KHINDIVI

AbsorptionFollowing oral administration of KHINDIVI (5 mg) in dexamethasone-suppressed healthy adult volunteers under fasted conditions, mean (range) maximum plasma concentration (C max ) of hydrocortisone is 152 (98-210) ng/mL. Mean (range) time to reach maximum concentration (T max ) is 0.5 (0.25-0.75) hours. Effect of Food No clinically significant differences in KHINDIVI pharmacokinetics were observed following administration of a high-fat meal. Distribution 90% or more of circulating hydro...

The following serious adverse reactions are described here and elsewhere in the label: Adrenal Crisis [see Warnings and Precautions (5.1) ] Systemic Adverse Reactions Due to Inactive Ingredients [see Warnings and Precautions (5.2) ] Immunosuppression and Increased Risk of Infection with Use of a Dosage Greater Than Replacement [see Warnings and Precautions (5.3) ] Growth Retardation [see Warnings and Precautions (5.4) ] Cushing's Syndrome Due to Use of Excessive Doses of Corticosteroids [see War...

KHINDIVI is contraindicated in patients with hypersensitivity to hydrocortisone or to any component of KHINDIVI. Reactions have included anaphylaxis in patients receiving corticosteroids [see Adverse Reactions (6.2) ] . Hypersensitivity to hydrocortisone or any component of KHINDIVI. ( 4 )

Adrenal Crisis : Undertreatment, sudden discontinuation of therapy, or switching from another oral hydrocortisone formulation may lead to adrenocortical insufficiency, adrenal crisis and death. Adrenal crisis may also be induced by stress events such as infections or surgery. During periods of stress switch to another oral hydrocortisone product and increase the dose. Switch patients who are vomiting, severely ill or unable to take oral medications to parenteral corticosteroid formulations. ( 5....

7 DRUG INTERACTIONS

Table 2Drug Interactions with KHINDIVI CYP3A4 Inhibitors Clinical Impact: Hydrocortisone is metabolized by cytochrome P450 3A4 (CYP3A4). Concomitant administration of inhibitors of CYP3A4 may lead to increases in serum concentrations of KHINDIVI and increase the risk of adverse reactions associated with the use of excessive doses. Intervention: Concomitant use of CYP3A4 inhib...