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FABHALTA - Novartis Pharmaceuticals Corporation

Manufacturer
Novartis Pharmaceuticals Corporation
Effective date
2025-03-20
Label type
Risk Evaluation & Mitigation Strategies
Version
8
Source
full-release
Hydrated at
2026-06-04 22:50:39

Label at a glance#

ProductFABHALTA
Label structure6 sections

Label contents#

Full prescribing information#

I. Administrative Information

REMS ADMINISTRATIVE INFORMATION

Risk: serious infections caused by encapsulated bacteria
Application Number: NDA 218276
Application Holder: Novartis Pharmaceuticals Corporation
Initial REMS Approval: 12/2023
Most Recent REMS Update: 03/2025

II. REMS Goal

REMS GOALS

The goal of the FABHALTA REMS is to mitigate the risk of serious infections caused by encapsulated bacteria.

  1. Patients are vaccinated against infections caused by encapsulated bacteria (Neisseria meningitidis serogroups A, C, W, Y, and B; and Streptococcus pneumoniae) prior to starting therapy according to current Advisory Committee on Immunization Practices (ACIP) recommendations and receive antibacterial drug prophylaxis if needed.
  2. Patients are aware of early signs and symptoms of serious encapsulated bacterial infections and the need for immediate medical evaluation.
  3. Prescribers are aware of early signs and symptoms of serious encapsulated bacterial infections and the need for immediate medical evaluation.

III. REMS Requirements

REMS REQUIREMENTS

REMS PARTICIPANT REQUIREMENTS

Novartis Pharmaceuticals Corporation must ensure that healthcare providers, patients, pharmacies, and wholesalers-distributors comply with the following requirements:

1. Healthcare providers who prescribe FABHALTA must:
To become certified to prescribe1. Review the drug’s Prescribing Information.
2. Review the following: Healthcare Provider Safety Brochure, Patient Guide, and Patient Safety Card.
3. Enroll by completing and submitting the Prescriber Enrollment Form to the REMS.
Before treatment initiation4. Assess the patient for unresolved serious infections caused by encapsulated bacteria.
5. For patients with an unresolved serious infection caused by encapsulated bacteria: Not initiate FABHALTA.
6. Assess the patient's vaccination status for Neisseria meningitidis serogroups A, C, W, Y, and B; and Streptococcus pneumoniae and vaccinate, as needed, according to the current Advisory Committee on Immunization Practices (ACIP) recommendations.
7. For patients who are not up to date with meningococcal and pneumococcal vaccines at least 2 weeks prior to initiation of treatment and who must start FABHALTA urgently: Provide the patient with a prescription for antibacterial drug prophylaxis.
8. Counsel the patient using the Patient Guide and Patient Safety Card. Provide a copy of the materials to the patient.
9. Counsel the patient on the need to carry the Patient Safety Card at all times during treatment and for 2 weeks following the last dose of FABHALTA.
During treatment10. Assess the patient for early signs and symptoms of serious bacterial infection and evaluate immediately, if infection is suspected.
11. Vaccinate patients as needed according to the current ACIP recommendations.
At all times12. Report adverse events suggestive of serious bacterial infections, including the patient's clinical outcomes, to Novartis Pharmaceuticals Corporation.

REMS PARTICIPANT REQUIREMENTS

2. Patients who are prescribed FABHALTA:
Before treatment initiation1. Get vaccinated as directed by your prescriber against the following encapsulated bacteria: Neisseria meningitidis serogroups A, C, W, Y, and B; and Streptococcus pneumoniae.
2. Take antibiotics as directed by your prescriber if you have to start FABHALTA right away.
3. Receive counseling from your prescriber using the Patient Guide and Patient Safety Card.
4. Get the Patient Guide and Patient Safety Card from your prescriber.
During treatment5. Get additional vaccines as directed by your prescriber.
At all times during treatment and for 2 weeks after the last dose6. Inform your prescriber or get emergency medical care right away if any of the following occur: fever with or without shivers or chills; fever and a rash; fever with chest pain and cough; fever with breathlessness or fast breathing; fever with high heart rate; headache with nausea or vomiting; headache and a fever; headache with stiff neck or stiff back; confusion; body aches with flu-like symptoms; clammy skin; eyes sensitive to light.
7. Have the Patient Safety Card with you.

