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Help your patients start their journey with FABHALTA

Get your patients started on FABHALTA with these 3 steps1

REMS program icon.

Getting REMS certified to prescribe FABHALTA

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. 

To enroll in the REMS:

  • Review the FABHALTA Prescribing Information and REMS materials

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

After enrollment:

  • Counsel patients about the risk of serious infections caused by encapsulated bacteria, the need for vaccinations, and the early signs and symptoms of serious infections

  • Provide patients with REMS educational materials and the Patient Safety Card. Instruct patients to always carry this card with them 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.

Vaccine icon.

Complete or update vaccinations before starting treatment with FABHALTA

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

Required vaccinations:

  • Streptococcus pneumoniae

  • Neisseria meningitidis (serogroups A, C, W, Y, and B)

  • Haemophilus influenzae type B

Complete or update vaccinations for encapsulated bacteria at least 2 weeks prior to 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 vaccines against encapsulated bacteria, 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 FABHALTA: 

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 receiving treatment for serious infections

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

Icon of prescription symbol.

Prescribing FABHALTA through a limited network of specialty pharmacies

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.

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Biologics by McKesson

IMPORTANT SAFETY INFORMATION

WARNING: SERIOUS INFECTIONS CAUSED BY ENCAPSULATED BACTERIA

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.

  • Complete or update vaccinations for encapsulated bacteria at least 2 weeks prior to the first dose of FABHALTA, unless the risks of delaying therapy with FABHALTA outweigh the risk of developing a serious infection. Comply with the most current Advisory Committee on Immunization Practices (ACIP) recommendations for vaccinations against encapsulated bacteria in patients receiving a complement inhibitor.

  • Patients receiving FABHALTA are at increased risk for invasive disease caused by encapsulated bacteria, even if they develop antibodies following vaccination. Monitor patients for early signs and symptoms of serious infections and evaluate immediately if infection is suspected.

Because of the risk of serious infections caused by encapsulated bacteria, FABHALTA is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the FABHALTA REMS.

INDICATION

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

CLICK OR SCROLL TO SEE IMPORTANT SAFETY INFORMATION, INCLUDING BOXED WARNING AND INDICATION

Definitions
ACIP, Advisory Committee on Immunization Practices; REMS, Risk Evaluation and Mitigation Strategy.

Reference
1. Fabhalta. Prescribing information. Novartis Pharmaceuticals Corp.