GAMIFANT- emapalumab-lzsg injection

País: Estados Unidos

Língua: inglês

Origem: NLM (National Library of Medicine)

Ingredientes ativos:

emapalumab (UNII: 3S252O2Z4X) (emapalumab - UNII:3S252O2Z4X)

Disponível em:

Swedish Orphan Biovitrum AB (publ)

Via de administração:

INTRAVENOUS

Tipo de prescrição:

PRESCRIPTION DRUG

Indicações terapêuticas:

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

Resumo do produto:

GAMIFANT (emapalumab-lzsg) injection is a sterile, clear to slightly opalescent, colorless to slightly yellow solution supplied in the following packaging configuration: NDC 66658-501-01 – containing one 10 mg/2 mL (5 mg/mL) single-dose vial NDC 66658-505-01 – containing one 50 mg/10 mL (5 mg/mL) single-dose vial NDC 66658-510-01 – containing one 100 mg/20 mL (5 mg/mL) single-dose vial NDC 66658-522-01 – containing one 50 mg/2 mL (25 mg/mL) single-dose vial NDC 66658-523-01 – containing one 100 mg/4 mL (25 mg/mL) single-dose vial NDC 66658-524-01 – containing one 250 mg/10 mL (25 mg/mL) single-dose vial NDC 66658-525-01 – containing one 500 mg/20 mL (25 mg/mL) single-dose vial Store GAMIFANT in a refrigerator at 2ºC to 8ºC (36ºF to 46ºF) in original carton to protect from light. Do not freeze or shake. This product contains no preservative.

Status de autorização:

Biologic Licensing Application

Folheto informativo - Bula

Swedish Orphan Biovitrum AB (publ)
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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

Características técnicas

GAMIFANT- EMAPALUMAB-LZSG INJECTION
SWEDISH ORPHAN BIOVITRUM AB (PUBL)
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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
Injection:
10 mg/2 mL (5 mg/mL) solution in a single-dose vial (3)
50 mg/10 mL (5 mg/mL) solution in a single-dose vial (3)
100 mg/20 mL (5 mg/mL) solution in a single-dose vial (3)
50 mg/2 mL (25 mg/mL) solution in a single-dose vial (3)
100 mg/4 mL (25 mg/mL) solution in a single-dose vial (3)
250 mg/10 mL (25 mg/mL) solution in a single-dose vial (3)
500 mg/20 mL (25 mg/mL) solution in a single-dose 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
jirovecii_ 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 REACTION