ODEFSEY (EMTRICITABINE/RILPIVIRINE HCL/TENOFOVIR ALAFENAMIDE FUMARATE)
- HIV infection
200 mg-25 mg-25 mg tablet
- 1 tablet by oral route once daily
HIV infection
- 1 tablet by oral route once daily
- Aciphex
- Aciphex Sprinkle
- adefovir
- amoxicil-clarithromy-lansopraz
- Aptiom
- B cplx-C-St.Johnwrt-K.&S.ginsg
- Belladonna-phenobarbital
- calcium-mag-B complex-D3-hrb61
- carbamazepine
- Carbatrol
- Cerebyx
- cidofovir
- Cold & Flu Fighter
- dexamethasone
- Dexamethasone Intensol
- dexamethasone sodium phos (PF)
- dexamethasone sodium phosphate
- Dexilant
- dexlansoprazole
- Dexpak 10 Day
- Dexpak 13 Day
- Dexpak 6 Day
- Dilantin
- Dilantin Extended
- Dilantin Infatabs
- Dilantin Kapseal
- Dilantin-125
- Donnatal
- elvitegr-cobicist-emtric-tenof
- enzalutamide
- Epitol
- Equetro
- eslicarbazepine
- esomeprazole magnesium
- esomeprazole sodium
- esomeprazole strontium
- etravirine
- Fatigue Relief Complex
- First-lansoprazole
- First-omeprazole
- fosphenytoin
- Heartburn Relief 24 Hour
- Heartburn Treatment 24 Hour
- Hepsera
- Intelence
- isoniazid-rifamp-pyrazinamide
- lansoprazole
- Luminal
- Mycobutin
- Mysoline
- naproxen-esomeprazole
- Nexium
- Nexium Iv
- Nexium Packet
- Omeclamox-pak
- omeprazole
- omeprazole magnesium
- Omeprazole+syrspend Sf Alka
- omeprazole-clarith-amoxicillin
- omeprazole-sodium bicarbonate
- oxcarbazepine
- Oxtellar Xr
- pantoprazole
- phenobarb-hyoscy-atropine-scop
- phenobarbital
- phenobarbital sodium
- Phenytek
- phenytoin
- phenytoin sodium
- phenytoin sodium extended
- Prevacid
- Prevacid 24Hr
- Prevacid Solutab
- Prevpac
- Priftin
- Prilosec
- Prilosec Otc
- primidone
- Protonix
- rabeprazole
- rifabutin
- Rifadin
- Rifamate
- rifampin
- rifampin-isoniazid
- rifapentine
- Rifater
- St. John's wort
- Stribild
- Tegretol
- Tegretol Xr
- Trileptal
- Vimovo
- Vistide
- vit C-St. John wort-elder-hb30
- Women's Complex
- Xtandi
- Zegerid
- Zegerid Otc
Contraindicated
- amiodarone
- amiodarone in dextrose,iso-osm
- artemether-lumefantrine
- Coartem
- Cordarone
- disopyramide
- dronedarone
- droperidol
- Geodon
- Multaq
- Nexterone
- Norpace
- Norpace Cr
- Orap
- Pacerone
- pimozide
- ziprasidone HCl
- ziprasidone mesylate
Severe
Moderate
- Ablavar
- Acid Control (ranitidine)
- Acid Controller
- Acid Controller Complete
- Acid Gone
- Acid Gone Antacid
- Acid Reducer (cimetidine)
- Acid Reducer (famotidine)
- Acid Reducer (ranitidine)
- Acid Reducer Complete (famot)
- Acid Relief (cimetidine)
- activated charcoal-calcium car
- Advair Diskus
- Advair Hfa
- Advanced Antacid-antigas
- Advil
- Advil Allergy Sinus
- Advil Allergy-congestion Rlf
- Advil Cold & Sinus
- Advil Congestion Relief
- Advil Liqui-gel
- Advil Migraine
- Advil Pm
- Advil Pm Liqui-gels
- Al hyd-Mg tr-alg ac-sod bicarb
- Alcalak
- Aleve
