Medical Editor: John P. Cunha, DO, FACOEP
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:
- 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.
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.
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].
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].
Read the entire FDA prescribing information for Prezcobix (Darunavir and Cobicistat Tablets)