Stribild HIV Medication: Side Effects & Warnings

What is Stribild, and how does it work?

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:
- 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:

Nausea
diarrhea

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.

WARNING

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.

Recommended Dosage

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.

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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),
- BCRP,
- OATP1B1, and
- OATP1B3.
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,
- acyclovir,
- cidofovir,
- ganciclovir,
- valacyclovir,
- valganciclovir,
- aminoglycosides (e.g., gentamicin), and
- high-dose or multiple NSAIDs.

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 NameEffect on Concentration†Clinical CommentAcid Reducing Agents: Antacids‡ e.g., aluminum and magnesium hydroxide↓ elvitegravirSeparate Stribild and antacid administration by at least 2 hours.Alpha 1-adrenoreceptor antagonist: alfuzosin↑alfuzosinCoadministration with alfuzosin is contraindicated due to potential for serious and/or life-threatening reactions such as hypotension.Antiarrhythmics: e.g., amiodarone
bepridil
digoxin‡
disopyramide
flecainide
systemic lidocaine
mexiletine
propafenone
quinidine↓ antiarrhythmics
↓ digoxinTherapeutic concentration monitoring, if available, is recommended for antiarrhythmics when coadministered with Stribild.Antibacterials: clarithromycin↓clarithromycin
↓ cobicistatPatients 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
rivaroxaban
betrixaban
dabigatran
edoxaban↑ apixabanDue 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.↑ rivaroxabanCoadministration of rivaroxaban with Stribild is not recommended because it may lead to an increased bleeding risk.warfarin↑betrixaban
↑ dabigatran
↑edoxabanDue 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 unknownMonitor international normalized ratio (INR) upon coadministration of warfarin with Stribild.Anticonvulsants:
carbamazepine
phenobarbital
phenytoin
oxcarbazepine
clonazepam
ethosuximide↓elvitegravir
↓ cobicistat
↑clonazepam
↑ etliosuximideCoadministration 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.,
paroxetine
Tricyclic Antidepressants (TCAs) e.g., amitriptyline
desipramine
imipramine
nortriptyline
bupropion
trazodone↑ SSRIs (except sertraline)
↑TCAs
↑ trazodoneCareful dose titration of the antidepressant and monitoring for antidepressant response are recommended when coadministered with Stribild.Antifungals:
itraconazole
ketoconazolet
voriconazole↑elvitegravir
↑ cobicistat
↑ itraconazole
↑ketoconazole
↑voriconazoleWhen 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↑ colchicineStribild 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).Antimycobacterial:
rifampin
rifabutin‡
rifapentine↓ elvitegravir
↓cobicistatCoadministration 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.Antipsychotics:
lurasidone
pimozide↑lurasidone
↑ pimozideCoadministration 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
risperidone
thioridazine↑ quetiapineInitiation 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.↑antipsychoticA decrease in the dose of antipsychotics that are metabolized by C YP3A4 or C YP2D6 may be needed when coadministered with Stribild.Beta-Blockers: e.g.,
metoprolol
timolol↑beta-blockersClinical 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
diltiazem
felodipine
nicardipine
nifedipine
verapamil↑ calcium channel blockersClinical monitoring is recommended upon coadministration of calcium channel blockers with Stribild.Corticosteroids (all routes excluding cutaneous): e.g., betamethasone
budesonide
ciclesonide
dexamethasone
fluticasone
methylprednisolone
mometasone
triamcinolone↓ elvitegravir
↓ cobicistat
↑corticosteroidsCoadministration 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↑bosentanCoadministration 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 derivativesCoadministration 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↑ cisaprideCoadministration 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↑tenofovirThe 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
↓ cobicistatCoadministration 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
↑ levonorgestrel
↑ norgestimate
↓ ethinyl estradiolAdditional 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
tacrolimus↑immuno-suppressantsTherapeutic monitoring of the immunosuppressive agents is recommended upon coadministration with Stribild.Lipid-modifying Agents: HMG-CoA Reductase Inhibitors:lovastatin
simvastatin↑ lovastatin
↑ simvastatinCoadministration with lovastatin or simvastatin is contraindicated due to potential for serious reactions such as myopathy including rhabdomyolysis.atorvastatin↑ atorvastatinInitiate 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↑ lomitapideCoadministration with lomitapide is contraindicated due to potential for markedly increased transaminases.Narcotic Analgesics: buprenorphine/naloxone‡ fentanyl
tramadol↑ buprenorphine
↑ norbuprenorphine
↓ naloxonePatients should be closely monitored for sedation and cognitive effects.fentanyl↑ fentanylCareful monitoring of therapeutic and adverse effects of fentanyl (including potentially fatal respiratory depression) is recommended with coadministration.tramadol↑ tramadolA dose decrease may be needed for tramadol with concomitant use.Inhaled Beta Agonist: salmeterol↑ salmeterolCoadministration 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
tadalafil
vardenafilt 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.
Use of tadalafil for PAH:

Coadministration of tadalafil in patients on Stribild:
In patients receiving Stribild for at least 1 week, start tadalafil at 20 mg once daily. Increase tadalafil dose to 40 mg once daily based upon individual tolerability.
Coadministration of Stribild in patients on tadalafil:
Avoid use of tadalafil during the initiation of Stribild. Stop tadalafil at least 24 hours prior to starting Stribild. After at least one week following initiation of Stribild, resume tadalafil at 20 mg once daily. Increase tadalafil dose to 40 mg once daily based upon individual tolerability.

Use of PDE-5 inhibitors for erectile dysfunction:
The below PDE-5 inhibitors can be used along with increased monitoring for PDE-5-inhibitor associated adverse events:

Sildenafil at a single dose not exceeding 25 mg in 48 hours, or
Tadalafil at a single dose not exceeding 10 mg in 72 hours, or
Vardenafil at a single dose not exceeding 2.5 mg in 72 hours

Sedative/hypnotics: midazolam (oral), triazolam↑ midazolam
↑triazolamCoadministration 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
clorazepate
diazepam
estazolam
flurazepam
buspirone
zolpidem↑ sedatives/hypnoticsCoadministration 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.
†↑=Increase, ↓=Decrease
‡Indicates that a drug-drug interaction trial was conducted.

Drugs Without Clinically Significant Interactions With Stribild

Based on drug interaction studies conducted with the components of Stribild, no clinically significant drug interactions have been observed when Stribild is combined with the following drugs:
- famciclovir,
- famotidine,
- methadone,
- omeprazole, and
- sertraline.

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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.

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