Voydeya: Uses, Side Effects and Dosage

Serious warnings and precautions box

Voydeya increases your chance of getting serious infections caused by certain types of bacteria. This includes serious infections caused by the bacteria Streptococcus pneumoniae, Neisseria meningitidis, and Haemophilus influenzae type B.

• You must be vaccinated against these bacteria, specifically Neisseria meningitidis and Streptococcus pneumoniae., If you have not already had these vaccines, make sure to be vaccinated at least 2 weeks before your first dose of Voydeya.
• If you start Voydeya therapy less than 2 weeks after being vaccinated, your healthcare professional will prescribe antibiotics. You must take antibiotics to reduce the risk of infection for 2 weeks after your vaccination.
• Your healthcare professional will monitor you for early signs of serious infections. Vaccines reduce the risk of serious infections, but do not prevent all serious infections. Seek medical care immediately if you experience symptoms of serious infections. See ‘Other warnings you should know about’ for more information.

What VOYDEYA is used for:

Voydeya is used in adults in the treatment of a blood disorder called paroxysmal nocturnal hemoglobinuria (PNH). Voydeya is used in addition with ravulizumab or eculizumab to treat patients whose anemia remains due to extravascular hemolysis (EVH).

How VOYDEYA works:

Voydeya contains the medicinal ingredient called danicopan. Danicopan blocks your body’s immune system from destroying your red blood cells outside of your blood vessels.

The ingredients in VOYDEYA are:

Medicinal ingredients: Danicopan

Non-medicinal ingredients: Colloidal silicon dioxide, croscarmellose sodium, hypromellose acetate succinate, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, sodium lauryl sulfate, talc, and titanium dioxide.

VOYDEYA comes in the following dosage forms:

Tablets: 50 mg and 100 mg

Do not use VOYDEYA if:

• you are allergic to danicopan or any of the other ingredients of this medicine or container.
• you have unresolved serious infection caused by encapsulated bacteria (i.e. Streptococcus pneumoniae, Neisseria meningitidis, and Haemophilus influenzae type B).

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take VOYDEYA. Talk about any health conditions or problems you may have, including if you:

• have an infection
• have rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption. Voydeya contains lactose.

Other warnings you should know about:

Serious infections caused by encapsulated bacteria

• To reduce the risk of infection, you must be vaccinated at least two weeks before you begin treatment with Voydeya. You may also need to revaccinated depending on the length of time of your treatment. Ensure that your current vaccinations are up to date.

• You should also be aware that vaccination may not prevent you from developing an infection. These are severe infections that can spread throughout the blood and body. They can affect major organs, including the brain and lungs. Speak to your healthcare professional immediately if you experience any of the following symptoms:

  • fever with or without shivers or the chills
  • fever and a rash
  • headache and a fever
  • headache with nausea or vomiting
  • headache with a stiff neck or stiff back or shortness of breath
  • high heart rate
  • extreme pain or discomfort
  • confusion
  • muscle aches with flu-like symptoms
  • clammy skin
  • eyes sensitive to light

Stopping treatment

Your healthcare professional may decide to end your treatment with Voydeya

• You should be monitored for signs and symptoms of hemolysis after your treatment with

Voydeya is ended. Symptoms can include tiredness and sudden decrease in hemoglobin levels.

• continue to take ravulizumab or eculizumab or consider alternative therapy.

Monitoring and blood tests

• Your healthcare professional will monitor the condition of your liver by conducting blood tests before you begin treatment and regularly afterwards. Depending on your test results or the side effects you experience, your healthcare professional may decide to end your treatment.
• Voydeya may increase the levels of cholesterol in your blood. Your healthcare professional will monitor your blood cholesterol levels during your treatment. You may be prescribed medication to lower the levels of cholesterol.

Pregnancy and breast-feeding

• If you are pregnant, able to get pregnant or think you are pregnant, speak to your healthcare professional for advice before taking this medicine.
• As a precautionary measure, you should not be taking Voydeya if you are pregnant.

