Tarpeyo
Generic: BUDESONIDE
Basic Information
Manufacturer
Calliditas Therapeutics AB
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
ORAL
FDA Set ID
938cada4-d6bf-4252-836f-dd40f9eadb4d
Indications & Usage
1 INDICATIONS AND USAGE TARPEYO is indicated to reduce the loss of kidney function in adults with primary immunoglobulin A nephropathy (IgAN) who are at risk for disease progression.
TARPEYO is a corticosteroid indicated to reduce the loss of kidney function in adults with primary immunoglobulin A nephropathy (IgAN) who are at risk for disease progression.
( 1 )
TARPEYO is a corticosteroid indicated to reduce the loss of kidney function in adults with primary immunoglobulin A nephropathy (IgAN) who are at risk for disease progression.
( 1 )
Adverse Reactions
6 ADVERSE REACTIONS 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, dermatitis, arthralgia, white blood cell count increased.
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Calliditas Therapeutics at 1-844-IGA-0011 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
6.1 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.
The safety of TARPEYO was evaluated in 389 patients in the randomized, double-blind, placebo-controlled study, NefIgArd (NCT: 03643965, Phase 3 clinical study in adults with primary IgAN).
The data below reflect TARPEYO exposure in 195 patients with a median duration of 41 weeks, compared with comparable exposure to placebo in 194 patients.
The most common adverse reactions, reported in greater than or equal to 5% of TARPEYO-treated patients and greater than or equal to 2% higher than placebo, in the 9-month treatment period are listed in Table 1 .
Most adverse reactions that occurred at a greater incidence for TARPEYO compared to placebo were consistent with hypercortisolism and reversible, resolving within 3 months after discontinuation.
Table 1: Reported adverse reactions occurring in greater than or equal to 5% of TARPEYO treated patients, and greater than or equal to 2% higher than Placebo Adverse Reaction TARPEYO 16 mg (N=195) Placebo (N=194) n (%) n (%) Peripheral edema 33 (17) 10 (5) Hypertension 23 (12) 6 (3) Muscle spasms 23 (12) 8 (4) Acne 22 (11) 2 (1) Headache 19 (10) 14 (7) Upper respiratory tract infection 16 (8) 12 (6) Face edema 15 (8) 1 (0.5) Weight increased 13 (7) 6 (3) Dyspepsia 13 (7) 4 (2) Dermatitis 12 (6) 2 (1) Arthralgia 12 (6) 4 (2) White blood cell count increased 11 (6) 1 (0.5)
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Calliditas Therapeutics at 1-844-IGA-0011 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
6.1 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.
The safety of TARPEYO was evaluated in 389 patients in the randomized, double-blind, placebo-controlled study, NefIgArd (NCT: 03643965, Phase 3 clinical study in adults with primary IgAN).
The data below reflect TARPEYO exposure in 195 patients with a median duration of 41 weeks, compared with comparable exposure to placebo in 194 patients.
The most common adverse reactions, reported in greater than or equal to 5% of TARPEYO-treated patients and greater than or equal to 2% higher than placebo, in the 9-month treatment period are listed in Table 1 .
Most adverse reactions that occurred at a greater incidence for TARPEYO compared to placebo were consistent with hypercortisolism and reversible, resolving within 3 months after discontinuation.
Table 1: Reported adverse reactions occurring in greater than or equal to 5% of TARPEYO treated patients, and greater than or equal to 2% higher than Placebo Adverse Reaction TARPEYO 16 mg (N=195) Placebo (N=194) n (%) n (%) Peripheral edema 33 (17) 10 (5) Hypertension 23 (12) 6 (3) Muscle spasms 23 (12) 8 (4) Acne 22 (11) 2 (1) Headache 19 (10) 14 (7) Upper respiratory tract infection 16 (8) 12 (6) Face edema 15 (8) 1 (0.5) Weight increased 13 (7) 6 (3) Dyspepsia 13 (7) 4 (2) Dermatitis 12 (6) 2 (1) Arthralgia 12 (6) 4 (2) White blood cell count increased 11 (6) 1 (0.5)