* Indications, safety, and efficacy of these products may vary. Please refer to the full Prescribing Information or Patient Information of each medication for more details.

† This chart does not include all HIV treatment formulations, treatment options, or dosing or safety considerations for the use of antiretroviral agents. ‡A pill containing a complete medicine regimen. § A pill containing a combination of N(t)RTIs. The brands listed are the trademarks or registered trademarks of their respective owners. EDURANT®, INTELENCE®, and PREZISTA® are registered

trademarks of Janssen Therapeutics, Division of Janssen Products, LP. PREZCOBIX™ is a trademark of Janssen Therapeutics, Division of Janssen Products, LP. Information provided is current as of January 2015.

Please see next page for Indication and Important Safety Information for EDURANT®, INTELENCE®, PREZCOBIX™, and PREZISTA®.

There are many different types of medicines to treat HIV (Human Immunodeficiency Virus). These medicines are called antiretrovirals, and they are grouped into classes.

Please be aware that HIV medicines, including EDURANT®, INTELENCE®, PREZCOBIX™, and PREZISTA®, do not cure HIV infection, do not reduce the risk of transmission of HIV to others, and should always be taken in combination with other HIV medicines as prescribed by your healthcare professional.†

• Follow your healthcare professional’s directions regarding the use of these medicines

• Discuss any questions you have about your treatment, including side effects and health status, with your healthcare professional

• Products are not shown at actual size

Distributed by: Janssen Therapeutics, Division of Janssen Products, LP, Titusville, NJ 08560© Janssen Therapeutics, Division of Janssen Products, LP 2015 02/15 014546-150205

Janssen Therapeutics, Division of Janssen Products, LP

HIV medicines*

ENTRY INHIBITORS

150 mg 300 mg

Selzentry® maraviroc

90 mg (1 mL)

Fuzeon® enfuvirtide

MULTICLASS SINGLE-TABLET REGIMENS

Atripla® efavirenz/emtricitabine/ tenofovir disoproxil fumarate‡

600/200/300 mg

Complera® emtricitabine/rilpivirine/ tenofovir disoproxil fumarate‡

Stribild® elvitegravir/cobicistat/emtricitabine/ tenofovir disoproxil fumarate‡

200/25/300 mg

150/150/200/300 mg

Triumeq® abacavir/dolutegravir/lamivudine‡

600/50/300 mg

NON-NUCLEOSIDE REVERSE TRANSCRIPTASE INHIBITORS (NNRTIs/non-nukes)

25 mg

EDURANT®

rilpivirine

Sustiva®

efavirenz

600 mg

Rescriptor® delavirdine mesylate

200 mg

Viramune®/Viramune XR®

nevirapine

100 mg

INTELENCE®

etravirine

200 mg

www.INTELENCE.com

www.EDURANT.com

200 mg 400 mg

NUCLEOSIDE/NUCLEOTIDE REVERSE TRANSCRIPTASE INHIBITORS (N[t]RTIs/nukes)

Trizivir® abacavir sulfate/lamivudine/ zidovudine§

300/150/300 mg

Truvada® emtricitabine/tenofovir disoproxil fumarate§

200/300 mg

300 mg

Viread® tenofovir disoproxil fumarate

Retrovir® zidovudine

300 mg

Combivir® lamivudine/ zidovudine§

150/300 mg

Emtriva® emtricitabine

200 mg

Epivir® lamivudine

150 mg 300 mg

Epzicom®

abacavir sulfate/lamivudine§

600/300 mg

Videx® EC didanosine

250 mg 400 mg

Zerit® stavudine

30 mg 40 mg

Ziagen® abacavir sulfate

PHARMACOKINETIC ENHANCER

150 mg

Tybost® cobicistat

PROTEASE INHIBITORS (PIs)

700 mg

Lexiva® fosamprenavir calcium

200/50 mg

Kaletra® lopinavir/ritonavir

Invirase® saquinavir mesylate

500 mg200 mg

400 mg

Crixivan® indinavir sulfate

Norvir® ritonavir

Tablet (Room temperature)

100 mg 100 mg

Soft gel (Refrigeration recommended)

