Gilead Sciences, Inc.

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Gilead Sciences, Inc. Drugs

Descovy

Descovy

2.1 Testing Prior to Initiation of DESCOVY

Prior to initiation of DESCOVY, patients should be tested for hepatitis B virus infection [see Warnings and Precautions (5.2)].

Estimated creatinine clearance, urine glucose, and urine protein should be assessed before initiating DESCOVY therapy and should be monitored during therapy in all patients [see Warnings and Precautions (5.5)].

2.2 Recommended Dosage

DESCOVY is a two-drug fixed dose combination product containing 200 mg of emtricitabine (FTC) and 25 mg of tenofovir alafenamide (TAF). The recommended dosage of DESCOVY is one tablet taken orally once daily with or without food in adults and pediatric patients 12 years of age and older with body weight at least 35 kg and creatinine clearance greater than or equal to 30 mL per minute [see Use in Specific Populations (8.6) and Clinical Pharmacology (12.3)].

For specific dosing recommendations for coadministered third agents, refer to their respective prescribing information [see Drug Interactions (7)].

2.3 Not Recommended in Patients with Severe Renal Impairment

DESCOVY is not recommended in patients with estimated creatinine clearance below 30 mL per minute [see Warnings and Precautions (5.5) and Use in Specific Populations (8.6)].
Aspirin

Aspirin

2.1 Recommended Dose for Treatment of HIV-1 Infection

The recommended dose of TRUVADA in adults and in pediatric patients 12 years of age and older with body weight greater than or equal to 35 kg (greater than or equal to 77 lb) is one tablet (containing 200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) once daily taken orally with or without food.

2.2 Recommended Dose for Pre-exposure Prophylaxis

The dose of TRUVADA in HIV-1 uninfected adults is one tablet (containing 200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) once daily taken orally with or without food.

2.3 Dose Adjustment for Renal Impairment

Treatment of HIV-1 Infection

Significantly increased drug exposures occurred when EMTRIVA or VIREAD were administered to subjects with moderate to severe renal impairment [See EMTRIVA or VIREAD Package Insert]. Therefore, adjust the dosing interval of TRUVADA in HIV-1 infected adult patients with baseline creatinine clearance 30–49 mL/min using the recommendations in Table 1. These dosing interval recommendations are based on modeling of single-dose pharmacokinetic data in non-HIV infected subjects. The safety and effectiveness of these dosing interval adjustment recommendations have not been clinically evaluated in patients with moderate renal impairment, therefore clinical response to treatment and renal function should be closely monitored in these patients [See Warnings and Precautions (5.3)] .

No dose adjustment is necessary for HIV-1 infected patients with mild renal impairment (creatinine clearance 50–80 mL/min). No data are available to make dose recommendations in pediatric patients with renal impairment.No dose adjustment is necessary for HIV-1 infected patients with mild renal impairment (creatinine clearance 50–80 mL/min). No data are available to make dose recommendations in pediatric patients with renal impairment.
Table 1 Dosage Adjustment for HIV-1 Infected Adult Patients with Altered Creatinine Clearance Creatinine Clearance (mL/min) * ≥50 30–49 <30 (Including Patients Requiring Hemodialysis) * Calculated using ideal (lean) body weight Recommended Dosing Interval Every 24 hours Every 48 hours TRUVADA should not be administered.
Routine monitoring of estimated creatinine clearance, serum phosphorus, urine glucose, and urine protein should be performed in all individuals with mild renal impairment . Routine monitoring of estimated creatinine clearance, serum phosphorus, urine glucose, and urine protein should be performed in all individuals with mild renal impairment [See Warnings and Precautions (5.3)] .

Pre-exposure Prophylaxis

Do not use TRUVADA for a PrEP indication in HIV-1 uninfected individuals with estimated creatinine clearance below 60 mL/min [See Warnings and Precautions (5.3)] .

Routine monitoring of estimated creatinine clearance, serum phosphorus, urine glucose, and urine protein should be performed in all individuals with mild renal impairment. If a decrease in estimated creatinine clearance is observed in uninfected individuals while using TRUVADA for PrEP, evaluate potential causes and re-assess potential risks and benefits of continued use [See Warnings and Precautions (5.3)] .
Harvoni Access

Harvoni Access

2.1 Recommended Dosage in Adults

HARVONI is a two-drug fixed-dose combination product that contains 90 mg of ledipasvir and 400 mg of sofosbuvir in a single tablet. The recommended dosage of HARVONI is one tablet taken orally once daily with or without food [see Clinical Pharmacology (12.3)].

Duration of Treatment

Relapse rates are affected by baseline host and viral factors and differ between treatment durations for certain subgroups [see Clinical Studies (14)].

Table 1 below provides the recommended HARVONI treatment durations for treatment-naïve and treatment-experienced patients and those with and without cirrhosis [see Clinical Studies (14)].
Table 1 Recommended Treatment Duration for HARVONI in Patients with CHC Genotype 1 Patient Population Recommended Treatment Duration * HARVONI for 8 weeks can be considered in treatment-naïve patients without cirrhosis who have pre-treatment HCV RNA less than 6 million IU/mL [see Clinical Studies (14)]. † Treatment-experienced patients who have failed treatment with either peginterferon alfa + ribavirin or an HCV protease inhibitor + peginterferon alfa + ribavirin. Treatment-naïve with or without cirrhosis 12 weeks* Treatment-experienced† without cirrhosis 12 weeks Treatment-experienced† with cirrhosis 24 weeks
2.2 Severe Renal Impairment and End Stage Renal Disease

No dose recommendation can be given for patients with severe renal impairment (estimated Glomerular Filtration Rate [eGFR] <30 mL/min/1.73m2) or with end stage renal disease (ESRD) due to higher exposures (up to 20-fold) of the predominant sofosbuvir metabolite [see Use in Specific Populations (8.6) and Clinical Pharmacology (12.3)].
Atripla Access

Atripla Access

Adults and pediatric patients 12 years of age and older with body weight at least 40 kg (at least 88 lbs): The dose of ATRIPLA is one tablet once daily taken orally on an empty stomach. Dosing at bedtime may improve the tolerability of nervous system symptoms.

