioid antagonist and may alter or slow down gastrointestinal transit.(1)

CLINICAL EFFECTS: Constipation related adverse events that sometimes required hospitalization have been reported, including the development of intestinal obstruction, intestinal perforation, and fecal impaction.(1)

PREDISPOSING FACTORS: None determined.

PATIENT MANAGEMENT: Avoid use with other drugs that may cause constipation. If concurrent use is necessary, evaluate the patient's bowel function regularly. Monitor for symptoms of constipation and GI hypomotility, including having bowel movements less than three times weekly or less than usual, difficulty having a bowel movement or passing gas, nausea, vomiting, and abdominal pain or distention.(1)

Instruct patients to stop eluxadoline and immediately contact their healthcare provider if they experience severe constipation. Loperamide may be used occasionally for acute management of severe diarrhea, but must be discontinued if constipation develops.(1)

DISCUSSION: In phase 3 clinical trials, constipation was the most commonly reported adverse reaction (8%). Approximately 50% of constipation events occurred within the first 2 weeks of treatment while the majority occurred within the first 3 months of therapy. Rates of severe constipation were less than 1% in patients receiving eluxadoline doses of 75 mg and 100 mg.(1)

ACETAMIN-CAFF-DIHYDROCODEINE, ACETAMINOPHEN-CODEINE, ADASUVE, AMITRIPTYLINE HCL, AMOXAPINE, ANAFRANIL, ANASPAZ, ANTIVERT, APADAZ, ASA-BUTALB-CAFFEINE-CODEINE, ASCOMP WITH CODEINE, ATROPEN, ATROPINE SULFATE, ATROVENT HFA, BELBUCA, BELLADONNA, BELLADONNA LEAF POWDER, BELLADONNA-OPIUM, BENZHYDROCODONE-ACETAMINOPHEN, BENZTROPINE MESYLATE, BEVESPI AEROSPHERE, BONJESTA, BREZTRI AEROSPHERE, BRIXADI, BROMFED DM, BROMPHENIRAMINE MALEATE, BROMPHENIRAMINE-PSEUDOEPHED-DM, BUPRENORPHINE, BUPRENORPHINE HCL, BUPRENORPHINE-NALOXONE, BUTALB-ACETAMINOPH-CAFF-CODEIN, BUTORPHANOL TARTRATE, BUTRANS, CARBINOXAMINE MALEATE, CARBINOXAMINE MALEATE ER, CARISOPRODOL-ASPIRIN-CODEINE, CHLORDIAZEPOXIDE-AMITRIPTYLINE, CHLORDIAZEPOXIDE-CLIDINIUM, CHLORPHENIRAMINE MALEATE, CHLORPROMAZINE HCL, CIMETIDINE, CLEMASTINE FUMARATE, CLEMASZ, CLIDINIUM BROMIDE, CLOMIPRAMINE HCL, COBENFY, COBENFY STARTER PACK, CODEINE PHOSPHATE, CODEINE SULFATE, COMBIVENT RESPIMAT, CONZIP, CUVPOSA, CYCLOPENTOLATE HCL, CYPROHEPTADINE HCL, DARIFENACIN ER, DARTISLA, DEMEROL, DESIPRAMINE HCL, DEXCHLORPHENIRAMINE MALEATE, DICLEGIS, DICYCLOMINE HCL, DIHYDROCODEINE BITARTRATE, DILAUDID, DIMENHYDRINATE, DIPHEN, DIPHENHYDRAMINE HCL, DIPHENHYDRAMINE-0.9% NACL, DIPHENOXYLATE-ATROPINE, DISKETS, DISOPYRAMIDE PHOSPHATE, DONNATAL, DOXEPIN HCL, DOXYLAMINE SUCC-PYRIDOXINE HCL, DOXYLAMINE SUCCINATE, DSUVIA, DUODOTE, DURAMORPH, ED-SPAZ, ENDOCET, FENTANYL, FENTANYL CITRATE, FENTANYL CITRATE-0.9% NACL, FENTANYL CITRATE-D5W, FENTANYL CITRATE-STERILE WATER, FENTANYL