EVKEEZA- evinacumab injection, solution, concentrate

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

evinacumab (UNII: T8B2ORP1DW) (evinacumab - UNII:T8B2ORP1DW)

Available from:

Regeneron Pharmaceuticals, Inc.

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

EVKEEZA is indicated as an adjunct to other low-density lipoprotein-cholesterol (LDL-C) lowering therapies for the treatment of adult and pediatric patients, aged 5 years and older, with homozygous familial hypercholesterolemia (HoFH). Limitations of Use: - The safety and effectiveness of EVKEEZA have not been established in patients with other causes of hypercholesterolemia, including those with heterozygous familial hypercholesterolemia (HeFH). - The effects of EVKEEZA on cardiovascular morbidity and mortality have not been determined. EVKEEZA is contraindicated in patients with a history of serious hypersensitivity reaction to evinacumab-dgnb or to any of the excipients in EVKEEZA. Serious hypersensitivity reactions, including anaphylaxis, have occurred [see Warnings and Precautions (5.1)]. Risk Summary Based on data from animal reproduction studies, EVKEEZA may cause fetal harm when administered to pregnant patients. Available human data are insufficient to evaluate for a drug-associated risk of major bir

Product summary:

EVKEEZA (evinacumab-dgnb) injection is a clear to slightly opalescent, colorless to pale yellow solution. It is supplied as one single-dose vial per carton. Storage Store in a refrigerator at 2 °C to 8 °C (36 °F to 46 °F). Store the vial in the original carton to protect from light. Do not freeze. Do not shake. EVKEEZA does not contain a preservative. If not used immediately, store the diluted solution refrigerated at 2 °C to 8 °C (36 °F to 46 °F) for no more than 24 hours from the time of preparation OR at room temperature up to 25 °C (77 °F) for no more than 6 hours from the time of infusion preparation to the end of the infusion [see Dosage and Administration (2.2)].

Authorization status:

Biologic Licensing Application

Summary of Product characteristics

EVKEEZA- EVINACUMAB INJECTION, SOLUTION, CONCENTRATE
REGENERON PHARMACEUTICALS, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
EVKEEZA SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR EVKEEZA.
EVKEEZA (EVINACUMAB-DGNB) INJECTION, FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 2021
RECENT MAJOR CHANGES
Indications and Usage (1)
03/2023
INDICATIONS AND USAGE
EVKEEZA is an angiopoietin-like 3 (ANGPTL3) inhibitor indicated as an
adjunct to other low-density
lipoprotein-cholesterol (LDL-C) lowering therapies for the treatment
of adult and pediatric patients, aged 5
years and older, with homozygous familial hypercholesterolemia (HoFH).
(1)
Limitations of Use:
The safety and effectiveness of EVKEEZA have not been established in
patients with other causes of
hypercholesterolemia, including those with heterozygous familial
hypercholesterolemia (HeFH). (1)
The effects of EVKEEZA on cardiovascular morbidity and mortality have
not been determined. (1)
DOSAGE AND ADMINISTRATION
The recommended dosage of EVKEEZA is 15 mg/kg administered by
intravenous (IV) infusion once
monthly (every 4 weeks). (2.1)
See the Full Prescribing Information for preparation instructions for
the intravenous infusion. (2.2)
Administer the diluted solution via IV infusion over 60 minutes
through an IV line containing a sterile, in-
line or add-on, 0.2-micron to 5-micron filter. (2.3)
Do not mix other medications with EVKEEZA or administer other
medications concomitantly via the
same infusion line. (2.3)
The rate of infusion may be slowed, interrupted or discontinued if the
patient develops any signs of
adverse reactions, including infusion or hypersensitivity reactions.
(2.3)
DOSAGE FORMS AND STRENGTHS
Injection: 345 mg/2.3 mL (150 mg/mL) and 1,200 mg/8 mL (150 mg/mL)
solution in single-dose vials.
(3)
CONTRAINDICATIONS
History of serious hypersensitivity reactions to evinacumab-dgnb or to
any of the excipients in
EVKEEZA. (4)
WARNINGS AND PRECAUTIONS
_Serious Hypersensit