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Yondelis

Yondelis

2.1 Recommended Dose and Schedule

The recommended dose is 1.5 mg/m2 administered as an intravenous infusion over 24 hours through a central venous line every 21 days (3 weeks), until disease progression or unacceptable toxicity, in patients with normal bilirubin and AST or ALT less than or equal to 2.5 times the upper limit of normal.

There is no recommended dose of YONDELIS in patients with serum bilirubin levels above the institutional upper limit of normal [see Warnings and Precautions (5.3) and Clinical Pharmacology (12.3)].

2.2 Premedication

Administer dexamethasone 20 mg intravenously 30 minutes prior to each dose of YONDELIS.

2.3 Dose Modifications

Permanently discontinue YONDELIS for:
Persistent adverse reactions requiring a delay in dosing of more than 3 weeks Adverse reactions requiring dose reduction following YONDELIS administered at 1.0 mg/m2 Severe liver dysfunction (all of the following: bilirubin two times the upper limit of normal and AST or ALT three times the upper limit of normal with alkaline phosphatase less than two times the upper limit of normal) in the prior treatment cycle
The recommended dose modifications for adverse reactions are listed in Table 1. Once reduced, the dose of YONDELIS should not be increased in subsequent treatment cycles. The dose reductions for YONDELIS are:
First dose reduction: YONDELIS 1.2 mg/m2 every 3 weeks Second dose reduction: YONDELIS 1.0 mg/m2 every 3 weeks Table 1: Recommended Dose Modification Laboratory Result or Adverse Reaction DELAY next dose of YONDELIS for up to 3 weeks REDUCE next dose of YONDELIS by one dose level for adverse reaction(s) during prior cycle Platelets Less than 100,000 platelets/microliter Less than 25,000 platelets/microliter Absolute neutrophil count Less than 1,500 neutrophils/microliter Less than 1,000 neutrophils/microliter with fever/infection Less than 500 neutrophils/microliter lasting more than 5 days Total bilirubin Greater than the upper limit of normal Greater than the upper limit of normal Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) More than 2.5 times the upper limit of normal More than 5 times the upper limit of normal Alkaline phosphatase (ALP) More than 2.5 times the upper limit of normal More than 2.5 times the upper limit of normal Creatine phosphokinase More than 2.5 times the upper limit of normal More than 5 times the upper limit of normal Decreased left ventricular ejection fraction Less than lower limit of normal; or Clinical evidence of cardiomyopathy Absolute decrease of 10% or more from baseline and less than lower limit of normal; or Clinical evidence of cardiomyopathy Other non-hematologic adverse reactions Grade 3 or 4 Grade 3 or 4
2.4 Preparation for Administration
YONDELIS is a cytotoxic drug. Follow applicable special handling and disposal procedures.1 Using aseptic technique, inject 20 mL of Sterile Water for Injection, USP into the vial. Shake the vial until complete dissolution. The reconstituted solution is clear, colorless to pale brownish-yellow, and contains 0.05 mg/mL of trabectedin. Inspect for particulate matter and discoloration prior to further dilution. Discard vial if particles or discoloration are observed. Immediately following reconstitution, withdraw the calculated volume of trabectedin and further dilute in 500 mL of 0.9% Sodium Chloride, USP or 5% Dextrose Injection, USP. Do not mix YONDELIS with other drugs. Discard any remaining solution within 30 hours of reconstituting the lyophilized powder. YONDELIS diluted solution is compatible with Type I colorless glass vials, polyvinylchloride (PVC) and polyethylene (PE) bags and tubing, PE and polypropylene (PP) mixture bags, polyethersulfone (PES) in-line filters, titanium, platinum or plastic ports, silicone and polyurethane catheters, and pumps having contact surfaces made of PVC, PE, or PE/PP.
2.5 Administration
Infuse the reconstituted, diluted solution over 24 hours through a central venous line using an infusion set with a 0.2 micron polyethersulfone (PES) in-line filter to reduce the risk of exposure to adventitious pathogens that may be introduced during solution preparation. Complete infusion within 30 hours of initial reconstitution. Discard any unused portion of the reconstituted product or of the infusion solution.
Odynia-u

