emtricitabine

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Related to Complera: rilpivirine, Stribild

emtricitabine

Emtriva

Pharmacologic class: Nucleoside reverse transcriptase inhibitor

Therapeutic class: Antiretroviral

Pregnancy risk category B

FDA Box Warning

• Drug has caused lactic acidosis and severe hepatomegaly with steatosis (including fatal cases) when used alone or in combination with other antiretrovirals.

• Drug isn't indicated for chronic hepatitis B virus (HBV) infection. Safety and efficacy haven't been established in patients co-infected with HBV and human immunodeficiency virus (HIV). Discontinuation has led to severe acute HBV exacerbations. Monitor hepatic function closely.

Action

Inhibits activity of HIV-1 reverse transcriptase by competing with natural substrate and by its incorporation into nascent viral DNA, thereby halting viral replication

Availability

Capsules: 200 mg

Oral solution: 10 mg/ml in 170-ml bottles

Indications and dosages

HIV-1 infection, with other antiretrovirals

Adults ages 18 and older: 200-mg capsule P.O. daily or 240 mg (24 ml) oral solution P.O. once daily

Children ages 3 months to 17 years weighing more than 33 kg (73 lb): 200-mg capsule P.O. once daily

Children ages 3 months to 17 years weighing less than 33 kg (73 lb): 6 mg/kg oral solution P.O. daily to maximum of 240 mg (24 ml) once daily

Children ages 0 to 3 months: 3 mg/kg oral solution P.O. once daily

Dosage adjustment

• Renal impairment

Contraindications

• Hypersensitivity to drug or its components

Precautions

Use cautiously in:

• renal impairment

• increased risk for lactic acidosis or hepatic impairment

• obese patients

• elderly patients

• children (safety and efficacy not established).

Administration

• Give with or without food.

• Know that drug must be given with other antiretrovirals.

• Know that capsule can be given to child weighing more than 33 kg if child can swallow an intact capsule.

Adverse reactions

CNS: dizziness, headache, insomnia, abnormal dreams, depression, peripheral neuritis or neuropathy, paresthesia

EENT: rhinitis

GI: nausea, vomiting, diarrhea, abdominal pain, dyspepsia

Hepatic: hepatotoxicity

Metabolic: cushingoid appearance (buffalo hump, moon face),lactic acidosis

Musculoskeletal: joint pain, myalgia

Respiratory: increased cough

Skin: rash, skin discoloration (hyperpigmentation on palms and soles)

Other: body fat redistribution

Interactions

Drug-drug. Tenofovir disoproxil fumarate: increased emtricitabine effect

Drug-diagnostic tests. Alanine aminotransferase, amylase, aspartate aminotransferase, bilirubin, creatine kinase, lipase, triglycerides: increased levels

Glucose: increased or decreased level

Neutrophils: decreased count

Patient monitoring

Monitor closely (especially in females and obese patients) for signs and symptoms of lactic acidosis and hepatotoxicity, even if patient doesn't have marked transaminase elevations.

• Assess neurologic status, checking especially for depression, peripheral neuropathy, and paresthesia.

• Monitor neutrophil count, lipid panel, liver function tests, and blood glucose level.

Monitor patient closely for several months after drug withdrawal. Severe, acute exacerbations of hepatitis B virus (HBV) have been reported after discontinuation in patients co-infected with HBV and HIV.

• Monitor nutritional and hydration status in light of GI adverse effects and underlying disease.

• Watch for cushingoid appearance and body fat redistribution.

Patient teaching

• Tell patient to take a missed dose as soon as he remembers. However, if it's almost time for next dose, tell him to skip the missed dose and take next dose as scheduled.

Instruct patient not to change dosage or stop taking drug unless prescriber approves.

• Tell patient drug should be taken only in combination with other drugs that treat HIV.

