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                HIV Treatment

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          HIV Treatment Information for Children
          HIV Treatment Information for Pregnant Patients Home
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    PrintDosing Information for Pregnant Patients

*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 Patients
	Brand
			Generic
			Drug Class
			Dosage Form
			Use in Pregnancy Conditions
			Pregnancy (Section 8.1)
			Visit Drugs@FDA to viewAtripla*
			efavirenz 600 mg
			emtricitabine 200 mg
			tenofovir disoproxil fumarate 300 mg
			Fixed Dose Combination Product
			Oral Tablet
			Embryo-Fetal Toxicity
			
			Atripla LabelBiktarvy*
			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 LabelCimduo*
			lamivudine 300 mg
			tenofovir disoproxil fumarate 300 mg
			Fixed Dose Combination Product
			Oral Tablet
			No dose adjustment needed
			Human Data
			Cimduo LabelCombivir*
			zidovudine 300 mg
			lamivudine 150 mg
			Fixed Dose Combination Product
			Oral Tablet
			No dose adjustment needed
			Human Data
			Combivir LabelComplera*
			emtricitabine 200 mg
			rilpivirine 25 mg
			tenofovir disoproxil fumarate 300 mg
			Fixed Dose Combination Product
			Oral Tablet
			For pregnant patients 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 LabelDelstrigo*
			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 LabelDescovy*
			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 LabelDovato*
			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 LabelEpzicom*
			abacavir 600 mg
			lamivudine 300 mg
			Fixed Dose Combination Product
			Oral Tablet
			No dose adjustment needed

			

			Pharmacokinetics: Pregnant Women
			Human Data
			Epzicom LabelEvotaz*
			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 LabelGenvoya*
			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 individuals. An alternative regimen is recommended for individuals who become pregnant during therapy with GENVOYA [see Use in Specific Populations (8.1)].
			Human Data
			Genvoya LabelJuluca
			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 LabelKaletra
			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 patients 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 LabelOdefsey*
			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 LabelPrezcobix
			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 individuals. An alternative regimen is recommended for those who become pregnant during therapy with PREZCOBIX.

			

			Pharmacokinetics: Pregnancy and Postpartum
			Human Data
			Prezcobix LabelStribild*
			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 individuals. An alternative regimen is recommended for individuals who become pregnant during therapy with STRIBILD [see Use in Specific Populations (8.1)].
			Human Data
			Stribild LabelSymfi*
			efavirenz 600 mg
			lamivudine 300 mg
			tenofovir disoproxil fumarate 300 mg
			Fixed Dose Combination Product
			Oral Tablet
			Embryo-Fetal Toxicity
			Human Data
			Symfi LabelSymfi 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 LabelSymtuza*
			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 individuals. An alternative regimen is recommended for those who become pregnant during therapy with SYMTUZA.

			

			Pharmacokinetics: Pregnancy and Postpartum
			Human Data
			Symtuza LabelTriumeq*
			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 LabelTrizivir*
			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 LabelTruvada*
			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 LabelEmtriva*
			emtricitabine 200 mg
			Nucleoside Reverse Transcriptase Inhibitors
			Oral Capsule
			No dose adjustment needed
			Human Data
			Emtriva LabelEpivir*
			lamivudine 150 mg, 300 mg
			Nucleoside Reverse Transcriptase Inhibitors
			Oral Tablet
			No dose adjustment needed

			Pharmacokinetics: Pregnant Women
			Human Data
			Epivir LabelRetrovir*
			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 LabelRetrovir*
			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 LabelTemixys*
			lamivudine 300 mg
			tenofovir disoproxil fumarate 300 mg
			Nucleoside Reverse Transcriptase Inhibitors
			Oral Tablet
			No dose adjustment needed
			Human Data
			Temixys LabelVidex*
			didanosine 2 g, 4 g
			Nucleoside Reverse Transcriptase Inhibitor
			Oral Powder for Solution
			Lactic Acidosis and Severe Hepatomegaly with Steatosis
			
			Videx LabelVidex 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 LabelViread*
			tenofovir disoproxil fumarate 150 mg, 200 mg, 250 mg, 300 mg
			Nucleoside Reverse Transcriptase Inhibitor
			Oral Tablet
			No dose adjustment needed
			Human Data
			Viread LabelZerit*
			stavudine 15 mg, 20 mg, 30 mg, 40 mg
			Nucleoside Reverse Transcriptase Inhibitor
			Oral Capsule
			Lactic Acidosis and Severe Hepatomegaly with Steatosis
			
