THALOMID- thalidomide capsule

国: アメリカ合衆国

言語: 英語

ソース: NLM (National Library of Medicine)

有効成分:

THALIDOMIDE (UNII: 4Z8R6ORS6L) (THALIDOMIDE - UNII:4Z8R6ORS6L)

から入手可能:

Celgene Corporation

INN（国際名）:

THALIDOMIDE

構図:

THALIDOMIDE 50 mg

投与経路:

ORAL

処方タイプ:

PRESCRIPTION DRUG

適応症:

THALOMID in combination with dexamethasone is indicated for the treatment of patients with newly diagnosed multiple myeloma (MM) [see Clinical Studies (14.1)] . THALOMID is indicated for the acute treatment of the cutaneous manifestations of moderate to severe erythema nodosum leprosum (ENL). THALOMID is not indicated as monotherapy for such ENL treatment in the presence of moderate to severe neuritis. THALOMID is also indicated as maintenance therapy for prevention and suppression of the cutaneous manifestations of ENL recurrence [see Clinical Studies (14.2)]. THALOMID is contraindicated in females who are pregnant. THALOMID can cause fetal harm when administered to a pregnant female [see Boxed Warning, Warnings and Precautions (5.1) and Use in Specific Populations (8.1)] . THALOMID is a powerful human teratogen, inducing a high frequency of severe and life-threatening birth defects, even after a single dose [see Boxed Warning] . Mortality at or shortly after birth has been reported in about 40% of infants.

製品概要:

(THIS PRODUCT IS ONLY SUPPLIED TO PHARMACIES CERTIFIED IN THE THALOMID REMS PROGRAM - See BOXED WARNING) 50 mg capsules [white opaque], imprinted "BMS/50 mg" with a "Do Not Get Pregnant" logo. Individual blister packs of 1 capsule (NDC 59572-205-17). Individual blister packs of 28 capsules (NDC 59572-205-14). 100 mg capsules [tan], imprinted "BMS/100 mg" with a "Do Not Get Pregnant" logo. Individual blister packs of 28 capsules (NDC 59572-210-15). 150 mg capsules [tan and blue], imprinted "BMS/150 mg" with a "Do Not Get Pregnant" logo. Individual blister packs of 28 capsules (NDC 59572-215-13). 200 mg capsules [blue], imprinted "BMS/200 mg" with a "Do Not Get Pregnant" logo. Individual blister packs of 28 capsules (NDC 59572-220-16). This drug must not be repackaged. Store at 20°C- 25°C (68°F -77°F); excursions permitted to 15-30º C (59-86º F). [See USP Controlled Room Temperature]. Protect from light. Care should be exercised in handling of THALOMID. THALOMID capsules should not be opened or crushed. If powder from THALOMID contacts the skin, wash the skin immediately and thoroughly with soap and water. If THALOMID contacts the mucous membranes, flush thoroughly with water. Procedures for proper handling and disposal of anticancer drugs should be considered. Several guidelines on the subject have been published1 . Rx only and only able to be prescribed and dispensed under the terms of the THALOMID REMS Restricted Distribution Program.

認証ステータス:

