1. How does it work?
Inebilizumab works by killing B-cells, a type of white blood cell felt to cause inflammation leading to injury in NMOSD. Mechanistically this drug is similar to Rituximab.
2. Who should not take this drug?
You should not receive Inebilizumab if you have: 1) had a life-threatening infusion reaction to Inebilizumab, 2) an active hepatitis B virus infection, or 3) active or untreated inactive (latent) tuberculosis.
3. How is it taken?
Intravascular (IV) infusion in an outpatient infusion center.
4. How often is it generally taken?
One infusion every six months, with the exception of the first dose which is divided into two infusions (at week 0 and week 2).
5. What is the typical dosage?
300 mg every six months.
6. How much does it reduce my risk of relapse?
In the N-Momentum clinical trial, Inebilizumab reduced the risk of relapse by roughly 73% compared to individuals with NMOSD not on therapy.
7. What are the side effects?
There is a higher risk of infections, most commonly respiratory tract and urinary tract infections. Joint pain may occur. Infusion reactions may occur, ranging from flu-like symptoms, low blood pressure, hives to swelling, shortness of breath and, in more severe cases, shock. There can be reactivation of old infections, like hepatitis and tuberculosis, which your doctor will screen for before starting the medication.
8. What should I do to prepare for taking this?
Your doctor should check your blood work for cell counts, liver enzymes, proteins called immunoglobulins, tuberculosis, and hepatitis.
9. What ongoing monitoring should occur when taking this drug?
Yearly tuberculosis and hepatitis screening. Your doctor may monitor your blood counts, including B-cell count, to determine if the drug is still working in your body.
10. Who makes this medication?
Inebilizumab is produced by Horizon Therapeutics.
11. How can I get help paying for it?
Horizon Therapeutics is committed to helping patients access Uplizna, and they have a team in place to support both patients and their care partners. Horizon By Your Side is a complimentary support program for patients, care partners and healthcare professionals. Case managers will help navigate insurance and financial assistance needs where appropriate. For more information on this program, please visit https://www.horizonbyyourside.com/.
12. Can I take it if I’m pregnant?
There is no FDA pregnancy category assigned to Inebilizumab. Studies have shown that Inebilizumab can cross the placenta and decrease fetal white blood cells, similar to Rituximab. It is unclear if this medication is safe for use in pregnancy and should be discussed with your doctor.
13. Clinical trial information
In the N-Momentum clinical trial, 230 individuals were studied. They were both positive and negative for the AQP-4 antibody. Individuals taking the drug were compared to individuals not taking any drug, with slightly better response in seropositive participants with a 77% reduction in relapse risk.
14. Will my insurance cover it?
This will depend on your insurance company and the billing code your doctor uses. For specific questions, call the customer service phone number on the back of your insurance card with the name of the drug in question, as well as ICD (diagnostic) code your doctor uses.
15. Is it FDA approved for NMOSD?