Odynia-u

2.1 OLYSIO Combination Treatment

Administer OLYSIO in combination with other antiviral drugs for the treatment of CHC infection. Monitor liver chemistry tests before and during OLYSIO combination therapy [see Warnings and Precautions (5.2)]. OLYSIO monotherapy is not recommended. For specific dosing recommendations for the antiviral drugs used in combination with OLYSIO, refer to their respective prescribing information. Administer OLYSIO in combination with either:
Peg-IFN-alfa and RBV: Table 1 displays the recommended dosage regimen and treatment duration of OLYSIO in combination with Peg-IFN-alfa and RBV. Refer to Table 3 for treatment stopping rules for OLYSIO combination therapy with Peg-IFN-alfa and RBV; or Sofosbuvir: Table 2 displays the recommended dosage regimen and treatment duration of OLYSIO in combination with sofosbuvir.
The recommended dosage of OLYSIO is one capsule taken orally once daily with food. The capsule should be swallowed as a whole.
Table 1: Recommended Dosage Regimens and Treatment Duration for OLYSIO, Peg-IFN-alfa, and RBV Combination Therapy for Treatment of CHC Infection in HCV Genotype 1 or 4 Mono-infected and HCV/HIV-1 Co-infected Patients Patient Population Treatment Regimen and Duration HIV = human immunodeficiency virus. * Prior relapser: HCV RNA not detected at the end of prior IFN-based therapy and HCV RNA detected during follow-up [see Clinical Studies (14)]. † Recommended duration of treatment if patient does not meet stopping rules (see Table 3). ‡ Prior partial responder: prior on-treatment ≥ 2 log10 IU/mL reduction in HCV RNA from baseline at Week 12 and HCV RNA detected at end of prior IFN-based therapy [see Clinical Studies (14)]. § Prior null responder: prior on-treatment < 2 log10 reduction in HCV RNA from baseline at Week 12 during prior IFN-based therapy [see Clinical Studies (14)]. Treatment-naïve patients and prior relapsers* with or without cirrhosis, who are not co-infected with HIV 12 weeks of OLYSIO in combination with Peg-IFN-alfa and RBV followed by an additional 12 weeks of Peg-IFN-alfa and RBV (total treatment duration of 24 weeks)† without cirrhosis, who are co-infected with HIV with cirrhosis, who are co-infected with HIV 12 weeks of OLYSIO in combination with Peg-IFN-alfa and RBV followed by an additional 36 weeks of Peg-IFN-alfa and RBV (total treatment duration of 48 weeks)† Prior non-responders (including partial‡ and null responders§), with or without cirrhosis, with or without HIV co-infection 12 weeks of OLYSIO in combination with Peg-IFN-alfa and RBV followed by an additional 36 weeks of Peg-IFN-alfa and RBV (total treatment duration of 48 weeks)† Table 2: Recommended Dosage Regimen and Treatment Duration for OLYSIO and Sofosbuvir Combination Therapy for Treatment of CHC Infection in HCV Genotype 1 Mono-infected Patients Patient Population Treatment Regimen and Duration * Treatment-experienced patients include prior relapsers, prior partial responders and prior null responders who failed prior IFN-based therapy. Treatment-naïve and treatment-experienced* patients without cirrhosis 12 weeks of OLYSIO + sofosbuvir Treatment-naïve and treatment-experienced* patients with cirrhosis 24 weeks of OLYSIO + sofosbuvir
2.2 Testing Prior to Initiation of OLYSIO in HCV Genotype 1a-Infected Patients

Prior to initiation of treatment with OLYSIO with Peg-IFN-alfa and RBV, screening patients with HCV genotype 1a infection for the presence of virus with the NS3 Q80K polymorphism is strongly recommended and alternative therapy should be considered for patients infected with HCV genotype 1a containing the Q80K polymorphism. Prior to initiation of treatment with OLYSIO with sofosbuvir, screening patients infected with HCV genotype 1a for the presence of virus with the NS3 Q80K polymorphism is not strongly recommended but may be considered [see Indications and Usage (1)].

2.3 Discontinuation of Dosing

Use with Peg-IFN-Alfa and RBV

During treatment, HCV RNA levels should be monitored as clinically indicated using a sensitive assay with a lower limit of quantification of at least 25 IU/mL.

Because patients with an inadequate on-treatment virologic response (i.e., HCV RNA ≥ 25 IU/mL) are not likely to achieve a sustained virologic response (SVR), discontinuation of treatment is recommended in these patients. Table 3 presents treatment stopping rules for patients who experience an inadequate on-treatment virologic response at Weeks 4, 12, and 24.
Table 3: Treatment Stopping Rules in Patients Receiving OLYSIO in Combination with Peg-IFN-alfa and RBV with Inadequate On-Treatment Virologic Response Treatment Week HCV RNA Action Week 4 ≥ 25 IU/mL Discontinue OLYSIO, Peg-IFN-alfa, and RBV Week 12 Discontinue Peg-IFN-alfa, and RBV (treatment with OLYSIO is complete at Week 12) Week 24 Discontinue Peg-IFN-alfa, and RBV (treatment with OLYSIO is complete at Week 12)
Use with Sofosbuvir

No treatment stopping rules apply to the combination of OLYSIO with sofosbuvir [see Clinical Studies (14)].

2.4 Dosage Adjustment or Interruption

To prevent treatment failure, avoid reducing the dosage of OLYSIO or interrupting treatment. If treatment with OLYSIO is discontinued because of adverse reactions or inadequate on-treatment virologic response, OLYSIO treatment must not be reinitiated.

If adverse reactions potentially related to the antiviral drug(s) used in combination with OLYSIO occur, refer to the instructions outlined in their respective prescribing information for recommendations on dosage adjustment or interruption.

If any of the other antiviral drugs used in combination with OLYSIO for the treatment of CHC infection are permanently discontinued for any reason, OLYSIO should also be discontinued.

2.5 Hepatic Impairment

OLYSIO is not recommended for patients with moderate or severe hepatic impairment (Child-Pugh Class B or C) [see Use in Specific Populations (8.8)]. There have been postmarketing reports of hepatic decompensation, hepatic failure, and death in patients with advanced or decompensated cirrhosis receiving OLYSIO combination therapy [see Warnings and Precautions (5.2) and Adverse Reactions (6.2)]. Simeprevir exposures are increased in patients with moderate or severe hepatic impairment (Child-Pugh Class B or C) [see Clinical Pharmacology (12.3)].

In clinical trials, higher simeprevir exposures have been associated with increased frequency of adverse reactions, including increased bilirubin, rash and photosensitivity [see Adverse Reactions (6.1)].

OLYSIO in combination with Peg-IFN-alfa and RBV is contraindicated in patients with decompensated cirrhosis (moderate or severe hepatic impairment) [see Peg-IFN-alfa prescribing information].
Prezcobix

Prezcobix

2.1 Recommended Dosage

PREZCOBIX is a fixed-dose combination product containing 800 mg of darunavir and 150 mg of cobicistat. In treatment-naïve and treatment-experienced adults with no darunavir resistance-associated substitutions, the recommended dosage of PREZCOBIX is one tablet taken once daily orally with food. Administer PREZCOBIX in conjunction with other antiretroviral agents.

2.2 Testing Prior to Initiation of PREZCOBIX

HIV Genotypic Testing:

HIV genotypic testing is recommended for antiretroviral treatment-experienced patients. However, when HIV genotypic testing is not feasible, PREZCOBIX can be used in protease inhibitor-naïve patients, but is not recommended in protease inhibitor-experienced patients.

Creatinine Clearance:

Prior to starting PREZCOBIX, assess estimated creatinine clearance because cobicistat 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 PREZCOBIX with tenofovir disoproxil fumarate (tenofovir DF) assess estimated creatinine clearance, urine glucose, and urine protein at baseline [see Warnings and Precautions (5.3)].

2.3 Patients with Renal Impairment

PREZCOBIX coadministered with tenofovir DF is not recommended in patients who have an estimated creatinine clearance below 70 mL/min [see Warnings and Precautions (5.3) and Adverse Reactions (6.1)].

2.4 Patients with Hepatic Impairment

PREZCOBIX is not recommended for use in patients with severe hepatic impairment [see Use in Specific Populations (8.6) and Clinical Pharmacology (12.3)].
Procrit

Procrit

2.1 Evaluation of Iron Stores and Nutritional Factors

Evaluate the iron status in all patients before and during treatment and maintain iron repletion. Correct or exclude other causes of anemia (e.g., vitamin deficiency, metabolic or chronic inflammatory conditions, bleeding, etc.) before initiating PROCRIT [see Warnings and Precautions (5.11)].

2.2 Patients with Chronic Kidney Disease

In controlled trials, patients experienced greater risks for death, serious adverse cardiovascular reactions, and stroke when administered erythropoiesis-stimulating agents (ESAs) to target a hemoglobin level of greater than 11 g/dL. No trial has identified a hemoglobin target level, ESA dose, or dosing strategy that does not increase these risks. Individualize dosing and use the lowest dose of PROCRIT sufficient to reduce the need for RBC transfusions [see Warnings and Precautions (5.1)]. Physicians and patients should weigh the possible benefits of decreasing transfusions against the increased risks of death and other serious cardiovascular adverse events [see Boxed Warning and Clinical Studies (14)].

For all patients with CKD:

When initiating or adjusting therapy, monitor hemoglobin levels at least weekly until stable, then monitor at least monthly. When adjusting therapy consider hemoglobin rate of rise, rate of decline, ESA responsiveness and hemoglobin variability. A single hemoglobin excursion may not require a dosing change.
Do not increase the dose more frequently than once every 4 weeks. Decreases in dose can occur more frequently. Avoid frequent dose adjustments. If the hemoglobin rises rapidly (e.g., more than 1 g/dL in any 2-week period), reduce the dose of PROCRIT by 25% or more as needed to reduce rapid responses. For patients who do not respond adequately, if the hemoglobin has not increased by more than 1 g/dL after 4 weeks of therapy, increase the dose by 25%. For patients who do not respond adequately over a 12-week escalation period, increasing the PROCRIT dose further is unlikely to improve response and may increase risks. Use the lowest dose that will maintain a hemoglobin level sufficient to reduce the need for RBC transfusions. Evaluate other causes of anemia. Discontinue PROCRIT if responsiveness does not improve.
For patients with CKD on dialysis:
Initiate PROCRIT treatment when the hemoglobin level is less than 10 g/dL. If the hemoglobin level approaches or exceeds 11 g/dL, reduce or interrupt the dose of PROCRIT. The recommended starting dose for adult patients is 50 to 100 Units/kg 3 times weekly intravenously or subcutaneously. For pediatric patients, a starting dose of 50 Units/kg 3 times weekly intravenously or subcutaneously is recommended. The intravenous route is recommended for patients on hemodialysis.
For patients with CKD not on dialysis:
Consider initiating PROCRIT treatment only when the hemoglobin level is less than 10 g/dL and the following considerations apply: The rate of hemoglobin decline indicates the likelihood of requiring a RBC transfusion and, Reducing the risk of alloimmunization and/or other RBC transfusion-related risks is a goal If the hemoglobin level exceeds 10 g/dL, reduce or interrupt the dose of PROCRIT, and use the lowest dose of PROCRIT sufficient to reduce the need for RBC transfusions. The recommended starting dose for adult patients is 50 to 100 Units/kg 3 times weekly intravenously or subcutaneously.
When treating patients who have chronic kidney disease and cancer, physicians should refer to Warnings and Precautions (5.1 and 5.3).

Refer patients who self-administer PROCRIT to the Instructions for Use [see Patient Counseling Information (17)].

2.3 Zidovudine-treated HIV-infected Patients

Starting Dose

The recommended starting dose in adults is 100 Units/kg as an intravenous or subcutaneous injection 3 times per week.

Dose Adjustment
If hemoglobin does not increase after 8 weeks of therapy, increase PROCRIT dose by approximately 50 to 100 Units/kg at 4- to 8-week intervals until hemoglobin reaches a level needed to avoid RBC transfusions or 300 Units/kg. Withhold PROCRIT if hemoglobin exceeds 12 g/dL. Resume therapy at a dose 25% below the previous dose when hemoglobin declines to less than 11 g/dL.
Discontinue PROCRIT if an increase in hemoglobin is not achieved at a dose of 300 Units/kg for 8 weeks.

2.4 Patients on Cancer Chemotherapy

Initiate PROCRIT in patients on cancer chemotherapy only if the hemoglobin is less than 10 g/dL, and if there is a minimum of two additional months of planned chemotherapy.

Use the lowest dose of PROCRIT necessary to avoid RBC transfusions.

Recommended Starting Dose

Adults:
150 Units/kg subcutaneously 3 times per week until completion of a chemotherapy course or 40,000 Units subcutaneously weekly until completion of a chemotherapy course.
Pediatric Patients (5 to 18 years):
600 Units/kg intravenously weekly until completion of a chemotherapy course.
Dose Reduction

Reduce dose by 25% if:
Hemoglobin increases greater than 1 g/dL in any 2-week period or Hemoglobin reaches a level needed to avoid RBC transfusion.
Withhold dose if hemoglobin exceeds a level needed to avoid RBC transfusion. Reinitiate at a dose 25% below the previous dose when hemoglobin approaches a level where RBC transfusions may be required.

Dose Increase

After the initial 4 weeks of PROCRIT therapy, if hemoglobin increases by less than 1 g/dL and remains below 10 g/dL, increase dose to:
300 Units/kg three times per week in adults or 60,000 Units weekly in adults 900 Units/kg (maximum 60,000 Units) weekly in children
After 8 weeks of therapy, if there is no response as measured by hemoglobin levels or if RBC transfusions are still required, discontinue PROCRIT.

2.5 Surgery Patients

The recommended PROCRIT regimens are:
300 Units/kg per day subcutaneously for 15 days total: administered daily for 10 days before surgery, on the day of surgery, and for 4 days after surgery. 600 Units/kg subcutaneously in 4 doses administered 21, 14, and 7 days before surgery and on the day of surgery.
Deep venous thrombosis prophylaxis is recommended during PROCRIT therapy [see Warnings and Precautions (5.1)].

2.6 Preparation and Administration
Do not shake. Do not use PROCRIT that has been shaken or frozen. Protect vials from light. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. Do not use any vials exhibiting particulate matter or discoloration. Discard unused portions of PROCRIT in preservative-free vials. Do not re-enter preservative-free vials. Store unused portions of PROCRIT in multidose vials at 36°F to 46°F (2°C to 8°C). Discard 21 days after initial entry. Do not dilute. Do not mix with other drug solutions except for admixing as described below: Preservative-free PROCRIT from single-use vials may be admixed in a syringe with bacteriostatic 0.9% sodium chloride injection, USP, with benzyl alcohol 0.9% (bacteriostatic saline) in a 1:1 ratio using aseptic technique at the time of administration. Risks are associated with benzyl alcohol in neonates, infants, pregnant women, and nursing mothers [see Use in Specific Populations (8.1, 8.3, 8.4)].
Prezista

Prezista

2.1 Adult Patients

PREZISTA must be co-administered with ritonavir to exert its therapeutic effect. Failure to correctly co-administer PREZISTA with ritonavir will result in plasma levels of darunavir that will be insufficient to achieve the desired antiviral effect and will alter some drug interactions.

Patients who have difficulty swallowing PREZISTA tablets can use the 100 mg/mL PREZISTA oral suspension.

Treatment-Naïve Adult Patients

The recommended oral dose of PREZISTA is 800 mg (one 800 mg tablet or 8 mL of the oral suspension) taken with ritonavir 100 mg (one 100 mg tablet/capsule or 1.25 mL of a 80 mg/mL ritonavir oral solution) once daily and with food. An 8 mL darunavir dose should be taken as two 4 mL administrations with the included oral dosing syringe.