250 mg

Aptivus® tipranavir

150 mg 200 mg

Reyataz® atazanavir sulfate

300 mg

Viracept® nelfinavir mesylate

Evotaz™ atazanavir sulfate/ cobicistat

625 mg250 mg

300/150 mg

PREZCOBIX™

darunavir/cobicistat

800/150 mg

PREZISTA®

darunavir

800 mg 600 mg

www.PREZCOBIX.com

www.PREZISTA.com

INTEGRASE INHIBITORS

400 mg

Isentress® raltegravir

Tivicay® dolutegravir

50 mg

Vitekta® elvitegravir

85 mg 150 mg

300 mg

IndicationINTELENCE® (etravirine), in combination with other antiretroviral (ARV) agents, is indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in ARV treatment-experienced patients ages 6 years and older, who have evidence of viral replication and HIV-1 strains resistant to a non-nucleoside reverse transcriptase inhibitor (NNRTI) and other ARV agents.

The indication for adult use is based on Week 48 analyses from 2 randomized, double-blind, placebo-controlled trials of INTELENCE®. Both studies were conducted in clinically advanced, 3-class ARV (NNRTI, N[t]RTI, PI) treatment-experienced adults. The indication for pediatric use is based on 24-week analyses of a single arm, Phase 2 trial in ARV treatment-experienced pediatric subjects 6 years to less than 18 years of age.

In treatment-experienced adult and pediatric patients, the following points should be considered when initiating therapy with INTELENCE®:

• Treatment history and resistance testing should guide the use of INTELENCE® due to concerns for potential cross-resistance

• In patients who have experienced virologic failure on an NNRTI-containing regimen, do not use INTELENCE® in combination with only N[t]RTIs

• The use of other active ARV agents with INTELENCE® is associated with an increased likelihood of treatment response

• The safety and efficacy of INTELENCE® have not been established in pediatric patients less than 6 years of age or in treatment-naïve adult or pediatric patients

Important Safety Information Warnings & Precautions

• Severe Skin and Hypersensitivity Reactions: - Severe, potentially life-threatening, and fatal skin reactions have been reported in patients taking INTELENCE®. These include cases

of Stevens-Johnson syndrome, toxic epidermal necrolysis, and erythema multiforme - Hypersensitivity reactions including Drug Rash with Eosinophilia and Systemic Symptoms (DRESS) have also been reported and were

characterized by rash, constitutional findings, and sometimes organ dysfunction, including hepatic failure In the DUET studies, Grade 3 and 4 rashes were reported in 1.3% of patients receiving INTELENCE® compared to 0.2% of patients in

the placebo arm. Discontinuation rate due to rash was 2.2% in patients taking INTELENCE®. In clinical trials of patients on INTELENCE®, the incidence of rash was higher in women compared to men. Rash occurred most commonly during the first 6 weeks of therapy. In the PIANO study of children ages 6 to ≤17 years of age, rash was seen more commonly than in adults and occurred in 15% (≥Grade 2) of pediatric subjects

Discontinue INTELENCE® immediately if signs or symptoms of severe skin reactions or hypersensitivity reactions develop (including, but not limited to, severe rash or rash accompanied by fever, general malaise, fatigue, muscle or joint aches, blisters, oral lesions, conjunctivitis, facial edema, hepatitis, eosinophilia, or angioedema)

- Monitor clinical status including liver transaminases, and initiate appropriate therapy - Delay in stopping INTELENCE® treatment after the onset of severe rash may result in a life-threatening reaction• Fat Redistribution: Redistribution and/or accumulation of body fat have been observed in patients receiving ARV therapy. The causal

relationship, mechanism, and long-term consequences of these events have not been established• Immune Reconstitution Syndrome has been reported in patients treated with combination ARV therapy, including INTELENCE®.