REMS PARTICIPANT REQUIREMENTS

3. Outpatient pharmacies that dispense FABHALTA must:
To become certified to dispense1. Designate an Authorized Representative to carry out the certification process and oversee implementation and compliance with the REMS on behalf of the pharmacy.
2. Have the Authorized Representative review the Healthcare Provider Safety Brochure.
3. Have the Authorized Representative enroll in the REMS by completing and submitting the Outpatient Pharmacy Enrollment Form to the REMS.
4. Train all relevant staff involved in dispensing FABHALTA using the Healthcare Provider Safety Brochure.
5. Establish processes and procedures to contact the prescriber to assess the patient’s vaccination status for up to date meningococcal and pneumococcal vaccines according to the current Advisory Committee on Immunization Practices (ACIP) recommendations including antibacterial drug prophylaxis, if needed, before treatment initiation and document the findings.
6. For patients who are not up to date with meningococcal and pneumococcal vaccines when starting treatment: Establish processes and procedures to assess the patient’s vaccination status for up to date meningococcal and pneumococcal vaccines including antibacterial drug prophylaxis, if needed, by contacting the prescriber before dispensing prescriptions for up to 6 months after the first dose and document the findings.
Before dispensing, first dose7. Obtain authorization to dispense each prescription by contacting the REMS to verify the prescriber is certified.
8. Assess the patient’s vaccination status for up to date meningococcal and pneumococcal vaccines according to the current ACIP recommendations including antibacterial drug prophylaxis, if needed, by contacting the prescriber and document the findings through the processes and procedures established as a requirement of the REMS.
Before dispensing, for up to 6 months after the first dose9. Obtain authorization to dispense each prescription by contacting the REMS to verify the prescriber is certified.
10. For patients who are not initially up to date with meningococcal and pneumococcal vaccines when starting treatment: Assess the patient’s vaccination status for up to date meningococcal and pneumococcal vaccines including antibacterial drug prophylaxis, if needed, by contacting the prescriber and document the findings through the processes and procedures established as a requirement of the REMS.
Before dispensing, 6 months after the first dose and thereafter11. Obtain authorization to dispense each prescription by contacting the REMS to verify the prescriber is certified.
To maintain certification to dispense12. If the Authorized Representative changes, have a new Authorized Representative enroll in the REMS by completing and submitting the Outpatient Pharmacy Enrollment Form to the REMS.
At all times13. Report adverse events suggestive of serious bacterial infections to Novartis Pharmaceuticals Corporation.
14. Not distribute, transfer, loan, or sell FABHALTA, except to certified pharmacies.
15. Maintain records of staff’s completion of REMS training.
16. Maintain records that all processes and procedures are in place and are being followed.
17. Comply with audits carried out by Novartis Pharmaceuticals Corporation or a third party acting on behalf of Novartis Pharmaceuticals Corporation to ensure that all processes and procedures are in place and are being followed.

