Brand name: Symtuza
What is Symtuza, and how does it work?
Symtuza is a prescription medicine that is used without other antiretroviral medicines to treat Human Immunodeficiency Virus-1 (HIV-1) infection in adults and in children who weigh at least 88 pounds (40 kg) who:
- have not received anti-HIV-1 medicines in the past, or
- when their healthcare provider determines that they meet certain requirements.
HIV-1 is the virus that causes Acquired Immune Deficiency Syndrome (AIDS).
Symtuza contains the prescription medicines darunavir, cobicistat, emtricitabine, and tenofovir alafenamide.
It is not known if Symtuza is safe and effective in children weighing less than 88 pounds (40 kg).
What are the side effects of Symtuza?
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.
Symtuza may cause serious side effects, including:
- Changes in your immune system (Immune Reconstitution Syndrome) can happen when you start taking HIV-1 medicines. Your immune system may get stronger and begin to fight infections that have been hidden in your body for a long time. Tell your healthcare provider right away if you start having new symptoms after starting your HIV-1 medicine.
- New or worse kidney problems, including kidney failure. Your healthcare provider should do blood and urine tests to check your kidneys before you start and while you are taking Symtuza. Your healthcare provider may tell you to stop taking Symtuza if you develop new or worse kidney problems.
- Too much lactic acid in your blood (lactic acidosis). Too much lactic acid is a serious but rare medical emergency that can lead to death. Tell your healthcare provider right away if you get these symptoms: weakness or being more tired than usual, unusual muscle pain, being short of breath or fast breathing, stomach pain with nausea and vomiting, cold or blue hands and feet, feel dizzy or lightheaded, or a fast or abnormal heartbeat.
- Diabetes and high blood sugar (hyperglycemia). Some people who take protease inhibitors including Symtuza can get high blood sugar, develop diabetes, or your diabetes can get worse. Tell your healthcare provider if you notice an increase in thirst or if you start urinating more often while taking Symtuza.
- Changes in body fat can happen in people who take HIV-1 medicines. The changes may include an increased amount of fat in the upper back and neck (“buffalo hump”), breast, and around the middle of your body (trunk). Loss of fat from the legs, arms, and face may also happen. The exact cause and long-term health effects of these conditions are not known.
- Increased bleeding for hemophiliacs. Some people with hemophilia have increased bleeding with protease inhibitors.
The most common side effects of Symtuza, include:
These are not all of the possible side effects of Symtuza.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800FDA-1088.
What is the dosage for Symtuza?
Testing Prior To Initiation Of Symtuza
Prior to or when initiating Symtuza, test patients for hepatitis B (HBV) virus infection.
Prior to or when initiating Symtuza, and during treatment with Symtuza, on a clinically appropriate schedule, assess serum creatinine, estimated creatinine clearance, urine glucose, and urine protein in all patients. In patients with chronic kidney disease, also assess serum phosphorus.
Symtuza is a four-drug fixed dose combination product containing 800 mg of darunavir (DRV), 150 mg of cobicistat (COBI), 200 mg of emtricitabine (FTC), and 10 mg of tenofovir alafenamide (TAF). The recommended dosage of Symtuza is one tablet taken orally once daily with food in adults and pediatric patients weighing at least 40 kg. For patients who are unable to swallow the whole tablet, Symtuza may be split into two pieces using a tablet-cutter, and the entire dose should be consumed immediately after splitting.
Not Recommended In Patients With Severe Renal Impairment
- Symtuza is not recommended in patients with creatinine clearance below 30 mL per minute.
Not Recommended In Patients With Severe Hepatic Impairment
- Symtuza is not recommended for use in patients with severe hepatic impairment (Child-Pugh Class C).
Not Recommended During Pregnancy
- Symtuza is not recommended during pregnancy because of substantially lower exposures of darunavir and cobicistat during the second and third trimesters.
- Symtuza should not be initiated in pregnant individuals. An alternative regimen is recommended for those who become pregnant during therapy with Symtuza.
What drugs interact with Symtuza?
Not Recommended With Other Antiretroviral Medications
- Symtuza is a complete regimen for HIV-1 infection and co-administration with other antiretroviral medications for the treatment of HIV-1 infection is not recommended. For this reason, information regarding potential drug-drug interactions with other antiretroviral medications is not provided.
Potential For Symtuza To Affect Other Drugs
- Darunavir co-administered with cobicistat is an inhibitor of CYP3A and CYP2D6.