• If you are able to get pregnant:

  • Use effective birth control during treatment and for 3 days after taking your last dose of Voydeya. Talk to your healthcare professional about birth control methods that may be right for you during this time.
  • Tell your healthcare professional right away if you become pregnant or think you may be pregnant during treatment with Voydeya.
• Voydeya may pass into breast milk. Do not breast-feed while you are taking Voydeya and for 3 days after taking your last dose of Voydeya.

Voydeya contains sodium

This medicine contains less than 23 mg of sodium per tablet.

Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.

The following may interact with VOYDEYA:

• Digoxin, a medicine to treat irregular heartbeat.
• Fexofenadine, a medicine to treat allergy symptoms.
• Tacrolimus, a medicine used to suppress the immune system.
• Dabigatran and edoxaban, medicines used to treat blood clots.
• Rosuvastatin, a medicine used to lower cholesterol.
• Sulfasalazine, a medicine used to treat ulcerative colitis, rheumatoid arthritis.

How to take VOYDEYA:

• Always take this medicine exactly as your healthcare professional has told you. Check with your healthcare professional if you are not sure.
• Voydeya should be taken in addition to your current PNH medicine (ravulizumab or eculizumab).

• You can take your tablets with or without food.

If you have been given Voydeya in a blister pack, follow these instructions to take the tablets out of the packaging:

1. 1. Push through black half-circle.
2. 2. Turn card over and peel tab to expose foil.
3. 3. Push on plastic blister to remove tablets.

Usual dose:

150 mg dosing schedule:

The recommended starting dose of Voydeya is 150 mg three times a day. Each 150 mg dose should be taken approximately 8 hours apart (plus or minus 2 hours). Each 150 mg dose includes one 50 mg tablet and one 100 mg tablet. The 50 mg tablet is marked with ʻDNC 50’ and the 100 mg tablet is marked with ‘DNC 100’.

200 mg dosing schedule:

Depending on how you respond to the treatment, your doctor may decide to increase your dosage of Voydeya to 200 mg. Take 200 mg three times a day. Each 200 mg dose should be taken approximately 8 hours apart (plus or minus 2 hours). For each dose you should take two 100 mg tablets. The 100 mg tablet is marked with ʻDNC 100ʼ.

Overdose:

If you think you, or a person you are caring for, have taken too much VOYDEYA, contact a healthcare professional, hospital emergency department, regional poison control centre or Health Canada’s toll-free number, 1-844 POISON-X (1-844-764-7669) immediately, even if there are no signs or symptoms.

Missed Dose:

If you miss a dose, take it as soon as possible. If it is 3 hours before your next dose, skip the missed dose. Then take the next dose at the normal time. Two or more doses should not be taken at the same time.

Possible side effects from using VOYDEYA:

These are not all the possible side effects you may have when taking Voydeya. If you experience any side effects not listed here, tell your healthcare professional.

Side effects of Voydeya include:

• Acne
• Constipation
• Coughing
• High blood pressure
• Joint pain
• Muscle pain
• Pain in arms and legs
• Pain in the back of throat
• Runny nose
• Tiredness
• Vomiting

Voydeya can cause abnormal blood tests. Your healthcare professional will decide when to do blood tests. They will interpret the results.

Serious side effects and what to do about them

If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.

Reporting Side Effects

You can report any suspected side effects associated with the use of health products to Health Canada by:

• Visiting the Web page on Adverse Reaction Reporting (canada.ca/drug-device-reporting) for information on how to report online, by mail or by fax; or
• Calling toll-free at 1-866-234-2345.

NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.

Storage:

Store in the original container between 15°C and 30°C.

Keep out of reach and sight of children.

If you want more information about Voydeya:

• Talk to your healthcare professional
• Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website: (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html; the manufacturer’s website www.alexion.com, or by calling 1-888-765-4747.

Date of Authorization: 2025-10-23