Nevada 150

Indications

Vadadustat is used to treat anaemia (a low red blood cell count) caused by chronic kidney disease in adults who are on regular dialysis. It is not meant for people with kidney disease who are not on dialysis, and it is not a replacement for urgent blood transfusion.

How It Works

Vadadustat is a hypoxia-inducible factor prolyl hydroxylase (HIF-PH) inhibitor. It blocks an enzyme that normally breaks down HIF, a natural signal the body uses when oxygen is low. With more HIF active, the body makes more of its own erythropoietin (the hormone that tells the bone marrow to make red blood cells) and uses iron better, so haemoglobin rises.

Dosage and Administration

The dose is started and adjusted by a kidney specialist, as prescribed, based on regular haemoglobin blood tests. It is taken by mouth once a day, with or without food, and can be taken at any time in relation to dialysis. Swallow the tablet whole. Take it at least 1 hour before any oral iron, iron-containing phosphate binders or other medicines containing iron. Do not change the dose yourself.

Interactions

• Oral iron supplements and phosphate binders containing iron, calcium or other metals can reduce absorption; take vadadustat at least 1 hour before them.
• It can raise blood levels of some statins (such as Rosuvastatin and Simvastatin), so your doctor may limit the statin dose.
• Some medicines such as Probenecid and certain enzyme inducers like Rifampicin may change vadadustat levels.
• Tell your doctor about every medicine and supplement you take.

Contraindications

• Allergy to vadadustat or any ingredient.
• Uncontrolled high blood pressure.

Side Effects

Common effects include diarrhoea, nausea, high blood pressure, cough, headache, abdominal pain and high potassium. Some patients may develop liver test changes or blood clots in the dialysis access.

Get urgent medical help for chest pain, shortness of breath, pain or swelling in the leg, sudden weakness or numbness of one side, trouble speaking, severe headache or confusion, a seizure, very high blood pressure, or yellowing of the skin or eyes with dark urine.

Pregnancy and Lactation

Safety in pregnancy is not established; use only if the specialist decides the benefit outweighs the risk. Breastfeeding is not recommended during treatment and for a short time after the last dose; discuss with your doctor.

Precautions and Warnings

• Like other medicines that raise haemoglobin, it may increase the risk of heart attack, stroke, blood clots and death, especially if haemoglobin is pushed too high; the lowest effective dose is used.
• Liver blood tests are checked before starting and regularly during the first months.
• Blood pressure should be well controlled and checked often.
• It is not recommended in people with active cancer without specialist advice.

Overdose

An overdose may raise haemoglobin too much or cause stomach upset. Contact a doctor promptly; blood tests and dose review may be needed.

Therapeutic Class

Anti-anaemic agent; hypoxia-inducible factor prolyl hydroxylase (HIF-PH) inhibitor.

Storage

Store below 30°C in a dry place, away from light, in the original pack, out of the reach of children.