HIV Treatment Information for Pregnant Women

Dosing Information for Pregnant Women

*Please refer to the most current drug label for adult patients with renal impairment.

For all drugs, adults formulation only provided.

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Dosing Information for Pregnant Women
Brand	Generic	Drug Class	Dosage Form	Use in Pregnancy Conditions	Pregnancy (Section 8.1)	Visit Drugs@FDA to view
Atripla*	efavirenz 600 mg emtricitabine 200 mg tenofovir disoproxil fumarate 300 mg	Fixed Dose Combination Product	Oral Tablet	Embryo-Fetal Toxicity		Atripla Label
Biktarvy*	bictegravir 50 mg emtricitabine 200 mg tenofovir Alafenamide 25 mg	Fixed Dose Combination Product	Oral Tablet	Dosing information not available for certain component(s) in the fixed dose combination	Human Data	Biktarvy Label
Cimduo*	lamivudine 300 mg tenofovir disoproxil fumarate 300 mg	Fixed Dose Combination Product	Oral Tablet	No dose adjustment needed	Human Data	Cimduo Label
Combivir*	zidovudine 300 mg lamivudine 150 mg	Fixed Dose Combination Product	Oral Tablet	No dose adjustment needed	Human Data	Combivir Label
Complera*	emtricitabine 200 mg rilpivirine 25 mg tenofovir disoproxil fumarate 300 mg	Fixed Dose Combination Product	Oral Tablet	For pregnant women who are already on COMPLERA prior to pregnancy and are virologically suppressed (HIV-1 RNA less than 50 copies per mL), one tablet of COMPLERA taken once daily may be continued. Lower exposures of rilpivirine, a component of COMPLERA, were observed during pregnancy, therefore viral load should be monitored closely [see Use in Specific Populations (8.1) and Clinical Pharmacology (12.3)]. Pharmacokinetics: Pregnancy and Postpartum	Human Data	Complera Label
Delstrigo*	doravirine 100 mg lamivudine 300 mg tenofovir disoproxil fumarate 300 mg	Fixed Dose Combination Product	Oral Tablet	Dosing information not available for certain component(s) in the fixed dose combination		Delstrigo Label
Descovy*	emtricitabine 200 mg tenofovir alafenamide 25 mg	Fixed Dose Combination Product	Oral Tablet	Dosing information not available for certain component(s) in the fixed dose combination	Human Data	Descovy Label
Dovato*	dolutegravir 50 mg lamivudine 300 mg	Fixed Dose Combination Product	Oral Tablet	Perform pregnancy testing before initiation of DOVATO in individuals of childbearing potential [see Warnings and Precautions (5.4), Use in Specific Populations (8.1, 8.3)]. Embryo-Fetal Toxicity	Human Data	Dovato Label
Epzicom*	abacavir 600 mg lamivudine 300 mg	Fixed Dose Combination Product	Oral Tablet	No dose adjustment needed Pharmacokinetics: Pregnant Women	Human Data	Epzicom Label
Evotaz*	atazanavir 300 mg cobicistat 150 mg	Fixed Dose Combination Product	Oral Tablet	Dosing information not available for certain component(s) in the fixed dose combination		Evotaz Label
Genvoya*	elvitegravir 150 mg cobicistat 150 mg tenofovir alafenamide 10 mg emtricitabine 200 mg	Fixed Dose Combination Product	Oral Tablet	• GENVOYA is not recommended for use during pregnancy because of substantially lower exposures of cobicistat and elvitegravir during the second and third trimesters [see Use in Specific Populations (8.1)]. • GENVOYA should not be initiated in pregnant women. An alternative regimen is recommended for women who become pregnant during therapy with GENVOYA [see Use in Specific Populations (8.1)].	Human Data	Genvoya Label
Juluca	dolutegravir 50 mg rilpivirine 25 mg	Fixed Dose Combination Product	Oral Tablet	Perform pregnancy testing before initiation of JULUCA in adolescents and adults of childbearing potential [see Warnings and Precautions (5.3), Use in Specific Populations (8.1, 8.3)]. Embryo-Fetal Toxicity	Human Data	Juluca Label
Kaletra	lopinavir 100 mg and ritonavir 25 mg lopinavir 200 mg and ritonavir 50 mg	Fixed Dose Combination Product	Oral Tablet	• Administer 400/100 mg of KALETRA twice daily in pregnant women with no documented lopinavir-associated resistance substitutions. • Once daily KALETRA dosing is not recommended in pregnancy [see Use in Specific Populations (8.1) and Clinical Pharmacology (12.3)]. • There are insufficient data to recommend dosing in pregnant women with any documented lopinavir-associated resistance substitutions. • No dosage adjustment of KALETRA is required for patients during the postpartum period. • Avoid use of KALETRA oral solution in pregnant women [see Use in Specific Populations (8.1)]. Pharmacokinetics: Pregnancy		Kaletra Label
