What is Stribild, and how does it work?
- who have not received anti-HIV-1 medicines in the past, or
- to replace their current anti-HIV-1 medicines:
- in people who have been on the same anti-HIV-1 medicine regimen for at least 6 months, and
- who have an amount of HIV-1 in their blood (this is called “viral load”) that is less than 50 copies/mL, and
- have never failed past HIV-1 treatment.
What are the side effects of Stribild?
Stribild may cause the following serious side effects, including:
- 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 Stribild. Your healthcare provider may tell you to stop taking Stribild 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.
- Severe liver problems. In rare cases, severe liver problems can happen that can lead to death. Tell your healthcare provider right away if you get these symptoms: skin or the white part of your eyes turns yellow, dark “tea-colored” urine, light-colored stools, loss of appetite for several days or longer, nausea, or stomach-area pain.
- Bone problems can happen in some people who take Stribild. Bone problems include bone pain, softening, or thinning (which may lead to fractures). Your healthcare provider may need to do tests to check your bones.
- 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 any new symptoms after starting your HIV-1 medicine.
The most common side effects of Stribild include:
These are not all the possible side effects of Stribild.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
POSTTREATMENT ACUTE EXACERBATION OF HEPATITIS B
Stribild is not approved for the treatment of chronic hepatitis B virus (HBV) infection, and the safety and efficacy of Stribild have not been established in patients coinfected with HBV and human immunodeficiency virus-1 (HIV-1).
Severe acute exacerbations of hepatitis B have been reported in patients who are coinfected with HBV and HIV-1 and have discontinued EMTRIVA or VIREAD, which are components of Stribild. Hepatic function should be monitored closely, with both clinical and laboratory follow-up for at least several months in patients who are coinfected with HIV-1 and HBV and discontinue Stribild. If appropriate, initiation of anti-hepatitis B therapy may be warranted.
What is the dosage for Stribild?
Testing Prior To Initiation And During Treatment With Stribild
- Prior to initiation of Stribild, test patients for hepatitis B virus infection.
- Prior to initiation and during use of Stribild, 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.
- Stribild is a four-drug fixed dose combination product containing 150 mg of elvitegravir, 150 mg of cobicistat, 200 mg of emtricitabine, and 300 mg of TDF.
- The recommended dosage of Stribild is one tablet taken orally once daily with food in adults and pediatric patients 12 years of age and older with a body weight at least 35 kg and creatinine clearance greater than or equal to 70 mL per minute.
Dosage Adjustment In Patients With Renal Impairment
- Initiation of Stribild in patients with estimated creatinine clearance below 70 mL per minute is not recommended.
- Because Stribild is a fixeddose combination tablet, Stribild should be discontinued if estimated creatinine clearance declines below 50 mL per minute during treatment with Stribild, as the dose interval adjustment required for emtricitabine and tenofovir disoproxil fumarate (DF) cannot be achieved.
- No data are available to make dose recommendations for pediatric patients with renal impairment.
Not Recommended In Patients With Severe Hepatic Impairment
- Stribild is not recommended for use in patients with severe hepatic impairment.
Not Recommended During Pregnancy
- Stribild is not recommended for use during pregnancy because of substantially lower exposures of cobicistat and elvitegravir during the second and third trimesters.
- Stribild should not be initiated in pregnant individuals.
- An alternative regimen is recommended for individuals who become pregnant during therapy with Stribild.
What drugs interact with Stribild?
Not Recommended With Other Antiretroviral Medications
- Stribild is a complete regimen for the treatment of HIV-1 infection; therefore, Stribild should not be administered with other antiretroviral medications for treatment of HIV-1 infection.
- Complete information regarding potential drug-drug interactions with other antiretroviral medications is not provided.
Potential For Stribild To Affect Other Drugs
- The change from baseline is the mean of within-patient changes from baseline for patients with both baseline and Week 144 values.
- Cobicistat, a component of Stribild, is an inhibitor of CYP3A and CYP2D6 and an inhibitor of the following transporters:
- P-glycoprotein (P-gp),
- OATP1B1, and
- Thus, coadministration of Stribild with drugs that are primarily metabolized by CYP3A or CYP2D6, or are substrates of P-gp, BCRP, OATP1B1, or OATP1B3, may result in increased plasma concentrations of such drugs.
- Elvitegravir is a modest inducer of CYP2C9 and may decrease the plasma concentrations of CYP2C9 substrates.
Potential For Other Drugs To Affect One Or More Components Of Stribild
- Elvitegravir and cobicistat, components of Stribild, are metabolized by CYP3A.
