SOLIRIS- eculizumab injection, solution, concentrate

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

ECULIZUMAB (UNII: A3ULP0F556) (ECULIZUMAB - UNII:A3ULP0F556)

Available from:

Alexion Pharmaceuticals Inc.

INN (International Name):

ECULIZUMAB

Composition:

ECULIZUMAB 300 mg in 30 mL

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

SOLIRIS is indicated for the treatment of patients with paroxysmal nocturnal hemoglobinuria (PNH) to reduce hemolysis. SOLIRIS is indicated for the treatment of patients with atypical hemolytic uremic syndrome (aHUS) to inhibit complement-mediated thrombotic microangiopathy. Limitation of Use SOLIRIS is not indicated for the treatment of patients with Shiga toxin E. coli related hemolytic uremic syndrome (STEC-HUS). SOLIRIS is indicated for the treatment of generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AchR) antibody positive. SOLIRIS is indicated for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQP4) antibody positive. SOLIRIS is contraindicated for initiation in patients with unresolved serious Neisseria meningitidis infection [see Warnings and Precautions (5.1)] . Risk Summary Limited data on outcomes of pregnancies that have occurred following SOLIRIS use in pregnant women have not identified a concern for specific adverse developmental outcomes (see Data ). There are risks to the mother and fetus associated with untreated paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS) in pregnancy (see Clinical Considerations ). Animal studies using a mouse analogue of the SOLIRIS molecule (murine anti-C5 antibody) showed increased rates of developmental abnormalities and an increased rate of dead and moribund offspring at doses 2-8 times the human dose (see Data ). The estimated background risk of major birth defects and miscarriage for the indicated populations is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defect and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. Clinical Considerations Disease-associated maternal and/or fetal/neonatal risk PNH in pregnancy is associated with adverse maternal outcomes, including worsening cytopenias, thrombotic events, infections, bleeding, miscarriages and increased maternal mortality, and adverse fetal outcomes, including fetal death and premature delivery. aHUS in pregnancy is associated with adverse maternal outcomes, including pre-eclampsia and preterm delivery, and adverse fetal/neonatal outcomes, including intrauterine growth restriction (IUGR), fetal death and low birth weight. Data Human Data A pooled analysis of prospectively (50.3%) and retrospectively (49.7%) collected data in more than 300 pregnant women with live births following exposure to SOLIRIS have not suggested safety concerns. However, these data cannot definitively exclude any drug-associated risk during pregnancy, because of the limited sample size. Animal Data Animal reproduction studies were conducted in mice using doses of a murine anti-C5 antibody that approximated 2-4 times (low dose) and 4-8 times (high dose) the recommended human SOLIRIS dose, based on a body weight comparison. When animal exposure to the antibody occurred in the time period from before mating until early gestation, no decrease in fertility or reproductive performance was observed. When maternal exposure to the antibody occurred during organogenesis, two cases of retinal dysplasia and one case of umbilical hernia were observed among 230 offspring born to mothers exposed to the higher antibody dose; however, the exposure did not increase fetal loss or neonatal death. When maternal exposure to the antibody occurred in the time period from implantation through weaning, a higher number of male offspring became moribund or died (1/25 controls, 2/25 low dose group, 5/25 high dose group). Surviving offspring had normal development and reproductive function. Risk Summary Although limited published data does not report detectable levels of eculizumab in human milk, maternal IgG is known to be present in human milk. Available information is insufficient to inform the effect of eculizumab on the breastfed infant. There are no data on the effects of eculizumab on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for SOLIRIS and any potential adverse effects on the breastfed child from eculizumab or from the underlying maternal condition. Safety and effectiveness of SOLIRIS for the treatment of PNH, gMG, or NMOSD in pediatric patients have not been established. The safety and effectiveness of SOLIRIS for the treatment of aHUS have been established in pediatric patients. Use of SOLIRIS in pediatric patients for this indication is supported by evidence from four adequate and well-controlled clinical studies assessing the safety and effectiveness of SOLIRIS for the treatment of aHUS. The studies included a total of 47 pediatric patients (ages 2 months to 17 years). The safety and effectiveness of SOLIRIS for the treatment of aHUS appear similar in pediatric and adult patients [see Adverse Reactions (6.1), and Clinical Studies (14.2) ]. Administer vaccinations for the prevention of infection due to Neisseria meningitidis , Streptococcus pneumoniae and Haemophilus influenzae type b (Hib) according to ACIP guidelines [see Warnings and Precautions (5.1, 5.3)] . Fifty-one patients 65 years of age or older (15 with PNH, 4 with aHUS, 26 with gMG, and 6 with NMOSD) were treated with SOLIRIS in clinical trials in the approved indications. Although there were no apparent age-related differences observed in these studies, the number of patients aged 65 and over is not sufficient to determine whether they respond differently from younger patients.