Renal Impairment: Because ATRIPLA is a fixed-dose combination, it should not be prescribed for patients requiring dosage adjustment such as those with moderate or severe renal impairment (estimated creatinine clearance below 50 mL/min).

Rifampin Coadministration: When ATRIPLA is administered with rifampin to patients weighing 50 kg or more, an additional 200 mg/day of efavirenz is recommended [See Drug Interactions (7.3), Table 4, and Clinical Pharmacology (12.3), Table 5].
Complera Access

Complera Access

Adults: The recommended dose of COMPLERA is one tablet taken orally once daily with food [See Clinical Pharmacology (12.3)].

Renal Impairment: Because COMPLERA is a fixed-dose combination, it should not be prescribed for patients requiring dose reduction such as those with moderate or severe renal impairment (estimated creatinine clearance below 50 mL per minute).

Rifabutin Coadministration: If COMPLERA is coadministered with rifabutin, an additional 25 mg tablet of rilpivirine (Edurant) once per day is recommended to be taken concomitantly with COMPLERA and with a meal for the duration of the rifabutin coadministration [See Drug Interactions (7.5) and Clinical Pharmacology (12.3)].
Ranexa

Ranexa

2.1 Dosing Information

Initiate Ranexa dosing at 500 mg twice daily and increase to 1000 mg twice daily, as needed, based on clinical symptoms. Take Ranexa with or without meals. Swallow Ranexa tablets whole; do not crush, break, or chew.

The maximum recommended daily dose of Ranexa is 1000 mg twice daily.

If a dose of Ranexa is missed, take the prescribed dose at the next scheduled time; do not double the next dose.

2.2 Dose Modification

Dose adjustments may be needed when Ranexa is taken in combination with certain other drugs [see Drug Interactions (7.1)]. Limit the maximum dose of Ranexa to 500 mg twice daily in patients on diltiazem, verapamil, and other moderate CYP3A inhibitors. Down-titrate Ranexa based on clinical response in patients concomitantly treated with P-gp inhibitors, such as cyclosporine.
Emtriva

Emtriva

2.1 Recommended Dose

EMTRIVA may be taken without regard to food.

2.2 Adult Patients (18 years of age and older)
EMTRIVA capsules: one 200 mg capsule administered once daily orally. EMTRIVA oral solution: 240 mg (24 mL) administered once daily orally.
2.3 Pediatric Patients (0–3 months of age)
EMTRIVA oral solution: 3 mg per kg administered once daily orally.
2.4 Pediatric Patients (3 months through 17 years)
EMTRIVA oral solution: 6 mg per kg up to a maximum of 240 mg (24 mL) administered once daily orally. EMTRIVA capsules: for children weighing more than 33 kg who can swallow an intact capsule, one 200 mg capsule administered once daily orally.
2.5 Dose Adjustment in Adult Patients with Renal Impairment

Significantly increased drug exposures were seen when EMTRIVA was administered to subjects with renal impairment [See Clinical Pharmacology (12.3)]. Therefore, the dosing interval or dose of EMTRIVA should be adjusted in patients with baseline creatinine clearance less than 50 mL per min using the following guidelines (see Table 1). The safety and effectiveness of these dose adjustment guidelines have not been clinically evaluated. Therefore, clinical response to treatment and renal function should be closely monitored in these patients.
Table 1 Dose Adjustment in Adult Patients with Renal Impairment Creatinine Clearance (mL/min) Formulation ≥50 mL/min 30–49 mL/min 15–29 mL/min <15 mL/min or on hemodialysis* * Hemodialysis Patients: If dosing on day of dialysis, give dose after dialysis. Capsule (200 mg) 200 mg every 24 hours 200 mg every 48 hours 200 mg every 72 hours 200 mg every 96 hours Oral Solution (10 mg/mL) 240 mg every 24 hours (24 mL) 120 mg every 24 hours (12 mL) 80 mg every 24 hours (8 mL) 60 mg every 24 hours (6 mL)
Although there are insufficient data to recommend a specific dose adjustment of EMTRIVA in pediatric patients with renal impairment, a reduction in the dose and/or an increase in the dosing interval similar to adjustments for adults should be considered.
Sertraline Hydrochlorid...

Sertraline Hydrochloride

Adults: The recommended dose of COMPLERA is one tablet taken orally once daily with food [See Clinical Pharmacology (12.3)].

Renal Impairment: Because COMPLERA is a fixed-dose combination, it should not be prescribed for patients requiring dose reduction such as those with moderate or severe renal impairment (estimated creatinine clearance below 50 mL per minute).

Rifabutin Coadministration: If COMPLERA is coadministered with rifabutin, an additional 25 mg tablet of rilpivirine (Edurant®) once per day is recommended to be taken concomitantly with COMPLERA and with a meal for the duration of the rifabutin coadministration [See Drug Interactions (7.5) and Clinical Pharmacology (12.3)].
Arnicare Procedure Reco...

Arnicare Procedure Recovery

2.1 Recommended Dosage

The recommended dosage of SOVALDI is one 400 mg tablet, taken orally, once daily with or without food [see Clinical Pharmacology (12.3)].

Administer SOVALDI in combination with ribavirin or in combination with pegylated interferon and ribavirin for the treatment of HCV. The recommended treatment regimen and duration for SOVALDI combination therapy is provided in Table 1.

