Atrasentan Dosage

Medically reviewed by Drugs.com. Last updated on May 12, 2025.

Usual Adult Dose for Primary Immunoglobulin A Nephropathy

0.75 mg orally once a day

Use: For the reduction of proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at risk of rapid disease progression, generally a urine protein-to-creatinine ratio 1.5 g/g or greater.

Renal Dose Adjustments

Renal dysfunction: Data not available; the manufacturer makes no recommendation.

Comments:

• Mild to severe renal dysfunction had no clinically significant effect on the exposure of this drug; however, no data are available in patients with end-stage renal disease.

Liver Dose Adjustments

LIVER DYSFUNCTION:

• Mild or moderate liver dysfunction: No adjustment recommended.
• Severe liver dysfunction (Child-Pugh B or C): Do not initiate therapy.

RECOMMENDATIONS FOR ELEVATED LIVER ENZYMES:

• Baseline elevated aminotransferases (greater than 3 times the upper limit of normal [3 x ULN]): Consider more frequent liver test monitoring during therapy
• Elevated aminotransferases during therapy OR elevated with increased bilirubin (greater than 2 x ULN): Discontinue therapy; may consider reinitiation when aminotransferase levels normalize.
• Symptoms of hepatotoxicity or jaundice: Discontinue therapy

Precautions

US FDA requires a medication guide to assure safe use. For additional information visit:
www.fda.gov/drugs/drug-safety-and-availability/medication-guides

US BOXED WARNING:

• EMBRYOFETAL TOXICITY: Use of this drug is contraindicated in pregnant patients. Based on data in animals, this drug may cause major birth defects. Exclude pregnancy prior to initiation of treatment. Advise patients to use effective contraception before starting therapy, during treatment, and for 2 weeks after the last dose. Stop therapy as soon as possible if the patient becomes pregnant.

CONTRAINDICATIONS:

• Known hypersensitivity to the active component or any of the ingredients
• Pregnancy

Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Comments:

• This drug is highly bound to plasma proteins; efficient removal via hemodialysis is unlikely.

Other Comments

Administration advice:

• Prior to administration, exclude pregnancy in women of childbearing potential.
• Dose may be administered with or without food.
• Swallow dose whole; do not cut, crush, or chew tablets.
• If a dose or doses are missed, administer dose at the next scheduled time; do not double up the dose.

Storage requirements:

• Store at 20C to 25C (68F to 77F); excursions permitted between 15C and 30C (59F and 86F).
• Store and dispense tablets in the original container.

General:

• This treatment is approved under accelerated approval based on a reduction of proteinuria. It has not been established whether this drug slows kidney function decline in patients with primary immunoglobulin A nephropathy; continued approval is contingent on additional studies.

Monitoring:

• Hepatic: Liver enzymes (at baseline and periodically during therapy as indicated; more often in patients with elevated liver enzymes at baseline)

Patient advice:

• Read the US FDA-approved patient labeling (Medication Guide).
• Contact your health care provider if signs/symptoms of hepatic injury such unexplained nausea, vomiting, right upper quadrant pain, fatigue, anorexia, jaundice, dark urine, fever, or itching occur.
• Tell your medical provider about all the medications you take (including over the counter products).
• Notify your health care provider of any symptoms of increased weight or ankle/leg swelling.
• Patients of childbearing potential:
• A negative pregnancy test is recommended prior to starting therapy.
• Effective contraception is encouraged before, during, and for 2 weeks after the last dose of treatment.
• Notify your health care provider of a known/suspected pregnancy, or if you are breastfeeding.

See also:

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer