Adult Dosing

Treatment of HIV Infection

• Capsules: 200 mg PO qd
• Solution: 240 mg (24 mL) PO qd

Pediatric Dosing

Treatment of HIV Infection

• <3 months
• Solution: 3 mg/kg PO qd

• 3 months-17 yrs
• Solution: 6 mg/kg PO qd
• Max: 240 mg (24 mL)

• 17 yrs and >33 kgs
• Capsules: 200 mg PO qd

[Outline]

• Adult Dosing
• Pediatric Dosing

• Treatment of HIV-1 infection in combination with other antiretroviral agents

• Hypersensitivity to any of the ingredients of the product

• Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have occurred with the use of nucleoside analogs alone or in combination with other antiretrovirals
• Not approved for the treatment of chronic hepatitis B virus (HBV) infection and the safety and efficacy of this drug have not been established in patients co-infected with HBV and HIV-1
• On discontinuing therapy, severe acute exacerbations of hepatitis B have occurred in patients
• Closely monitor hepatic function with clinical and laboratory follow-up for at least several months in patients who are co-infected with HIV-1 and HBV and also in patients with discontinued therapy. Initiate appropriate anti-hepatitis B therapy

Renal Dose Adjustment (Based on CrCl)

• Capsules
• >50 mL/min: 200 mg PO qd
• 30-49 mL/min: 200 mg PO q48 hrs
• 15-29 mL/min: 200 mg PO q72 hrs
• <15 mL/min: 200 mg PO q96 hrs

• Solution
• >50 mL/min: 240 mg PO q24 qd
• 30-49 mL/min:120 mg PO qd
• 15-29 mL/min: 80 mg PO qd
• <15 mL/min: 60 mg PO qd

Hepatic Dose Adjustment

• Hepatic impairment: Dose adjustments not defined

• Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have occurred with the use of nucleoside analogs alone or in combination with other antiretrovirals (US Black Box Warning)
• Obesity, female gender, and prolonged therapy with nucleosides may cause increased risk for lactic acidosis, and severe hepatomegaly with steatosis; discontinue therapy if these conditions are suspected.
• Test all patients with HIV-1 for the presence of chronic Hepatitis B virus (HBV) before initiating antiretroviral therapy
• Not approved for the treatment of chronic HBV infection, and the safety and efficacy of this drug have not been established in patients coinfected with HBV and HIV (US Black Box Warning)
• Severe acute exacerbations of Hepatitis B have occurred in patients after the discontinuation of therapy (US Black Box Warning)
• Closely monitor hepatic function with clinical and laboratory follow-up for at least several months in patients who are coinfected with HIV-1 and HBV and also in patients with discontinued therapy (US Black Box Warning). Initiate appropriate anti-hepatitis B therapy
• Avoid concomitant administration with a fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate and fixed-dose combination of efavirenz, emtricitabine, and tenofovir disoproxil fumarate. Also avoid coadministration with other drugs containing lamivudine, lamivudine/zidovudine, lamivudine, abacavir sulfate/lamivudine, or abacavir sulfate/lamivudine/zidovudine
• Reduction of the dosage is recommended for patients with impaired renal function
• Redistribution/accumulation of body fat including central obesity, dorsocervical fat enlargement (buffalo hump), peripheral wasting, facial wasting, breast enlargement, and "cushingoid appearance" have occurred in patients receiving antiretroviral therapy
• Immune reconstitution syndrome has occurred in patients treated with combination antiretroviral therapy
• During the initial phase of combination antiretroviral treatment, patients may develop an inflammatory response to indolent or residual opportunistic infections. Further evaluation and treatment is needed

Cautions: Use cautiously in:

• Renal impairment
• Hepatic impairment
• Risk of hepatic disease
• HBV co-infection
• Prolonged therapy with nucleosides
• Females
• Obesity

