ASPARLAS- calaspargase pegol injection, solution

Nchi: Marekani

Lugha: Kiingereza

Chanzo: NLM (National Library of Medicine)

Viambatanisho vya kazi:

CALASPARGASE PEGOL (UNII: T9FVH03HMZ) (CALASPARGASE PEGOL - UNII:T9FVH03HMZ)

Inapatikana kutoka:

Servier Pharmaceuticals LLC

Njia ya uendeshaji:

INTRAVENOUS

Dawa ya aina:

PRESCRIPTION DRUG

Matibabu dalili:

ASPARLAS is indicated as a component of a multi-agent chemotherapeutic regimen for the treatment of acute lymphoblastic leukemia in pediatric and young adult patients age 1 month to 21 years. ASPARLAS is contraindicated in patients with: - History of serious hypersensitivity reactions, including anaphylaxis, to pegylated L-asparaginase therapy [see Warnings and Precautions (5.1)] - History of serious pancreatitis during previous L-asparaginase therapy [see Warnings and Precautions (5.2)] - History of serious thrombosis during previous L-asparaginase therapy [see Warnings and Precautions (5.3)] - History of serious hemorrhagic events during previous L-asparaginase therapy [see Warnings and Precautions (5.4)] - Severe hepatic impairment [see Warnings and Precautions (5.5)] Risk Summary Based on published literature studies with L-asparaginase in pregnant animals, ASPARLAS can cause fetal harm when administered to a pregnant woman. There are no available data on ASPARLAS use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. In animal reproduction studies, intravenous administration of calaspargase pegol-mknl to pregnant rats during organogenesis at doses 0.2 to 1 times the maximum recommended human doses did not result in adverse developmental outcomes. Published literature studies in pregnant rabbits, however, suggest asparagine depletion may cause harm to the animal offspring (see Data) . 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 are 2 to 4% and 15 to 20%, respectively. Data Animal Data In an embryo-fetal development study, calaspargase pegol-mknl was administered intravenously at doses of 75, 150, and 300 U/kg (0.2, 0.6 and 1 times the maximum recommended human dose, respectively, based on AUC) to pregnant rats during the period of organogenesis. Maternal toxicity of decreased body weight and food consumption was seen at all dose levels resulting in reductions in gravid uterine and placental weights, and slight reductions in fetal body weights. No evidence of structural abnormalities or embryo-fetal mortality were observed in this study at any of the doses tested. Published literature studies in which pregnant rabbits were administered L-asparaginase suggested harm to the animal offspring. Risk Summary There are no data on the presence of calaspargase pegol-mknl in human milk, the effects on the breastfed child, or the effects on milk production. Because of the potential for adverse reactions in the breastfed child, advise women not to breastfeed during treatment with ASPARLAS and for 3 months after the last dose. ASPARLAS can cause fetal harm when administered to a pregnant woman [see Use in Specific Populations (8.1)] . Pregnancy Testing Pregnancy testing is recommended in females of reproductive potential prior to initiating ASPARLAS. Contraception Advise females of reproductive potential to use effective non-hormonal contraceptive methods during treatment with ASPARLAS and for at least 3 months after the last dose. The safety and effectiveness of ASPARLAS in the treatment of ALL have been established in pediatric patients 1 month to <17 years (no data for the age group <1 month old). Use of ASPARLAS in these age groups is supported by evidence from an adequate and well-controlled trial with additional safety from a second trial. The trials included 208 children with ALL or lymphoblastic lymphoma treated with ASPARLAS; there were 19 infants (1 month to <2 years old), 128 children (2 years to <12 years old), and 61 adolescents (12 years to <17 years old). There were no clinically meaningful differences in safety or nadir serum asparaginase activity across age groups [see Adverse Reactions (6.1), Clinical Studies (14)] .

Bidhaa muhtasari:

ASPARLAS (calaspargase pegol-mknl) injection is supplied as a clear, colorless, preservative-free sterile solution in a single-dose vial containing 3,750 units of calaspargase pegol-mknl per 5 mL solution (NDC 72694-515-01). Store ASPARLAS refrigerated at 2°C to 8°C (36°F to 46°F) in the original carton to protect from light. Do not shake or freeze product. Unopened vials may be stored at room temperature (15°C to 25°C [59°F to 77°F]) for no more than 48 hours.

Idhini hali ya:

Biologic Licensing Application

Tabia za bidhaa

ASPARLAS- CALASPARGASE PEGOL INJECTION, SOLUTION
SERVIER PHARMACEUTICALS LLC
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ASPARLAS SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR ASPARLAS.
ASPARLAS (CALASPARGASE PEGOL-MKNL) INJECTION, FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 2018
RECENT MAJOR CHANGES
Warnings and Precautions: Hepatotoxicity (5.5)
11/2023
INDICATIONS AND USAGE
ASPARLAS is an asparagine specific enzyme indicated as a component of
a multi-agent chemotherapeutic
regimen for the treatment of acute lymphoblastic leukemia in pediatric
and young adult patients age 1
month to 21 years. (1.1)
DOSAGE AND ADMINISTRATION
Recommended Dosage: 2,500 units/m intravenously no more frequently
than every 21 days. (2.1)
See Full Prescribing Information for important details regarding
dosing modifications and preparation
and administration. (2.2, 2.3, 2.4)
DOSAGE FORMS AND STRENGTHS
Injection: 3,750 units/5 mL (750 units/mL) in a single-dose vial. (3)
CONTRAINDICATIONS
History of serious hypersensitivity reactions to pegylated
L-asparaginase. (4)
History of serious thrombosis during L-asparaginase therapy. (4)
History of serious pancreatitis related to previous L-asparaginase
treatment. (4)
History of serious hemorrhagic events during previous L-asparaginase
therapy. (4)
Severe hepatic impairment. (4)
WARNINGS AND PRECAUTIONS
Hypersensitivity: Observe patients for one hour after administration.
Discontinue ASPARLAS in patients
with serious hypersensitivity reactions. (5.1)
Pancreatitis: Discontinue ASPARLAS in patients with pancreatitis.
Monitor blood glucose. (5.2)
Thrombosis: Discontinue ASPARLAS for severe or life-threatening
thrombosis. (5.3)
Hemorrhage: Discontinue ASPARLAS for severe or life-threatening
hemorrhage. Evaluate for etiology
and treat. (5.4)
Hepatotoxicity, including hepatic veno-occlusive disease (VOD):
Monitor for toxicity through recovery
from cycle. Discontinue ASPARLAS for severe liver toxicity. (5.5)
ADVERSE RE