place of work [70:<70 mL/minute. Sulfonamide allergy: Use with caution in patients with sulfonamide allergy (darunavir contains sulfa moiety). Disease-related concerns: Diabetes: Changes in glucose tolerance, hyperglycemia, exacerbation of diabetes, DKA, and new-onset diabetes mellitus have been reported in patients receiving protease inhibitors. Initiation or dose adjustments of antidiabetic agents may be required. Hemophilia A or B: Use with caution in patients with hemophilia A or B; increased bleeding (eg, spontaneous skin hematomas and hemarthroses) has been reported during protease inhibitor therapy. Some patients receive additional factor VIII. In more than half of the cases, protease inhibitor treatment was continued or reintroduced if treatment was discontinued. Hepatic impairment: Darunavir may exacerbate preexisting hepatic impairment; use with caution in patients with underlying hepatic disease, such as hepatitis B or C or cirrhosis. Use in severe impairment (Child-Pugh class C) is not recommended; closely monitor patients with mild or moderate impairment (Child-Pugh class A or B). Concurrent drug therapy issues: Drug-drug interactions: Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions database for more detailed information. Other warning/precautions: False elevations in serum creatinine: Cobicistat may inhibit tubular secretion of creatinine without affecting actual renal glomerular function; use caution when interpreting serum creatinine values in patients with medical conditions or receiving drugs needing to be monitored with estimated CrCl. Patients who experience a confirmed increase in serum creatinine> 0.4 mg/dL from baseline should have renal function monitored closely. Assess estimated CrCl prior to initiating therapy; consider alternative medications that do not require dosage adjustments in patients with renal impairment. Monitoring Parameters Viral load, baseline genotyping in treatment-experienced patients (if possible); serum glucose; liver function prior to and during therapy (increase monitoring in patients at risk for liver impairment), cholesterol, triglycerides; CBC with differential, reticulocyte count, CD4 count, serum creatinine at baseline and when clinically indicated during therapy; when coadministered with tenofovir, serum creatinine, urine glucose, and urine protein prior to initiation and as clinically indicated during therapy; assess serum phosphorus in patients with or at risk for renal impairment. Patients who experience a confirmed increase in serum creatinine >0.4 mg/dL from baseline should have renal function monitored closely. Testing for HBV is recommended prior to the initiation of antiretroviral therapy. Pregnancy Considerations In general, women who become pregnant on a stable combination antiretroviral therapy (cART) regimen may continue that regimen if viral suppression is effective, appropriate drug exposure can be achieved, contraindications for use in pregnancy are not present, and the regimen is well tolerated. The Health and Human Services (HHS) Perinatal HIV Guidelines note there are no pharmacokinetic or safety data available in pregnant women; therefore, this combination product is not recommended for routine use as initial therapy in antiretroviral-naive pregnant women (HHS [perinatal] 2016). See individual agents. Patient Education Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?) Patient may experience headache, diarrhea, abdominal pain, vomiting, or nausea. Have patient report immediately to prescriber signs of infection, signs of liver problems (dark urine, fatigue, lack of appetite, nausea, abdominal pain, light-colored stools, vomiting, or jaundice), signs of high blood sugar (confusion, fatigue, increased thirst, increased hunger, polyuria, flushing, fast breathing, or breath that smells like fruit), signs of kidney problems (urinary retention, hematuria, change in amount of urine passed, or weight gain), change in body fat, enlarged lymph nodes, muscle pain, joint pain, severe loss of strength and energy, or signs of Stevens-Johnson syndrome/toxic epidermal necrolysis (red, swollen, blistered, or peeling skin [with or without fever]; red or irritated eyes; or sores in mouth, throat, nose, or eyes) (HCAHPS). Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions. Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients. Next Interactions Print this page Add to My Med List More about cobicistat/darunavir Side Effects During Pregnancy Dosage Information Drug Interactions Support Group En Español 3 Reviews Add your own review/rating Drug class: antiviral combinations Consumer resources Cobicistat and darunavir Darunavir and Cobicistat Darunavir and cobicistat (Advanced Reading) Professional resources Other brands: Prezcobix Related treatment guides HIV Infection ] Drug Status Rx Availability Prescription only C Pregnancy Category Risk cannot be ruled out N/A CSA Schedule Not a controlled drug Approval History Drug history at FDA Cobicistat / darunavir Rating 3 User Reviews 4.0 /10 3 User Reviews 4.0 Rate it! 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