SAFETY & SIDE EFFECTS
Serious risk of infections and vaccines
What is the most important information to know about FABHALTA®?
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 and 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.
If you have been vaccinated against these bacteria in the past, you might need additional vaccinations before starting FABHALTA. Your doctor 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.
Safety profile of FABHALTA in the clinical trial
It is important to understand and discuss the safety of FABHALTA. Be open with your doctor about any questions or concerns you may have during treatment.
The following safety data reflect patients with IgAN (eGFR ≥20 mL/min/1.73 m2 at baseline) who received FABHALTA (N = 235) or placebo (sugar pill) (N = 235) treatment as of the time of the efficacy analysis.
Adverse reactions reported in ≥3% of adult patients with immunoglobulin A nephropathy (IgAN) treated with FABHALTA and ≥2% higher in frequency than placebo (sugar pill) in the clinical trial*
*The median time of exposure for FABHALTA was 43 weeks.
†Includes similar terms.
Tell your doctor about any side effect that bothers you or that does not go away. These are not all of the possible side effects of FABHALTA.
FABHALTA may cause serious side effects, including increased cholesterol and triglyceride (lipid) levels in your blood. Your health care provider will do blood tests to check your cholesterol and triglycerides during treatment with FABHALTA. Your health care provider may start you on a medicine to lower your cholesterol if needed.
FABHALTA may cause side effects. If you and your doctor decide that FABHALTA is right for you, discussing potential side effects is crucial.
Because of the risk of serious infections caused by encapsulated bacteria, FABHALTA is only available through a Risk Evaluation and Mitigation Strategy (REMS) program that requires vaccinations
Tell your health care provider about any side effect that bothers you or that does not go away. These are not all of the possible side effects of FABHALTA. Call your doctor for medical advice about side effects. You may report side effects to FDA at www.fda.gov/medwatch ↗, or call 1-800-FDA-1088.
Talk with your doctor if you think FABHALTA may be right for you. See Getting Started & Vaccinations for more detailed information.
