Danicopan (dan-i-KOE-pan)

Treats extravascular hemolysis (breakdown of red blood cells that takes place outside of the blood vessels) in patients with paroxysmal nocturnal hemoglobinuria (PNH).

Brand Name(s):

Voydeya

When This Medicine Should Not Be Used:

How to Use This Medicine:

Tablet

• Take your medicine as directed. Your dose may need to be changed several times to find what works best for you. Take this medicine at the same time each day.
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.
• Missed dose: If you miss a dose, take it as soon as possible. If you miss a dose and it is within 3 hours of your next scheduled dose, skip the missed dose and take your next dose at the regular time. Do not use extra medicine to make up for a missed dose.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Some medicines can affect how danicopan works. Tell your doctor if you are using fexofenadine, rosuvastatin, or tacrolimus.

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant, or if you have liver disease, a weak immune system, or any kind of infection.
• Do not breastfeed during treatment and for 3 days after the last dose.
• This medicine can increase your risk of serious infections, including pneumonia and meningitis. You will need to be vaccinated against these infections at least 2 weeks before you start treatment with this medicine. You may be given antibiotic medicines to prevent infections if you are to use this medicine right away. You will also be given a patient safety card that lists the symptoms of infection and what to do if you have them. Carry the card with you at all times. Show the card to any doctor who treats you.
• This medicine may cause the following problems:
  • Liver problems
  • High levels of cholesterol and triglycerides (fats)
• If you stop taking this medicine, you may develop hemolysis (breakdown of red blood cells). Your doctor will monitor you for at least 2 weeks after the last dose.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Blurred vision, headache, fast or slow heartbeat
• Dark urine or pale stools, nausea, vomiting, loss of appetite, stomach pain, yellow skin or eyes
• Fever, chills, cough, stuffy or runny nose, sore throat, body aches

If you notice these less serious side effects, talk with your doctor:

• Arm or leg pain

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088