ULTOMIRIS- ravulizumab solution, concentrate ULTOMIRIS- ravulizumab kit

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

ravulizumab (UNII: C3VX249T6L) (ravulizumab - UNII:C3VX249T6L)

Commercializzato da:

Alexion Pharmaceuticals Inc.

Via di somministrazione:

INTRAVENOUS

Tipo di ricetta:

PRESCRIPTION DRUG

Indicazioni terapeutiche:

ULTOMIRIS is indicated for the treatment of adult and pediatric patients one month of age and older with paroxysmal nocturnal hemoglobinuria (PNH). ULTOMIRIS is indicated for the treatment of adult and pediatric patients one month of age and older with atypical hemolytic uremic syndrome (aHUS) to inhibit complement-mediated thrombotic microangiopathy (TMA). Limitations of Use: ULTOMIRIS is not indicated for the treatment of patients with Shiga toxin E. coli related hemolytic uremic syndrome (STEC-HUS). ULTOMIRIS is indicated for the treatment of adult patients with generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody-positive. ULTOMIRIS is indicated for the treatment of adult patients with neuromyelitis optica spectrum disorder (NMOSD) who are anti-aquaporin-4 (AQP4) antibody positive. ULTOMIRIS is contraindicated for initiation in patients with unresolved serious Neisseria meningitidis infection [see Warnings and Precautions (5.1)] . Risk Summary There are no available data on ULTOMIRIS use in pregnant women to inform a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. There are risks to the mother and fetus associated with untreated PNH and aHUS in pregnancy (see Clinical Considerations ). Animal studies using a mouse analogue of the ravulizumab-cwvz molecule (murine anti-mouse complement component 5 [C5] antibody) showed increased rates of developmental abnormalities and an increased rate of dead and moribund offspring at doses 0.8-2.2 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 defects 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. In pregnancy, aHUS is associated with adverse maternal outcomes, including preeclampsia and preterm delivery, and adverse fetal/neonatal outcomes, including intrauterine growth restriction (IUGR), fetal death and low birth weight. Data Animal Data Animal reproduction studies were conducted in mice using doses of a murine anti-C5 antibody that approximated 1-2.2 times (loading dose) and 0.8-1.8 times (maintenance dose) the recommended human ULTOMIRIS 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, 2 cases of retinal dysplasia and 1 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. Human IgG are known to cross the human placental barrier, and thus ULTOMIRIS may potentially cause terminal complement inhibition in fetal circulation. Risk summary There are no data on the presence of ravulizumab-cwvz in human milk, the effect on the breastfed child, or the effect on milk production. Since many medicinal products and immunoglobulins are secreted into human milk, and because of the potential for serious adverse reactions in a nursing child, breastfeeding should be discontinued during treatment and for 8 months after the final dose. The safety and effectiveness of ULTOMIRIS administered intravenously for the treatment of PNH have been established in pediatric patients aged one month and older. Use of ULTOMIRIS for this indication is supported by evidence from adequate and well-controlled trials in adults with additional pharmacokinetic, efficacy and safety data in pediatric patients aged 9 to 17 years [see Adverse Reactions (6.1), Clinical Pharmacology (12.3), and Clinical Studies (14.1)] . The safety and efficacy for the treatment of pediatric and adult patients with PNH appear similar. Use of ULTOMIRIS administered intravenously in pediatric patients with PNH aged less than 9 years and body weight < 30 kg is based on extrapolation of pharmacokinetic / pharmacodynamic (PK/PD), and efficacy and safety data from aHUS and PNH clinical studies [see Clinical Pharmacology (12.3) and Clinical Studies (14)] . The safety and effectiveness of ULTOMIRIS administered intravenously for the treatment of aHUS have been established in pediatric patients aged one month and older. Use of ULTOMIRIS for this indication is supported by evidence from adequate and well-controlled studies in adults with additional pharmacokinetic, safety, and efficacy data in pediatric patients aged 10 months to < 17 years. The safety and efficacy of ULTOMIRIS administered intravenously for the treatment of aHUS appear similar in pediatric and adult patients [see Adverse Reactions (6.1), and Clinical Studies (14.2)] . The safety and effectiveness of ULTOMIRIS for the treatment of gMG or NMOSD