Approved Drug Label (PDF)
5
Warnings and Precautions
5.1 Severe Acute Exacerbation of Hepatitis B in Individuals with HBV Infection
(Subsection title
revised; Additions and/or revisions underlined)
All
individuals should be tested for the presence of chronic hepatitis B virus
(HBV) before or when initiating TRUVADA [see
Dosage and Administration (2.1)].
Severe
acute exacerbations of hepatitis B (e.g., liver decompensation and liver failure)
have been reported in HBV-infected individuals who have discontinued TRUVADA.
Individuals infected with HBV who discontinue TRUVADA should be closely monitored
with both clinical and laboratory follow-up for at least several months after stopping
treatment. If appropriate, anti-hepatitis B therapy may be warranted, especially
in individuals with advanced liver disease or cirrhosis, since posttreatment exacerbation
of hepatitis may lead to hepatic decompensation and liver failure. HBV-uninfected
individuals should be offered vaccination.
5.2 Comprehensive Management to Reduce the Risk of Sexually Transmitted Infections, Including HIV-1, and Development of HIV-1 Resistance When Truvada Is Used for HIV-1 PrEP
(Subsection title
revised; Additions and/or revisions underlined)
Use
TRUVADA for HIV-1 PrEP to reduce the risk of HIV-1 infection as part of a
comprehensive prevention strategy that includes other prevention measures, including
adherence to daily administration and safer sex practices, including condoms,
to reduce the risk of sexually transmitted infections (STIs). The time from initiation
of TRUVADA for HIV-1 PrEP to maximal protection against HIV-1 infection is
unknown.
Risk
for HIV-1 acquisition
includes behavioral, biological, or epidemiologic factors including but not limited
to condomless sex, past or current STIs, self-identified HIV risk, having
sexual partners of unknown HIV-1 viremic status, or sexual activity in a high prevalence
area or network.
Counsel
individuals on the use of other prevention measures (e.g., consistent and
correct condom use, knowledge of partner(s)’ HIV-1 status, including
viral suppression status, regular testing for STIs that can facilitate
HIV-1 transmission). Inform uninfected individuals about and support their
efforts in reducing sexual risk behavior.
Use
TRUVADA to reduce the risk of acquiring HIV-1 only in individuals confirmed to be
HIV-negative. HIV-1 resistance substitutions
may emerge in individuals with undetected HIV-1 infection who are taking only TRUVADA,
because TRUVADA alone does not constitute a complete regimen for HIV-1 treatment
[see Microbiology (12.4)]; therefore,
care should be taken to minimize the risk of initiating or continuing TRUVADA
before confirming the individual is HIV-1 negative.
Some HIV-1 tests only detect anti-HIV antibodies
and may not identify HIV-1 during the acute stage of infection. Prior to initiating
TRUVADA for HIV-1 PrEP, ask seronegative individuals about recent (in
past month) potential exposure events (e.g., condomless sex or condom breaking during
sex with a partner of unknown HIV-1 status or unknown viremic status, or a recent
STI), and evaluate for current or recent signs or symptoms consistent with acute
HIV-1 infection (e.g., fever, fatigue, myalgia, skin rash)
- If recent (<1 month) exposures to HIV-1 are suspected
or
clinical symptoms consistent with acute HIV-1 infection are present, use
a test approved or cleared by the FDA as an aid in the diagnosis of acute or primary
HIV-1 infection.
While
using TRUVADA for HIV-1 PrEP, HIV-1 testing should be repeated at least every
3 months, and upon diagnosis of any other STIs.
- If
an HIV-1 test indicates possible HIV-1 infection, or if symptoms consistent
with acute HIV-1 infection develop following a potential exposure event, convert
the HIV-1 PrEP regimen to an HIV treatment regimen until negative infection status
is confirmed using a test approved or cleared by the FDA as an aid in the
diagnosis of acute or primary HIV-1 infection.
Counsel
HIV-1 uninfected individuals to strictly adhere to the once daily
TRUVADA dosing schedule. The effectiveness of TRUVADA in reducing the risk of acquiring
HIV-1 is strongly correlated with adherence, as demonstrated by measurable drug
levels in clinical trials of TRUVADA for HIV-1 PrEP. Some individuals, such as
adolescents, may benefit from more frequent visits and counseling to support adherence
[see Use in Specific Populations (8.4),
Microbiology (12.4), and Clinical Studies (14.3 and 14.4)].
