Fareston (Page 5 of 5)
17PATIENT COUNSELING INFORMATION
Vaginal bleeding has been reported in patients using FARESTON. Patients should be informed about this and instructed to contact their physician if such bleeding or other gynecological symptoms (changes in vaginal discharge, pelvic pain or pressure) occur. Patients should have a gynecological examination prior to initiation of therapy and at regular intervals while on therapy.
Liver disorders including transaminits grade 3 and 4, hyperbilirubinemia with jaundice have been reported in patients using FARESTON. Patients should have liver function tests performed periodically while on therapy.
FARESTON may harm the fetus and increase the risk for pregnancy loss [see Warnings and Precautions (5.7) and Use in Specific Populations (8.1)].
Premenopausal women using FARESTON should use nonhormonal contraception during treatment and should be apprised of the potential hazard to the fetus should pregnancy occur [see Warnings and Precautions (5.8)].
Patients with bone metastases should be informed about the typical signs and symptoms of hypercalcemia and instructed to contact their physician for further assessment if such signs or symptoms occur.
Patients who must take medications known to prolong the QT interval, or potent CYP3A4 inhibitors, should be informed of the effect of toremifene on QT interval. Toremifene has been shown to prolong the QTc interval in a dose-related manner [see Boxed Warning, Warnings and Precautions (5.1), and Clinical Pharmacology (12.2)].
Specific interactions with foods that inhibit CYP3A4, including grapefruit juice, have not been studied but may increase toremifene concentrations. Patients should avoid grapefruit products and other foods that are known to inhibit CYP3A4 during FARESTON treatment.
Certain other medicines, including over-the-counter medications or herbal supplements (such as St. John’s Wort) and toremifene, can reduce concentrations of co-administered drugs [see Drug Interactions (7.3)].
Distributed by
Kyowa Kirin, Inc.
Bedminster, NJ 07921, USA
Product covered by Orion Product Patents and related patent numbers
© 2017 Kyowa Kirin, Inc.
All rights reserved.
Rev. 05/2017
PRINCIPAL DISPLAY PANEL — 60 mg Tablet Carton
NDC 42747-327-30
Fareston®
(toremifene citrate)Tablets
30 TABLETS
Rx only
60 mg
KYOWA KIRIN
| FARESTON toremifene citrate tablet | ||||||||||||||||||
| ||||||||||||||||||
| ||||||||||||||||||
| ||||||||||||||||||
| ||||||||||||||||||
| ||||||||||||||||||
| ||||||||||||||||||
| Labeler — KYOWA KIRIN, INC, (014778321) |
| Establishment | |||
| Name | Address | ID/FEI | Operations |
| Orion Corporation, Orion Pharma | 537940319 | manufacture (42747-327), pack (42747-327), analysis (42747-327) | |
Revised: 12/2022 KYOWA KIRIN, INC,
All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.