Drug Interaction:
EDURANT should not be used in combination with NNRTIs.
Co-administration of EDURANT with drugs that induce or inhibit CYP3A4 may
affect the plasma concentrations of rilpivirine.
Co-administration of EDURANT with drugs that increase gastric pH may
decrease plasma concentrations of rilpivirine.
Refer to the Full Prescribing Information for other drugs that should not be
co-administered with EDURANT and for other drugs that may require a
change in dose or regimen.
Indication:
EDURANT (rilpivirine) [Tablets]
Initial U.S. Approval: 2011
RECENT MAJOR CHANGES
Warnings and Precautions Immune Reconstitution Syndrome (5.4) 08/2012
Drug Name- Edurant
Active Ingredient - Rilpivirine
For the treatment of HIV-1 infection in adults who have never taken
HIV therapy
Indication-
Treatment of HIV-1 infection in adults who have never taken
HIV therapy
Approved by FDA on 20-5-2011 (Ref- FDA approved List- 2011)
Adverse Reaction:
The most common adverse drug reactions to EDURANT (incidence > 2%)
of at least moderate to severe intensity (> Grade 2) were depression, insomnia,
headache and rash.
Contra-Indications:
CONTRAINDICATIONS
Co-administration of EDURANT is contraindicated with drugs where significant
decreases in rilpivirine plasma concentrations may occur, which may result in loss
of virologic response and possible resistance and cross-resistance.
WARNINGS AND PRECAUTIONS
Caution should be given to prescribing EDURANT with drugs that may reduce
the exposure of rilpivirine.
Caution should be given to prescribing EDURANT
with drugs with a known risk of Torsade de Pointes.
Depressive Disorders: Severe depressive disorders (depressed mood, depression,
dysphoria, major depression, mood altered, negative thoughts, suicide attempt,
suicidal ideation) have been reported. Immediate medical evaluation is
recommended for severe depressive disorders.
Patients may develop redistribution/accumulation of body fat
or immune reconstitution syndrome.
Dosages/ Overdosage Etc:
Indication-
Treatment of HIV-1 infection in adults who have never taken
HIV therapy
INDICATIONS AND USAGE
EDURANT is a human immunodeficiency virus type 1 (HIV-1) specific, non-nucleoside
reverse transcriptase inhibitor (NNRTI)indicated:
In combination with other antiretroviral agents for the treatment of
HIV-1 infection in treatment-naive adult patients.
The following points should be considered when initiating therapy
with EDURANT:
More EDURANT treated subjects with HIV-1 RNA greater than 100,000 copies/mL
at the start of therapy experienced virologic failure compared to subjects
with HIV-1 RNA less than 100,000 copies/mL at the start of therapy.
The observed virologic failure rate in EDURANT treated subjects conferred a
higher rate of overall treatment resistance and cross-resistance to the NNRTI class
compared to efavirenz.
More subjects treated with EDURANT developed lamivudine/emtricitabine
associated resistance compared to efavirenz.
DOSAGE AND ADMINISTRATION
25 mg (one 25 mg tablet) taken once daily with a meal.
DOSAGE FORMS AND STRENGTHS
25 mg tablets
Patient Information:
PATIENT INFORMATION
1.Patients should be informed that EDURANT is not a cure for HIV infection.
2.Patients must stay on continuous HIV therapy to control HIV infection and
decrease HIV-related illnesses.
3. Patients should be advised to continue to practice safer sex and to use latex
or polyurethane condoms to lower the chance of sexual contact with any body fluids
such as semen, vaginal secretions or blood.
4.Patients should also be advised to never re-use or share needles.
5. Patients should be told that sustained decreases in plasma HIV RNA have
been associated with a reduced risk of progression to AIDS and death.
6. Patients should remain under the care of a physician while using EDURANT.
Pharmacology/ Pharmacokinetics:
1. Mechanism of Action
Rilpivirine is an antiviral drug
2. Pharmacokinetics
The pharmacokinetic properties of rilpivirine have been evaluated in adult healthy
subjects and in adult antiretroviral treatment-naïve HIV-1-infected subjects.
Exposure to rilpivirine was generally lower in HIV-1 infected subjects than in healthy subjects
Pregnancy and lactation:
USE IN SPECIFIC POPULATIONS
1. Pregnancy
Pregnancy Category B
No adequate and well-controlled or pharmacokinetic studies of EDURANT use in
pregnant women have been conducted.
EDURANT should be used during pregnancy only if the potential benefit justifies
the potential risk to the fetus.
2. Nursing mothers
The Centers for Disease Control and Prevention recommend that HIV-infected mothers
not breastfeed their infants to avoid risking postnatal transmission of HIV.
Because of both the potential for HIV transmission and the potential for adverse
reactions in nursing infants, mothers should be instructed not to breastfeed
if they are receiving EDURANT.
3. Pediatric Use
Safety and effectiveness in pediatric patients have not been established.
4. Geriatric Use
Clinical studies of EDURANT did not include sufficient numbers of subjects
aged 65 and over to determine whether they respond differently from younger
subjects.
In general, caution should be exercised in the administration and
monitoring of EDURANT in elderly patients reflecting the greater frequency
of decreased renal and hepatic function, and of concomitant disease
or other drug therapy.
Manufacturer Details