Treatment-Experienced Adult Patients
Table 1: Treatment-Experienced Adult Patients * V11I, V32I, L33F, I47V, I50V, I54L, I54M, T74P, L76V, I84V and L89V † An 8 mL darunavir dose should be taken as two 4 mL administrations with the included oral dosing syringe With no darunavir resistance associated substitutions* With at least one darunavir resistance associated substitution* Formulations: PREZISTA tablets or oral suspension (100 mg/mL) and ritonavir tablets/capsules (100 mg) or solution (80 mg/mL) PREZISTA 800 mg (one 800 mg tablet) or 8 mL† (oral suspension) once daily with ritonavir 100 mg (one 100 mg tablet/capsule or 1.25 mL (oral solution) once daily and with food PREZISTA 600 mg (e.g. one 600 mg tablet) or 6 mL (oral suspension) twice daily with ritonavir 100 mg (one 100 mg tablet/capsule or 1.25 mL (oral solution) twice daily and with food
For antiretroviral treatment-experienced patients genotypic testing is recommended. However, when genotypic testing is not feasible, PREZISTA/ritonavir 600/100 mg twice daily dosing is recommended.

2.2 Pediatric Patients (age 3 to less than 18 years)

Healthcare professionals should pay special attention to accurate dose selection of PREZISTA, transcription of the medication order, dispensing information and dosing instruction to minimize risk for medication errors, overdose, and underdose.

Prescribers should select the appropriate dose of PREZISTA/ritonavir for each individual child based on body weight (kg) and should not exceed the recommended dose for adults.

Before prescribing PREZISTA, children weighing greater than or equal to 15 kg should be assessed for the ability to swallow tablets. If a child is unable to reliably swallow a tablet, the use of PREZISTA oral suspension should be considered.

The recommended dose of PREZISTA/ritonavir for pediatric patients (3 to less than 18 years of age and weighing at least 10 kg is based on body weight (see Tables 2, 3, 4, and 5) and should not exceed the recommended adult dose. PREZISTA should be taken with ritonavir and with food.

The recommendations for the PREZISTA/ritonavir dosage regimens were based on the following:

Twice daily dosing
Results from two trials in treatment-experienced pediatric subjects 3 to less 18 years of age demonstrating similar darunavir plasma exposures, virologic response rate and safety profile compared to treatment-experienced adults.
Once daily dosing
Results from one trial in treatment-naïve pediatric subjects 12 to less than 18 years of age demonstrating similar darunavir plasma exposures, virologic response rate and safety profile compared to treatment-naïve adults. Results from population pharmacokinetic modeling and simulation in children 3 to less than 12 years of age predicting similar darunavir plasma exposures compared to treatment-naïve adults. Although no clinical trial was conducted to collect exposure-safety data, the predicted exposures from the once daily dosing is supported by exposures observed in a pediatric clinical trial where twice-daily dosing was administered.
Dosing recommendations for treatment-naïve pediatric patients or antiretroviral treatment-experienced pediatric patients with no darunavir resistance associated substitutions

• Pediatric patients weighing at least 10 kg but less than 15 kg

The weight-based dose in antiretroviral treatment-naïve pediatric patients or antiretroviral treatment-experienced pediatric patients with no darunavir resistance associated substitutions is PREZISTA 35 mg/kg once daily with ritonavir 7 mg/kg once daily using the following table.
Table 2: Recommended dose for pediatric patients weighing 10 kg to less than 15 kg who are treatment-naïve or treatment-experienced with no darunavir resistance associated substitutions* Body weight (kg) Formulation: PREZISTA oral suspension (100 mg/mL) and Ritonavir oral solution (80 mg/mL) Dose: once daily with food * darunavir resistance associated substitutions: V11I, V32I, L33F, I47V, I50V, I54M, I54L, T74P, L76V, I84V and L89V † The 350 mg, 385 mg, 455 mg and 490 mg darunavir dose for the specified weight groups were rounded up for suspension dosing convenience to 3.6 mL, 4 mL, 4.6 mL and 5 mL, respectively. Greater than or equal to 10 kg to less than 11 kg PREZISTA 3.6 mL† (350 mg) with ritonavir 0.8 mL (64 mg) Greater than or equal to 11 kg to less than 12 kg PREZISTA 4 mL† (385 mg) with ritonavir 0.8 mL (64 mg) Greater than or equal to 12 kg to less than 13 kg PREZISTA 4.2 mL (420 mg) with ritonavir 1 mL (80 mg) Greater than or equal to 13 kg to less than 14 kg PREZISTA 4.6 mL† (455 mg) with ritonavir 1 mL (80 mg) Greater than or equal to 14 kg to less than 15 kg PREZISTA 5 mL† (490 mg) with ritonavir 1.2 mL (96 mg)
• Pediatric patients weighing at least 15 kg

