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Fabhalta

Name: Fabhalta
Brand: Novartis
Availability: InStock

Iptacopan

Prescription required

$203490.00

200mg · 3 × 56 capsules · 3 months supply

BrandBranded medicine· By Novartis

$67830.00 per month

How long a supply?

1 month$67830.00 a monthOne-off$67830.00

3 months$67830.00 a monthOne-off$203490.00

6 months$67830.00 a monthOne-off$406980.00

Supplied from Israel

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Annual cost

$881790a year at this pack size

Prescription required

Upload your prescription after ordering, or send it to our pharmacy team. We dispense only against a valid prescription.

FDA boxed warningSerious infections caused by encapsulated bacteria

FABHALTA, a complement inhibitor, increases the risk of serious infections, especially those caused by encapsulated bacteria, such as Streptococcus pneumoniae, Neisseria meningitidis, and Haemophilus influenzae type b. Life-threatening and fatal infections with encapsulated bacteria have occurred in patients treated with complement inhibitors. These infections may become rapidly life-threatening or fatal if not recognized and treated early.

Complete or update vaccination for encapsulated bacteria at least 2 weeks prior to the first dose of FABHALTA, unless the risks of delaying therapy with FABHALTA outweigh the risk of developing a serious infection. Comply with the most current Advisory Committee on Immunization Practices (ACIP) recommendations for vaccinations against encapsulated bacteria in patients receiving a complement inhibitor. See Warnings and Precautions for additional guidance on the management of the risk of serious infections caused by encapsulated bacteria.

Patients receiving FABHALTA are at increased risk for invasive disease caused by encapsulated bacteria, even if they develop antibodies following vaccination. Monitor patients for early signs and symptoms of serious infections and evaluate immediately if infection is suspected.

Because of the risk of serious infections caused by encapsulated bacteria, FABHALTA is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the FABHALTA REMS.

FABHALTA increases the risk of serious and life-threatening infections caused by encapsulated bacteria, including Streptococcus pneumoniae, Neisseria meningitidis, and Haemophilus influenzae type b.

Complete or update vaccination for encapsulated bacteria at least 2 weeks prior to the first dose of FABHALTA, unless the risks of delaying FABHALTA outweigh the risk of developing a serious infection. Comply with the most current Advisory Committee on Immunization Practices (ACIP) recommendations for vaccinations against encapsulated bacteria in patients receiving a complement inhibitor.

FABHALTA is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called FABHALTA REMS.

Read this with the rest of the clinical information

About Fabhalta

Overview

Fabhalta contains iptacopan, a complement factor B inhibitor supplied as capsules. It is used to treat adults with paroxysmal nocturnal hemoglobinuria (PNH). It is also used to slow kidney function decline in adults with primary immunoglobulin A nephropathy (IgAN) at risk of disease progression, and to reduce protein in the urine in adults with complement 3 glomerulopathy (C3G). It works by blocking factor B, a protein involved in a chain of reactions called the alternative complement pathway.

What it treats

- Paroxysmal nocturnal hemoglobinuria (PNH) in adults. - Primary immunoglobulin A nephropathy (IgAN) in adults at risk of disease progression, to slow kidney function decline. - Complement 3 glomerulopathy (C3G) in adults, to reduce protein in the urine.

Safety information

Side effects

Common side effects vary by the condition being treated. In adults with PNH, they include headache, nose and throat inflammation, diarrhea, abdominal pain, bacterial and viral infections, nausea and rash. In adults with IgAN, the most common side effects are abdominal pain and dizziness. In adults with C3G, they are nose and throat inflammation and viral infections. Serious infections caused by encapsulated bacteria can occur and warrant contacting a doctor. Fabhalta can also raise blood lipid levels. Your doctor should check these periodically and may prescribe cholesterol-lowering medicine if needed. After Fabhalta is stopped, people with PNH need monitoring for hemolysis (the breakdown of red blood cells). Contact your doctor if signs of hemolysis occur.

FDA boxed warning

Serious infections caused by encapsulated bacteria

FABHALTA increases the risk of serious and life-threatening infections caused by encapsulated bacteria, including Streptococcus pneumoniae, Neisseria meningitidis, and Haemophilus influenzae type b.

FABHALTA is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called FABHALTA REMS.

A boxed warning is the strongest warning the US Food and Drug Administration requires on a medicine label. Text is taken from the official label, with internal section references removed.

When to call your doctor

- Seek medical attention immediately if you think you have an infection, even if you have been vaccinated. Infections during Fabhalta treatment can quickly become life-threatening.

If symptoms are severe or getting worse quickly, seek emergency care rather than waiting.

Before taking this medicine

Do not take Fabhalta if you have a serious allergy to iptacopan or any of its other ingredients. Do not start treatment if you have an unresolved serious infection caused by encapsulated bacteria, including Streptococcus pneumoniae, Neisseria meningitidis or Haemophilus influenzae type b. Fabhalta is not recommended for people with severe liver impairment. Blood lipid levels should be checked periodically during treatment, and cholesterol-lowering medicine may be needed. After stopping Fabhalta, monitoring is needed for signs of haemolysis (the breakdown of red blood cells).

Interactions

Tell your doctor if you take rifampin or gemfibrozil. Rifampin and other CYP2C8 inducers may lower iptacopan levels, so your doctor should monitor whether Fabhalta is working effectively. Gemfibrozil and other strong CYP2C8 inhibitors may raise iptacopan levels; taking them with Fabhalta is not recommended.

Using Fabhalta

Dosing

Dosing is set by your prescriber. Each health care professional may prescribe medication differently according to a patient's medical history and condition, so follow the directions on your prescription label and speak to your doctor or pharmacist before changing anything.

Storage

Store below 25°C in a dry place, in the original pack, away from direct light and moisture. Do not keep it in a bathroom. Keep all medicines out of the sight and reach of children.

Clinical information on this page is summarised from the US FDA label FABHALTA (IPTACOPAN) CAPSULE [NOVARTIS PHARMACEUTICALS CORPORATION] (DailyMed, retrieved 19 September 2026).

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