in pediatric patients have not been established. Subcutaneous administration of ULTOMIRIS has not been evaluated and is not approved for use in pediatric patients. Clinical studies of ULTOMIRIS did not include sufficient numbers of subjects aged 65 and over (58 patients with PNH, 9 with aHUS, 54 with gMG, and 7 with NMOSD) to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between elderly and younger patients. - It is important that you receive training from your healthcare provider on how to inject ULTOMIRIS before giving an injection. - If you have a serious allergic reaction (such as chest pain, trouble breathing, facial swelling, and/or feeling faint), remove the on-body injector(s) to stop the injection and get medical help right away. - You will need 2 ULTOMIRIS on-body injectors and 2 prefilled cartridges to receive your full dose. - Store ULTOMIRIS injector and cartridge in the refrigerator between 36°F to 46°F (2°C to 8°C). - Keep the injector and cartridge in the original carton to protect from light or physical damage. - For your injection, take 2 injectors and 2 cartridges out of the refrigerator and let them sit at room temperature for at least 45 minutes before you inject. - Do not return to the refrigerator. The injector and cartridge may be stored in the original carton box at room temperature between 68°F to 77°F (20°C to 25°C) for up to 3 days. Discard (throw away) after 3 days if unused. - Do not freeze. - Keep ULTOMIRIS and all medicines out of the reach of children. - Do not shake or drop the injector or cartridge. - Do not remove the injector or cartridge from the carton or clear tray until you are ready to inject. - Do not press the blue start button on the injector until you place the loaded injector onto your skin and are ready to inject. - After you insert the cartridge into the injector, make sure you inject within 5 minutes. Loading the cartridge more than 5 minutes before your injection can dry out the medicine. - Do not use the injector or cartridge if the packaging appears to be opened, or if the injector or cartridge has been dropped or appears to be broken or damaged. Part of the on-body injector or prefilled cartridge may be broken even if you cannot see the damage. - Do not reuse the on-body injector and prefilled cartridge. They are single-use only. - Do not let the injector get wet from water or other liquids. It contains electronic parts that should not get wet. - Keep the on-body injector a minimum of 4 inches (10 cm) away from other electronics such as cellular phones. - Do not use the injector or cartridge past the expiration date printed on the carton and cartridge. - Do not use a microwave, hot water, hair dryer, or any other heat sources to warm the prefilled cartridge. - Do not return to the refrigerator. The injectors and cartridges may be stored in the original carton box at room temperature between 68°F to 77°F (20°C to 25°C) for up to 3 days. Throw away (discard) after 3 days if unused. - Do not touch the blue start button until the injectors are on your skin and you are ready to inject. - Do not use if the white paper cover(s) or plastic cover(s) is missing or damaged. If either is missing, call 1-888-765-4747. - 2 clear trays containing the on-body injectors and prefilled cartridges (See Figure E) - Alcohol wipes - Cotton ball or gauze pad - Adhesive bandage - Sharps disposal container - Do not inject into areas of the skin that are tender, bruised, red or hard, or areas with wrinkles, skin folds, scars, tattoos, stretch marks, moles, or excessive hair. - Do not use the same sites 2 weeks in a row. Change (rotate) your injection sites every week to reduce irritation. 2A - Do not use if the medicine is cloudy, discolored, or contains flakes or particles. - Do not use if any part of cartridge looks cracked, broken, or if pieces are missing. - Do not hold it by the ends. - Do not turn (rotate) or remove the top or bottom of the cartridge. - Do not touch the cartridge bottom after cleaning. - Note: It is okay to see a few drops of the medicine coming out of the needle. - Do not pull the skin adhesive backing off of the injector. - Do not touch the skin adhesive. - Do not touch the start button until you have placed the loaded injector onto your skin. - To prevent injury, do not touch the needle cover area. - Do not place the loaded injector on your body if the red status light flashes continuously. - Do not fold the skin adhesive over onto itself. - You can see the status light. - The injectors are at least 1 inch (2.5 cm) apart. - Clothing is kept away from adhesive. - Do not move the loaded injector after