Why you need certain vaccinations before starting FABHALTA

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

FABHALTA is a medicine that affects part of your immune system and may lower your ability to fight infections.

The reason you need certain vaccinations before starting treatment is because 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 cause death if not recognized and treated early.

You must complete or update the following vaccinations at least 2 weeks before your first dose of FABHALTA:

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.

Ask your doctor about any additional vaccines that may be helpful.

Preparing to start FABHALTA: vaccinations and timing

Your health care provider will review your vaccination history and guide you through the dosing and scheduling options.

This chart can help you understand what is needed to start FABHALTA:

*Some vaccines may require more than 1 dose, so it’s important to know how many doses you need for each vaccine.

While taking FABHALTA, you should be revaccinated according to current medical guidelines for encapsulated bacteria. Your health care provider or Novartis Patient Support™ can help you locate places to get vaccinations.

Vaccines do not prevent all infections caused by encapsulated bacteria.

How can I get help in obtaining my vaccinations?

Your care team is your best source of information. Still have questions? Novartis Patient Support can help you locate vaccination centers and offer other assistance along the way.

Understanding vaccination requirements

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

Before you can take FABHALTA, your health care provider must:

• Enroll in the FABHALTA REMS program.

• Counsel you about the risk of serious infections caused by certain bacteria.

• Give you written information about the symptoms of serious infections.

• Make sure that you are vaccinated against serious infections caused by encapsulated bacteria. 

• Make sure 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.

Your health care provider will give you a Patient Safety Card about the risk of serious infections. Carry this card with you at all times during treatment and for 2 weeks after your last dose of FABHALTA. 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 health care provider who treats you. This will help them diagnose and treat you quickly.

If you notice any signs or symptoms described on the Patient Safety Card, contact your doctor or get emergency medical assistance immediately.

To learn more about the FABHALTA REMS program, please call the REMS helpline at 1-866-201-3101 between 8:00 AM and 4:00 PM ET or visit Fabhalta-REMS.com today.