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Tybost

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Overview

What is Tybost?

TYBOST (cobicistat) is a mechanism-based CYP3A inhibitor.

The chemical name for cobicistat is 1,3-thiazol-5-ylmethyl [(2,5)-5-{[(2)-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 CHNOS 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.



What does Tybost look like?



What are the available doses of Tybost?

Tablets: 150 mg. ()

What should I talk to my health care provider before I take Tybost?

How should I use Tybost?

TYBOST 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

Administer TYBOST in conjunction with atazanavir or darunavir and other antiretroviral agents in the treatment of adults with HIV-1 infection. The recommended dosages of TYBOST and atazanavir or darunavir given with food are presented in Table 1. TYBOST must be coadministered at the same time as atazanavir or darunavir Consult the prescribing information for atazanavir or darunavir.


What interacts with Tybost?

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What are the warnings of Tybost?

Sorry No Records found


What are the precautions of Tybost?

Sorry No Records found


What are the side effects of Tybost?

Sorry No records found


What should I look out for while using Tybost?

The concomitant use of TYBOST with atazanavir or darunavir and the following drugs (see ) is contraindicated due to the potential for serious and/or life-threatening events or loss of therapeutic effect .


What might happen if I take too much Tybost?

If overdose occurs, the patient must be monitored for evidence of toxicity. Treatment of overdose with TYBOST consists of general supportive measures including monitoring of vital signs, as well as observation of the clinical status of the patient.

As cobicistat is highly bound to plasma proteins, it is unlikely that it will be significantly removed by hemodialysis or peritoneal dialysis.


How should I store and handle Tybost?

Store at 25°C (77°F); excursions permitted to 15 to 30°C (59 to 86°F) [see USP Controlled Room Temperature]. Pharmacist: Dispense in a tight, light-resistant container with a child-resistant closure and medication guide. Store at 25°C (77°F); excursions permitted to 15 to 30°C (59 to 86°F) [see USP Controlled Room Temperature]. Pharmacist: Dispense in a tight, light-resistant container with a child-resistant closure and medication guide. 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.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.


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Clinical Information

Chemical Structure

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Clinical Pharmacology

Cobicistat is a mechanism-based inhibitor of cytochrome P450 3A (CYP3A). Inhibition of CYP3A-mediated metabolism by cobicistat increases the systemic exposure of CYP3A substrates atazanavir and darunavir.

Non-Clinical Toxicology
The concomitant use of TYBOST with atazanavir or darunavir and the following drugs (see ) is contraindicated due to the potential for serious and/or life-threatening events or loss of therapeutic effect .

Due to the potential for additive effects, caution and careful titration are warranted in patients receiving diltiazem concomitantly with any agents known to affect cardiac contractility and/or conduction. (See .)

Pharmacologic studies indicate that there may be additive effects in prolonging AV conduction when using beta-blockers or digitalis concomitantly with diltiazem. (See .)

As with all drugs, care should be exercised when treating patients with multiple medications. Diltiazem is both a substrate and an inhibitor of the cytochrome P-450 3A4 enzyme system. Other drugs that are specific substrates, inhibitors, or inducers of this enzyme system may have a significant impact on the efficacy and side effect profile of diltiazem. Patients taking other drugs that are substrates of CYP450 3A4, especially patients with renal and/or hepatic impairment, may require dosage adjustment when starting or stopping concomitantly administered diltiazem in order to maintain optimum therapeutic blood levels.

TYBOST decreases estimated creatinine clearance due to inhibition of tubular secretion of creatinine without affecting actual renal glomerular function. This effect should be considered when interpreting changes in estimated creatinine clearance in patients initiating TYBOST, particularly in patients with medical conditions or receiving drugs needing monitoring with estimated creatinine clearance.

Prior to initiating therapy with TYBOST, assess estimated creatinine clearance . Dosage recommendations are not available for drugs that require dosage adjustments in TYBOST-treated patients with renal impairment . Consider alternative medications that do not require dosage adjustments in patients with renal impairment.

Although TYBOST may cause modest increases in serum creatinine and modest declines in estimated creatinine clearance without affecting renal glomerular function, patients who experience a confirmed increase in serum creatinine of greater than 0.4 mg/dL from baseline should be closely monitored for renal safety.

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

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Professional

Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72
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Interactions

Interactions

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