U.S. Department of Health & Human Services

U.S. Food and Drug Administration

U.S. Department of Health & Human Services / U.S. Food & Drug Administration 1

Truvada for PrEP Fact Sheet: 

Ensuring Safe and Proper Use

On July 16, 2012, the U.S. Food and 

Drug Administration approved Truvada 

(emtricitabine/tenofovir disoproxil fumarate) 

for pre-exposure prophylaxis (PrEP) in combination 

with safer sex practices to reduce the risk of sexually 

acquired HIV-infection in adults at high risk. FDA has 

asked the manufacturer to put in place a variety of 

elements to ensure Truvada for PrEP is used safely 

and appropriately. 

What is Truvada?

A tablet taken orally once daily with or without food, Truvada is a 

drug used with other antiviral medicines to treat HIV infection in 

adults and children 12 years of age and older. It is a combination 

of two drugs, emtricitabine and tenofovir disoproxil fumarate, 

and is used to block the action of a protein that HIV needs to 

replicate in a person’s body.

What is PrEP?

PrEP is short for Pre-Exposure Prophylaxis and may be part 

of a comprehensive HIV prevention strategy that includes safer 

sex practices, such as consistent and correct condom use, 

regular HIV testing and risk reduction counseling. As part of 

PrEP, HIV-uninfected individuals who are at high risk of sexually 

acquired HIV infection take antiretroviral medication daily to try 

to lower their chances of becoming infected with HIV if they 

are exposed to the virus.

What is a Risk Evaluation and Mitigation 

Strategy (REMS)?

A REMS is a risk management plan that FDA can require a 

drug company to develop and implement to manage serious 

risks associated with use of a drug. Under the Food and Drug 

Administration Amendments Act of 2007, FDA has the authority 

to require a manufacturer to develop a REMS when the agency 

finds a REMS is necessary to ensure that the benefits of a drug 

outweigh its risks. 

A REMS goes beyond a drug’s written prescribing information 

and can include a Medication Guide, communication plan, 

and other elements to ensure safe use of a drug. A REMS is 

required to mitigate a serious risk listed in the product label. 

Elements to ensure safe use must:

• be appropriate for the specific, serious risk(s) listed in

the labeling;

• when possible, conform with REMS elements for other 

drugs with similar serious risks;

• when possible, be designed for compatibility with 

established drug distribution, procurement and dispensing 

systems; and

• cannot make it excessively difficult for patients to access 

the drug.

Every REMS is developed to address the unique risk-benefit 

profile of a specific drug or drug class.

REMS for Truvada for the PrEP Indication

The central component of the REMS for Truvada for PrEP is 

a training and education program directed to prescribers and 

other health care professionals to help them educate uninfected 

individuals considering or taking Truvada for PrEP. This training 

and education program is not mandatory in order for prescribers 

to prescribe Truvada for the PrEP indication. The REMS for 

Truvada for PrEP includes: 

• A Medication Guide to support the education of uninfected 

individuals taking Truvada for PrEP about the serious risk 
U.S. Department of Health & Human Services

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U.S. Food and Drug Administration

of becoming infected with HIV and the development of 

drug-resistant variants if they continue taking Truvada after 

becoming infected with HIV.

• Prescriber training and education targets likely prescribers of 

Truvada for PrEP. This program includes:

o A training guide for health care professionals that 

emphasizes the importance of screening patients for 

sexually transmitted infections (STIs), the need for 

uninfected individuals to have a negative HIV-1 test 

result before taking Truvada for PrEP, the importance 

of patients strictly adhering to the recommended dosing 

regimen, and the use of Truvada for PrEP as part of a 

comprehensive prevention strategy that includes safe 

sex practices and regular HIV testing.

o A safety brochure for prescribers outlining key serious 

risk information about Truvada for the PrEP indication, the 

importance of comprehensive management with regular 

monitoring of uninfected individuals’ HIV-infection status 

and the importance of uninfected individuals adhering to 

the recommended dosing regimen.

o A safety brochure for uninfected individuals outlining 

key serious risk information about Truvada for PrEP, 

recommended screening tests before starting Truvada 

for PrEP, the importance of regular testing for HIV status 

while taking Truvada for PrEP and key information to 

tell one’s health care provider.

o An education slide deck for face-to-face meetings 

between the drug maker and prescribers.

o A checklist for prescribers indicating they have taken 

the necessary steps to ensure the drug will be used 

appropriately, to be placed in the uninfected individual’s 

medical record.

o An Agreement Form for Initiating Truvada for PrEP to be 

signed by both the prescriber and uninfected individual 

and placed in the individual’s medical record.

• Assessment of the REMS annually to determine if the REMS 

is effective in informing and educating prescribers, health 

care professionals, and uninfected individuals about the risks 

of Truvada for a PrEP indication. If the FDA determines the 

REMS is not meeting its goals, the agency will re-evaluate 

the program and take appropriate action to ensure safe use 

of the drug.

Additional actions to ensure safe use

FDA is also strengthening the language on Truvada’s product 

label for the PrEP indication to ensure uninfected individuals 

and prescribers are fully aware of the risks and benefits of 

taking Truvada for PrEP. 

This includes:

• Additional language to the BOXED WARNING alerting 

individuals and prescribers that a negative HIV test must be 

confirmed before prescribing the drug and at least every 3 

months during use for PrEP. 

• Detailed information in the INDICATIONS AND USAGE 

section outlining factors that may be considered to place 

uninfected individuals at high risk for becoming HIV infected.

• A new CONTRAINDICATION for use as PrEP in HIV-infected 

individuals or individuals with unknown HIV status.

• Added language to the WARNINGS AND PRECAUTIONS 

section describing how Truvada for PrEP should be used 

as part of a comprehensive management strategy, and the 

importance of strict adherence to the dosing regimen.

Furthermore, as a condition of approval, FDA is requiring 

Truvada’s manufacturer to collect certain post-marketing data 

to help evaluate the drug’s use for a PrEP indication in realworld practice. 

Created: July 2012

FDA is requiring Truvada’s manufacturer to collect 

certain post-marketing data to help evaluate the drug’s 

use for a PrEP indication in real-world practice.