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Name | Symbol | Market | Type |
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GSK plc | NYSE:GSK | NYSE | Depository Receipt |
Price Change | % Change | Price | High Price | Low Price | Open Price | Traded | Last Trade | |
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-1.13 | -2.84% | 38.64 | 45,558 | 12:29:55 |
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other antiretroviral agents for the treatment of HIV-1 infection in
adults and pediatric patients weighing at least 30 kg
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rilpivirine as a complete regimen for the treatment of HIV-1
infection in adults to replace the current antiretroviral regimen
in those who are virologically suppressed (HIV-1 RNA < 50 copies
per mL) on a stable antiretroviral regimen for ≥6 months with
no history of treatment failure or known substitutions associated
with resistance to either antiretroviral agent.
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Previous hypersensitivity reaction to dolutegravir.
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Coadministration with dofetilide.
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Hypersensitivity reactions characterized by rash, constitutional
findings, and sometimes organ dysfunction, including liver injury,
have been reported. Discontinue TIVICAY and other suspect agents
immediately if signs or symptoms of hypersensitivity reactions
develop, as a delay in stopping treatment may result in a
life-threatening reaction.
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Hepatotoxicity has been reported in patients receiving
dolutegravir-containing regimens. Patients with underlying
hepatitis B or C may be at increased risk for worsening or
development of transaminase elevations. Monitoring for hepatoxicity
is recommended.
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Embryo-fetal toxicity may occur when used at the time of conception
and in early pregnancy. Avoid use of TIVICAY at the time of
conception through the first trimester of pregnancy due to the risk
of neural tube defects. Advise adolescents and adults of
childbearing potential to use effective contraception.
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Immune reconstitution syndrome has been reported in patients
treated with combination antiretroviral therapy.
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Refer to the full prescribing information for important drug
interactions with TIVICAY.
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Drugs that are metabolic inducers may decrease the plasma
concentrations of dolutegravir.
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TIVICAY should be taken 2 hours before or 6 hours after taking
cation-containing antacids or laxatives, sucralfate, oral
supplements containing iron or calcium, or buffered medications.
Alternatively, TIVICAY and supplements containing calcium or iron
can be taken together with food.
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Pregnancy: Avoid use of TIVICAY at the time of conception through
the first trimester due to the risk of neural tube
defects.
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Lactation: Breastfeeding is not recommended.
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Females and males of reproductive potential: Pregnancy testing and
contraception are recommended in adolescents and adults of
childbearing potential.
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Severe acute exacerbations of hepatitis B have been reported in
patients who are co-infected with hepatitis B virus (HBV) and human
immunodeficiency virus (HIV-1) and have discontinued EPIVIR.
Monitor hepatic function closely in these patients and, if
appropriate, initiate anti-hepatitis B treatment.
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Patients with HIV-1 infection should receive only dosage forms of
EPIVIR appropriate for treatment of HIV-1.
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EPIVIR is contraindicated in patients with previous
hypersensitivity reaction to lamivudine
.
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Co-infected HIV-1/HBV Patients: Emergence of lamivudine-resistant
HBV variants associated with lamivudine-containing antiretroviral
regimens has been reported.
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Lactic acidosis and severe hepatomegaly with steatosis, including
fatal cases, have been reported with the use of nucleoside
analogues.
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Hepatic decompensation, some fatal, has occurred in HIV-1/HCV
co-infected patients receiving interferon and ribavirin-based
regimens. Monitor for treatment-associated toxicities. Discontinue
EPIVIR as medically appropriate and consider dose reduction or
discontinuation of interferon alfa, ribavirin, or
both.
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Pancreatitis: Use with caution in pediatric patients with a history
of pancreatitis or other significant risk factors for pancreatitis.
Discontinue treatment as clinically appropriate. (5.4)
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Immune reconstitution syndrome has been reported in patients
treated with combination antiretroviral therapy.
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Lower virologic suppression rates and increased risk of viral
resistance were observed in pediatric subjects who received EPIVIR
oral solution concomitantly with other antiretroviral oral
solutions compared with those who received tablets. An all-tablet
regimen should be used when possible.
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The most common reported adverse reactions (incidence greater than
or equal to 15%) in adults were headache, nausea, malaise and
fatigue, nasal signs and symptoms, diarrhea, and
cough.
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The most common reported adverse reactions (incidence greater than
or equal to 15%) in pediatric subjects were fever and
cough.
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Sorbitol: Coadministration of lamivudine and sorbitol may decrease
lamivudine concentrations; when possible, avoid chronic
coadministration.
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Lactation: Women infected with HIV should be instructed not to
breastfeed due to potential for HIV transmission.
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ViiV
Healthcare Media enquiries:
|
Melinda
Stubbee
|
+1 919
491 0831
|
|
Audrey
Abernathy
|
+1 919
605 4521
|
|
|
|
GSK
Global Media enquiries:
|
Simon
Steel
|
+44 (0)
20 8047 5502
|
|
Sarah
Spencer
|
+1 215
751 3335
|
Analyst/Investor
enquiries:
|
Sarah
Elton-Farr
|
+44 (0)
20 8047 5194
|
|
Mel
Foster-Hawes
|
+44 (0)
20 8047 0674
|
|
Danielle
Smith
James
Dodwell
|
+44 (0)
20 8047 0932
+44 (0)
20 8047 2406
|
|
Jeff
McLaughlin
|
+1 215
751 7002
|
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GlaxoSmithKline plc
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(Registrant)
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Date: September
14, 2018
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By: VICTORIA
WHYTE
--------------------------
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Victoria Whyte
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Authorised
Signatory for and on
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behalf
of GlaxoSmithKline plc
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