Get patients on track for treatment with FABHALTA^® (iptacopan)

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 enrollment:

Counsel patients on 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.

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

Required vaccinations: Streptococcus pneumoniae and Neisseria meningitidis (serogroups A, C, W, Y, and B). Complete or update vaccination against encapsulated bacteria (according to the most current ACIP recommendations for patients receiving a complement inhibitor) 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 according to ACIP recommendations as soon as possible. For additional details on antibacterial drug prophylaxis, please see the FABHALTA Prescribing Information, Warnings and Precautions (Section 5.1).

It is required to complete or update vaccinations at least 2 weeks before starting Fabhalta against Streptococcus pneumoniae and Neisseria meningitidis. Complete required vaccinations, wait at least 2 weeks, then start Fabhalta. If urgent treatment with Fabhalta is required at any point, provide antibiotic prophylaxis + Fabhalta and administer these vaccines as soon as possible. Patient must wait at least 2 weeks since the last required vaccination dose was administered prior to starting Fabhalta.

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 become rapidly 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

"I learned from my doctor that vaccinations were required before starting FABHALTA because of an increased risk of certain infections. I got them done and was happy to start treatment."

Sarah, a real FABHALTA patient, is compensated for her time by Novartis. Individual results may vary.