Pediatric patients weighing at least 15 kg can be dosed with PREZISTA oral tablet(s) or suspension using the following table:
Table 3: Recommended dose for pediatric patients weighing at least 15 kg who are treatment-naïve or treatment-experienced with no darunavir resistance associated substitutions* Body Weight(kg) Formulation: PREZISTA tablet(s) and ritonavir capsules or tablets (100 mg) Formulation: PREZISTA oral suspension (100 mg/mL) and ritonavir oral solution (80 mg/mL) Dose: once daily with food Dose: once daily with food * darunavir resistance associated substitutions: V11I, V32I, L33F, I47V, I50V, I54M, I54L, T74P, L76V, I84V and L89V † The 675 mg dose using darunavir tablets for this weight group is rounded up to 6.8 mL for suspension dosing convenience. ‡ The 6.8 mL and 8 mL darunavir dose should be taken as two (3.4 mL or 4 mL respectively) administrations with the included oral dosing syringe Greater than or equal to 15 kg to less than 30 kg PREZISTA 600 mg with ritonavir 100 mg PREZISTA 6 mL (600 mg) with ritonavir 1.25 mL (100 mg) Greater than or equal to 30 kg to less than 40 kg PREZISTA 675 mg with ritonavir 100 mg PREZISTA 6.8 mL†‡ (675 mg) with ritonavir 1.25 mL (100 mg) Greater than or equal to 40 kg PREZISTA 800 mg with ritonavir 100 mg PREZISTA 8 mL‡ (800 mg) with ritonavir 1.25 mL (100 mg)
Dosing recommendations for treatment-experienced pediatric patients with at least one darunavir resistance associated substitutions

• Pediatric patients weighing at least 10 kg but less than 15 kg

The weight-based dose in antiretroviral treatment-experienced pediatric patients with at least one darunavir resistance associated substitution is PREZISTA 20 mg/kg twice daily with ritonavir 3 mg/kg twice daily using the following table:
Table 4: Recommended dose for pediatric patients weighing 10 kg to less than 15 kg who are treatment-experienced with at least one darunavir resistance associated substitution* Body weight (kg) Formulation: PREZISTA oral suspension (100 mg/mL) and Ritonavir oral solution (80 mg/mL) Dose: twice daily with food * darunavir resistance associated substitutions: V11I, V32I, L33F, I47V, I50V, I54M, I54L, T74P, L76V, I84V and L89V Greater than or equal to 10 kg to less than 11 kg PREZISTA 2 mL (200 mg) with ritonavir 0.4 mL (32 mg) Greater than or equal to 11 kg to less than 12 kg PREZISTA 2.2 mL (220 mg) with ritonavir 0.4 mL (32 mg) Greater than or equal to 12 kg to less than 13 kg PREZISTA 2.4 mL (240 mg) with ritonavir 0.5 mL (40 mg) Greater than or equal to 13 kg to less than 14 kg PREZISTA 2.6 mL (260 mg) with ritonavir 0.5 mL (40 mg) Greater than or equal to 14 kg to less than 15 kg PREZISTA 2.8 mL (280 mg) with ritonavir 0.6 mL (48 mg)
• Pediatric patients weighing at least 15 kg

Pediatric patients weighing at least 15 kg can be dosed with PREZISTA oral tablet(s) or suspension using the following table:
Table 5: Recommended dose for pediatric patients weighing at least 15 kg who are treatment-experienced with at least one darunavir resistance associated substitution* Body Weight (kg) Formulation: PREZISTA tablet(s) and ritonavir tablets, capsules (100 mg) or oral solution (80 mg/mL) Formulation: PREZISTA oral suspension (100 mg/mL) and ritonavir oral solution (80 mg/mL) Dose: twice daily with food Dose: twice daily with food * darunavir resistance associated substitutions: V11I, V32I, L33F, I47V, I50V, I54M, I54L, T74P, L76V, I84V and L89V † The 375 mg and 450 mg dose using darunavir tablets for this weight group is rounded up to 3.8 mL and 4.6 mL for suspension dosing convenience. Greater than or equal to 15 kg to less than 30 kg PREZISTA 375 mg with ritonavir 0.6 mL (48 mg) PREZISTA 3.8 mL (375 mg) with ritonavir 0.6 mL (48 mg) Greater than or equal to 30 kg to less than 40 kg PREZISTA 450 mg with ritonavir 0.75 mL (60 mg) PREZISTA 4.6 mL (450 mg)† with ritonavir 0.75 mL (60 mg) Greater than or equal to 40 kg PREZISTA 600 mg with ritonavir 100 mg PREZISTA 6 mL (600 mg) with ritonavir 1.25 mL (100 mg)
Do not use PREZISTA/ritonavir in pediatric patients below 3 years of age [see Warnings and Precautions (5.11) and Nonclinical Toxicology (13.2)].

2.3 Patients with Hepatic Impairment

No dose adjustment is required in patients with mild or moderate hepatic impairment. No data are available regarding the use of PREZISTA/ritonavir when co-administered to subjects with severe hepatic impairment; therefore, PREZISTA/ritonavir is not recommended for use in patients with severe hepatic impairment [see Use in Specific Populations (8.6) and Clinical Pharmacology (12.3)].
Doxil

Doxil

2.1 Important Use Information

Do not substitute DOXIL for doxorubicin HCl injection.

Do not administer as an undiluted suspension or as an intravenous bolus [see Warnings and Precautions (5.2)].

2.2 Ovarian Cancer

The recommended dose of DOXIL is 50 mg/m2 intravenously over 60 minutes every 28 days until disease progression or unacceptable toxicity.

2.3 AIDS-Related Kaposi's Sarcoma

The recommended dose of DOXIL is 20 mg/m2 intravenously over 60 minutes every 21 days until disease progression or unacceptable toxicity.

