Prezcobix Side Effects Center

Last updated on RxList: 5/4/2022
Prezcobix Side Effects Center

What Is Prezcobix?

Prezcobix (darunavir and cobicistat) is a combination of a human immunodeficiency virus (HIV-1) protease inhibitor and a CYP3A inhibitor and is indicated for the treatment of HIV-1 infection in adult patients.

What Are Side Effects of Prezcobix?

Common side effects of Prezcobix include:

  • diarrhea,
  • nausea,
  • rash,
  • headache,
  • abdominal pain,
  • vomiting, and
  • changes in body fat distribution.

Dosage for Prezcobix

The recommended dosage of Prezcobix is one tablet taken once daily with food.

What Drugs, Substances, or Supplements Interact with Prezcobix?

Prezcobix may interact with other HIV-1 antiviral drugs, antiarrhythmics, antibacterials, anticancer agents, anticoagulants, anticonvulsants, antidepressants, antifungals, anti-gout medications, anti-malaria drugs, beta-blockers, calcium channel blockers, corticosteroids, endothelin receptor antagonists, drugs to treat hepatitis C, statin drugs, hormonal contraceptives, immunosuppressants, inhaled beta agonists, narcotics, neuroleptics, PDE-5 inhibitors, sedatives, and hypnotics. Tell your doctor all medications and supplements you use.

Prezcobix During Pregnancy and Breastfeeding

During pregnancy, Prezcobix should only be used if prescribed. Women who have HIV/AIDS should not breastfeed due to the potential for HIV transmission and the potential for serious adverse reactions in nursing infants.

Additional Information

Our Prezcobix (darunavir and cobicistat) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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Get emergency medical help if you have signs of an allergic reaction (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning in your eyes, skin pain, red or purple skin rash that spreads and causes blistering and peeling).

Call your doctor at once if you have:

  • high blood sugar--increased thirst, increased urination, dry mouth, fruity breath odor, headache, blurred vision; or
  • liver problems--upper stomach pain, vomiting, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Cobicistat and darunavir affects your immune system, which may cause certain side effects (even weeks or months after you've taken this medicine). Tell your doctor if you have:

  • signs of a new infection--fever, night sweats, swollen glands, cold sores, cough, wheezing, diarrhea, weight loss;
  • stomach pain, tiredness, itching, skin redness, yellowing of the skin or eyes;
  • trouble speaking or swallowing, problems with balance or eye movement, weakness or prickly feeling; or
  • swelling in your neck or throat (enlarged thyroid), menstrual changes, impotence.

Common side effects may include:

  • nausea, vomiting, stomach pain, diarrhea;
  • headache;
  • rash; or
  • changes in the shape or location of body fat (especially in your arms, legs, face, neck, breasts, and waist).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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SIDE EFFECTS

The following adverse reactions are discussed in other sections of the labeling:

  • Hepatotoxicity [see WARNINGS AND PRECAUTIONS]
  • Severe skin reactions [see WARNINGS AND PRECAUTIONS]
  • Effects on serum creatinine [see WARNINGS AND PRECAUTIONS]
  • New onset or worsening renal impairment when used with tenofovir DF [see WARNINGS AND PRECAUTIONS]
  • Immune Reconstitution Syndrome [see WARNINGS AND PRECAUTIONS]

Clinical 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.

Clinical Trials In Adults

During the darunavir clinical development program, where darunavir was co-administered with ritonavir 100 mg once or twice daily, the most common clinical adverse reactions (incidence greater than or equal to 5%) of at least moderate intensity (greater than or equal to Grade 2) were diarrhea, nausea, rash, headache, abdominal pain, and vomiting. See the darunavir full prescribing information for additional information on adverse reactions reported with darunavir co-administered with ritonavir. See cobicistat full prescribing information for clinical trial information on adverse reactions reported with cobicistat.

One single arm clinical trial was conducted with darunavir and cobicistat administered as single entities in 313 subjects with HIV-1 infection. Adverse reactions evaluated through Week 24 did not differ substantially from those reported in clinical trials with darunavir co-administered with ritonavir.

