emtricitabine

Therapeutic Classification: antiretrovirals

Pharmacologic Classification: nucleoside reverse transcriptase inhibitors

REMS

HIV infection (with other antiretrovirals).

Phosphorylated intracellularly where it inhibits HIV reverse transcriptase, resulting in viral DNA chain termination.

Therapeutic Effects:

Slowed progression of HIV infection and decreased occurrence of sequelae.
Increases CD4 cell counts and decreases viral load.

Absorption: Rapidly and extensively absorbed; 93% bioavailable.

Distribution: Unknown.

Metabolism/Excretion: Some metabolism, 86% renally excreted, 14% fecal excretion.

Half-life: 10 hr.

(blood levels†)

ROUTE	ONSET	PEAK	DURATION
PO	rapid	1–2 hr	24 hr

†Normal renal function.

Contraindicated in:

Hypersensitivity
Lactation: Breast feeding not recommended in HIV-infected patients.

Use Cautiously in:

Hepatitis B co-infection (may exacerbate following discontinuation)
Renal impairment
OB: Use during pregnancy only if benefit to patient outweighs potential risk to fetus
Geri: May be at ↑ risk for adverse effects.

Derm: rash, skin discoloration.

F and E: LACTIC ACIDOSIS.

GI: abdominal pain, diarrhea, nausea, dyspepsia,, SEVERE HEPATOMEGALY WITH STEATOSIS, vomiting.

MS: arthralgia, myalgia.

Neuro: dizziness, headache, insomnia, weakness, depression, neuropathy, nightmares, paresthesia.

Resp: cough, rhinitis.

Misc: immune reconstitution syndrome.

Drug-Drug:

None noted.

PO (Adults ≥18 yr): 200 mg once daily.

Renal Impairment

PO (Adults ≥18 yr): CCr 30–49 mL/min: 200 mg every 48 hr; CCr 15–29 mL/min: 200 mg every 72 hr; CCr <15 mL/min: 200 mg every 96 hr.

(Generic available)

Capsules: 200 mg;
Oral solution (cotton candy flavor): 10 mg/mL;
In combination with: efavirenz and tenofovir (Atripla); tenofovir (Truvada); rilpivirine and tenofovir (Complera); cobicistat, and tenofovir disoproxil fumarate (Stribild); cobicistat, darunavir, and tenofovir alafenamide (Symtuza). See Appendix [not included in this PDA edition].

Assess patient for change in severity of HIV symptoms and for symptoms of opportunistic infections during therapy.
May cause lactic acidosis and severe hepatomegaly with steatosis. These events are more likely to occur if patients are female, obese, or receiving nucleoside analogue medications for extended periods of time. Monitor patient for signs (increased serum lactate levels, elevated liver enzymes, liver enlargement on palpation). Therapy should be suspended if clinical or laboratory signs occur.

Lab Test Considerations:

Monitor viral load and CD4 cell count regularly during therapy.Test patients for chronic hepatitis B virus (HBV) before initiating therapy. Emtricitabine is not indicated for treatment of HBV. If therapy is discontinued, may cause severe exacerbation of hepatitis B. Monitor liver function in co-infected patients for several mo after stopping therapy.
- May cause ↑ AST, ALT, bilirubin, creatine kinase, serum amylase, serum lipase, and triglycerides. May cause ↑ or ↓ serum glucose. May cause ↓ neutrophil count.

PO: May be administered with or without food.

Emphasize the importance of taking emtricitabine as directed. It must always be used in combination with other antiretroviral drugs. Do not take more than prescribed amount and do not stop taking without consulting health care professional. Take missed doses as soon as remembered, but not if almost time for next dose; do not double doses. Advise patient to read Patient Information before starting therapy and with each Rx refill in case of changes.
Instruct patient that emtricitabine should not be shared with others.
Inform patient that emtricitabine does not cure AIDS or prevent associated or opportunistic infections. Emtricitabine does not reduce the risk of transmission of HIV to others through sexual contact or blood contamination. Caution patient to use a condom and to avoid sharing needles or donating blood to prevent spreading the AIDS virus to others. Advise patient that the long-term effects of emtricitabine are unknown at this time.
Instruct patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and consult health care professional before taking any new medications.
Instruct patient to notify health care professional immediately if symptoms of lactic acidosis (tiredness or weakness, unusual muscle pain, trouble breathing, stomach pain with nausea and vomiting, cold especially in arms or legs, dizziness, fast or irregular heartbeat) or if signs of hepatotoxicity (yellow skin or whites of eyes, dark urine, light colored stools, lack of appetite for several days or longer, nausea, abdominal pain) occur. These symptoms may occur more frequently in patients that are female, obese, or have been taking medications like emtricitabine for a long time.
Advise patient to notify health care professional if signs and symptoms of Immune Reconstitution Syndrome (signs and symptoms of an infection) occur.
Rep: Advise patient to notify health care professional if pregnancy is planned or suspected. Encourage pregnant women to enroll in the Antiretroviral Pregnancy Registry by calling 1-800-258-4263. Advise female patient to avoid breast feeding during therapy.
Emphasize the importance of regular follow-up exams and blood counts to determine progress and monitor for side effects.

Delayed progression of AIDS and decreased opportunistic infections in patients with HIV.
Decrease in viral load and increase in CD4 cell counts.

NDC Code^*

61958- Gilead Sciences, Inc.
61958-0601- Emtriva 61958-0601-1- 30 CAPSULE in 1 BOTTLE, PLASTIC (61958-0601-1)

61958- Gilead Sciences, Inc.
61958-0602- Emtriva 61958-0602-1- 1 BOTTLE, DISPENSING in 1 CARTON (61958-0602-1) > 170 mL in 1 BOTTLE, DISPENSING

70518- REMEDYREPACK INC.
70518-1847- Emtriva 70518-1847-0- 4 CAPSULE in 1 BLISTER PACK (70518-1847-0)

section name header

Pronunciation ⬇

Classifications ⬆ ⬇

Indications ⬆ ⬇

Action ⬆ ⬇

Pharmacokinetics ⬆ ⬇

Time/Action Profile ⬆ ⬇

Contraind./Precautions ⬆ ⬇

Adv. Reactions/Side Effects ⬆ ⬇

Interactions ⬆ ⬇

Route/Dosage ⬆ ⬇

Availability ⬆ ⬇

Assessment ⬆ ⬇

Implementation ⬆ ⬇

Patient/Family Teaching ⬆ ⬇

Evaluation/Desired Outcomes ⬆ ⬇

US Brand Names ⬆ ⬇

Code ⬆