For patients with HCV/HIV-1 co-infection, follow the dosage recommendations in Table 1. Refer to Drug Interactions (7) for dosage recommendations for concomitant HIV-1 antiviral drugs.
Table 1 Recommended Treatment Regimens and Duration Patient Population Treatment Regimen Duration * See peginterferon alfa prescribing information for dosage recommendation for patients with genotype 1 or 4 HCV. † Dosage of ribavirin is weight-based (<75 kg = 1000 mg and ≥75 kg = 1200 mg). The daily dosage of ribavirin is administered orally in two divided doses with food. Patients with renal impairment (CrCl ≤50 mL/min) require ribavirin dosage reduction; refer to ribavirin prescribing information. Genotype 1 or 4 SOVALDI + peginterferon alfa* + ribavirin† 12 weeks Genotype 2 SOVALDI + ribavirin† 12 weeks Genotype 3 SOVALDI + ribavirin† 24 weeks
Patients with Genotype 1 HCV Who are Ineligible to Receive an Interferon-Based Regimen

SOVALDI in combination with ribavirin for 24 weeks can be considered as a therapeutic option for patients with genotype 1 infection who are ineligible to receive an interferon-based regimen [see Clinical Studies (14.4)]. Treatment decision should be guided by an assessment of the potential benefits and risks for the individual patient.

Patients with Hepatocellular Carcinoma Awaiting Liver Transplantation

Administer SOVALDI in combination with ribavirin for up to 48 weeks or until the time of liver transplantation, whichever occurs first, to prevent post-transplant HCV reinfection [see Use in Specific Populations (8.8)].

2.2 Dosage Modification

Dosage reduction of SOVALDI is not recommended.

If a patient has a serious adverse reaction potentially related to peginterferon alfa and/or ribavirin, the peginterferon alfa and/or ribavirin dosage should be reduced or discontinued, if appropriate, until the adverse reaction abates or decreases in severity. Refer to the peginterferon alfa and ribavirin prescribing information for additional information about how to reduce and/or discontinue the peginterferon alfa and/or ribavirin dosage.

2.3 Discontinuation of Dosing

If the other agents used in combination with SOVALDI are permanently discontinued, SOVALDI should also be discontinued.

2.4 Severe Renal Impairment and End Stage Renal Disease

No dosage recommendation can be given for patients with severe renal impairment (estimated Glomerular Filtration Rate [eGFR] less than 30 mL/min/1.73m2) or with end stage renal disease (ESRD) due to higher exposures (up to 20-fold) of the predominant sofosbuvir metabolite [see Use in Specific Populations (8.6) and Clinical Pharmacology (12.3)].
Hepsera

Hepsera

2.1 Chronic Hepatitis B

The recommended dose of HEPSERA in chronic hepatitis B patients for patients 12 years of age and older with adequate renal function is 10 mg, once daily, taken orally, without regard to food. The optimal duration of treatment is unknown.

HEPSERA is not recommended for use in children less than 12 years of age.

2.2 Dose Adjustment in Renal Impairment

Significantly increased drug exposures were seen when HEPSERA was administered to adult patients with renal impairment [See Warnings and Precautions (5.2) and Clinical Pharmacology (12.3)]. Therefore, the dosing interval of HEPSERA should be adjusted in adult patients with baseline creatinine clearance less than 50 mL per minute using the following suggested guidelines (See Table 1). The safety and effectiveness of these dosing interval adjustment guidelines have not been clinically evaluated.

Additionally, it is important to note that these guidelines were derived from data in patients with pre-existing renal impairment at baseline. They may not be appropriate for patients in whom renal insufficiency evolves during treatment with HEPSERA. Therefore, clinical response to treatment and renal function should be closely monitored in these patients.
Table 1 Dosing Interval Adjustment of HEPSERA in Adult Patients with Renal Impairment Creatinine Clearance (mL/min)* Greater than or equal to 50 30–49 10–29 Hemodialysis Patients * Creatinine clearance calculated by Cockcroft-Gault method using lean or ideal body weight. Recommended doseand dosing interval 10 mg every24 hours 10 mg every48 hours 10 mg every72 hours 10 mg every 7 days followingdialysis
The pharmacokinetics of adefovir have not been evaluated in non-hemodialysis patients with creatinine clearance less than 10 mL per minute; therefore, no dosing recommendation is available for these patients.

No clinical data are available to make dosing recommendations in adolescent patients with renal insufficiency [See Warnings and Precautions (5.2)].
Vistide

Vistide

VISTIDE MUST NOT BE ADMINISTERED BY INTRAOCULAR INJECTION.

Dosage

THE RECOMMENDED DOSAGE, FREQUENCY, OR INFUSION RATE MUST NOT BE EXCEEDED. VISTIDE MUST BE DILUTED IN 100 MILLILITERS 0.9% (NORMAL) SALINE PRIOR TO ADMINISTRATION. TO MINIMIZE POTENTIAL NEPHROTOXICITY, PROBENECID AND INTRAVENOUS SALINE PREHYDRATION MUST BE ADMINISTERED WITH EACH VISTIDE INFUSION.

Induction Treatment

The recommended induction dose of VISTIDE for patients with a serum creatinine of ≤ 1.5 mg/dL, a calculated creatinine clearance > 55 mL/min, and a urine protein < 100 mg/dL (equivalent to < 2+ proteinuria) is 5 mg/kg body weight (given as an intravenous infusion at a constant rate over 1 hr) administered once weekly for two consecutive weeks. Because serum creatinine in patients with advanced AIDS and CMV retinitis may not provide a complete picture of the patient's underlying renal status, it is important to utilize the Cockcroft-Gault formula to more precisely estimate creatinine clearance (CrCl). As creatinine clearance is dependent on serum creatinine and patient weight, it is necessary to calculate clearance prior to initiation of VISTIDE. CrCl (mL/min) should be calculated according to the following formula:
Creatinine clearance for males = [140-age (years)] × [body wt (kg)] 72 × [serum creatinine (mg/dL)] Creatinine clearance for females = [140-age (years)] × [body wt (kg)] × 0.85 72 × [serum creatinine (mg/dL)]
Maintenance Treatment

The recommended maintenance dose of VISTIDE is 5 mg/kg body weight (given as an intravenous infusion at a constant rate over 1 hr), administered once every 2 weeks.

