Your first 90 days
Your first 90 days on Fabhalta for PNH
What happens before the first fill, the days that matter, the label's rules and who to call, from the label, the drugmaker's own program and one insurer's written rules.
Fabhalta is a PNH medicine taken by mouth, 1 capsule twice a day. Before the first bottle, the label requires vaccines against 2 kinds of bacteria, and the pharmacy checks with your doctor that they happened. If you are coming from Soliris or Ultomiris, the label also sets how soon after your last infusion Fabhalta starts. This page lays out those first 3 months from the FDA label, the REMS, Novartis's own support program and one insurer's written rules.
What has to happen before the first bottle ships
Fabhalta is available only through a REMS, and only a limited number of certified pharmacies dispense it. The first fill waits on vaccines, a certified prescriber and an insurance approval. These are the 6 things in the way, in order.
Vaccines, at least 2 weeks before the first dose
Fabhalta blocks part of the complement system, which the body uses against encapsulated bacteria.
- The label requires vaccines at least 2 weeks before day 1.
- One is against Streptococcus pneumoniae, a pneumococcal shot.
- The others are against Neisseria meningitidis serogroups A, C, W, Y and B, the MenACWY and MenB shots.
- The schedule is the ACIP one for people on a complement inhibitor, which differs from the usual one.
- Shots you had before may not be enough, and your hematologist decides what else you need.FDA label
Or antibiotics, if treatment cannot wait
If you are not up to date and Fabhalta has to start right away, the label says to give antibiotics and the vaccines as soon as possible.
- The REMS requires the prescriber to write that antibiotic prescription.
- The Medication Guide says to take the antibiotics for as long as your healthcare provider tells you.FDA label
A certified prescriber, and the counseling the REMS requires
Your hematologist must be enrolled in the FABHALTA REMS.
- The REMS requires them to check for an unresolved serious infection, review your vaccines, and counsel you with the Patient Guide.
- They also hand you the Patient Safety Card.
- There is no patient enrollment form for this REMS.
- The label lists the REMS line as 1-833-993-2242, the same number as Novartis Patient Support.FDA REMS page
If you are switching, the date of your last infusion
The label sets a window to lower the risk of red blood cell breakdown from stopping another PNH drug suddenly.
- From eculizumab (Soliris), Fabhalta starts no later than 1 week after the last dose.
- From ravulizumab (Ultomiris), it starts no later than 6 weeks after the last dose.
- For other PNH treatments, the label says there is no information on timing.
- Your hematologist sets the dates.FDA label
The pharmacy's check
Only pharmacies certified in the REMS can dispense Fabhalta.
- Before the first fill, the pharmacy must confirm your prescriber is certified and contact the office to document your vaccines or the antibiotic plan.
- If you were not up to date at the start, it repeats that check before each fill for up to 6 months.FDA REMS page
Insurance approval, and help while you wait
Novartis Patient Support checks your coverage first, which it says typically takes 2 to 3 business days.
- If you have private insurance and the plan needs prior authorization or first says no, its Bridge Program can supply Fabhalta free for up to 12 months.
- The office must file the prior authorization or an appeal within the first 45 days of enrollment.Novartis support FAQs
The days that matter
Counted from the first dose, with the vaccine deadline 2 weeks before it, the switch window after a last Soliris or Ultomiris dose, and a refill every 30 days. Type your first-dose date and the tiles become real dates you can add to your calendar.
The tiles below count days from a first dose. Enter the date of yours, or the date you expect, and each tile becomes a real date on your calendar.
The date stays on your device. It is not sent to Trial Friend or anyone else. The calendar file works with Apple, Google and Outlook calendars.Vaccines done, or scheduled
The pneumococcal and meningococcal shots need at least 2 weeks before day 1 to count.
- Novartis says some vaccines need more than 1 dose, so ask how many doses each one takes.
- For eligible patients, Novartis Patient Support can help schedule vaccination appointments at home.
Insurance approval and the pharmacy's check
The pharmacy confirms your prescriber's REMS certification and documents your vaccine dates with the office.
- If you were not up to date on vaccines, the REMS has the pharmacy document the antibiotic plan instead.
- If you are switching, the date of your last Soliris or Ultomiris dose sets the window for day 1.
First dose, 1 capsule, then another that evening
One 200mg capsule twice a day, swallowed whole, with or without food.
- For people switching, the label puts day 1 no later than 1 week after the last eculizumab dose, or 6 weeks after the last ravulizumab dose.
- Put the Patient Safety Card in your wallet the same day.
Two weeks in
Headache, cold-like symptoms, diarrhea, belly pain and nausea were among the most common side effects in the PNH trials.
- The Medication Guide says to tell your healthcare provider about any side effect that bothers you or does not go away.
