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

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