it has been placed onto your skin. - You will hear 3 "beeps" when the blue button is pressed and injection starts. - The status light will flash green during the injection. - The sound of the injector motor will be heard for about 10 minutes during the injection. - You may feel a pinch. - Light physical activities can be done during injection, such as walking, reaching, and bending. - The injector should stay dry. Do not let the injector get wet from water or other liquids. It contains electronic parts that should not get wet. - Status light turns solid green. - Begins "beeping" 3 times every 30 seconds. - White plunger fills the medicine window. (See Figure Q) - Put the used ULTOMIRIS on-body injectors and prefilled cartridges in an FDA-cleared sharps disposal container right away after use. Do not throw away (dispose of) the ULTOMIRIS on-body injectors and prefilled cartridges in your household trash. - If you do not have an FDA-cleared sharps disposal container, you may use a household container that is: - made of a heavy-duty plastic, - can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out, - upright and stable during use, - leak-resistant, and - properly labeled to warn of hazardous waste inside the container. - When your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. There may be state or local laws about how you should throw away needles and syringes. For more information about safe sharps disposal, and for specific information about sharps disposal in the state you live in, go to the FDA's website at: http://www.fda.gov/safesharpsdisposal - Do not recycle your used sharps disposal container. - If there is blood at the injection sites, press a cotton ball or gauze pad on site. - Apply an adhesive bandage if necessary. - Do not rub the injection site. Frequently Asked Questions - You need 2 on-body injectors and 2 prefilled cartridges for a full weekly dose. You may prepare and use 2 on-body injectors and 2 prefilled cartridges at the same time. - If the status light flashes red at any time, this means there is an error and the on-body injector will no longer work. Remove the on-body injector from the body (if it is attached) and place it in the original packaging. Do not remove the prefilled cartridge from the on-body injector. Contact 1-888-765-4747 and return the on-body injector and cartridge per the instructions given. - See Step 2A and Figure I. If you still cannot open it, contact 1-888-765-4747. - First check that both pull tabs on the back of the on-body injector have been fully removed, including the battery strip. If the on-body injector still does not turn on, use a new on-body injector and prefilled cartridge. Contact 1-888-765-4747. - If you removed the pull tabs and pressed the start button, the on-body injector will make a beeping sound and you will see the status light flash red. The on-body injector will no longer work. Stop using the on-body injector and contact 1-888-765-4747. - Make sure you firmly press the blue start button. If it still does not start, remove the on-body injector and contact 1-888-765-4747. Do not reapply the same on-body injector as it will not work. Use a new on-body injector and prefilled cartridge. - Do not use the on-body injector or prefilled cartridge and contact 1-888-765-4747. - It is important to inject within 5 minutes after loading the prefilled cartridge. - After you load the prefilled cartridge into the on-body injector, it is completely normal to see the medicine drop out of the needle. This is to get rid of the air from the on-body injector needle. However, if you wait more than 5 minutes to start your injection, you may lose some of your medicine. Additionally, this may dry out the medicine and clog the on-body injector needle. - Do not return to the refrigerator the on-body injectors and prefilled cartridges after they reach room temperature. This may degrade the medicine. If needed, the on-body injectors and prefilled cartridges may be stored in the original carton box at room temperature between 68°F to 77°F (20°C to 25°C) for up to 3 days. Throw away after 3 days if unused. - Relative humidity range is 15% to 85%. - Altitude range is -984 feet to 11483 feet (-300 meters to 3500 meters). - During injection, keep the on-body injector a minimum of 4 inches (10 cm) away from other electronics such as cellular phones. - Warning: Do not modify the on-body injector or prefilled cartridge. - Warning: Magnetic Resonance (MR) is unsafe, the on-body injector for ULTOMIRIS should not enter the MR scanning room. - On-body injector operating temperature range is 59°F to 104°F (15°C to 40°C).