Odefsey*	emtricitabine 200 mg rilpivirine 25 mg tenofovir alafenamide 25 mg	Fixed Dose Combination Product	Oral Tablet	For pregnant patients who are already on ODEFSEY prior to pregnancy and are virologically suppressed (HIV-1 RNA less than 50 copies per mL), one tablet of ODEFSEY taken once daily may be continued. Lower exposures of rilpivirine, a component of ODEFSEY, were observed during pregnancy, therefore viral load should be monitored closely [see Use in Specific Populations (8.1) and Clinical Pharmacology (12.3)]. Pharmacokinetics: Pregnancy and Postpartum	Human Data	Odefsey Label
Prezcobix	darunavir 800 mg cobicistat 150 mg	Fixed Dose Combination Product	Oral Tablet	PREZCOBIX is not recommended during pregnancy because of substantially lower exposures of darunavir and cobicistat during the second and third trimesters [see Use in Specific Populations (8.1) and Clinical Pharmacology (12.3)]. PREZCOBIX should not be initiated in pregnant women. An alternative regimen is recommended for women who become pregnant during therapy with PREZCOBIX. Pharmacokinetics: Pregnancy and Postpartum	Human Data	Prezcobix Label
Stribild*	elvitegravir 150 mg cobicistat 150 mg emtricitabine 200 mg tenofovir disoproxil fumarate 300 mg	Fixed Dose Combination Product	Oral Tablet	STRIBILD is not recommended for use during pregnancy because of substantially lower exposures of cobicistat and elvitegravir during the second and third trimesters [see Use in Specific Populations (8.1)]. STRIBILD should not be initiated in pregnant women. An alternative regimen is recommended for women who become pregnant during therapy with STRIBILD [see Use in Specific Populations (8.1)].	Human Data	Stribild Label
Symfi*	efavirenz 600 mg lamivudine 300 mg tenofovir disoproxil fumarate 300 mg	Fixed Dose Combination Product	Oral Tablet	Embryo-Fetal Toxicity	Human Data	Symfi Label
Symfi Lo*	efavirenz 400 mg lamivudine 300 mg tenofovir disoproxil fumarate 300 mg	Fixed Dose Combination Product	Oral Tablet	Embryo-Fetal Toxicity	Human Data	Symfi Lo Label
Symtuza*	darunavir 800 mg cobicistat 150 mg emtricitabine 200 mg tenofovir alafenamide 10 mg	Fixed Dose Combination Product	Oral Tablet	SYMTUZA is not recommended during pregnancy because of substantially lower exposures of darunavir and cobicistat during the second and third trimesters [see Use in Specific Populations (8.1) and Clinical Pharmacology (12.3)]. SYMTUZA should not be initiated in pregnant women. An alternative regimen is recommended for women who become pregnant during therapy with SYMTUZA. Pharmacokinetics: Pregnancy and Postpartum	Human Data	Symtuza Label
Triumeq*	dolutegravir 50 mg abacavir 600 mg lamivudine 300 mg	Fixed Dose Combination Product	Oral Tablet	Perform pregnancy testing before initiation of TRIUMEQ in adolescents and adults of childbearing potential [see Warnings and Precautions (5.6), Use in Specific Populations (8.1, 8.3)]. Embryo-Fetal Toxicity	Human Data	Triumeq Label
Trizivir*	abacavir 300 mg lamivudine 150 mg zidovudine 300 mg	Fixed Dose Combination Product	Oral Tablet	No dose adjustment needed Pharmacokinetics: Pregnant Women	Human Data	Trizivir Label
Truvada*	emtricitabine (FTC), tenofovir disoproxil fumarate (TDF): 100 mg FTC/150 mg TDF 133 mg FTC/200 mg TDF 167 mg FTC/250 mg TDF 200 mg FTC/300 mg TDF	Fixed Dose Combination Product	Oral Tablet	No dose adjustment needed	Human Data	Truvada Label
Emtriva*	emtricitabine 200 mg	Nucleoside Reverse Transcriptase Inhibitors	Oral Capsule	No dose adjustment needed	Human Data	Emtriva Label
Epivir*	lamivudine 150 mg, 300 mg	Nucleoside Reverse Transcriptase Inhibitors	Oral Tablet	No dose adjustment needed Pharmacokinetics: Pregnant Women	Human Data	Epivir Label