2.4 Multiple Myeloma

The recommended dose of DOXIL is 30 mg/m2 intravenously over 60 minutes on day 4 of each 21-day cycle for eight cycles or until disease progression or unacceptable toxicity. Administer DOXIL after bortezomib on day 4 of each cycle [see Clinical Studies (14.3)].

2.5 Dose Modifications for Adverse Reactions

Do not increase DOXIL after a dose reduction for toxicity.
Table 1: Recommended Dose Modifications for Hand-Foot Syndrome, Stomatitis, or Hematologic Adverse Reactions Toxicity Dose Adjustment Hand-Foot Syndrome (HFS) Grade 1: Mild erythema, swelling, or desquamation not interfering with daily activities If no previous Grade 3 or 4 HFS: no dose adjustment. If previous Grade 3 or 4 HFS: delay dose up to 2 weeks, then decrease dose by 25%. Grade 2: Erythema, desquamation, or swelling interfering with, but not precluding normal physical activities; small blisters or ulcerations less than 2 cm in diameter Delay dosing up to 2 weeks or until resolved to Grade 0–1. Discontinue DOXIL if no resolution after 2 weeks. If resolved to Grade 0–1 within 2 weeks: And no previous Grade 3 or 4 HFS: continue treatment at previous dose. And previous Grade 3 or 4 toxicity: decrease dose by 25%. Grade 3: Blistering, ulceration, or swelling interfering with walking or normal daily activities; cannot wear regular clothing Delay dosing up to 2 weeks or until resolved to Grade 0–1, then decrease dose by 25%. Discontinue DOXIL if no resolution after 2 weeks. Grade 4: Diffuse or local process causing infectious complications, or a bed ridden state or hospitalization Delay dosing up to 2 weeks or until resolved to Grade 0–1, then decrease dose by 25%. Discontinue DOXIL if no resolution after 2 weeks. Stomatitis Grade 1: Painless ulcers, erythema, or mild soreness If no previous Grade 3 or 4 toxicity: no dose adjustment. If previous Grade 3 or 4 toxicity: delay up to 2 weeks then decrease dose by 25%. Grade 2: Painful erythema, edema, or ulcers, but can eat Delay dosing up to 2 weeks or until resolved to Grade 0–1. Discontinue DOXIL if there is no resolution after 2 weeks. If resolved to Grade 0–1 within 2 weeks: And no previous Grade 3 or 4 stomatitis: resume treatment at previous dose. And previous Grade 3 or 4 toxicity: decrease dose by 25%. Grade 3: Painful erythema, edema, or ulcers, and cannot eat Delay dosing up to 2 weeks or until resolved to Grade 0–1. Decrease dose by 25% and return to original dose interval. If after 2 weeks there is no resolution, discontinue DOXIL. Grade 4: Requires parenteral or enteral support Delay dosing up to 2 weeks or until resolved to Grade 0–1. Decrease dose by 25% and return to original dose interval. If after 2 weeks there is no resolution, discontinue DOXIL. Neutropenia or Thrombocytopenia Grade 1 No dose reduction Grade 2 Delay until ANC ≥ 1,500 and platelets ≥ 75,000; resume treatment at previous dose Grade 3 Delay until ANC ≥ 1,500 and platelets ≥ 75,000; resume treatment at previous dose Grade 4 Delay until ANC ≥ 1,500 and platelets ≥ 75,000; resume at 25% dose reduction or continue previous dose with prophylactic granulocyte growth factor Table 2: Recommended Dose Modifications of DOXIL for Toxicity When Administered in Combination With Bortezomib Toxicity DOXIL Fever ≥38°C and ANC <1,000/mm3 Withhold dose for this cycle if before Day 4; Decrease dose by 25%, if after Day 4 of previous cycle. On any day of drug administration after Day 1 of each cycle: Platelet count <25,000/mm3 Hemoglobin <8 g/dL ANC <500/mm3 Withhold dose for this cycle if before Day 4; Decrease dose by 25%, if after Day 4 of previous cycle AND if bortezomib is reduced for hematologic toxicity. Grade 3 or 4 non-hematologic drug related toxicity Do not dose until recovered to Grade <2, then reduce dose by 25%.
For neuropathic pain or peripheral neuropathy, no dosage adjustments are required for DOXIL. Refer to bortezomib manufacturer's prescribing information.

2.6 Preparation and Administration

Preparation

Dilute DOXIL doses up to 90 mg in 250 mL of 5% Dextrose Injection, USP prior to administration. Dilute doses exceeding 90 mg in 500 mL of 5% Dextrose Injection, USP prior to administration. Refrigerate diluted DOXIL at 2°C to 8°C (36°F to 46°F) and administer within 24 hours.

Administration

Inspect parenteral drug products visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Do not use if a precipitate or foreign matter is present.

Do not use with in-line filters.

Administer the first dose of DOXIL at an initial rate of 1 mg/min. If no infusion-related adverse reactions are observed, increase the infusion rate to complete the administration of the drug over one hour [see Warnings and Precautions (5.2)]. Do not rapidly flush the infusion line.

