GAMIFANT (- emapalumab-lzsg injection

Страна: Соединенные Штаты

Язык: английский

Источник: NLM (National Library of Medicine)

Активный ингредиент:

EMAPALUMAB (UNII: 3S252O2Z4X) (EMAPALUMAB - UNII:3S252O2Z4X)

Доступна с:

NovImmune SA

Администрация маршрут:

INTRAVENOUS

Тип рецепта:

PRESCRIPTION DRUG

Терапевтические показания :

GAMIFANT is indicated for the treatment of adult and pediatric (newborn and older) patients with primary hemophagocytic lymphohistiocytosis (HLH) with refractory, recurrent or progressive disease or intolerance with conventional HLH therapy. None. Risk Summary There are no available data on GAMIFANT use in pregnant women to inform a drug-associated risk of adverse developmental outcomes. In an animal reproduction study, a murine surrogate anti-mouse IFNγ antibody administered to pregnant mice throughout gestation crossed the placental barrier, and no fetal harm was observed (see Data). The estimated background risk of major birth defects and miscarriage for the indicated population 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 to 4% and 15 to 20%, respectively. Data Animal Data In a mouse embryo-fetal development s

Обзор продуктов:

GAMIFANT (emapalumab-lzsg) injection is a sterile, clear to slightly opalescent, colorless to slightly yellow solution supplied in the following packaging configuration: NDC 72171-501-01 – containing one 10 mg/2 mL (5 mg/mL) single-dose vial NDC 72171-505-01 – containing one 50 mg/10 mL (5 mg/mL) single-dose vial Store GAMIFANT in a refrigerator at 2°C to 8ºC (36°F to 46°F) in original carton to protect from light. Do not freeze or shake. This product contains no preservative.

Статус Авторизация:

Biologic Licensing Application

тонкая брошюра

NovImmune SA
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MEDICATION GUIDE
GAMIFANT® (gam' i fant)
(emapalumab-lzsg)
injection, for intravenous use
What is the most important information I should know about GAMIFANT?
GAMIFANT can cause serious side effects including:Infections. GAMIFANT
is a medicine that affects
your immune system and may lower the ability of your immune system to
fight infections. GAMIFANT
may increase your risk of serious infections that can lead to death.
These infections include tuberculosis
(TB), histoplasmosis, Herpes zoster infection (shingles) and other
infections caused by viruses, fungi or
bacteria that can spread throughout the body.
Your healthcare provider will:
•
test you for TB before you start treatment with GAMIFANT.
•
treat you with a medicine for TB if you at risk for TB or if you have
a known positive TB test.
Infections are common in people treated with GAMIFANT.
Before starting GAMIFANT, tell your healthcare provider if you:
•
had TB in the past, or if you or a member of your family have been in
recent close contact with
someone with TB.
•
have ever had a positive TB skin test (PPD).
•
currently have or have had history of infections, including
histoplasmosis or Herpes zoster
(shingles).
•
are being treated for an active infection.
•
have symptoms of an infection, such as fever, sweat and chills, cough,
breathing problems, blood
in mucus (phlegm), warm, red, or painful skin or sores on your body.
Your healthcare provider will give you medicine to help prevent
certain infections before you receive
GAMIFANT. After starting GAMIFANT, tell your healthcare provider if:
•
new symptoms of an infection appear.
•
symptoms of an infection that you already had when starting GAMIFANT
worsen.
Your healthcare provider will monitor you closely for signs and
symptoms of infections during treatment
with GAMIFANT.
See "What are the possible side effects of GAMIFANT?" for more
information about side effects.
What is GAMIFANT?
GAMIFANT is a prescription medicine used for the treatment of adults
and children

Характеристики продукта

GAMIFANT- (EMAPALUMAB-LZSG) INJECTION
NOVIMMUNE SA
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
GAMIFANT SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR GAMIFANT.
GAMIFANT (EMAPALUMAB-LZSG) INJECTION, FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 2018
INDICATIONS AND USAGE
GAMIFANT is an interferon gamma (IFNγ) blocking antibody indicated
for the treatment of adult and pediatric (newborn
and older) patients with primary hemophagocytic lymphohistiocytosis
(HLH) with refractory, recurrent or progressive
disease or intolerance with conventional HLH therapy. (1)
DOSAGE AND ADMINISTRATION
For intravenous infusion only:
Recommended starting dosage: 1 mg/kg as an intravenous infusion over 1
hour twice per week. (2.1)
Administer dexamethasone concomitantly with GAMIFANT. (2.3)
DOSAGE FORMS AND STRENGTHS
Inje ction:
10 mg/2 mL (5 mg/mL) solution in a single-use vial (3)
50 mg/10 mL (5 mg/mL) solution in a single-use vial (3)
CONTRAINDICATIONS
None. (4)
WARNINGS AND PRECAUTIONS
Infections: Monitor patients for signs and symptoms and treat
promptly. Test for latent tuberculosis. Administer
prophylactic treatment against Herpes Zoster, _Pneumocystis jiroveci_
and fungal infections. (5.1)
Live Vaccines: Do not administer live or live attenuated vaccines to
patients receiving GAMIFANT. (5.2)
Infusion-Related Reactions: Monitor patients for infusion-related
reactions. Interrupt infusion for severe infusion
reactions and institute appropriate medical management. (5.3)
ADVERSE REACTIONS
The most common adverse reactions (≥ 20%) were: infections,
hypertension, infusion-related reactions, and pyrexia. (6.1)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT 1-866-773-5274 OR FDA
AT 1-800-FDA-1088 OR
_WWW.FDA.GOV/MEDWATCH._
SEE 17 FOR PATIENT COUNSELING INFORMATION AND MEDICATION GUIDE.
REVISED: 11/2018
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
2.1 Recommended Dosing
2.2 Monitoring to Assess Safety
2.3 Pre