• PREZCOBIX® (darunavir 800 mg/cobicistat 150 mg)

    PREZCOBIX® is indicated in combination with other antiretroviral agents for the treatment of Human Immunodeficiency Virus (HIV-1) infection in treatment-naïve and treatment-experienced adults and pediatric patients weighing at least 40 kg with no darunavir resistance-associated substitutions (V11I, V32I, L33F, I47V, I50V, I54L, I54M, T74P, L76V, I84V, L89V).

    Contraindications

    • Darunavir and cobicistat are both inhibitors and substrates of the cytochrome P450 3A (CYP3A) isoform. PREZCOBIX® should not be co-administered with medicinal products that are highly dependent on CYP3A for clearance and for which increased plasma concentrations are associated with serious and/or life-threatening events (narrow therapeutic index). In addition, co-administration of PREZCOBIX® with CYP3A inducers may lead to lower exposures of darunavir and cobicistat, and potential loss of efficacy of darunavir and possible resistance.

      Examples of drugs that are contraindicated for co-administration with PREZCOBIX® are: alfuzosin, carbamazepine, colchicine (in patients with renal and/or hepatic impairment), dihydroergotamine, dronedarone, elbasvir/grazoprevir, ergotamine, ivabradine, lomitapide, lovastatin, lurasidone, methylergonovine, oral midazolam, naloxegol, phenobarbital, phenytoin, pimozide, ranolazine, rifampin, St. John’s wort (Hypericum perforatum), sildenafil for pulmonary arterial hypertension, simvastatin, and triazolam.

    Warnings and Precautions

    • Hepatotoxicity: Patients with pre-existing liver dysfunction, including chronic active hepatitis B or C, have an increased risk for liver function abnormalities, including severe hepatic adverse reactions. Drug-induced hepatitis and cases of liver injury, including some fatalities, have been reported.

      Appropriate laboratory testing should be conducted prior to initiating and during therapy with PREZCOBIX®. Evidence of new or worsening liver dysfunction in patients on PREZCOBIX® should prompt consideration of interruption or discontinuation of treatment.

    • Severe Skin Reactions: Severe skin reactions including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug rash with eosinophilia and systemic symptoms, and acute generalized exanthematous pustulosis have been reported in patients receiving darunavir coadministered with ritonavir. Mild-to-moderate rash was also reported and often occurred and resolved with continued dosing. Discontinue PREZCOBIX® immediately if signs or symptoms of severe skin reaction develop.

    • Sulfa Allergy: Monitor patients with a known sulfonamide allergy after initiating PREZCOBIX®.

    • Effects on Serum Creatinine: Cobicistat decreases estimated creatinine clearance (CrCl) due to inhibition of tubular secretion of creatinine without affecting actual renal glomerular function. Prior to starting PREZCOBIX®, assess estimated CrCl. Patients who experience a confirmed increase in serum creatinine of greater than 0.4 mg/dL from baseline should be closely monitored for renal safety. Consider alternative medications that do not require dosage adjustments in patients with renal impairment.

    • Renal Impairment When Used With Tenofovir Disoproxil Fumarate (DF): Renal impairment, including cases of acute renal failure and Fanconi syndrome, has been reported with the use of tenofovir DF and cobicistat. Coadministration with tenofovir DF is not recommended in patients who have an estimated CrCl <70 mL/min. In all patients, monitor estimated CrCl, urine glucose, and urine protein prior to initiating and during therapy. Measure serum phosphorus in patients at risk of renal impairment. Coadministration of PREZCOBIX® and tenofovir DF in combination with concomitant or recent use of a nephrotoxic agent is not recommended.

    • Risk of Serious Adverse Reactions or Loss of Virologic Response Due to Drug Interactions: Initiation of PREZCOBIX®, which inhibits CYP3A, in patients receiving medications metabolized by CYP3A or initiation of medications metabolized by CYP3A in patients already receiving PREZCOBIX® may increase plasma concentrations of medications metabolized by CYP3A and reduce plasma concentrations of active metabolite(s) formed by CYP3A. Initiation of medications that inhibit or induce CYP3A may respectively increase or decrease concentrations of PREZCOBIX®. These interactions may lead to clinically significant adverse reactions, potentially leading to severe, life-threatening, or fatal events from higher exposures of concomitant medications; clinically significant adverse reactions from higher exposures of PREZCOBIX®; loss of therapeutic effect of concomitant medications from lower exposures of active metabolite(s); or loss of therapeutic effect of PREZCOBIX® and possible development of resistance from lower exposures of PREZCOBIX®.

    • Antiretrovirals Not Recommended: Do not use PREZCOBIX® in combination with other antiretroviral drugs that require pharmacokinetic boosting or which contain the individual components of PREZCOBIX® (darunavir and cobicistat) or with ritonavir.

    • Diabetes Mellitus/Hyperglycemia and Hemophilia: New onset or exacerbation of pre-existing diabetes mellitus and hyperglycemia have been reported in patients receiving protease inhibitors. Initiation or dose adjustments of insulin or oral hypoglycemic agents may be required. Increased bleeding in hemophiliacs has been reported in patients receiving protease inhibitors.