Pregnancy Category:B

Breastfeeding: HIV-infected mothers should generally not breastfeed their infants. In countries in which no acceptable, feasible, sustainable and safe replacement feeding is available, exclusive breastfeeding for 6 months is recommended for HIV-infected mothers to reduce the risk of HIV transmission from the mother to the infant compared with mixed feeding. In these settings, abrupt weaning at 4 months does not reduce the risk of HIV transmission or produce an overall health benefit compared to continued breastfeeding, and increases the risk of infant death in HIV-infected infants. Extended antiretroviral prophylaxis in breastfed infants with antiretroviral reduces the rate of HIV transmission during breastfeeding by about half, but the optimal regimen and duration of prophylaxis has not yet been defined. Prefer an alternate drug especially while nursing a newborn or preterm infant as there is little published experience with emtricitabine during breastfeeding. This information is based upon LactMed database (available at http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT last accessed 31 December 2010). Centers for disease control and prevention recommend that to avoid risking postnatal transmission of HIV-1 infected mothers should not breast-feed their infants. Unknown whether emtricitabine is excreted in human milk. Manufacturer advises to instruct infected mothers to avoid breast-feeding during therapy because of both the potential for HIV-1 transmission and the potential for serious adverse reactions in nursing infants.

• GI: Hepatomegaly, hepatotoxicity, steatosis, diarrhea, nausea, vomiting, abdominal pain, dyspepsia, elevated liver transaminases
• CNS: Headache, asthenia, depression, insomnia, fatigue, dizziness, abnormal dreams
• NEURO: Paresthesias
• METABOLIC: Lactic acidosis, hypertriglyceridemia, hypercholesterolemia, elevated amylase, elevated lipase, hyperglycemia, hypoglycemia, lipodystrophy
• HEMA: Neutropenia
• DERM: Palmar-plantar hyperpigmentation, rash
• EENT: Rhinitis
• RESP: Cough
• GU: Elevated CK
• IMMUINE: Immune reconstitution syndrome, HBV exacerbation
• MUSC: Myalgia, arthralgia

• Nucleoside and nucleotide reverse transcriptase inhibitors; phosphorylated by cellular enzymes to form emtricitabine 5'-triphosphate. inhibits the activity of the HIV-1 reverse transcriptase by competing with the natural substrate deoxycytidine 5'-triphosphate and by incorporating into nascent viral DNA
• Absolute bioavailability: 93%
• Metabolized by oxidation and conjugation with glucuronic acid
• Excreted in urine (86%) and fecus (14%)
• Half life: 10 hrs

US Trade Name(s)

• Emtriva

US Availability

Emtriva

• CAPS: 200 mg
• SOLN: 10 mg/mL

Canadian Trade Name(s)

• Emtriva

Canadian Availability

Emtriva

• CAPS: 200 mg

UK Trade Name(s)

• Emtriva

UK Availability

Emtriva

• CAPS: 200 mg
• SOLN: 10 mg/mL

Australian Trade Name(s)

• Emtriva

Australian Availability

• CAPS: 200 mg

[Outline]

Antimicrobials

Antiviral (HIV) Agents

NRTIs

Infectious Disease

Antiviral (HIV) Agents

NRTIs

Pricing data from www.DrugStore.com in U.S.A.

• Emtriva 200 MG CAPS [Bottle] (GILEAD SCIENCES)
  30 mg = $475.97
  60 mg = $890.01

Warning: This pricing information is subject to change at the sole discretion of DS Pharmacy. For the most current and up-to-date pricing information, please visit drugstore.com.

Drug Name: Emtriva (emtricitabine 200 mg)

Ingredient(s): N/A

Imprint: 200;mg;GILEAD

Color(s): White

Shape: Capsule

Size (mm): 19.00

Score: 1

Inactive Ingredient(s): N/A

Drug Label Author:
Excella GmbH

DEA Schedule:
Non-Scheduled

Drug Name: Emtriva 200 MG Oral Capsule

Pill Image:

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Ingredient(s): Emtricitabine

Imprint: 200;mg;GILEAD

Color(s): White

Shape: Capsule

Size (mm): 19.00

Score: 1

Inactive Ingredient(s): N/A

Drug Label Author:
Gilead Sciences, Inc.

DEA Schedule:
Non-Scheduled