- Cobicistat inhibits the following transporters: P-glycoprotein (P-gp), BCRP, MATE1, OATP1B1 and OATP1B3. Therefore, co-administration of Symtuza with drugs that are primarily metabolized by CYP3A and/or CYP2D6, or are substrates of P-gp, BCRP, MATE1, OATP1B1 or OATP1B3 may result in increased plasma concentrations of such drugs, which could increase or prolong their therapeutic effect and can be associated with adverse events.
- Co-administration of Symtuza with drugs that have active metabolite(s) formed by CYP3A may result in reduced plasma concentrations of these active metabolite(s), potentially leading to loss of their therapeutic effect (see Table 4).
Potential For Other Drugs To Affect Symtuza
- Darunavir is metabolized by CYP3A. Cobicistat is metabolized by CYP3A and, to a minor extent, by CYP2D6.
- Co-administration of drugs that induce CYP3A activity are expected to increase the clearance of darunavir and cobicistat, resulting in lowered plasma concentrations which may lead to loss of therapeutic effect and development of resistance.
- Co-administration of Symtuza with other drugs that inhibit CYP3A may result in increased plasma concentrations of darunavir and cobicistat (see Table 4).
- Tenofovir alafenamide (TAF) is a substrate of P-gp, BCRP, OATP1B1, and OATP1B3. Drugs that strongly affect P-gp activity may lead to changes in TAF absorption.
- Drugs that induce P-gp activity are expected to decrease the absorption of TAF, resulting in decreased plasma concentrations of TAF, which may lead to loss of therapeutic effect of Symtuza and development of resistance.
- Co-administration of Symtuza with other drugs that inhibit P-gp may increase the absorption and plasma concentrations of TAF (see Table 4).
Drugs Affecting Renal Function
- Because emtricitabine and tenofovir are primarily excreted by the kidneys through glomerular filtration and active tubular secretion, co-administration of Symtuza with drugs that reduce renal function orcompete foractive tubularsecretion may increaseconcentrations ofemtricitabine, tenofovir, and other renally eliminated drugs and this may increase the risk of adverse reactions.
- Some examples of drugs that are eliminated by active tubular secretion include, but are not limited to, acyclovir, cidofovir, ganciclovir, valacyclovir, valganciclovir, aminoglycosides (e.g., gentamicin), and high-dose or multiple NSAIDs.
Significant Drug Interactions
- Table 4 provides a listing of established or potentially clinically significant drug interactions with Symtuza and recommended steps to prevent or manage these interactions.
- These recommendations are based on drug interaction trials conducted with the components of Symtuza, as individual agents or in combination, or are predicted interactions.
- No drug interaction trials have been performed with Symtuza or with all the components administered together.
- Drug interaction trials have been conducted with darunavir co-administered with ritonavir or cobicistat or with emtricitabine and tenofovir prodrugs. The table includes potentially significant interactions but is not all inclusive.
Table 4: Significant Drug Interactions
|Concomitant Drug Class: Drug Name||Effect on Concentration||Clinical Comment|
|Alpha 1 -adrenoreceptor antagonist: Alfuzosin||↑alfuzosin||Co-administration is contraindicated due to potential for serious and/or life-threatening reactions such as hypotension.|
|Antibacterials: clarithromycin, erythromycin, telithromycin||↑ darunavir|
|Consider alternative antibiotics with concomitant use of Symtuza.|
|Anticancer agents: dasatinib, nilotinibvinblastine, vincristine||↑ anticancer agent||A decreas e in the dosage or an adjustment of the dosing interval of dasatinib or nilotinib may be necessary when co-administered with Symtuza. Consult the dasatinib and nilotinib prescribing information for dosing instructions.|
|For vincristine and vinblastine, consider temporarily withholding the cobicistat-containing antiretroviral regimen in patients who develop significant hematologic or gastrointestinal side effects when Symtuza is administered concurrently with vincristine or vinblastine. If the antiretroviral regimen must be withheld for a prolonged period, consider initiating a revis ed regimen that does not include a CYP3A or P-gp inhibitor.|
|Anticoagulants: Direct Oral Anticoagulants (DOACs) apixaban||↑apixaban||Due to potentially increased bleeding risk, dosing recommendations for co-administration of apixaban with Symtuza depends on the apixaban dose. Refer to apixaban dosing instructions for co-administration with strong CYP3A and P-gp inhibitors in apixaban prescribing information.|
|rivaroxaban||↑ rivaroxaban||Co-administration ofrivaroxaban with Symtuza is not recommended because it may lead to an increased bleeding risk.|
|No dose adjustment is needed when betrixaban, dabigatran, or edoxaban is co-administered with Symtuza.|