- Cobicistat is also metabolized, to a minor extent, by CYP2D6.
- Drugs that induce CYP3A activity are expected to increase the clearance of elvitegravir and cobicistat, resulting in decreased plasma concentration of cobicistat and elvitegravir, which may lead to loss of therapeutic effect of Stribild and development of resistance (Table 5).
- Coadministration of Stribild with other drugs that inhibit CYP3A may decrease the clearance and increase the plasma concentration of cobicistat (Table 5).
Drugs Affecting Renal Function
- Because emtricitabine and tenofovir, components of Stribild, are primarily excreted by the kidneys by a combination of glomerular filtration and active tubular secretion, coadministration of Stribild with drugs that reduce renal function or compete for active tubular secretion may increase concentrations of emtricitabine, 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,
Established And Other Potentially Significant Interactions
- Table 5 provides a listing of established or potentially clinically significant drug interactions.
- The drug interactions described are based on studies conducted with either Stribild or the components of Stribild (elvitegravir, cobicistat, emtricitabine, and TDF) as individual agents and/or in combination, or are predicted drug interactions that may occur with Stribild.
- The table includes potentially significant interactions but is not all inclusive.
Table 5 : Established and Other Potentially Significant* Drug Interactions: Alteration in Dose or Regimen May Be Recommended Based on Drug Interaction Studies or Predicted Interaction
|Concomitant Drug Class: Drug Name||Effect on Concentration†||Clinical Comment|
|Acid Reducing Agents: Antacids‡ e.g., aluminum and magnesium hydroxide||↓ elvitegravir||Separate Stribild and antacid administration by at least 2 hours.|
|Alpha 1-adrenoreceptor antagonist: alfuzosin||↑alfuzosin||Coadministration with alfuzosin is contraindicated due to potential for serious and/or life-threatening reactions such as hypotension.|
|Antiarrhythmics: e.g., amiodarone|
|Therapeutic concentration monitoring, if available, is recommended for antiarrhythmics when coadministered with Stribild.|
|Patients with CLcr areater than or eaual to 60 mL/minute:|
No dose adjustment of clarithromycin is required.
Patients with CLcr between 50 mL/minute and 60 mL/minute:
The dose of clarithromycin should be reduced by 50%.
|Anticoagulants: Direct Oral Anticoagulants (DOACs)|
|↑ apixaban||Due to potentially increased bleeding risk, dosing recommendations for coadministration with Stribild depends on the apixaban dose. Refer to apixaban dosing instructions for coadministration with strong C YP3A and P-gp inhibitors in apixaban prescribing information.|
|↑ rivaroxaban||Coadministration of rivaroxaban with Stribild is not recommended because it may lead to an increased bleeding risk.|
|Due to potentially increased bleeding risk, dosing recommendations for coadministration of betrixaban, dabigatran, or edoxaban with a P-gp inhibitor such as Stribild depends on DO AC indication and renal function. Refer to DOAC dosing instructions for coadministration with P-gp inliibitors in DOAC prescribing information.|
|Effect on warfarin unknown||Monitor international normalized ratio (INR) upon coadministration of warfarin with Stribild.|
|Coadministration with carbamazepine, phenobarbital, or phenytoin is contraindicated due to potential for loss of elvitegravir therapeutic effect and development of resistance. Alternative anticonvulsants should be considered when Stribild is coadministered with oxcarbazepine. Clinical monitoring is recommended upon coadministration of clonazepam or etliosuximide with Stribild.|
|Antidepressants: Selective Serotonin Reuptake Inhibitors (SSRIs) e.g.,|
Tricyclic Antidepressants (TCAs) e.g., amitriptyline
|↑ SSRIs (except sertraline)|
|Careful dose titration of the antidepressant and monitoring for antidepressant response are recommended when coadministered with Stribild.|
|When coadministered with Stribild, the maximum daily dose of ketoconazole or itraconazole should not exceed 200 mg per day. An assessment of benefit/risk ratio is recommended to justify use of voriconazole with Stribild.|
|Anti-gout: colchicine||↑ colchicine||Stribild is not recommended to be coadministered with colchicine to patients with renal or hepatic impairment.|
Treatment of sout-flares - coadministration of colchicine in patients receivins STRTBTLD:
0.6 mg (1 tablet) x 1 dose, followed by 0.3 mg (half tablet) 1 hour later. Treatment course to be repeated no earlier than 3 days.