Dose Adjustment

Changes in Renal Function During VISTIDE Therapy

The maintenance dose of VISTIDE must be reduced from 5 mg/kg to 3 mg/kg for an increase in serum creatinine of 0.3 – 0.4 mg/dL above baseline. VISTIDE therapy must be discontinued for an increase in serum creatinine of ≥ 0.5 mg/dL above baseline or development of ≥ 3+ proteinuria.

Preexisting Renal Impairment

VISTIDE is contraindicated in patients with a serum creatinine concentration > 1.5 mg/dL, a calculated creatinine clearance ≤ 55 mL/min, or a urine protein ≥ 100 mg/dL (equivalent to ≥ 2+ proteinuria).

Probenecid

Probenecid must be administered orally with each VISTIDE dose. Two grams must be administered 3 hr prior to the VISTIDE dose and one gram administered at 2 and again at 8 hr after completion of the 1 hr VISTIDE infusion (for a total of 4 grams).

Ingestion of food prior to each dose of probenecid may reduce drug-related nausea and vomiting. Administration of an antiemetic may reduce the potential for nausea associated with probenecid ingestion. In patients who develop allergic or hypersensitivity symptoms to probenecid, the use of an appropriate prophylactic or therapeutic antihistamine and/or acetaminophen should be considered (see CONTRAINDICATIONS).

Hydration

Patients must receive at least one liter of 0.9% (normal) saline solution intravenously with each infusion of VISTIDE. The saline solution should be infused over a 1–2 hr period immediately before the VISTIDE infusion. Patients who can tolerate the additional fluid load should receive a second liter. If administered, the second liter of saline should be initiated either at the start of the VISTIDE infusion or immediately afterwards, and infused over a 1 to 3 hr period.

Method of Preparation and Administration

Inspect vials visually for particulate matter and discoloration prior to administration. If particulate matter or discoloration is observed, the vial should not be used. With a syringe, extract the appropriate volume of VISTIDE from the vial and transfer the dose to an infusion bag containing 100 mL 0.9% (normal) saline solution. Infuse the entire volume intravenously into the patient at a constant rate over a 1 hr period. Use of a standard infusion pump for administration is recommended.

It is recommended that VISTIDE infusion admixtures be administered within 24 hr of preparation and that refrigerator or freezer storage not be used to extend this 24 hr limit.

If admixtures are not intended for immediate use, they may be stored under refrigeration (2–8°C) for no more than 24 hr. Refrigerated admixtures should be allowed to equilibrate to room temperature prior to use.

The chemical stability of VISTIDE admixtures was demonstrated in polyvinyl chloride composition and ethylene/propylene copolymer composition commercial infusion bags, and in glass bottles. No data are available to support the addition of other drugs or supplements to the cidofovir admixture for concurrent administration.

VISTIDE is supplied in single-use vials. Partially used vials should be discarded (see Handling and Disposal).

Compatibility with Ringer's solution, Lactated Ringer's solution or bacteriostatic infusion fluids has not been evaluated.

Handling and Disposal

Due to the mutagenic properties of cidofovir, adequate precautions including the use of appropriate safety equipment are recommended for the preparation, administration, and disposal of VISTIDE. The National Institutes of Health presently recommends that such agents be prepared in a Class II laminar flow biological safety cabinet and that personnel preparing drugs of this class wear surgical gloves and a closed front surgical-type gown with knit cuffs. If VISTIDE contacts the skin, wash membranes and flush thoroughly with water. Excess VISTIDE and all other materials used in the admixture preparation and administration should be placed in a leak-proof, puncture-proof container. The recommended method of disposal is high temperature incineration.

Patient Monitoring

Serum creatinine and urine protein must be monitored within 48 hours prior to each dose. White blood cell counts with differential should be monitored prior to each dose. In patients with proteinuria, intravenous hydration should be administered and the test repeated. Intraocular pressure, visual acuity and ocular symptoms should be monitored periodically.
Viread

Viread

2.1 Recommended Dose in Adults and Pediatric Patients 12 Years of Age and Older (35 kg or more)

For the treatment of HIV-1 or chronic hepatitis B: The dose is one 300 mg VIREAD tablet once daily taken orally, without regard to food.

For patients unable to swallow VIREAD tablets, the oral powder formulation (7.5 scoops) may be used.

In the treatment of chronic hepatitis B, the optimal duration of treatment is unknown. Safety and efficacy in pediatric patients with chronic hepatitis B weighing less than 35 kg have not been established.

2.2 Recommended Dose in Pediatric Patients 2 Years to Less than 12 Years of Age

HIV-1 Infection

For the treatment of HIV-1 in pediatric patients 2 years of age and older, the recommended oral dose of VIREAD is 8 mg of tenofovir disoproxil fumarate per kilogram of body weight (up to a maximum of 300 mg) once daily administered as oral powder or tablets.

VIREAD oral powder should be measured only with the supplied dosing scoop. One level scoop delivers 1 g of powder which contains 40 mg of tenofovir disoproxil fumarate. VIREAD oral powder should be mixed in a container with 2 to 4 ounces of soft food not requiring chewing (e.g., applesauce, baby food, yogurt). The entire mixture should be ingested immediately to avoid a bitter taste. Do not administer VIREAD oral powder in a liquid as the powder may float on top of the liquid even after stirring. Further patient instructions on how to administer VIREAD oral powder with the supplied dosing scoop are provided in the FDA-approved patient labeling (Patient Information).

