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Generic Name
Darunavir
Brand Names
Symtuza, Darunavir 600, Prezista
FDA approval date: March 08, 2008
Classification: Protease Inhibitor
Form: Tablet, Suspension
What is Symtuza (Darunavir)?
Darunavir tablets, co-administered with ritonavir , in combination with other antiretroviral agents, is indicated for the treatment of human immunodeficiency virus infection in adult and pediatric patients 3 years of age and older [see Use in Specific Populations.
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Brand Information
Symtuza (Darunavir, Cobicistat, Emtricitabine, and Tenofovir alafenamide)
WARNING: POST TREATMENT ACUTE EXACERBATION OF HEPATITIS B
Severe acute exacerbations of hepatitis B (HBV) have been reported in patients who are coinfected with HIV-1 and HBV and have discontinued products containing emtricitabine and/or tenofovir disoproxil fumarate (TDF), and may occur with discontinuation of SYMTUZA. Closely monitor hepatic function with both clinical and laboratory follow-up for at least several months in patients who are coinfected with HIV-1 and HBV and discontinue SYMTUZA. If appropriate, anti-hepatitis B therapy may be warranted
1INDICATIONS AND USAGE
SYMTUZA is indicated as a complete regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults and pediatric patients weighing at least 40 kg:
- who have no prior antiretroviral treatment history or
- who are virologically suppressed (HIV-1 RNA less than 50 copies per mL) on a stable antiretroviral regimen for at least 6 months and have no known substitutions associated with resistance to darunavir or tenofovir.
2DOSAGE FORMS AND STRENGTHS
Each SYMTUZA tablet contains darunavir ethanolate equivalent to 800 mg of darunavir, 150 mg of cobicistat, 200 mg of emtricitabine (FTC), and tenofovir alafenamide fumarate equivalent to 10 mg of tenofovir alafenamide (TAF). The yellow to yellowish-brown, capsule-shaped, film-coated tablet is debossed with "8121" on one side and "JG" on the other side.
3CONTRAINDICATIONS
Darunavir and cobicistat are both inhibitors of the cytochrome P450 3A (CYP3A) isoform. SYMTUZA 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 SYMTUZA with CYP3A inducers is expected to lower plasma concentrations of darunavir and cobicistat which may lead to loss of efficacy of darunavir and development of resistance. Examples of drugs that are contraindicated for co-administration with SYMTUZA due to the potential for serious and/or life-threatening events or loss of therapeutic effect
- 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:
- Severe acute exacerbations of hepatitis B
- Hepatotoxicity
- Severe skin reactions
- Immune reconstitution syndrome
- New onset or worsening renal impairment
- Lactic acidosis/severe hepatomegaly with steatosis
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 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 SYMTUZA is limited. There is no specific antidote for overdose with SYMTUZA. Treatment of overdose with SYMTUZA consists of general supportive measures including monitoring of vital signs and observation of the clinical status of the patient.
Since darunavir and cobicistat are highly bound to plasma proteins, it is unlikely that they will be significantly removed by hemodialysis or peritoneal dialysis. 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/min and a dialysate flow rate of 600 mL/min). Tenofovir is efficiently removed by hemodialysis with an extraction coefficient of approximately 54%. It is not known whether emtricitabine or tenofovir can be removed by peritoneal dialysis.
6DESCRIPTION
SYMTUZA
- Darunavir is an inhibitor of the HIV-1 protease.
- Cobicistat is a mechanism-based inhibitor of cytochrome P450 (CYP) enzymes of the CYP3A family.
- Emtricitabine, a synthetic nucleoside analog of cytidine, is an HIV nucleoside analog reverse transcriptase inhibitor (HIV NRTI).
- Tenofovir alafenamide, an HIV NRTI, is converted
SYMTUZA tablets are for oral administration. Each tablet contains darunavir ethanolate equivalent to 800 mg of darunavir, 150 mg of cobicistat, 200 mg of emtricitabine, and 11.2 mg of tenofovir alafenamide fumarate equivalent to 10 mg of tenofovir alafenamide. The tablets include the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, and microcrystalline cellulose. The tablets are film-coated with a coating material containing polyethylene glycol (macrogol), polyvinyl alcohol (partially hydrolyzed), talc, titanium dioxide, and yellow ferric oxide.
7HOW SUPPLIED/STORAGE AND HANDLING
SYMTUZA
SYMTUZA is packaged in bottles of 30 tablets (NDC 59676-800-30), with a silica gel desiccant and child-resistant closure.
8PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Patient Information).
9PRINCIPAL DISPLAY PANEL - 30 Tablet Bottle Label
NDC 59676-800-30
Symtuza
800 mg / 150 mg /
Each tablet contains darunavir
Rx only
30 Tablets