    • Fat Redistribution: Redistribution and/or accumulation of body fat have been observed in patients receiving antiretroviral therapy.

    • Immune Reconstitution Syndrome including the occurrence of autoimmune disorders with variable time to onset has been reported.

    Adverse Reactions

    • The most common clinical adverse reactions (incidence ≥5%) of at least moderate intensity (≥Grade 2) were diarrhea, nausea, rash, headache, abdominal pain, and vomiting during the darunavir clinical development program, where darunavir was coadministered with ritonavir.

    This is not a complete list of all adverse drug reactions reported with the use of PREZCOBIX®. Please refer to the full Prescribing Information for a complete list of adverse drug reactions.

    Drug Interactions

    • Consult the full Prescribing Information for PREZCOBIX® for information on potentially significant drug interactions, including clinical comments.

    Use in Specific Populations

    • PREZCOBIX® is not recommended for use during pregnancy because of substantially lower exposures of darunavir and cobicistat during pregnancy.
    • PREZCOBIX® should not be initiated in pregnant individuals. An alternative regimen is recommended for those who become pregnant during therapy with PREZCOBIX®.

      Lactation: The Centers for Disease Control and Prevention recommends that HIV-infected mothers in the United States not breastfeed their infants to avoid risking postnatal transmission of HIV-1 infection.

    • The safety and effectiveness of PREZCOBIX® have not been established and is not recommended in pediatric patients weighing less than 40 kg.

    • Consult the full Prescribing Information for PREZCOBIX® for additional information on the Uses in Specific Populations.

    Please see full Prescribing Information for more details.

    cp-08641v12

    INDICATION
Click on the left to see the Important Safety Information

INDICATIONS

IMPORTANT SAFETY INFORMATION

  • https://www.janssenlabels.com/package-insert/product-monograph/prescribing-information/PREZCOBIX-pi.pdf

Prior Authorizations, Exceptions & Appeals

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Prior Authorizations, Exceptions & Appeals

In certain states, a standardized Prior Authorization (PA) form may be required for submission to a health plan along with clinical documentation. These standard forms can be used across payers.

  • Most standardized PA forms are only for prescription drugs, but some states allow them for other medical services.
  • Standardized PA forms may not be used by self-funded employer-sponsored health plans, Medicare Part D plans, and Medicaid fee-for-service plans.

An exception is a request made to a patient's insurance company. It asks them to release a restriction they have placed on the healthcare provider's recommended treatment. Restrictions can include medication not in the formulary, step therapy, quantity limit, or high tier. Usually, a healthcare provider is required to send a statement explaining the medical reason for the exception.

You can request information on the exceptions process for your patient by calling Janssen CarePath.

Appeals are actions taken by the patient or their healthcare provider. An appeal is used to challenge when the insurance company refuses to cover the patient's recommended treatment, or the level of coverage does not meet the patient’s expectations. The goal is to overturn the decision.

Additional information on the PA process at major payers is shown below. Within the Provider Portal, we can give you payer-specific PA forms to complete online. You can also contact Janssen CarePath at 877-CarePath (877-227-3728) for assistance in obtaining PA forms. Please see below for more details. [1]

Click on the payer links to be taken to the payer's website.

R8

[1] Collected in 11/21 and may change.

This information does not give advice or promise coverage or payment. Legal requirements and plan information can be updated frequently. Contact the plan for more information about current coverage, restrictions, or requirements that may apply.

Important Safety Information For

  • PREZCOBIX®

    PREZCOBIX® is indicated in combination with other antiretroviral agents for the treatment of Human Immunodeficiency Virus (HIV-1) infection in treatment-naïve and treatment-experienced adults and pediatric patients weighing at least 40 kg with no darunavir resistance-associated substitutions (V11I, V32I, L33F, I47V, I50V, I54L, I54M, T74P, L76V, I84V, L89V).

    Contraindications

    • Darunavir and cobicistat are both inhibitors and substrates of the cytochrome P450 3A (CYP3A) isoform. PREZCOBIX® should not be co-administered with medicinal products that are highly dependent on CYP3A for clearance and for which increased plasma concentrations are associated with serious and/or life-threatening events (narrow therapeutic index). In addition, co-administration of PREZCOBIX® with CYP3A inducers may lead to lower exposures of darunavir and cobicistat, and potential loss of efficacy of darunavir and possible resistance.

      Examples of drugs that are contraindicated for co-administration with PREZCOBIX® are: alfuzosin, carbamazepine, colchicine (in patients with renal and/or hepatic impairment), dihydroergotamine, dronedarone, elbasvir/grazoprevir, ergotamine, ivabradine, lomitapide, lovastatin, lurasidone, methylergonovine, oral midazolam, naloxegol, phenobarbital, phenytoin, pimozide, ranolazine, rifampin, St. John’s wort (Hypericum perforatum), sildenafil for pulmonary arterial hypertension, simvastatin, and triazolam.

    Warnings and Precautions

    • Hepatotoxicity: Patients with pre-existing liver dysfunction, including chronic active hepatitis B or C, have an increased risk for liver function abnormalities, including severe hepatic adverse reactions. Drug-induced hepatitis and cases of liver injury, including some fatalities, have been reported.

      Appropriate laboratory testing should be conducted prior to initiating and during therapy with PREZCOBIX®. Evidence of new or worsening liver dysfunction in patients on PREZCOBIX® should prompt consideration of interruption or discontinuation of treatment.

    • Severe Skin Reactions: Severe skin reactions including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug rash with eosinophilia and systemic symptoms, and acute generalized exanthematous pustulosis have been reported in patients receiving darunavir coadministered with ritonavir. Mild-to-moderate rash was also reported and often occurred and resolved with continued dosing. Discontinue PREZCOBIX® immediately if signs or symptoms of severe skin reaction develop.

    • Sulfa Allergy: Monitor patients with a known sulfonamide allergy after initiating PREZCOBIX®.

    • Effects on Serum Creatinine: Cobicistat decreases estimated creatinine clearance (CrCl) due to inhibition of tubular secretion of creatinine without affecting actual renal glomerular function. Prior to starting PREZCOBIX®, assess estimated CrCl. Patients who experience a confirmed increase in serum creatinine of greater than 0.4 mg/dL from baseline should be closely monitored for renal safety. Consider alternative medications that do not require dosage adjustments in patients with renal impairment.

    • Renal Impairment When Used With Tenofovir Disoproxil Fumarate (DF): Renal impairment, including cases of acute renal failure and Fanconi syndrome, has been reported with the use of tenofovir DF and cobicistat. Coadministration with tenofovir DF is not recommended in patients who have an estimated CrCl <70 mL/min. In all patients, monitor estimated CrCl, urine glucose, and urine protein prior to initiating and during therapy. Measure serum phosphorus in patients at risk of renal impairment. Coadministration of PREZCOBIX® and tenofovir DF in combination with concomitant or recent use of a nephrotoxic agent is not recommended.

    • Risk of Serious Adverse Reactions or Loss of Virologic Response Due to Drug Interactions: Initiation of PREZCOBIX®, which inhibits CYP3A, in patients receiving medications metabolized by CYP3A or initiation of medications metabolized by CYP3A in patients already receiving PREZCOBIX® may increase plasma concentrations of medications metabolized by CYP3A and reduce plasma concentrations of active metabolite(s) formed by CYP3A. Initiation of medications that inhibit or induce CYP3A may respectively increase or decrease concentrations of PREZCOBIX®. These interactions may lead to clinically significant adverse reactions, potentially leading to severe, life-threatening, or fatal events from higher exposures of concomitant medications; clinically significant adverse reactions from higher exposures of PREZCOBIX®; loss of therapeutic effect of concomitant medications from lower exposures of active metabolite(s); or loss of therapeutic effect of PREZCOBIX® and possible development of resistance from lower exposures of PREZCOBIX®.

    • Antiretrovirals Not Recommended: Do not use PREZCOBIX® in combination with other antiretroviral drugs that require pharmacokinetic boosting or which contain the individual components of PREZCOBIX® (darunavir and cobicistat) or with ritonavir.

    • Diabetes Mellitus/Hyperglycemia and Hemophilia: New onset or exacerbation of pre-existing diabetes mellitus and hyperglycemia have been reported in patients receiving protease inhibitors. Initiation or dose adjustments of insulin or oral hypoglycemic agents may be required. Increased bleeding in hemophiliacs has been reported in patients receiving protease inhibitors.

    • Fat Redistribution: Redistribution and/or accumulation of body fat have been observed in patients receiving antiretroviral therapy.

    • Immune Reconstitution Syndrome including the occurrence of autoimmune disorders with variable time to onset has been reported.

    Adverse Reactions

    • The most common clinical adverse reactions (incidence ≥5%) of at least moderate intensity (≥Grade 2) were diarrhea, nausea, rash, headache, abdominal pain, and vomiting during the darunavir clinical development program, where darunavir was coadministered with ritonavir.

    This is not a complete list of all adverse drug reactions reported with the use of PREZCOBIX®. Please refer to the full Prescribing Information for a complete list of adverse drug reactions.

    Drug Interactions

    • Consult the full Prescribing Information for PREZCOBIX® for information on potentially significant drug interactions, including clinical comments.

    Use in Specific Populations

    • PREZCOBIX® is not recommended for use during pregnancy because of substantially lower exposures of darunavir and cobicistat during pregnancy.
    • PREZCOBIX® should not be initiated in pregnant individuals. An alternative regimen is recommended for those who become pregnant during therapy with PREZCOBIX®.

      Lactation: The Centers for Disease Control and Prevention recommends that HIV-infected mothers in the United States not breastfeed their infants to avoid risking postnatal transmission of HIV-1 infection.

    • The safety and effectiveness of PREZCOBIX® have not been established and is not recommended in pediatric patients weighing less than 40 kg.

    • Consult the full Prescribing Information for PREZCOBIX® for additional information on the Uses in Specific Populations.

    Please see full Prescribing Information for more details.

    cp-08641v12

    INDICATION

IMPORTANT SAFETY INFORMATION

INDICATIONS

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