Darunavir Cobicistat Brand Name– PREZCOBIX
What is Darunavir Cobicistat
Darunavir cobicistat is a fixed-dose combination product containing a protease inhibitor (darunavir) and a pharmacokinetic enhancer (cobicistat).
The drug is indicated for use in combination with other antiretroviral agents to treat HIV-1 infection in both treatment-naive and treatment-experienced adults with no darunavir resistance-associated substitutions.
The manufacturer recommends genotypic testing prior to initiating treatment in order to identify resistance-associated amino acid substitutions.
If testing is not available, the drug can still be used in protease inhibitor-naive patients; however use is not recommended for those who have previously received a protease inhibitor.
Approval was based on efficacy demonstrated in clinical trials of darunavir coadministered with ritonavir.
Darunavir cobicistat was approved by the FDA in January 2015
Indications
- human immunodeficiency virus (HIV)
- human immunodeficiency virus (HIV) infection
Side Effects
- abdominal pain
- acute generalized exanthematous pustulosis (AGEP)
- angioedema
- anorexia
- asthenia
- bleeding
- breast enlargement
- conjunctivitis
- Cushingoid features
- depression
- diabetes mellitus
- diabetic ketoacidosis
- diarrhea
- Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)
- dyspepsia
- elevated hepatic enzymes
- eosinophilia
- Fanconi syndrome
- fatigue
- fever
- flatulence
- folliculitis
- glycosuria
- gynecomastia
- headache
- hematoma
- hematuria
- hepatitis
- hyperamylasemia
- hyperbilirubinemia
- hypercholesterolemia
- hyperglycemia
- hyperlipidemia
- hypertriglyceridemia
- hypophosphatemia
- insomnia
- jaundice
- lipodystrophy
- maculopapular rash
- malaise
- myalgia
- nausea
- nephrolithiasis
- nightmares
- oral ulceration
- pancreatitis
- pruritus
- rash
- renal failure (unspecified)
- rhabdomyolysis
- Stevens-Johnson syndrome
- toxic epidermal necrolysis
- urticaria
- vomiting
Monitoring Parameters
- blood glucose
- CBC with differential
- CD4+ T cell count
- hepatitis B serology
- LFTs
- plasma hepatitis C RNA
- plasma HIV RNA
- pregnancy testing
- serum bilirubin (total and direct)
- serum cholesterol
- serum creatinine/BUN
- serum lipid profile
- serum triglycerides
- urinalysis
Contraindications
- autoimmune disease
- bleeding
- breast-feeding
- children
- diabetes mellitus
- diabetic ketoacidosis
- dialysis
- Graves’ disease
- Guillain-Barre syndrome
- hemophilia
- hepatic disease
- hepatitis
- hepatitis B and HIV coinfection
- hepatitis C and HIV coinfection
- human immunodeficiency virus (HIV) infection resistance
- hypercholesterolemia
- hyperglycemia
- hyperlipidemia
- hypertriglyceridemia
- immune reconstitution syndrome
- infants
- jaundice
- neonates
- pancreatitis
- pregnancy
- renal failure
- renal impairment
- serious rash
- sulfonamide hypersensitivity
Interactions
- Abacavir; Dolutegravir; Lamivudine
- Abemaciclib
- Acalabrutinib
- Acarbose
- Acetaminophen; Butalbital
- Acetaminophen; Butalbital; Caffeine
- Acetaminophen; Butalbital; Caffeine; Codeine
- Acetaminophen; Caffeine; Dihydrocodeine
- Acetaminophen; Chlorpheniramine; Dextromethorphan; Phenylephrine
- Acetaminophen; Chlorpheniramine; Dextromethorphan; Pseudoephedrine
- Acetaminophen; Chlorpheniramine; Phenylephrine; Phenyltoloxamine
- Acetaminophen; Codeine
- Acetaminophen; Dextromethorphan
- Acetaminophen; Dextromethorphan; Doxylamine
- Acetaminophen; Dextromethorphan; Guaifenesin; Phenylephrine
- Acetaminophen; Dextromethorphan; Phenylephrine
- Acetaminophen; Dextromethorphan; Pseudoephedrine
- Acetaminophen; Diphenhydramine
- Acetaminophen; Hydrocodone
- Acetaminophen; Oxycodone
- Acetaminophen; Tramadol
- Adefovir
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- Amlodipine; Hydrochlorothiazide, HCTZ; Valsartan
- Amlodipine; Olmesartan
- Amlodipine; Telmisartan
- Amlodipine; Valsartan
- Amobarbital
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- Aspirin, ASA; Caffeine; Dihydrocodeine
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- Aspirin, ASA; Omeprazole
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- Chlorpheniramine; Dihydrocodeine; Phenylephrine
- Chlorpheniramine; Dihydrocodeine; Pseudoephedrine
- Chlorpheniramine; Guaifenesin; Hydrocodone; Pseudoephedrine
- Chlorpheniramine; Hydrocodone
- Chlorpheniramine; Hydrocodone; Phenylephrine
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- Empagliflozin; Metformin
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