2. About Drug
• FDA has granted accelerated approval for budesonide-
Controlled release tablets to reduce proteinuria (increased
protein levels in the urine) in adults with primary
immunoglobulin A (IgA) nephropathy at risk of rapid disease
progression.
3. Disease or Condition
• IgA nephropathy, also known as Berger’s disease, is a rare kidney
disease that occurs when IgA (a type of antibody) deposits build up in
the kidneys, causing inflammation that damages kidney tissues. The
deposits can cause the kidneys to leak blood and protein into the
urine. IgA nephropathy complications can include high blood pressure
and chronic kidney disease, which can sometimes progress to kidney
failure.
4. Effectiveness
The effect of the drug was assessed in research participants with IgA
nephropathy, reduced kidney function, and proteinuria who were taking a
stable dose of maximally tolerated renin-angiotensin system (RAS) inhibitor
therapy. Participants were assigned to receive either 16 mg once daily or a
placebo for nine months, followed by a two-week tapering period of either 8
mg once daily or a placebo.
The primary endpoint was the percentage reduction in urine protein-to-
creatinine ratio (UPCR) at nine months compared to the beginning of the
study. The UPCR is a method to estimate daily protein excretion in the urine,
with a lower number indicating less protein. At nine months, research
participants receiving Budesonide had an average 34% reduction in UPCR,
whereas participants receiving the placebo had an average 5% reduction in
UPCR.
5. Safety Information
• Who have allergic to budesonide must not take this medication
• Side Effects- Hypercortisolism (High levels of Cortisol Hormone) and
Adrenal Suppression (not able to produce enough Cortisol).
• Budesonide is an immunosuppressant. As such, patients should avoid
if they have tuberculosis; untreated fungal, bacterial, systemic viral or
parasitic infections; or ocular herpes simplex (an eye infection).
• Patients taking budesonide should avoid being exposed to active,
easily transmitted infections.
6. • The most common side effects of Tarpeyo are high blood pressure;
swelling in the lower legs and hands; muscle spasms; acne; skin
irritation; weight increase; difficulty breathing; face swelling;
indigestion; fatigue; and excess hair, often around the nose and
mouth.
7. Common Side effects.
• Headache
• Abdominal pain
• Depression
• Joint pain
• Cushing syndrome
• Dyspepsia
• Increased risk of infection
• Muscle pain
• Muscle weakness
• Muscle twitching
• Osteoporosis
• Irritability
• Euphoria (feeling of intense excitement and happiness)
• Constipation
• Nausea
