Drug Safety-related Labeling Changes (SrLC)

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Drug Safety-related Labeling Changes (SrLC) Database

ANDA	Abbreviated New Drug Application
BLA	Biologics License Application
CDER	Center for Drug Evaluation and Research
MG	Medication Guide
NDA	New Drug Application
PCI	Patient Counseling Information
PI	Patient Information
PLR	Physician Labeling Rule
PLLR	Pregnancy and Lactation Labeling Rule
Italics	For the most part, italics indicate an FDA comment such as: Additions and/or revisions underlined These italics usually appear at the beginning of the section. In some cases, italics may be an inherent part of the label, and will most often appear in the body of the section.
Underlines	Any text that is underlined indicates text that has been added or revised. There are exceptions where underlining occurs in a section subtitle or heading. This is the case when there is just one word underlined in the body of the text.

Sections

BW	Box Warning
WP	Warnings and Precautions all in one section (PLR-format) Warnings as one section (pre-PLR format) Precautions as one section (pre-PLR format)
AR	Adverse Reactions (in pre-PLR format, this may be a subheading under precautions).
DI	Drug Interactions (in pre-PLR format, this may be a subheading under precautions).
USP	Use in Specific Populations (Inclusive on one or more of the following: Pregnancy; Lactation (PLLR- format); Nursing Mothers (pre-PLLR format); Females and Males of Reproductive Potential (PLLR format only); Pediatric Use, Geriatric Use, Renal Impairment, Hepatic Impairment, Sex, Race (these last six may be a subheading of precautions if label in pre-PLLR format.
PCI/PI/MG	Patient Counseling Information (PLR format only) - summarizes the information that a health care provider should convey to a patient (or caregiver when applicable) when a counseling discussion is taking place (e.g., a physician prescribing a drug during an office visit, a nurse providing discharge instructions at a hospital, or a pharmacist conveying information at a pharmacy). Patient Information - FDA approved patient labeling. Medication Guide - paper handouts that come with many prescription medicines. The guides address issues that are specific to particular drugs and drug classes, and they contain FDA-approved information that can help patients avoid serious adverse events.

Only NDAs and CDER regulated BLAs are included in this database. ANDAs are not included.

Applications that remain active, even if the product has been discontinued, undergo safety-related labeling changes.

VEMLIDY (NDA-208464)

(TENOFOVIR ALAFENAMIDE FUMARATE)

Safety-related Labeling Changes Approved by FDA Center for Drug Evaluation and Research (CDER)

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03/27/2024 (SUPPL-16)

Approved Drug Label (PDF)

6 Adverse Reactions

6.1 Clinical Trials Experience

Additions and/or revisions underlined:

…

Adverse Reactions in Pediatric Subjects with Chronic Hepatitis B

The safety of VEMLIDY was evaluated in HBV-infected treatment-naïve and treatment- experienced pediatric subjects between the ages of 12 to less than 18 years and weighing at least 35 kg (Cohort 1; N=70) and 6 to less than 12 years and weighing at least 25 kg (Cohort 2, Group 1: N=18) through Week 24 in a randomized, double-blind, placebo-controlled clinical trial (Trial 1092). Subjects were then eligible to roll over to receive open-label VEMLIDY. Safety data are available through Week 96 [see Clinical Studies (14.5)]. The safety profile of VEMLIDY was similar to that in adults.

Bone Mineral Density Effects

Among the Cohort 1 and Cohort 2, Group 1 subjects treated with VEMLIDY and placebo, the mean percent change in BMD from baseline to Week 24 was 1.6% (N=48) and 1.9% (N=23) for lumbar spine, and 1.9% (N=50) and 2.0% (N=23) for whole body, respectively. At Week 24, mean changes from baseline BMD Z-scores were 0.01 and

-0.07 for lumbar spine, and -0.04 and -0.04 for whole body, for the VEMLIDY and placebo groups, respectively. At Week 24, BMD declines of 4% or greater at lumbar spine and whole body were experienced by 6% and 2% of VEMLIDY subjects, respectively.

