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Abacavir And Lamivudine

Also known as: Abacavir And Lamivudine

Hepatitis B Virus Nucleoside Analog Reverse Transcriptase InhibitorHuman Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase InhibitorNucleoside Reverse Transcriptase Inhibitors

Route: Oral

Check Abacavir And Lamivudine Interactions →

5 interactions on record⛔ Black Box Warning

Abacavir And Lamivudine has 5 known drug interactions based on U.S. FDA drug labeling data. Notable interactions include combinations with Methadone, Riociguat, Sorbitol. Patients taking Abacavir And Lamivudine should inform their healthcare provider of all current medications — including over-the-counter drugs and supplements — to avoid potentially harmful combinations. Data sourced from OpenFDA and the NIH National Library of Medicine.

Total: 5
Moderate: 3

Moderate (3)

Abacavir And Lamivudine + Methadone— Increased methadone clearance; an increased methadone dose may be required in a small number of patients receiving abaca…
Abacavir And Lamivudine + Riociguat— Coadministration increases riociguat exposure, which may increase the risk of riociguat adverse reactions; riociguat dos…
Abacavir And Lamivudine + Sorbitol— Coadministration may decrease lamivudine concentrations; avoid chronic coadministration of sorbitol-containing medicines…

Abacavir And Lamivudine + Methadone🟡Moderate

Increased methadone clearance; an increased methadone dose may be required in a small number of patients receiving abacavir.

Abacavir And Lamivudine + Riociguat🟡Moderate

Coadministration increases riociguat exposure, which may increase the risk of riociguat adverse reactions; riociguat dose may need to be reduced.

Abacavir And Lamivudine + Sorbitol🟡Moderate

Coadministration may decrease lamivudine concentrations; avoid chronic coadministration of sorbitol-containing medicines with lamivudine when possible.

Abacavir And Lamivudine + Abacavirℹ️Unknown

7.3 Riociguat Coadministration with fixed-dose abacavir/dolutegravir/lamivudine resulted in increased riociguat exposure, which may increase the risk of riociguat adverse reactions [see Clinical Pharmacology (12.3) ] .

Abacavir And Lamivudine + Dolutegravirℹ️Unknown

⛔ FDA Black Box Warning

WARNING: HYPERSENSITIVITY REACTIONS and EXACERBATIONS OF HEPATITIS B Hypersensitivity Reactions Serious and sometimes fatal hypersensitivity reactions, with multiple organ involvement, have occurred with abacavir, a component of abacavir and lamivudine tablets Patients who carry the HLA-B*5701 allele are at a higher risk of a hypersensitivity reaction to abacavir; although, hypersensitivity reactions have occurred in patients who do not carry the HLA-B*5701 allele [see Warnings and Precautions ( 5.1 )]. Abacavir and lamivudine tablets is contraindicated in patients with a prior hypersensitivity reaction to abacavir and in HLA-B*5701-positive patients [see Contraindications ( 4 ), Warnings and Precautions ( 5.1 )]. All patients should be screened for the HLA-B*5701 allele prior to initiating therapy with abacavir and lamivudine tablets or reinitiation of therapy with abacavir and lamivudine tablets unless patients have a previously documented HLA-B*5701 allele assessment. Discontinue abacavir and lamivudine tablets immediately if a hypersensitivity reaction is suspected, regardless of HLA-B*5701 status and even when other diagnoses are possible [see Contraindications ( 4 ), Warnings and Precautions ( 5.1 )]. Following a hypersensitivity reaction to abacavir and lamivudine tablets, NEVER restart abacavir and lamivudine tablets or any other abacavir-containing product because more severe symptoms, including death, can occur within hours. Similar severe reactions have also occurred rarely following the reintroduction of abacavir-containing products in patients who have no history of abacavir hypersensitivity [see Warnings and Precautions ( 5.1 )]. Exacerbations of Hepatitis B Severe acute exacerbations of hepatitis B have been reported in patients who are co-infected with hepatitis B virus (HBV) and human immunodeficiency virus (HIV-1) and have discontinued lamivudine, which is a component of abacavir and lamivudine tablets. Hepatic function should be monitored closely

Contraindications

4 CONTRAINDICATIONS Abacavir and lamivudine tablets is contraindicated in patients: • who have the HLA-B*5701 allele [see Warnings and Precautions ( 5.1 )]. • with prior hypersensitivity reaction to abacavir [see Warnings and Precautions ( 5.1 )] or lamivudine. • with moderate or severe hepatic impairment [see Use in Specific Populations ( 8.7 )]. • Presence of HLA-B*5701 allele. ( 4 ) • Prior hypersensitivity reaction to abacavir or lamivudine. ( 4 ) • Moderate or severe hepatic impairment. ( 4 , 8.7 )

Pregnancy & Breastfeeding

8.1 Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to abacavir and lamivudine tablets during pregnancy. Healthcare providers are encouraged to register patients by calling the Antiretroviral Pregnancy Registry (APR) at 1-800-258-4263. Risk Summary Available data from the APR show no difference in the overall risk of birth defects for abacavir or lamivudine compared with the background rate for birth defects of 2.7% in the Metropolitan Atlanta Congenital Defects Program (MACDP) reference population (see Data). The APR uses the MACDP as the U.S. reference population for birth defects in the general population. The MACDP evaluates women and infants from a limited geographic area and does not include outcomes for births that occurred at less than 20 weeks’ gestation. The rate of miscarriage is not reported in the APR. The estimated background rate of miscarriage in clinically recognized pregnancies in the U.S. general population is 15% to 20%. The background risk for major birth defects and miscarriage for the indicated population is unknown. In animal reproduction studies, oral administration of abacavir to pregnant rats during organogenesis resulted in fetal malformations and other embryonic and fetal toxicities at exposures 35 times the human exposure (AUC) at the recommended clinical daily dose. However, no adverse developmental effects were observed following oral administration of abacavir to pregnant rabbits during organogenesis, at exposures approximately 9 times the human exposure (AUC) at the recommended clinical dose. Oral administration of lamivudine to pregnant rabbits during organogenesis resulted in embryolethality at systemic exposure (AUC) similar to the recommended clinical dose; however, no adverse development effects were observed with oral administration of lamivudine to pregnant rats during organogenesis at plasma concentrations (C max ) 35 times the recommended clinica

Data sourced from U.S. FDA drug labeling via openFDA and the NIH National Library of Medicine. For informational purposes only. Always consult your pharmacist or physician.