- Aleve Cold & Sinus
- Aleve Sinus & Headache
- Aleve-d Sinus & Cold
- Aleve-d Sinus & Headache
- alfuzosin
- All Day Pain Relief
- All Day Pain Relief Sinus & Co
- All Day Relief
- Almacone
- Almacone-2
- Aloxi
- alum-mag hydroxide-simeth
- aluminum hydrox-magnesium carb
- aluminum hydroxide gel
- aluminum-magnesium hydroxide
- amantadine HCl
- Anaprox
- Anaprox Ds
- Ansaid
- Antacid
- Antacid Anti-gas
- Antacid Anti-gas Double Str
- Antacid Calcium
- Antacid Extra Strength
- Antacid Extra-strength
- Antacid Ii Plus Simethicone
- Antacid Liquid
- Antacid M
- Antacid Maximum Strength
- Antacid Multi-symptom
- Antacid Plus Anti-gas
- Antacid Plus Extra Strength
- Antacid Regular Strength
- Antacid Supreme
- Antacid Tablet
- Antacid Ultra Strength
- Antacid With Simethicone
- Antacid-antigas
- Antacid-antigas Ii
- Antacid-simethicone
- Antacid-simethicone Ds
- Anzemet
- Apokyn
- apomorphine
- arsenic trioxide
- Arthrotec 50
- ASA-acetaminophen-caff-buffers
- asenapine
- aspirin, buffered
- aspirin-calcium carbonate
- Astagraf Xl
- Avelox
- Avelox Abc Pack
- Avelox In Nacl (iso-osmotic)
- azithromycin
- Bayer Plus Extra Strength
- bedaquiline
- Betapace
- Betapace Af
- Biaxin
- Biaxin Xl
- Biaxin Xl Pak
- budesonide-formoterol
- Buffered Aspirin
- Bufferin
- cal phos-mag hydrx-C & D3-phos
- Cal-gest Antacid
- calcium & magnesium carbonates
- Calcium Antacid
- Calcium Antacid Tropical
- Calcium Antacid Ultra Max St
- calcium carb-mag hydrox-simeth
- calcium carbonate
- calcium carbonate-mag hydroxid
- calcium-simethicone
- Caldolor
- Cambia
- Cardene Iv
- Cardene Iv In Dextrose
- Cardene Iv In Sodium Chloride
- Cardene Sr
- Cataflam
- Celebrex
- celecoxib
- Child Ibuprofen
- Children's Advil
- Children's Ibu-drops
- Children's Ibuprofen
- Children's Medi-profen
- Children's Motrin
- Children's Pepto
- Children's Profen Ib
- Children's Soothe
- chloroquine phosphate
- chlorphen-phenyleph-ibuprofen
- chlorphen-pseudoeph-ibuprofen
- chlorpromazine
- cimetidine
- Cipro
- Cipro In D5W
- Cipro Xr
- ciprofloxacin
- ciprofloxacin (mixture)
- ciprofloxacin in D5W
- clarithromycin
- clozapine
- Clozaril
- Cold & Sinus Pain Relief
- Cold-sinus Relief
- Comfort Gel
- Comfort Gel Extra Strength
- Complete
- Corvert
- crizotinib
- dasatinib
- Daypro
- Deprizine
- dextromethorphan-quinidine
- diclofenac epolamine
- diclofenac potassium
- diclofenac sodium
- diclofenac submicronized
- diclofenac-misoprostol
- didanosine
- diosmin complex no.1
- Diskets
- dofetilide
- dolasetron
- Dolophine
- Dual Action Complete
- Duexis
- Dulera
- Ec-naprosyn
- Effexor Xr
- Eovist
- eribulin
- Erythrocin
- erythromycin
- erythromycin-sulfisoxazole
- escitalopram oxalate
- etodolac
- ezogabine
- famotidine
- famotidine-Ca carb-mag hydrox
- Fareston
- Fazaclo
