BAVENCIO- avelumab injection, solution, concentrate

País: Estados Unidos

Idioma: inglés

Fuente: NLM (National Library of Medicine)

Ingredientes activos:

avelumab (UNII: KXG2PJ551I) (avelumab - UNII:KXG2PJ551I)

Disponible desde:

EMD Serono, Inc.

Designación común internacional (DCI):

avelumab

Composición:

avelumab 20 mg in 1 mL

Vía de administración:

INTRAVENOUS

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

BAVENCIO (avelumab) is indicated for the treatment of adults and pediatric patients 12 years and older with metastatic Merkel cell carcinoma (MCC). First-Line Maintenance Treatment of Urothelial Carcinoma BAVENCIO is indicated for the maintenance treatment of patients with locally advanced or metastatic urothelial carcinoma (UC) that has not progressed with first-line platinum-containing chemotherapy [see Clinical Studies (14.2)] . Previously-treated Urothelial Carcinoma BAVENCIO is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma (UC) who: - Have disease progression during or following platinum-containing chemotherapy - Have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy [see Clinical Studies (14.2)]. BAVENCIO in combination with axitinib is indicated for the first-line treatment of patients with advanced renal cell carcinoma (RCC) [see Clinical Studies (14.3)] . None. Risk Summary Based on its mechanism of action, BAVENCIO can cause fetal harm when administered to a pregnant woman. There are no available data on the use of BAVENCIO in pregnant women [see Clinical Pharmacology (12.1)] . Animal studies have demonstrated that inhibition of the PD-1/PD-L1 pathway can lead to increased risk of immune-mediated rejection of the developing fetus resulting in fetal death [see Data] . Human IgG1 immunoglobulins (IgG1) are known to cross the placenta. Therefore, BAVENCIO has the potential to be transmitted from the mother to the developing fetus. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, advise the patient of the potential risk to a fetus. 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 Animal reproduction studies have not been conducted with BAVENCIO to evaluate its effect on reproduction and fetal development. A central function of the PD-1/PD-L1 pathway is to preserve pregnancy by maintaining maternal immune tolerance to the fetus. In murine models of pregnancy, blockade of PD-L1 signaling has been shown to disrupt tolerance to the fetus and to result in an increase in fetal loss; therefore, potential risks of administering BAVENCIO during pregnancy include increased rates of abortion or stillbirth. As reported in the literature, there were no malformations related to the blockade of PD-1/PD-L1 signaling in the offspring of these animals; however, immune-mediated disorders occurred in PD-1 and PD-L1 knockout mice. Based on its mechanism of action, fetal exposure to BAVENCIO may increase the risk of developing immune-related disorders or altering the normal immune response. Risk Summary There is no information regarding the presence of avelumab in human milk, the effects on the breastfed infant, or the effects on milk production. Since many drugs including antibodies are excreted in human milk, advise a lactating woman not to breastfeed during treatment and for at least one month after the last dose of BAVENCIO due to the potential for serious adverse reactions in breastfed infants. Contraception Based on its mechanism of action, BAVENCIO can cause fetal harm when administered to a pregnant woman [see Use in Specific Populations (8.1)] . Advise females of reproductive potential to use effective contraception during treatment with BAVENCIO and for at least 1 month after the last dose of BAVENCIO. The safety and effectiveness of BAVENCIO have been established in pediatric patients aged 12 years and older for metastatic MCC. Use of BAVENCIO in this age group is supported by evidence from adequate and well-controlled studies of BAVENCIO in adults with additional population pharmacokinetic data demonstrating that age and body weight had no clinically meaningful effect on the steady state exposure of avelumab, that drug exposure is generally similar between adults and pediatric patients age 12 years and older for monoclonal antibodies, and that the course of MCC is sufficiently similar in adult and pediatric patients to allow extrapolation of data in adults to pediatric patients. The recommended dose in pediatric patients 12 years of age or greater is the same as that in adults [see Dosage and Administration (2.2), Clinical Pharmacology (12.3), and Clinical Studies (14)] . Safety and effectiveness of BAVENCIO have not been established in pediatric patients less than 12 years of age. Metastatic Merkel Cell Carcinoma Of the 204 patients with MCC who received BAVENCIO in the JAVELIN Merkel 200 trial, 78% were 65 years or older and 43% were 75 years or older. No overall differences in safety or efficacy were observed between elderly patients and younger patients. Locally Advanced or Metastatic Urothelial Carcinoma Of the 344 patients randomized to BAVENCIO 10 mg/kg plus BSC in the JAVELIN Bladder 100 trial, 63% were 65 years or older and 24% were 75 years or older. No overall differences in safety or efficacy were reported between elderly patients and younger patients. Advanced Renal Cell Carcinoma Of the 434 patients randomized to BAVENCIO 10 mg/kg administered in combination with axitinib 5 mg twice daily in the JAVELIN Renal 101 trial, 38% were 65 years or older and 8% were 75 years or older. No overall difference in safety or efficacy were reported between elderly patients and younger patients.

