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
infusionwith 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, non-medical,
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.