- felbamate
- Felbatol
- Feldene
- fenoprofen
- Flanax
- flecainide
- Flector
- flurbiprofen
- fluticasone-salmeterol
- Foaming Antacid
- Foaming Antacid Extra Strength
- Foradil Aerolizer
- formoterol fumarate
- foscarnet
- Foscavir
- gadofosveset trisodium
- gadoxetate
- Gaviscon
- Gaviscon Extra Strength
- Gelusil Antacid & Anti-gas
- Geri-lanta
- Geri-mox Antacid-antigas
- granisetron
- granisetron (PF)
- Granisol
- Halaven
- Haldol
- Haldol Decanoate
- haloperidol
- haloperidol decanoate
- haloperidol lactate
- Heartburn Antacid
- Heartburn Prevention
- Heartburn Relief
- Heartburn Relief (famotidine)
- Heartburn Relief (ranitidine)
- Hecoria
- hydrocodone-ibuprofen
- I-prin
- Ibu-drops
- Ibudone
- ibuprofen
- Ibuprofen Cold
- Ibuprofen Cold-sinus(with Pse)
- Ibuprofen Ib
- Ibuprofen Jr Strength
- ibuprofen lysine (PF)
- Ibuprofen Pm
- ibuprofen-diphenhydramine
- ibuprofen-diphenhydramine HCl
- ibuprofen-famotidine
- ibuprofen-oxycodone
- ibuprofen-phenylephrine HCl
- ibutilide fumarate
- Incivek
- indapamide
- Indocin
- indomethacin
- indomethacin sodium
- Infant's Ibuprofen
- Infant's Medi-profen
- Infant's Motrin
- Infants Ibu-drops
- Infants Profenib
- Invega
- Invega Sustenna
- isradipine
- Istodax
- Kaletra
- Ketek
- ketoprofen
- ketorolac
- lapatinib
- Levaquin
- Levaquin In 5 % Dextrose
- Levitra
- levofloxacin
- levofloxacin in D5W
- Lexapro
- Liquid Antacid
- lithium carbonate
- lithium citrate
- Lithobid
- lopinavir-ritonavir
- Maalox Advanced
- Maalox Maximum Strength
- Mag-al
- Mag-al Plus
- Mag-al Plus Extra Strength
- magaldrate
- magaldrate-simethicone
- Maglox
- magnesium hydroxide
- magnesium-aluminum-alginic ac
- Masanti Double Strength
- Medi-profen
- Mediproxen
- mefenamic acid
- meloxicam
- methadone
- Methadone Intensol
- Methadose
- Mi-acid
- Midol (naproxen)
- Milk Of Magnesia
- Milk Of Magnesia Concentrated
- Mintox
- Mintox Maximum Strength
- Mintox Plus
- Mobic
- moexipril
- moexipril-hydrochlorothiazide
- mometasone-formoterol
- Motrin Ib
- Motrin Pm
- moxifloxacin
- moxifloxacin in NaCl (iso-osm)
- nabumetone
- Nalfon
- Naprelan Cr
- Naprosyn
- naproxen
- naproxen sodium
- naproxen-pseudoephedrine
- Nebupent
- Neoprofen (ibuprofen Lysn)(pf)
- Nexavar
- nicardipine
- nicardipine in dextrose,iso-os
- nicardipine in NaCl (iso-os)
- nilotinib
- nizatidine
- norfloxacin
- Noroxin
- Noxafil
- Nuedexta
- Ob Complete One
- octreotide acetate
- ofloxacin
- ondansetron
- ondansetron HCl
- ondansetron HCl (PF)
- oxaprozin
- paliperidone
- paliperidone palmitate
- palonosetron
- pasireotide
- pazopanib
- Pedia-lax
- Pennsaid
- Pentam
- pentamidine
- Pepcid
- Pepcid Ac
- Pepcid Complete
- Perforomist
- Phillips Milk Of Magnesia
- piroxicam
- PN85-iron cb&asp g-FA-dha-fish
- Ponstel
- posaconazole
- Potiga
- Pro-cal
