Dolutegravir - Tivicay- @- (Aug 2013)- Anti-viral
Drug Name:Dolutegravir - Tivicay- @- (Aug 2013)- Anti-viral
List Of Brands:
Indication Type Description:
Drug Interaction
Indication
Adverse Reaction
Contra-Indications
Dosages/ Overdosage Etc
Patient Information
Pharmacology/ Pharmacokinetics
Pregnancy and lactation
Drug Interaction:
Drugs that are metabolic inducers may decrease the plasma concentrations
of dolutegravir.
.
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.
Indication:
TIVICAY (dolutegravir) tablets for oral use
Initial U.S. Approval: 2013
Drug Name- Tivicay
Active Ingredient - Dolutegravir
To treat HIV -1 Infection
Indication-
HIV-1 Infection
Approved by FDA on 12-8-2013 (Ref- FDA approved List- 2013)
Adverse Reaction:
The most common adverse reactions of moderate to severe intensity
and incidence .2% (in those receiving TIVICAY in any one adult trial) are
insomnia and headache.
Contra-Indications:
CONTRAINDICATIONS
Coadministration with dofetilide is contraindicated
WARNINGS AND PRECAUTIONS
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.
TIVICAY should not be used in patients who have experienced a previous
hypersensitivity reaction to TIVICAY.
.
Patients with underlying hepatitis B or C may be at increased risk for
worsening or development of transaminase elevations with use
of TIVICAY.
Appropriate laboratory testing prior to initiating therapy and
monitoring for hepatotoxicity during therapy with TIVICAY is
recommended in patients with underlying hepatic disease such
as hepatitis B or C.
.
Redistribution/accumulation of body fat and immune reconstitution
syndrome have been reported in patients treated with combination
antiretroviral therapy.
Dosages/ Overdosage Etc:
INDICATIONS AND USAGE
TIVICAY is a human immunodeficiency virus type 1 (HIV-1) integrase
strand transfer inhibitor (INSTI) indicated in combination with other
antiretroviral agents for the treatment of HIV-1 infection in adults and
children aged 12 years and older and weighing at least 40 kg.
The following should be considered prior to initiating TIVICAY:
Poor virologic response was observed in subjects treated with
TIVICAY 50 mg twice daily with an INSTI-resistance Q148 substitution plus
2 or more additional INSTI-resistance substitutions including
L74I/M, E138A/D/K/T, G140A/S, Y143H/R, E157Q, G163E/K/Q/R/S,
or G193E/R.
DOSAGE AND ADMINISTRATION
May be taken without regard to meals.
Adult Population
Recommended Dose
Treatment-naïve or treatment-experienced INSTI-naïve 50 mg once daily
Treatment-naïve or treatment-experienced INSTI-naïve when coadministered
with the following potent UGT1A/CYP3A inducers: efavirenz,
fosamprenavir/ritonavir, tipranavir/ritonavir, or rifampin 50 mg twice daily
INSTI-experienced with certain INSTI-associated resistance substitutions
or clinically suspected INSTI resistance 50 mg twice daily
a Alternative combinations that do not include metabolic inducers
should be considered where possible.
Pediatric Patients: (Treatment-naïve or treatment-experienced INSTI-naïve
aged 12 years and older, and weighing at least 40 kg).
The recommended dose is TIVICAY 50 mg once daily.
If efavirenz, fosamprenavir/ritonavir, tipranavir/ritonavir, or rifampin are
coadministered, then the dose is TIVICAY 50 mg twice daily.
DOSAGE FORMS AND STRENGTHS
Tablets: 50 mg
Patient Information:
PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Patient Information).
Drug Interactions: TIVICAY should not be coadministered with dofetilide because
interactions between these drugs can result in potentially life-threatening
adverse events
Hypersensitivity Reactions:
Patients should be advised to immediately contact
their healthcare provider if they develop rash. Instruct patients to immediately
stop taking TIVICAY and other suspect agents, and seek medical attention
if they develop a rash associated with any of the following symptoms,
as it may be a sign of a more serious reaction such as severe hypersensitivity:
fever; generally ill feeling; extreme tiredness; muscle or joint aches; blisters etc.
Patients should understand that if hypersensitivity occurs, they will be
closely monitored, laboratory tests will be ordered, and appropriate therapy will
be initiated.
Patients should also be told that it is very important that they remain
under a physicians care during treatment with TIVICAY of any symptoms of infection
Information About HIV-1 Infection:
TIVICAY is not a cure for HIV-1 infection and patients may continue to experience
illnesses associated with HIV-1 infection, including opportunistic infections.
Patients must remain on continuous HIV therapy to control HIV infection and
decrease HIV-related illness.
Patients should be told that sustained decreases in plasma HIV RNA have
been associated with a reduced risk of progression to AIDS and death.
Patients should remain under the care of a physician when using TIVICAY.
Patients should be informed to take all HIV medications exactly as prescribed.
Patients should be advised to avoid doing things that can spread HIV-1 infection to others.
Do not re-use or 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.
Continue to practice safe sex by using a latex or polyurethane condom to
lower the chance of sexual contact with semen, vaginal secretions, or blood.
Female patients should be advised not to breastfeed because it is not known
if TIVICAY can be passed to the baby in your breast milk and whether it coul
harm the baby. Mothers with HIV-1 should not breastfeed because
HIV-1 can be passed to the baby in the breast milk.
Physicians should instruct their patients to read the Patient Information
before starting TIVICAY and to reread it each time the prescription
is renewed.
Patients should be instructed to inform their physician or pharmacist if they
develop any unusual symptom, or if any known symptom persists or worsens.
Pharmacology/ Pharmacokinetics:
CLINICAL PHARMACOLOGY
1. Mechanism of Action
Dolutegravir is an HIV-1 antiviral agent
2. Pharmacokinetics
The pharmacokinetic properties of dolutegravir have been evaluated in healthy
adult subjects and HIV-1infected adult subjects. Exposure to dolutegravir was
generally similar between healthy subjects and HIV-1infected subjects.
Pregnancy and lactation:
USE IN SPECIFIC POPULATIONS
Pregnancy:
TIVICAY should be used during pregnancy only if the potential benefit justifies
the potential risk.
Nursing mothers:
Breastfeeding is not recommended due to the potential for HIV transmission.
Pediatric patients:
Safety and efficacy of TIVICAY have not been established in pediatric
patients younger than 12 years or weighing less than 40 kg, or in pediatric patients
who are INSTI-experienced with documented or clinically suspected resistance
to other INSTIs (raltegravir, elvitegravir).
Geriatric Use
Clinical trials of TIVICAY did not include sufficient numbers of subjects aged 65 and
older to determine whether they respond differently from younger subjects.
In general, caution should be exercised in the administration of TIVICAY in elderly
patients reflecting the greater frequency of decreased hepatic, renal,
or cardiac function, and of concomitant disease or other drug therapy