CITRATE-WATER, FENTANYL-BUPIVACAINE-0.9% NACL, FENTANYL-BUPIVACAINE-NACL, FENTANYL-ROPIVACAINE-0.9% NACL, FENTANYL-ROPIVACAINE-NACL, FESOTERODINE FUMARATE ER, FIORICET WITH CODEINE, FLAVOXATE HCL, GLYCATE, GLYCOPYRROLATE, GLYCOPYRROLATE-STERILE WATER, GLYCOPYRROLATE-WATER, GLYRX-PF, HOMATROPINE METHYLBROMIDE, HYCODAN, HYDROCODONE BITARTRATE, HYDROCODONE BITARTRATE ER, HYDROCODONE-ACETAMINOPHEN, HYDROCODONE-CHLORPHENIRAMNE ER, HYDROCODONE-HOMATROPINE MBR, HYDROCODONE-IBUPROFEN, HYDROMET, HYDROMORPHONE ER, HYDROMORPHONE HCL, HYDROMORPHONE HCL-0.9% NACL, HYDROMORPHONE HCL-D5W, HYDROMORPHONE HCL-NACL, HYDROMORPHONE HCL-WATER, HYDROXYZINE HCL, HYDROXYZINE PAMOATE, HYOSCYAMINE SULFATE, HYOSCYAMINE SULFATE ER, HYOSCYAMINE SULFATE SR, HYOSYNE, HYSINGLA ER, IMIPRAMINE HCL, IMIPRAMINE PAMOATE, INFUMORPH, IPRATROPIUM BROMIDE, IPRATROPIUM-ALBUTEROL, ISOPROPAMIDE IODIDE, KARBINAL ER, LEVBID, LEVORPHANOL TARTRATE, LEVSIN, LEVSIN-SL, LIBRAX, LOMOTIL, LOXAPINE, MB CAPS, ME-NAPHOS-MB-HYO 1, MECLIZINE HCL, MEPERIDINE HCL, MEPERIDINE HCL-0.9% NACL, METHADONE HCL, METHADONE HCL-0.9% NACL, METHADONE HCL-NACL, METHADONE INTENSOL, METHADOSE, METHSCOPOLAMINE BROMIDE, MITIGO, MORPHINE SULFATE, MORPHINE SULFATE ER, MORPHINE SULFATE-0.9% NACL, MORPHINE SULFATE-NACL, MOTOFEN, MS CONTIN, NALOCET, NORGESIC, NORGESIC FORTE, NORPACE, NORPACE CR, NORPRAMIN, NORTRIPTYLINE HCL, NUCYNTA, NUCYNTA ER, NULEV, OLINVYK, OPIUM TINCTURE, ORPHENADRINE CITRATE, ORPHENADRINE CITRATE ER, ORPHENADRINE-ASPIRIN-CAFFEINE, ORPHENGESIC FORTE, OSCIMIN, OSCIMIN SL, OXCARBAZEPINE, OXCARBAZEPINE ER, OXTELLAR XR, OXYBUTYNIN CHLORIDE, OXYBUTYNIN CHLORIDE ER, OXYCODONE HCL, OXYCODONE HCL ER, OXYCODONE HYDROCHLORIDE, OXYCODONE-ACETAMINOPHEN, OXYCONTIN, OXYMORPHONE HCL, OXYMORPHONE HCL ER, OXYTROL, PAMELOR, PENTAZOCINE-NALOXONE HCL, PERCOCET, PERPHENAZINE-AMITRIPTYLINE, PHENERGAN, PHENOBARBITAL-BELLADONNA, PHENOBARBITAL-HYOSC-ATROP-SCOP, PHENOHYTRO, PREVDUO, PRIMLEV, PROLATE, PROMETHAZINE HCL, PROMETHAZINE HCL-0.9% NACL, PROMETHAZINE VC, PROMETHAZINE-CODEINE, PROMETHAZINE-DM, PROMETHAZINE-PHENYLEPHRINE HCL, PROMETHEGAN, PROPANTHELINE BROMIDE, PROTRIPTYLINE HCL, PYRILAMINE MALEATE, QDOLO, REMIFENTANIL HCL, RESPA A.R., ROBINUL, ROBINUL FORTE, ROXICODONE, ROXYBOND, RYCLORA, RYVENT, SCOPOLAMINE, SCOPOLAMINE HYDROBROMIDE, SCOPOLAMINE METHYL NITRATE, SILENOR, SOLIFENACIN SUCCINATE, SPIRIVA HANDIHALER, SPIRIVA RESPIMAT, STIOLTO RESPIMAT, SUBLOCADE, SUBOXONE, SUFENTANIL CITRATE, SYMAX, SYMAX DUOTAB, SYMAX-SL, SYMAX-SR, THIORIDAZINE HCL, THIORIDAZINE HYDROCHLORIDE, TIOTROPIUM BROMIDE, TOLTERODINE TARTRATE, TOLTERODINE TARTRATE ER, TOVIAZ, TRAMADOL HCL, TRAMADOL HCL ER, TRAMADOL HCL-ACETAMINOPHEN, TRANSDERM-SCOP, TREZIX, TRIFLUOPERAZINE HCL, TRIHEXYPHENIDYL HCL, TRILEPTAL, TRIMIPRAMINE MALEATE, TRIPROLIDINE HCL, TROPICAMIDE, TROSPIUM CHLORIDE, TROSPIUM CHLORIDE ER, TUXARIN ER, ULTIVA, URELLE, URETRON D-S, URIBEL TABS, URIMAR-T, URNEVA, URO-MP, URO-SP, UROGESIC-BLUE, URYL, VESICARE, VESICARE LS, XTAMPZA ER, ZUBSOLV

