Viiv Healthcare Company

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Selzentry

Selzentry

2.1 Dose Recommendations for Patients With Normal Renal Function

The recommended dose of SELZENTRY differs based on concomitant medications due to drug interactions (see Table 1). SELZENTRY can be taken with or without food. SELZENTRY must be given in combination with other antiretroviral medications.

Table 1 gives the recommended dose adjustments [see Drug Interactions (7.1)].
Table 1. Recommended Dosing Regimen Concomitant Medications Dose of SELZENTRY
Potent CYP3A inhibitors (with or without a potent CYP3A inducer) including:
protease inhibitors (except tipranavir/ritonavir) delavirdine ketoconazole, itraconazole, clarithromycin other potent CYP3A inhibitors (e.g., nefazodone, telithromycin) 150 mg twice daily Other concomitant medications, including tipranavir/ritonavir, nevirapine, raltegravir, all NRTIs, and enfuvirtide 300 mg twice daily
Potent CYP3A inducers (without a potent CYP3A inhibitor) including:
efavirenz rifampin etravirine carbamazepine, phenobarbital, and phenytoin 600 mg twice daily
2.2 Dose Recommendations for Patients With Renal Impairment

Table 2 provides dosing recommendations for patients based on renal function and concomitant medications.
Table 2. Recommended Dosing Regimens Based on Renal Function Concomitant Medicationsa Dose of SELZENTRY Based on Renal Function
Normal
(CrCl>80 mL/min)
Mild
(CrCl >50 and ≤80 mL/min)
Moderate
(CrCl ≥30 and ≤50 mL/min)
Severe
(CrCl <30 mL/min)
End-Stage Renal Disease (ESRD)
On Regular Hemodialysis Potent CYP3A inhibitors (with or without a CYP3A inducer)a 150 mg twice daily 150 mg twice daily 150 mg twice daily NR NR Other concomitant medicationsa 300 mg twice daily 300 mg twice daily 300 mg twice daily 300 mg twice dailyb 300 mg twice dailyb Potent CYP3A Inducers (without a potent CYP3A inhibitor)a 600 mg twice daily 600 mg twice daily 600 mg twice daily NR NR
NR = Not recommended.

a See Table 1 for the list of concomitant medications.

b The dose of SELZENTRY should be reduced to 150 mg twice daily if there are any symptoms of postural hypotension [see Warnings and Precautions (5.2)].
Male Genital Desensitiz...

Male Genital Desensitizer Stud 100

2.1 Adults - Treatment of HIV-1 Infection

Oral Dosing

The recommended oral dose of RETROVIR is 300 mg twice daily in combination with other antiretroviral agents.

Intravenous (IV) Dosing

The recommended intravenous dose is 1 mg per kg infused at a constant rate over 1 hour every 4 hours. Patients should receive RETROVIR injection only until oral therapy can be administered.
• RETROVIR injection must be diluted prior to administration. The calculated dose should be removed from the 20 mL vial and added to 5% Dextrose injection solution to achieve a concentration no greater than 4 mg per mL. • After dilution, the solution is physically and chemically stable for 24 hours at room temperature and 48 hours if refrigerated at 2° to 8°C (36° to 46°F). As an additional precaution, the diluted solution should be administered within 8 hours if stored at 25°C (77°F) or 24 hours if refrigerated at 2° to 8°C to minimize potential administration of a microbially contaminated solution. • Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit and discarded if either is observed. • Rapid infusion or bolus injection should be avoided. RETROVIR injection should not be given intramuscularly.
2.2 Pediatric Patients (Aged 4 Weeks to Less than 18 Years)

Healthcare professionals should pay special attention to accurate calculation of the dose of RETROVIR, transcription of the medication order, dispensing information, and dosing instructions to minimize risk for medication dosing errors.

Prescribers should calculate the appropriate dose of RETROVIR for each child based on body weight (kg) and should not exceed the recommended adult dose.

