Note: This document contains side effect information about cobicistat / darunavir. Some of the dosage forms listed on this page may not apply to the brand name Prezcobix.
Applies to cobicistat / darunavir: oral tablet, tablet oral
Along with its needed effects, cobicistat / darunavir may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur while taking cobicistat / darunavir:
Incidence not known
Some side effects of cobicistat / darunavir may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
Incidence not known
Applies to cobicistat / darunavir: oral tablet
In clinical trials, safety of this drug was evaluated in therapy-naive and therapy-experienced patients using the individual components with other antiretrovirals. Safety data was also provided from clinical trials and postmarketing experience of darunavir/ritonavir and cobicistat in combination with other antiretrovirals. In a clinical trial with darunavir and cobicistat, the most common side effects were diarrhea, nausea, and rash; serious side effects were diabetes mellitus, drug hypersensitivity, immune reconstitution inflammatory syndrome, rash, and vomiting. In clinical trials and postmarketing experience with darunavir 600 mg plus ritonavir 100 mg twice a day, the most common side effects were diarrhea, nausea, rash, headache, and vomiting; the most common serious side effects were acute renal failure, myocardial infarction, immune reconstitution inflammatory syndrome, thrombocytopenia, osteonecrosis, diarrhea, hepatitis, and pyrexia. The manufacturer product information for cobicistat and darunavir should be consulted.
Increased pancreatic amylase (grade 2: 6.5%; grade 3: 2.6%) and lipase (grade 2: 3.9%; grade 3: 1%; grade 4: 1.3%) were reported.
Very common (10% or more): Diarrhea (up to 28%), nausea (up to 23%)
Common (1% to 10%): Increased pancreatic amylase, increased lipase, vomiting, abdominal pain, abdominal distension, flatulence, dyspepsia, increased pancreatic enzymes
Uncommon (0.1% to 1%): Acute pancreatitis
-Common (1% to 10%): Abdominal pain, diarrhea, nausea, vomiting, increased pancreatic amylase, increased pancreatic lipase, increased pancreatic enzyme
-Uncommon (0.1% to 1%): Acute pancreatitis, dyspepsia, flatulence
-Frequency not reported: Abdominal distension
-Postmarketing reports: Pancreatitis, relapsing pancreatitis, rectal hemorrhage, gastritis, esophageal candidiasis
Very common (10% or more): Rash (included allergic dermatitis, drug eruption, erythema, rash, erythematous rash, generalized rash, macular rash, maculopapular rash, pruritic rash, papular rash, skin reaction, papular urticaria; up to 15.7%)
Common (1% to 10%): Pruritus, angioedema, urticaria
-Postmarketing reports: Toxic epidermal necrolysis, acute generalized exanthematous pustulosis, drug rash with eosinophilia and systemic symptoms (DRESS)
-Common (1% to 10%): Pruritus, rash
-Uncommon (0.1% to 1%): Lipodystrophy (lipohypertrophy, lipodystrophy, lipoatrophy), Stevens-Johnson syndrome, severe skin reactions (sometimes with fever and/or transaminase elevations)
-Rare (less than 0.1%): DRESS
-Postmarketing reports: Swelling face, toxic epidermal necrolysis, acute generalized exanthematous pustulosis, urticaria, angioedema
In clinical trials with darunavir/ritonavir and darunavir/cobicistat, rashes were generally mild-to-moderate, often occurring within the first 4 weeks of therapy and resolving with continued use. In a trial using darunavir 800 mg plus cobicistat 150 mg once a day with other antiretrovirals, therapy was discontinued due to rash in 2.2% of patients.
Very common (10% or more): Increased low-density lipoprotein (LDL) cholesterol (up to 10.9%), increased total cholesterol (up to 10.6%)
Common (1% to 10%): Fatigue, increased triglycerides
Uncommon (0.1% to 1%): Asthenia, increased alkaline phosphatase
-Very common (10% or more): Increased total cholesterol (up to 22.9%), increased LDL cholesterol (up to 14.1%)
-Common (1% to 10%): Increased alkaline phosphatase, increased triglycerides
-Uncommon (0.1% to 1%): Asthenia, fatigue
-Postmarketing reports: Increased blood alkaline phosphatase, clostridial infection, cryptosporidiosis infection, sepsis, drug toxicity
-Frequency not reported: Increased weight, increased blood lipids
Increased LDL cholesterol (grade 2: 10.9%; grade 3: 4.8%), total cholesterol (grade 2: 10.6%; grade 3: 1%), triglycerides (grade 2: 1.4%; grade 3: 1.4%), and alkaline phosphatase (grade 2: 1%) were reported.
Very common (10% or more): Headache
-Common (1% to 10%): Headache
-Postmarketing reports: Cytomegalovirus encephalitis, progressive multifocal leukoencephalopathy, altered state of consciousness, cerebrovascular accident, dizziness, facial palsy, grand mal convulsion, ischemic cerebral infarction, nervous system disorder, neuromyopathy, petit mal epilepsy
Increased glucose (grade 2: 6.5%) was reported.