Prophvlaxis of sout-flares - coadministration of colchicine in patients receivins Stribild:
If the original regimen was 0.6 mg twice a day, the regimen should be adjusted to 0.3 mg once a day. If the original regimen was 0.6 mg once a day, the regimen should be adjusted to 0.3 mg once every other day.
Treatment of familial Mediterranean fever - coadministration of colchicine in patients receivins Stribild:
Maximum daily dose of 0.6 mg (may be given as 0.3 mg twice a day).
|Coadministration with rifampin is contraindicated due to potential for loss of elvitegravir therapeutic effect and development of resistance.|
Coadministration of Stribild with rifabutin or rifapentine is not recommended.
|Coadministration with lurasidone is contraindicated due to potential for serious and/or life-threatening reactions. Coadministration with pimozide is contraindicated due to potential for serious and/or life-threatening reactions such as cardiac arrhythmias.|
|quetiapine Other antipsychotics e.g., perphenazine|
|↑ quetiapine||Initiation of Stribild in patients takina quetiapine:|
Consider alternative antiretroviral therapy to avoid increases in quetiapine exposure. If coadministration is necessary, reduce the quetiapine dose to 1/6 of the current dose and monitor for quetiapine-associated adverse reactions. Refer to the quetiapine prescribing information for recommendations on adverse reaction monitoring.
Initiation of quetiapine in patients takins STRTBILD:
Refer to the quetiapine prescribing information for initial dosing and titration of quetiapine.
|↑antipsychotic||A decrease in the dose of antipsychotics that are metabolized by C YP3A4 or C YP2D6 may be needed when coadministered with Stribild.|
|↑beta-blockers||Clinical monitoring is recommended and a dose decrease of the beta-blocker may be necessary when these agents are coadministered with Stribild.|
|Calcium Channel Blockers: e.g., amlodipine|
|↑ calcium channel blockers||Clinical monitoring is recommended upon coadministration of calcium channel blockers with Stribild.|
|Corticosteroids (all routes excluding cutaneous): e.g., betamethasone|
|Coadministration with oral dexamethasone or other systemic corticosteroids that induce C YP3A may result in loss of therapeutic effect and development of resistance to elvitegravir.|
Consider alternative corticosteroids.
Coadministration with corticosteroids whose exposures are significantly increased by strong C YP3A inliibitors can increase the risk for Cushing's syndrome and adrenal suppression.
Alternative corticosteroids including beclomethasone, prednisone, and prednisolone (whose PK and/or PD are less affected by strong C YP3A inliibitors relative to other studied steroids) should be considered, particularly for long-term use.
|Endothelin Receptor Antagonists: bosentan||↑bosentan||Coadministration of bosentan in patients on Stribild:|
In patients who have been receiving Stribild for at least 10 days, start bosentan at 62.5 mg once daily or every other day based upon individual tolerability.
Coadministration of Stribild in patients on bosentan:
Discontinue use of bosentan at least 36 hours prior to initiation of Stribild. After at least 10 days following the initiation of Stribild, resume bosentan at 62.5 mg once daily or every other day based upon individual tolerability.
|Ergot Derivatives: dihydroergotamine, ergotamine, methylergonovine||↑ergot derivatives||Coadministration 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||Coadministration is contraindicated due to potential for serious and/or life-threatening reactions such as cardiac arrhythmias.|
|Hepatitis C Antiviral Agents: ledipasvir/ sofosbuvir sofosbuvir/ velpatasvir‡ sofosbuvir/ velpatasvir/ voxilaprevir||↑tenofovir||The safety of increased tenofovir concentrations in the setting of HARVONI (ledipasvir/sofosbuvir) and Stribild has not been established. Coadministration is not recommended.|
Patients receiving Stribild concomitantly with EPCLUSA (sofosbuvir/velpatasvir) or VOSEVI (sofosbuvir/velpatasvir/voxilaprevir) should be monitored for adverse reactions associated with tenofovir disoproxil fumarate.
|Herbal Products: St. Jolm's wort (Hypericum perforatum)||↓ elvitegravir|
|Coadministration is contraindicated due to potential for loss of elvitegravir therapeutic effect and development of resistance.|
|Hormonal Contraceptives: drospirenone/ethinyl estradiol levonorgestrel norgestimate/ethinyl estradiolt||↑ drospirenone|
↓ ethinyl estradiol
|Additional or alternative non-honnonal forms of contraception should be considered when estrogen based contraceptives are coadministered with Stribild.|
Plasma concentrations of drospirenone may be increased when coadministered with cobicistat- containing products. Clinical monitoring is recommended due to the potential for hyperkalemia. The effects of increases in the concentration of the progestational component norgestimate are not fully known and can include increased risk of insulin resistance, dyslipidemia, acne, and venous thrombosis. The potential risks and benefits associated with coadministration of norgestimate/ethinyl estradiol with Stribild should be considered, particularly in women who have risk factors for these events.