Instruct patient not to take this drug if already taking Altripla (combination of efavirenz, emtricitabine, and tenofovir), Combivir (combination of lamivudine and zidovudine), Epivir (lamivudine), Epzicom (combination of abacavir and lamivudine), Trizivir (combination of abacavir, lamivudine, and zidovidine), or Truvada (combination of emtricitabine and tenofovir), because these drugs contain the same or similar ingredients.

Tell patient to immediately report signs or symptoms of lactic acidosis-unusual tiredness or muscle pain, difficulty breathing, stomach pain with nausea and vomiting, coldness, dizziness or light-headedness, or fast or irregular heartbeat.

Instruct patient to immediately report signs or symptoms of liver problems-unusual tiredness, yellowing of skin or eyes, dark urine, lightcolored feces, appetite loss, nausea, or pain in lower abdominal area.

• Advise patient to report adverse CNS reactions and to use good judgment about driving and other hazardous activities.

• Caution patient that drug may cause depression. Tell him to notify prescriber if he develops symptoms.

• Inform patient that drug may cause body fat redistribution, dark areas on palms and soles, and rash.

• Tell female patient to inform prescriber if she is pregnant or plans to become pregnant.

• Caution HIV-positive patient not to breastfeed.

• As appropriate, review all other significant and life-threatening adverse reactions and interactions, especially those related to the drugs and tests mentioned above.

McGraw-Hill Nurse's Drug Handbook, 7th Ed. Copyright © 2013 by The McGraw-Hill Companies, Inc. All rights reserved

emtricitabine

(ĕm′trĭ-sĭt′ə-bēn′, -sī′tə-)
n.
An antiviral drug, C8H10FN3O3S, that is a nucleoside reverse transcriptor inhibitor and is used in combination with other drugs to treat HIV infection or to reduce the risk of HIV infection.
The American Heritage® Medical Dictionary Copyright © 2007, 2004 by Houghton Mifflin Company. Published by Houghton Mifflin Company. All rights reserved.

emtricitabine

A synthetic analogue of cytosine that acts as an inhibitor of HIV reverse transcriptase. The drug is taken once a day in combination with other antiretroviral drugs to treat HIV infection. It is also active against the hepatitis B virus.
Collins Dictionary of Medicine © Robert M. Youngson 2004, 2005
References in periodicals archive ?
The marketed Complera tablets containing 200 mg of EMT, 300 mg of TDF, and 25 mg of RPV were subjected to various forced degradation conditions to effect partial degradation of the drug preferably in 2-30% range [29, 30].
Our earlier HPLC method was optimized with respect to mobile phase composition, buffer concentration, and flow rate to achieve an optimal chromatographic condition for the separation and simultaneous quantification of EMT, TDF, and RPV from Complera tablet containing EMT 200 mg, TDF 300 mg, and RPV 25 mg.
Biopharmaceutical company Gilead Sciences Inc (Nasdaq:GILD) announced on Friday the approval by the US Food and Drug Administration (FDA) of the single tablet HIV-1 regimen Complera (emtricitabine/rilpivirine/tenofovir disoproxil fumarate) for use in certain virologically-suppressed (HIV RNA
[dagger] Viread is part of the single-pill combination antiretrovirals Truvada, Atripla, Complera, and Stribild.
It took five years, but a sequel has arrived with Complera, approved last fall.
The product was approved under the trade name Complera (emtricitabine/rilpivirine/tenofovir disoproxil fumarate) by the US Food and Drug Administration in August 2011.
Complera sales were $360 million, up 9%.Viread sales were $297 million, up 8%.
(Viread is also part of three combination drugs: Truvada, Atripla, and Complera.) Figure 1 Seven factors independently affected the risk of a broken hip, upper arm, or spine bone in a study of 40,115 US male veterans with HIV infection.
In the HIV franchise, Truvada sales were $771 million, up 1%; Atripla sales were down 6% to $734 million; Stribild sales were up 66% to $356 million; Complera sales were up 27% to $320 million; and Viread sales were $234 million, up 11%.
Sales of the company's newest product, Complera for the treatment of I-IIV infection, were $19.0 million in the quarter.