Before prescribing RETROVIR capsules, children should be assessed for the ability to swallow capsules. If a child is unable to reliably swallow a RETROVIR capsule, the RETROVIR syrup formulation should be prescribed.

The recommended oral dosage in pediatric patients aged 4 weeks to less than 18 years and weighing greater than or equal to 4 kg is provided in Table 1. RETROVIR syrup should be used to provide accurate dosage when capsules are not appropriate.
Table 1. Recommended Pediatric Oral Dosage of RETROVIR
Body Weight

(kg)

Total Daily Dose

Dosage Regimen and Dose

Twice Daily

Three Times Daily

4 to <9

24 mg/kg/day

12 mg/kg

8 mg/kg

≥9 to <30

18 mg/kg/day

9 mg/kg

6 mg/kg

≥30

600 mg/day

300 mg

200 mg

Alternatively, dosing for RETROVIR can be based on body surface area (BSA) for each child. The recommended oral dose of RETROVIR is 480 mg per m2 per day in divided doses (240 mg per m2 twice daily or 160 mg per m2 three times daily). In some cases the dose calculated by mg per kg will not be the same as that calculated by BSA.

2.3 Prevention of Maternal-Fetal HIV-1 Transmission

The recommended dosage regimen for administration to pregnant women (greater than 14 weeks of pregnancy) and their neonates is:

Maternal Dosing

100 mg orally 5 times per day until the start of labor [see Clinical Studies (14.3)]. During labor and delivery, intravenous RETROVIR should be administered at 2 mg per kg (total body weight) over 1 hour followed by a continuous intravenous infusion of 1 mg per kg per hour (total body weight) until clamping of the umbilical cord.

Neonatal Dosing

Start neonatal dosing within 12 hours after birth and continue through 6 weeks of age. Neonates unable to receive oral dosing may be administered RETROVIR intravenously. See Table 2.
Table 2. Recommended Neonatal Dosages of RETROVIR
Route

Total Daily Dose

Dose and Dosage Regimen

Oral

8 mg/kg/day

2 mg/kg every 6 hours

Intravenous

6 mg/kg/day

1.5 mg/kg infused over 30 minutes, every 6 hours

2.4 Patients with Severe Anemia and/or Neutropenia

Significant anemia (hemoglobin less than 7.5 g per dL or reduction greater than 25% of baseline) and/or significant neutropenia (granulocyte count less than 750 cells per mm3 or reduction greater than 50% from baseline) may require a dose interruption until evidence of marrow recovery is observed [see Warnings and Precautions (5.1)]. In patients who develop significant anemia, dose interruption does not necessarily eliminate the need for transfusion. If marrow recovery occurs following dose interruption, resumption in dose may be appropriate using adjunctive measures such as epoetin alfa at recommended doses, depending on hematologic indices such as serum erythropoietin level and patient tolerance.

2.5 Patients with Renal Impairment

In patients maintained on hemodialysis or peritoneal dialysis or with creatinine clearance (CrCl) by Cockcroft-Gault less than 15 mL per min, the recommended oral dosage is 100 mg every 6 to 8 hours. The intravenous dosing regimen equivalent to the oral administration of 100 mg every 6 to 8 hours is approximately 1 mg per kg every 6 to 8 hours [see Use in Specific Populations (8.6), Clinical Pharmacology (12.3)].

2.6 Patients with Hepatic Impairment

There are insufficient data to recommend dose adjustment of RETROVIR in patients with impaired hepatic function or liver cirrhosis. Frequent monitoring of hematologic toxicities is advised [see Use in Specific Populations (8.7)].
Rescriptor

Rescriptor

The recommended dosage for RESCRIPTOR Tablets is 400 mg (four 100-mg or two 200-mg tablets) 3 times daily. RESCRIPTOR should be used in combination with other antiretroviral therapy. The complete prescribing information for other antiretroviral agents should be consulted for information on dosage and administration.