|Other Anticoagulants Warfarin||warfarin: effect unknown||Monitor international normalized ratio (INR) upon co-administration of Symtuza with warfarin.|
|Anticonvulsants: carbamazepine, phenobarbital, phenytoin||↓ cobicistat|
|Co-administration is contraindicated due to potential for loss of therapeutic effect and development ofresistance.|
|Anticonvulsants with CYP3A induction effects that are NOT contraindicated: e.g., eslicarbazepine, oxcarbazepine||↓ cobicistat|
↓ tenofovir alafenamide darunavir: effect unknown
|Cons ider alternative anticonvuls ant or antiretroviral therapy to avoid potential changes in exposures. If co-administration is necessary, monitor for lack or loss ofviro logic response.|
|Anticonvulsants that are metabolized by CYP3A: e.g., clonazepam||↑ clonazepam||Clinical monitoring of anticonvulsants is recommended.|
|Antidepressants: Selective Serotonin Reuptake Inhibitors (SSRIs): e.g., paroxetine, sertraline Tricyclic||SSRIs: effects unknown||When co-administering with SSRIs, TCAs, or trazodone, careful do se titration of the antidepressant to the desired effect, including using the lowest feasible initial or maintenance dose, and monitoring for antidepressant response are recommended.|
|Antidepressants (TCAs): e.g., amitriptyline, desipramine, imipramine, nortriptyline||↑ TCAs|
|Other antidepressants: Trazodone||↑trazodone|
|Antifungals: itraconazole, isavuconazole, ketoconazole, posaconazole|
↔posaconazole (not studied) voriconazole: effects unknown
|Monitor for increased darunavir or cobicistat and/or antifungal adverse reactions.|
Specific dosing recommendations are not available for co-administration with these antifungals. Monitor for increased itraconazole or ketoconazole adverse reactions.
Co-administration with voriconazole is not recommended unless benefit/risk as sessment justifies the use of voriconazole.
|Anti-gout: Colchicine||↑colchicine||Co-administration is contraindicated in patients with renal and/or hepatic impairment due to potential for serious and/or life-threatening reactions.|
For patients without renal or hepatic impairment:
|Antimalarial: artemether/lumefantrine||artemether: effect unknown lumefantrine: effect unknown||Monitor for a potential decrease of antimalarial efficacy or potential QT prolongation.|
|Antimycobacterials: Rifampin||↓ cobicistat|
|Co-administration is contraindicated due to potential for loss of therapeutic effect and development ofresistance.|
↓ TAF cobicistat: effects unknown darunavir: effects unknown
|Co-administration of Symtuza with rifabutin is not recommended. Ifthe combination is needed, the recommended dose of rifabutin is 150 mg every other day. Monitor for rifabutin-associated adverse reactions including neutropenia and uveitis.|
|Co-administration with rifapentine is not recommended.|
|Antipsychotics: lurasidone||↑ lurasidone||Co-administration is contraindicated due to potential for serious and/or life-threatening reactions.|
|pimozide||↑ pimozide||Co-administration is contraindicated due to potential for serious and/or life-threatening reactions such as cardiac arrhythmias.|
|e.g., perphenazine, risperidone, thioridazine Quetiapine||↑ antipsychotic|
|A decrease in the dose of antipsychotics that are metabolized by CYP3A or CYP2D6 may be needed when co-administered with
Initiation of Symtuza in patients taking auetiapine: Consider alternative antiretroviral therapy to avoid increases in quetiapine exposure. If co-administration is necessary, reduce the quetiapinedoseto 1/6 ofthe current dose and monitor for quetiapine-associated adverse reactions. Refer to the quetiapineprescribing information for recommendations on adverse reaction monitoring.
Initiation of quetiapine in patients taking Symtuza: Refer to the quetiapineprescribing information for initial dosing and titration of quetiapine.
|β-Blockers: e.g., carvedilol, metoprolol, timolol||↑beta-blockers||Clinical monitoring is recommended for coadministration with beta-blockers that are metabolized by CYP2D6.|
|Calcium channel blockers: e.g., amlodipine, diltiazem, felodipine, nifedipine, verapamil||↑ calcium channel blockers||Clinical monitoring is recommended for coadministration with calciumchannel blockers metabolized by CYP3A.|
|Cardiac Disorders: ranolazine, ivabradine dronedarone Other antiarrhy thmics e.g., amiodarone, disopyramide, flecainide, lidocaine (systemic), mexiletine, propafenone, quinidine Digoxin||↑ ranolazine|
|Co-administration is contraindicated due to potential for serious and/or life-threatening reactions.|
Co-administration is contraindicated due to potential for serious and/or life-threatening reactions such as cardiac arrhythmias
Clinical monitoring is recommended upon coadministration with antiarrhythmics. When co-administering with digoxin, titrate the digoxin dose and monitor digoxin concentrations.
