emtricitabine

em-tri-SI-ti-been

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: Breastfeeding not recommended in HIV-infected patients.

Use Cautiously in:

Chronic hepatitis B virus (HBV) infection (may exacerbate following discontinuation);
Renal impairment;
OB: Use during pregnancy only if benefit to patient outweighs potential risk to fetus;
Geri: Older adults 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 reported.

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 solutioncotton candy flavor: 10 mg/mL
In combination with:
efavirenz and tenofovir (generic only); tenofovir (Truvada); rilpivirine and tenofovir (Complera); cobicistat, and tenofovir disoproxil fumarate (Stribild); cobicistat, darunavir, and tenofovir alafenamide (Symtuza). See Combination Drugs.

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 (↑ serum lactate levels, ↑ 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.
- Assess for HBV. Emtricitabine is not approved for administration in patients with HIV and HBV. If therapy is discontinued, may cause severe exacerbation of HBV. Monitor liver function in coinfected patients for several months after stopping therapy.
- Monitor liver function tests prior to, during, and following therapy.
- May ↑ AST, ALT, bilirubin, CK, serum amylase, serum lipase, and triglycerides. May ↑ 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. 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.
Do not stop taking without consulting health care professional. Discontinuing therapy may lead to severe exacerbations. Inform patient of importance of HBV testing before starting antiretroviral therapy.
Instruct patient that emtricitabine should not be shared with others.
Inform patient that emtricitabine does not cure HIV or prevent associated or opportunistic infections. Emtricitabine does not ↓ 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.
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 and to avoid breastfeeding during therapy. Encourage pregnant women to enroll in the Antiretroviral Pregnancy Registry by calling 1-800-258-4263.
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.

Emtriva

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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 ⬆