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Dovato
dolutegravir/ lamivudine
Black Box Warnings .
HBV Resistance
test for HBV infection prior to tx start; resistant HBV emergence associated with lamivudine-containing antiretroviral tx reported; initiate additional anti-HBV tx if HBV co-infection or consider alternative antiretroviral regimen
Hepatitis B Exacerbation
severe acute HBV exacerbations in HBV/HIV co-infected patients upon lamivudine D/C; monitor hepatic function closely in HBV/HIV co-infected patients who D/C lamivudine; initiate anti-HBV tx if needed
Adult Dosing .
Dosage forms: TAB: 50 mg/300 mg
HIV infection
- [tx-naive patients]
- Dose: 1 tab PO qd; Info: for patients with HIV-1 RNA <500,000 and no baseline resistance to dolutegravir or lamivudine
- [tx-experienced patients]
- Dose: 1 tab PO qd; Info: for patients with HIV-1 RNA <50 and no known tx failure or resistance to dolutegravir or lamivudine
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 or B: no adjustment; Child-Pugh Class C: not defined
Peds Dosing .
- Dosage forms: TAB: 50 mg/300 mg
HIV infection
- [tx-naive patients, 12 yo and older, >25 kg]
- Dose: 1 tab PO qd; Info: for patients with HIV-1 RNA <500,000 and no baseline resistance to dolutegravir or lamivudine
- [tx-experienced patients, 12 yo and older, >25 kg]
- Dose: 1 tab PO qd; Info: for patients with HIV-1 RNA <50 and no known tx failure or resistance to dolutegravir or lamivudine
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 or B: no adjustment; Child-Pugh Class C: not defined
Contraindications / Cautions .
- hypersensitivity to drug or ingredient
- pregnancy (complete two-drug regimen in tx-naive patients)
- pregnancy (complete two-drug regimen in patients restarting tx)
- pregnancy (complete two-drug regimen in non-virologically suppressed tx-experienced patients)
- 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: CrCl <50
- caution: HIV infection and HBV infection, concurrent
- caution: HIV infection and HCV infection, concurrent
- caution: hepatic disease risk
- caution: obesity
- caution: nucleoside tx, long-term
- caution: pancreatitis history
- caution: pancreatitis risk
- caution: psychiatric disorder
Drug Interactions .
Overview
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
Avoid/Use Alternative
Monitor/Modify Tx
Caution Advised
Adverse Reactions .
Serious Reactions
- hypersensitivity reaction, including multi-organ
- anaphylaxis
- immune reconstitution syndrome
- autoimmune disorder
- neutropenia
- hepatic impairment (HBV or HCV co-infected patients)
- hepatotoxicity
- HBV exacerbation, post-tx (HBV co-infected patients)
- HBV resistance (HBV co-infected patients)
- lactic acidosis
- hepatomegaly with steatosis
- pancreatitis
- peripheral neuropathy
- rhabdomyolysis
- anemia, severe
- suicidality
- myopathy
Common Reactions
- headache
- diarrhea
- nausea
- insomnia
- fatigue
- hyperglycemia
- hyperlipasemia
- CK elevated
- LFTs elevated
- anxiety
- vomiting
- depression
- rash
- abnormal dreams
- arthralgia
- myalgia
- nasal symptoms
- cough
- neuropathy
- anorexia
- dizziness
- musculoskeletal pain
- hyperamylasemia
- neutropenia
- hypercholesterolemia
- weight gain
- Cr incr.
Safety/Monitoring .
Monitoring Parameters
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
Virologically Suppressed Tx-Experienced Patients: may continue use as a complete two-drug regimen during pregnancy; monitor HIV-1 RNA q1-2mo during pregnancy; risk of congenital neural tube defects low with dolutegravir based on human data; no known risk of teratogenicity with lamivudine, though possible risk of neonatal mitochondrial dysfunction and anemia based on limited human data
All Other Patients: avoid use during pregnancy as a complete two-drug regimen, otherwise may use during pregnancy with other antiretrovirals; risk of congenital neural tube defects low with dolutegravir based on human data; no known risk of teratogenicity with lamivudine, 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; 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 dolutegravir based on 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 dolutegravir: liver primarily; CYP450: 3A substrate (minor); UGT: 1A1 (primary), 1A3, 1A9 substrate; for lamivudine: intracellular; CYP450: minimal; Info: active metabolite
Excretion: for dolutegravir: feces primarily (53% unchanged), urine 31% (<1% unchanged); Half-life: 14h; for lamivudine: urine 70% (primarily unchanged); Half-life: 13-19h
Subclass: HIV: Integrase Strand Transfer Inhibitors (INSTIs) ; HIV: Nucleoside/Nucleotide Reverse Transcriptase Inhibitors (NRTIs)
Mechanism of Action
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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