REMS PARTICIPANT REQUIREMENTS

4. Inpatient pharmacies that dispense FABHALTA must:
To become certified to dispense1. Designate an Authorized Representative to carry out the certification process and oversee implementation and compliance with the REMS on behalf of the pharmacy.
2. Have the Authorized Representative review the Healthcare Provider Safety Brochure.
3. Have the Authorized Representative enroll in the REMS by completing and submitting the Inpatient Pharmacy Enrollment Form to the REMS.
4. Train all relevant staff involved in dispensing FABHALTA using the Healthcare Provider Safety Brochure.
5. Establish processes and procedures to verify if the patient is initiating or continuing treatment.
6. For patients initiating treatment: Establish processes and procedures to contact the prescriber to assess the patient’s vaccination status for up to date meningococcal and pneumococcal vaccines according to the current Advisory Committee on Immunization Practices (ACIP) recommendations including antibacterial drug prophylaxis, if needed, before treatment initiation and document the findings.
Before dispensing, first dose7. Verify if the patient is initiating or continuing treatment through the processes and procedures established as a requirement of the REMS.
8. For patients initiating treatment: Obtain authorization to dispense by contacting the REMS to verify the prescriber is certified.
9. For patients initiating treatment: Assess the patient’s vaccination status for up to date meningococcal and pneumococcal vaccines according to the current ACIP recommendations, including antibacterial drug prophylaxis, by contacting the prescriber and document the findings through the processes and procedures established as a requirement of the REMS.
At discharge10. Dispense no more than a 30 days’ supply.
To maintain certification to dispense11. If the Authorized Representative changes, have a new Authorized Representative enroll in the REMS by completing and submitting the Inpatient Pharmacy Enrollment Form to the REMS.
At all times12. Report adverse events suggestive of serious bacterial infections to Novartis Pharmaceuticals Corporation.
13. Not distribute, transfer, loan, or sell FABHALTA, except to certified pharmacies.
14. Maintain records of staff’s completion of REMS training.
15. Maintain records that all processes and procedures are in place and are being followed.
16. Comply with audits carried out by Novartis Pharmaceuticals Corporation or a third party acting on behalf of Novartis Pharmaceuticals Corporation to ensure that all processes and procedures are in place and are being followed.

REMS PARTICIPANT REQUIREMENTS

5. Wholesalers-distributors that distribute FABHALTA must:
To be able to distribute1. Establish processes and procedures to ensure that the drug is distributed only to certified pharmacies.
2. Train relevant staff involved in FABHALTA distribution on the REMS requirements.
At all times3. Distribute only to certified pharmacies.
4. Maintain records of all drug distributions.
5. Comply with audits carried out by Novartis Pharmaceuticals Corporation or a third party acting on behalf of the applicant to ensure that all processes and procedures are in place and are being followed.

REMS APPLICANT REQUIREMENTS

Novartis Pharmaceuticals Corporation must provide training to healthcare providers who prescribe FABHALTA.
The training includes the following educational materials: Healthcare Provider Safety Brochure, Patient Guide, and Patient Safety Card. The training must be available online and by hard copy via fax and mail.

Novartis Pharmaceuticals Corporation must provide training to pharmacies that dispense FABHALTA.
The training includes the following educational material: Healthcare Provider Safety Brochure. The training must be available online and by hard copy via fax, and mail.

To support REMS operations, Novartis Pharmaceuticals Corporation must:
1. Establish and maintain a REMS Website, www.FABHALTA-REMS.com. The REMS Website must include the capability to complete prescriber certification online and the option to print the Prescribing Information, Medication Guide, and REMS materials. All product websites for consumers and healthcare providers must include prominent REMS-specific links to the REMS Website. The REMS Website must not link back to the promotional product website(s).
2. Make the REMS Website fully operational and all REMS materials available through the REMS Website and REMS Coordinating Center by the date FABHALTA is first commercially distributed.
3. Establish and maintain a REMS Coordinating Center for REMS participants at 1-833-99FABHA (1-833-993-2242).
4. Establish and maintain a validated, secure database of all REMS participants who are certified in the FABHALTA REMS.
5. Ensure prescribers are able to enroll in the REMS by fax and online.
6. Ensure pharmacies are able to enroll in the REMS by fax.
7. Ensure pharmacies are able to obtain authorization to dispense by phone or online.
8. Ensure prescribers and pharmacies are able to report adverse events suggestive of serious bacterial infections by phone.
9. Ensure that once an adverse event suggestive of serious bacterial infection is received, Novartis Pharmaceuticals Corporation will follow-up with the healthcare provider to obtain all required data. This requirement does not affect Novartis Pharmaceuticals Corporation’s other reporting and follow-up requirements under FDA regulations.
10. Provide the Healthcare Provider Safety Brochure, Prescriber Enrollment Form, Patient Guide, Patient Safety Card, and the Prescribing Information to prescribers who (1) attempt to prescribe FABHALTA and are not yet certified or (2) inquire about how to become certified.
11. Provide the Healthcare Provider Safety Brochure and Outpatient Pharmacy Enrollment Form or Inpatient Pharmacy Enrollment Form to pharmacies who (1) attempt to order/dispense and are not yet certified or (2) inquire about how to become certified.
12. Notify prescribers and pharmacies within 2 business days after they become certified in the REMS.
13. Provide certified outpatient pharmacies access to the database of certified prescribers.
14. Provide certified prescribers access to the database of certified pharmacies.
15. Provide authorized wholesalers-distributors access to the database of certified pharmacies.

