ENJAYMO- sutimlimab-jome injection, solution, concentrate

Krajina: Spojené štáty

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktívna zložka:

SUTIMLIMAB (UNII: GNWE7KJ995) (SUTIMLIMAB - UNII:GNWE7KJ995)

Dostupné z:

Bioverativ Therapeutics Inc.

Spôsob podávania:

INTRAVENOUS

Typ predpisu:

PRESCRIPTION DRUG

Terapeutické indikácie:

Cold Agglutinin Disease ENJAYMO (sutimlimab-jome) is indicated for the treatment of hemolysis in adults with cold agglutinin disease (CAD). ENJAYMO is contraindicated in patients with known hypersensitivity to sutimlimab-jome or any of the inactive ingredients [see Warnings and Precautions (5.2) and Adverse Reactions (6.1)] . Risk Summary There are no available data on ENJAYMO use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Human immunoglobulin G (IgG) antibodies are known to cross the placental barrier; therefore, sutimlimab-jome may be transmitted from the mother to the developing fetus. In animal reproduction studies, intravenous administration of sutimlimab-jome to pregnant monkeys during organogenesis at doses 2 to 3 times the maximum recommended human doses did not result in adverse effects on pregnancy or offspring development (see

Prehľad produktov:

How Supplied ENJAYMO (sutimlimab-jome) injection is a clear to slightly opalescent, colorless to slightly yellow, preservative-free solution supplied as one 1,100 mg/22 mL (50 mg/mL) single-dose vial per carton (NDC 80203-347-01). Storage and Handling Store ENJAYMO vials refrigerated at 36°F to 46°F (2°C to 8°C) in the original carton to protect from light. Do not freeze. Do not shake. Discard unused portion.

Stav Autorizácia:

Biologic Licensing Application

Príbalový leták

Bioverativ Therapeutics Inc.
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This Medication Guide has been approved by the U.S. Food and Drug
Administration.
Revised: January 2023
MEDICATION GUIDE
ENJAYMO ® (en-jaye-moe)
(sutimlimab-jome)
injection, for intravenous use
What is the most important information I should know about ENJAYMO?
ENJAYMO can cause serious side effects, including:
Serious infections. ENJAYMO is a prescription medicine that affects
your immune system. ENJAYMO
can lower the ability of your immune system to fight infections.
People who are treated with ENJAYMO
may have an increased risk of getting infections caused by certain
kinds of bacteria such as Neisseria
meningitidis, Streptococcus pneumoniae, and Haemophilus influenzae.
These infections may be serious
or life-threatening. Some infections may quickly become
life-threatening or cause death if not recognized
and treated early.
•
You need to receive vaccinations against infections caused by certain
kinds of bacteria at least 2
weeks before your first dose of ENJAYMO. You may need to have
additional vaccinations during
treatment with ENJAYMO.
•
If your healthcare provider decides that urgent treatment with ENJAYMO
is needed, you should
receive vaccinations as soon as possible.
•
Vaccinations may reduce the risk of these infections, but do not
prevent all infections. Call your
healthcare provider or get medical help right away if you get any new
signs and symptoms of an
infection, including:
•
fever
•
severe headache with stiff
neck or back
•
pain during urination or
urinating more often than
usual
•
cough or difficulty breathing
•
flu-like symptoms
•
pain, redness, or swelling of the
skin
See " What are the possible side effects of ENJAYMO?" for more
information about side effects.
What is ENJAYMO?
ENJAYMO is a prescription medicine used to treat the breakdown of red
blood cells (hemolysis) in
adults with cold agglutinin disease (CAD).
It is not known if ENJAYMO is safe and effective in children.
Who should not receive ENJAYMO?
Do not receive ENJAYMO if you

Súhrn charakteristických

ENJAYMO- SUTIMLIMAB-JOME INJECTION, SOLUTION, CONCENTRATE
BIOVERATIV THERAPEUTICS INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ENJAYMO SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR ENJAYMO.
ENJAYMO (SUTIMLIMAB-JOME) INJECTION, FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 2022
RECENT MAJOR CHANGES
Indications and Usage ( 1)
01/2023
Dosage and Administration ( 2.3)
01/2023
Warnings and Precautions ( 5.1, 5.2)
01/2023
INDICATIONS AND USAGE
ENJAYMO is a classical complement inhibitor indicated for the
treatment of hemolysis in adults with cold
agglutinin disease (CAD). ( 1)
DOSAGE AND ADMINISTRATION
Vaccinate against encapsulated bacteria at least two weeks prior to
treatment. ( 2.1)
Weight-based dosage weekly for two weeks then every two weeks:
For patients weighing 39 kg to less than 75 kg: 6,500 mg by
intravenous infusion. ( 2.2)
For patients weighing 75 kg or more: 7,500 mg by intravenous infusion.
( 2.2)
See Full Prescribing Information for important preparation and
administration instructions. ( 2.2, 2.3)
DOSAGE FORMS AND STRENGTHS
Injection: 1,100 mg/22 mL (50 mg/mL) in a single-dose vial ( 3)
CONTRAINDICATIONS
ENJAYMO is contraindicated in patients with known hypersensitivity to
sutimlimab-jome or any of the
inactive ingredients. ( 4)
WARNINGS AND PRECAUTIONS
Serious Infections: Ensure patients are vaccinated against
encapsulated bacteria. Monitor patients for
early signs and symptoms of infections. ( 5.1)
Infusion-Related Reactions: Monitor patients for infusion-related
reactions, interrupt if reaction occurs,
and institute appropriate medical management as needed. ( 5.2)
Risk of Autoimmune Disease: Monitor patients for signs and symptoms
and manage medically. ( 5.3)
Recurrent Hemolysis After ENJAYMO Discontinuation: Monitor patients
for signs and symptoms of
hemolysis if treatment with ENJAYMO is interrupted. ( 5.4)
ADVERSE REACTIONS
Most common adverse reactions in the CADENZA study (Part A) (incidence
≥18%) are rhini