- procainamide
- Prograf
- propafenone
- Provil
- pseudoephedrine-ibuprofen
- Qualaquin
- quetiapine
- quinidine gluconate
- quinidine sulfate
- quinine sulfate
- ranitidine HCl
- Reprexain
- Ri-gel
- Ri-gel Ii
- Ri-mag
- Ri-mag Plus
- Ri-mox
- Ri-mox Plus
- Riginic
- Risperdal
- Risperdal Consta
- Risperdal M-tab
- risperidone
- risperidone microspheres
- romidepsin
- Rulox
- Rythmol
- salmeterol
- Sancuso
- Sandostatin
- Sandostatin Lar Depot
- Saphris
- Saphris (black Cherry)
- Serevent Diskus
- Seroquel
- Seroquel Xr
- Signifor
- Sinus & Cold-d
- Sirturo
- Smooth Antacid
- Solaraze
- Soltamox
- sorafenib
- Sorine
- sotalol
- Sotalol Af
- Sprix
- Sprycel
- sulindac
- sunitinib
- Supreme Antacid
- Sutent
- Symbicort
- tacrolimus
- Tagamet Hb
- tamoxifen
- Tasigna
- telaprevir
- telavancin
- telithromycin
- tetrabenazine
- thioridazine
- Tikosyn
- tizanidine
- tolmetin
- toremifene
- Toxin Control
- Tri-buffered Aspirin
- Trisenox
- Tums
- Tums Dual Action
- Tums E-x
- Tums Extra Strength Smoothies
- Tums Freshers
- Tums Ultra
- Tykerb
- Ultra Strength Antacid
- Ultra Strength Calcium Antacid
- Uniretic
- Univasc
- Uroxatral
- Vanquish
- vardenafil
- Vasculera
- vemurafenib
- venlafaxine
- Versacloz
- Vfend
- Vfend Iv
- Vibativ
- Vicoprofen
- Videx 2 Gram Pediatric
- Videx 4 Gram Pediatric
- Videx Ec
- Voltaren-xr
- voriconazole
- Votrient
- Wal-profen
- Wal-profen Cold-sinus
- Wal-proxen
- Wal-zan 150
- Women's Aspirin With Calcium
- Xalkori
- Xenazine
- Zanaflex
- Zantac
- Zantac Maximum Strength
- Zelboraf
- Zipsor
- Zithromax
- Zithromax Tri-pak
- Zithromax Z-pak
- Zmax
- Zofran
- Zofran Odt
- Zorvolex
- Zuplenz
- Lactating mother
- Lactic acidosis
Contraindicated
- Acute renal failure
- Chronic kidney disease stage 3A (moderate) GFR 45-59
- Chronic kidney disease stage 3B (moderate) GFR 30-44
- Chronic kidney disease stage 4 (severe) GFR 15-29 ml/min
- Chronic kidney disease stage 5 (failure) GFr<15 ml/min
- Depression
- Disease of liver
- Fanconi syndrome
- Hypophosphatemia
- Kidney disease with reduction in GFR
- Osteomalacia
- Pathological fracture
- Suicidal ideation
Severe
Moderate
- Chronic hepatitis B
- Kidney disease with likely reduction in GFR
- Osteopenia
- Viral hepatitis
ODEFSEY (EMTRICITABINE/RILPIVIRINE HCL/TENOFOVIR ALAFENAMIDE FUMARATE)
- HIV infection
- Depression
- Gastroenteritis
- Skin rash
- Vomiting
- Acute abdominal pain
- Back pain
- Cough
- Depression
- Diarrhea
- Dizziness
- Dream disorder
- Fatigue
- Fever
- Flatulence
- General weakness
- Headache disorder
- Insomnia
- Nausea
- Pain
- Pruritus of skin
- Rhinitis
- Skin rash
- Vomiting
More Frequent
Severe
Less Severe
- Anemia
- Bullous dermatitis
- Hypercholesterolemia
- Increased alanine transaminase
- Increased aspartate transaminase
