Tarpeyo

TARPEYO- budesonide capsule, delayed release
Calliditas Therapeutics AB

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.

2 DOSAGE AND ADMINISTRATION

The recommended duration of therapy is 9 months, with a dosage of 16 mg administered orally once daily [see Clinical Studies (14.1)]. When discontinuing therapy, reduce the dosage to 8 mg once daily for the last 2 weeks of therapy [see Warnings and Precautions (5.1)].

The delayed release capsules should be swallowed whole in the morning, at least 1 hour before a meal. Do not open, crush or chew.

If a dose is missed, take the prescribed dose at the next scheduled time. Do not double the next dose.

Safety and efficacy of treatment with subsequent courses of TARPEYO have not been established.

3 DOSAGE FORMS AND STRENGTHS

Delayed release capsule containing 4 mg budesonide. White coated opaque capsules printed with “CAL10 4MG” in black ink.

4 CONTRAINDICATIONS

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.

5 WARNINGS AND PRECAUTIONS

5.1 Hypercorticism and Adrenal Axis Suppression

When corticosteroids are used chronically, systemic effects such as hypercorticism and adrenal suppression may occur. Corticosteroids can reduce the response of the hypothalamus-pituitary-adrenal (HPA) axis to stress. In situations where patients are subject to surgery or other stress situations, supplementation with a systemic corticosteroid is recommended. When discontinuing therapy [see Dosing and Administration (2)] or switching between corticosteroids, monitor for signs of adrenal axis suppression.

Patients with moderate to severe hepatic impairment (Child-Pugh Class B and C respectively) could be at an increased risk of hypercorticism and adrenal axis suppression due to an increased systemic exposure of oral budesonide. Avoid use in patients with severe hepatic impairment (Child-Pugh Class C). Monitor for increased signs and/or symptoms of hypercorticism in patients with moderate hepatic impairment (Child-Pugh Class B) [see Use in Specific Populations (8.6), Clinical Pharmacology (12.3)].

5.2 Risks of Immunosuppression

Patients who are on drugs that suppress the immune system are more susceptible to infection than healthy individuals. Chickenpox and measles, for example, can have a more serious or even fatal course in susceptible patients or patients on immunosuppressant doses of corticosteroids. Avoid corticosteroid therapy in patients with active or quiescent tuberculosis infection, untreated fungal, bacterial, systemic viral or parasitic infections, or ocular herpes simplex. Avoid exposure to active, easily-transmitted infections (e.g., chicken pox, measles). Corticosteroid therapy may decrease the immune response to some vaccines.

How the dose, route, and duration of corticosteroid administration affect the risk of developing a disseminated infection is not known. The contribution of the underlying disease and/or prior corticosteroid treatment to the risk is also not known. If exposed to chickenpox, consider therapy with varicella zoster immune globulin (VZIG) or pooled intravenous immunoglobulin (IVIG). If exposed to measles, consider prophylaxis with pooled intramuscular immunoglobulin (IG). If chickenpox develops, consider treatment with antiviral agents.

5.3 Other Corticosteroid Effects

TARPEYO is a systemically available corticosteroid and is expected to cause related adverse reactions. Monitor patients with hypertension, prediabetes, diabetes mellitus, osteoporosis, peptic ulcer, glaucoma or cataracts, or with a family history of diabetes or glaucoma, or with any other condition where corticosteroids may have unwanted effects.

6 ADVERSE REACTIONS

The following clinically significant adverse reactions are described elsewhere in the labeling:

  • Hypercorticism and adrenal 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)]

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 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 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)
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