Autoimmune disorders (such as Graves’ disease, polymyositis, and Guillain-Barré syndrome) have also been reported to occur in the setting of immune reconstitution; however, the time to onset is more variable and can occur many months after initiation of treatment

Use in Specific Populations

• Hepatic Impairment: INTELENCE® should be used with caution in patients with severe hepatic impairment (Child-Pugh Class C) as pharmacokinetics of INTELENCE® have not been evaluated in these patients

• Pregnancy Category B: INTELENCE® should be used during pregnancy only if the potential benefit justifies the potential risk. No adequate and well-controlled studies have been conducted in pregnant women

Adverse Reactions

• The most common adverse drug reactions (≥2%) of at least moderate intensity (≥Grade 2) reported in adult patients taking INTELENCE® and that occurred at a higher rate compared with placebo were rash (10% vs 3%) and peripheral neuropathy (4% vs 2%). The most common adverse drug reactions in at least 2% of pediatric subjects were rash and diarrhea

Drug Interactions

• INTELENCE® should not be coadministered with the following ARVs: fosamprenavir/ritonavir, tipranavir/ritonavir, full-dose ritonavir (600 mg bid), PIs administered without low-dose ritonavir, and other NNRTIs

• INTELENCE® should only be used with dolutegravir when coadministered with atazanavir/ritonavir, darunavir/ritonavir, or lopinavir/ritonavir. INTELENCE® should not be coadministered with dolutegravir in the absence of a boosted PI. INTELENCE® significantly reduces plasma concentrations of dolutegravir

• INTELENCE® should not be coadministered with carbamazepine, phenobarbital, phenytoin, rifampin, rifapentine, rifabutin (when part of a regimen containing PI/ritonavir), or products containing St. John’s wort (Hypericum perforatum)

• Caution should be used when prescribing agents such as substrates, inhibitors, or inducers of CYP3A, CYP2C9, CYP2C19, and/or P-glycoprotein in patients receiving INTELENCE® as it may alter the therapeutic effect or adverse reaction profile of INTELENCE® or the coadministered drug(s)

This is not a complete list of potential drug interactions.

Please see accompanying full Prescribing Information for more details.

028189-150121

IndicationEDURANT® (rilpivirine), in combination with other antiretroviral agents, is a non-nucleoside reverse transcriptase inhibitor (NNRTI) indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in antiretroviral treatment-naïve adult patients with HIV-1 RNA less than or equal to 100,000 copies/mL at the start of therapy. This indication is based on safety and efficacy analyses through 96 weeks from 2 randomized, double-blind, active-controlled, Phase 3 trials in treatment-naïve subjects.The following points should be considered when initiating therapy with EDURANT®:

• More EDURANT®-treated subjects with HIV-1 RNA greater than 100,000 copies/mL at the start of therapy experienced virologic failure (HIV-1 RNA ≥ 50 copies/mL) compared to EDURANT®-treated subjects with HIV-1 RNA less than or equal to 100,000 copies/mL

• Regardless of HIV-1 RNA at the start of therapy, more EDURANT®-treated subjects with CD4+ cell count less than 200 cells/mm3 experienced virologic failure compared to EDURANT®-treated subjects with CD4+ cell count greater than or equal to 200 cells/mm3

• The observed virologic failure rate in EDURANT®-treated subjects conferred a higher rate of overall treatment resistance and cross-resistance to the NNRTI class compared to efavirenz

• More subjects treated with EDURANT® developed tenofovir and lamivudine/emtricitabine-associated resistance compared to efavirenz

EDURANT® is not recommended for patients less than 18 years of age.

Important Safety Information Contraindications• Coadministration of EDURANT® with the following drugs is contraindicated because significant decreases in rilpivirine plasma

concentrations may occur due to CYP3A enzyme induction or gastric pH increase, which may result in loss of virologic response and possible resistance and cross-resistance: carbamazepine, oxcarbazepine, phenobarbital, phenytoin, rifampin, rifapentine, proton pump inhibitors such as esomeprazole, lansoprazole, omeprazole, pantoprazole, and rabeprazole, systemic dexamethasone (more than single dose), and products containing St. John’s wort (Hypericum perforatum)

Warnings and Precautions

• Depressive Disorders: Severe depressive disorders, defined as depressed mood, depression, dysphoria, major depression, mood altered, negative thoughts, suicide attempt, and suicidal ideation, have been reported with EDURANT®. Immediate medical evaluation is recommended for severe depressive symptoms