- Maculopapular rash
- Peripheral neuropathy
- Pneumonia
- Urticaria
- Acute bacterial otitis media
- Anorexia
- Arthralgias
- Chest pain
- Dizziness
- Dream disorder
- Dyspepsia
- Fatigue
- Insomnia
- Myalgias
- Nausea
- Paresthesia
- Pharyngitis
- Polyuria
- Proteinuria
- Sinusitis
- Vomiting
- Weight loss
Less Frequent
Severe
Less Severe
Rare / Very Rare
Severe
- Abnormal hepatic function tests
- Acute renal failure
- Angioedema
- Biliary calculus
- Blistering skin
- Cholecystitis
- Conjunctivitis
- DRESS syndrome
- Dyspnea
- Eosinophilia
- Facial edema
- Fanconi syndrome
- Glomerulonephritis
- Graves' disease
- Guillain-barre syndrome
- Hepatitis
- Hypokalemia
- Hypophosphatemia
- Interstitial nephritis
- Kidney disease with reduction in GFR
- Kidney stone
- Lactic acidosis
- Nephrogenic diabetes insipidus
- Nephrotic syndrome
- Osteomalacia
- Pancreatitis
- Peripheral neuropathy
- Pneumonia
- Polymyositis
- Prolonged QT interval
- Renal tubular necrosis
- Rhabdomyolysis
- Steatosis of liver
- Suicidal
- Suicidal ideation
Less Severe
- Acute abdominal pain
- Anorexia
- Diarrhea
- Drowsy
- Dyschromia
- Fever
- Hyperhidrosis
- Hypertriglyceridemia
- Muscle weakness
- Myopathy
- Sleep disorder
- Stomatitis
- Symptoms of anxiety
- Urticaria
- Weight gain
Contraindicated
None
Severe Precaution
Rilpivirine
Reported risk of depression, mood changes, suicidal ideation in adults. Safety and efficacy not established age < 12 years or weight < 35 kg.
- 1 Day – 12 Years
- Reported risk of depression, mood changes, suicidal ideation in adults. Safety and efficacy not established age < 12 years or weight < 35 kg.
Management or Monitoring Precaution
Emtricitabine_Rilpivirine_Tenofov
Risk of lower bone density than expected for developing pediatric patients with tenofovir use. Assess BMD with history of fracture or bone loss.
- 12 Years – 18 Years
- Risk of lower bone density than expected for developing pediatric patients with tenofovir use. Assess BMD with history of fracture or bone loss.
Emtricitabine
- Severity Level:
2
- Additional Notes: Available human data show no increased risk for major malformations.
Rilpivirine
- Severity Level:
2
- Additional Notes: Available human data suggests no known risk
Tenofovir Alafenamide
- Severity Level:
2
- Additional Notes: Insuff human data; animal data do not sug dev tox
Contraindicated
Emtricitabine
Cdc does not recommend breastfeeding in hiv-positive women.
Cdc does not recommend breastfeeding in hiv-positive women
General | Excretion Potential | Effect on Infant | Notes |
Drug should not be given to breast feeding mothers | Excreted | Not known; no or inclusive data | Cdc does not recommend breastfeeding in hiv-positive women. |
Rilpivirine
Cdc does not recommend breastfeeding in hiv-positive women.