Refill, then every 30 days
A 60-capsule bottle runs out here.
- The label tells people with PNH that taking Fabhalta as prescribed lowers the risk of red blood cell breakdown.
Refill, number 2
Blood counts and a cholesterol check
The label says Fabhalta can raise cholesterol and triglycerides and asks prescribers to check them periodically.
- It sets no fixed date, so your hematologist decides when.
- In the PNH trials, the hemoglobin results were measured after 24 weeks of treatment.
Refill, number 3
The label, revision by revision
The FDA lists which sections changed in each revision of a label. These are the revisions the current Fabhalta label records, dated by the FDA, with a plain note on what each one meant for a patient. Older references and handouts can lag these by months.
Current label dated July 16, 2026, read from the FDA's label database today. FDA label
- July 2026
Full approval for the IgA nephropathy use. The label's revision list names only that section, so the PNH use, dose and switching rules did not change. The REMS materials were updated the same day.FDA letter
- March 2025
Complement 3 glomerulopathy was added as a third use. The REMS brochure, Patient Guide and website were updated to include it.FDA REMS page
- August 2024
IgA nephropathy was added as a second use. The REMS Patient Guide was also updated to say that people may need more vaccinations before starting, even if they were vaccinated before.FDA REMS page
- March 2024
The Hib vaccine requirement was removed after an FDA letter about adults on complement inhibitors, leaving pneumococcal and meningococcal vaccination. The REMS followed in May 2024. Some insurer policies still list Hib.FDA letter
- December 2023
First approval, for adults with PNH. The FDA approved the FABHALTA REMS on the same day and required a registry on long-term safety in PNH, with up to 5 years of follow-up.FDA letter
How the label says to take it
The parts of the prescribing information and the patient leaflet that come up in the first 3 months, in plain words.
- Twice a day, whole, with or without food
The label says 200mg twice daily, swallowed whole, never opened, broken or chewed.
- Food does not matter.FDA label
- If you miss a dose
The Medication Guide says to take 1 dose as soon as you remember, even if it is almost time for the next one.
- After that, the next dose goes at the regular time.
- The label tells people with PNH that taking Fabhalta as prescribed lowers the risk of red blood cell breakdown.FDA label
- Fever is a call, not a wait
The Medication Guide lists fever with or without shivers or chills, fever and a rash, and fever with chest pain and cough.
- It also lists fever with breathlessness, fast breathing or a high heart rate, and headache with fever, nausea, vomiting or a stiff neck or back.
- Confusion, clammy skin, body aches with flu-like symptoms and eyes sensitive to light are on the list too.
- It says to tell your healthcare provider or get emergency medical care right away, and to show the Patient Safety Card.FDA label
- The card outlasts the drug
The label requires carrying the Patient Safety Card at all times during treatment and for 2 weeks after the last dose.
- The infection risk may continue for a few weeks after stopping.FDA label
- Stopping has its own watch period
The label says stopping Fabhalta can bring back red blood cell breakdown from PNH, which can be serious.
- Anyone with PNH who stops is monitored closely for at least 2 weeks after the last dose.
- The Medication Guide says not to change the dose or stop unless your healthcare provider tells you.
- Any change to treatment is a decision for your hematologist.FDA label
- Medicines that interact
The label does not recommend strong CYP2C8 inhibitors such as gemfibrozil with Fabhalta, because they may raise its level.
- CYP2C8 inducers such as rifampin may lower its level and make it work less well.
- The Medication Guide says to tell your healthcare provider about every medicine, vitamin and herbal supplement you take.FDA label
- Boosters
The label says to revaccinate on the ACIP schedule for as long as treatment lasts.
- Vaccines lower the risk but do not remove it, which is why the fever rule never goes away.FDA label
- Pregnancy, breastfeeding and liver problems
The label says the data in pregnancy are not enough to know the risk, and that PNH itself carries risks in pregnancy.
- It leaves the decision to a risk and benefit assessment with the prescriber.
- It says not to breastfeed during treatment and for 5 days after the final dose.
- It does not recommend Fabhalta in severe liver impairment.FDA label
- Storage
Room temperature, 68 to 77 degrees Fahrenheit.
- The bottle has a child-resistant cap.FDA label
What the label says to act on
The symptoms the label singles out, and what it tells patients and prescribers to do about each. If any of these happen, the label's instruction is the one to follow, with your care team.
Signs the label ties to serious infection
Fever with or without shivers or chills, fever and a rash, or fever with chest pain and cough.
- Fever with breathlessness, fast breathing or a high heart rate.
- Headache with fever, nausea, vomiting or a stiff neck or back.
- Confusion, clammy skin, body aches with flu-like symptoms, or eyes sensitive to light.
- The Medication Guide says these infections may quickly become life-threatening.
- Tell your healthcare provider or get emergency medical care right away, card in hand.FDA label
Signs of red blood cell breakdown
The Medication Guide lists a lower hemoglobin level, blood in your urine, shortness of breath, trouble swallowing, tiredness and pain in the stomach.
- It also lists blood clots, stroke, heart attack and erectile dysfunction.
- The label lists them as signs to watch for after stopping Fabhalta.
- Tell your hematologist about any of them.FDA label
Headache, stomach upset and infections
In the APPLY-PNH trial, headache occurred in 19% of people on Fabhalta against 3% of those who stayed on eculizumab or ravulizumab.
- Diarrhea was 15% against 6%, belly pain 15% against 3%, and nausea 10% against 3%.
- Bacterial infections were 11% in both groups, and viral infections were 10% against 31%.
- In APPOINT-PNH, where everyone took Fabhalta, headache was 28% and rash 10%.FDA label
Cholesterol and platelets, found on blood tests
The label reports higher total cholesterol, LDL and triglycerides in the PNH trials.
- Among 54 people in APPLY-PNH with normal cholesterol at the start, 43% developed mildly high cholesterol.
- Among 37 people with normal platelet counts at the start, 43% had a drop in platelets during the trial.
- These show up on blood tests, not as symptoms.FDA label
Why the pharmacy or the insurer says no, and what fixes it
Most first-fill delays are one of these. Knowing which one tells you who to call.
- The pharmacy cannot document the vaccinesThe REMS requires the pharmacy to assess your vaccines or antibiotic plan with the prescriber before the first fill, and to document what it finds. Sending the vaccine dates, or the antibiotic prescription, gives the pharmacy what it needs.FDA REMS page
- The prescription went to a pharmacy that is not certifiedOnly a limited number of pharmacies certified in the FABHALTA REMS dispense it. A prescription sent to a pharmacy outside the REMS is a routing problem, not a denial. The FABHALTA REMS website has a Certified Pharmacy Locator, and the office can resend it to a pharmacy on that list.FABHALTA REMS site
- Prior authorization pending or deniedThe FEP policy below asks for a baseline hemoglobin, proof of the vaccines, and the prescriber's REMS enrollment. For private insurance, the Novartis Bridge Program supplies Fabhalta free for up to 12 months while coverage is pursued. The prior authorization or an appeal must be filed within the first 45 days of enrollment.Novartis Patient Support
- The plan does not allow 2 PNH drugs at onceThe FEP policy below rules out dual therapy with Soliris, Ultomiris or Empaveli. The Fabhalta label describes no overlap period, and it times the first dose from the last eculizumab or ravulizumab dose. The office can show the plan the date of that last dose.FEP Blue policy
- The vaccines themselves cost moneyCo-Pay Plus covers up to $1,000 a year of qualifying vaccine costs for people with private insurance, not counting administration fees. The Vaccination Support program gives the required shots at home at no cost for eligible patients, regardless of insurance.Novartis Patient Support
- A copay you cannot payPrivate insurance: Co-Pay Plus, as little as $0, up to $20,000 a calendar year. Medicare, Medicaid, TRICARE, VA, DoD and other federal or state programs are excluded. Novartis points people without insurance, and some with government insurance, to the Novartis Patient Assistance Foundation at 1-800-277-2254. Our help paying page lists the charity funds that are open.Novartis Patient Support
Blue Cross Blue Shield Federal Employee Program prior authorization policy, April 1, 2026
- PNH, age 18 or older
- A baseline hemoglobin on record
- Vaccinated against pneumococcus, meningococcus and Hib at least 2 weeks before starting, unless treatment cannot be delayed
- The prescriber is enrolled in the Fabhalta REMS
- Not used together with another PNH drug that needs prior approval: Soliris, Ultomiris or Empaveli
Approval length. Twelve months at a time, renewed if hemoglobin has risen from the starting level with no unacceptable side effects, with a limit of 400mg a day.
This policy was approved March 6, 2026 and cites the March 2025 label, so it predates the July 2026 label. That later change was to the IgA nephropathy use, not PNH. It still lists the Hib vaccine, which the FDA dropped from the label in March 2024. It is here as an example of what a plan asks for, not as a rule. FEP Blue policy
Who to call, and what they can do
The drugmaker's program handles most of the first-fill problems above. Charity funds and foundation help are on the help paying page.
