FABHALTA affects part of your immune system and may lower your ability to fight infections.

FABHALTA increases your chance of getting serious infections caused by encapsulated bacteria, including Streptococcus pneumoniae, Neisseria meningitidis, and Haemophilus influenzae type B. These serious infections may quickly become life-threatening or fatal if not recognized and treated early.

• Your doctor will review your vaccine history before starting treatment with FABHALTA and let you know which vaccines you need.

• You must complete or be up to date with the vaccines against Streptococcus pneumoniae and Neisseria meningitidis at least 2 weeks before starting FABHALTA.

• If you have not completed your vaccinations and FABHALTA must be started right away, you should receive the required vaccinations as soon as possible. 

• If you have not been vaccinated and FABHALTA must be started right away, you should also receive antibiotics to take for as long as your health care provider tells you. 

• If you have been vaccinated against these bacteria in the past, you might need additional vaccinations before starting FABHALTA. Your health care provider will decide if you need additional vaccinations.

• While taking FABHALTA, you should be revaccinated according to current medical guidelines for encapsulated bacteria.

Click here to learn more about vaccinations and other important FABHALTA safety information.

Replace PNH infusions with an innovative oral treatment

When switching treatments for PNH, it’s important to make a plan with your health care provider or doctor.

• For patients switching from ULTOMIRIS^® (ravulizumab-cwvz): start taking FABHALTA no later than 6 weeks after the last dose of ravulizumab

• For patients switching from SOLIRIS^® (eculizumab): start taking FABHALTA no later than 1 week after the last dose of eculizumab

If you have PNH and you stop taking FABHALTA

• Your health care provider will need to monitor you closely for at least 2 weeks after stopping FABHALTA

• Stopping treatment with FABHALTA may cause a breakdown of red blood cells due to PNH

• Symptoms or problems that can happen due to red blood cell (RBC) breakdown include:

  • decreased hemoglobin level in your blood

  • blood in your urine

  • shortness of breath

  • trouble swallowing

  • tiredness

  • pain in the stomach (abdomen)

  • blood clots, stroke, and heart attack

  • erectile dysfunction

• It is important that you take FABHALTA exactly as your healthcare provider tells you in order to lower the possibility of breakdown of red blood cells due to PNH

Take FABHALTA exactly as your doctor tells you. Don’t change the dose or stop taking FABHALTA unless your doctor tells you to.

ULTOMIRIS (ravulizumab-cwvz) and SOLIRIS (eculizumab) are registered trademarks of Alexion Pharmaceuticals, Inc.

Because of the risk of serious infection that comes with taking FABHALTA, it’s only available through a restricted program called Risk Evaluation and Mitigation Strategy (REMS).

Before you can take FABHALTA, your healthcare provider must:

• Enroll in the FABHALTA REMS program

• 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 infection caused by encapsulated bacteria and that you receive antibiotics if you need to start FABHALTA right away and you are not up to date on your vaccinations

• Give you a Patient Safety Card about your risk of serious infections

To learn more about the FABHALTA REMS program, please call the REMS helpline at 1-833-99FABHA (1-833-993-2242) between 8:00 AM and 8:00 PM ET or visit www. Fabhalta-REMS.com  today.

Your doctor will give you a patient safety card about the risk of serious infection. Carry this card with you at all times during treatment and for 2 weeks after your last dose. Your risk of serious infections may continue for a few weeks after your last dose of FABHALTA. It is important to show this card to any healthcare provider who treats you. This will help them diagnose and treat you quickly. 

If you notice any signs or symptoms described on this card, contact your doctor or get emergency medical assistance immediately.

See the FABHALTA Medication Guide