5.3 New Onset or Worsening Renal Impairment
(Additions and/or
revisions underlined)
Emtricitabine
and tenofovir are principally eliminated by the kidney. Renal impairment, including
cases of acute renal failure and Fanconi syndrome (renal tubular injury with severe
hypophosphatemia), has been reported with the use of TDF, a component of TRUVADA
[see Adverse Reactions (6.2)].
Prior
to initiation and during use of TRUVADA, on a clinically appropriate schedule, assess
serum creatinine, estimated creatinine clearance, urine glucose, and urine protein
in all individuals. In individuals with chronic kidney disease, also
assess serum phosphorus.
TRUVADA
should be avoided with concurrent or recent use of a nephrotoxic agent (e.g., high-dose
or multiple non-steroidal anti-inflammatory drugs [NSAIDs]) [see Drug Interactions (7.1)]. Cases of acute
renal failure after initiation of high-dose or multiple NSAIDs have been reported
in HIV-infected patients with risk factors for renal dysfunction who appeared stable
on TDF. Some patients required hospitalization and renal replacement therapy. Alternatives
to NSAIDs should be considered, if needed, in patients at risk for renal dysfunction.
Persistent
or worsening bone pain, pain in extremities, fractures, and/or muscular pain or
weakness may be manifestations of proximal renal tubulopathy and should prompt an
evaluation of renal function in individuals at risk of renal dysfunction.
…
5.4 Immune Reconstitution Syndrome
(Additions and/or
revisions underlined)
Immune
reconstitution syndrome has been reported in HIV-1 infected patients treated with
combination antiretroviral therapy, including TRUVADA. During the initial phase
of combination antiretroviral treatment, HIV-1 infected patients whose immune system
responds may develop an inflammatory response to indolent or residual opportunistic
infections (such as Mycobacterium avium infection,
cytomegalovirus, Pneumocystis jirovecii pneumonia
[PCP], or tuberculosis), which may necessitate further evaluation and treatment.
Autoimmune
disorders (such as Graves’ disease, polymyositis, Guillain-Barré syndrome, and
autoimmune hepatitis) have also been reported to occur in the setting of immune
reconstitution; however, the time to onset is more variable and can occur many months
after initiation of treatment.
8
Use in Specific Populations
8.1 Pregnancy
(Additions and/or
revisions underlined)
Pregnancy
Exposure Registry
There
is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed
to TRUVADA during pregnancy. Healthcare providers are encouraged to register patients
by calling the Antiretroviral Pregnancy Registry (APR) at 1-800-258-4263.
Risk
Summary
Data
on the use of TRUVADA during pregnancy from observational studies have shown no
increased risk of major birth defects. Available data from the APR show no significant
difference in the overall risk of major birth defects with first trimester exposure
for emtricitabine (FTC) (2.3%) or tenofovir disoproxil fumarate (TDF) (2.1%) compared
with the background rate for major birth defects of 2.7% in a U.S. reference population
of the Metropolitan Atlanta Congenital Defects Program (MACDP) (see Data). The rate of miscarriage for individual
drugs is not reported in the APR. In the U.S. general population, the estimated
background risk of miscarriage in clinically recognized pregnancies is 15– 20%.
…
Data
Human Data
TRUVADA for HIV-1 PrEP:
In
an observational study based on prospective reports to the APR, 78 HIV-seronegative
women exposed to TRUVADA during pregnancy delivered live-born infants with no major
malformations. All but one were first trimester exposures, and the median
duration of exposure was 10.5 weeks. There were no new safety findings in the women
receiving TRUVADA for HIV-1 PrEP compared with HIV-1 infected women treated with
other antiretroviral medications.
Emtricitabine: Based on prospective
reports to the APR of exposures to FTC-containing regimens during pregnancy resulting
in live births (including over 3,300 exposed in the first trimester and over
1,300 exposed in the second/third trimester), the prevalence of major
birth defects in live births was 2.6% (95% CI: 2.1% to 3.2%)
and 2.3% (95% CI: 1.6% to 3.3%) following first and second/third trimester
exposure, respectively, to FTC-containing regimens.