• Hepatotoxicity: Hepatic adverse events were reported. Patients with underlying hepatic disease, including hepatitis B or C, or marked elevations in transaminases before treatment may be at increased risk for worsening or development of transaminase elevations. Monitor liver function tests (LFTs) before and during treatment. A few hepatotoxicity cases occurred in patients with no pre-existing hepatic disease or other identifiable risk factors; therefore, monitoring of LFTs should be considered in all patients

• Fat Redistribution: Redistribution and/or accumulation of body fat have been observed in patients receiving ARV therapy. The causal relationship, mechanism, and long-term consequences of these events have not been established

• Immune Reconstitution Syndrome has been reported in patients treated with combination ARV therapy, including EDURANT®. Autoimmune disorders (such as Graves disease, polymyositis, and Guillain-Barré syndrome) have also been reported to occur in the setting of immune reconstitution; however, the time to onset is more variable and can occur many months after initiation of treatment

Drug Interactions

• EDURANT® should be used with caution when coadministered with drugs that may reduce the exposure of rilpivirine, such as antacids and H2-receptor antagonists

• Concomitant use of EDURANT® with rifabutin may cause a decrease in the plasma concentrations of rilpivirine. Please read the Dosage and Administration Section of the Prescribing Information for more details regarding the concomitant use of EDURANT® and rifabutin

• EDURANT® should be used with caution when coadministered with a drug with a known risk of Torsade de Pointes• EDURANT® should not be used in combination with NNRTIs

This is not a complete list of potential drug interactions.

Please see full Prescribing Information for more details.

Use in Specific Populations

• Hepatic Impairment: EDURANT® should be used with caution in patients with severe hepatic impairment (Child-Pugh Class C) as pharmacokinetics of EDURANT® have not been evaluated in these patients

• Pregnancy Category B: EDURANT® should be used during pregnancy only if the potential benefit justifies the potential risk. No adequate and well-controlled studies have been conducted in pregnant women

Adverse Reactions

• The most common adverse drug reactions reported (incidence >2%) of at least moderate intensity (≥ Grade 2) in patients taking EDURANT® through 96 weeks were depressive disorders (5%), headache (3%), insomnia (3%), and rash (3%)

Please see accompanying full Prescribing Information for more details.

015341-140514

IndicationPREZISTA® (darunavir), coadministered with ritonavir (PREZISTA®/r), and with other antiretroviral agents (ARVs), is indicated for the treatment of human immunodeficiency virus (HIV-1) infection.

This indication is based on analyses of plasma HIV-1 RNA levels and CD4+ cell counts from 2 controlled Phase 3 trials of 48 weeks duration in ARV treatment-naïve and treatment-experienced patients and 2 controlled Phase 2 trials of 96 weeks duration in clinically advanced, treatment-experienced adult patients.

In treatment-experienced adult patients, the following points should be considered when initiating therapy with PREZISTA®/r:

• Treatment history and, when available, genotypic or phenotypic testing should guide the use of PREZISTA®/r

• The use of other active agents with PREZISTA®/r is associated with a greater likelihood of treatment response

Important Safety Information Drug Interactions • Coadministration of PREZISTA®/r is contraindicated with drugs that are highly dependent on CYP3A for clearance and for which elevated

plasma concentrations are associated with serious and/or life-threatening events (eg, alfuzosin, dihydroergotamine, ergotamine, methylergonovine, cisapride, pimozide, oral midazolam, triazolam, lovastatin, simvastatin, or sildenafil for the treatment of pulmonary arterial hypertension)

• Coadministration of PREZISTA®/r is also contraindicated with rifampin and products containing St. John’s wort (Hypericum perforatum) because this may cause significant decrease in plasma concentrations of darunavir, resulting in loss of therapeutic effect and development of resistance

• Coadministration is not recommended with indinavir, lopinavir/ritonavir, saquinavir, salmeterol, boceprevir, telaprevir, and colchicine in patients with hepatic or renal impairment

• Caution should be used when prescribing agents such as sildenafil, vardenafil, tadalafil, or other substrates, inhibitors, or inducers of CYP3A in patients receiving PREZISTA®/r

This list of potential drug interactions is not complete.

