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.¹

 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 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.¹

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

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.¹

Required vaccinations: Streptococcus pneumoniae and Neisseria meningitidis (serogroups A, C, W, Y, and B).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 vaccines according to ACIP recommendations as soon as possible.¹

Click on image to enlarge.

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

Choose one of two ways to submit Rx for FABHALTA

1. SEND RX DIRECTLY TO ONE OF THE TWO LIMITED NETWORK SPECIALTY PHARMACIES

CareMed is a subsidiary of Onco360^®.

2. COMPLETE START FORM WITH NOVARTIS PATIENT SUPPORT™

^†Limitations apply. Up to $10,000 annual limit. Offer not valid under Medicare, Medicaid, or any other federal or state health insurance program. Patients with private insurance and a prior authorization requirement or an initial denial of coverage may receive up to 12 months of free product while coverage is pursued. Novartis reserves the right to rescind, revoke, or amend this program without notice. Additional limitations may apply. See complete Terms & Conditions at www.fabhalta.com for details.

Working with a specialty pharmacy

Unlike a traditional retail pharmacy, the specialty pharmacy will ship FABHALTA directly to your patients. Ensure your patient is aware which specialty pharmacy will deliver their medication. 

Novartis does not recommend or require the use of any particular pharmacy. 

Typical support offered by specialty pharmacies can include the following:

• Clinical and educational support

•  Assistance navigating insurance coverage

• Affordability support

• Refill reminders

• Ongoing communication

Please reach out to the specialty pharmacy to learn more about the support that may be available. 

Pharmacies that dispense FABHALTA must be certified in the FABHALTA REMS and must verify that prescribers are certified.¹