- One dedicated team member from the start, a Welcome Kit, and help locating and keeping track of vaccinations and boosters
- Co-Pay Plus for private insurance, as little as $0 for Fabhalta up to $20,000 a calendar year, plus up to $1,000 toward qualifying vaccine costs
- Co-Pay Plus is not valid under Medicare, Medicaid, TRICARE, VA, DoD or any other federal or state health care program
- Bridge Program for private insurance: free Fabhalta for up to 12 months or until coverage is approved, if a prior authorization or appeal is filed within the first 45 days
- Vaccination Support: a licensed clinician gives the required vaccines at home at no cost for eligible patients, regardless of insurance
- Benefits verification, which Novartis says typically takes 2 to 3 business days, and help with insurance forms Novartis support FAQs
- Novartis Patient Assistance Foundation, 1-800-277-2254, for eligible people who are uninsured or have government insurance and cannot afford their costs
Details as the drugmaker publishes them. Novartis Patient Support
Five questions for the pharmacist or the support line
- Have you documented my vaccine dates with my hematologist's office, and is anything still missing before you can fill it?
- My last Soliris or Ultomiris dose was on this date. Will the first bottle reach me inside the window the label sets?
- I take these other medicines. Are any of them CYP2C8 inhibitors or inducers?
- If a refill is late, who do I call so I do not miss doses?
- When is my next meningococcal dose or booster due, and does Novartis or my plan pay for it?
Questions people ask in the first weeks
How long does it take to get Fabhalta after it is prescribed?
The vaccines set the floor: at least 2 weeks between the shots and the first dose, by the label, unless the hematologist starts antibiotics instead. The prior authorization and the pharmacy's REMS check run alongside. Novartis says checking your benefits typically takes 2 to 3 business days.
Which vaccines do I need before Fabhalta?
By the label, vaccines against Streptococcus pneumoniae and Neisseria meningitidis serogroups A, C, W, Y and B, at least 2 weeks before the first dose. In plain terms, that is a pneumococcal shot plus the MenACWY and MenB shots. Earlier shots may not be enough, and your healthcare provider decides if you need more. The label notes that the ACIP schedule for people on complement inhibitors differs from the standard one.
How do I switch from Soliris or Ultomiris to Fabhalta?
The label says people on eculizumab (Soliris) start Fabhalta no later than 1 week after their last dose. People on ravulizumab (Ultomiris) start no later than 6 weeks after their last dose. The timing is meant to lower the risk of red blood cell breakdown, and your hematologist sets the dates.
How do I switch from Empaveli to Fabhalta?
The label gives no schedule for that switch. It says there is no available information on when to start Fabhalta after PNH treatments other than eculizumab and ravulizumab. Your hematologist decides the timing.
What if I miss a dose of Fabhalta?
Take 1 dose as soon as you remember, even if the next one is close, then take the next dose at the regular time. That is the Medication Guide's wording. The label adds that people with PNH lower their risk of red blood cell breakdown by taking Fabhalta as prescribed.
What happens if I stop taking Fabhalta?
The label says red blood cell breakdown from PNH can return, and that your healthcare provider monitors you closely for at least 2 weeks after the last dose. The Patient Safety Card stays with you for those 2 weeks. The Medication Guide says not to stop unless your healthcare provider tells you.
Why was Fabhalta denied by my insurance?
One federal employee plan's policy asks for a baseline hemoglobin, proof of the vaccines, the prescriber's REMS enrollment, and proof you are not on a second PNH drug. The hematologist's office can send the records for each point. Novartis's Bridge Program may supply Fabhalta while a private plan decides.
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Sources
- FABHALTA (iptacopan) capsules, for oral use: prescribing information and Medication Guide, revised July 2026, Novartis, via openFDA and DailyMed, July 16, 2026.
- Approved Risk Evaluation and Mitigation Strategies (REMS): Fabhalta (iptacopan), NDA 218276, FDA, July 16, 2026.
- FABHALTA REMS, Novartis, November 13, 2026.
- About Novartis Patient Support | FABHALTA (iptacopan), Novartis, November 13, 2026.
- Novartis Patient Support FAQs | FABHALTA (iptacopan), Novartis, November 13, 2026.
- Vaccinations & Getting Started | PNH | FABHALTA (iptacopan), Novartis, November 13, 2026.
- Pharmacy Policy 5.85.055, Fabhalta (iptacopan), Blue Cross Blue Shield Federal Employee Program, April 1, 2026.
- NDA 218276/S-002 supplement approval letter, Hib vaccination recommendation removed, FDA, March 26, 2024.
- NDA 218276/S-007 supplement approval letter, Subpart H requirement fulfilled for IgA nephropathy, FDA, July 16, 2026.
- NDA 218276 approval letter, Fabhalta (iptacopan) capsules, FDA, December 5, 2023.
This page explains what the FDA label, the drugmaker's support program and an insurer policy say. It is not medical advice and does not tell anyone to start, stop or change a medicine. Dosing, test timing and restarts after a gap are decisions for the prescribing hematologist. Found an error? Use the report link in the footer and it will be checked against the source.