In the open-label phase, mean percentage change in lumbar spine and whole body BMD and BMD Z-scores from baseline to Week 96 was similar in subjects who remained on VEMLIDY compared to those who switched from placebo to VEMLIDY.

8 Use in Specific Populations

8.1 Pregnancy

Additions and/or revisions underlined:

…

Data

Human Data

Based on prospective reports to the APR of over 1330 exposures to TAF-containing regimens during pregnancy resulting in live births (including over 1080 exposed in the first trimester and over 240 exposed in the second/third trimester), the prevalence of birth defects in live births was 3.9% (95% CI: 2.8% to 5.2%) and 4.8% (95% CI: 2.5% to 8.3%) following first and second/third trimester exposure, respectively, to TAF- containing regimens. Methodologic limitations of the APR include the use of MACDP as the external comparator group. The MACDP population is not disease-specific, evaluates women and infants from a limited geographic area, and does not include outcomes for births that occurred at less than 20 weeks gestation.

8.4 Pediatric Use

Additions and/or revisions underlined:

The pharmacokinetics, safety, and effectiveness of VEMLIDY for the treatment of chronic HBV infection have been established in pediatric patients between the ages of 6 to less than 18 years and weighing at least 25 kg (N=59) in Trial 1092 up to 96 weeks. No clinically meaningful differences in pharmacokinetics or safety were observed in comparison to those observed in adults [see Adverse Reactions (6.1), Clinical Pharmacology (12.3), and Clinical Studies (14.5)].

Safety and effectiveness of VEMLIDY has not been established in pediatric patients with chronic HBV infection who are less than 6 years of age or weigh less than 25 kg.

17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)

PATIENT INFORMATION

Additions and/or revisions underlined:

…

What is VEMLIDY?

VEMLIDY is a prescription medicine used to treat chronic (long-lasting) hepatitis B virus (HBV) in adults and children 6 years of age and older who weigh at least 55 pounds (25 kg) with stable (compensated) liver disease.

…

03/27/2024 (SUPPL-17)

Approved Drug Label (PDF)

6 Adverse Reactions

6.1 Clinical Trials Experience

Additions and/or revisions underlined:

…

Adverse Reactions in Pediatric Subjects with Chronic Hepatitis B

Bone Mineral Density Effects

8 Use in Specific Populations

8.4 Pediatric Use

Additions and/or revisions underlined:

Safety and effectiveness of VEMLIDY has not been established in pediatric patients with chronic HBV infection who are less than 6 years of age or weigh less than 25 kg.

8.1 Pregnancy

Additions and/or revisions underlined:

…

Data

Human Data

8.2 Lactation

Additions and/or revisions underlined:

Risk Summary

Data from the published literature report the presence of TAF and tenofovir in human milk. Data from the published literature have not reported adverse effects of TAF on a breastfed child. There are no data on the effects of TAF on milk production.

The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for VEMLIDY and any potential adverse effects on the breastfed infant from VEMLIDY or from the underlying maternal condition.

17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)

PATIENT INFORMATION

Additions and/or revisions underlined:

…

What is VEMLIDY?

…

What should I tell my healthcare provider before taking VEMLIDY?

Before taking VEMLIDY, tell your healthcare provider about all of your medical conditions, including if you:

…

are breastfeeding or plan to breastfeed. VEMLIDY may pass into your breastmilk. Talk with your healthcare provider about the best way to feed your baby.
…

10/17/2022 (SUPPL-14)

Approved Drug Label (PDF)

6 Adverse Reactions

6.1 Clinical Trials Experience

Additions and/or revisions underlined:

…

Adverse Reactions in Pediatric Subjects with Chronic Hepatitis B

The safety of VEMLIDY was evaluated in HBV-infected treatment-naïve and treatment- experienced pediatric subjects between the ages of 12 to less than 18 years (Cohort 1; N=70) through Week 24 in a randomized, double-blind, placebo-controlled clinical trial (Trial 1092) [see Clinical Studies (14.5)]. The safety profile of VEMLIDY was similar to that in adults.

