ALYMSYS- bevacizumab-maly injection, solution

Pajjiż: Stati Uniti

Lingwa: Ingliż

Sors: NLM (National Library of Medicine)

Ingredjent attiv:

BEVACIZUMAB (UNII: 2S9ZZM9Q9V) (BEVACIZUMAB - UNII:2S9ZZM9Q9V)

Disponibbli minn:

Amneal Pharmaceuticals LLC

Rotta amministrattiva:

INTRAVENOUS

Tip ta 'preskrizzjoni:

PRESCRIPTION DRUG

Indikazzjonijiet terapewtiċi:

Alymsys, in combination with intravenous fluorouracil-based chemotherapy, is indicated for the first-or second-line treatment of patients with metastatic colorectal cancer (mCRC). Alymsys, in combination with fluoropyrimidine-irinotecan- or fluoropyrimidine-oxaliplatin-based chemotherapy, is indicated for the second-line treatment of patients with mCRC who have progressed on a first-line bevacizumab product-containing regimen. Limitations of Use: Alymsys is not indicated for adjuvant treatment of colon cancer [see Clinical Studies (14.2)] . Alymsys, in combination with carboplatin and paclitaxel, is indicated for the first-line treatment of patients with unresectable, locally advanced, recurrent or metastatic non–squamous non–small cell lung cancer (NSCLC). Alymsys is indicated for the treatment of recurrent glioblastoma (GBM) in adults. Alymsys, in combination with interferon alfa, is indicated for the treatment of metastatic renal cell carcinoma (mRCC). Alymsys, in combination with paclitaxel and cisplatin or paclitaxel and topotecan, is indicated for the treatment of patients with persistent, recurrent, or metastatic cervical cancer. Alymsys, in combination with paclitaxel, pegylated liposomal doxorubicin, or topotecan, is indicated for the treatment of patients with platinum-resistant recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer who received no more than 2 prior chemotherapy regimens. None. Risk Summary Based on findings from animal studies and their mechanism of action [see Clinical Pharmacology (12.1)] , bevacizumab products may cause fetal harm in pregnant women. Limited postmarketing reports describe cases of fetal malformations with use of bevacizumab products in pregnancy; however, these reports are insufficient to determine drug-associated risks. In animal reproduction studies, intravenous administration of bevacizumab to pregnant rabbits every 3 days during organogenesis at doses approximately 1 to 10 times the clinical dose of 10 mg/kg produced fetal resorptions, decreased maternal and fetal weight gain and multiple congenital malformations including corneal opacities and abnormal ossification of the skull and skeleton including limb and phalangeal defects (see Data) . Furthermore, animal models link angiogenesis and VEGF and VEGFR2 to critical aspects of female reproduction, embryofetal development, and postnatal development. Advise pregnant women 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 Pregnant rabbits dosed with 10 mg/kg to 100 mg/kg bevacizumab (approximately 1 to 10 times the clinical dose of 10 mg/kg) every three days during the period of organogenesis (gestation day 6 to 18) exhibited decreases in maternal and fetal body weights and increased number of fetal resorptions. There were dose-related increases in the number of litters containing fetuses with any type of malformation (42% for the 0 mg/kg dose, 76% for the 30 mg/kg dose, and 95% for the 100 mg/kg dose) or fetal alterations (9% for the 0 mg/kg dose, 15% for the 30 mg/kg dose, and 61% for the 100 mg/kg dose). Skeletal deformities were observed at all dose levels, with some abnormalities including meningocele observed only at the 100 mg/kg dose level. Teratogenic effects included: reduced or irregular ossification in the skull, jaw, spine, ribs, tibia and bones of the paws; fontanel, rib and hindlimb deformities; corneal opacity; and absent hindlimb phalanges. Risk Summary No data are available regarding the presence of bevacizumab products in human milk, the effects on the breast fed infant, or the effects on milk production. Human IgG is present in human milk, but published data suggest that breast milk antibodies do not enter the neonatal and infant circulation in substantial amounts. Because of the potential for serious adverse reactions in breastfed infants from bevacizumab products, advise women not to breastfeed during treatment with Alymsys and for 6 months after the last dose. Contraception Females Bevacizumab products may 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 Alymsys and for 6 months after the last dose. Infertility Females Bevacizumab products increase the risk of ovarian failure and may impair fertility. Inform females of reproductive potential of the risk of ovarian failure prior to the first-dose of Alymsys. Long-term effects of bevacizumab products on fertility are not known. In a clinical study of 179 premenopausal women randomized to receive chemotherapy with or without bevacizumab, the incidence of ovarian failure was higher in patients who received bevacizumab with chemotherapy (34%) compared to patients who received chemotherapy alone (2%). After discontinuing bevacizumab with chemotherapy, recovery of ovarian function occurred in 22% of these patients [see Warnings and Precautions (5.11), Adverse Reactions (6.1)] . The safety and effectiveness of bevacizumab products in pediatric patients have not been established. In published literature reports, cases of non-mandibular osteonecrosis have been observed in patients under the age of 18 years who received bevacizumab. Bevacizumab products are not approved for use in patients under the age of 18 years. Antitumor activity was not observed among eight pediatric patients with relapsed GBM who received bevacizumab and irinotecan. Addition of bevacizumab to standard of care did not result in improved event-free survival in pediatric patients enrolled in two randomized clinical studies, one in high grade glioma (n= 121) and one in metastatic rhabdomyosarcoma or non-rhabdomyosarcoma soft tissue sarcoma (n= 154). Based on the population pharmacokinetics analysis of data from 152 pediatric and young adult patients with cancer (7 months to 21 years of age), bevacizumab clearance normalized by body weight in pediatrics was comparable to that in adults. Juvenile Animal Toxicity Data Juvenile cynomolgus monkeys with open growth plates exhibited physeal dysplasia following 4 to 26 weeks exposure at 0.4 to 20 times the recommended human dose (based on mg/kg and exposure). The incidence and severity of physeal dysplasia were dose-related and were partially reversible upon cessation of treatment. In an exploratory pooled analysis of 1,745 patients from five randomized, controlled studies, 35% of patients were ≥65 years old. The overall incidence of ATE was increased in all patients receiving bevacizumab with chemotherapy as compared to those receiving chemotherapy alone, regardless of age; however, the increase in the incidence of ATE was greater in patients ≥65 years (8% vs. 3%) as compared to patients <65 years (2% vs. 1%) [see Warnings and Precautions (5.4)] .