VIREAD is also available as tablets in 150, 200, 250 and 300 mg strengths for pediatric patients who weigh greater than or equal to 17 kg and who are able to reliably swallow intact tablets. The dose is one tablet once daily taken orally, without regard to food.

Tables 1 and 2 contain dosing recommendations for VIREAD oral powder and tablets based on body weight. Weight should be monitored periodically and the VIREAD dose adjusted accordingly.
Table 1 Dosing Recommendations for Pediatric Patients ≥2 Years of Age Using VIREAD Oral Powder Body WeightKilogram (kg) Oral Powder Once DailyScoops of Powder 10 to <12 2 12 to <14 2.5 14 to <17 3 17 to <19 3.5 19 to <22 4 22 to <24 4.5 24 to <27 5 27 to <29 5.5 29 to <32 6 32 to <34 6.5 34 to <35 7 ≥35 7.5 Table 2 Dosing Recommendations for Pediatric Patients ≥2 Years of Age and Weighing ≥17 kg Using VIREAD Tablets Body WeightKilogram (kg) Tablets Once Daily 17 to <22 150 mg 22 to <28 200 mg 28 to <35 250 mg ≥35 300 mg
Chronic Hepatitis B

Safety and efficacy of VIREAD in patients younger than 12 years of age have not been established.

2.3 Dose Adjustment for Renal Impairment in Adults

Significantly increased drug exposures occurred when VIREAD was administered to subjects with moderate to severe renal impairment [See Clinical Pharmacology (12.3)]. Therefore, the dosing interval of VIREAD tablets 300 mg should be adjusted in patients with baseline creatinine clearance below 50 mL/min using the recommendations in Table 3. These dosing interval recommendations are based on modeling of single-dose pharmacokinetic data in non-HIV and non-HBV infected subjects with varying degrees of renal impairment, including end-stage renal disease requiring hemodialysis. The safety and effectiveness of these dosing interval adjustment recommendations have not been clinically evaluated in patients with moderate or severe renal impairment, therefore clinical response to treatment and renal function should be closely monitored in these patients [See Warnings and Precautions (5.3)]. There are no data to recommend use of VIREAD tablets 150, 200 or 250 mg or VIREAD oral powder in patients with renal impairment.

No dose adjustment of VIREAD tablets 300 mg is necessary for patients with mild renal impairment (creatinine clearance 50–80 mL/min). Routine monitoring of estimated creatinine clearance, serum phosphorus, urine glucose, and urine protein should be performed in patients with mild renal impairment [See Warnings and Precautions (5.3)].
Table 3 Dosage Adjustment for Patients with Altered Creatinine Clearance Creatinine Clearance (mL/min)* ≥50 30–49 10–29 Hemodialysis Patients * Calculated using ideal (lean) body weight. † Generally once weekly assuming three hemodialysis sessions a week of approximately 4 hours duration. VIREAD should be administered following completion of dialysis. Recommended 300 mg Dosing Interval Every 24 hours Every 48 hours Every 72 to 96 hours Every 7 days or after a total of approximately 12 hours of dialysis†
The pharmacokinetics of tenofovir have not been evaluated in non-hemodialysis patients with creatinine clearance below 10 mL/min; therefore, no dosing recommendation is available for these patients.

No data are available to make dose recommendations in pediatric patients with renal impairment.
Truvada

Truvada

2.1 Recommended Dose for Treatment of HIV-1 Infection

The recommended dose of TRUVADA in adults and in pediatric patients 12 years of age and older with body weight greater than or equal to 35 kg (greater than or equal to 77 lb) is one tablet (containing 200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) once daily taken orally with or without food.

2.2 Recommended Dose for Pre-exposure Prophylaxis

The dose of TRUVADA in HIV-1 uninfected adults is one tablet (containing 200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) once daily taken orally with or without food.

2.3 Dose Adjustment for Renal Impairment

Treatment of HIV-1 Infection

Significantly increased drug exposures occurred when EMTRIVA or VIREAD were administered to subjects with moderate to severe renal impairment [See EMTRIVA or VIREAD Package Insert]. Therefore, adjust the dosing interval of TRUVADA in HIV-1 infected adult patients with baseline creatinine clearance 30–49 mL/min using the recommendations in Table 1. These dosing interval recommendations are based on modeling of single-dose pharmacokinetic data in non-HIV infected subjects. The safety and effectiveness of these dosing interval adjustment recommendations have not been clinically evaluated in patients with moderate renal impairment, therefore clinical response to treatment and renal function should be closely monitored in these patients [See Warnings and Precautions (5.3)].

No dose adjustment is necessary for HIV-1 infected patients with mild renal impairment (creatinine clearance 50–80 mL/min). No data are available to make dose recommendations in pediatric patients with renal impairment.
Table 1 Dosage Adjustment for HIV-1 Infected Adult Patients with Altered Creatinine Clearance Creatinine Clearance (mL/min)* ≥50 30–49 <30(Including Patients Requiring Hemodialysis) * Calculated using ideal (lean) body weight Recommended Dosing Interval Every 24 hours Every 48 hours TRUVADA should not be administered.
Routine monitoring of estimated creatinine clearance, serum phosphorus, urine glucose, and urine protein should be performed in all individuals with mild renal impairment [See Warnings and Precautions (5.3)].

Pre-exposure Prophylaxis

Do not use TRUVADA for a PrEP indication in HIV-1 uninfected individuals with estimated creatinine clearance below 60 mL/min [See Warnings and Precautions (5.3)].

