Regulatory Affairs

FABHALTA™ (iptacopan)

200 mg Hard capsules

National Succinct Statement (NSS)

Version 1.3

                              Effective date:                                          17-Oct-2024

                              Safety Label Change (SLC)

                              Tracking number:                                      N/A

                              Document status:                                     Final

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May not be used, divulged, published or otherwise disclosed

without the consent of Novartis

FABHALTA™

Important note:  Before prescribing, consult full prescribing information:

https://www.fda.gov/

Presentation:

Hard capsules containing 200 mg of iptacopan

1.    INDICATIONS AND USAGE

    

   1. Paroxysmal Nocturnal Hemoglobinuria

       

      FABHALTA is indicated for the treatment of adults with paroxysmal nocturnal hemoglobinuria (PNH).

       

   2. Immunoglobulin A Nephropathy

FABHALTA is indicated to reduce proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at risk of rapid disease progression, generally a urine protein-to- creatinine ratio (UPCR) ≥1.5 g/g.

This indication is approved under accelerated approval based on reduction of proteinuria. It has not been established whether FABHALTA slows kidney function decline in patients with IgAN. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory clinical trial.

 2    DOSAGE AND ADMINISTRATION

•  2.1   Recommended Vaccination and Prophylaxis for Encapsulated Bacterial Infections

  Vaccinate patients against encapsulated bacteria, including Streptococcus pneumoniae and Neisseria meningitidis (serogroups A, C, W, Y and B), according to current ACIP recommendations at least 2 weeks prior to initiation of FABHALTA [see Warnings and Precautions (5.1)].

  If urgent FABHALTA therapy is indicated in a patient who is not up to date with vaccines for Streptococcus pneumoniae and Neisseria meningitidis according to ACIP recommendations, provide the patient with antibacterial drug prophylaxis and administer these vaccines as soon as possible [see Warnings and Precautions (5.1)].

   

  Healthcare providers who prescribe FABHALTA must enroll in the FABHALTA REMS [see Warnings and Precautions (5.2)].

   

• 2.2   Recommended Dosage

  The recommended dosage of FABHALTA is 200 mg orally twice daily without regard to food.

  Swallow capsules whole. Do not open, break, or chew capsules.

  If a dose or doses are missed, advise the patient to take one dose of FABHALTA as soon as possible (even if it is soon before the next scheduled dose) and then to resume the regular dosing schedule.

   

• 2.3  PNH Patients Switching From Anti-C5 (eculizumab, ravulizumab) to FABHALTA

To reduce the potential risk of hemolysis with abrupt discontinuation of other PNH therapies:

• For patients switching from eculizumab, initiate FABHALTA no later than 1 week after

  the last dose of eculizumab.

• For patients switching from ravulizumab, initiate FABHALTA no later than 6 weeks after the last dose of ravulizumab.

  There is no available information regarding the timeframe for initiation of FABHALTA after other PNH therapies.

   

  Contraindications:

  • Hypersensitivity to iptacopan or to any of the excipients. ♦For initiation in patients with unresolved serious infection caused by encapsulated bacteria, including Streptococcus pneumoniae, Neisseria meningitidis, or Haemophilus influenzae type B.

     

    Warnings and precautions:

    Serious infections caused by encapsulated bacteria:

  • Complement inhibitors such as Fabhalta may predispose individuals to serious, life- threatening, or fatal infections. ♦To reduce the risk of infection, patients must be vaccinated against encapsulated bacteria, including Neisseria meningitidis and Streptococcus pneumoniae. It is recommended to vaccinate against Haemophilus influenzae type B if available. ♦Vaccines should be administered at least 2 weeks prior to administration of the first dose of Fabhalta. ♦If Fabhalta must be initiated prior to vaccination, administer the vaccine as soon as possible after the first dose of Fabhalta and provide patients with antibacterial drug prophylaxis until 2 weeks after vaccination. ♦If necessary, patients may be revaccinated. ♦Patients should be informed of and monitored for early signs and symptoms of serious bacterial infection. ♦Immediately evaluate and treat patients if a bacterial infection is suspected.

    Monitoring PNH Manifestations after Discontinuation of Fabhalta:

  • Monitor patients for at least two weeks for signs and symptoms of hemolysis. ♦Signs and symptoms include elevated lactate dehydrogenase (LDH) levels, along with sudden decrease in hemoglobin or PNH clone size, fatigue, hemoglobinuria, abdominal pain, dyspnea, major adverse vascular events (including thrombosis), dysphagia, or erectile dysfunction ♦Consider alternative therapy if discontinuation of Fabhalta is necessary. ♦Consider restarting Fabhalta if hemolysis occurs.

   

  Pregnancy, lactation, females and males of reproductive potential

  Pregnancy: Animal reproduction studies have not shown risk of increased fetal abnormalities. There are risks to the mother and fetus associated with untreated PNH and C3G. May consider use in pregnant women or women planning to become pregnant following an assessment of the risks and benefits.

  Lactation: Not known if transferred into human milk. No data on the effects on the breast-fed child or on milk production. The developmental and health benefits of breast-feeding should be considered along with the mother’s clinical need for Fabhalta and any potential adverse effects (e.g., serious infections from encapsulated bacteria) on the breast-fed child from Fabhalta or from the underlying maternal condition.

   

  Adverse drug reactions:

  The following clinically significant adverse reaction is discussed in greater detail in other sections of the labeling:

• Serious Infections Caused by Encapsulated Bacteria

• Hyperlipidemia

Interactions:

1. CYP2C8 Inducers

   Concomitant use of CYP2C8 inducers (e.g., rifampin) may decrease iptacopan exposure, which may result in loss of or reduced efficacy of FABHALTA. Monitor the clinical response and discontinue use of the CYP2C8 inducer if loss of efficacy of FABHALTA is evident.

2. Strong CYP2C8 Inhibitors

Concomitant use of strong CYP2C8 inhibitors (e.g., gemfibrozil) may increase iptacopan exposure, which may result in an increased risk for adverse reactions with FABHALTA. Coadministration with a strong CYP2C8 inhibitor is not recommended.

Packs and prices: Country-specific.

Legal classification: Country-specific.

Leaflet revision date: August 2024

NSS version number: v1.3

Leaflet presentation: R02