The 100-mg RESCRIPTOR Tablets may be dispersed in water prior to consumption. To prepare a dispersion, add four 100-mg RESCRIPTOR Tablets to at least 3 ounces of water, allow to stand for a few minutes, and then stir until a uniform dispersion occurs (see CLINICAL PHARMACOLOGY: Pharmacokinetics: Absorption and Bioavailability). The dispersion should be consumed promptly. The glass should be rinsed with water and the rinse swallowed to insure the entire dose is consumed. The 200-mg tablets should be taken as intact tablets, because they are not readily dispersed in water. Note: The 200-mg tablets are approximately one-third smaller in size than the 100-mg tablets.

RESCRIPTOR Tablets may be administered with or without food (see CLINICAL PHARMACOLOGY: Pharmacokinetics: Absorption and Bioavailability). Patients with achlorhydria should take RESCRIPTOR with an acidic beverage (e.g., orange or cranberry juice). However, the effect of an acidic beverage on the absorption of delavirdine in patients with achlorhydria has not been investigated.

Patients taking both RESCRIPTOR and antacids should be advised to take them at least 1 hour apart.
Childrens Pain Relief G...

Childrens Pain Relief Grape Flavor

2.1 Screening for HLA-B*5701 Allele prior to Starting TRIUMEQ

Screen for the HLA‑B*5701 allele prior to initiating therapy with TRIUMEQ [see Boxed Warning, Warnings and Precautions (5.1)].

2.2 Recommended Dosage

TRIUMEQ is a fixed-dose combination product containing 600 mg of abacavir, 50 mg of dolutegravir, and 300 mg of lamivudine. The recommended dosage regimen of TRIUMEQ in adults is one tablet once daily orally with or without food.

2.3 Dosage Recommendation with Certain Concomitant Medications

The dolutegravir dose (50 mg) in TRIUMEQ is insufficient when coadministered with medications listed in Table 1 that may decrease dolutegravir concentrations; the following dolutegravir dosage regimen is recommended.

Table 1. Dosing Recommendations for TRIUMEQ with Coadministered Medications

Coadministered Drug

Dosing Recommendation

Efavirenz, fosamprenavir/ritonavir, tipranavir/ritonavir, carbamazepine, or rifampin

The recommended dolutegravir dosage regimen is 50 mg twice daily. An additional dolutegravir 50-mg tablet, separated by 12 hours from TRIUMEQ, should be taken.

2.4 Not Recommended Due to Lack of Dosage Adjustment

Because TRIUMEQ is a fixed-dose tablet and cannot be dose adjusted, TRIUMEQ is not recommended in:
• patients with creatinine clearance less than 50 mL per minute [see Use in Specific Populations (8.6)]. • patients with mild hepatic impairment. TRIUMEQ is contraindicated in patients with moderate or severe hepatic impairment [see Contraindications (4), Use in Specific Populations (8.7)].
Selzentry

Selzentry

2.1 Dose Recommendations for Patients with Normal Renal Function

The recommended dose of SELZENTRY differs based on concomitant medications due to drug interactions (see Table 1). SELZENTRY can be taken with or without food. SELZENTRY must be given in combination with other antiretroviral medications.

Table 1 gives the recommended dose adjustments [see Drug Interactions (7.1)].
Table 1. Recommended Dosing Regimen
Concomitant Medications

Dose of SELZENTRY

Potent CYP3A inhibitors (with or without a potent CYP3A inducer) including:
• protease inhibitors (except tipranavir/ritonavir) • delavirdine • elvitegravir/ritonavir • ketoconazole, itraconazole, clarithromycin • other potent CYP3A inhibitors (e.g., nefazodone, telithromycin) • boceprevir
150 mg twice daily

Other concomitant medications, including tipranavir/ritonavir, nevirapine, raltegravir, all NRTIs, and enfuvirtide

300 mg twice daily

Potent CYP3A inducers (without a potent CYP3A inhibitor) including:
• efavirenz • rifampin • etravirine • carbamazepine, phenobarbital, and phenytoin
600 mg twice daily

