FABHALTA, a complement factor B inhibitor, is the first oral medication approved to treat adults with paroxysmal nocturnal hemoglobinuria (PNH). It was approved by the U.S. Food and Drug Administration in December 2023. Fabhalta is taken twice a day in a capsule form.
What is FABHALTA?
FABHALTA, a complement factor B inhibitor, is the first oral medication approved to treat adults with paroxysmal nocturnal hemoglobinuria (PNH)
It is not known if FABHALTA is safe or effective for children.
Who should not take FABHALTA?
You should not take FABHALTA if you are allergic to Iptacopan and any other ingredients in FABHALTA.
Do not take FABHALTA if you have been diagnosed with a serious infection caused by a encapsulated bacteria including Steptococcus pneumoniae, Neisseria meningitidis or Haemophilis influenzae type when you are starting treatment.
Before taking FABHALTA, tell your healthcare provider about all your medical conditions, including if you:
- have an infection or fever
- kidney or liver problems
- are pregnant or plan to become pregnant. FABHALTA can harm your unborn baby. Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with FABHALTA.
- are breastfeeding or plan to breastfeed. It is not known if FABHALTA passes into breast milk. Do not breastfeed during treatment with FABHALTA and for 5 days after the last dose of FABHALTA.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Certain medications may affect the way FABHALTA works and may cause side effects.
How will I take FABHALTA?
Take FABHALTA exactly as your healthcare provider tells you. Do not change the dose or stop taking FABHALTA told to do so by your healthcare provider.
If you miss a dose or doses, take 1 dose of FABHALTA as soon as you remember even if it is close to your next dose. Take your next dose as scheduled.
If you are switching treatment from Soliris to FABHALTA, you should take your starting dose of FABHALTA no later than 1 week after your last dose of Soliris.
If you are switching treatment from Ultomiris to FABHALTA, you should take the starting dose no later than 6 weeks after your last dose of Ultomiris.
If you stop taking FABHALTA, your healthcare provider will need to monitor you closely for 2 weeks. Stopping treatment may cause a breakdown of red blood cells due to PNH. Symptoms or problems that can happen include decrease in hemoglobin, blood in your urine, shortness of breath, trouble slowing, tiredness, pain in abdomen, blood clots, stroke, heart attack and erectile dysfunction.
What are the possible side effects of FABHALTA?
FABHALTA may cause serious side effects, including:
- Increasing your chance of getting serious infections caused by encapsulated bacteria, including Streptococcus pneumoniae, Neisseria meningitidis and Haemophilus influenzae type B. These infections can quickly become life threatening or fatal when not recognized and treated early.
- You must be update on your vaccinations against these bacteria at least 2 weeks prior to your first dose of FABHALTA.
- If you have not completed your vaccinations and must start FABHATA right away, you should receive the vaccinations as soon as possible.
- If you have not been vaccinated and must start FABHALTA right away, you should receive antibiotics from your healthcare provider. You will take the antibiotics for as long as the healthcare provider recommends.
- If you have been vaccinated in the past against these bacteria, you might need additional vaccinations before starting FABHALTA. Your healthcare provider will decide if additional vaccinations are needed.
Call your healthcare provider right away if you get any of the following signs and symptoms of infection: fever with or without chills, fever with or without chest pain and cough, fever with a high heart rate, headache and fever, confusion, clammy skin, fever and a rash, fever with difficult breathing, headache with nausea or vomiting, headache with stiff neck or stiff back, body aches with flu-like symptoms and eyes sensitive to light.
The most common side effects of FABHALTA include headache, nasal congestion, runny nose, cough, sneezing and sore throat, diarrhea, pain in abdomen, infections (viral and bacterial), nausea and rash.
FABHALTA may increase your cholesterol and triglycerides. Your healthcare provider will do blood tests to check them periodically during treatment.
What is a Patient Safety Card?
Your healthcare provider will provide you with a patient safety card about the risks of serious infections. It is important you always carry this card with you. You should show this card to any healthcare provider that treats you. This will help them diagnosis and treat you quickly.