Do not mix DOXIL with other drugs.

Management of Suspected Extravasation

Discontinue DOXIL for burning or stinging sensation or other evidence indicating perivenous infiltration or extravasation. Manage confirmed or suspected extravasation as follows:
Do not remove the needle until attempts are made to aspirate extravasated fluid Do not flush the line Avoid applying pressure to the site Apply ice to the site intermittently for 15 min 4 times a day for 3 days If the extravasation is in an extremity, elevate the extremity
2.7 Procedure for Proper Handling and Disposal

DOXIL is a cytotoxic drug. Follow applicable special handling and disposal procedures.1 If DOXIL comes into contact with skin or mucosa, immediately wash thoroughly with soap and water.
Ampicillin And Sulbacta...

Ampicillin And Sulbactam

2.1 Important Administration Instructions
Administer SIRTURO by directly observed therapy (DOT). Use SIRTURO only in combination with other anti-mycobacterial drugs [see Dosage and Administration (2.3)]. Emphasize the need for compliance with full course of therapy.
2.2 Required Testing Prior to Administration

Prior to treatment with SIRTURO, obtain the following:
Susceptibility information for the background regimen against M. tuberculosis isolate if possible [see Dosage and Administration (2.3)] ECG [see Warnings and Precautions (5.2)] Serum potassium, calcium, and magnesium concentrations [see Warnings and Precautions (5.2)] Liver enzymes [see Warnings and Precautions (5.3)]
2.3 Recommended Dosage in Combination Therapy

Only use SIRTURO in combination with at least 3 other drugs to which the patient's MDR-TB isolate has been shown to be susceptible in vitro. If in vitro testing results are unavailable, SIRTURO treatment may be initiated in combination with at least 4 other drugs to which the patient's MDR-TB isolate is likely to be susceptible.

The recommended dosage of SIRTURO is 400 mg orally once daily for the first two weeks, followed by 200 mg orally three times per week (with at least 48 hours between doses) for 22 weeks (total duration of 24 weeks).

The SIRTURO tablet should be swallowed whole with water and taken with food.

If a dose is missed during the first 2 weeks of treatment, do not administer the missed dose (skip the dose and then continue the daily dosing regimen). From Week 3 onwards, if a 200 mg dose is missed, administer the missed dose as soon as possible, and then resume the 3 times a week dosing regimen.
Edurant

Edurant

The recommended dosage of EDURANT in patients 12 years of age and older and weighing at least 35 kg is one 25 mg tablet once daily taken orally with a meal [see Use in Specific Populations (8.4) and Clinical Pharmacology (12.3)]. EDURANT is not recommended for patients less than 12 years of age.

Rifabutin Co-administration: For patients concomitantly receiving rifabutin, the EDURANT dose should be increased to 50 mg (two tablets of 25 mg each) once daily, taken with a meal. When rifabutin co-administration is stopped, the EDURANT dose should be decreased to 25 mg once daily, taken with a meal [see Drug Interactions (7), Clinical Pharmacology (12.3)].
Intelence

Intelence

2.1 Adult Patients

The recommended oral dose of INTELENCE® tablets is 200 mg (one 200 mg tablet or two 100 mg tablets) taken twice daily following a meal [see Clinical Pharmacology (12.3)]. The type of food does not affect the exposure to etravirine.

2.2 Pediatric Patients (6 years to less than 18 years of age)

The recommended dose of INTELENCE® for pediatric patients 6 years to less than 18 years of age and weighing at least 16 kg is based on body weight (see table below) not exceeding the recommended adult dose. INTELENCE® tablet(s) should be taken orally, following a meal [see Clinical Pharmacology (12.3)]. The type of food does not affect the exposure to etravirine.
Recommended dose of INTELENCE® for pediatric patients 6 years to less than 18 years of age Weight kilograms (kg) Dose greater than or equal to 16 kg to less than 20 kg 100 mg twice daily greater than or equal to 20 kg to less than 25 kg 125 mg twice daily greater than or equal to 25 kg to less than 30 kg 150 mg twice daily greater than or equal to 30 kg 200 mg twice daily
The safety and efficacy of INTELENCE® have not been established in children less than 6 years of age [see Clinical Pharmacology (12.3)].

Healthcare professionals should pay special attention to the accurate dose selection of INTELENCE®, the transcription of the medication order, the dispensing information and the dosing instructions to minimize the risk of medication errors, overdosing, and underdosing.

2.3 Method of Administration

Patients should be instructed to swallow the INTELENCE® tablet(s) whole with a liquid such as water. Patients who are unable to swallow the INTELENCE® tablet(s) whole may disperse the tablet(s) in a glass of water. The patient should be instructed to do the following:
place the tablet(s) in 5 mL (1 teaspoon) of water, or at least enough liquid to cover the medication, stir well until the water looks milky, if desired, add more water or alternatively orange juice or milk (patients should not place the tablets in orange juice or milk without first adding water). The use of grapefruit juice or warm (greater than 40°C) or carbonated beverages should be avoided. drink it immediately, rinse the glass several times with water, orange juice, or milk and completely swallow the rinse each time to make sure the patient takes the entire dose.

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