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 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.
Click here to learn more about vaccinations and other important FABHALTA safety information.
Replace PNH infusions with an innovative oral treatment
Take FABHALTA at home, or on the go
One capsule, twice a day, every day
With or without food
Swallow the capsules whole. Do not open, break or chew capsules
You do not need to refrigerate FABHALTA*
*Store at 20 °C to 25 °C (68 °F to 77 °F); excursions permitted between 15 °C and 30 °C (59 °F and 86 °F).
If you miss your FABHALTA dose or doses
As soon as you remember, take one dose of FABHALTA, even if it is almost time to take your next scheduled dose
Then take your next dose of FABHALTA at your regularly scheduled time
What you need to know about switching to FABHALTA
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 breakdown of red blood cells 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 you take FABHALTA exactly as your health care provider tells you 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.
The FABHALTA REMS Program
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.
The FABHALTA Patient Safety Card:
Your health care 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 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.