Coadministration of Stribild with otlier hormonal contraceptives (e.g., contraceptive patch, contraceptive vaginal ring, or injectable contraceptives) or oral contraceptives containing progestagens otlier than drospirenone, levonorgestrel, or norgestimate has not been studied; therefore, alternative (non-honnonal) methods of contraception can be considered.
|Immuno-suppressants: e.g., cyclosporine sirolimus|
|↑immuno-suppressants||Therapeutic monitoring of the immunosuppressive agents is recommended upon coadministration with Stribild.|
|Lipid-modifying Agents: HMG-CoA Reductase Inhibitors:|
|Coadministration with lovastatin or simvastatin is contraindicated due to potential for serious reactions such as myopathy including rhabdomyolysis.|
|atorvastatin||↑ atorvastatin||Initiate atorvastatin with the lowest starting dose of atorvastatin and titrate carefully while monitoring for safety (e.g., myopathy). Do not exceed a dosage of atorvastatin 20 mg daily.|
|Other Lipid-modifying Agents: lomitapide||↑ lomitapide||Coadministration with lomitapide is contraindicated due to potential for markedly increased transaminases.|
|Narcotic Analgesics: buprenorphine/naloxone‡ fentanyl|
|Patients should be closely monitored for sedation and cognitive effects.|
|fentanyl||↑ fentanyl||Careful monitoring of therapeutic and adverse effects of fentanyl (including potentially fatal respiratory depression) is recommended with coadministration.|
|tramadol||↑ tramadol||A dose decrease may be needed for tramadol with concomitant use.|
|Inhaled Beta Agonist: salmeterol||↑ salmeterol||Coadministration of salmeterol and Stribild is not recommended because it may result in increased risk of cardiovascular adverse events associated with salmeterol, including QT prolongation, palpitations, and sinus tachycardia.|
|Phosphodiesterase-5 (PDE-5) Inhibitors: sildenafil|
|t PDE-5 inhibitors|
Coadministration of sildenafil with Stribild is contraindicated when used for treatment of pulmonary arterial hypertension (PAH), due to potential for PDE-5 inhibitor associated adverse reactions, including hypotension, syncope, visual disturbances, and priapism.
The below PDE-5 inhibitors can be used along with increased monitoring for PDE-5-inhibitor associated adverse events:
|midazolam (oral), triazolam||↑ midazolam|
|Coadministration with triazolam or orally administered midazolam is contraindicated due to potential for serious and/or life-threatening reactions such as prolonged or increased sedation or respiratory depression.|
Triazolam and orally administered midazolam are extensively metabolized by C YP3A. Coadministration of triazolam or orally administered midazolam with Stribild may cause large increases in the concentrations of these benzodiazepines.
|Otlier benzodiazepines: e.g., parenterally administered midazolam|
|↑ sedatives/hypnotics||Coadministration of parenteral midazolam with Stribild should be done in a setting that ensures close clinical monitoring and appropriate medical management in case of respiratory depression and/or prolonged sedation. Dosage reduction for midazolam should be considered, especially if more than a single dose of midazolam is administered. With otlier sedative/hypnotics, dose reduction may be necessary and clinical monitoring is recommended.|
|*This table is not all inclusive.|
‡Indicates that a drug-drug interaction trial was conducted.
Drugs Without Clinically Significant Interactions With Stribild
Is Stribild safe to use while pregnant or breastfeeding?
- Stribild is not recommended during pregnancy and to alert their healthcare provider if they become pregnant while taking Stribild.
- There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to Stribild during pregnancy.
- Healthcare providers are encouraged to register patients by calling the Antiretroviral Pregnancy Registry (APR) at 1-800-258-4263.
- Mothers with HIV-1 infection should not breastfeed because HIV-1 can be passed to the baby in breast milM.
Stribild is a prescription medicine that is used without other antiretroviral medicines to treat Human Immunodeficiency Virus-1 (HIV-1) in people 12 years of age and older who have not received anti-HIV-1 medicines in the past, or to replace their current anti-HIV-1 medicines. Serious side effects of Stribild include kidney problems, too much lactic acid in your blood (lactic acidosis), severe liver problems, bone problems, and changes in your immune system.
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