Sommarju tal-prodott:

Alymsys (bevacizumab-maly) injection is a clear to slightly opalescent, colorless to pale brown, sterile solution for intravenous infusion supplied in a carton containing single-dose vial in the following strengths and packaging configurations: Store refrigerated at 2°C to 8°C (36°F to 46°F) in the original carton until time of use to protect from light. Do not freeze or shake the vial or carton.

L-istatus ta 'awtorizzazzjoni:

Biologic Licensing Application

Karatteristiċi tal-prodott

ALYMSYS- BEVACIZUMAB-MALY INJECTION, SOLUTION
AMNEAL PHARMACEUTICALS LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ALYMSYSSAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR ALYMSYS. ALYMSYS®
(BEVACIZUMAB-MALY)
INJECTION, FOR INTRAVENOUS USE INITIAL U.S. APPROVAL: 2022 ALYMSYS
(BEVACIZUMAB-MALY) IS
BIOSIMILAR* TO AVASTIN (BEVACIZUMAB)
INDICATIONS AND USAGE
Alymsys is a vascular endothelial growth factor inhibitor indicated
for the treatment of: (1)
Metastatic colorectal cancer, in combination with intravenous
fluorouracil-based chemotherapy for first-
or second-line treatment. (1.1)
Metastatic colorectal cancer, in combination with
fluoropyrimidine-irinotecan- or fluoropyrimidine-
oxaliplatin-based chemotherapy for second-line treatment in patients
who have progressed on a first-
line bevacizumab product-containing regimen. (1.1)
Limitations of Use: Alymsys is not indicated for adjuvant treatment of
colon cancer. (1.1) (1)
Unresectable, locally advanced, recurrent or metastatic non-squamous
non-small cell lung cancer, in
combination with carboplatin and paclitaxel for first-line treatment.
(1.2)
Recurrent glioblastoma in adults. (1.3)
Metastatic renal cell carcinoma in combination with interferon alfa.
(1.4)
Persistent, recurrent, or metastatic cervical cancer, in combination
with paclitaxel and cisplatin, or
paclitaxel and topotecan. (1.5)
Epithelial ovarian, fallopian tube, or primary peritoneal cancer in
combination with paclitaxel, pegylated
liposomal doxorubicin, or topotecan for platinum-resistant recurrent
disease who received no more
than 2 prior chemotherapy regimens (1.6)
DOSAGE AND ADMINISTRATION
Withhold for at least 28 days prior to elective surgery. Do not
administer Alymsys for 28 days following
major surgery and until adequate wound healing. (2.1) (2)
Metastatic colorectal cancer (2.2) (2)
5 mg/kg every 2 weeks with bolus-IFL
10 mg/kg every 2 weeks with FOLFOX4
5 mg/kg every 2 weeks or 7.5 mg/kg every 3 weeks with
f