			Zerit LabelZiagen
			abacavir 300 mg
			Nucleoside Reverse Transcriptase Inhibitor
			Oral Tablet
			No dose adjustment needed

			Pharmacokinetics: Pregnant Women
			
			Ziagen LabelEdurant
			rilpivirine 25 mg
			Nonnucleoside Reverse Transcriptase Inhibitor
			Oral Tablet
			For pregnant patients 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 LabelIntelence
			etravirine 100 mg, 200 mg
			Nonnucleoside Reverse Transcriptase Inhibitor
			Oral Tablet
			No dose adjustment needed

			

			Pharmacokinetics: Pregnancy and Postpartum
			Human Data
			Intelence LabelPifeltro
			doravirine 100 mg
			Nonnucleoside Reverse Transcriptase Inhibitor
			Oral Tablet
			No dosing information available
			
			Pifeltro LabelRescriptor
			delavirdine 200 mg
			Nonnucleoside Reverse Transcriptase Inhibitor
			Oral Tablet
			No dosing information available
			Pregnancy Data
			Rescriptor LabelSustiva
			efavirenz 600 mg
			Nonnucleoside Reverse Transcriptase Inhibitor
			Oral Tablet
			Embryo-Fetal Toxicity
			
			Sustiva LabelViramune*
			nevirapine 200 mg
			Nonnucleoside Reverse Transcriptase Inhibitor
			Oral Tablet
			No dosing information available
			Human Data
			Viramune LabelViramune XR*
			nevirapine extended-release 400 mg
			Nonnucleoside Reverse Transcriptase Inhibitor
			Oral Extended-Release Tablet
			No dosing information available
			
			Viramune XR LabelAptivus
			tipranavir 250 mg
			Protease Inhibitor
			Oral Capsule
			No dosing information available
			
			Aptivus LabelCrixivan
			indinavir 200 mg, 400 mg
			Protease Inhibitor
			Oral Capsule
			Optimal dosing regimen has not been established
			Pregnant Patients
			Crixivan LabelInvirase
			saquinavir mesylate 500 mg
			Protease Inhibitor
			Oral Tablet
			No dosing information  available
			Human Data
			Invirase LabelLexiva
			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 patients 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 LabelNorvir
			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 LabelNorvir
			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 LabelNorvir
			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 LabelPrezista
			darunavir 75 mg, 150 mg, 600 mg, 800 mg
			Protease Inhibitor
			Oral Tablet
			The recommended dosage in pregnant patients 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 patients 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 LabelReyataz*
			atazanavir sulfate 150 mg, 200 mg, 300 mg
			Protease Inhibitor
			Oral Capsule
			Dosing with Ritonavir

			

			Pharmacokinetics: Pregnancy
			Human Data
			Reyataz LabelViracept
			nelfinavir mesylate 250 mg, 625 mg
			Protease Inhibitor
			Oral Tablet
			No dosing  information available
			
			Viracept LabelFuzeon
			enfuvirtide 90 mg/vial
			Fusion Inhibitor
			Subcutaneous Injection
			No dosing information available
			
			Fuzeon LabelSelzentry*
			maraviroc 25 mg, 75 mg, 150 mg, 300 mg
			Entry Inhibitors - CCR5 co-receptor antagonist
			Oral Tablet
			No dosing information available
			
			Selzentry LabelIsentress
			raltegravir 400 mg
			Integrase Inhibitor
			Oral Tablet
			No dosing information available
			Human Data
			Isentress LabelIsentress HD
			raltegravir 600 mg
			Integrase Inhibitor
			Oral Tablet
			No dosing information available
			
			Isentress LabelTivicay*
			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 LabelTybost*
			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 individuals. An alternative regimen is recommended for individuals who become pregnant during therapy with TYBOST coadministered with darunavir or atazanavir.
			Human Data
			Tybost LabelTrogarzo
			ibalizumab-uiyk 150mg/ml
			CD4-directed post-attachment HIV-1 inhibitor
			Intravenous Injection
			No dosing information available
			
			Trogarzo Label

                                                                                  Content current as of:
      08/07/2020
              
              
Regulated Product(s)
		 Drugs
			  			     			  						              
			
			
			
			
						  HIV/AIDS Drugs
			  			     			  			     Generic DrugsHealth Topic(s)
			  HIV/AIDSLaw(s) & Regulation(s)
			  President's Emergency Plan for AIDS Relief (PEPFAR)HIV Treatment

          
                        HIV Treatment Information for Adults
          HIV Treatment Information for Children
          HIV Treatment Information for Pregnant Patients
 
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