|Systemic/Inhaled/ Nasal/Ophthalmic Corticosteroids: e.g., betamethasone|
|Co-administration with systemic dexamethasone or other sy stemic corticosteroids that induce CYP3 A may result in loss oftherapeutic effect and development ofresistance to
Symtuza. Consider alternative corticosteroids.|
Co-administration with corticosteroids of which exposures are significantly increased by strong CYP3A inhibitors can increase the risk for Cushing’s syndrome and adrenal suppression. Alternative corticosteroids including beclomethasone, prednisone, and prednisolone (for which PK and/or PD are less affected by strong CYP3A inhibitors relative to other steroids) should be considered, particularly for long termuse.
|Endothelin receptor antagonists: Bosentan||↓ darunavir|
|Initiation ofbosentan in patients taking
Symtuza: In patients who have been receiving Symtuza for at least 10 days, start bosentan at 62.5mg once daily or every other day based upon individual tolerability.|
Initiation of Symtuza in patients on bosentan: Discontinue use ofbosentan at least 36 hours prior to initiation of Symtuza. After at least 10 days following the initiation of Symtuza, resume bosentan at 62.5 mg once daily or every other day based upon individual tolerability.
Switching from darunavir co-administered with ritonavir to Symtuza in patients on bosentan: Maintain bosentan dose.
|Ergot derivatives: e.g., dihydroergotamine, ergotamine, methylergonovine||↑ergot derivatives||Co-administration is contraindicated due to potential for serious and/or life-threatening reactions such as acute ergot toxicity characterized by peripheral vasospasm and ischemia of the extremities and other tissues.|
|GI motility agent: Cisapride||↑ cisapride||Co-administration is contraindicated due to potential for serious and/or life-threatening reactions such as cardiac arrhythmias.|
|Hepatitis C virus (HCV): Direct-Acting Antivirals: elbasvir/grazoprevir glecaprevir/pibrentasvir||↑ elbasvir/grazoprevir|
|Co-administration is contraindicated due to potential for the increased risk of alanine transaminase (ALT) elevations.|
Co-administration of SYTMUZA with glecaprevir/pibrentasvir is not recommended.
|Herbal product: St. John’s wort (Hypericum perforatum)||↓ cobicistat|
|Co-administration is contraindicated due to potential for loss of therapeutic effect and development ofresistance.|
|Hormonal contraceptives: drosp erinone/ethinyle stradiol other progestin/estrogen contraceptives||↑ drosperinone|
↓ ethinylestradiol progestin: effects unknown
|Additional or alternative (non-hormonal) forms of contraception should be considered when estrogen based contraceptives are co-administered with Symtuza. For co-administration with drospirenone, clinical monitoring is recommended due to the potential for hyperkalemia.|
|estrogen: effects unknown||No data are available to make recommendations on co-administration with oral or other hormonal contraceptives.|
|Immunos uppressants: cyclosporine, sirolimus, tacrolimus|
Immunosuppressant /neoplastic: everolimus irinotecan
|↑ immunosuppressants||These immunosuppressant agents are metabolized by CYP3A. Therapeutic drug monitoring is recommended with concomitant use.|
Co-administration of everolimus and Symtuza is not recommended.
Discontinue Symtuza at least 1 week prior to starting irinotecan therapy. Do not administer Symtuza with irinotecan unless there are no therapeutic alternatives.
|Inhaled beta agonist: salmeterol||↑salmeterol||Co-administration with salmeterol is not recommended and may result in increased risk of cardiovascular adverse events associated with salmeterol, including QT prolongation, palpitations, and sinus tachycardia.|
|Lipid modifying agents: HMG-CoA reductase inhibitors: lovastatin, simvastatin e.g., atorvastatin, fluvastatin, pitavastatin, pravastatin, rosuvastatin Other lipid modifying agents: lomitapide||↑ lovastatin|
pitavastatin: effect unknown
|Co-administration is contraindicated due to potential for serious reactions such as myopathy including rhabdomyoly sis.|
For atorvastatin, fluvastatin, pitavastatin, pravastatin, and rosuvastatin, start with the lowest recommended dose and titrate while monitoring for safety.