Routine monitoring of estimated creatinine clearance, serum phosphorus, urine glucose, and urine protein should be performed in all individuals with mild renal impairment. If a decrease in estimated creatinine clearance is observed in uninfected individuals while using TRUVADA for PrEP, evaluate potential causes and re-assess potential risks and benefits of continued use [See Warnings and Precautions (5.3)].
Ranexa

Ranexa

2.1 Dosing Information

Initiate RANEXA dosing at 500 mg twice daily and increase to 1000 mg twice daily, as needed, based on clinical symptoms. Take RANEXA with or without meals. Swallow RANEXA tablets whole; do not crush, break, or chew.

The maximum recommended daily dose of RANEXA is 1000 mg twice daily.

If a dose of RANEXA is missed, take the prescribed dose at the next scheduled time; do not double the next dose.

2.2 Dose Modification

Dose adjustments may be needed when RANEXA is taken in combination with certain other drugs [see Drug Interactions (7.1)] . Limit the maximum dose of RANEXA to 500 mg twice daily in patients on moderate CYP3A inhibitors such as diltiazem, verapamil, and erythromycin. Use of RANEXA with strong CYP3A inhibitors is contraindicated [see Contraindications (4), Drug Interactions (7.1)]. Use of P-gp inhibitors, such as cyclosporine, may increase exposure to RANEXA. Titrate RANEXA based on clinical response [see Drug Interactions (7.1)].
Citalopram

Citalopram

2.1 Dosage Information

The recommended dosage of STRIBILD is one tablet taken orally once daily with food [see Clinical Pharmacology (12.3)].

2.2 Dosage Adjustment in Patients with Renal Impairment

Initiation of STRIBILD in patients with estimated creatinine clearance below 70 mL per minute is not recommended. Because STRIBILD is a fixed-dose combination tablet, STRIBILD should be discontinued if estimated creatinine clearance declines below 50 mL per minute during treatment with STRIBILD, as the dose interval adjustment required for emtricitabine and tenofovir disoproxil fumarate (DF) cannot be achieved [see Warnings and Precautions (5.3), Adverse Reactions (6.1), Use in Specific Populations (8.6), Clinical Pharmacology (12.3), and Clinical Studies (14)].

2.3 Dosage in Patients with Hepatic Impairment

No dosage adjustment of STRIBILD is required in patients with mild (Child-Pugh Class A) or moderate (Child-Pugh Class B) hepatic impairment. No pharmacokinetic or safety data are available regarding the use of STRIBILD in patients with severe hepatic impairment (Child-Pugh Class C). Therefore, STRIBILD is not recommended for use in patients with severe hepatic impairment [see Use in Specific Populations (8.7) and Clinical Pharmacology (12.3)].

2.4 Testing Prior to Initiation of STRIBILD

Prior to initiation of STRIBILD, patients should be tested for hepatitis B infection [see Warnings and Precautions (5.2)] and estimated creatinine clearance, urine glucose and urine protein should be documented in all patients [see Warnings and Precautions (5.3)].
Parure De Lumiere Light...

Parure De Lumiere Light-diffusing Foundation With Sunscreen Moisture Infusion Broad Spectrum Spf 25 31 Ambre Pale

2.1 Dosage Information

The recommended dosage of STRIBILD is one tablet taken orally once daily with food [see Clinical Pharmacology (12.3)].

2.2 Dosage Adjustment in Patients with Renal Impairment

Initiation of STRIBILD in patients with estimated creatinine clearance below 70 mL per minute is not recommended. Because STRIBILD is a fixed-dose combination tablet, STRIBILD should be discontinued if estimated creatinine clearance declines below 50 mL per minute during treatment with STRIBILD as the dose interval adjustment required for emtricitabine and tenofovir disoproxil fumarate (DF) cannot be achieved [see Warnings and Precautions (5.3), Adverse Reactions (6.1), Use in Specific Populations (8.6), Clinical Pharmacology (12.3), and Clinical Studies (14)].

2.3 Dosage in Patients with Hepatic Impairment

No dosage adjustment of STRIBILD is required in patients with mild (Child-Pugh Class A) or moderate (Child-Pugh Class B) hepatic impairment. No pharmacokinetic or safety data are available regarding the use of STRIBILD in patients with severe hepatic impairment (Child-Pugh Class C). Therefore, STRIBILD is not recommended for use in patients with severe hepatic impairment [see Use in Specific Populations (8.7) and Clinical Pharmacology (12.3)].

2.4 Testing Prior to Initiation of STRIBILD

Prior to initiation of STRIBILD, patients should be tested for hepatitis B infection [see Warnings and Precautions (5.2)] and estimated creatinine clearance, urine glucose and urine protein should be documented in all patients [see Warnings and Precautions (5.3)].
Zithromax

Zithromax

2.1 Adult Dosage

Initiate treatment at 5 mg once daily, with or without tadalafil 20 mg once daily. At 4-week intervals, either the dose of Letairis or tadalafil can be increased, as needed and tolerated, to Letairis 10 mg or tadalafil 40 mg.

Do not split, crush, or chew tablets.

2.2 Pregnancy Testing in Females of Reproductive Potential

Initiate treatment with Letairis in females of reproductive potential only after a negative pregnancy test. Obtain monthly pregnancy tests during treatment [see Use in Specific Populations (8.6)].
Pain Relief Childrens

Pain Relief Childrens

2.1 Recommended Dose in Adults and Pediatric Patients 12 Years of Age and Older (35 kg or more)

For the treatment of HIV-1 or chronic hepatitis B: The dose is one 300 mg VIREAD tablet once daily taken orally, without regard to food.

In the treatment of chronic hepatitis B, the optimal duration of treatment is unknown. Safety and efficacy in pediatric patients less than 12 years of age or weighing less than 35 kg have not been established.In the treatment of chronic hepatitis B, the optimal duration of treatment is unknown. Safety and efficacy in pediatric patients less than 12 years of age or weighing less than 35 kg have not been established.