Bone Mineral Density Effects

Among the Cohort 1 subjects treated with VEMLIDY and placebo, the mean percent change in BMD from baseline to Week 24 was 2.4% (N=37) and 1.9% (N=18) for lumbar spine, and 1.5% (N=39) and 1.9% (N=18) for whole body, respectively. At Week 24, mean changes from baseline BMD Z-scores were -0.03 and -0.09 for lumbar spine, and -0.05 and -0.01 for whole body, for the Cohort 1 VEMLIDY and placebo groups, respectively.

8 Use in Specific Populations

8.1 Pregnancy

Additions and/or revisions underlined:

…

Human Data

Based on prospective reports to the APR of over 800 exposures to TAF-containing regimens during pregnancy resulting in live births (including over 650 exposed in the first trimester and over 150 exposed in the second/third trimester), the prevalence of birth defects in live births was 3.5% (95% CI: 2.3% to 5.2%) and 3.3% (95% CI: 1.1% to 7.5%) following first and second/third trimester exposure, respectively, to TAF- containing regimens. Methodologic limitations of the APR include the use of MACDP as the external comparator group. The MACDP population is not disease-specific, evaluates women and infants from a limited geographic area, and does not include outcomes for births that occurred at less than 20 weeks gestation.

…

8.4 Pediatric Use

Additions and/or revisions underlined:

The pharmacokinetics, safety, and effectiveness of VEMLIDY for the treatment of chronic HBV infection have been established in pediatric patients between the ages of 12 to less than 18 years (N=47) in Trial 1092 for 24 weeks. No clinically meaningful differences in pharmacokinetics or safety were observed in comparison to those observed in adults [see Adverse Reactions (6.1), Clinical Pharmacology (12.3), and Clinical Studies (14.5)].

Safety and effectiveness of VEMLIDY has not been established in pediatric patients with chronic HBV infection who are less than 12 years of age.

17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)

PATIENT INFORMATION

Additions and/or revisions underlined:

…

What is VEMLIDY?

VEMLIDY is a prescription medicine used to treat chronic (long-lasting) hepatitis B virus (HBV) in adults and children 12 years of age and older with stable (compensated) liver disease.

VEMLIDY may lower the amount of HBV in your body.

VEMLIDY may improve the condition of your liver.

It is not known if VEMLIDY is safe and effective in children with chronic HBV infection who are under 12 years of age.

…

09/15/2021 (SUPPL-13)

Approved Drug Label (PDF)

8 Use in Specific Populations

Pregnancy

(Additions and/or revisions underlined)

Pregnancy Exposure Registry

Data

Human Data

Based on prospective reports to the APR of over 660 exposures to TAF-containing regimens during pregnancy resulting in live births (including over 520 exposed in the first trimester and over 130 exposed in the second/third trimester), the prevalence of birth defects in live births was 4.2% (95% CI: 2.6% to 6.3%) and 3.0% (95% CI: 0.8% to 7.5%) following first and second/third trimester exposure, respectively, to TAF- containing regimens. Methodologic limitations of the APR include the use of MACDP as the external comparator group. The MACDP population is not disease-specific, evaluates women and infants from a limited geographic area, and does not include outcomes for births that occurred at less than 20 weeks gestation.

03/04/2021 (SUPPL-12)

Approved Drug Label (PDF)

5 Warnings and Precautions

5.3 New Onset or Worsening Renal Impairment

Additions and/or revisions underlined

Postmarketing cases of renal impairment, including acute renal failure, proximal renal tubulopathy (PRT), and Fanconi syndrome have been reported with TAF-containing products; while most of these cases were characterized by potential confounders that may have contributed to the reported renal events, it is also possible these factors may have predisposed patients to tenofovir-related adverse events [see Adverse Reactions (6.2)].

…

6 Adverse Reactions

6.2 Postmarketing Experience

Additions underlined

The following adverse reactions have been identified during post approval use of VEMLIDY or other products containing tenofovir alafenamide.