2.2 Dose Recommendations for Patients with Renal Impairment

Table 2 provides dosing recommendations for patients based on renal function and concomitant medications.
Table 2. Recommended Dosing Regimens Based on Renal Function
Concomitant Medications

Dose of SELZENTRY Based on Renal Function

Normal

(CrCl >80 mL/min)

Mild

(CrCl >50 and ≤80 mL/min)

Moderate

(CrCl ≥30 and ≤50 mL/min)

Severe

(CrCl <30 mL/min)

End-stage Renal Disease

on Regular Hemodialysis

Potent CYP3A inhibitors (with or without a CYP3A inducer)a

150 mg twice daily

150 mg twice daily

150 mg twice daily

NR

NR

Other concomitant medicationsa

300 mg twice daily

300 mg twice daily

300 mg twice daily

300 mg twice dailyb

300 mg twice dailyb

Potent CYP3A Inducers (without a potent CYP3A inhibitor)a

600 mg twice daily

600 mg twice daily

600 mg twice daily

NR

NR

NR = Not recommended.

aSee Table 1 for the list of concomitant medications.

bThe dose of SELZENTRY should be reduced to 150 mg twice daily if there are any symptoms of postural hypotension [see Contraindications (4), Warnings and Precautions (5.3)].
Ramipril

Ramipril

2.1 Recommended Dosage for Adults and Adolescents

The recommended dosage of COMBIVIR in HIV‑1‑infected adults and adolescents weighing greater than or equal to 30 kg is 1 tablet (containing 150 mg of lamivudine and 300 mg of zidovudine) taken orally twice daily.

2.2 Recommended Dosage for Pediatric Patients

The recommended dosage of scored COMBIVIR tablets for pediatric patients who weigh greater than or equal to 30 kg and for whom a solid oral dosage form is appropriate is 1 tablet administered orally twice daily.

Before prescribing COMBIVIR tablets, children should be assessed for the ability to swallow tablets. If a child is unable to reliably swallow a COMBIVIR tablet, the liquid oral formulations should be prescribed: EPIVIR® (lamivudine) oral solution and RETROVIR® (zidovudine) syrup.

2.3 Not Recommended Due to Lack of Dosage Adjustment

Because COMBIVIR is a fixed‑dose tablet and cannot be dose adjusted, COMBIVIR is not recommended for:
• pediatric patients weighing less than 30 kg [see Use in Specific Populations (8.4)]. • patients with creatinine clearance less than 50 mL per minute [see Use in Specific Populations (8.6)]. • patients with hepatic impairment [see Use in Specific Populations (8.7)]. • patients experiencing dose‑limiting adverse reactions.
Liquid and solid oral formulations of the individual components of COMBIVIR are available for these populations.
Lexiva

Lexiva

LEXIVA tablets may be taken with or without food.

Adults should take LEXIVA oral suspension without food. Pediatric patients should take LEXIVA oral suspension with food [see Clinical Pharmacology (12.3)]. If emesis occurs within 30 minutes after dosing, re-dosing of LEXIVA oral suspension should occur.

Higher-than-approved dose combinations of LEXIVA plus ritonavir are not recommended due to an increased risk of transaminase elevations [see Overdosage (10)].

When LEXIVA is used in combination with ritonavir, prescribers should consult the full prescribing information for ritonavir.

2.1 Adults

Therapy-naive Adults
• LEXIVA 1,400 mg twice daily (without ritonavir). • LEXIVA 1,400 mg once daily plus ritonavir 200 mg once daily. • LEXIVA 1,400 mg once daily plus ritonavir 100 mg once daily. • Dosing of LEXIVA 1,400 mg once daily plus ritonavir 100 mg once daily is supported by pharmacokinetic data [see Clinical Pharmacology (12.3)]. • LEXIVA 700 mg twice daily plus ritonavir 100 mg twice daily. • Dosing of LEXIVA 700 mg twice daily plus 100 mg ritonavir twice daily is supported by pharmacokinetic and safety data [see Clinical Pharmacology (12.3)].
Protease Inhibitor-experienced Adults
• LEXIVA 700 mg twice daily plus ritonavir 100 mg twice daily.
2.2 Pediatric Patients (Aged at Least 4 Weeks to 18 Years)

The recommended dosage of LEXIVA in patients aged at least 4 weeks to 18 years should be calculated based on body weight (kg) and should not exceed the recommended adult dose (Table 1).