Tenofovir Disoproxil
Fumarate: Based
on prospective reports to the APR of exposures to TDF- containing
regimens during pregnancy resulting in live births (including over 4,000
exposed in the first trimester and over 1,700 exposed in the second/third
trimester), the prevalence of major birth defects in live births was 2.4%
(95% CI: 2.0% to 2.9%) and 2.4% (95% CI: 1.7% to 3.2%)
following first and second/third trimester exposure, respectively, to
TDF-containing regimens.
…
8.4 Pediatric Use
(Additions and/or
revisions underlined)
…
Safety
and effectiveness of Truvada for HIV-1 PrEP in pediatric patients weighing less
than 35 kg have not been established.
8.6 Renal Impairment
(Additions and/or
revisions underlined)
Treatment of HIV-1
Infection
The
dosing interval for TRUVADA should be modified in HIV-infected adult individuals
with estimated creatinine clearance of 30–49 mL/min. TRUVADA is not recommended
in individuals with estimated creatinine clearance below 30 mL/min and
in individuals with end-stage renal disease requiring dialysis [see Dosage and Administration (2.6)].
HIV-1 PrEP
TRUVADA
for HIV-1 PrEP is not recommended in HIV-1 uninfected individuals with
estimated creatinine clearance below 60 mL/min. If a decrease in estimated
creatinine clearance is observed in uninfected individuals while using TRUVADA for
HIV-1 PrEP, evaluate potential causes and re- assess potential risks and benefits
of continued use [see Dosage and Administration
(2.6)].
17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)
MEDICATION GUIDE
(Extensive
changes; please refer to label)
PATIENT COUNSELING INFORMATION
(Additions and/or
revisions underlined)
Advise
the patient to read the FDA-approved patient labeling (Medication Guide).
Important
Information for Uninfected Individuals Taking TRUVADA for HIV-1 PrEP
Advise
HIV-uninfected individuals about the following [see Warnings and Precautions (5.2)]:
The
need to confirm that they are HIV-negative before starting to take TRUVADA to reduce
the risk of acquiring HIV-1.
That
HIV-1 resistance substitutions may emerge in individuals with undetected HIV-1 infection
who are taking TRUVADA, because TRUVADA alone does not constitute a complete regimen
for HIV-1 treatment.
The
importance of taking TRUVADA on a regular dosing schedule and strict adherence to
the recommended dosing schedule to reduce the risk of acquiring HIV-1. Uninfected
individuals who miss doses are at greater risk of acquiring HIV-1 than those who
do not miss doses.
That
TRUVADA does not prevent other sexually acquired infections and should only
be used as part of a complete prevention strategy including other prevention measures.
To
use condoms consistently and correctly to lower the chances of sexual contact with
any body fluids such as semen, vaginal secretions, or blood.
The
importance of knowing their HIV-1 status and the HIV-1 status of their partner(s).
The
importance of virologic suppression in their partner(s) with HIV-1.
The
need to get tested regularly for HIV-1 (at least every 3 months, or more frequently
for some individuals such as adolescents) and to ask their partner(s) to get tested
as well.
To
report any symptoms of acute HIV-1 infection (flu-like symptoms) to their healthcare
provider immediately.
That
the signs and symptoms of acute infection include fever, headache, fatigue, arthralgia,
vomiting, myalgia, diarrhea, pharyngitis, rash, night sweats, and adenopathy (cervical
and inguinal).
To
get tested for other sexually transmitted infections, such as syphilis, chlamydia,
and gonorrhea, that may facilitate HIV-1 transmission.
- To
assess their sexual risk behavior and get support to help reduce sexual risk behavior.
Severe
Acute Exacerbation of Hepatitis B in Patients Infected with HBV
Inform
individuals that severe acute exacerbations of hepatitis B have been reported
in patients who are infected with HBV and have discontinued TRUVADA [see Warnings and Precautions (5.1)].
Advise
HBV-infected individuals to not discontinue TRUVADA without first informing
their healthcare provider.