Cdc does not recommend breastfeeding in hiv-positive women
General | Excretion Potential | Effect on Infant | Notes |
Drug should not be given to breast feeding mothers | Unknown | Not known; no or inclusive data | Cdc does not recommend breastfeeding in hiv-positive women |
Precaution Exists
Tenofovir
Limited data suggest no known adverse effects in nursing infant
General | Excretion Potential | Effect on Infant | Notes |
Evaluate use carefully | Excreted | Not known; no or inclusive data | Limited data suggest no known adverse effects in nursing infant |
No Known Risk
None
General | Excretion Potential | Effect on Infant | Notes |
None |
Contraindicated
None
Precaution Exists
Emtricitabine
Renal- Adhere to manufacturer guidelines for renal impairment and lower CrCL.
Musculoskeletal-Decreases in bone mineral density have been observed. Consider calcium and vitamin D3 supplementation.
Organ / System | HEP | REN | CARD | ENDO | NEURO / PSYCH | PULM |
Increased Risk / Adverse Effects | Y | Y | N | N | N | N |
BEERS: N HEDIS: N STOPP: N
Tenofovir Alafenamide
Renal- Adhere to manufacturer guidelines for renal impairment and lower CrCL.
Musculoskeletal-Decreases in bone mineral density have been observed. Consider calcium and vitamin D3 supplementation.
Organ / System | HEP | REN | CARD | ENDO | NEURO / PSYCH | PULM |
Increased Risk / Adverse Effects | Y | Y | Y | N | N | N |
BEERS: N HEDIS: N STOPP: N
No Known Risk
None
- If you have hepatitis B infection, your hepatitis symptoms may get worse or become very serious if you stop taking this medication. Talk with your doctor before stopping this medication. Your doctor will monitor liver tests for several months after you stop emtricitabine/rilpivirine/tenofovir alafenamide. Tell your doctor right away if you have symptoms of worsening liver problems.
HIV infection | |
B20 | Human immunodeficiency virus [HIv] disease |
B97.35 | Human immunodeficiency virus, type 2 [HIV 2] as the cause of diseases classified elsewhere |
O98.7 | Human immunodeficiency virus [HIv] disease complicating pregnancy, childbirth and the puerperium |
O98.71 | Human immunodeficiency virus [HIv] disease complicating pregnancy |
O98.711 | Human immunodeficiency virus [HIv] disease complicating pregnancy, first trimester |
O98.712 | Human immunodeficiency virus [HIv] disease complicating pregnancy, second trimester |
O98.713 | Human immunodeficiency virus [HIv] disease complicating pregnancy, third trimester |
O98.719 | Human immunodeficiency virus [HIv] disease complicating pregnancy, unspecified trimester |
O98.72 | Human immunodeficiency virus [HIv] disease complicating childbirth |
O98.73 | Human immunodeficiency virus [HIv] disease complicating the puerperium |
Z21 | Asymptomatic human immunodeficiency virus [HIv] infection status |
0-9 | A-Z |
---|---|
B20 | Human immunodeficiency virus [HIv] disease |
B97.35 | Human immunodeficiency virus, type 2 [HIV 2] as the cause of diseases classified elsewhere |
O98.7 | Human immunodeficiency virus [HIv] disease complicating pregnancy, childbirth and the puerperium |
O98.71 | Human immunodeficiency virus [HIv] disease complicating pregnancy |
O98.711 | Human immunodeficiency virus [HIv] disease complicating pregnancy, first trimester |
O98.712 | Human immunodeficiency virus [HIv] disease complicating pregnancy, second trimester |
O98.713 | Human immunodeficiency virus [HIv] disease complicating pregnancy, third trimester |
O98.719 | Human immunodeficiency virus [HIv] disease complicating pregnancy, unspecified trimester |
O98.72 | Human immunodeficiency virus [HIv] disease complicating childbirth |
O98.73 | Human immunodeficiency virus [HIv] disease complicating the puerperium |
Z21 | Asymptomatic human immunodeficiency virus [HIv] infection status |