…

Renal and Urinary Disorders

Acute renal failure, acute tubular necrosis, proximal renal tubulopathy, and Fanconi syndrome

17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)

PATIENT COUNSELING INFORMATION

Additions underlined

…

New Onset or Worsening Renal Impairment

Postmarketing cases of renal impairment, including acute renal failure, have been reported [see Warnings and Precautions (5.3)].

PATIENT INFORMATION

Additions underlined

…

What is the most important information I should know about VEMLIDY?

…

If you stop taking VEMLIDY, your healthcare provider will need to check your health often and do blood tests regularly for several months to check your liver. Tell your healthcare provider about any new or unusual symptoms you may have after you stop taking VEMLIDY.

…

08/18/2020 (SUPPL-10)

Approved Drug Label (PDF)

5 Warnings and Precautions

5.3 New Onset or Worsening Renal Impairment

Additions and/or revisions underlined:

… Discontinue VEMLIDY in patients who develop clinically significant decreases in renal function or evidence of Fanconi syndrome [see Adverse Reactions (6.1) and Use in Specific Populations (8.6)].

6 Adverse Reactions

6.1 Clinical Trials Experience

Additions and/or revisions underlined:

Renal Laboratory Tests

… In subjects who remained on blinded treatment beyond Week 96 in Trials 108 and 110, change from baseline in renal laboratory parameter values in each group at Week 120 were similar to those at Week 96. In the open-label phase, median change in estimated creatinine clearance by Cockcroft-Gault method from Week 96 to Week 120 was -0.6 mL per minute in subjects who remained on VEMLIDY and +1.8 mL per minute in those who switched from TDF to VEMLIDY at Week 96. Mean serum creatinine and median serum phosphorus …

Newly added information to bottom of subsection:

Adverse Reactions in Adult Subjects with Chronic Hepatitis B and Renal Impairment

In an open-label trial (Trial 4035) in virologically suppressed adult subjects with chronic hepatitis B switching to VEMLIDY 25 mg, the safety of VEMLIDY was assessed in 78 subjects with moderate to severe renal impairment (estimated creatinine clearance between 15 and 59 mL per minute by Cockcroft-Gault method; Part A, Cohort 1) and 15 subjects with ESRD (estimated creatinine clearance below 15 mL per minute) receiving chronic hemodialysis (Part A, Cohort 2). The safety of VEMLIDY, including changes from baseline in renal function, BMD, and lipid parameters, was similar to that observed in clinical trials of VEMLIDY in subjects with compensated liver disease but without renal impairment [see Use in Specific Populations (8.6) and Clinical Studies (14.4)].

8 Use in Specific Populations

8.6 Renal Impairment

Additions and/or revisions underlined:

No dosage adjustment of VEMLIDY is required in patients with mild, moderate, or severe renal impairment, or in patients with ESRD (estimated creatinine clearance below 15 mL per minute) who are receiving chronic hemodialysis. On days of hemodialysis, administer VEMLIDY after completion of hemodialysis treatment [see Dosage and Administration (2.3)].

The safety and efficacy of VEMLIDY in HBV-infected adult subjects with moderate to severe renal impairment (estimated creatinine clearance between 15 and 59 mL per minute by Cockcroft-Gault method) and ESRD (estimated creatinine clearance of less than 15 mL per minute by Cockcroft-Gault method) receiving chronic hemodialysis were evaluated in 78 and 15 subjects, respectively, in an open-label trial (Trial 4035, Part A). Overall, 98% of subjects achieved HBV DNA <20 IU/mL at Week 24 (Cohort 1, 97%; Cohort 2, 100%) and the safety of VEMLIDY was similar to that observed in clinical trials of VEMLIDY in subjects with compensated liver disease but without renal impairment [see Adverse Reactions (6.1) and Clinical Studies (14.4)].

The safety and efficacy of elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide 150/150/200/10 mg was previously evaluated in 55 virologically suppressed HIV-1 infected subjects with ESRD receiving chronic hemodialysis in an open-label study (Trial 1825). Tenofovir alafenamide exposures are similar when comparing tenofovir alafenamide 25 mg and tenofovir alafenamide 10 mg as part of elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide.