Retrovir*	zidovudine 100 mg	Nucleoside Reverse Transcriptase Inhibitor	Oral Capsule	The recommended dosage regimen for administration to pregnant women (greater than 14 weeks of pregnancy) and their neonates is: Maternal Dosing 100 mg orally 5 times per day until the start of labor [see Clinical Studies (14.3)]. During labor and delivery, intravenous RETROVIR should be administered at 2 mg per kg (total body weight) over 1 hour followed by a continuous intravenous infusion of 1 mg per kg per hour (total body weight) until clamping of the umbilical cord. Pharmacokinetics: Pregnant Women	Human Data	Retrovir Label
Retrovir*	zidovudine 20-ml single-use vial (10 mg/mL)	Nucleoside Reverse Transcriptase Inhibitor	Intravenous Injection	The recommended dosage regimen for administration to pregnant women (greater than 14 weeks of pregnancy) and their neonates is: Maternal Dosing During labor and delivery, intravenous RETROVIR should be administered at 2 mg per kg (total body weight) over 1 hour followed by a continuous intravenous infusion of 1 mg per kg per hour (total body weight) until clamping of the umbilical cord. Pharmacokinetics: Pregnant Women	Human Data	Retrovir Label
Temixys*	lamivudine 300 mg tenofovir disoproxil fumarate 300 mg	Nucleoside Reverse Transcriptase Inhibitors	Oral Tablet	No dose adjustment needed	Human Data	Temixys Label
Videx*	didanosine 2 g, 4 g	Nucleoside Reverse Transcriptase Inhibitor	Oral Powder for Solution	Lactic Acidosis and Severe Hepatomegaly with Steatosis		Videx Label
Videx EC*	didanosine delayed-release capsule 125 mg, 200 mg, 250 mg, 400 mg	Nucleoside Reverse Transcriptase Inhibitor	Oral Capsule	Lactic Acidosis and Severe Hepatomegaly with Steatosis		Videx EC Label
Viread*	tenofovir disoproxil fumarate 150 mg, 200 mg, 250 mg, 300 mg	Nucleoside Reverse Transcriptase Inhibitor	Oral Tablet	No dose adjustment needed	Human Data	Viread Label
Zerit*	stavudine 15 mg, 20 mg, 30 mg, 40 mg	Nucleoside Reverse Transcriptase Inhibitor	Oral Capsule	Lactic Acidosis and Severe Hepatomegaly with Steatosis		Zerit Label
Ziagen	abacavir 300 mg	Nucleoside Reverse Transcriptase Inhibitor	Oral Tablet	No dose adjustment needed Pharmacokinetics: Pregnant Women		Ziagen Label
Edurant	rilpivirine 25 mg	Nonnucleoside Reverse Transcriptase Inhibitor	Oral Tablet	For pregnant women who are already on a stable EDURANT regimen prior to pregnancy and who are virologically suppressed (HIV-1 RNA less than 50 copies per mL) the recommended dosage is one 25 mg tablet once daily taken orally with a meal. Lower exposures of rilpivirine were observed during pregnancy, therefore viral load should be monitored closely [see Use in Specific Populations (8.1) and Clinical Pharmacology (12.3)]. Pharmacokinetics: Pregnancy and Postpartum	Human Data	Edurant Label
Intelence	etravirine 100 mg, 200 mg	Nonnucleoside Reverse Transcriptase Inhibitor	Oral Tablet	No dose adjustment needed Pharmacokinetics: Pregnancy and Postpartum	Human Data	Intelence Label
Pifeltro	doravirine 100 mg	Nonnucleoside Reverse Transcriptase Inhibitor	Oral Tablet	No dosing information available		Pifeltro Label
Rescriptor	delavirdine 200 mg	Nonnucleoside Reverse Transcriptase Inhibitor	Oral Tablet	No dosing information available	Pregnancy Data	Rescriptor Label
Sustiva	efavirenz 600 mg	Nonnucleoside Reverse Transcriptase Inhibitor	Oral Tablet	Embryo-Fetal Toxicity		Sustiva Label
Viramune*	nevirapine 200 mg	Nonnucleoside Reverse Transcriptase Inhibitor	Oral Tablet	No dosing information available	Human Data	Viramune Label
Viramune XR*	nevirapine extended-release 400 mg	Nonnucleoside Reverse Transcriptase Inhibitor	Oral Extended-Release Tablet	No dosing information available		Viramune XR Label
Aptivus	tipranavir 250 mg	Protease Inhibitor	Oral Capsule	No dosing information available		Aptivus Label
Crixivan	indinavir 200 mg, 400 mg	Protease Inhibitor	Oral Capsule	Optimal dosing regimen has not been established	Pregnant Women	Crixivan Label
Invirase	saquinavir mesylate 500 mg	Protease Inhibitor	Oral Tablet	No dosing information available	Human Data	Invirase Label
