Prezcobix

Medical Editor: John P. Cunha, DO, FACOEP Last updated on RxList: 8/9/2021
Prezcobix Side Effects Center

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:

  • 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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Prezcobix Consumer Information

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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.

Read the entire detailed patient monograph for Prezcobix (Darunavir and Cobicistat Tablets)

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A Timeline of the HIV/AIDS Pandemic See Slideshow
Prezcobix Professional Information

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].

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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