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  • Eviplera
    / Janssen


    Active Ingredient *
    Emtricitavine 200 mg
    Rilpivirine (as HCl) 25 mg
    Tenofovir Disoproxil (as Fumarate) 245 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 77155 5567

    Related information


    Dosage

    Adults: The recommended dose is one tablet taken orally once daily with food.
    Renal Impairment: Because this product is a fixed-dose combination, it should not be prescribed for patients requiring dose reduction such as those with moderate or severe renal impairment (estimated creatinine clearance below 50 mL per minute).
    Rifabutin Coadministration: If this product is coadministered with rifabutin, an additional 25 mg tablet of rilpivirine (Edurant) once per day is recommended to be taken concomitantly with this product and with a meal for the duration of the rifabutin coadministration. If a patient misses a dose of Eviplera within 12 hours of the time it is usually taken, the patient should take Eviplera with food as soon as possible and resume the normal dosing schedule. If a patient misses a dose of Eviplera by more than 12 hours, the patient should not take the missed dose and simply resume the usual dosing schedule. If a patient vomits within 4 hours of taking Eviplera another Eviplera tablet should be taken with food . If a patient vomits more than 4 hours after taking Eviplera they do not need to take another dose of Eviplera until the next regularly scheduled dose.
    For full details see prescribing information.


    Indications

    Indicated for use as a complete regimen for the treatment of HIV-1 infection in antiretroviral treatment-naive adults. This indication is based on Week 48 safety and efficacy analyses from 2 randomized, double-blind, active controlled, Phase 3 trials in treatment-naive subjects comparing rilpivirine to efavirenz . The following points should be considered when initiating therapy with this product: More rilpivirine-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 rilpivirine-treated subjects conferred a higher rate of overall treatment resistance and cross-resistance to the NNRTI class compared to efavirenz . More subjects treated with rilpivirine developed lamivudine/emtricitabine associated resistance compared to efavirenz.


    Contra-Indications

    Hypersensitivity to the active substances or to any of the excipients.
    this product should not be coadministered 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 this product or to the class of NNRTIs: The anticonvulsants – carbamazepine, oxcarbazepine, phenobarbital, phenytoin. The antimycobacterials – rifabutin, rifampin, rifapentine. Proton pump inhibitors, such as esomeprazole, lansoprazole, omeprazole, antoprazole, rabeprazole. The glucocorticoid systemic dexamethasone (more than a single dose). St. John’s wort (Hypericum perforatum).


    Special Precautions

    this product is not recommended for patients less than 18 years of age .
    Lactic Acidosis/Severe Hepatomegaly with Steatosis: Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogs, including tenofovir DF, a component of this product, in combination with other antiretrovirals.
    Patients Coinfected with HIV-1 and HBV: It is recommended that all patients with HIV-1 be tested for the presence of chronic hepatitis B virus before initiating antiretroviral therapy. EVIPLERA is not approved for the treatment of chronic HBV infection and the safety and efficacy have not been established in patients co infected with HBV and HIV-1.
    New Onset or Worsening Renal Impairment: Renal impairment, including cases of acute renal failure and Fanconi syndrome (renal tubular injury with severe hypophosphatemia), has been reported with the use of tenofovir DF. It is recommended that creatinine clearance be calculated in all patients prior to initiating therapy and as clinically appropriate during therapy. Since this product is a combination product and the dose of the individual components cannot be altered, patients with creatinine clearance below 50 mL per minute should not receive this product.
    Depressive Disorders: The adverse reaction depressive disorders (depressed mood, depression, dysphoria, major depression, mood altered, negative thoughts, suicide attempt, suicidal ideation) has been reported with rilpivirine.
    Decreases in Bone Mineral Density: Bone mineral density (BMD) monitoring should be considered for HIV-1 infected patients who have a history of pathologic bone fracture or other risk factors for osteoporosis or bone loss.
    Coadministration with Other Products: EVIPLERA should not be administered concurrently with other medicinal products containing any of the same active components, emtricitabine, rilpivirine, or tenofovir DF, with medicinal products containing lamivudine, or with adefovir dipivoxil.
    Fat Redistribution: Redistribution/accumulation of body fat including central obesity, dorsocervical fat enlargement (buffalo hump), peripheral wasting, facial wasting, breast enlargement, and “cushingoid appearance” have been observed in patients receiving antiretroviral therapy.
    Immune Reconstitution Syndrome: Immune reconstitution syndrome has been reported in patients treated with combination antiretroviral therapy, including the components of this product. Autoimmune disorders (such as Graves’ disease, polymyositis, and Guillain-Barré syndrome) have also been reported to occur in the setting of immune reconstitution, however, the time to onset is more variable, and can occur many months after initiation of treatment.
    Osteonecrosis: Although the aetiology is considered to be multifactorial (including corticosteroid use, alcohol consumption, severe immunosuppression, higher body mass index), cases of osteonecrosis have been reported particularly in patients with advanced HIV disease and/or long-term exposure to CART.
    Mitochondrial dysfunction: Nucleoside and nucleotide analogues have been demonstrated in vitro and in vivo to cause a variable degree of mitochondrial damage. There have been reports of mitochondrial dysfunction in HIV negative infants exposed in utero and/or postnatally to nucleoside analogues.
    See prescribing information for full details.