Warnings & Precautions • PREZISTA® must be coadministered with ritonavir and food to achieve the desired antiviral effect. Failure to administer PREZISTA® with

ritonavir and food may result in a loss of efficacy of darunavir. Please refer to ritonavir prescribing information for additional information on precautionary measures

• Drug-induced hepatitis (eg, acute hepatitis, cytolytic hepatitis) has been reported with PREZISTA®/r. During the clinical development program (N=3063), hepatitis has been reported in 0.5% of patients receiving combination therapy with PREZISTA®/r. Patients with preexisting liver dysfunction, including chronic active hepatitis B or C, have an increased risk for liver function abnormalities, including severe hepatic adverse events

Post-marketing cases of liver injury, including some fatalities, have been reported. A causal relationship with PREZISTA®/r therapy has not been established

Appropriate laboratory testing should be conducted prior to initiating therapy with PREZISTA®/r and patients should be monitored during treatment. Increased AST/ALT monitoring should be considered in patients with underlying chronic hepatitis, cirrhosis, or in patients who have pretreatment elevations of transaminases, especially during the first several months of PREZISTA®/r treatment. Evidence of new or worsening liver dysfunction (including clinically significant elevation of liver enzymes and/or symptoms such as fatigue, anorexia, nausea, jaundice, dark urine, liver tenderness, hepatomegaly) in patients on PREZISTA®/r should prompt consideration of interruption or discontinuation of treatment

• Severe Skin Reactions: Severe skin reactions (0.4%), accompanied by fever and/or elevations of transaminases in some cases, and Stevens-Johnson Syndrome (<0.1%) have been reported in patients receiving PREZISTA®/r. During post-marketing experience, toxic epidermal necrolysis, drug rash with eosinophilia and systemic symptoms, and acute generalized exanthematous pustulosis have been reported in patients receiving PREZISTA®/r. Discontinue PREZISTA®/r immediately if signs or symptoms of severe skin reactions develop (including, but not limited to, severe rash or rash accompanied with fever, general malaise, fatigue, muscle or joint aches, blisters, oral lesions, conjunctivitis, hepatitis, and/or eosinophilia)

In clinical trials (N=3063), rash (all grades, generally mild to moderate, regardless of causality) occurred in 10.3% of patients receiving PREZISTA®/r. Discontinuation due to rash was 0.5%

Rash occurred more commonly in treatment-experienced subjects receiving regimens containing PREZISTA®/r + raltegravir compared to subjects receiving either drug regimen alone. However, rash that was considered drug related occurred at similar rates. These rashes were mild to moderate in severity and did not limit therapy; there were no discontinuations due to rash

• Sulfa Allergy: PREZISTA® should be used with caution in patients with known sulfonamide allergy

• Diabetes Mellitus/Hyperglycemia and Hemophilia: New-onset or exacerbations of preexisting diabetes mellitus, hyperglycemia, and increased bleeding in hemophiliacs have been reported in patients receiving protease inhibitors. Initiation or dose adjustments of insulin or oral hypoglycemic agents may be required. A causal relationship between protease inhibitors and these events has not been established

• Fat Redistribution: Redistribution and/or accumulation of body fat have been observed in patients receiving ARV therapy. The causal relationship, mechanism, and long-term consequences of these events have not been established

• Immune reconstitution syndrome has been reported in patients treated with combination ARV therapy, including PREZISTA®

Autoimmune disorders (such as Graves’ disease, polymyositis, and Guillain-Barré syndrome) have also been reported to occur in the setting of immune reconstitution; however, the time of onset is more variable and can occur many months after the initiation of treatment

• Resistance/Cross-Resistance: The potential for HIV cross-resistance among protease inhibitors has not been fully explored in PREZISTA®/r-treated patients