Lexiva	fosamprenavir 700 mg	Protease Inhibitor	Oral Tablet	Dosing of LEXIVA 700 mg twice daily plus ritonavir 100 mg twice daily should only be considered in pregnant women who are already on a stable twice-daily regimen of LEXIVA/ritonavir 700 mg/100 mg prior to pregnancy and who are virologically suppressed (HIV-1 RNA less than 50 copies per mL). Lower exposures of amprenavir were observed during pregnancy; therefore, viral load should be monitored closely to ensure viral suppression is maintained [see Use in Specific Populations (8.1), Clinical Pharmacology (12.3)]. Data regarding use of other regimens of LEXIVA (with or without ritonavir) in pregnancy are not available. Pharmacokinetics: Pregnant Women	Human Data	Lexiva Label
Norvir	ritonavir 100 mg/packet	Protease Inhibitor	Oral Packet	No dosing information available for the approved treatment dose of 600 mg twice daily. Refer to other protease inhibitors for dosing with ritonavir as a cytochrome CYP3A inhibitor	Human Data	Norvir Label
Norvir	ritonavir 100 mg	Protease Inhibitor	Oral Tablet	No dosing information available for the approved treatment dose of 600 mg twice daily. Refer to other protease inhibitors for dosing with ritonavir as a cytochrome CYP3A inhibitor	Human Data	Norvir Label
Norvir	ritonavir 80 mg/mL	Protease Inhibitor	Oral Solution	NORVIR oral solution is NOT recommended during pregnancy due to its ethanol content. NORVIR oral solution contains the excipients ethanol (approx. 43% v/v) and propylene glycol (approx. 27% w/v) [see Use in Specific Populations (8.1)].	Human Data	Norvir Label
Prezista	darunavir 75 mg, 150 mg, 600 mg, 800 mg	Protease Inhibitor	Oral Tablet	The recommended dosage in pregnant women is PREZISTA 600 mg taken with ritonavir 100 mg twice daily with food. PREZISTA 800 mg taken with ritonavir 100 mg once daily should only be considered in certain pregnant women who are already on a stable PREZISTA 800 mg with ritonavir 100 mg once daily regimen prior to pregnancy, are virologically suppressed (HIV-1 RNA less than 50 copies per mL), and in whom a change to twice daily PREZISTA 600 mg with ritonavir 100 mg may compromise tolerability or compliance. Pharmacokinetics: Pregnancy and Postpartum	Human Data	Prezista Label
Reyataz*	atazanavir sulfate 150 mg, 200 mg, 300 mg	Protease Inhibitor	Oral Capsule	Dosing with Ritonavir Pharmacokinetics: Pregnancy	Human Data	Reyataz Label
Viracept	nelfinavir mesylate 250 mg, 625 mg	Protease Inhibitor	Oral Tablet	No dosing information available		Viracept Label
Fuzeon	enfuvirtide 90 mg/vial	Fusion Inhibitor	Subcutaneous Injection	No dosing information available		Fuzeon Label
Selzentry*	maraviroc 25 mg, 75 mg, 150 mg, 300 mg	Entry Inhibitors - CCR5 co-receptor antagonist	Oral Tablet	No dosing information available		Selzentry Label
Isentress	raltegravir 400 mg	Integrase Inhibitor	Oral Tablet	No dosing information available	Human Data	Isentress Label
Isentress HD	raltegravir 600 mg	Integrase Inhibitor	Oral Tablet	No dosing information available		Isentress Label
Tivicay*	dolutegravir 10 mg, 25mg, 50 mg	Integrase Inhibitor	Oral Tablet	Perform pregnancy testing before initiation of TIVICAY in adolescents and adults of childbearing potential [see Warnings and Precautions (5.3), Use in Specific Populations (8.1, 8.3)]. Embryo-Fetal Toxicity	Human Data	Tivicay Label
Tybost*	cobicistat 150 mg	CYP3A Inhibitor	Oral Tablet	TYBOST coadministered with darunavir is not recommended for use during pregnancy because of substantially lower exposures of darunavir and cobicistat during the second and third trimesters [see Use in Specific Populations (8.1) and Clinical Pharmacology (12.3)]. TYBOST coadministered with atazanavir is not recommended for use during pregnancy because of substantially lower exposures of cobicistat during the second and third trimesters [see Use in Specific Populations (8.1) and Clinical Pharmacology (12.3)]. TYBOST coadministered with darunavir or atazanavir should not be initiated in pregnant women. An alternative regimen is recommended for women who become pregnant during therapy with TYBOST coadministered with darunavir or atazanavir.	Human Data	Tybost Label
Trogarzo	ibalizumab-uiyk 150mg/ml	CD4-directed post-attachment HIV-1 inhibitor	Intravenous Injection	No dosing information available		Trogarzo Label