Help your patients start their journey with FABHALTA^® (iptacopan)

GET YOUR PATIENTS STARTED

Because of the risk of serious infections caused by encapsulated bacteria, you will need to become certified in the FABHALTA REMS and fulfill its requirements.

 Enroll in the FABHALTA REMS:

• Review the FABHALTA Prescribing Information and REMS materials

• Submit the completed Prescriber Enrollment form online at www.FABHALTA-REMS.com or by fax to 1-877-206-3255

After enrollment¹:

• Counsel patients about the risk of serious infections caused by encapsulated bacteria, vaccination requirements, and early signs and symptoms of serious infections

• Provide patients with REMS educational materials and the Patient Safety Card

• Instruct patients to always carry the card during treatment and for 2 weeks following the last dose of FABHALTA

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.¹

Additional information is available by telephone at 1-833-99FABHA or online at www.FABHALTA-REMS.com.

Comply with the most current ACIP recommendations for vaccinations against encapsulated bacteria in patients receiving a complement inhibitor.¹

If urgent FABHALTA therapy is indicated in a patient who is not up-to-date with these vaccines, provide antibacterial drug prophylaxis and administer the recommended vaccines according to ACIP recommendations as soon as possible.

HOW TO START YOUR PATIENTS ON FABHALTA

Required vaccinations¹: Streptococcus pneumoniae and Neisseria meningitidis (serogroups A, C, W, Y, and B)

Complete or update vaccines at least 2 weeks before starting FABHALTA, unless the risks of delaying FABHALTA outweigh the risk of developing a serious infection.

If urgent FABHALTA therapy is indicated in a patient who is not up to date with these vaccines:

• Provide the patient with antibacterial drug prophylaxis and administer these vaccines as soon as possible. For additional details on antibacterial drug prophylaxis, please see the FABHALTA Prescribing Information, Warnings and Precautions (Section 5.1)

During treatment with FABHALTA¹:
As vaccination does not eliminate the risk of serious encapsulated bacterial infections, closely monitor patients for early signs and symptoms. Inform patients of these signs and symptoms, and instruct patients to seek immediate medical care if they occur.

• Evaluate and treat immediately if infection is suspected, as serious infection may rapidly become life threatening or fatal if not recognized and treated early. Promptly treat known infections

• Consider interruption of FABHALTA in patients who are undergoing treatment for serious infections, depending on the risks of interrupting treatment for IgAN

• While on therapy, patients are required to be revaccinated as needed

Prescribing FABHALTA through a limited network of specialty pharmacies

Once you are ready to prescribe FABHALTA, inform your patient which specialty pharmacy in the limited network will be dispensing their FABHALTA prescription.*

Submit Rx by downloading and completing a Start Form with Novartis Patient Support, a comprehensive program that offers assistance to health care professionals and patients for getting started on FABHALTA.

Start Form*: Here         Phone: 1-833-99FABHA          Fax: 1-877-44FABHA 

OR send the Rx directly to one of the limited network specialty pharmacies*

CareMed

• Website: caremedsp.com ↗

• Phone: 1-877-227-3405

• Fax: 1-877-542-2731

Biologics by McKesson

• Website: biologics.mckesson.com ↗

• Phone: 1-800-850-4306

• Fax: 1-800-823-4506

*Inform your patient which specialty pharmacy will be dispensing their FABHALTA prescription, and tell them to expect a phone call to arrange delivery of their prescription. Pharmacies that dispense FABHALTA must be certified in the FABHALTA REMS and must verify that prescribers are certified.¹

CareMed, an Onco360 Specialty Pharmacy.