2.2 Dose Adjustment for Renal Impairment in Adults

Significantly increased drug exposures occurred when VIREAD was administered to subjects with moderate to severe renal impairment [See Clinical Pharmacology (12.3)] . Therefore, the dosing interval of VIREAD should be adjusted in patients with baseline creatinine clearance below 50 mL/min using the recommendations in Table 1. These dosing interval recommendations are based on modeling of single-dose pharmacokinetic data in non-HIV and non-HBV infected subjects with varying degrees of renal impairment, including end-stage renal disease requiring hemodialysis. The safety and effectiveness of these dosing interval adjustment recommendations have not been clinically evaluated in patients with moderate or severe renal impairment; therefore clinical response to treatment and renal function should be closely monitored in these patients [See Warnings and Precautions (5.3)] .

No dose adjustment is necessary for patients with mild renal impairment (creatinine clearance 50–80 mL/min). Routine monitoring of estimated creatinine clearance, serum phosphorus, urine glucose, and urine protein should be performed in patients with mild renal impairment . No dose adjustment is necessary for patients with mild renal impairment (creatinine clearance 50–80 mL/min). Routine monitoring of estimated creatinine clearance, serum phosphorus, urine glucose, and urine protein should be performed in patients with mild renal impairment [See Warnings and Precautions (5.3)] .
Table 1 Dosage Adjustment for Patients with Altered Creatinine Clearance Creatinine Clearance (mL/min) * Hemodialysis Patients ≥50 30–49 10–29 * Calculated using ideal (lean) body weight. † Generally once weekly assuming three hemodialysis sessions a week of approximately 4 hours duration. VIREAD should be administered following completion of dialysis. Recommended 300 mg Dosing Interval Every 24 hours Every 48 hours Every 72 to 96 hours Every 7 days or after a total of approximately 12 hours of dialysis †
The pharmacokinetics of tenofovir have not been evaluated in non-hemodialysis patients with creatinine clearance below 10 mL/min; therefore, no dosing recommendation is available for these patients.The pharmacokinetics of tenofovir have not been evaluated in non-hemodialysis patients with creatinine clearance below 10 mL/min; therefore, no dosing recommendation is available for these patients.

No data are available to make dose recommendations in pediatric patients 12 years of age and older with renal impairment.No data are available to make dose recommendations in pediatric patients 12 years of age and older with renal impairment.
Cayston

Cayston

2.1 Dosing Information

The recommended dose of CAYSTON for both adults and pediatric patients 7 years of age and older is one single-use vial (75 mg of aztreonam) reconstituted with 1 mL of sterile diluent administered 3 times a day for a 28-day course (followed by 28 days off CAYSTON therapy). Dosage is not based on weight or adjusted for age. Doses should be taken at least 4 hours apart.

CAYSTON is administered by inhalation using an Altera® Nebulizer System. Patients should use a bronchodilator before administration of CAYSTON.

2.2 Instructions for CAYSTON Reconstitution

CAYSTON should be administered immediately after reconstitution. Do not reconstitute CAYSTON until ready to administer a dose.

Take one amber glass vial containing CAYSTON and one diluent ampule from the carton. To open the glass vial, carefully remove the metal ring by lifting or pulling the tab and remove the gray rubber stopper. Twist the tip off the diluent ampule and squeeze the liquid into the glass vial. Replace the rubber stopper, then gently swirl the vial until contents have completely dissolved.

The empty vial, stopper, and diluent ampule should be disposed of properly upon completion of dosing.

2.3 Instructions for CAYSTON Administration

CAYSTON is administered by inhalation using an Altera Nebulizer System. CAYSTON should not be administered with any other nebulizer. CAYSTON should not be mixed with any other drugs in the Altera Nebulizer Handset.

CAYSTON is not for intravenous or intramuscular administration.

Patients should use a bronchodilator before administration of CAYSTON. Short-acting bronchodilators can be taken between 15 minutes and 4 hours prior to each dose of CAYSTON. Alternatively, long-acting bronchodilators can be taken between 30 minutes and 12 hours prior to administration of CAYSTON. For patients taking multiple inhaled therapies, the recommended order of administration is as follows: bronchodilator, mucolytics, and lastly, CAYSTON.

To administer CAYSTON, pour the reconstituted solution into the handset of the nebulizer system. Turn the unit on. Place the mouthpiece of the handset in your mouth and breathe normally only through your mouth. Administration typically takes between 2 and 3 minutes. Further patient instructions on how to administer CAYSTON are provided in the FDA-approved patient labeling. Instructions on testing nebulizer functionality and cleaning the handset are provided in the Instructions for Use included with the nebulizer system.
Sovaldi Access

Sovaldi Access

2.1 Recommended Dose in Adults

The recommended dose of SOVALDI is one 400 mg tablet, taken orally, once daily with or without food [See Clinical Pharmacology (12.3)] .

SOVALDI should be used in combination with ribavirin or in combination with pegylated interferon and ribavirin for the treatment of CHC in adults. The recommended regimen and treatment duration for SOVALDI combination therapy is provided in Table 1.
Table 1 Recommended Regimens and Treatment Duration for SOVALDI Combination Therapy in HCV Mono-infected and HCV/HIV-1 Co-infected Patients Treatment Duration * See peginterferon alfa prescribing information for dosing recommendation for patients with genotype 1 or 4 CHC. † Dose of ribavirin is weight-based (<75 kg = 1000 mg and ≥75 kg = 1200 mg). The daily dose of ribavirin is administered orally in two divided doses with food. Patients with renal impairment (CrCl ≤ 50 mL/min) require ribavirin dose reduction; refer to ribavirin prescribing information. Patients with genotype 1 or 4 CHC SOVALDI + peginterferon alfa * + ribavirin † 12 weeks Patients with genotype 2 CHC SOVALDI + ribavirin † 12 weeks Patients with genotype 3 CHC SOVALDI + ribavirin † 24 weeks
SOVALDI in combination with ribavirin for 24 weeks can be considered as a therapeutic option for CHC patients with genotype 1 infection who are ineligible to receive an interferon-based regimen [See Use in Specific Populations (8.8) and Clinical Studies (14.4)] . Treatment decision should be guided by an assessment of the potential benefits and risks for the individual patient.