Clinical Trials In Pediatric Patients

No clinical trials with PREZCOBIX were performed in pediatric patients. However, the safety of the components of PREZCOBIX, darunavir and cobicistat, co-administered with two nucleoside reverse transcriptase inhibitors, was evaluated in pediatric subjects of 12 to less than 18 years of age with HIV-1 infection through clinical trial GS-US-216-0128 (virologically-suppressed, N=7 with weight ≥40 kg) through Week 48. Safety analyses of this trial in these pediatric subjects did not identify new safety concerns compared to the known safety profile of PREZCOBIX in adult subjects [see Clinical Studies].

Postmarketing Experience

The following events have been identified during post-approval use of darunavir. Because these events 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.

Metabolism And Nutrition Disorders

Redistribution of body fat

Musculoskeletal And Connective Tissue Disorders

Rhabdomyolysis (associated with co-administration with HMG-CoA reductase inhibitors)

Skin And Subcutaneous Tissue Disorders

Toxic epidermal necrolysis, acute generalized exanthematous pustulosis, drug rash with eosinophilia and systemic symptoms [see WARNINGS AND PRECAUTIONS].

DRUG INTERACTIONS

Potential For PREZCOBIX 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 PREZCOBIX 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 PREZCOBIX 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 therapeuti effect (see Table 1).

Potential For Other Drugs To Affect PREZCOBIX

Darunavir is metabolized by CYP3A. Cobicistat is metabolized by CYP3A, and to a minor extent, by CYP2D6. Co-administration of PREZCOBIX and drugs that induce CYP3A activity are expected to increase the clearance of darunavir and cobicistat, resulting in lowered plasma concentrations of darunavir and cobicistat which may lead to loss of therapeutic effect and development of resistance. Co-administration of PREZCOBIX and other drugs that inhibit CYP3A may result in increased plasma concentrations of darunavir and cobicistat (see Table 1).

Established And Other Potentially Significant Drug Interactions

Table 1 provides dosing recommendations for expected clinically relevant interactions with PREZCOBIX (this table is not all inclusive). These recommendations are based on either drug interaction trials or predicted interactions due to the expected magnitude of interaction and potential for serious adverse events or loss of therapeutic effect. The table includes examples of potentially significant interactions but is not all inclusive, and therefore the label of each drug that is co-administered with PREZCOBIX should be consulted for information related to the route of metabolism, interaction pathways, potential risks, and specific actions to be taken with regard to co-administration. For the list of examples of contraindicated drugs, [see CONTRAINDICATIONS].

Table 1: Established and Other Potentially Significant* Drug Interactions: Alterations in Dose or Regimen May Be Recommended