New
Onset or Worsening Renal Impairment
Inform
HIV-1 infected patients and uninfected individuals that renal impairment,
including cases of acute renal failure and Fanconi syndrome, has been reported in
association with the use of TDF, a component of TRUVADA. Advise patients to
avoid TRUVADA with concurrent or recent use of a nephrotoxic agent (e.g.,
high-dose or multiple NSAIDs) [see Warnings
and Precautions (5.3)]. The dosing interval of TRUVADA may need adjustment
in HIV-1 infected patients with renal impairment. TRUVADA for HIV-1 PrEP should
not be used in HIV-1 uninfected individuals if estimated creatinine clearance is
less than 60 mL/min. If a decrease in estimated creatinine clearance is observed
in uninfected individuals while using TRUVADA for HIV-1 PrEP, evaluate
potential causes and re- assess potential risks and benefits of continued use [see Dosage and Administration (2.6)].
Immune
Reconstitution Syndrome
Inform
HIV-1 infected patients that in some patients with advanced HIV infection
(AIDS), signs and symptoms of inflammation from previous infections may occur soon
after anti-HIV treatment is started. It is believed that these symptoms are due
to an improvement in the body’s immune response, enabling the body to fight infections
that may have been present with no obvious symptoms. Advise patients to inform their
healthcare provider immediately of any symptoms of infection [see Warnings and Precautions (5.4)].
…
Lactic
Acidosis and Severe Hepatomegaly
Inform
HIV-1 infected patients and uninfected individuals that lactic acidosis and
severe hepatomegaly with steatosis, including fatal cases, have been reported. Treatment
with TRUVADA should be suspended in any person who develops clinical symptoms suggestive
of lactic acidosis or pronounced hepatotoxicity [see Warnings and Precautions (5.6)].
Drug
Interactions
Advise
individuals that TRUVADA may interact with many drugs; therefore, advise
individuals to report to their healthcare provider the use of any other medication,
including other HIV drugs and drugs for treatment of hepatitis C virus [see Warnings and Precautions (5.7) and Drug
Interactions (7)].
Dosage
Recommendations for Treatment of HIV-1 Infection
Inform
HIV-1 infected patients that it is important to take TRUVADA with other antiretroviral
drugs for the treatment of HIV-1 on a regular dosing schedule with or without food
and to avoid missing doses as it can result in development of resistance.
Pregnancy
Registry
Inform
individuals using TRUVADA for HIV-1 treatment or HIV-1 PrEP that there
is an antiretroviral pregnancy registry to monitor fetal outcomes of pregnant women
exposed to TRUVADA [see Use in Specific Populations
(8.1)].
…
Approved Drug Label (PDF)
5
Warnings and Precautions
5.1 Severe Acute Exacerbation of Hepatitis B in Patients with HBV Infection
(additions underlind)
![]()
All
patients should be tested for the presence of chronic hepatitis
B virus (HBV) before or when initiating TRUVADA
Severe acute exacerbations of hepatitis B (e.g., liver
decompensation and liver failure) have been reported in HBV-infected
patients who have discontinued TRUVADA. Patients infected with HBV who
discontinue TRUVADA should be closely monitored with both clinical and
laboratory follow-up for at least several months after stopping treatment. If
appropriate, initiation of anti-hepatitis B therapy may be warranted, especially
in patients with advanced liver disease or cirrhosis, since posttreatment
exacerbation of hepatitis may lead to hepatic decompensation and liver failure.
HBV-uninfected individuals should be offered vaccination.
5.2 Comprehensive Management to Reduce the Risk of Acquiring HIV-1 and Development of HIV-1 Resistance When TRUVADA Is Used for HIV-1 PrEP
(new subsection added)
Use TRUVADA for HIV-1 PrEP only as part of a
comprehensive prevention strategy that includes other prevention measures, such
as safer sex practices, because TRUVADA is not always effective in preventing
acquisition of HIV-1.
![]()
Counsel
uninfected individuals about safer sex practices that include consistent and
correct use of condoms, knowledge of their HIV-1 status and that of their partner(s),
the importance of virologic suppression in their partner(s) with HIV-1, and
regular testing for other sexually transmitted infections that can facilitate
HIV-1 transmission (such as syphilis, chlamydia, and gonorrhea).
Inform uninfected individuals about and
support their efforts in reducing sexual risk behavior.
Use TRUVADA to reduce the risk of acquiring HIV-1 only in
individuals confirmed to be HIV-negative.
HIV-1 resistance substitutions may emerge in individuals with undetected
HIV-1 infection who are taking only TRUVADA, because TRUVADA alone does not
constitute a complete regimen for HIV-1 treatment ; therefore, care should be taken to minimize drug exposure in
HIV-infected individuals.
