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Tybost

Tybost (Cobicistat Tablets) side effects drug center

 

PROFESSIONAL

CONSUMER

SIDE EFFECTS

 

Tybost Side Effects Center

What Is Tybost?

Tybost (cobicistat) is a CYP3A inhibitor indicated to increase systemic exposure of atazanavir or darunavir (once daily dosing regimen) in combination with other antiretroviral agents in the treatment of HIV-1 infection.

What Are Side Effects of Tybost?

Common side effects of Tybost include:

  • yellowing of the skin and eyes (jaundice),
  • rash (including itching and hives),
  • nausea,
  • diarrhea, and
  • headache.

Less common side effects of Tybost include:

Dosage for Tybost?

The recommended dosage of Tybost is 150 mg orally once daily, coadministered with atazanavir or darunavir at the same time, with food, and in combination with other HIV-1 antiretroviral agents.

What Drugs, Substances, or Supplements Interact with Tybost?

Tybost may interact with alpha 1-adrenoreceptor antagonists, antiarrhythmics, anticonvulsants, antimycobacterials, antineoplastics, ergot derivatives, GI motility agents, St. John's wort, HMG-CoA reductase inhibitors, neuroleptics, non-nucleoside reverse transcriptase inhibitors, phosphodiesterase-5 (PDE-5) inhibitors, protease inhibitors, sedatives, hypnotics, and others. Tell your doctor all medications and supplements you use.

Tybost During Pregnancy and Breastfeeding

During pregnancy, Tybost should only be taken if prescribed. There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to Tybost during pregnancy. Women infected with HIV should not breastfeed due to the potential for HIV transmission.

Additional Information

Our Tybost (cobicistat) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

 

Tybost Consumer Information

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • kidney problems--little or no urination, swelling in your feet or ankles, feeling tired or short of breath; or
  • liver problems--upper stomach pain, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Common side effects may include:

  • nausea;
  • jaundice; or
  • rash.

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 Tybost (Cobicistat Tablets)

 

Tybost Professional Information

SIDE EFFECTS

The following adverse reaction is described in greater detail in another section of the labeling:

  • New Onset or Worsening Renal Impairment When Used with Tenofovir Disoproxil Fumarate [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 practice.

Adverse Reactions From Clinical Trials Experience In Adults

The safety of TYBOST is based on Week 144 data from a Phase 3 trial, Trial 114, in which 692 HIV-1 infected, antiretroviral treatment-naïve subjects received:

  • TYBOST coadministered with atazanavir and TDF/emtricitabine (administered as TRUVADA) (N=344) or
  • ritonavir coadministered with atazanavir and TDF/emtricitabine (administered as TRUVADA) (N=348).

The most common adverse reactions (Grades 2−4) and reported in >5% of subjects in the TYBOST group were jaundice (6%) and rash (5%). The proportion of subjects who discontinued study treatment due to adverse events, regardless of severity, was 11% in both the TYBOST and ritonavir groups. Table 3 displays the frequency of adverse reactions (Grades 2−4) occurring in at least 2% of subjects in the TYBOST group in Trial 114.

Table 3 - Selected Adverse Reactionsa (Grades 2−4) Reported in ≥2% of HIV-1 Infected Treatment-Naïve Adults in the TYBOST Coadministered with Atazanavir Group in Trial 114 (Week 144 Analysis)

  TYBOST Coadministered with Atazanavir + TRUVADA
N=344		 Ritonavir Coadministered with Atazanavir + TRUVADA
N=348
Jaundice 6% 3%
Rashb 5% 4%
Ocular icterus 4% 2%
Nausea 2% 2%
Diarrhea 2% 1%
Headache 2% 1%
a. Frequencies of adverse reactions are based on Grades 2−4 adverse events attributed to study drugs.
b. Rash events include dermatitis allergic, drug hypersensitivity, pruritus generalized, eosinophilic pustular folliculitis, rash, rash generalized, rash macular, rash maculo-papular, rash morbilliform, rash papular, and urticaria.

Less Common Adverse Reactions

Selected adverse reactions of at least moderate severity (≥Grade 2) occurring in less than 2% of subjects receiving TYBOST coadministered with atazanavir and TRUVADA are listed below. These events have been included because of the investigator’s assessment of potential causal relationship and were considered serious or have been reported in more than one subject treated with TYBOST and with greater frequency compared with ritonavir.