Patients with Hepatocellular Carcinoma Awaiting Liver Transplantation

SOVALDI in combination with ribavirin is recommended for up to 48 weeks or until the time of liver transplantation, whichever occurs first, to prevent post-transplant HCV reinfection [See Use in Specific Populations (8.9)] .

2.2 Dose Modification

Dose reduction of SOVALDI is not recommended.

Genotype 1 and 4:

If a patient has a serious adverse reaction potentially related to peginterferon alfa and/or ribavirin, the peginterferon alfa and/or ribavirin dose should be reduced or discontinued. Refer to the peginterferon alfa and ribavirin prescribing information for additional information about how to reduce and/or discontinue the peginterferon alfa and/or ribavirin dose.

Genotype 2 and 3:

If a patient has a serious adverse reaction potentially related to ribavirin, the ribavirin dose should be modified or discontinued, if appropriate, until the adverse reaction abates or decreases in severity. Table 2 provides guidelines for dose modifications and discontinuation based on the patient's hemoglobin concentration and cardiac status.
Table 2 Ribavirin Dose Modification Guideline for Coadministration with SOVALDI Laboratory Values Reduce Ribavirin Dose to 600 mg/day * If: Discontinue Ribavirin If: † * The daily dose of ribavirin is administered orally in two divided doses with food. † Once ribavirin has been withheld due to either a laboratory abnormality or clinical manifestation, an attempt may be made to restart ribavirin at 600 mg daily and further increase the dose to 800 mg daily. However, it is not recommended that ribavirin be increased to the original assigned dose (1000 mg to 1200 mg daily). Hemoglobin in patients with no cardiac disease <10 g/dL <8.5 g/dL Hemoglobin in patients with history of stable cardiac disease ≥2 g/dL decrease in hemoglobin during any 4 week treatment period <12 g/dL despite 4 weeks at reduced dose
2.3 Discontinuation of Dosing

If the other agents used in combination with SOVALDI are permanently discontinued, SOVALDI should also be discontinued.

2.4 Severe Renal Impairment and End Stage Renal Disease

No dose recommendation can be given for patients with severe renal impairment (estimated Glomerular Filtration Rate (eGFR) <30 mL/min/1.73m 2) or with end stage renal disease (ESRD) due to higher exposures (up to 20-fold) of the predominant sofosbuvir metabolite [See Use in Specific Populations (8.6) and Clinical Pharmacology (12.3)] .
Vitekta

Vitekta

VITEKTA must be administered once daily with food in combination with a protease inhibitor coadministered with ritonavir and another antiretroviral drug. The protease inhibitor and ritonavir dosing regimens presented in Table 1 are the recommended regimens for use with VITEKTA. For additional dosing instructions for these protease inhibitors and other concomitant antiretroviral drugs, refer to their respective prescribing information.
Table 1 Recommended Regimens* Dosage of VITEKTA Dosage of Concomitant Protease Inhibitor Dosage of Concomitant Ritonavir * VITEKTA in combination with a protease inhibitor and ritonavir must be coadministered with another antiretroviral drug. 85 mg orally once daily Atazanavir 300 mg orally once daily 100 mg orally once daily Lopinavir 400 mg orally twice daily 100 mg orally twice daily 150 mg orally once daily Darunavir 600 mg orally twice daily 100 mg orally twice daily Fosamprenavir 700 mg mg orally twice daily 100 mg orally twice daily Tipranavir 500 mg orally twice daily 200 mg orally twice daily
Treatment history and, when available, resistance testing should guide the use of VITEKTA-containing regimens.
Tybost

Tybost

2.1 Recommended Dosage

Administer TYBOST in conjunction with atazanavir or darunavir and other antiretroviral agents in the treatment of adults with HIV-1 infection. The recommended dosages of TYBOST and atazanavir or darunavir given with food are presented in Table 1. TYBOST must be coadministered at the same time as atazanavir or darunavir [see Drug Interactions (7)]. Consult the prescribing information for atazanavir or darunavir.
Table 1 Recommended Dosing Regimens TYBOST Dosage Coadministered Agent Dosage Patient Populations 150 mg orally once daily atazanavir 300 mg orally once daily Treatment-naïve or experienced darunavir 800 mg orally once daily Treatment-naïveTreatment-experienced with no darunavir resistance associated substitutions
2.2 Testing Prior to Initiation of TYBOST

Prior to starting TYBOST, assess estimated creatinine clearance because TYBOST decreases estimated creatinine clearance due to inhibition of tubular secretion of creatinine without affecting actual renal glomerular function [see Warnings and Precautions (5.1)]. When coadministering TYBOST with tenofovir disoproxil fumarate (tenofovir DF) assess estimated creatinine clearance, urine glucose, and urine protein at baseline [see Warnings and Precautions 5.2].

2.3 Renal Impairment

TYBOST coadministered with tenofovir DF is not recommended in patients who have an estimated creatinine clearance below 70 mL/min because dose adjustment of tenofovir DF is required below 50 mL/min and such dose adjustments have not been established for coadministration with TYBOST [see Warnings and Precautions (5.2) and Adverse Reactions (6.1)].

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