Approved Drug Label (PDF)
4
Contraindications
(additions
underlined)
…
With
drugs that are highly dependent on CYP3A for clearance and for which elevated
plasma concentrations are associated with serious and/or life-threatening
events :
…
With
drugs that are moderate or strong inducers of CYP3A and strong inducers of
CYP2C8 and may lead to reduced efficacy of VIEKIRA XR:
7
Drug Interactions
7.3 Established and Other Potential Drug Interactions
(additions
underlined)
Clearance
of HCV infection with direct-acting antivirals may lead to changes in hepatic
function, which may impact the safe and effective use of concomitant
medications. For example, altered blood glucose control resulting in serious
symptomatic hypoglycemia has been reported in diabetic patients in
postmarketing case reports and published epidemiological studies. Management of
hypoglycemia in these cases required either discontinuation or dose
modification of concomitant medications used for diabetes treatment.
Frequent
monitoring of relevant laboratory parameters (e.g. International Normalized
Ratio [INR] in patients taking warfarin, blood glucose levels in diabetic
patients) or drug concentrations of concomitant medications such as CYP P450
substrates with a narrow therapeutic index (e.g. certain immunosuppressants) is
recommended to ensure safe and effective use. Dose adjustments of concomitant
medications may be necessary.
…
Table
4. Drug Interactions
(addition of the
following to Table 4, please refer to label for more information)
ANTICANCER
AGENTS/KINASE INHIBITORS
encorafenib
fostamatinib
ibrutinib
ivosidenib
GnRH RECEPTOR
ANTAGONISTS
elagolix
…
17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)
MEDICATION GUIDE
(additions
underlined)
…
Do not take
VIEKIRA XR if you:
…
…
...
Approved Drug Label (PDF)
6
Adverse Reactions
6.2 Postmarketing Experience
(addition
underlined)
…
Immune System Disorders: Anaphylactic
reactions and other hypersensitivity reactions (including angioedema).
…
7
Drug Interactions
7.3 Established and Other Potential Drug Interactions
(Table
5 updated to include information regarding Fentanyl)
17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)
PATIENT COUNSELING INFORMATION
(additions
underlined)
…
Pregnancy
Advise patients that extreme care must be taken to
avoid pregnancy during treatment with VIEKIRA XR with ribavirin and within 6
months of stopping ribavirin in both female patients and in female partners
of male patients. Inform patients to notify their health care provider
immediately in the event of a pregnancy.
…
Administration
...
Advise patients not to remove tablets from the
daily dose pack until they are ready to take them.
…
Approved Drug Label (PDF)
6
Adverse Reactions
6.2 Post-Marketing Adverse Reactions
(additions underlined)
…
Skin and Subcutaneous Tissue Disorders: Erythema multiforme (EM)
7
Drug Interactions
7.1 Potential for VIEKIRA XR to Affect Other Drugs
(additions underlined)
…
Fluctuations in INR values may occur in patients receiving warfarin
concomitant with HCV treatment, including treatment with VIEKIRA XR. If VIEKIRA
XR is coadministered with warfarin, close monitoring of INR values is
recommended during treatment and post-treatment follow-up.
Approved Drug Label (PDF)
4
Contraindications
Table 2. Drugs
that are Contraindicated with VIEKIRA XR (Table has been revised; please refer to label)
7
Drug Interactions
7.3 Established and Other Potential Drug Interactions
Table 5.
Established Drug Interactions Based on Drug Interaction Trials (Table has been revised; please refer to
label)
17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)
MEDICATION GUIDE
(Additions and/or revisions are underlined)
Who should not
take VIEKIRA XR?
Do not take
VIEKIRA XR if you:
Approved Drug Label (PDF)
4
Contraindications
Table 2. Drugs
that are Contraindicated with VIEKIRA XR (Table has been revised; please refer to label)
7
Drug Interactions
7.3 Established and Other Potential Drug Interactions
Table 5.
Established Drug Interactions Based on Drug Interaction Trials (Table has been revised; please refer to
label)
17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)
MEDICATION GUIDE
(Additions and/or revisions are underlined)
Who should not
take VIEKIRA XR?