Among subjects with ESRD receiving chronic hemodialysis and administered tenofovir alafenamide, higher exposures of tenofovir were observed in HBV-infected subjects (Trial 4035 Part A) compared to HIV-infected subjects (Trial 1825). The clinical significance of these higher exposures is not established [see Clinical Pharmacology (12.3)] …

08/18/2020 (SUPPL-11)

Approved Drug Label (PDF)

17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)

8.5 Geriatric Use

Additions and/or revisions underlined:

In clinical trials, VEMLIDY was administered to 89 subjects aged 65 and over. No clinically significant differences in safety or efficacy have been observed between elderly subjects and subjects between 18 and less than 65 years of age.

02/04/2020 (SUPPL-8)

Approved Drug Label (PDF)

5 Warnings and Precautions

5.4 Lactic Acidosis/Severe Hepatomegaly with Steatosis

(Additions and/or revisions underlined)

Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogs, including tenofovir disoproxil fumarate (TDF), another prodrug of tenofovir, alone or in combination with other antiretrovirals. Treatment with VEMLIDY should be suspended in any patient who develops clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity (which may include hepatomegaly and steatosis even in the absence of marked transaminase elevations).

6 Adverse Reactions

6.1 Clinical Trials Experience

(Extensive changes; please refer to label)

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 VEMLIDY during pregnancy. Healthcare providers are encouraged to register patients by calling the Antiretroviral Pregnancy Registry (APR) at 1-800-258- 4263.

Risk Summary

Available data from the APR show no significant difference in the overall risk of birth defects for tenofovir alafenamide (TAF) compared with the background rate for major birth defects of 2.7% in the U.S. reference population of the Metropolitan Atlanta Congenital Defects Program (MACDP). The rate of miscarriage is not reported in the APR. The estimated background rate of miscarriage in clinically recognized pregnancies in the U.S. general population is 15% to 20%.

In animal studies, no adverse developmental effects were observed when tenofovir alafenamide was administered during the period of organogenesis at exposure equal to or 51 times (rats and rabbits, respectively) the tenofovir alafenamide exposure at the recommended daily dose of VEMLIDY. No adverse effects were observed in the offspring when TDF was administered through lactation at tenofovir exposures of approximately 12 times the exposure at the recommended daily dosage of VEMLIDY.

Data

Human Data

Based on prospective reports to the APR of exposures to TAF-containing regimens during pregnancy resulting in live births (including over 200 exposed in the first trimester and over 80 exposed in the second/third trimester), the prevalence of birth defects in live births was 5.2% (95% CI: 2.7% to 8.8%) and 1.2% (95% CI: 0% to 6.5%) following first and second/third trimester exposure, respectively, to TAF-containing regimens.

Methodologic limitations of the APR include the use of MACDP as the external comparator group. The MACDP population is not disease-specific, evaluates women and infants from a limited geographic area, and does not include outcomes for births that occurred at <20 weeks gestation.

Animal Data

Embryonic fetal development studies performed in rats and rabbits revealed no evidence of impaired fertility or harm to the fetus. The embryo-fetal NOAELs (no observed adverse effect level) in rats and rabbits occurred at tenofovir alafenamide exposures similar to and 51 times higher than, respectively, the exposure in humans at the recommended daily dose. Tenofovir alafenamide is rapidly converted to tenofovir; the observed tenofovir exposure in rats and rabbits were 54 (rats) and 85 (rabbits) times higher than human tenofovir exposures at the recommended daily dose.

