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Important safety
information

IMPORTANT SAFETY INFORMATION FOR VOYDEYA

What is the most important information I should know about VOYDEYA?

VOYDEYA is a medicine that affects your immune system. VOYDEYA may lower the ability of your immune system to fight infections.

  • VOYDEYA increases your chance of getting serious infections caused by encapsulated bacteria. These serious infections may quickly become life-threatening and cause death if not recognized and treated early.
  1. You must complete or update meningococcal vaccine(s) and streptococcus vaccine(s) at least 2 weeks before your first dose of VOYDEYA.
  2. If you have not completed your vaccinations and VOYDEYA must be started right away, you should receive the required vaccinations as soon as possible.
  3. If you have not been vaccinated at least 2 weeks before your first VOYDEYA dose and VOYDEYA must be started right away, you should also receive antibiotics to take for as long as your healthcare provider tells you.
  4. If you have been vaccinated against these bacteria in the past, you might need additional vaccinations before starting VOYDEYA. Your healthcare provider will decide if you need additional vaccinations.
  5. Vaccines do not prevent all infections caused by encapsulated bacteria. Call your healthcare provider or get emergency medical care right away if you have any of these signs and symptoms of a serious infection: fever with or without chills, fever and a rash, fever with chest pain and cough, fever with breathlessness/fast breathing, fever with high heart rate, headache with nausea or vomiting, headache and a fever, headache with a stiff neck or stiff back, confusion, body aches with flu-like symptoms, clammy skin, eyes sensitive to light.

Your healthcare provider will give you a Patient Safety Card about the risk of serious infections. Carry it with you at all times during treatment and for 1 week after your last VOYDEYA dose. Your risk of serious infections may continue for a few days after your last dose of VOYDEYA. It is important to show this card to any healthcare provider who treats you. This will help them diagnose and treat you quickly.

VOYDEYA is only available through a program called the VOYDEYA Risk Evaluation and Mitigation Strategy (REMS). Before you can take VOYDEYA, your healthcare provider must: enroll in the VOYDEYA REMS; counsel you about the risk of serious infections caused by certain bacteria; give you information about the symptoms of serious infections; make sure that you are vaccinated against serious infections caused by encapsulated bacteria and that you receive antibiotics if you need to start VOYDEYA right away and you are not up to date on your vaccinations; give you a Patient Safety Card about your risk of serious infections, as discussed above.

Who should not receive VOYDEYA?

Do not take VOYDEYA if you have a serious infection caused by encapsulated bacteria, including Neisseria meningitidis, Streptococcus pneumoniae, or Haemophilus influenzae type B infection.

Before taking VOYDEYA, tell your healthcare provider about all of your medical conditions, including if you: have an infection or fever, have liver problems, are pregnant or plan to become pregnant, or are breastfeeding. It is not known if VOYDEYA will harm your unborn baby or if it passes into your breast milk. Do not breastfeed during treatment with VOYDEYA and for 3 days after the last dose.

Tell your healthcare provider about all the vaccines you receive and medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements which could affect your treatment. VOYDEYA may affect the way other medicines work.

If you stop taking VOYDEYA, your healthcare provider will need to monitor you closely for at least 2 weeks after your last dose. Stopping treatment with VOYDEYA may cause a breakdown of red blood cells due to PNH. Symptoms or problems that can happen due to breakdown of red blood cells include: decreased hemoglobin level in your blood and tiredness

What are the possible side effects of VOYDEYA?

VOYDEYA can cause serious side effects, including increased liver enzyme levels and increased cholesterol. Your healthcare provider will do blood tests to check your liver enzyme levels and cholesterol before and during treatment with VOYDEYA. Your healthcare provider may temporarily or permanently stop treatment with VOYDEYA if you develop increased liver enzyme levels.

The most common side effect of VOYDEYA is headache.

Tell your healthcare provider about any side effect that bothers you or that does not go away. These are not all of the possible side effects of VOYDEYA. For more information, ask your healthcare provider or pharmacist. Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

INDICATION

What is VOYDEYA?

VOYDEYA is a prescription medicine used along with ravulizumab or eculizumab to treat breakdown of red blood cells that takes place outside of blood vessels (extravascular hemolysis), in adults with paroxysmal nocturnal hemoglobinuria (PNH).

It is not known if VOYDEYA is safe and effective in children.

Please see the full Prescribing Information and Medication Guide for VOYDEYA, including Boxed WARNING regarding serious infections caused by encapsulated bacteria.