Table 1. Twice-daily Dosage Regimens by Weight for Protease Inhibitor-naive Pediatric Patients (Aged 4 Weeks and Older) and for Protease Inhibitor-experienced Pediatric Patients (Aged 6 Months and Older) Using LEXIVA Oral Suspension with Concurrent Ritonavir

Weight

Twice-daily Dosage Regimen

<11 kg

LEXIVA 45 mg/kg plus ritonavir 7 mg/kga

11 kg - <15 kg

LEXIVA 30 mg/kg plus ritonavir 3 mg/kga

15 kg - <20 kg

LEXIVA 23 mg/kg plus ritonavir 3 mg/kga

≥20 kg

LEXIVA 18 mg/kg plus ritonavir 3 mg/kga

aWhen dosing with ritonavir, do not exceed the adult dose of LEXIVA 700 mg/ritonavir 100 mg twice-daily dose.

Alternatively, protease inhibitor-naive children aged 2 years and older can be administered LEXIVA (without ritonavir) 30 mg per kg twice daily.

LEXIVA should only be administered to infants born at 38 weeks gestation or greater and who have attained a post-natal age of 28 days.

For pediatric patients, pharmacokinetic and clinical data:
• do not support once-daily dosing of LEXIVA alone or in combination with ritonavir [see Clinical Studies (14.3)]. • do not support administration of LEXIVA alone or in combination with ritonavir for protease inhibitor‑experienced children younger than 6 months [see Clinical Pharmacology (12.3)]. • do not support twice-daily dosing of LEXIVA without ritonavir in pediatric patients younger than 2 years [see Clinical Pharmacology (12.3)].
Other Dosing Considerations:
• When administered without ritonavir, the adult regimen of LEXIVA tablets 1,400 mg twice daily may be used for pediatric patients weighing at least 47 kg. • When administered in combination with ritonavir, LEXIVA tablets may be used for pediatric patients weighing at least 39 kg; ritonavir capsules may be used for pediatric patients weighing at least 33 kg.
2.3 Patients with Hepatic Impairment

See Clinical Pharmacology (12.3).

Mild Hepatic Impairment (Child-Pugh Score Ranging from 5 to 6)

LEXIVA should be used with caution at a reduced dosage of 700 mg twice daily without ritonavir (therapy-naive) or 700 mg twice daily plus ritonavir 100 mg once daily (therapy-naive or protease inhibitor-experienced).

Moderate Hepatic Impairment (Child-Pugh Score Ranging from 7 to 9)

LEXIVA should be used with caution at a reduced dosage of 700 mg twice daily without ritonavir (therapy-naive), or 450 mg twice daily plus ritonavir 100 mg once daily (therapy-naive or protease inhibitor-experienced).

Severe Hepatic Impairment (Child-Pugh Score Ranging from 10 to 15)

LEXIVA should be used with caution at a reduced dosage of 350 mg twice daily without ritonavir (therapy-naive) or 300 mg twice daily plus ritonavir 100 mg once daily (therapy-naive or protease inhibitor-experienced).

There are no data to support dosing recommendations for pediatric patients with hepatic impairment.
Ziagen

Ziagen

2.1 Screening for HLAB*5701 Allele prior to Starting ZIAGEN

Screen for the HLA‑B*5701 allele prior to initiating therapy with ZIAGEN [see Boxed Warning, Warnings and Precautions (5.1)].

2.2 Recommended Dosage for Adult Patients

The recommended dosage of ZIAGEN for adults is 600 mg daily, administered orally as either 300 mg twice daily or 600 mg once daily, in combination with other antiretroviral agents.

