Adult Dosing

HIV-1 infection in antiretroviral treatment-naive adult patients

• 25 mg PO qd with a meal

Pediatric Dosing

• Safety and effectiveness in pediatric patients have not been established

[Outline]

• Adult Dosing
• Pediatric Dosing

• Used concomitantly with other antiretroviral agents for the treatment of HIV-1 infection in antiretroviral treatment-naive adult patients with HIV-1 RNA 100,000 copies/mL at start of therapy

• Hypersensitivity to any of the ingredients of the product
• Concomitant administration with anticonvulsants, proton pump inhibitors, antimycobacterials, St. John's Wort, and more than a single dose of systemic dexamethasone

• N/A

Renal Dose Adjustment

• Mild or moderate renal impairment: No dose adjustments
• Severe renal impairment/ESRD: Caution advised

Hepatic Dose Adjustment

• Mild or moderate hepatic impairment (Child-Pugh Classes A and B): No dose adjustments
• Severe hepatic impairment (Child-Pugh Class C): Dose adjustments not defined

See Supplemental Patient Information

• Exercise caution when prescribing rilpivirine with drugs that reduce the exposure to therapy
• Depressive disorders such as depressed mood, depression, dysphoria, major depression, altered mood, negative thoughts, suicide attempt, and suicidal ideation have occurred with rilpivirine. If severe depressive symptoms occur, seek immediate medical evaluation
• Monitor liver function tests before and during treatment treatment in patients with liver disease including hepatitis B or C or in patients with raised baseline transaminases. Consider monitoring liver functions tests in patients without pre-existing hepatic dysfunction
• Redistribution/accumulation of body fat, including central obesity, dorsocervical fat enlargement (buffalo hump), peripheral wasting, facial wasting, breast enlargement, and cushingoid appearance have been reported in patients receiving rilpivirine
• Immune reconstitution syndrome has been occurred in patients treated with combination antiretroviral therapy
• Autoimmune disorders including Graves disease, polymyositis, and Guillain-Barré syndrome may occur in the setting of immune reconstitution

Cautions: Use cautiously in

• Severe renal impairment
• Psychiatric disorders
• HBV or HCV co-infection

Supplemental Patient Information

• Instruct patient that rilpivirine is not a cure for HIV infection
• Advise patients not to alter the dose of rilpivirine or discontinue without consulting their physician

Edurant interacts with :

	Aciphex
	Akne-mycin
	Amiodarone
	Aprepitant
	Axid
	Axid AR
	Barbiturates
	Biaxin
	Biaxin XL
	Boceprevir
	Bosentan
	Calan
	Calan SR
	Carbamazepine
	Carbatrol
	Cardizem
	Cardizem CD
	Cardizem LA
	Cartia XT
	Ceritinib
	Cetraxal
	Ciloxan
	Cimetidine
	Cipro
	Cipro IV
	Cipro XR
	Ciprofloxacin
	Clarithromycin
	Cobicistat
	Conivaptan
	Cordarone
	Covera-HS
	Cyclosporine
	Dabrafenib
	Decadron
	Dexamethasone
	Dexilant
	Dexlansoprazole
	Diflucan
	Dilacor XR
	Dilantin
	Dilantin Infatabs
	Dilantin-125
	Dilt-CD
	Diltiazem
	Diltzac
	Dronedarone
	E-Mycin
	E.E.S.
	Efavirenz
	Emend
	Epitol
	Equetro
	Ery-Tab
	Eryc
	Erygel
	Eryped
	Erythra-Derm
	Erythro-statin
	Erythrocin
	Erythromycin
	Esomeprazole
	Extina
	Famotidine
	Fluconazole
	Fluvoxamine
	Fluxid
	Gengraf
	Gleevec
	Grapefruit
	Imatinib
	Isoptin
	Isoptin SR
	Itraconazole
	Juxtapid
	Kapidex
	Ketek
	Ketoconazole
	Korlym
	Lansoprazole
	Lapatinib
	Lomitapide
	Lumacaftor
	Luvox
	Luvox CR
	Maxidex
	Mifepristone
	Multaq
	Mycobutin
	Mysoline
	Nefazodone
	Neoral
	Nevirapine
	Nexium
	Nexium IV
	Nexterone
	Nizatidine
	Nizoral
	Nizoral A-D Shampoo
	Nizoral Shampoo
	Noxafil
	Omeprazole
	Onmel
	Orkambi
	Oxcarbazepine
	Oxtellar XR
	Ozudrex
	Pacerone
	Pantoprazole
	PCE
	Pediamycin
	Pepcid
	Pepcid AC
	Pepcid RPD
	Phenytek
	Phenytoin
	Posaconazole
	Prevacid
	Prevacid 24 HR OTC
	Priftin
	Prilosec
	Prilosec OTC
	Primidone
	Proquin XR
	Protonix
	Protonix IV
	Quinupristin
	Rabeprazole
	Ranitidine
	Restasis
	Rifabutin
	Rifadin
	Rifampin
	Rifapentine
	Rimactane
	Sandimmune
	Sporanox
	St. John's Wort
	Stribild
	Sustiva
	Synercid
	Tafinlar
	Tagamet
	Tagamet HB
	TAO
	Taztia XT
	Tegretol
	Tegretol XR
	Telithromycin
	Teril
	Tiazac
	Tracleer
	Trileptal
	Troleandomycin
	Tykerb
	Vaprisol
	Veralan
	Verapamil
	Verelan PM
	Vfend
	Victrelis
	Viramune
	Viramune XR
	Voriconazole
	Xolegel
	Zantac
	Zantac 150
	Zantac 25
	Zantac 300
	Zantac 75
	Zykadia

Pregnancy Category:B

Breastfeeding: The Center for Disease Control and Prevention advises that HIV-infected mothers should not breastfeed their infants to avoid risking postnatal transmission of HIV. It is unknown whether rilpivirine is secreted in human milk. Because of both the potential for HIV transmission and the potential for adverse reactions in nursing infants, instruct mothers not to breastfeed if they are receiving rilpivirine.

• NEURO: Headache
• PSYCHIATRIC: Depressed mood, depression, dysphoria, major depression, mood altered, negative thoughts, suicide attempt, suicidal ideation, insomnia
• METABOLIC: Hypertriglyceridemia
• DERM: Rash
• IMMU: Immune reconstitution syndrome
• LABTESTS: Elevated Cr, elevated bilirubin

• Antiviral agent; reverse transcriptase inhibitor of HIV-1 and inhibits HIV-1 replication by non-competitive inhibition of HIV-1 reverse transcriptase
• Metabolized by liver; CYP450: 3A system
• Excreted in feces (85%) and urine (6.1%)
• Half-life: 50 hrs

US Trade Name(s)

• Edurant

US Availability

Edurant

• TABS: 25 mg

Canadian Trade Name(s)

• N/A

Canadian Availability

• N/A

UK Trade Name(s)

• N/A

UK Availability

• N/A

Australian Trade Name(s)

• N/A

Australian Availability

• N/A

[Outline]

Antimicrobials

Antiviral

NNRTIs

Pricing data from www.DrugStore.com in U.S.A.

• Edurant 25 MG TABS [Bottle] (JANSSEN PRODUCTS)
  30 mg = $739.97
  90 mg = $2129.88

Warning: This pricing information is subject to change at the sole discretion of DS Pharmacy. For the most current and up-to-date pricing information, please visit drugstore.com.