Common (1% to 10%): Increased glucose, anorexia, diabetes mellitus, hypercholesterolemia, hypertriglyceridemia, hyperlipidemia
-Postmarketing reports: Redistribution of body fat
-Very common (10% or more): Increased glucose (up to 10.8%)
-Common (1% to 10%): Anorexia
-Uncommon (0.1% to 1%): Diabetes mellitus
-Frequency not reported: Hypercholesterolemia, hyperglycemia, hypertriglyceridemia
-Postmarketing reports: Dehydration, hyperkalemia, metabolic acidosis, redistribution of body fat
HIV protease inhibitors:
-Postmarketing reports: New onset diabetes mellitus, exacerbation of preexisting diabetes, hyperglycemia, diabetic ketoacidosis
-Frequency not reported: Increased glucose, redistribution/accumulation of body fat (including central obesity, dorsocervical fat enlargement, peripheral wasting, facial wasting, breast enlargement, "cushingoid appearance"), metabolic abnormalities (such as hypertriglyceridemia, hypercholesterolemia, insulin resistance, hyperglycemia, hyperlactatemia)
Increased AST (grade 2: 6.1%; grade 3: 2.3%; grade 4: 0.6%) and ALT (grade 2: 3.2%; grade 3: 1.9%; grade 4: 1%) were reported.
In patients using darunavir/ritonavir, hepatic transaminase elevations were reported more often in those coinfected with HIV and hepatitis B and/or C virus than in patients infected with HIV only.
Common (1% to 10%): Increased AST, increased ALT, increased hepatic enzyme
-Common (1% to 10%): Increased ALT, increased AST
-Uncommon (0.1% to 1%): Drug-induced hepatitis, hepatitis, cytolytic hepatitis, acute hepatitis
-Frequency not reported: Hyperbilirubinemia, hepatic transaminase elevations
-Postmarketing reports: Bile duct obstruction, hepatic cirrhosis, hepatic failure, hepatotoxicity, jaundice, hepatitis B, increased blood bilirubin, abnormal liver function test, liver injury (including fatalities)
Common (1% to 10%): Increased creatinine
-Frequency not reported: Decreased estimated CrCl, increased serum creatinine, renal tubular secretion of creatinine inhibited (actual renal glomerular function not affected), decreased estimated glomerular filtration rate (based on CrCl), renal impairment (including acute renal failure, Fanconi syndrome)
-Postmarketing reports: Acute renal failure, renal tubular necrosis, decreased creatinine renal clearance, decreased glomerular filtration rate, renal failure
Increased creatinine (grade 2) was reported in 3.2% of patients.
Within 7 days after starting cobicistat 150 mg in a phase I trial, estimated glomerular filtration rate (eGFR) change from baseline averaged -9.9 mL/min in patients with normal renal function (eGFR at least 80 mL/min [calculated by Cockcroft-Gault method]) and -11.9 mL/min in patients with mild to moderate renal dysfunction (eGFR 50 to 79 mL/min [calculated by Cockcroft-Gault method]). These eGFR decreases were reversible after cobicistat was discontinued and did not affect the actual glomerular filtration rate.
In a phase III trial, eGFR (calculated by Cockcroft-Gault method) change from baseline averaged -9.6 mL/min at week 2, -11.5 mL/min at week 24, and -9.6 mL/min at week 48.
Renal impairment (including acute renal failure and Fanconi syndrome) has been reported when cobicistat was used in a regimen containing tenofovir.
Common (1% to 10%): Drug hypersensitivity
-Postmarketing reports: Drug hypersensitivity
Common (1% to 10%): Myalgia
-Postmarketing reports: Rhabdomyolysis (associated with coadministration with HMG-CoA reductase inhibitors)
-Uncommon (0.1% to 1%): Myalgia, osteonecrosis
-Postmarketing reports: Myositis, rhabdomyolysis, sensation of heaviness, arthritis, bone pain, pain in extremities, arthropathy
HIV protease inhibitors:
-Rare (0.01% to 0.1%): Rhabdomyolysis
-Frequency not reported: Increased creatine phosphokinase (CPK), myalgia, myositis
Increased CPK, myalgia, myositis, and rarely, rhabdomyolysis have been reported with HIV protease inhibitors, especially when coadministered with nucleoside reverse transcriptase inhibitors.
Osteonecrosis has been reported, particularly with commonly known risk factors (e.g., corticosteroid use, alcohol use, severe immunosuppression, higher body mass index), advanced HIV disease, or long-term combination antiretroviral therapy.
Common (1% to 10%): Abnormal dreams
-Uncommon (0.1% to 1%): Abnormal dreams
-Postmarketing reports: Completed suicide, anxiety, depression
Uncommon (0.1% to 1%): Immune reconstitution inflammatory syndrome
-Uncommon (0.1% to 1%): Immune reconstitution syndrome
Combination antiretroviral therapy:
-Frequency not reported: Immune reconstitution syndrome, autoimmune disorders in the setting of immune reconstitution (e.g., Graves' disease, polymyositis, Guillain-Barre syndrome, autoimmune hepatitis)
-Uncommon (0.1% to 1%): Gynecomastia
-Postmarketing reports: Bradycardia, myocarditis
-Postmarketing reports: Anemia, pancytopenia, thrombocytopenia, neutropenia
HIV protease inhibitors:
-Frequency not reported: Increased bleeding (including spontaneous skin hematomas, hemarthrosis) in hemophiliacs
-Postmarketing reports: Acute respiratory distress syndrome, pharyngeal lesion, pneumothorax, respiratory failure, pulmonary edema, epistaxis
-Postmarketing reports: Hematuria, proteinuria
-Postmarketing reports: Diffuse large B-cell neoplasm, malignant hepatic neoplasm, lymphoma
-Postmarketing reports: Eye swelling, uveitis, maculopathy, blurred vision
Medically reviewed by BestRx Medical Team Last updated on 1/1/2020.
Source: Drugs.com Prezcobix