Resumen del producto:

BAVENCIO (avelumab) Injection is a sterile, preservative-free, and clear, colorless to slightly yellow solution for intravenous infusion supplied as a single-dose vial of 200 mg/10 mL (20 mg/mL), individually packed into a carton (NDC 44087-3535-1). Store refrigerated at 36°F to 46°F (2°C to 8°C) in original package to protect from light. Do not freeze or shake the vial. The vial stopper is not made with natural rubber latex.

Estado de Autorización:

Biologic Licensing Application

Información para el usuario

EMD Serono, Inc.
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This Medication Guide has been approved by the U.S. Food and Drug
Administration.
Revised: 09/2023
MEDICATION GUIDE
BAVENCIO® (buh-VEN-see-oh)
(avelumab)
injection
What is the most important information I should know about BAVENCIO?
BAVENCIO is a medicine that may treat certain cancers by working with
your immune system.
BAVENCIO can cause your immune system to attack normal organs and
tissues in any area of your body
and can affect the way they work. These problems can sometimes become
severe or life-threatening and
can lead to death. You can have more than one of these problems at the
same time. These problems may
happen anytime during treatment or even after your treatment has
ended.
Call or see your healthcare provider right away if you get any new or
worsening signs or symptoms,
including:
Lung problems.
•
cough
•
shortness of breath
•
chest pain
Intestinal problems.
•
diarrhea (loose stools) or more frequent bowel movements than usual
•
stools that are black, tarry, sticky, or have blood or mucus
•
severe stomach-area (abdomen) pain or tenderness
Liver problems.
•
yellowing of your skin or the whites of your eyes
•
severe nausea or vomiting
•
pain on the right side of your stomach-area
(abdomen)
•
dark urine (tea colored)
•
bleeding or bruising more easily
than normal
Hormone gland problems.
•
headache that will not go away or unusual
headaches
•
eye sensitivity to light
•
eye problems
•
rapid heartbeat
•
increased sweating
•
extreme tiredness
•
weight gain or weight loss
•
feeling more hungry or thirsty than usual
•
urinating more often than usual
•
hair loss
•
feeling cold
•
constipation
•
your voice gets deeper
•
dizziness or fainting
•
changes in mood or behavior, such as
decreased sex drive, irritability, or
forgetfulness
Kidney problems.
•
decrease in your amount of urine
•
blood in your urine
•
swelling of your ankles
•
loss of appetite
Skin problems.
•
rash
•
itching
•
skin blistering or peeling
•
painfu

Ficha técnica

BAVENCIO- AVELUMAB INJECTION, SOLUTION, CONCENTRATE
EMD SERONO, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
BAVENCIO SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR BAVENCIO.
BAVENCIO (AVELUMAB) INJECTION, FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 2017
RECENT MAJOR CHANGES
Indication and Usage (1.1)
09/2023
Warnings and Precautions (5.1, 5.2)
03/2024
INDICATIONS AND USAGE
BAVENCIO is a programmed death ligand-1 (PD-L1) blocking antibody
indicated for:
Merkel Cell Carcinoma (MCC)
Adults and pediatric patients 12 years and older with metastatic MCC.
(1.1, 14.1)
Urothelial Carcinoma (UC)
Maintenance treatment of patients with locally advanced or metastatic
UC that has not progressed with
first-line platinum-containing chemotherapy. (1.2, 14.2)
Patients with locally advanced or metastatic UC who:
Have disease progression during or following platinum-containing
chemotherapy. (1.2, 14.2)
Have disease progression within 12 months of neoadjuvant or adjuvant
treatment with platinum-
containing chemotherapy. (1.2, 14.2)
Renal Cell Carcinoma (RCC)
First-line treatment, in combination with axitinib, of patients with
advanced RCC. (1.3, 14.3)
DOSAGE AND ADMINISTRATION
Premedicate for the first 4 infusions and subsequently as needed.
(2.1)
Merkel Cell Carcinoma: 800 mg every 2 weeks. (2.2)
Urothelial Carcinoma; 800 mg every 2 weeks. (2.3)
Renal Cell Carcinoma: 800 mg every 2 weeks in combination with
axitinib 5 mg orally twice daily. (2.4)
Administer BAVENCIO as an intravenous infusion over 60 minutes.
DOSAGE FORMS AND STRENGTHS
Injection: 200 mg/10 mL (20 mg/mL) solution in single-dose vial. (3)
CONTRAINDICATIONS
None. (4)
WARNINGS AND PRECAUTIONS
Immune-Mediated Adverse Reactions (5.1)
Immune-mediated adverse reactions, which may be severe or fatal, can
occur in any organ system
or tissue, including the following: immune-mediated pneumonitis,
immune-mediated colitis,
immune-mediated hepatitis, immune-mediated endocrinopathies,
immune-me