Many HIV-1 tests, such as rapid tests, detect
anti-HIV antibodies and may not identify HIV-1 during the acute stage of
infection. Prior to initiating TRUVADA for HIV-1 PrEP, evaluate seronegative
individuals for current or recent signs or symptoms consistent with acute viral
infections (e.g., fever, fatigue, myalgia, skin rash) and ask about potential
exposure events (e.g., unprotected, or condom broke during, sex with an HIV-1
infected partner) that may have occurred within the last month.
![]()
If
clinical symptoms consistent with acute viral infection are present and recent
(<1 month) exposures are suspected, delay starting HIV-1 PrEP for at least
one month and reconfirm HIV-1 status or use a test approved or cleared by the
FDA as an aid in the diagnosis of HIV-1 infection, including acute or primary
HIV-1 infection.
While using TRUVADA for HIV-1 PrEP, HIV-1 screening tests
should be repeated at least every 3 months, and upon diagnosis of any sexually
transmitted infections. Some individuals, such as adolescents, may benefit from
more frequent visits and counseling.
If a screening test indicates possible HIV-1
infection, or if symptoms consistent with acute HIV-1 infection develop
following a potential exposure event, convert the HIV-1 PrEP regimen to an HIV
treatment regimen until negative infection status is confirmed using a test
approved or cleared by the FDA as an aid in the diagnosis of HIV-1, including
acute or primary HIV-1 infection.
Counsel uninfected individuals to strictly adhere to the
recommended TRUVADA dosing schedule. The effectiveness of TRUVADA in reducing
the risk of acquiring HIV-1 is strongly correlated with adherence, as
demonstrated by measurable drug levels in clinical trials.
5.3 New Onset or Worsening Renal Impairment
(additions underlined)
![]()
…
Prior to initiation and during use of
TRUVADA, on a clinically appropriate schedule, assess
serum creatinine, estimated creatinine clearance, urine glucose, and urine
protein in all patients. In patients with chronic kidney disease, also
assess serum phosphorus.
…
5.7 Risk of Adverse Reactions Due to Drug Interactions
(subsection revised)
The concomitant use of TRUVADA and other drugs may result
in known or potentially significant drug interactions, some of which may lead
to possible clinically significant adverse reactions from greater exposures of
concomitant drugs.
See Table 7 for steps to prevent or manage these possible
and known significant drug interactions, including dosing recommendations.
Consider the potential for drug interactions prior to and during therapy with
TRUVADA; review concomitant medications during therapy with TRUVADA; and
monitor for adverse reactions associated with the concomitant drugs.
6
Adverse Reactions
6.1 Clinical Trials Experience
(extensive
additions and revisions, please refer to label)
7
Drug Interactions
7.2 Established and Significant Interactions
(new subsection added)
Table 7 provides a listing of established or clinically
significant drug interactions. The drug interactions described are based on
studies conducted with either TRUVADA, the components of TRUVADA (FTC and TDF)
as individual agents and/or in combination, or are predicted drug interactions
that may occur with TRUVADA.
Table
7 Established and Significanta
Drug Interactions: Alteration in Dose or Regimen May Be Recommended Based on
Drug Interaction Trials
(please
refer to label to view table 7)
8
Use in Specific Populations
8.1 Pregnancy
(PLLR
conversion, please refer to label)
8.2 Lactation
(PLLR
conversion)
Risk Summary
Based on published data, FTC and tenofovir have been
shown to be present in human breast milk (see
Data). It is not known if the components of TRUVADA affect milk production
or have effects on the breastfed child.
Treatment
of HIV-1 Infection:
The Centers for Disease Control and Prevention recommend
that HIV-1 infected mothers not breastfeed their infants to avoid risking
postnatal transmission of HIV-1.
Because of the potential for: (1) HIV transmission (in
HIV-negative infants); (2) developing viral resistance (in HIV-positive
infants); and (3) adverse reactions in a breastfed infant similar to those seen
in adults, instruct mothers not to breastfeed if they are taking TRUVADA for
the treatment of HIV-1.
HIV-1
PrEP:
In HIV-uninfected women, the developmental and health
benefits of breastfeeding and the mother’s clinical need for TRUVADA for HIV-1
PrEP should be considered along with any potential adverse effects on the
breastfed child from TRUVADA and the risk of HIV-1 acquisition due to nonadherence
and subsequent mother to child transmission.