Gastrointestinal Disorders: vomiting, upper abdominal pain

General Disorders and Administration Site Conditions: fatigue

Musculoskeletal and Connective Tissue Disorders: rhabdomyolysis

Psychiatric Disorders: depression, abnormal dreams, insomnia

Renal and Urinary Disorders: nephropathy, Fanconi syndrome acquired, nephrolithiasis

Refer to the prescribing information for atazanavir or darunavir for information regarding adverse reactions with these drugs.

Laboratory Abnormalities

The frequency of laboratory abnormalities (Grades 3−4) occurring in at least 2% of subjects in the TYBOST group in Trial 114 is presented in Table 4.

Table 4 - Laboratory Abnormalities (Grades 3−4) in ≥2% of HIV-1 Infected Treatment-Naïve Adults in the TYBOST Coadministered withs Atazanavir Group in Trial 114 (Week 144 Analysis)

  TYBOST + Atazanavir + TRUVADA Ritonavir + Atazanavir + TRUVADA
Laboratory Parameter Abnormality N=344 N=348
Total Bilirubin (>2.5 × ULN) 73% 66%
Creatine Kinase (≥10.0 × ULN) 8% 9%
Urine RBC (Hematuria) (>75 RBC/HPF) 6% 3%
ALT (>5.0 × ULN) 6% 3%
AST (>5.0 × ULN) 4% 3%
GGT (>5.0 × ULN) 4% 2%
Serum Amylasea (>2.0 × ULN) 4% 2%
Urine Glucose (Glycosuria) (≥1000 mg/dL) 3% 3%
Neutrophils (<750/mm3) 3% 2%
Serum Glucose (Hyperglycemia) (>250 mg/dL) 2% 2%
a. For subjects with serum amylase >1.5 × upper limit of normal, lipase test was also performed. The frequency of increased lipase (Grades 3−4) occurring in the TYBOST (N=46) and ritonavir (N=35) groups was 7% and 3%, respectively.

Increase in Serum Creatinine

TYBOST causes increases in serum creatinine and decreases in estimated creatinine clearance due to inhibition of tubular secretion of creatinine without affecting actual renal glomerular function [see WARNINGS AND PRECAUTIONS and CLINICAL PHARMACOLOGY]. In Trial 114, increases in serum creatinine and decreases in estimated creatinine clearance occurred early in treatment with TYBOST, after which they stabilized. The mean (± SD) change in estimated glomerular filtration rate (eGFR) by Cockcroft-Gault method after 144 weeks of treatment was –15.1 ± 16.5 mL/min in the TYBOST group and –8.0 ± 16.8 mL/min in the ritonavir group.

Serum Lipids

Changes from baseline in total cholesterol, HDL-cholesterol, LDL-cholesterol, and triglycerides are presented in Table 5. In both groups, mean values for serum lipids remained within the study reference range for each laboratory test. The clinical significance of these changes is unknown.

Table 5 - Lipid Values, Mean Change from Baseline, Reported in HIV-1 Infected Treatment-Naïve Adults Receiving TYBOST Coadministered with Atazanavir + TRUVADA or Ritonavir Coadministered with Atazanavir + TRUVADA in Trial 114 (Week 144 Analysis)

  TYBOST + Atazanavir + TRUVADA Ritonavir + Atazanavir + TRUVADA
Baseline Week 144 Baseline Week 144
mg/dL Change from baselinea mg/dL Change from baselinea
Total Cholesterol (fasted) 163
[N=219]		 +11
[N=219]		 165
[N=227]		 +13
[N=227]
HDL-cholesterol (fasted) 43
[N=218]		 +7
[N=218]		 43
[N=228]		 +6
[N=228]
LDL-cholesterol (fasted) 102
[N=218]		 +11
[N=218]		 104
[N=228]		 +16
[N=228]
Triglycerides (fasted) 130
[N=219]		 +14
[N=219]		 131
[N=227]		 +14
[N=227]
a. The change from baseline is the mean of within-patient changes from baseline for patients with both baseline and Week 144 values. Analysis excludes subjects receiving an HMG-CoA reductase inhibitor drug.

Adverse Reactions From Clinical Trials Experience In Pediatric Subjects

The safety of TYBOST was evaluated in HIV-1 infected virologically suppressed pediatric subjects between the ages of 12 to less than 18 years through Week 48 in an open-label clinical trial (Trial 128) of TYBOST coadministered with atazanavir (N=14) or darunavir (N=7) plus two nucleoside reverse transcriptase inhibitors [see Clinical Studies]. In this trial, the safety profile of TYBOST was similar to that in adults.

Read the entire FDA prescribing information for Tybost (Cobicistat Tablets)

&Copy; Tybost Patient Information is supplied by Cerner Multum, Inc. and Tybost Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.