EVEROLIMUS tablet, for suspension

Země: Spojené státy

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktivní složka:

EVEROLIMUS (UNII: 9HW64Q8G6G) (EVEROLIMUS - UNII:9HW64Q8G6G)

Dostupné s:

Mylan Pharmaceuticals Inc.

Podání:

ORAL

Druh předpisu:

PRESCRIPTION DRUG

Terapeutické indikace:

Everolimus tablets for oral suspension are indicated in adult and pediatric patients aged 1 year and older with TSC for the treatment of SEGA that requires therapeutic intervention but cannot be curatively resected. Everolimus tablets for oral suspension are indicated for the adjunctive treatment of adult and pediatric patients aged 2 years and older with TSC-associated partial-onset seizures. Everolimus tablets for oral suspension are contraindicated in patients with clinically significant hypersensitivity to everolimus or to other rapamycin derivatives [see Warnings and Precautions (5.3)] . Based on animal studies and the mechanism of action [see Clinical Pharmacology (12.1)] , everolimus tablets for oral suspension can cause fetal harm when administered to a pregnant woman. There are limited case reports of AFINITOR use in pregnant women; however, these reports are not sufficient to inform about risks of birth defects or miscarriage. In animal studies, everolimus caused embryo-fetal toxicities in rats when

Přehled produktů:

Everolimus Tablets for Oral Suspension are available containing 2 mg, 3 mg, or 5 mg of everolimus. The 2 mg tablets are white to slightly yellow, round, unscored tablets debossed with M on one side of the tablet and EVD over 2 on the other side. They are available as follows: NDC 0378-0005-85 cartons of 28 tablets The 3 mg tablets are white to slightly yellow, round, unscored tablets debossed with M on one side of the tablet and EVD over 3 on the other side. They are available as follows: NDC 0378-0006-85 cartons of 28 tablets The 5 mg tablets are white to slightly yellow, round, unscored tablets debossed with M on one side of the tablet and EVD over 5 on the other side. They are available as follows: NDC 0378-0007-85 cartons of 28 tablets Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Store in the original container, protect from light and moisture. Follow special handling and disposal procedures for anti-cancer pharmaceuticals.1

Stav Autorizace:

Abbreviated New Drug Application

Charakteristika produktu

EVEROLIMUS- EVEROLIMUS TABLET, FOR SUSPENSION
MYLAN PHARMACEUTICALS INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
EVEROLIMUS TABLETS
FOR ORAL SUSPENSION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR
EVEROLIMUS TABLETS FOR ORAL SUSPENSION.
EVEROLIMUS TABLETS FOR ORAL SUSPENSION
INITIAL U.S. APPROVAL: 2009
RECENT MAJOR CHANGES
Warnings and Precautions, Radiation Sensitization and Radiation Recall
(5.12) 4/2021
INDICATIONS AND USAGE
Everolimus tablets for oral suspension are a kinase inhibitor
indicated for the treatment of adult and
pediatric patients aged 1 year and older with TSC who have
subependymal giant cell astrocytoma (SEGA)
that requires therapeutic intervention but cannot be curatively
resected. (1.5)
Everolimus tablets for oral suspension are a kinase inhibitor
indicated for the adjunctive treatment of adult
and pediatric patients aged 2 years and older with TSC-associated
partial-onset seizures. (1.6)
DOSAGE AND ADMINISTRATION
Do not combine AFINITOR and everolimus tablets for oral suspension to
achieve the total daily dose.
(2.1)
Modify the dose for patients with hepatic impairment or for patients
taking drugs that inhibit or induce P-
glycoprotein (P-gp) and CYP3A4. (2.1)
TSC-Associated SEGA:
•
TSC-Associated Partial-Onset Seizures:
•
DOSAGE FORMS AND STRENGTHS
Everolimus tablets for oral suspension: 2 mg, 3 mg, and 5 mg tablets
(3)
CONTRAINDICATIONS
Clinically significant hypersensitivity to everolimus or to other
rapamycin derivatives. (4)
WARNINGS AND PRECAUTIONS
•
•
•
•
•
•
•
•
•
•
•
®
4.5 mg/m orally once daily; adjust dose to attain trough
concentrations of 5-15 ng/mL. (2.6, 2.8)
2
5 mg/m orally once daily; adjust dose to attain trough concentrations
of 5-15 ng/mL. (2.7, 2.8)
2
Non-Infectious Pneumonitis: Monitor for clinical symptoms or
radiological changes. Withhold or
permanently discontinue based on severity. (2.9, 5.1)
Infections: Monitor for signs and symptoms of infection. W