Women should not breastfeed if acute HIV-1 infection is
suspected because of the risk of HIV-1 transmission to the infant.
Data
HIV-1
PrEP: In a study of 50 breastfeeding women who received TRUVADA
for HIV-1 PrEP between 1 and 24 weeks postpartum (median 13 weeks), after 7
days of treatment, tenofovir was undetectable but FTC was detectable in the
plasma of most infants. In these infants, the average FTC plasma concentration
was less than 1% of the FTC Cmax observed in HIV-infected infants (up to 3
months of age) receiving the therapeutic dose of FTC (3 mg/kg/day). There were
no serious adverse events.
Two infants (4%) had an adverse event of mild diarrhea
which resolved.
8.4 Pediatric Use
(additions
underlined)
Treatment
of HIV-1 Infection
No pediatric clinical trial was conducted to evaluate the
safety and efficacy of TRUVADA in patients with HIV-1 infection. Data
from previously conducted trials with the individual drug products, FTC and
TDF, were relied upon to support dosage recommendations for TRUVADA. For
additional information, consult the prescribing information for EMTRIVA and
VIREAD.
TRUVADA should only be administered to HIV-1 infected
pediatric patients with body weight greater than or equal to 17 kg and who are
able to swallow a tablet. Because it is a fixed-dose combination tablet,
TRUVADA cannot be adjusted for patients of lower weigh. TRUVADA is not approved
for use in pediatric patients weighing less than 17 kg.
HIV-1
PrEP
The safety and effectiveness of TRUVADA for
HIV-1 PrEP in at-risk adolescents weighing at least 35 kg is supported by data
from adequate and well-controlled studies of TRUVADA for HIV-1 PrEP in adults
with additional data from safety and pharmacokinetic studies in previously conducted
trials with the individual drug products, FTC and TDF, in HIV-1 infected adults
and pediatric subjects.
Safety, adherence, and resistance were
evaluated in a single-arm, open-label clinical trial (ATN113) in which 67 HIV-1
uninfected at-risk adolescent men who have sex with men received TRUVADA once
daily for HIV-1 PrEP. The mean age of subjects was 17 years (range 15 to 18
years); 46% were Hispanic, 52% Black, and 37% White. The safety profile of
TRUVADA in ATN113 was similar to that observed in the adult HIV-1 PrEP trials.
In the ATN113 trial, HIV-1 seroconversion
occurred in 3 subjects. Tenofovir diphosphate levels in dried blood spot assays
indicate that these subjects had poor adherence. No tenofovir- or FTC-
associated HIV-1 resistance substitutions were detected in virus isolated from
the 3 subjects who seroconverted.
Adherence to study drug, as demonstrated by
tenofovir diphosphate levels in dried blood spot assays, declined markedly
after Week 12 once subjects switched from monthly to quarterly visits,
suggesting that adolescents may benefit from more frequent visits and
counseling.
17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)
Medication Guide
(additions,
please refer to label)
PATIENT COUNSELING INFORMATION
(extensive
additions and revisions, please refer to label)
Approved Drug Label (PDF)
5
Warnings and Precautions
5.3 Lactic Acidosis/Severe Hepatomegaly with Steatosis
(Additions and/or revisions are underlined)
Lactic acidosis and severe hepatomegaly with steatosis,
including fatal cases, have been reported with the use of nucleoside analogs,
including tenofovir DF and emtricitabine, components of TRUVADA,
alone or in combination with other antiretrovirals…
5.4 Coadministration with Other Products
(Additions and/or revisions are underlined)
TRUVADA is a fixed-dose combination of emtricitabine and
tenofovir DF. Do not coadminister TRUVADA with other drugs containing
emtricitabine, tenofovir DF, or tenofovir alafenamide, including ATRIPLA,
COMPLERA, DESCOVY, EMTRIVA, GENVOYA, ODEFSEY, STRIBILD, VEMLIDY,
or VIREAD…
7
Drug Interactions
7.3 Hepatitis C Antiviral Agents
(Additions and/or revisions are underlined)
Coadministration of TRUVADA and EPCLUSA
(sofosbuvir/velpatasvir) or HARVONI (ledipasvir/sofosbuvir has been shown
to increase tenofovir exposure.