There are 1 moderate interactions. The clinician should assess the patient’s characteristics and take action as needed. Actions required for moderate interactions include, but are not limited to, discontinuing one or both agents, adjusting dosage, altering administration.

Drug Interaction	Drug Names
Desmopressin/Agents with Hyponatremia Risk SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed. MECHANISM OF ACTION: Carbamazepine, chlorpromazine, lamotrigine, NSAIDs, opioids, SSRIs, thiazide diuretics, and/or tricyclic antidepressants increase the risk of hyponatremia.(1-3) CLINICAL EFFECTS: Concurrent use may increase the risk of hyponatremia with desmopressin.(1-3) PREDISPOSING FACTORS: Predisposing factors for hyponatremia include: polydipsia, renal impairment (eGFR < 50 ml/min/1.73m2), illnesses that can cause fluid/electrolyte imbalances, age >=65, medications that cause water retention and/or increase the risk of hyponatremia (glucocorticoids, loop diuretics). PATIENT MANAGEMENT: The concurrent use of agents with a risk of hyponatremia with desmopressin may increase the risk of hyponatremia. If concurrent use is deemed medically necessary, make sure serum sodium levels are normal before beginning therapy and consider using the desmopressin nasal 0.83 mcg dose. Consider measuring serum sodium levels more frequently than the recommended intervals of: within 7 days of concurrent therapy initiation, one month after concurrent therapy initiation and periodically during treatment. Counsel patients to report symptoms of hyponatremia, which may include: headache, nausea/vomiting, feeling restless, fatigue, drowsiness, dizziness, muscle cramps, changes in mental state (confusion, decreased awareness/alertness), seizures, coma, and trouble breathing. Counsel patients to limit the amount of fluids they drink in the evening and night-time and to stop taking desmopressin if they develop a stomach/intestinal virus with nausea/vomiting or any nose problems (blockage, stuffy/runny nose, drainage).(1) DISCUSSION: In clinical trials of desmopressin for the treatment of nocturia, 4 of 5 patients who developed severe hyponatremia (serum sodium <= 125 mmol/L) were taking systemic or inhaled glucocorticoids. Three of these patients were also taking NSAIDs and one was receiving a thiazide diuretic.(2) Drugs associated with hyponatremia may increase the risk, including loop diuretics, carbamazepine, chlorpromazine, glucocorticoids, lamotrigine, NSAIDs, opioids, SSRIs, thiazide diuretics, and/or tricyclic antidepressants.(1,3-4)	DDAVP, DESMOPRESSIN ACETATE, NOCDURNA