Use in Specific Populations• Hepatic Impairment: PREZISTA®/r is not recommended for use in patients with severe hepatic impairment. There are no pharmacokinetic

or safety data available in patients with severe hepatic impairment

• Pregnancy: PREZISTA® should be used during pregnancy only if the potential benefit justifies the potential risk. No adequate and well-controlled studies have been conducted in pregnant women

Adverse Reactions • In treatment-naïve adult patients, the most common adverse drug reactions (≥5%) reported of at least moderate intensity (≥Grade 2)

in the PREZISTA®/r arm through 192 weeks were diarrhea (9%), headache (7%), abdominal pain (6%), and rash (6%)

• In treatment-experienced adult patients, the most common adverse drug reactions (≥5%) reported of at least moderate intensity (≥Grade 2) in the PREZISTA®/r arm through 96 weeks were diarrhea (14%), nausea (7%), rash (7%), abdominal pain (6%), and vomiting (5%)

This is not a complete list of all adverse drug reactions reported with the use of PREZISTA®/r.

Please see accompanying full Prescribing Information for more details.

013728-140523

IndicationPREZCOBIX™ is indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (HIV-1) infection in treatment-naïve and treatment-experienced adults with no darunavir resistance-associated substitutions (V11I, V32I, L33F, I47V, I50V, I54L, I54M, T74P, L76V, I84V, L89V).

Important Safety Information Contraindications• Coadministration: The concomitant use of PREZCOBIX™ and the following drugs is contraindicated due to the potential for serious

and/or life-threatening events or loss of therapeutic effect: alfuzosin, ranolazine, dronedarone, colchicine, rifampin, lurasidone, pimozide, dihydroergotamine, ergotamine, methylergonovine, cisapride, St. John’s Wort (Hypericum perforatum), lovastatin, simvastatin, sildenafil for pulmonary arterial hypertension, oral midazolam, and triazolam

Warnings and Precautions

• Hepatotoxicity: Drug-induced hepatitis has been reported with darunavir coadministered with ritonavir in 0.5% of subjects during the clinical development program (N=3063). Patients with pre-existing liver dysfunction, including chronic active hepatitis B or C, have an increased risk for liver function abnormalities, including severe hepatic adverse reactions

Post-marketing cases of liver injury, including some fatalities, have also been reported with darunavir coadministered with ritonavir. These have generally occurred in patients with advanced HIV-1 disease taking multiple concomitant medications, having co-morbidities including hepatitis B or C co-infection, and/or developing immune reconstitution syndrome. A causal relationship with darunavir coadministered with ritonavir has not been established

Appropriate laboratory testing should be conducted prior to initiating therapy with PREZCOBIX™ and patients should be monitored during treatment. Increased AST/ALT monitoring should be considered in patients with underlying chronic hepatitis, cirrhosis, or in patients who have pre-treatment elevations of transaminases, especially during the first several months of PREZCOBIX™ treatment

Evidence of new or worsening liver dysfunction (including clinically significant elevation of liver enzymes and/or symptoms such as fatigue, anorexia, nausea, jaundice, dark urine, liver tenderness, hepatomegaly) in patients on PREZCOBIX™ should prompt consideration of interruption or discontinuation of treatment

• Severe Skin Reactions: Severe skin reactions (0.4%, N=3063), accompanied by fever and/or elevations of transaminases in some cases, and Stevens-Johnson syndrome (<0.1%) have been reported in patients receiving darunavir coadministered with ritonavir. During post-marketing experience, toxic epidermal necrolysis, drug rash with eosinophilia and systemic symptoms, and acute generalized exanthematous pustulosis have been reported in patients receiving darunavir coadministered with ritonavir. Discontinue PREZCOBIX™ immediately if signs or symptoms of severe skin reactions develop, including, but not limited to, severe rash or rash accompanied with fever, general malaise, fatigue, muscle or joint aches, blisters, oral lesions, conjunctivitis, hepatitis and/or eosinophilia. Mild-to-moderate rash was also reported and often occurred within the first four weeks of treatment and resolved with continued dosing