2.3 Recommended Dosage for Pediatric Patients

The recommended dosage of ZIAGEN oral solution in HIV-1-infected pediatric patients aged 3 months and older is 8 mg per kg orally twice daily or 16 mg per kg orally once daily (up to a maximum of 600 mg daily) in combination with other antiretroviral agents.

ZIAGEN is also available as a scored tablet for HIV-1-infected pediatric patients weighing greater than or equal to 14 kg for whom a solid dosage form is appropriate. Before prescribing ZIAGEN tablets, children should be assessed for the ability to swallow tablets. If a child is unable to reliably swallow ZIAGEN tablets, the oral solution formulation should be prescribed. The recommended oral dosage of ZIAGEN tablets for HIV-1-infected pediatric patients is presented in Table 1.
Table 1. Dosing Recommendations for ZIAGEN Scored Tablets in Pediatric Patients
Weight

(kg)

Once-daily Dosing Regimena

Twice-daily Dosing Regimen

AM Dose

PM Dose

Total Daily Dose

14 to <20

1 tablet (300 mg)

½ tablet (150 mg)

½ tablet (150 mg)

300 mg

≥20 to <25

1½ tablets (450 mg)

½ tablet (150 mg)

1 tablet (300 mg)

450 mg

≥25

2 tablets (600 mg)

1 tablet (300 mg)

1 tablet (300 mg)

600 mg

aData regarding the efficacy of once-daily dosing is limited to subjects who transitioned from twice-daily dosing to once-daily dosing after 36 weeks of treatment [see Clinical Studies (14.2)].

2.4 Recommended Dosage for Patients with Hepatic Impairment

The recommended dose of ZIAGEN in patients with mild hepatic impairment (Child‑Pugh Class A) is 200 mg twice daily. To enable dose reduction, ZIAGEN oral solution (10 mL twice daily) should be used for the treatment of these patients. The safety, efficacy, and pharmacokinetic properties of abacavir have not been established in patients with moderate to severe hepatic impairment; therefore, ZIAGEN is contraindicated in these patients.
Epzicom

Epzicom

• A Medication Guide and Warning Card that provide information about recognition of hypersensitivity reactions should be dispensed with each new prescription and refill. • EPZICOM can be taken with or without food.
2.1 Adult Patients

The recommended oral dose of EPZICOM for adults is one tablet daily, in combination with other antiretroviral agents.

2.2 Pediatric Patients

The recommended oral dose of EPZICOM for pediatric patients weighing at least 25 kg is one tablet daily in combination with other antiretroviral agents [see Clinical Studies (14.2)]. Before prescribing EPZICOM tablets, pediatric patients should be assessed for the ability to swallow tablets.

2.3 Dosage Adjustment

Because it is a fixed-dose combination, EPZICOM should not be prescribed for:
• patients requiring dosage adjustment such as those with creatinine clearance less than 50 mL per min, • patients with hepatic impairment.
Use of EPIVIR® (lamivudine) oral solution or tablets and ZIAGEN® (abacavir sulfate) oral solution may be considered.
Trizivir

Trizivir

2.1 Screening for HLA-B*5701 Allele prior to Starting TRIZIVIR

Screen for the HLA-B*5701 allele prior to initiating therapy with TRIZIVIR [see Boxed Warning, Warnings andPrecautions (5.1)].

2.2 Recommended Dosage for Adults and Pediatric Patients Weighing at Least 40 kg

The recommended dosage of TRIZIVIR is one tablet taken orally twice daily with or without food.

2.3 Not Recommended Due to Lack of Dosage Adjustment

Because TRIZIVIR is a fixed-dose tablet and cannot be dose adjusted, TRIZIVIR is not recommended in:
• pediatric patients who weigh less than 40 kg [see Use in Specific Populations (8.4)]. • patients with creatinine clearance less than 50 mL per minute [see Use in Specific Populations (8.6)]. • patients with mild hepatic impairment. TRIZIVIR is contraindicated in patients with moderate or severe hepatic impairment [see Contraindications (4), Use in Specific Populations (8.7)].
Retrovir

Retrovir

Adults:

The recommended intravenous dose is 1 mg/kg infused over 1 hour. This dose should be administered 5 to 6 times daily (5 to 6 mg/kg daily). The effectiveness of this dose compared with higher dosing regimens in improving the neurologic dysfunction associated with HIV disease is unknown. A small randomized trial found a greater effect of higher doses of RETROVIR on improvement of neurological symptoms in subjects with pre-existing neurological disease.

