VYVGART- efgartigimod alfa injection

Land: Verenigde Staten

Taal: Engels

Bron: NLM (National Library of Medicine)

Werkstoffen:

EFGARTIGIMOD ALFA (UNII: 961YV2O515) (EFGARTIGIMOD ALFA - UNII:961YV2O515)

Beschikbaar vanaf:

argenx US

Toedieningsweg:

INTRAVENOUS

Prescription-type:

PRESCRIPTION DRUG

therapeutische indicaties:

VYVGART is indicated for the treatment of generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) antibody positive. VYVGART is contraindicated in patients with serious hypersensitivity to efgartigimod alfa products or to any of the excipients of VYVGART. Reactions have included anaphylaxis and hypotension leading to syncope [see Warnings and Precautions (5.2)] . Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to VYVGART during pregnancy. Healthcare providers and patients may call 1-855-272-6524 or go to https://www.Vyvgartpregnancy.com to enroll in or to obtain information about the registry. Risk Summary There are no available data on the use of VYVGART during pregnancy. There is no evidence of adverse developmental outcomes following the administration of VYVGART at up to 100 mg/kg/day in rats and rabbits (see Data). The background rate of major birth defects and miscarriage in the indicated population is unknown. In the U.S. general population, the estimated background rate of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Clinical Considerations Fetal/Neonatal Adverse Reactions Monoclonal antibodies are increasingly transported across the placenta as pregnancy progresses, with the largest amount transferred during the third trimester. Therefore, efgartigimod alfa-fcab may be transmitted from the mother to the developing fetus. As VYVGART is expected to reduce maternal IgG antibody levels, reduction in passive protection to the newborn is anticipated. Risk and benefits should be considered prior to administering live or live-attenuated vaccines to infants exposed to VYVGART in utero [see Warnings and Precautions (5.1)]. Data Animal Data Intravenous administration of efgartigimod alfa-fcab (0, 30, or 100 mg/kg/day) to pregnant rats and rabbits throughout organogenesis resulted in no adverse effects on embryofetal development in either species. The doses tested are 3 and 10 times the recommended human dose (RHD) of 10 mg/kg, on a body weight (mg/kg) basis. Intravenous administration of efgartigimod alfa-fcab (0, 30, or 100 mg/kg/day) to rats throughout gestation and lactation resulted in no adverse effects on pre- or postnatal development. The doses tested are 3 and 10 times the recommended human dose (RHD) of 10 mg/kg, on a body weight (mg/kg) basis. Risk Summary There is no information regarding the presence of efgartigimod alfa-fcab in human milk, the effects on the breastfed infant, or the effects on milk production. Maternal IgG is known to be present in human milk. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for VYVGART and any potential adverse effects on the breastfed infant from VYVGART or from the underlying maternal condition. Safety and effectiveness in pediatric patients have not been established. Clinical studies of VYVGART did not include sufficient numbers of patients aged 65 and older to determine whether they respond differently from younger adult patients. No dose adjustment of VYVGART is needed for patients with mild renal impairment. There are insufficient data to evaluate the impact of moderate renal impairment (eGFR 30-59 mL/min/1.73 m2 ) and severe renal impairment (eGFR <30 mL/min/1.73 m2 ) on pharmacokinetic parameters of efgartigimod alfa-fcab [see Clinical Pharmacology (12.3)].

Product samenvatting:

VYVGART (efgartigimod alfa-fcab) injection is a preservative free, sterile, colorless to slightly yellow, clear to slightly opalescent solution supplied as 400 mg/20 mL (20 mg/mL) in one single-dose vial per carton (NDC 73475-3041-5). Store VYVGART vials refrigerated at 2°C to 8°C (36°F to 46°F) in the original carton to protect from light until time of use. Do not freeze. Do not shake. Refer to Dosage and Administration (2.3) for information on stability and storage of the diluted solutions of VYVGART.

Autorisatie-status:

Biologic Licensing Application

Productkenmerken

VYVGART- EFGARTIGIMOD ALFA INJECTION
ARGENX US
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
VYVGART SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR VYVGART.
VYVGART (EFGARTIGIMOD ALFA-FCAB) INJECTION, FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 2021
RECENT MAJOR CHANGES
Contraindications (4)
12/2023
Warnings and Precautions (5.2, 5.3)
12/2023
INDICATIONS AND USAGE
VYVGART is a neonatal Fc receptor blocker indicated for the treatment
of generalized myasthenia gravis
(gMG) in adult patients who are anti-acetylcholine receptor (AChR)
antibody positive. (1)
DOSAGE AND ADMINISTRATION
Evaluate the need to administer age-appropriate vaccines according to
immunization guidelines before
initiation of a new treatment cycle with VYVGART. (2.1)
The recommended dosage is 10 mg/kg administered as an intravenous
infusion over one hour once
weekly for 4 weeks. In patients weighing 120 kg or more, the
recommended dose is 1200 mg per
infusion. (2.2)
Administer subsequent treatment cycles based on clinical evaluation;
safety of initiating subsequent
cycles sooner than 50 days from the start of the previous treatment
cycle has not been established.
(2.2)
Must be diluted with 0.9% Sodium Chloride Injection, USP prior to
administration. (2.3)
Administer as an intravenous infusion over one hour via a 0.2 micron
in-line filter. (2.3)
DOSAGE FORMS AND STRENGTHS
Injection: 400 mg in 20 mL (20 mg/mL) single-dose vial. (3)
CONTRAINDICATIONS
VYVGART is contraindicated in patients with serious hypersensitivity
to efgartigimod alfa products or to any
of the excipients of VYVGART. (4)
WARNINGS AND PRECAUTIONS
Infections: Delay administration of VYVGART to patients with an active
infection. Monitor for signs and
symptoms of infection in patients treated with VYVGART. If serious
infection occurs, administer
appropriate treatment and consider withholding VYVGART until the
infection has resolved. (5.1)
Hypersensitivity Reactions: Anaphylaxis, hypotension leading to
sy