Ultomiris (ravulizumab-cwvz)

• Paroxysmal nocturnal hemoglobinuria (PNH): adults and children 1 month and older with PNH (a rare blood disease where red blood cells break down).
• Atypical hemolytic uremic syndrome (aHUS): adults and children 1 month and older with aHUS (a rare disease that causes blood clots in small blood vessels and can harm the kidneys); not for HUS caused by Shiga toxin E. coli (STEC-HUS).
• Generalized myasthenia gravis: adults with generalized myasthenia gravis (an immune disease that causes muscle weakness) who test positive for anti-acetylcholine receptor (AChR) antibodies.
• Neuromyelitis optica spectrum disorder (NMOSD): adults with NMOSD (an immune disease that harms the nerves of the eyes and spinal cord) who test positive for anti-aquaporin-4 (AQP4) antibodies.
• Immunoglobulin A nephropathy (IgAN): adults with primary IgAN (a kidney disease in which an antibody called IgA builds up in the kidneys) who are at risk of the disease getting worse, to lower the amount of protein in the urine (proteinuria). This use has accelerated approval (an early approval that depends on the results of a further study).

A prescription is required. Your prescriber decides whether Ultomiris is right for you.

IV infusion, given by a healthcare professional. When your prescriber agrees it can be given at home, we send a skilled nurse from an accredited nursing agency to give it.

Before the first dose, your prescriber may ask for:

• meningococcal vaccines (shots against meningococcal bacteria, groups A, C, W, Y and B) at least 2 weeks before the first dose; if treatment must start sooner, you get antibiotics and the vaccines as soon as possible
• for children, vaccines against pneumococcus and Haemophilus influenzae type b (Hib)
• your prescriber must be enrolled in a restricted program (the Ultomiris and Soliris REMS), and you will get a wallet card (the Patient Safety Card) to carry with you at all times during treatment and for 8 months after it ends

Important safety information: This medicine has a boxed warning about serious, life-threatening meningococcal infections (infections of the blood or the lining of the brain). Because of this risk, it is only available through a restricted program called the Ultomiris and Soliris REMS.

Ultomiris is available only through the Ultomiris and Soliris REMS, a safety program the FDA requires. MedRx Infusion is certified to dispense it.

Read the Medication Guide and the full Ultomiris prescribing information, and ask your prescriber or our pharmacists about side effects. Our pharmacists are on call 24 hours a day.

Health plans often require prior authorization for Ultomiris. Our intake team checks your coverage and works with your prescriber’s office on the paperwork before your first delivery.

The manufacturer runs a support program, Alexion OneSource, that may help eligible patients with costs and access.

Offices can call (844) 671-2600 or fax a referral to (844) 671-2601. Use the Neurology Referral Form (PDF).

The manufacturer also publishes Ultomiris access and reimbursement resources (Alexion Access Navigator).