New Drug Application

情報リーフレット

Celgene Corporation
----------
This Medication Guide has been approved by the U.S. Food and Drug
Administration.
Revised: March 2023
MEDICATION GUIDE
THALOMID® (tha-lo-mid)
(thalidomide)
capsules
What is the most important information I should know about THALOMID?
Before you begin taking THALOMID, you must read and agree to all of
the instructions in the
THALOMID REMS® program. For more information, call 1-888-423-5436 or
go to
www.thalomidrems.com. Before prescribing THALOMID, your healthcare
provider will explain the
THALOMID REMS program to you and have you sign the Patient-Physician
Agreement Form.
THALOMID can cause serious side effects including:
•
Severe and life-threatening human birth defects (deformed babies) or
death of an unborn baby.
Females who are pregnant or who plan to become pregnant must not take
THALOMID.
•
Females must not get pregnant:
o
For at least 4 weeks before starting THALOMID
o
While taking THALOMID
o
During any breaks (interruptions) in your treatment with THALOMID
o
For at least 4 weeks after stopping THALOMID
•
Females who can become pregnant:
o
Will have pregnancy tests weekly for 4 weeks, then every 4 weeks if
your menstrual cycle is
regular, or every 2 weeks if your menstrual cycle is irregular.
o
If you miss your period or have unusual bleeding, you will need to
have a pregnancy test and
receive counseling.
o
Must agree to use two acceptable forms of birth control at the same
time, for at least 4 weeks
before, while taking, during any breaks (interruptions) in your
treatment, and for at least 4
weeks after stopping THALOMID.
o
Talk with your healthcare provider to find out about options for
acceptable forms of birth
control that you may use to prevent pregnancy before, during, and
after treatment with
THALOMID.
o
Stop taking THALOMID and call your healthcare provider right away if
you have
unprotected sex or if you think your birth control has failed.
•
If you become pregnant while taking THALOMID, stop taking it right
away and call your
healthcare provider. If your h

製品の特徴

THALOMID- THALIDOMIDE CAPSULE
CELGENE CORPORATION
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
THALOMID SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR THALOMID.
THALOMID (THALIDOMIDE) CAPSULES, FOR ORAL USE
INITIAL U.S. APPROVAL: 1998
WARNING: EMBRYO-FETAL TOXICITY AND VENOUS THROMBOEMBOLISM
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
EMBRYO -FETAL TOXICITY
•
•
THALOMID IS ONLY AVAILABLE THROUGH A RESTRICTED DISTRIBUTION PROGRAM,
THE THALOMID
REMS PROGRAM (5.2).
VENOUS THROMBOEMBOLISM
•
INDICATIONS AND USAGE
•
•
DOSAGE AND ADMINISTRATION
•
•
DOSAGE FORMS AND STRENGTHS
Capsules: 50 mg, 100 mg, 150 mg and 200 mg. (3)
CONTRAINDICATIONS
•
•
WARNINGS AND PRECAUTIONS
•
®
IF THALOMID IS TAKEN DURING PREGNANCY, IT CAN CAUSE SEVERE BIRTH
DEFECTS OR
EMBRYO-FETAL DEATH. THALOMID SHOULD NEVER BE USED BY FEMALES WHO ARE
PREGNANT
OR WHO COULD BE PREGNANT WHILE TAKING THE DRUG. EVEN A SINGLE DOSE [1
CAPSULE
(REGARDLESS OF STRENGTH)] TAKEN BY A PREGNANT WOMAN DURING HER
PREGNANCY CAN
CAUSE SEVERE BIRTH DEFECTS.
PREGNANCY MUST BE EXCLUDED BEFORE START OF TREATMENT. PREVENT
PREGNANCY
THEREAFTER BY THE USE OF TWO RELIABLE METHODS OF CONTRACEPTION. (5.1,
8.3)
®
SIGNIFICANT INCREASED RISK OF DEEP VEIN THROMBOSIS (DVT) AND PULMONARY
EMBOLISM
(PE) IN PATIENTS WITH MULTIPLE MYELOMA RECEIVING THALOMID WITH
DEXAMETHASONE
(5.3).
THALOMID in combination with dexamethasone is indicated for the
treatment of patients with newly
diagnosed multiple myeloma (MM). (1.1)
THALOMID is indicated for the acute treatment of the cutaneous
manifestations of moderate to
severe erythema nodosum leprosum (ENL).
THALOMID is not indicated as monotherapy for such ENL treatment in the
presence of moderate to
severe neuritis.
THALOMID is also indicated as maintenance therapy for prevention and
suppression of the cutaneous
manifestations of ENL recurrence. (1.2)
MM: 200 mg orally once daily. The recommended dose of dexamethasone is
40 mg/day