Drug Interaction

Drug Names

Desmopressin/Agents with Hyponatremia Risk

SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed.

MECHANISM OF ACTION: Carbamazepine, chlorpromazine, lamotrigine, NSAIDs, opioids, SSRIs, thiazide diuretics, and/or tricyclic antidepressants increase the risk of hyponatremia.(1-3)

CLINICAL EFFECTS: Concurrent use may increase the risk of hyponatremia with desmopressin.(1-3)

PREDISPOSING FACTORS: Predisposing factors for hyponatremia include: polydipsia, renal impairment (eGFR < 50 ml/min/1.73m2), illnesses that can cause fluid/electrolyte imbalances, age >=65, medications that cause water retention and/or increase the risk of hyponatremia (glucocorticoids, loop diuretics).

PATIENT MANAGEMENT: The concurrent use of agents with a risk of hyponatremia with desmopressin may increase the risk of hyponatremia. If concurrent use is deemed medically necessary, make sure serum sodium levels are normal before beginning therapy and consider using the desmopressin nasal 0.83 mcg dose.

Consider measuring serum sodium levels more frequently than the recommended intervals of: within 7 days of concurrent therapy initiation, one month after concurrent therapy initiation and periodically during treatment. Counsel patients to report symptoms of hyponatremia, which may include: headache, nausea/vomiting, feeling restless, fatigue, drowsiness, dizziness, muscle cramps, changes in mental state (confusion, decreased awareness/alertness), seizures, coma, and trouble breathing. Counsel patients to limit the amount of fluids they drink in the evening and night-time and to stop taking desmopressin if they develop a stomach/intestinal virus with nausea/vomiting or any nose problems (blockage, stuffy/runny nose, drainage).(1)

DISCUSSION: In clinical trials of desmopressin for the treatment of nocturia, 4 of 5 patients who developed severe hyponatremia (serum sodium <= 125 mmol/L) were taking systemic or inhaled glucocorticoids. Three of these patients were also taking NSAIDs and one was receiving a thiazide diuretic.(2) Drugs associated with hyponatremia may increase the risk, including loop diuretics, carbamazepine, chlorpromazine, glucocorticoids, lamotrigine, NSAIDs, opioids, SSRIs, thiazide diuretics, and/or tricyclic antidepressants.(1,3-4)

DDAVP, DESMOPRESSIN ACETATE, NOCDURNA

The following contraindication information is available for VIBERZI (eluxadoline):

Overview
Contraindicated
Severe
Moderate

Drug contraindication overview.

Eluxadoline is contraindicated in patients who do not have a gallbladder because of the increased risk for pancreatitis and/or sphincter of Oddi spasm in such patients; the drug also is contraindicated in patients with known or suspected biliary duct obstruction or sphincter of Oddi disease or dysfunction because of the increased risk for sphincter of Oddi spasm. (See Pancreatitis and also see Sphincter of Oddi Spasm under Cautions: Warnings/Precautions.) Because of the increased risk of acute pancreatitis, eluxadoline is contraindicated in patients with alcoholism, alcohol abuse or addiction, alcohol consumption in excess of 3 alcoholic beverages per day, or a history of pancreatitis or structural pancreatic diseases, including known or suspected pancreatic duct obstruction. (See Pancreatitis under Cautions: Warnings/Precautions.) Eluxadoline is contraindicated in patients with severe hepatic impairment (Child-Pugh class C) because of the potential for substantially increased plasma concentrations of the drug.

