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Triumeq PD
abacavir/ dolutegravir/ lamivudine
Black Box Warnings .
Hypersensitivity Reaction
serious or fatal hypersensitivity reaction have occurred with abacavir-containing products; abacavir hypersensitivity is a multi-organ clinical syndrome; HLA-B*57:01 allele carriers at higher risk of hypersensitivity reactions; abacavir/dolutegravir/lamivudine contraindicated in HLA-B*57:01-positive patients or in patients with prior hypersensitivity reaction to abacavir; permanently D/C if hypersensitivity reaction suspected or cannot be ruled out, regardless of HLA-B*57:01 status; NEVER restart any abacavir-containing products after hypersensitivity reaction
Hepatitis B Exacerbation
all patients with HIV infection should be tested for HBV before starting abacavir/dolutegravir/lamivudine; lamividine-resistant HBV variants associated with lamivudine-containing regimens reported; consider additional tx for chronic HBV tx if abacavir/dolutegravir/lamivudine used in HBV/HIV co-infected patients, or consider alternative regimen; severe acute HBV exacerbations in HBV/HIV co-infected patients upon lamivudine D/C; monitor hepatic function closely for at least several months in HBV/HIV co-infected patients who D/C abacavir/dolutegravir/lamivudine; initiate anti-HBV tx if needed
Adult Dosing .
Adult dosing is currently unavailable or not applicable for this drug.
Peds Dosing .
- Dosage forms: DISPERSE TAB: 60 mg/5 mg/30 mg
Special Note
- [equivalency or interchangeability info]
- Info: not interchangeable with abacavir/dolutegravir/lamivudine tabs; do not substitute on a mg to mg basis
HIV infection
- [3 mo and older, 6-9 kg]
- Dose: 3 tabs PO qd; Info: D/C drug and do not restart if hypersensitivity reaction suspected; do not cut/crush/chew tab or swallow tab whole
- [3 mo and older, 10-13 kg]
- Dose: 4 tabs PO qd; Info: D/C drug and do not restart if hypersensitivity reaction suspected; do not cut/crush/chew tab or swallow tab whole
- [3 mo and older, 14-19 kg]
- Dose: 5 tabs PO qd; Info: D/C drug and do not restart if hypersensitivity reaction suspected; do not cut/crush/chew tab or swallow tab whole
- [3 mo and older, 20-24 kg]
- Dose: 6 tabs PO qd; Info: D/C drug and do not restart if hypersensitivity reaction suspected; do not cut/crush/chew tab or swallow tab whole
renal dosing
- [see below]
- CrCl 30-49: avoid use if lamivudine-related toxicities, dose adjustment not possible with fixed-dose combo, otherwise no adjustment; CrCl <30: avoid use, dose adjustment not possible with fixed-dose combo
- HD/PD: avoid use, dose adjustment not possible with fixed-dose combo
hepatic dosing
- [see below]
- Child-Pugh Class A: avoid use, dose adjustment not possible with fixed-dose combo; Child-Pugh Class B or C: contraindicated
Contraindications / Cautions .
- hypersensitivity to drug or ingredient
- HLA-B*57:01 allele carriers
- INSTI-experienced patients with INSTI resistance
- hepatic impairment
- avoid: breastfeeding (patients with non-virological suppression throughout 3rd trimester)
- avoid: breastfeeding (patients with non-virological suppression postpartum)
- avoid: breastfeeding (patients with cracked nipple or bleeding nipple)
- avoid: breastfeeding (patients with mastitis)
- caution: hepatic disease risk
- caution: HIV infection and HBV infection, concurrent
- caution: HIV infection and HCV infection, concurrent
- caution: cardiovascular disease risk
- caution: CrCl <50
- caution: obesity
- caution: psychiatric disorder
- caution: nucleoside tx, long-term
Drug Interactions .