    Side Effects

    Nausea, headache, dizziness, insomnia, abnormal dreams, diarrhea.
    For full details see prescribing information.


    Pregnancy and Lactation

    Pregnancy Category B Emtricitabine: The incidence of fetal variations and malformations was not increased in embryofetal toxicity studies performed with emtricitabine in mice at exposures (AUC) approximately 60 times higher and in rabbits at approximately 120-times higher than human exposures at the recommended daily dose.
    Rilpivirine: Studies in animals have shown no evidence of embryonic or fetal toxicity or an effect on reproductive function. In offspring from rat and rabbit dams treated with rilpivirine during pregnancy and lactation, there were no toxicologically significant effects on developmental endpoints. The exposures at the embryo-fetal No Observed Adverse Effects Levels in rats and rabbits were respectively 15 and 70 times higher than the exposure in humans at the recommended dose of 25 mg once daily.
    Tenofovir Disoproxil Fumarate: Reproduction studies have been performed in rats and rabbits at doses up to 14 and 19 times the human dose based on body surface area comparisons and revealed no evidence of impaired fertility or harm to the fetus due to tenofovir. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, This product should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
    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. Emtricitabine: Samples of breast milk obtained from five HIV-1-infected mothers show that emtricitabine is secreted in human milk. Breastfeeding infants whose mothers are being treated with emtricitabine may be at risk for developing viral resistance to emtricitabine. Other emtricitabine-associated risks in infants breastfed by mothers being treated with emtricitabine are unknown.
    Rilpivirine: Studies in lactating rats and their offspring indicate that rilpivirine was present in rat milk. It is not known whether rilpivirine is secreted in human milk.
    Tenofovir Disoproxil Fumarate: Samples of breast milk obtained from five HIV-1-infected mothers in the first post-partum week show that tenofovir is excreted in human milk. The impact of this exposure in breastfed infants is unknown. Because of both the potential for HIV transmission and the potential for serious adverse reactions in nursing infants, mothers should be instructed not to breastfeed if they are receiving this product.


    Overdose

    If overdose occurs the patient must be monitored for evidence of toxicity. Treatment of overdose with this product 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. Emtricitabine: Limited clinical experience is available at doses higher than the therapeutic dose. In one clinical pharmacology study, single doses of emtricitabine 1200 mg were administered to 11 subjects. No severe adverse reactions were reported. The effects of higher doses are not known. Hemodialysis treatment removes approximately 30% of the emtricitabine dose over a 3-hour dialysis period starting within 1.5 hours of emtricitabine dosing (blood flow rate of 400 mL per minute and a dialysate flow rate of 600 mL per minute). It is not known whether emtricitabine can be removed by peritoneal dialysis. Rilpivirine: There is no specific antidote for overdose with rilpivirine. Human experience of overdose with rilpivirine is limited. Since rilpivirine is highly bound to plasma protein, dialysis is unlikely to result in significant removal of rilpivirine. 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. Tenofovir Disoproxil Fumarate: Limited clinical experience at doses higher than the therapeutic dose of VIREAD 300 mg is available. In one study, 600 mg tenofovir DF was administered to 8 subjects orally for 28 days, and no severe adverse reactions were reported. The effects of higher doses are not known. Tenofovir is efficiently removed by hemodialysis with an extraction coefficient of approximately 54%. Following a single 300 mg dose of VIREAD, a four-hour hemodialysis session removed approximately 10% of the administered tenofovir dose.


    Manufacturer
    Janssen Cilag
    Licence holder
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