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

PRINCIPAL DISPLAY PANEL -- 60 mg Tablet Carton Label
(click image for full-size original)
FARESTON toremifene citrate tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42747-327
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TOREMIFENE CITRATE (TOREMIFENE) TOREMIFENE 60 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
ANHYDROUS LACTOSE
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
POVIDONE, UNSPECIFIED
SODIUM STARCH GLYCOLATE TYPE A POTATO
STARCH, CORN
Product Characteristics
Color WHITE (white) Score no score
Shape ROUND (ROUND) Size 9mm
Flavor Imprint Code TO;60
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:42747-327-30 30 TABLET in 1 BOTTLE None
2 NDC:42747-327-72 7 TABLET in 1 BLISTER PACK None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020497 06/30/1997
Labeler — KYOWA KIRIN, INC, (014778321)
Establishment
Name Address ID/FEI Operations
Orion Corporation 537940319 API MANUFACTURE (42747-327), MANUFACTURE (42747-327)

Revised: 08/2020 KYOWA KIRIN, INC,

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