In patients receiving TRUVADA concomitantly with EPCLUSA,
monitor for adverse reactions associated with tenofovir DF.
17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)
17 PATIENT COUNSELING INFORMATION
(Additions and/or revisions are underlined)
Advise patients and uninfected
individuals to avoid doing things that can spread HIV-1 or HBV infection
Do not share needles or other injection
equipment.
Do not share personal items that can have
blood or body fluids on them, like toothbrushes and razor blades.
Patients Coinfected with HIV-1 and HBV
Inform patients that severe acute exacerbations of
hepatitis B have been reported in patients who are coinfected with hepatitis B
virus (HBV) and HIV-1 and have discontinued TRUVADA. Patients should not
discontinue TRUVADA without first informing their healthcare provider…
New Onset or Worsening Renal Impairment
Inform patients that renal impairment, including
cases of acute renal failure and Fanconi syndrome, has been reported in
association with the use of VIREAD…
Lactic Acidosis and Severe Hepatomegaly
Inform patients
and uninfected individuals that lactic acidosis and severe hepatomegaly with
steatosis, including fatal cases, have been reported. Treatment with TRUVADA
should be suspended in any patient or uninfected individual who develops
clinical symptoms suggestive of lactic acidosis or pronounced hepatotoxicity.
Drug
Interactions
Inform patients
that:
TRUVADA
should not be coadministered
with ATRIPLA, COMPLERA, DESCOVY, EMTRIVA, GENVOYA, ODEFSEY, STRIBILD, or
VIREAD; or with drugs containing lamivudine,…
TRUVADA
should not be coadministered with HEPSERA
Bone Effects
Inform patients
that decreases in bone mineral
density have been observed with the use of VIREAD or TRUVADA…
Immune
Reconstitution Syndrome
In some patients
treated with combination antiretroviral therapy, including TRUVADA, signs and
symptoms of inflammation from previous infections may occur soon after anti-
HIV treatment is started. It is believed that these symptoms are due to an
improvement in the body’s immune response, enabling the body to fight
infections that may have been present with no obvious symptoms. Advise patients
to inform their healthcare provider immediately of any symptoms of infection.
Medication Guide
(Additions and/or revisions are underlined)
Do
not take TRUVADA if you also take any of the medicines listed below:
medicines
which also contain emtricitabine or tenofovir disoproxil fumarate, (ATRIPLA,
COMPLERA, EMTRIVA, GENVOYA, ODEFSEY, STRIBILD, VEMLIDY, or VIREAD).
medicines
which contain tenofovir alafenamide (DESCOVY, GENVOYA, or ODEFSEY)
TRUVADA may
interact with other medicines. Especially tell your healthcare provider if you
take:
What
are the possible side effects of TRUVADA?
TRUVADA may cause serious side effects, including:
Too
much lactic acid in your blood (lactic acidosis). Too much lactic acid is a serious but rare
medical emergency that can lead to death. Tell your healthcare provider right
away if you get these symptoms: weakness or being more tired than usual,
unusual muscle pain, being short of breath or fast breathing, stomach pain with
nausea and vomiting, cold or blue hands and feet, feel dizzy or lightheaded, or
a fast or abnormal heartbeat.
Severe
liver problems. In
rare cases, severe liver problems can happen that can lead to death. Tell your
healthcare provider right away if you get these symptoms: skin or the white
part of your eyes turns yellow, dark “tea-colored” urine, light-colored stools,
loss of appetite for several days or longer, nausea, or stomach-area pain.
What
are the ingredients in TRUVADA?
Active ingredients:
emtricitabine and tenofovir disoproxil fumarate.
Inactive
ingredients: Croscarmellose sodium, lactose monohydrate, magnesium stearate,
microcrystalline cellulose, and pregelatinized starch (gluten free). The 200
mg/300 mg strength tablets are coated with Opadry II Blue Y-30-10701, which
contains FD&C Blue #2 aluminum lake, hypromellose 2910, lactose
monohydrate, titanium dioxide, and triacetin. The 167 mg/250 mg, 133 mg/200 mg,
and 100 mg/150 mg strength tablets are coated with Opadry II Blue, which
contains FD&C Blue #2 aluminum lake, hypromellose 2910, lactose
monohydrate
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