Source: FDA, National Drug Code (US) Revision Year: 2021
TYBOST (cobicistat) is a mechanism-based CYP3A inhibitor.
The chemical name for cobicistat is 1,3-thiazol-5-ylmethyl [(2R,5R)5{[(2S)2[(methyl{[2-(propan-2-yl)-1,3-thiazol-4-yl]methyl}carbamoyl)amino]4(morpholin-4-yl)butanoyl]amino}-1,6-diphenylhexan-2-yl]carbamate. It has a molecular formula of C40H53N7O5S2 and a molecular weight of 776.0.
It has the following structural formula:
Cobicistat is adsorbed onto silicon dioxide. Cobicistat on silicon dioxide is a white to pale yellow solid with a solubility of 0.1 mg/mL in water at 20°C.
TYBOST tablets are for oral administration. Each tablet contains 150 mg of cobicistat. The tablets include the following inactive ingredients: silicon dioxide, microcrystalline cellulose, croscarmellose sodium, and magnesium stearate. The tablets are film-coated with a coating material containing the following inactive ingredients: polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide, sunset yellow FCF (FD&C Yellow #6) aluminum lake, and iron oxide yellow.
| Dosage Forms and Strengths |
|---|
|
Orange, round, biconvex, film-coated tablets debossed with “GSI” on one side and plain faced on the other side providing 150 mg of cobicistat. |
| How Supplied |
|---|
|
TYBOST tablets, 150 mg, are orange, round, biconvex, film-coated, and debossed with “GSI” on one side and plain faced on the other side. Each bottle contains 30 tablets (NDC 61958-1401-1) and a silica gel desiccant, with a child-resistant closure. |
| Drug | Countries | |
|---|---|---|
| TYBOST | Austria, Estonia, Spain, Finland, France, Croatia, Ireland, Italy, Lithuania, Netherlands, Poland, United Kingdom, United States |
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