Do not take
VIEKIRA XR if you:
Approved Drug Label (PDF)
Boxed Warning
(Newly added section)
WARNING: RISK OF HEPATITIS B VIRUS REACTIVATION IN
PATIENTS COINFECTED WITH HCV AND HBV
Test all
patients for evidence of current or prior hepatitis B virus (HBV) infection
before initiating treatment with VIEKIRA XR. HBV reactivation has been reported
in HCV/HBV coinfected patients who were undergoing or had completed treatment
with HCV direct acting antivirals and were not receiving HBV antiviral therapy.
Some cases have resulted in fulminant hepatitis, hepatic failure, and death.
Monitor HCV/HBV coinfected patients for hepatitis flare or HBV reactivation
during HCV treatment and post-treatment follow-up. Initiate appropriate patient
management for HBV infection as clinically indicated.
5
Warnings and Precautions
5.1 Risk of Hepatitis B Virus Reactivation in Patients Coinfected with HCV and HBV
(Newly added subsection)
Hepatitis B virus
(HBV) reactivation has been reported in HCV/HBV coinfected patients who were
undergoing or had completed treatment with HCV direct acting antivirals, and
who were not receiving HBV antiviral therapy. Some cases have resulted in
fulminant hepatitis, hepatic failure and death. Cases have been reported in
patients who are HBsAg positive and also in patients with serologic evidence of
resolved HBV infection (i.e., HBsAg negative and anti-HBc positive). HBV
reactivation has also been reported in patients receiving certain
immunosuppressant or chemotherapeutic agents; the risk of HBV reactivation
associated with treatment with HCV direct-acting antivirals may be increased in
these patients.
HBV reactivation is
characterized as an abrupt increase in HBV replication manifesting as a rapid
increase in serum HBV DNA level. In patients with resolved HBV infection
reappearance of HBsAg can occur. Reactivation of HBV replication may be
accompanied by hepatitis, i.e., increase in aminotransferase levels and, in
severe cases, increases in bilirubin levels, liver failure, and death can
occur.
Test all patients
for evidence of current or prior HBV infection by measuring HBsAg and anti- HBc
before initiating HCV treatment with VIEKIRA XR. In patients with serologic
evidence of HBV infection, monitor for clinical and laboratory signs of
hepatitis flare or HBV reactivation during HCV treatment with VIEKIRA XR and
during post-treatment follow-up. Initiate appropriate patient management for
HBV infection as clinically indicated.
17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)
17 PATIENT COUNSELING INFORMATION
(Additions and/or revisions are underlined)
Risk of
Hepatitis B Virus Reactivation in Patients Coinfected with HCV and HBV
Inform patients
that HBV reactivation can occur in patients coinfected with HBV during or after
treatment of HCV infection. Advise patients to tell their healthcare provider
if they have a history of hepatitis B virus infection.
MEDICATION GUIDE
(Additions and/or revisions are underlined)
What
is the most important information I should know about VIEKIRA XR?
VIEKIRA XR can
cause serious side effects, including,
Hepatitis B
virus reactivation:
Before starting treatment with VIEKIRA XR, your healthcare provider will do
blood tests to check for hepatitis B virus infection. If you have ever had
hepatitis B virus infection, the hepatitis B virus could become active again
during or after treatment of hepatitis C virus with VIEKIRA XR. Hepatitis B
virus becoming active again (called reactivation) may cause serious liver
problems including liver failure and death. Your healthcare provider will
monitor you if you are at risk for hepatitis B virus reactivation during
treatment and after you stop taking VIEKIRA XR.
For more
information about side effects, see the section “What are the possible side
effects of
VIEKIRA XR?”
What should I
tell my healthcare provider before taking VIEKIRA XR?
Before taking
VIEKIRA XR, tell your healthcare provider about all of your medical conditions,
including if you:
- have ever had hepatitis B virus infection
What are the
possible side effects of VIEKIRA XR?
VIEKIRA XR can
cause serious side effects, including:
- Hepatitis B virus reactivation. See “What
is the most important information I should know about VIEKIRA XR?”
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