• Effects on Serum Creatinine: Cobicistat decreases estimated creatinine clearance (CrCl) due to inhibition of tubular secretion of creatinine without affecting actual renal glomerular function. This effect should be considered when interpreting changes in estimated CrCl in patients initiating PREZCOBIX™. Prior to starting PREZCOBIX™, assess estimated CrCl. Patients who experience a confirmed increase in serum creatinine of greater than 0.4 mg/dL from baseline should be closely monitored for renal safety. Consider alternative medications that do not require dosage adjustments in patients with renal impairment

• Renal Impairment When Used with Tenofovir: Renal impairment, including cases of acute renal failure and Fanconi syndrome, has been reported with the use of tenofovir DF and cobicistat, a component of PREZCOBIX™. Coadministration of PREZCOBIX™ and tenofovir DF is not recommended in patients who have an estimated CrCl <70 mL/min. In all patients, monitor estimated CrCl, urine glucose, and urine protein prior to initiating and during therapy. In patients with or at risk for renal impairment, additionally monitor serum phosphorus. Coadministration of PREZCOBIX™ and tenofovir DF in combination with concomitant or recent use of a nephrotoxic agent is not recommended

• Antiretrovirals Not Recommended: PREZCOBIX™ is not recommended in combination with other antiretroviral drugs that require pharmacokinetic boosting or which contain the individual components of PREZCOBIX™ (darunavir and cobicistat) or with ritonavir

• Sulfa Allergy: Monitor patients with a known sulfonamide allergy after initiating PREZCOBIX™. In clinical studies with darunavir coadministered with ritonavir, the incidence and severity of rash were similar in subjects with or without a history of sulfonamide allergy

• Diabetes Mellitus/Hyperglycemia and Hemophilia: New onset or exacerbation of pre-existing diabetes mellitus and hyperglycemia have been reported in patients receiving protease inhibitors. Initiation or dose adjustments of insulin or oral hypoglycemic agents may be required. Increased bleeding in hemophiliacs has been reported in patients receiving protease inhibitors. A causal relationship between protease inhibitors and these events has not been established

• Fat Redistribution: Redistribution and/or accumulation of body fat have been observed in patients receiving antiretroviral therapy • Immune Reconstitution Syndrome including the occurrence of autoimmune disorders with variable time to onset has been reportedAdverse Reactions• The most common clinical adverse reactions (incidence ≥5%) of at least moderate intensity (≥Grade 2) were diarrhea, nausea, rash,

headache, abdominal pain, and vomiting during the darunavir clinical development program, where darunavir was coadministered with ritonavir. A clinical trial (n=313) was conducted with darunavir and cobicistat. Adverse reactions of darunavir/cobicistat at 24 weeks did not differ substantially from those reported in clinical trials with darunavir coadministered with ritonavir

This is not a complete list of all adverse drug reactions reported with the use of PREZCOBIX™. Please refer to the full Prescribing Information for a complete list of adverse drug reactions.

Drug Interactions• No drug interaction trials have been performed using PREZCOBIX™ or with darunavir coadministered with cobicistat as single entities.

Drug interaction trials have only been conducted with darunavir coadministered with ritonavir and with cobicistat alone• Coadministration of PREZCOBIX™ with drugs that are primarily metabolized by CYP3A and/or CYP2D6 or are substrates of P-gp, BCRP,

OATP1B1, or OATP1B3 may result in increased plasma concentrations of such drugs, which could increase or prolong their therapeutic effect. Clinically significant adverse reactions, including life-threatening or fatal reactions, associated with the concomitant medications may also occur

• Drugs that induce CYP3A can decrease the concentrations of components of PREZCOBIX™, which may lead to loss of efficacy and possible resistance to darunavir

Consult the full Prescribing Information for PREZCOBIX™ for more information on potentially significant drug interactions, including clinical comments.

Use in Specific Populations• Pregnancy: Category C. PREZCOBIX™ should be used during pregnancy only if the potential benefit justifies the potential risk. No

adequate and well-controlled studies have been conducted in pregnant women• Hepatic Impairment: PREZCOBIX™ is not recommended for use in patients with severe hepatic impairment

This is not a complete list of Uses in Specific Populations for PREZCOBIX™.

Please see accompanying full Prescribing Information for more details.

027407-150108