Nefecon Application Scope

Nefecon (Tarpeyo, budesonide delayed-release capsules) is indicated to reduce the loss of kidney function in adults with primary immunoglobulin A nephropathy (IgAN) who are at risk for disease progression.

Nefecon Characteristics

Ingredients: Budesonide
Properties: White or almost white capsules, printed with “CAL10 4MG” in black
Packaging Specification: High-density polyethylene bottle with a child-resistant closure. 120 capsules/bottle
Storage: Store in a tightly closed container at temperatures not exceeding 30°C
Expiry Date: 36 months
Executive Standard: US FDA prescribing information, NDA 215935
Approval Number: National Drug Approval Number H20230130 (China)
Date of Revision: Please refer to the latest package insert
Manufacturer: Calliditas Therapeutics AB

Guidelines for the Use of Nefecon

Dosage and Administration:
- Recommended Dose: The recommended course is 16 mg (four 4 mg capsules) taken orally once daily for 9 months
- Administration: Capsules must be taken in the morning, on an empty stomach, at least 1 hour before a meal. They must be swallowed whole with water. Do not open, crush, or chew the capsules
- Missed Dose: If a dose is missed, take the next dose at the regular scheduled time. Do not double the dose to make up for a missed one.
Adverse Reactions:
- Common Adverse Reactions: Include acne (≈10%), hypertension, peripheral edema, facial edema, dyspepsia, headache, muscle cramps
- Serious Adverse Reactions: Although less common due to low systemic exposure, potential serious reactions related to systemic corticosteroids may occur, such as adrenal suppression, hypercortisolism, increased risk of infections, elevated blood pressure, glucose intolerance, mood changes, osteoporosis, and glaucoma.
Contraindications:
- Hypersensitivity to budesonide or any excipients in Nefecon.
- Patients with severe hepatic impairment (Child-Pugh Class C)
Precautions:
- Monitor for adrenal suppression, especially if the patient is under physiological stress (e.g., surgery, trauma) or when tapering off the drug.
- Patients with conditions exacerbated by corticosteroids (e.g., hypertension, diabetes mellitus, glaucoma, osteoporosis) should be monitored.
- Avoid using with potent CYP3A4 inhibitors (which can raise systemic budesonide levels). Avoid grapefruit juice.
- For pregnancies/breastfeeding: use only if benefits justify risk; monitor potential for fetal/neonatal adrenal suppression.

Nefecon Interactions

Budesonide is a substrate of CYP3A4. Potent inhibitors of CYP3A4 (e.g., ketoconazole, itraconazole, ritonavir, and erythromycin) may significantly increase systemic exposure and should be avoided or used with caution.
Grapefruit juice (inhibitor of CYP3A4) should be avoided.

Note:

If there is a new packaging for the drug, the new packaging shall prevail. The above information is sourced from DengYue Medicine.
This content is for reference only. Prescription drugs must be used under a doctor’s guidance and purchased from authorized sources.