Dosage recommendations with atorvastatin or rosuvastatin are as follows:
|Narcotic analgesics metabolized by CYP3A: e.g., fentanyl, oxycodone|
|Careful monitoring of therapeutic effects and adverse reactions associated with CYP3A-metabolized narcotic analgesics (including potentially fatal respiratory depression) is recommended with co-administration.|
A dose decrease may be needed for tramadol with concomitant use.
|Narcotic analgesic for treatment of opioid dependence: buprenorphine, buprenorphine/naloxone, methadone||buprenorphine or buprenorphine/ naloxone: effects unknown methadone: effects unknown||Initiation ofbuprenorphine, buprenorphine/naloxone or methadone in patients taking
Symtuza: Carefully titrate the dose of buprenorphine, buprenorphine/naloxone or methadone to the desired effect; use the lowest feasible initial or maintenance dose.|
Initiation of Symtuza in patients taking buprenorphine, buprenorphine/naloxone, or methadone: A dose adjustment for buprenorphine, buprenorphine/naloxone, or methadone may be needed. Monitor clinical signs and symptoms.
|Opioid Antagonist naloxegol||↑naloxegol||Co administration of Symtuza and naloxegol is contraindicated due to potential for precipitating opioid withdrawal symptoms.|
|Phosphodiesterase PDE-5 inhibitors: e.g., avanafil, sildenafil, tadalafil, vardenafil||↑PDE-5 inhibitors||Co-administration with avanafil is not recommended because a safe and effective avanafil dosage regimen has not been established.|
Co-administration with PDE-5 inhibitors may result in an increase in PDE-5 inhibitor-associated adverse reactions including hypotension, syncope, visual disturbances, and priapism.
Use of PDE-5 inhibitors for pulmonary arterial hypertension (PAH): Co-administration with sildenafil used for PAH is contraindicated due to potential for sildenafil associated adverse reactions (which include visual disturbances, hypotension, prolonged erection, and syncope). The following dose adjustments are recommended for use of tadalafil with Symtuza:
|Platelet aggregation inhibitor:|
↓ clopidogrel active metabolite
↔ prasugrel active metabolite
Symtuza and ticagrelor is not recommended.|
Co-administration of Symtuza and clopidogrel is not recommended due to potential reduction of the antiplatelet activity of clopidogrel.
No dose adjustment is needed when prasugrel is coadministered with Symtuza.
|Sedatives/hypnotics: orally administered midazolam, triazolam|
metabolized by CYP3A: e.g., buspirone, diazepam, estazolam, zolpidem parenterally administered midazolam
|Co-administration is contraindicated due to potential for serious and/or life-threatening reactions such as prolonged or increased sedation or respiratory depression.|
With concomitant use, titration is recommended with sedatives/hypnotics metabolized by CYP3A and a lower dose of the sedatives/hypnotics should be considered with monitoring for increased and prolonged effects or adverse reactions.
Co-administration of parenteral midazolam should be done in a setting that ensures close clinical monitoring and appropriate medical management in case of respiratory depression and/or prolonged sedation. Dose reduction for parenteral midazolam should be considered, especially ifmo re than a single dose ofmidazolamis administered.
|Urinary antispasmodics fesoterodine|
|When fesoterodine is co-administered with
Symtuza, do not exceed a fesoterodine dose of 4 mg once daily.|
When solifenacin is co-administered with Symtuza, do not exceed a solifenacin dose of 5 mg once daily.
|This table is not all inclusive|
↑ = increase, ↓ = decrease, ↔ = no effect
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Is Symtuza safe to use while pregnant or breastfeeding?
- There are insufficient human data on the use of Symtuza in pregnant individuals from the APR to inform on a potential drug-associated risk of birth defects and miscarriage.
- Symtuza is not recommended for use during pregnancy because of substantially lower exposures of darunavir and cobicistat during pregnancy.
- The Centers for Disease Control and Prevention recommend that HIV-infected mothers in the United States must not breastfeed their infants to avoid risking postnatal transmission of HIV-1 infection.
- Based on published data, emtricitabine has been shown to be present in human breast milk.
- There are no data on the presence of darunavir, cobicistat, or TAF in human milk, the effects on the breastfed infant, or the effects on milk production.
Symtuza is a prescription medicine that is used without other antiretroviral medicines to treat Human Immunodeficiency Virus-1 (HIV-1) infection in adults and in children. Serious side effects of Symtuza include severe acute exacerbations of hepatitis B (HBV), changes in your immune system (Immune Reconstitution Syndrome), new or worse kidney problems (including kidney failure), too much lactic acid in your blood (lactic acidosis), changes in body fat can happen in people who take HIV-1 medicines, diabetes and high blood sugar (hyperglycemia), and increased bleeding for hemophiliacs.
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