Concomitant Drug Class: Drug Name Examples Effect on Concentration of Darunavir, Cobicistat, or Concomitant Drug Clinical Comment
HIV-1 antiviral agents: Nucleoside Reverse Transcriptase Inhibitors (NRTIs)
didanosine ↔ darunavir
↔ cobicistat
↔ didanosine
Didanosine should be administered one hour before or two hours after PREZCOBIX (administered with food).
HIV-1 antiviral agents: Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTIs)
efavirenz etravirine ↓ cobicistat
↓darunavir
Co-administration with efavirenz is not recommended because it may result in loss of therapeutic effect and development of resistance to darunavir.
↓ cobicistat
darunavir: effect unknown
Co-administration with etravirine is not recommended because it may result in loss of therapeutic effect and development of resistance to darunavir.
nevirapine ↓ cobicistat
darunavir: effect unknown
Co-administration with nevirapine is not recommended because it may result in loss of therapeutic effect and development of resistance to darunavir.
HIV-1 antiviral agents: CCR5 co-receptor antagonists
maraviroc ↑ maraviroc Maraviroc is a substrate of CYP3A. When coadministered with PREZCOBIX, patients should receive maraviroc 150 mg twice daily.
Other agents
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
↑ cobicistat
↑ antibacterial
Consider alternative antibiotics with concomitant use of PREZCOBIX.
Anticancer agents: dasatinib, nilotinib vinblastine, vincristine ↑anticancer agent A decrease in the dosage or an adjustment of the dosing interval of dasatinib or nilotinib may be necessary when co-administered with PREZCOBIX. 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 PREZCOBIX is administered concurrently with vincristine or vinblastine. If the antiretroviral regimen must be withheld for a prolonged period, consider initiating a revised 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 PREZCOBIX 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 of rivaroxaban with PREZCOBIX is not recommended because it may lead to an increased bleeding risk.
betrixaban
dabigatran
edoxaban
↔ betrixaban
↔dabigatran
↔edoxaban
No dose adjustment is needed when betrixaban, dabigatran, or edoxaban is co-administered with PREZCOBIX.
Other Anticoagulants: warfarin warfarin: effect unknown Monitor the international normalized ratio (INR) when co-administering with warfarin.
Anticonvulsants: carbamazepine, phenobarbital, phenytoin ↓darunavir
↓ cobicistat
Co-administration is contraindicated due to potential for reduced plasma concentrations of darunavir, which may result in loss of therapeutic effect and development of resistance.
Anticonvulsants with CYP3A induction effects that are NOT contraindicated: e.g. eslicarbazepine, oxcarbazepine ↓ cobicistat
darunavir: effect unknown
Consider alternative anticonvulsant or antiretroviral therapy to avoid potential changes in exposures. If co-administration is necessary, monitor for lack or loss of virologic 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 SSRIs: effects unknown When co-administering with SSRIs, TCAs, or trazodone, careful dose titration of the antidepressant to the desired effect, including using the lowest feasible initial or maintenance dose, and monitoring for antidepressant response are recommended.
Tricyclic Antidepressants (TCAs): e.g. amitriptyline, desipramine, imipramine, nortriptyline ↑ TCAs
Other antidepressants: trazodone ↑ trazodone
Antifungals: itraconazole, isavuconazole, ketoconazole, posaconazole ↑ darunavir
↑cobicistat
Monitor for increased darunavir or cobicistat and/or antifungal adverse reactions.
↑itraconazole
↑ ketoconazole
↑ isavuconazole
Specific dosing recommendations are not available for co-administration with these antifungals. Monitor for increased itraconazole or ketoconazole adverse reactions.
voriconazole ↔ posaconazole
voriconazole: effects unknown
Co-administration with voriconazole is not recommended unless benefit/risk assessment 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:

  • Treatment of gout flares - co-administration of colchicine: 0.6 me (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.
  • Prophylaxis of gout flares - co-administration of colchicine: 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 -co-administration of colchicine: Maximum daily dose of 0.6 mg (may be given as 0.3 mg twice a day).
Antimalarial: artemether/lumefantrine artemether: effect unknown
lumefantrine: effect unknown
Monitor for a potential decrease of antimalarial efficacy or potential QT prolongation.
Antimycobacterials: rifampin ↓ darunavir
↓ cobicistat
Co-administration is contraindicated due to potential for loss of therapeutic effect and development of resistance.
rifabutin ↑ rifabutin
cobicistat: effects unknown
darunavir: effects unknown
When used in combination with PREZCOBIX, the recommended dose of rifabutin is 150 mg every other day. Monitor for rifabutin-associated adverse reactions including neutropenia and uveitis.
rifapentine ↓ darunavir 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 ↑ antipsychotic A decrease in the dose of antipsychotics that are metabolized by CYP3A or CYP2D6 may be needed when co-administered with PREZCOBIX.
quetiapine ↑ quetiapine Initiation of PREZCOBIX in patients taking quetiapine: Consider alternative antiretroviral therapy to avoid increases in quetiapine exposure. If co-administration 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 PREZCOBIX: Refer to the quetiapine prescribing 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 calcium channel blockers metabolized by CYP3A.
Cardiac Disorders: ranolazine, ivabradine ↑ ranolazine
↑ivabradine
Co-administration is contraindicated due to potential for serious and/or life-threatening reactions.
dronedarone ↑dronedarone Co-administration is contraindicated due to potential for serious and/or life-threatening reactions such as cardiac arrhythmias.
Other antiarrhvthmics e.g. amiodarone, disopyramide, flecainide, lidocaine (systemic), mexiletine, propafenone, quinidine ↑antiarrhythmics Clinical monitoring is recommended upon coadministration with antiarrhythmics.
digoxin ↑ digoxin When co-administering with digoxin, titrate the digoxin dose and monitor digoxin concentrations.
Corticosteroids: dexamethasone (systemic) ↓ darunavir
↓ cobicistat
Co-administration with systemic dexamethasone or other systemic corticosteroids that induce CYP3A may result in loss of therapeutic effect and development of resistance to PREZCOBIX.
Corticosteroids primarily metabolized by CYP3A: e.g. betamethasone
budesonide
ciclesonide
fluticasone
methylprednisolone
mometasone
triamcinolone
↑ corticosteroids Consider alternative corticosteroids. Co-administration with corticosteroids (all routes of administration) 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-term use.
Endothelin receptor antagonists: bosentan ↓ darunavir
↓ cobicistat
↑ bosentan
Initiation of bosentan in patients taking PREZCOBIX: In patients who have been receiving PREZCOBIX for at least 10 days, start bosentan at 62.5 mg once daily or every other day based upon individual tolerability.
Initiation of PREZCOBIX in patients on bosentan: Discontinue use of bosentan at least 36 hours prior to initiation of PREZCOBIX. After at least 10 days following the initiation of PREZCOBIX, resume bosentan at 62.5 mg once daily or every other day based upon individual tolerability.
Switching from darunavir co-administered with ritonavir to PREZCOBIX 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.
Hepatitis C virus (HCV): Direct-Acting Antivirals: elbasvir/grazoprevir ↑elbasvir/grazoprevir Co-administration is contraindicated due to potential for the increased risk of alanine transaminase (ALT) elevations.
glecaprevir/pibrentasvir ↑ glecaprevir
↑pibrentasvir
Co-administration of PREZCOBIX with glecaprevir/pibrentasvir is not recommended.
Herbal product: St. John’s wort (Hypericum perforatum) ↓darunavir
↓cobicistat
Co-administration is contraindicated due to potential for reduced plasma concentrations of darunavir, which may result in loss of therapeutic effect and development of resistance.
Hormonal contraceptives: Additional or alternative (non-hormonal) forms of contraception should be considered when estrogen-containing contraceptives are co-administered with PREZCOBIX [see Use In Specific Populations ].
drospirenone/ethinylestradiol ↑ drospirenone
↓ ethinylestradiol
For co-administration with drospirenone, clinical monitoring is recommended due to the potential for hyperkalemia.
Other progestin/estrogen contraceptives progestin: effects unknown
estrogen: effects unknown
No data are available to make recommendations on co-administration with other hormonal contraceptives.
Immunosuppressants: cyclosporine, sirolimus, tacrolimus ↑ immunosuppressants These immunosuppressant agents are metabolized by CYP3A. Therapeutic drug monitoring is recommended with concomitant use
