Danicopan

Generic name: danicopan [ DAN-i-KOE-pan ]
Brand name: Voydeya
Dosage form: oral tablet (100 mg; 50 mg-100 mg)
Drug class: Selective immunosuppressants

Medically reviewed by Drugs.com on Apr 19, 2024. Written by Cerner Multum.

What is danicopan?

Danicopan is used together with eculizumab or ravulizumab to treat the breakdown of red blood cells that occurs outside of blood vessels (extravascular hemolysis), in adults with a disease called paroxysmal nocturnal hemoglobinuria (PNH).

Danicopan is available only under a special program and from a certified pharmacy. You must understand the risks and benefits of danicopan.

Danicopan may also be used for purposes not listed in this medication guide.

Danicopan side effects

Get emergency medical help if you have signs of an allergic reaction: hives, difficult breathing, swelling of your face, lips, tongue, or throat.

You may get infections more easily, even serious or fatal infections. Call your doctor right away if you have signs of infection such as:

• fever, chills, sore throat;

• mouth sores, red or swollen gums;

• pale skin, easy bruising, unusual bleeding;

• chest discomfort, wheezing, dry cough or hack, rapid weight loss; or

• symptoms of meningitis--headache, neck stiffness, increased sensitivity to light, nausea, vomiting, confusion, drowsiness.

Your condition may get worse if you stop taking this medicine. Tell your doctor if you have symptoms of low red blood cells (anemia) such as pale skin, tiredness, feeling light-headed or short of breath, cold hands and feet.

Your treatment may be delayed or permanently discontinued if you have certain side effects.

Common side effects of danicopan may include:

• abnormal liver function tests;

• high cholesterol; or

• headache.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Warnings

You may get infections more easily, even serious or fatal infections. Call your doctor if you have flu symptoms, cough, night sweats, neck stiffness, confusion, or vision problems.

Before taking this medicine

Before you start using danicopan, tell your doctor if you have any signs of infection such as fever, chills, cough, body aches, tiredness, open sores or skin wounds, diarrhea, stomach pain, weight loss, painful urination, or coughing up blood.

You should not use danicopan if you have a serious infection caused by certain types of bacteria such as meningitis, pneumonia, or a bloodstream infection.

Tell your doctor if you have or have ever had:

• a chronic or recent infection;

• fever;

• high cholesterol;

• recently received a vaccine or are scheduled to receive a vaccine; or

• liver disease.

Make sure you are current on all vaccines that protect against serious bacterial infections at least 2 weeks before you start using danicopan. If you were vaccinated in the past, you may need additional vaccinations or booster doses.

It is not known if danicopan will harm an unborn baby. However, having paroxysmal nocturnal hemoglobinuria (PNH) during pregnancy may cause complications or medical problems in both mother and baby. The benefit of treating this condition may outweigh any risks to the baby.

Do not breastfeed while using danicopan, and for at least 3 days after your last dose.

How should I take danicopan?

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Read the Patient Wallet Card about serious side effects and learn what symptoms to watch for. Keep the card with you at all times, and for at least 1 week after your last dose.

You will need to take more than one tablet to receive your total dose of danicopan. Follow your doctor's dosing instructions very carefully.

Danicopan is usually taken three times a day, with or without food. Take it the same way each time.

You may be given other medications to help treat or prevent a serious infection or certain side effects. Keep taking these medicines for as long as your doctor has prescribed.

You may get infections more easily, even serious or fatal infections. You will need frequent medical tests.

You will need frequent blood tests to check your liver function before and during treatment with danicopan. You will also need medical tests to check your cholesterol during your treatment.

Your condition may get worse if you change your dose or stop using danicopan suddenly. Ask your doctor before stopping the medicine. Your doctor will watch you closely for at least 2 weeks if you stop taking danicopan.

Store this medicine in the original container at room temperature away from moisture and heat.

Danicopan dosing information

Usual Adult Dose for Paroxysmal Nocturnal Hemoglobinuria:

Initial dose: 150 mg orally 3 times a day
Maintenance dose: May increase to 200 mg orally 3 times a day based on the following parameters:
-Hemoglobin (Hgb) level has not increased by greater than 2 g/dL after 4 weeks of therapy, OR
-A transfusion was required during the previous 4 weeks, OR
-The dose needs to be increased to achieve an appropriate Hgb response based on clinical judgement.

Comments:
-Vaccination against encapsulated bacteria should be completed at least 2 weeks prior to starting therapy.
-Health care professionals who prescribe this drug must enroll in the REMS program for this product.
-Limitations of use: This drug not been shown to be effective as monotherapy and should only be prescribed as an add-on to ravulizumab or eculizumab.

Use: As add-on therapy with ravulizumab or eculizumab, for the treatment of extravascular hemolysis in patients with paroxysmal nocturnal hemoglobinuria (PNH)

What happens if I miss a dose?

Take the medicine as soon as you can, but skip the missed dose and go back to your regular schedule if your next dose is due within 3 hours. Do not take two doses at one time.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while taking danicopan?

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

What other drugs will affect danicopan?

Other drugs may affect danicopan, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all other medicines you use.

Further information

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

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

Medical Disclaimer

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