Generic Name
Tenofovir Alafenamide
Brand Names
Prezcobix, Tybost, Vemlidy
FDA approval date: September 24, 2014
Classification: Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor
Form: Tablet
What is Prezcobix (Tenofovir Alafenamide)?
PREZCOBIX and PREZCOBIX PED are indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus in treatment-naïve and treatment-experienced adults and pediatric patients 3 years of age and older weighing at least 15 kg with no darunavir resistance-associated substitutions [see Use in Specific Populations.
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Brand Information
PREZCOBIX (DARUNAVIR ETHANOLATE and COBICISTAT)
1INDICATIONS AND USAGE
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).
2DOSAGE FORMS AND STRENGTHS
PREZCOBIX is supplied as pink, oval-shaped, film-coated tablets containing darunavir ethanolate equivalent to 800 mg of darunavir and 150 mg cobicistat. Each tablet is debossed with "800" on one side and "TG" on the other side.
3CONTRAINDICATIONS
Darunavir and cobicistat are both inhibitors 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). Darunavir and cobicistat are both substrates of the cytochrome P450 3A (CYP3A) isoform. 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
- Alpha 1-adrenoreceptor antagonist: alfuzosin
- Anticonvulsants: carbamazepine, phenobarbital, phenytoin
- Anti-gout: colchicine, in patients with renal and/or hepatic impairment
- Antimycobacterial: rifampin
- Antipsychotics: lurasidone, pimozide
- Cardiac Disorders: dronedarone, ivabradine, ranolazine
- Ergot derivatives, e.g. dihydroergotamine, ergotamine, methylergonovine
- Herbal product: St. John's wort (
- Hepatitis C direct acting antiviral: elbasvir/grazoprevir
- Lipid modifying agents: lomitapide, lovastatin, simvastatin
- Opioid Antagonist: naloxegol
- PDE-5 inhibitor: sildenafil when used for treatment of pulmonary arterial hypertension
- Sedatives/hypnotics: orally administered midazolam, triazolam
4ADVERSE REACTIONS
The following adverse reactions are discussed in other sections of the labeling:
- Hepatotoxicity
- Severe skin reactions
- Effects on serum creatinine
- New onset or worsening renal impairment when used with tenofovir DF
- Immune Reconstitution Syndrome
4.1Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.
4.2Postmarketing Experience
The following adverse reactions have been identified during post-approval use of darunavir. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
5OVERDOSAGE
Human experience of acute overdose with PREZCOBIX is limited. No specific antidote is available for overdose with PREZCOBIX. Treatment of overdose with PREZCOBIX consists of general supportive measures including monitoring of vital signs and observation of the clinical status of the patient. Since both darunavir and cobicistat are highly protein bound, dialysis is unlikely to be beneficial in significant removal of the active substance.
6DESCRIPTION
PREZCOBIX
PREZCOBIX tablets are for oral administration. Each tablet contains darunavir ethanolate equivalent to 800 mg of darunavir and 150 mg of cobicistat. The tablets include the following inactive ingredients: colloidal silicon dioxide, crospovidone, hypromellose, magnesium stearate, and silicified microcrystalline cellulose. The tablets are film-coated with a coating material containing iron oxide black, iron oxide red, polyethylene glycol, polyvinyl alcohol (partially hydrolyzed), talc, and titanium dioxide.
7HOW SUPPLIED/STORAGE AND HANDLING
Product: 50090-1723
NDC: 50090-1723-0 30 TABLET, FILM COATED in a BOTTLE
8PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Patient Information).
9DARUNAVIR ETHANOLATE and COBICISTAT