Patients should receive RETROVIR IV Infusion only until oral therapy can be administered. The intravenous dosing regimen equivalent to the oral administration of 100 mg every 4 hours is approximately 1 mg/kg intravenously every 4 hours.

Maternal-Fetal HIV Transmission:

The recommended dosing regimen for administration to pregnant women (>14 weeks of pregnancy) and their neonates is:

Maternal Dosing: 100 mg orally 5 times per day until the start of labor. During labor and delivery, intravenous RETROVIR should be administered at 2 mg/kg (total body weight) over 1 hour followed by a continuous intravenous infusion of 1 mg/kg/hour (total body weight) until clamping of the umbilical cord.

Neonatal Dosing: Start neonatal dosing within 12 hours after birth and continue through 6 weeks of age. Neonates unable to receive oral dosing may be administered RETROVIR intravenously. See Table 9. (See PRECAUTIONS if hepatic disease or renal insufficiency is present.)

Table 9. Recommended Neonatal Dosages of RETROVIR

Route

Total Daily Dose

Dose and Dosage Regimen

Oral

8 mg/kg/day

2 mg/kg every 6 hours

IV

6 mg/kg/day

1.5 mg/kg infused over 30 minutes, every 6 hours

Monitoring of Patients:

Hematologic toxicities appear to be related to pretreatment bone marrow reserve and to dose and duration of therapy. In patients with poor bone marrow reserve, particularly in patients with advanced symptomatic HIV disease, frequent monitoring of hematologic indices is recommended to detect serious anemia or neutropenia (see WARNINGS). In patients who experience hematologic toxicity, reduction in hemoglobin may occur as early as 2 to 4 weeks, and neutropenia usually occurs after 6 to 8 weeks.

Dose Adjustment:

Anemia: Significant anemia (hemoglobin of <7.5 g/dL or reduction of >25% of baseline) and/or significant neutropenia (granulocyte count of<750 cells/mm3 or reduction of >50% from baseline) may require a dose interruption until evidence of marrow recovery is observed (see WARNINGS). In patients who develop significant anemia, dose interruption does not necessarily eliminate the need for transfusion. If marrow recovery occurs following dose interruption, resumption in dose may be appropriate using adjunctive measures such as epoetin alfa at recommended doses, depending on hematologic indices such as serum erythropoetin level and patient tolerance.

For patients experiencing pronounced anemia while receiving chronic coadministration of zidovudine and some of the drugs (e.g., fluconazole, valproic acid) listed in Table 4, zidovudine dose reduction may be considered.

End-Stage Renal Disease: In patients maintained on hemodialysis or peritoneal dialysis (CrCl <15 mL/min), recommended dosing is 1 mg/kg every 6 to 8 hours (see CLINICAL PHARMACOLOGY: Pharmacokinetics).

Hepatic Impairment: There are insufficient data to recommend dose adjustment of RETROVIR in patients with mild to moderate impaired hepatic function or liver cirrhosis. Since RETROVIR is primarily eliminated by hepatic metabolism, a reduction in the daily dose may be necessary in these patients. Frequent monitoring of hematologic toxicities is advised (see CLINICAL PHARMACOLOGY: Pharmacokinetics and PRECAUTIONS: General).

Method of Preparation:

RETROVIR IV Infusion must be diluted prior to administration. The calculated dose should be removed from the 20-mL vial and added to 5% Dextrose Injection solution to achieve a concentration no greater than 4 mg/mL. Admixture in biologic or colloidal fluids (e.g., blood products, protein solutions, etc.) is not recommended.