Tenofovir alafenamide was administered orally to pregnant rats (25, 100, or 250 mg/kg/day) and rabbits (10, 30, or 100 mg/kg/day) through organogenesis (on gestation days 6 through 17, and 7 through 20, respectively). No adverse embryo-fetal effects were observed in rats and rabbits at tenofovir alafenamide exposures approximately similar to (rats) and 51 (rabbits) times higher than the exposure in humans at the recommended daily dose of VEMLIDY. Tenofovir alafenamide is rapidly converted to tenofovir; the observed tenofovir exposures in rats and rabbits were 54 (rats) and 85 (rabbits) times higher than human tenofovir exposures at the recommended daily dose. Since tenofovir alafenamide is rapidly converted to tenofovir and a lower tenofovir exposure in rats and mice was observed after tenofovir alafenamide administration compared to TDF, another prodrug for tenofovir administration, a pre/postnatal development study in rats was conducted only with TDF. Doses up to 600 mg/kg/day were administered through lactation; no adverse effects were observed in the offspring on gestation day 7 [and lactation day 20] at tenofovir exposures of approximately 12 [18] times higher than the exposures in humans at the recommended daily dose of VEMLIDY.

8.5 Geriatric Use

(Additions and/or revisions underlined)

Clinical trials of VEMLIDY did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, treatment of an elderly patient should be done with caution; the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy should be considered.

02/04/2019 (SUPPL-7)

Approved Drug Label (PDF)

5 Warnings and Precautions

5.3 New Onset or Worsening Renal Impairment

(additions and revisions underlined)

…

Prior to or when initiating VEMLIDY, and during treatment with VEMLIDY 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. Discontinue VEMLIDY in patients who develop clinically significant decreases in renal function or evidence of Fanconi syndrome.

6 Adverse Reactions

6.1 Clinical Trials Experience

(additions and revisions, please refer to label)

6.2 Postmarketing Experience

(new subsection added)

The following events have been identified during post approval use of VEMLIDY. Because these events are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Skin and Subcutaneous Tissue Disorders

Angioedema, urticaria

7 Drug Interactions

7.4 Drugs without Clinically Significant Interactions with VEMLIDY

(additions underlined)

Based on drug interaction studies conducted with VEMLIDY, no clinically significant drug interactions have been observed with: ethinyl estradiol, ledipasvir/sofosbuvir, midazolam, norgestimate, sertraline, sofosbuvir, sofosbuvir/velpatasvir, and sofosbuvir/velpatasvir/voxilaprevir.

8 Use in Specific Populations

8.6 Renal Impairment

(additions underlined)

The pharmacokinetics and safety of tenofovir alafenamide were studied in HIV-1 infected adults with ESRD (estimated creatinine clearance below 15 mL per minute by Cockcroft-Gault method) receiving chronic hemodialysis in an open-label trial of 55 subjects who received elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide 150/150/200/10 mg. Tenofovir alafenamide 10 mg, given in this combination, achieves similar exposures as tenofovir alafenamide 25 mg alone. The safety profile of subjects in this trial was consistent with that expected in patients with ESRD on chronic hemodialysis and HIV-1 infection.

VEMLIDY is not recommended in patients with ESRD (estimated creatinine clearance below 15 mL per minute by Cockcroft-Gault method) who are not receiving chronic hemodialysis as the safety of VEMLIDY has not been established in this population.

17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)

PATIENT INFORMATION

(additions underlined)

…

Take VEMLIDY exactly as your healthcare provider tells you to take it.
Take VEMLIDY 1 time each day.
Take VEMLIDY with food.
If you are on dialysis, on your dialysis days, take your daily dose of VEMLIDY following dialysis.
…

07/03/2018 (SUPPL-4)

5 Warnings and Precautions

5.3 New Onset or Worsening Renal Impairment

(Additions and/or revisions are underlined)

6 Adverse Reactions

6.1 Clinical Trials Experience

(Extensive changes; please refer to labeling)

7 Drug Interactions

7.4 Drugs without Clinically Significant Interactions with VEMLIDY

(Additions and/or revisions are underlined)

04/07/2017 (SUPPL-1)

Approved Drug Label (PDF)

5 Warnings and Precautions

5.4 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, another prodrug of tenofovir, alone or in combination with other antiretrovirals.

17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)

Patient Information

(Additions and/or revisions are underlined)

What are the possible side effects of VEMLIDY?

VEMLIDY 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.