Overview
abacavir
NRTI
- CYP1A1 inhibitor
- intracellular phosphorylation inhibitor
- affected by altered fat absorption
- interferes w/ gene therapy
- some formulations of abacavir contain sorbitol
dolutegravir
HIV integrase inhibitor
- CYP3A4 substrate
- UGT1A1 substrate
- BCRP substrate
- P-gp substrate
- MATE1 inhibitor
- OCT2 inhibitor
- affected by altered fat absorption
- binds to polyvalent cations
- interferes w/ gene therapy
lamivudine
NRTI
- MATE1 substrate
- MATE2-K substrate
- OCT2 substrate
- intracellular phosphorylation inhibitor
- affected by altered fat absorption
- affected by altered gastrointestinal motility
- interferes w/ gene therapy
- avoid combo of lamivudine oral solution with oral products containing sorbitol; may give lamivudine tab formulation or monitor virologic response more frequently if combo cannot be avoided; sorbitol may decr. bioavailability of lamivudine, resulting in decr. levels, efficacy
Contraindicated
- dofetilide
Avoid/Use Alternative
- apalutamide
- armodafinil
- atidarsagene autotemcel
- belzutifan
- betibeglogene autotemcel
- bexarotene
- bictegravir
- bosentan
- brigatinib
- butalbital
- carbamazepine
- cenobamate
- cladribine oral
- clobazam
- dabrafenib
- danshen
- darolutamide
- dexamethasone
- dicloxacillin
- echinacea
- elafibranor
- elagolix
- elivaldogene autotemcel
- enasidenib
- encorafenib
- enzalutamide
- eslicarbazepine acetate
- etravirine
- felbamate
- fexinidazole
- fosamprenavir
- fosphenytoin
- garlic
- ginkgo
- ginseng, Asian
- glycerol phenylbutyrate
- griseofulvin
- ivosidenib
- lorlatinib
- lovotibeglogene autotemcel
- lumacaftor/ivacaftor
- mavacamten
- mitapivat
- mitotane
- mobocertinib
- modafinil
- nafcillin
- nevirapine
- odevixibat
- olutasidenib
- omaveloxolone
- orlistat
- oxcarbazepine
- pacritinib
- pentobarbital
- perampanel
- pexidartinib
- phenobarbital
- phenytoin
- pioglitazone
- primidone
- repotrectinib
- rifapentine
- rufinamide
- sarilumab
- sorbitol
- sorbitol (in some formulations)
- sotorasib
- St. John's wort
- stiripentol
- sunvozertinib
- suzetrigine
- tazemetostat
- tecovirimat
- tocilizumab
- topiramate
- tovorafenib
- valproic acid
- vamorolone
- vemurafenib
- vinblastine
- vorasidenib
- zanubrutinib
Monitor/Modify Tx
- aluminum hydroxide
- calcium acetate
- calcium carbonate
- calcium citrate
- calcium gluconate
- chromium
- crizotinib
- efavirenz
- etuvetidigene autotemcel
- ferric citrate
- ferric maltol
- ferrous fumarate
- ferrous gluconate
- ferrous sulfate
- lanthanum
- magnesium carbonate
- magnesium citrate
- magnesium hydroxide
- magnesium oxide
- magnesium supplement
- metformin
- molindone
- pindolol
- procainamide
- quinapril
- rifampin
- riociguat
- sucralfate
- sucroferric oxyhydroxide
- sulfate bowel prep
- tipranavir
- zinc oral
Caution Advised
- abemaciclib
- arimoclomol
- artemether/lumefantrine
- capmatinib
- cephalexin
- cimetidine
- cobicistat
- dalfampridine
- dolutegravir
- entecavir
- fedratinib
- gilteritinib
- givinostat
- isavuconazonium
- ketoconazole
- lamivudine
- lamotrigine
- levoketoconazole
- memantine
- meropenem
- methadone
- niraparib
- olaparib
- ondansetron
- pramipexole
- pyrimethamine
- quinidine (antiarrhythmic)
- ranolazine
- ribociclib
- risdiplam
- tafenoquine
- telotristat ethyl
- triamterene
- trilaciclib
- tucatinib
- turmeric
- vaborbactam
- vandetanib
- verapamil
- vimseltinib
Adverse Reactions .
