FABHALTA® affects part of your immune system and may lower your ability to fight infections. You must complete or update required vaccinations before starting FABHALTA and your care team will be there to help along the way.

FABHALTA increases your chance of getting serious infections caused by encapsulated bacteria, including Streptococcus pneumoniae (pneumonia), Neisseria meningitidis (meningitis), 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 update your vaccinations against Streptococcus pneumoniae and Neisseria meningitidis at least 2 weeks before your first dose of 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.

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

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

FABHALTA can fit into your daily routine

Click here to learn more about important FABHALTA safety information.

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 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 infections 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

The FABHALTA Patient Safety Card

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 this 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.

A specialty pharmacy is a service that allows you to have your medication shipped directly to your door and refilled every month. Someone at the pharmacy will reach out to you directly with all the details, so check your messages and missed calls. You can also contact your doctor if you haven't heard anything or to get an update.