Dettagli prodotto:

Intravenous: ULTOMIRIS (ravulizumab-cwvz) injection 100 mg/mL is translucent, clear to yellowish color solution supplied in one single-dose vial per carton as: ULTOMIRIS (ravulizumab-cwvz) injection 10 mg/mL is clear to translucent, slight whitish color solution supplied in one single-dose vial per carton as: Subcutaneous: ULTOMIRIS (ravulizumab-cwvz) injection 70 mg/mL is translucent, clear to yellowish color solution supplied in one single-dose cartridge as part of a single-use on-body delivery system: Intravenous: Store ULTOMIRIS vials refrigerated at 2°C - 8°C (36°F - 46°F) in the original carton to protect from light. Do not freeze. Do not shake. Refer to Dosage and Administration (2) for information on the stability and storage of diluted solutions of ULTOMIRIS. Subcutaneous: Store ULTOMIRIS prefilled cartridges and on-body injectors refrigerated at 2°C - 8°C (36°F - 46°F) in the original carton to protect from light and physical damage. Do not freeze. Do not shake or drop. Do not allow the on-body injector to get wet from water or other liquids. If removed from the refrigerator, store ULTOMIRIS on-body injector and prefilled cartridge in the original carton box at room temperature between 68°F - 77°F (20°C - 25°C) for up to 3 days. If stored at room temperature, discard after 3 days. Do not return to the refrigerator. The single-use on-body injector with prefilled cartridge is not made with natural rubber latex.

Stato dell'autorizzazione:

Biologic Licensing Application

Foglio illustrativo

ULTOMIRIS- RAVULIZUMAB
Alexion Pharmaceuticals Inc.
----------
This Medication Guide has been approved by the U.S. Food and
Drug Administration.
Revised: 03/2024
MEDICATION GUIDE
ULTOMIRIS® (ul-toe-meer-is)
(ravulizumab-cwvz)
injection
for intravenous or subcutaneous use
What is the most important information I should know about ULTOMIRIS?
ULTOMIRIS is a medicine that affects your immune system. ULTOMIRIS may
lower the ability of your
immune system to fight infections.
•
ULTOMIRIS 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 ULTOMIRIS.
•
If you have not completed your meningococcal vaccines and ULTOMIRIS
must be started
right away, you should receive the required vaccine(s) as soon as
possible.
•
If you have not been vaccinated and ULTOMIRIS 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 ULTOMIRIS. 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
•
muscle aches with flu-like symptoms
•
fever and a rash
•
headache with nausea or vomiting
•
headache with 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 8
months after your last dose of
ULTOMIRIS. You

Scheda tecnica

ULTOMIRIS- RAVULIZUMAB SOLUTION, CONCENTRATE
ULTOMIRIS- RAVULIZUMAB
ALEXION PHARMACEUTICALS INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ULTOMIRIS SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR ULTOMIRIS.
ULTOMIRIS (RAVULIZUMAB-CWVZ) INJECTION, FOR INTRAVENOUS OR
SUBCUTANEOUS USE
INITIAL U.S. APPROVAL: 2018
WARNING: SERIOUS MENINGOCOCCAL INFECTIONS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
ULTOMIRIS 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 ULTOMIRIS, UNLESS THE RISKS OF DELAYING ULTOMIRIS OUTWEIGH THE
RISKS 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 ULTOMIRIS 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)
ULTOMIRIS IS AVAILABLE ONLY THROUGH A RESTRICTED PROGRAM CALLED
ULTOMIRIS AND SOLIRIS
REMS. (5.2)
RECENT MAJOR CHANGES
Boxed Warning
02/2024
Indications and Usage (1.4)
03/2024
Dosage and Administration (2.2, 2.3, 2.6)
03/2024
Contraindications (4)
02/2024
Warnings and Precautions (5.1, 5.2, 5.3, 5.6)
03/2024
INDICATIONS AND USAGE
ULTOMIRIS is a complement inhibitor indicated for:
the treatment of adult and pediatric patients one month of age and
older with paroxysmal nocturnal
hemoglobinuria (PNH). (1.1)
the treatment of adult and pediatric patients one month of age and
older with atypical hemolytic
uremic syndrome (aHUS) to inhibit complement-mediated thrombotic
microangiopathy (TMA). (1.2)
Limitations of Use:
ULTOMIRIS is not indicated for the treatment of patie