Product summary:

SOLIRIS (eculizumab) injection is a sterile, preservative-free, clear, colorless solution supplied as one 300 mg/30 mL (10 mg/mL) single-dose vial per carton (NDC 25682-001-01). Store SOLIRIS vials refrigerated at 2°-8° C (36°-46° F) in the original carton to protect from light until time of use. SOLIRIS vials may be stored in the original carton at controlled room temperature (not more than 25° C/77° F) for only a single period up to 3 days. Do not use beyond the expiration date stamped on the carton. Refer to Dosage and Administration (2) for information on the stability and storage of diluted solutions of SOLIRIS. DO NOT FREEZE. DO NOT SHAKE.

Authorization status:

Biologic Licensing Application

Patient Information leaflet

Alexion Pharmaceuticals Inc.
----------
This Medication Guide has been approved by the U.S. Food and Drug
Administration
Revised 02/2024
MEDICATION GUIDE
SOLIRIS® (so-leer-is)
(eculizumab)
injection, for intravenous use
What is the most important information I should know about SOLIRIS?
SOLIRIS is a medicine that affects your immune system. SOLIRIS may
lower the ability of your
immune system to fight infections.
•
SOLIRIS increases your chance of getting serious meningococcal
infections caused by
Neisseria meningitidis bacteria. Meningococcal infections may quickly
become life-
threatening or cause death if not recognized and treated early.
•
You must complete or update your meningococcal vaccine(s) at least 2
weeks before
your first dose of SOLIRIS.
•
If you have not completed your meningococcal vaccines and SOLIRIS must
be
started right away, you should receive the required vaccine(s) as soon
as possible.
•
If you have not been vaccinated and SOLIRIS must be started right
away, you should
also receive antibiotics to take for as long as your healthcare
provider tells you.
•
If you had a meningococcal vaccine in the past, you might need
additional vaccines
before starting SOLIRIS. Your healthcare provider will decide if you
need additional
meningococcal vaccines.
•
Meningococcal vaccines do not prevent all meningococcal infections.
Call your
healthcare provider or get emergency medical care right away if you
get any of these
signs and symptoms of a serious meningococcal infection:
•
fever
•
fever with high heart rate
•
headache and fever
•
confusion
•
body aches with flu-like symptoms
•
fever and a rash
•
headache with nausea or vomiting
•
headache with a stiff neck or stiff
back
•
eyes sensitive to light
Your healthcare provider will give you a Patient Safety Card about the
risk of serious
meningococcal infection. Carry it with you at all times during
treatment and for 3 months after your
last dose of SOLIRIS. Your risk of meningococcal infection may
continue for several weeks afte

Summary of Product characteristics

SOLIRIS- ECULIZUMAB INJECTION, SOLUTION, CONCENTRATE
ALEXION PHARMACEUTICALS INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
SOLIRIS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR SOLIRIS.
SOLIRIS (ECULIZUMAB) INJECTION, FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 2007
WARNING: SERIOUS MENINGOCOCCAL INFECTIONS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
SOLIRIS INCREASES THE RISK OF SERIOUS AND LIFE-THREATENING INFECTIONS
CAUSED BY
_NEISSERIA MENINGITIDIS_.
COMPLETE OR UPDATE MENINGOCOCCAL VACCINATION AT LEAST 2 WEEKS PRIOR TO
THE FIRST DOSE OF SOLIRIS, UNLESS THE
RISKS OF DELAYING SOLIRIS OUTWEIGH THE RISK OF DEVELOPING A SERIOUS
INFECTION. COMPLY WITH THE MOST CURRENT
ADVISORY COMMITTEE ON IMMUNIZATION PRACTICES (ACIP) RECOMMENDATIONS
FOR MENINGOCOCCAL VACCINATION IN
PATIENTS RECEIVING A COMPLEMENT INHIBITOR. (5.1)
PATIENTS RECEIVING SOLIRIS ARE AT INCREASED RISK FOR INVASIVE DISEASE
CAUSED BY
_N. MENINGITIDIS_, EVEN IF THEY
DEVELOP ANTIBODIES FOLLOWING VACCINATION. MONITOR PATIENTS FOR EARLY
SIGNS AND SYMPTOMS OF MENINGOCOCCAL
INFECTIONS AND EVALUATE IMMEDIATELY IF INFECTION IS SUSPECTED. (5.1)
SOLIRIS IS AVAILABLE ONLY THROUGH A RESTRICTED PROGRAM CALLED SOLIRIS
REMS. ( 5.2)
RECENT MAJOR CHANGES
Boxed Warning
02/2024
Dosage and Administration (2.1)
02/2024
Contraindications (4)
02/2024
Warnings and Precautions (5.1, 5.2)
02/2024
INDICATIONS AND USAGE
SOLIRIS is a complement inhibitor indicated for:
The treatment of patients with paroxysmal nocturnal hemoglobinuria
(PNH) to reduce hemolysis. (1.1)
The treatment of patients with atypical hemolytic uremic syndrome
(aHUS) to inhibit complement-mediated thrombotic
microangiopathy. (1.2)
Limitation of Use
SOLIRIS is not indicated for the treatment of patients with Shiga
toxin E. coli related hemolytic uremic syndrome (STEC-HUS).
The treatment of generalized myasthenia gravis (gMG) in adult patients
who are anti-acetylcholine receptor (AchR) antibody
positive. (1.