To ensure REMS participants’ compliance with the REMS, Novartis Pharmaceuticals Corporation must:
16. Maintain adequate records to demonstrate that REMS requirements have been met, including, but not limited to, records of: FABHALTA distribution and dispensing; certification of prescribers and pharmacies; and audits of REMS participants. These records must be readily available for FDA inspections.
17. Verify annually that the designated Authorized Representative’s name and contact information correspond to those of the current designated Authorized Representative for the pharmacy. If different, the pharmacy must be required to re-certify with a new Authorized Representative.
18. Establish and maintain a plan for addressing noncompliance with REMS requirements.
19. Monitor prescribers and pharmacies on an ongoing basis to ensure the requirements of the REMS are being met. Take corrective action if non-compliance is identified, including decertification.
20. Audit certified outpatient and inpatient pharmacies no later than 180 calendar days after they receive their first shipment and annually thereafter to ensure that all REMS processes and procedures are in place, functioning, and comply with REMS requirements.
21. Audit wholesalers-distributors no later than 180 calendar days after their first commercial distribution of FABHALTA and annually thereafter to ensure that all REMS processes and procedures are in place, functioning, and comply with REMS requirements.
22. Take reasonable steps to improve operations of and compliance with the requirements of the FABHALTA REMS based on monitoring and evaluation of the FABHALTA REMS.

IV. REMS Assessment Timetable

REMS TIMETABLE FOR SUBMISSION ASSESSMENTS

Novartis Pharmaceuticals Corporation must submit REMS Assessments at 6 months, 12 months, and annually thereafter from the date of the initial approval of the REMS. To facilitate inclusion of as much information as possible while allowing reasonable time to prepare the submission, the reporting interval covered by each assessment should conclude no earlier than 60 calendar days before the submission date for that assessment. Novartis Pharmaceuticals Corporation must submit each assessment so that it will be received by the FDA on or before the due date.

V. REMS Materials

REMS MATERIAL

The following materials are part of the FABHALTA REMS:

Enrollment Forms:

Prescriber:

1. Prescriber Enrollment Form

Pharmacy:

2. Outpatient Pharmacy Enrollment Form
3. Inpatient Pharmacy Enrollment Form

Training and Educational Materials:

Prescriber:

4. Healthcare Provider Safety Brochure

Patient:

5. Patient Guide
6. Patient Safety Card

Pharmacy:

7. Healthcare Provider Safety Brochure

Other Materials:

8. REMS Website

VI. Statutory Elements

REMS ELEMENTS

This REMS is required under section 505-1 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355-1) and consists of the following elements:

  1. Elements to Assure Safe Use:
    • Health care providers who prescribe FABHALTA are specially certified under 505 1(f)(3)(A)
    • Pharmacies that dispense FABHALTA are specially certified under 505-1(f)(3)(B)
    • FABHALTA is dispensed to patients with evidence or other documentation of safe-use conditions under 505-1(f)(3)(D)
  2. Implementation System
  3. Timetable for Submission of Assessments

DailyMed Product Concepts#

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2098f44a-7b07-4419-8818-6f745bc41537Product name120241218

DailyMed REMS / Drug Safety Documents#

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DailyMed labelRelationVersionEffectiveManufacturerSource
These highlights do not include all the information needed to use FABHALTA safely and effectively. See full prescribing information for FABHALTA. FABHALTA ® (iptacopan) capsules, for oral use Initial U.S. Approval: 2023SPL related document2026-07-16Novartis Pharmaceuticals Corporation20250627_7b169235-e220-43f1-9471-487c5f23ee58.zip!4ea84865-fb97-4922-a806-5a582f2a5660.xml

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Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FABHALTAIPTACOPANNovartis Pharmaceuticals Corporationa76b5845-6e21-4d3b-ad07-cd8df1b60bee2026-07-16Boxed warning, Warnings, Adverse reactionsName fallback
brand name: FABHALTA

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