TARPEYO

AbsorptionFollowing single oral administration of TARPEYO 16 mg to healthy subjects, the average geometric mean C max (CV%) was 4.4 ng/mL (58.3), and AUC 0-24 was 24.1 h*ng/mL (49.7). Median T lag (min, max) was 3.1 h (0, 6) while median T max (min, max) was 5.1 h (4.5, 10). Food Effect There was no clinically relevant food effect observed on the overall systemic exposure of budesonide when either a moderate or high fat meal was consumed 1 hour after administration of TARPEYO.

DistributionAppr...

14.1 Treatment of IgAN TARPEYO was shown to reduce the loss of kidney function in adults with primary IgAN at risk of disease progression in the NefIgArd trial. While the effect on kidney function that was seen during the 9-month treatment period persisted following completion of treatment, TARPEYO did not change the long-term rate of decline in kidney function. NefIgArd Study: A Phase 3, Double-Blind Placebo-Controlled, Randomized Trial in Adults with Primary IgAN The effect of TARPEYO on proteinuria and kidney function (estimated glomerular filtration rate, eGFR) was assessed in a randomized...

The following clinically significant adverse reactions are described elsewhere in the labeling: Hypercorticism and adrenal axis suppression [see Warnings and Precautions ( 5.1 )] Risks of immunosuppression [see Warnings and Precautions ( 5.2 )] Other corticosteroid effects [see Warnings and Precautions ( 5.3 )] Most common adverse reactions ( ≥5%) are peripheral edema, hypertension, muscle spasms, acne, headache, upper respiratory tract infection, face edema, weight increased, dyspepsia, dermati...

TARPEYO is contraindicated in patients with hypersensitivity to budesonide or any of the ingredients of TARPEYO. Serious hypersensitivity reactions, including anaphylaxis have occurred with other budesonide formulations. Hypersensitivity to budesonide or any of the ingredients in TARPEYO. ( 4 )

Hypercorticism and Adrenal Axis Suppression: Follow general warnings concerning corticosteroids, patients with hepatic impairment may be at increased risk. Taper upon discontinuation. ( 2 , 5.1 , 8.6 , 12.3 ) Immunosuppression and Increased Risk of Infection: Avoid use in patients with active or quiescent tuberculosis infection, untreated fungal, bacterial, systemic viral or parasitic infections, or ocular herpes simplex. May affect vaccine efficacy. ( 5.2 ) Other Corticosteroid Effects: Monitor...

7 DRUG INTERACTIONS Potent CYP3A4 Inhibitors (e.g. ketoconazole, grapefruit juice): Can increase systemic budesonide concentrations: avoid concomitant use. ( 7.1 ) 7.1 Interaction with CYP3A4 Inhibitors Budesonide is a substrate for CYP3A4. Avoid use with potent CYP3A4 inhibitors; e.g. ketoconazole, itraconazole, ritonavir, indinavir, saquinavir, erythromycin, and cyclosporine [see Clinical Pharma...