Serious Reactions
- hypersensitivity reaction, including multi-organ
- anaphylaxis
- Stevens-Johnson syndrome
- toxic epidermal necrolysis
- rash, severe
- lactic acidosis
- hepatomegaly with steatosis
- hepatic impairment (HBV or HCV co-infected patients)
- HBV exacerbation, post-tx (HBV co-infected patients)
- HBV resistance (HBV co-infected patients)
- hepatotoxicity
- pancreatitis
- immune reconstitution syndrome
- autoimmune disorder
- MI
- rhabdomyolysis
- myopathy
- anemia, severe
- neutropenia
- peripheral neuropathy
- suicidality
Common Reactions
- hyperlipasemia
- hyperglycemia
- CK elevated
- neutropenia
- insomnia
- LFTs elevated
- headache
- fatigue
- hypersensitivity reaction
- diarrhea
- hypercholesterolemia
- weight gain
- nasal symptoms
- cough
- neuropathy
- anorexia
- dizziness
- hyperamylasemia
- anxiety
- Cr incr.
Safety/Monitoring .
Monitoring Parameters
HLA-B*57:01 genotyping before tx start; hepatitis B serology including HBsAg at baseline; Cr at baseline, 2-8wk after tx start or change, then q3-6mo; LFTs at baseline, 2-8wk after tx start or change, then q3-6mo, then if HBV co-infection, continue for several mo after D/C
Pregnancy/Lactation .
Pregnancy
Clinical Summary
abacavir: benefits outweigh risks during pregnancy; no known risk of teratogenicity based on human data
dolutegravir: may use during pregnancy; risk of congenital neural tube defects low based on human data
lamivudine: benefits outweigh risks during pregnancy; no known risk of teratogenicity, though possible risk of neonatal mitochondrial dysfunction and anemia based on limited human data
Pregnancy Registry
enroll patients in Antiretroviral Pregnancy Registry at 1-800-258-4263; additional info at www.apregistry.com
Lactation
Clinical Summary
weigh risk/benefit if virologically suppressed throughout 3rd trimester and at delivery, otherwise avoid breastfeeding; avoid breastfeeding if mastitis or nipples cracked or bleeding; give infant antiretroviral prophylaxis with zidovudine or nevirapine; consider screening infant for HLA-B*57:01 allele status; risk of postnatal HIV transmission if non-virologically suppressed based on human data; risk of postnatal HIV transmission low if virologically suppressed based on limited human data; risk of infant harm low with abacavir based on limited human data and limited drug excretion into milk; risk of infant harm low with dolutegravir based on limited human data; no known risk of infant harm with lamivudine based on human data; no human data available to assess effects on milk production
Pharmacology .
Metabolism: for abacavir: liver; CYP450: none; for dolutegravir: liver primarily; CYP450: 3A substrate (minor); UGT: 1A1 (primary), 1A3, 1A9 substrate; for lamivudine: intracellular; CYP450: minimal; Info: active metabolite
Excretion: for abacavir: urine 82.2% (1.2% unchanged), feces 16%; Half-life: 1.5h, 2.4h (Child-Pugh score 5-6); for dolutegravir: feces primarily (53% unchanged), urine 31% (<1% unchanged); Half-life: 14h; for lamivudine: urine (primarily unchanged); Half-life: 5-7h
Subclass: HIV: Integrase Strand Transfer Inhibitors (INSTIs) ; HIV: Nucleoside/Nucleotide Reverse Transcriptase Inhibitors (NRTIs)
Mechanism of Action
for abacavir: inhibits reverse transcriptase and incorporates into viral DNA, resulting in DNA chain termination; for dolutegravir: inhibits HIV integrase, preventing viral DNA insertion into host cell DNA; for lamivudine: inhibits reverse transcriptase and incorporates into viral DNA, resulting in DNA chain termination
Formulary .
No Formulary Selected
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