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  • Edurant
    / Janssen


    Active Ingredient
    Rilpivirine 25 mg

    Status in Israel
    RX

    Presentation and Status in Health Basket

    Presentation Basket Yarpa Pharmasoft

    Film Coated Tablets

    30 X 25 mg

    partial basket chart 77136 5561

    Related information


    Dosage

    The recommended dose of EDURANT is one 25 mg tablet once daily taken orally with a meal.
    Rifabutin Co-administration: For patients concomitantly receiving rifabutin, the EDURANT dose should be increased to 50 mg (two tablets of 25 mg each) once daily, taken with a meal. When rifabutin co-administration is stopped, the EDURANT dose should be decreased to 25 mg once daily, taken with a meal.


    Indications

    EDURANT™, in combination with other antiretroviral agents, is indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in antiretroviral treatment-naïve adult patients with HIV-1 RNA less than or equal to 100,000 copies/mL at the start of therapy.


    Contra-Indications

    Hypersensitivity to the active substance or to any of the excipients.
    EDURANT is not recommended for patients less than 18 years of age.
    This drug should not be co-administered with the following drugs, as significant decreases in rilpivirine plasma concentrations may occur due to CYP3A enzyme induction or gastric pH increase, which may result in loss of virologic response and possible resistance to the drug  or to the class of NNRTIs:
    – Anticonvulsants: carbamazepine, oxcarbazepine, phenobarbital, phenytoin.
    – Antimycobacterials: rifabutin, rifampin, rifapentine.
    – PPIs:  esomeprazole, lansoprazole, omeprazole, pantoprazole, rabeprazole.
    – Systemic use of glucocorticoid dexamethasone (more than a single dose).
    – St John’s wort (Hypericum perforatum).


    Special Precautions

    Caution should be given to prescribing EDURANT with drugs that may reduce the exposure of rilpivirine. (See contraindications above.) Should be used with caution when co-administered with a drug with a known risk of Torsade de Pointes.
    See prescribing information for full details.


    Side Effects

    Common: Nausea, Abdominal pain, Vomiting, Fatigue, Headache, Dizziness,
    Depressive disorders, Insomnia, Abnormal Dreams, Rash. 
    See prescribing information for full details.


    Drug interactions

    Rilpivirine is primarily metabolized by cytochrome P450 (CYP)3A, and drugs that induce or inhibit CYP3A may thus affect the clearance of rilpivirine. Co-administration of EDURANT and drugs that induce CYP3A may result in decreased plasma concentrations of rilpivirine and loss of virologic response and possible resistance to rilpivirine or to the class of NNRTIs. Co-administration of EDURANT and drugs that inhibit CYP3A may result in increased plasma concentrations of rilpivirine.
    Co-administration of EDURANT with drugs that increase gastric pH may result in decreased plasma concentrations of rilpivirine and loss of virologic response and possible resistance to rilpivirine or to the class of NNRTIs.
    EDURANT at a dose of 25 mg once daily is not likely to have a clinically relevant effect on the exposure of drugs metabolized by CYP enzymes.
    See prescribing information for full details.


    Pregnancy and Lactation

    Pregnancy: No adequate and well-controlled studies of this drug use in pregnant women have been conducted. This drug should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
    Lactation: The Centers for Disease Control and Prevention recommend that HIV-infected mothers not breastfeed their infants to avoid risking postnatal transmission of HIV. It is not known whether rilpivirine is secreted in human milk. 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 this drug.
    See prescribing information for full details.


    Overdose

    There is no specific antidote for overdose with this drug. Human experience of overdose with EDURANT is limited. Treatment of overdose consists of general supportive measures including monitoring of vital signs and ECG (QT interval) as well as observation of the clinical status of the patient. If indicated, elimination of unabsorbed active substance may be achieved by gastric lavage. Administration of activated charcoal may also be used to aid in removal of unabsorbed active substance. Since rilpivirine is highly bound to plasma protein, dialysis is unlikely to result in significant removal of the active substance.


    Manufacturer
    Janssen Cilag S.P.A., Italy
    Licence holder
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