(See Hepatic Impairment under Warnings/Precautions: Specific Populations, in Cautions.) Eluxadoline also is contraindicated in patients with a history of chronic or severe constipation or sequelae from constipation and those with known or suspected mechanical GI obstruction, since these patients may be at risk for severe complications of bowel obstruction.

There are 8 contraindications. Absolute contraindication.

Contraindication List
Alcohol use disorder
Biliary obstruction
Biliary tract disorder
Child-pugh class C hepatic impairment
Congenital absence of gallbladder
Gastrointestinal obstruction
History of cholecystectomy
Pancreatitis

There are 8 severe contraindications. Adequate patient monitoring is recommended for safer drug use.

Severe List
Child-pugh class A hepatic impairment
Child-pugh class B hepatic impairment
Chronic kidney disease stage 3A (moderate) GFR 45-59 ml/min
Chronic kidney disease stage 3B (moderate) GFR 30-44 ml/min
Chronic kidney disease stage 4 (severe) GFR 15-29 ml/min
Chronic kidney disease stage 5 (failure) GFr<15 ml/min
Disease of liver
Severe constipation

There are 0 moderate contraindications.

The following adverse reaction information is available for VIBERZI (eluxadoline):

Overview
Severe
Less Severe

Adverse reaction overview.

Adverse effects reported in more than 2% of patients receiving eluxadoline 75 or 100 mg twice daily for irritable bowel syndrome (IBS) with diarrhea (and with greater frequency than in patients receiving placebo) include constipation, nausea, abdominal pain, upper respiratory tract infection, vomiting, nasopharyngitis, abdominal distention, bronchitis, dizziness, flatulence, rash, increased ALT concentrations, fatigue, and viral gastroenteritis.

There are 15 severe adverse reactions.

More Frequent	Less Frequent
None.	Abnormal hepatic function tests Increased alanine transaminase

Rare/Very Rare
Accidental fall Acute respiratory failure Anaphylaxis Angioedema Bronchospastic pulmonary disease Dyspnea Fecal impaction Gastrointestinal obstruction Increased aspartate transaminase Intestinal perforation Pancreatitis Spasm of sphincter of oddi Throat constriction

There are 22 less severe adverse reactions.

More Frequent	Less Frequent
Acute abdominal pain Constipation Nausea	Abdominal distension Bronchitis Dizziness Fatigue Flatulence Pharyngitis Pruritus of skin Skin rash Upper respiratory infection Viral gastroenteritis Vomiting

Rare/Very Rare
Asthma Chest pain Chest tightness Drowsy Euphoria Gastroesophageal reflux disease Sedation Wheezing

The following precautions are available for VIBERZI (eluxadoline):

Pediatric
Pregnant
Lactation
Geriatric

Safety and efficacy of eluxadoline have not been established in pediatric patients.

Contraindicated

None

Severe Precaution

None

Management or Monitoring Precaution

None

There are no studies in pregnant women assessing eluxadoline-associated risks. Reproduction studies in rats and rabbits have not revealed evidence of teratogenicity, and a prenatal and postnatal development study in rats revealed no evidence of adverse effects in the offspring.

It is not known whether eluxadoline is distributed into human milk; however, the drug is distributed into milk in rats. The benefits of breast-feeding and the importance of eluxadoline to the woman should be considered along with any potential adverse effects on the breast-fed child from the drug or from the underlying maternal condition.

In clinical studies evaluating eluxadoline in patients with IBS, 7.7% of those who received the study drug were 65 years of age or older, while 0.8% were 75 years of age or older.

No overall differences in efficacy or types of adverse effects were observed between geriatric patients and younger adults. However, a higher proportion of geriatric patients, compared with younger adults, experienced adverse effects (66 versus 59%), serious adverse effects (9 versus 4%), and adverse GI effects (39 versus 28%).

Diarrhea predominant irritable bowel syndrome
K58.0	Irritable bowel syndrome with diarrhea