There are a few key steps to know when preparing an UPLIZNA® (inebilizumab-cdon) infusion. Let’s walk through some specifics of the UPLIZNA infusion process.
UPLIZNA is an intravenous infusion that is FDA approved to treat adult patients with AQP4-IgG antibody-positive neuromyelitis optica spectrum disorder, also called NMOSD.
NMOSD is a rare autoimmune disease characterized by repeated inflammatory attacks. These attacks often result in debilitating symptoms and permanent disability.
Let’s walk through an UPLIZNA infusion with an example patient.
Meet Abby. She’s been diagnosed with AQP4-IgG-positive NMOSD. Her doctor has decided to prescribe UPLIZNA for her.
Abby has arrived for her first infusion. Since this is Abby’s first dose, she’s already been screened for hepatitis B virus, quantitative serum immunoglobulins, and tuberculosis. It’s also been confirmed that Abby does not have any active infections. This step should be completed before every infusion.
Please also note that immunizations should be administered according to guidelines at least 4 weeks prior to UPLIZNA initiation.
She will receive her first dose today and another in 14 days. After that, her maintenance treatments will be twice a year, starting 6 months from the first dose.
Let’s go through the preparation steps for Abby’s UPLIZNA infusion.
You’ve already received UPLIZNA and have been storing it in the refrigerator.
UPLIZNA is shipped cold and should be stored in the carton, upright, and protected from light.
Do not freeze or shake UPLIZNA.
Inside the carton, you’ll see UPLIZNA supplied as three 100 mg/10 mL single-dose vials.
Remove UPLIZNA from the refrigerator and visually inspect the solution to make sure it is safe and ready to use.
If the solution is cloudy, discolored, or it contains discrete particulate matter, do not use and contact Horizon Therapeutics. The UPLIZNA vials for Abby’s treatment are intact and ready to be prepared.
Next, you will prepare Abby’s premedications. She will receive a corticosteroid, an antihistamine, and an antipyretic to reduce the frequency and severity of infusion reactions, should they occur.
Premedications should be administered approximately 30 to 60 minutes prior to each UPLIZNA infusion.
Now it’s time to dilute the UPLIZNA solution.
Let’s gather all the materials you’ll need to prepare Abby’s treatment: an infusion pump, an IV line with an in-line filter, and a 250-mL IV bag of normal saline. Do not use other diluents to dilute UPLIZNA.
Next, withdraw 10 mL of UPLIZNA from each of the 3 vials contained in the carton and transfer a total of 30 mL into the 250-mL IV bag.
Mix the diluted solution by gentle inversion. Make sure that you do not shake the solution.
Discard the unused portion remaining in the vials.
Once diluted, the UPLIZNA infusion solution should be administered immediately. Ensure the solution is at room temperature before beginning the infusion.
If UPLIZNA is not administered immediately, store the infusion solution following the specific time and temperature requirements.
Excellent, you are ready to begin Abby’s infusion!
Let’s go through the steps for administering the UPLIZNA infusion.
Abby is comfortable and ready to start. She will receive a total of 300 mg of UPLIZNA over approximately 90 minutes.
Ensure that you follow the infusion rates recommended for UPLIZNA administration. During the infusion, Abby should be monitored closely for infusion reactions.
After the infusion, it’s important to continue to monitor Abby for at least 1 hour.
That’s it! Abby will come back on Day 15 of her dosing schedule to finish her initial dosing.
For more information about infusing UPLIZNA, view the Infusion Guide at UPLIZNAhcp.com.
Horizon By Your Side is a patient support program for patients prescribed UPLIZNA. The Horizon By Your Side team will provide information on patient support, nonmedical, logistical assistance, insurance benefits investigation, and financial assistance. Healthcare providers can enroll patients, like Abby, in Horizon By Your Side by completing the Patient Enrollment Form.
Additionally, patients may be eligible for a $0 co-pay for both the cost of the medication and the infusion administration.
Resources to support patients are available at UPLIZNA.com, and specific resources for sites of care can be found in the UPLIZNA Resource Library.
- A history of life-threatening infusion reaction to UPLIZNA
- Active hepatitis B infection
- Active or untreated latent tuberculosis
WARNINGS AND PRECAUTIONS
Infusion Reactions: UPLIZNA can cause infusion reactions, which can include headache, nausea, somnolence, dyspnea, fever, myalgia, rash, or other symptoms. Infusion reactions were most common with the first infusion but were also observed during subsequent infusions. Administer pre-medication with a corticosteroid, an antihistamine, and an anti-pyretic
Infections: The most common infections reported by UPLIZNA-treated patients in the randomized and open-label periods included urinary tract infection (20%), nasopharyngitis (13%), upper respiratory tract infection (8%), and influenza (7%). Delay UPLIZNA administration in patients with an active infection until the infection is resolved.
Increased immunosuppressive effects are possible if combining UPLIZNA with another immunosuppressive therapy.
The risk of Hepatitis B Virus (HBV) reactivation has been observed with other B-cell-depleting antibodies. Perform HBV screening in all patients before initiation of treatment with UPLIZNA. Do not administer to patients with active hepatitis.
Although no confirmed cases of Progressive Multifocal Leukoencephalopathy (PML) were identified in UPLIZNA clinical trials, JC virus infection resulting in PML has been observed in patients treated with other B-cell-depleting antibodies and other therapies that affect immune competence. At the first sign or symptom suggestive of PML, withhold UPLIZNA and perform an appropriate diagnostic evaluation.
Patients should be evaluated for tuberculosis risk factors and tested for latent infection prior to initiating UPLIZNA.
Vaccination with live-attenuated or live vaccines is not recommended during treatment and after discontinuation, until B-cell repletion.
Reduction in Immunoglobulins: There may be a progressive and prolonged hypogammaglobulinemia or decline in the levels of total and individual immunoglobulins such as immunoglobulins G and M (IgG and IgM) with continued UPLIZNA treatment. Monitor the level of immunoglobulins at the beginning, during, and after discontinuation of treatment with UPLIZNA until B-cell repletion especially in patients with opportunistic or recurrent infections.
Fetal Risk: May cause fetal harm based on animal data. Advise females of reproductive potential of the potential risk to a fetus and to use an effective method of contraception during treatment and for 6 months after stopping UPLIZNA.
Adverse Reactions: The most common adverse reactions (at least 10% of patients treated with UPLIZNA and greater than placebo) were urinary tract infection and arthralgia.
Please see Full Prescribing Information for more information.