After dilution, the solution is physically and chemically stable for 24 hours at room temperature and 48 hours if refrigerated at 2° to 8°C (36° to 46°F). Care should be taken during admixture to prevent inadvertent contamination. As an additional precaution, the diluted solution should be administered within 8 hours if stored at 25°C (77°F) or 24 hours if refrigerated at 2° to 8°C to minimize potential administration of a microbially contaminated solution.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit. Should either be observed, the solution should be discarded and fresh solution prepared.

Administration:

RETROVIR IV Infusion is administered intravenously at a constant rate over 1 hour. Rapid infusion or bolus injection should be avoided. RETROVIR IV Infusion should not be given intramuscularly.
Epivir

Epivir

2.1 Recommended Dosage for Adult Patients

The recommended dosage of EPIVIR in HIV‑1-infected adults is 300 mg daily, administered as either 150 mg taken orally twice daily or 300 mg taken orally once daily with or without food. If lamivudine is administered to a patient infected with HIV‑1 and HBV, the dosage indicated for HIV‑1 therapy should be used as part of an appropriate combination regimen [see Warnings and Precautions (5.2)].

2.2 Recommended Dosage for Pediatric Patients

The recommended dosage of EPIVIR oral solution in HIV‑1-infected pediatric patients aged 3 months and older is 4 mg per kg taken orally twice daily or 8 mg per kg taken orally once daily (up to a maximum of 300 mg daily), administered in combination with other antiretroviral agents. Consider HIV-1 viral load and CD4+ cell count/percentage when selecting the dosing interval for patients initiating treatment with oral solution [see Clinical Pharmacology (12.3)].

EPIVIR is also available as a scored tablet for HIV‑1-infected pediatric patients who weigh at least 14 kg and for whom a solid dosage form is appropriate. Before prescribing EPIVIR tablets, children should be assessed for the ability to swallow tablets. If a child is unable to reliably swallow EPIVIR tablets, the oral solution formulation should be prescribed. The recommended oral dosage of EPIVIR tablets for HIV‑1-infected pediatric patients is presented in Table 1.
Table 1. Dosing Recommendations for EPIVIR Scored (150-mg) Tablets in Pediatric Patients
Weight

(kg)

Once-daily Dosing Regimena

Twice-daily Dosing Regimen Using Scored 150-mg Tablet

AM Dose

PM Dose

Total Daily Dose

14 to <20

1 tablet (150 mg)

½ tablet (75 mg)

½ tablet (75 mg)

150 mg

≥20 to <25

1½ tablets (225 mg)

½ tablet (75 mg)

1 tablet (150 mg)

225 mg

≥25

2 tablets (300 mg)b

1 tablet (150 mg)

1 tablet (150 mg)

300 mg

aData regarding the efficacy of once-daily dosing is limited to subjects who transitioned from twice-daily dosing to once-daily dosing after 36 weeks of treatment [see Clinical Studies (14.2)].

bPatients may alternatively take one 300-mg tablet, which is not scored.

2.3 Patients with Renal Impairment

Dosing of EPIVIR is adjusted in accordance with renal function. Dosage adjustments are listed in Table 2 [see Clinical Pharmacology (12.3)].
Table 2. Adjustment of Dosage of EPIVIR in Adults and Adolescents (Greater than or Equal to 25 kg) in Accordance with Creatinine Clearance
Creatinine Clearance (mL/min)

Recommended Dosage of EPIVIR

    ≥50

       150 mg twice daily or 300 mg once daily

    30-49

       150 mg once daily

    15-29

       150 mg first dose, then 100 mg once daily

    5-14

       150 mg first dose, then 50 mg once daily

    <5

         50 mg first dose, then 25 mg once daily

No additional dosing of EPIVIR is required after routine (4-hour) hemodialysis or peritoneal dialysis.

Although there are insufficient data to recommend a specific dose adjustment of EPIVIR in pediatric patients with renal impairment, a reduction in the dose and/or an increase in the dosing interval should be considered.

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