Immunosuppressant /neoplastic: everolimus ↑ immunosuppressants Co-administration of everolimus and PREZCOBIX is not recommended.
irinotecan Discontinue PREZCOBIX at least 1 week prior to starting irinotecan therapy. Do not administer PREZCOBIX 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 ↑ lovastatin
↑ simvastatin
Co-administration is contraindicated due to potential for serious reactions such as myopathy including rhabdomyolysis.
atorvastatin, fluvastatin, pitavastatin, pravastatin, rosuvastatin ↑ atorvastatin
↑ fluvastatin
↑ pravastatin
↑ rosuvastatin
pitavastatin: effect unknown
For atorvastatin, fluvastatin, pitavastatin, pravastatin, and rosuvastatin, start with the lowest recommended dose and titrate while monitoring for safety (e.g. myopathy).
Dosage recommendations with atorvastatin or rosuvastatin are as follows:
  • atorvastatin dosage should not exceed 20 mg/day
  • rosuvastatin dosage should not exceed 20 mg/day
Other lipid modifying agents: lomitapide ↑lomitapide Co-administration is contraindicated due to potential for markedly increased transaminases associated with increased plasma concentrations of lomitapide.
Narcotic analgesics metabolized by CYP3A: e.g. fentanyl, oxycodone ↑ 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.
tramadol ↑ tramadol 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 of buprenorphine, bumenorphine/naloxone or methadone in patients taking PREZCOBIX: Carefully titrate the dose of buprenorphine, buprenorphine/naloxone or methadone to the desired effect; use the lowest feasible initial or maintenance dose.
Initiation of PREZCOBIX 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 PREZCOBIX 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 PREZCOBIX:
  • Initiation of tadalafil in patients taking PREZCOBIX: In patients receiving PREZCOBIX for at least one week, start tadalafil at 20 mg once daily. Increase to 40 mg once daily based upon individual tolerability.
  • Initiation of PREZCOBIX in patients taking tadalafil: Avoid use of tadalafil during the initiation of PREZCOBIX. Stop tadalafil at least 24 hours prior to starting PREZCOBIX. After at least one week following the initiation of PREZCOBIX, resume tadalafil at 20 mg once daily. Increase to 40 mg once daily based upon individual tolerability.
  • Patients switching from darunavir coadministered with ritonavir to PREZCOBIX: Maintain tadalafil dose.
Use of PDE-5 inhibitors for erectile dysfunction: Sildenafil at a single dose not exceeding 25 mg in 48 hours, vardenafil at a single dose not exceeding 2.5 mg dose in 72 hours, or tadalafil at a single dose not exceeding 10 mg dose in 72 hours can be used with increased monitoring for PDE-5 inhibitor-associated adverse reactions.
Platelet aggregation inhibitor: ticagrelor ↑ticagrelor Co-administration of PREZCOBIX and ticagrelor is not recommended.
clopidogrel ↓ clopidogrel active metabolite Co-administration of PREZCOBIX with clopidogrel is not recommended due to the potential reduction of the antiplatelet activity of clopidogrel.
prasugrel ↔ prasugrel active metabolite No dose adjustment is needed when prasugrel is co-administered with PREZCOBIX.
Sedatives/hypnotics: orally administered midazolam, triazolam ↑midazolam
↑triazolam
Co-administration 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 CYP3A. Co-administration of triazolam or orally administered midazolam with PREZCOBIX may cause large increases in the concentrations of these benzodiazepines.
metabolized by CYP3A: e.g. buspirone, diazepam, estazolam, zolpidem ↑ sedatives/hypnotics 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.
parenterally administered midazolam 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 if more than a single dose of midazolam is administered.
Urinary antispasmodics
fesoterodine ↑fesoterodine When fesoterodine is co-administered with PREZCOBIX, do not exceed a fesoterodine dose of 4 mg once daily.
solifenacin ↑ solifenacin When solifenacin is co-administered with PREZCOBIX, do not exceed a solifenacin dose of 5 mg once daily.
* this table is not all inclusive

Drugs Without Clinically Significant Interactions With PREZCOBIX

Clinically relevant drug-drug interactions have not been observed or are not anticipated with concomitant use of darunavir and cobicistat with rilpivirine, dolutegravir, raltegravir, abacavir, emtricitabine, emtricitabine/tenofovir alafenamide, tenofovir DF, lamivudine, stavudine, zidovudine, or acid modifying medications (antacids, H2-receptor antagonists, proton pump inhibitors).

Read the entire FDA prescribing information for Prezcobix (Darunavir and Cobicistat Tablets)

© Prezcobix Patient Information is supplied by Cerner Multum, Inc. and Prezcobix Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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