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 (pneumonia), Neisseria meningitidis (meningitis), 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:
 

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 vaccinations. 

Vaccines do not prevent all infections caused by encapsulated bacteria. 

Tell your health care provider or get emergency medical care right away if you get any of these signs and symptoms of a serious infection: 

• Fever with or without shivers or chills 

• Fever with chest pain and cough 

• Fever with high heart rate 

• Headache and fever 

• Confusion 

• Clammy skin

• Fever and rash 

• Fever with breathlessness or fast breathing 

• Headache with nausea or vomiting 

• Headache with stiff neck or stiff back 

• Eyes sensitive to light

SAFETY PROFILE OF FABHALTA

The most common side effects of FABHALTA in adults include:

• Headache

• Nasal congestion, runny nose, cough, sneezing, and sore throat (nasopharyngitis)

• Diarrhea

• Feeling dizzy

• Pain in the stomach (abdomen)

• Infections (bacterial and viral)

• Nausea

• Rash

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.

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 health care provider for medical advice about side effects. You may report side effects to FDA at https://www.fda.gov/medwatch ↗, or call 1-800-FDA-1088.

Talk with your doctor if you think FABHALTA may be right for you.