REVLIMID- lenalidomide capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

LENALIDOMIDE (UNII: F0P408N6V4) (LENALIDOMIDE - UNII:F0P408N6V4)

Available from:

Celgene Corporation

INN (International Name):

LENALIDOMIDE

Composition:

LENALIDOMIDE 2.5 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

REVLIMID in combination with dexamethasone is indicated for the treatment of adult patients with multiple myeloma (MM). REVLIMID is indicated as maintenance therapy in adult patients with MM following autologous hematopoietic stem cell transplantation (auto-HSCT). REVLIMID is indicated for the treatment of adult patients with transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes (MDS) associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities. REVLIMID is indicated for the treatment of adult patients with mantle cell lymphoma (MCL) whose disease has relapsed or progressed after two prior therapies, one of which included bortezomib. REVLIMID in combination with a rituximab product, is indicated for the treatment of adult patients with previously treated follicular lymphoma (FL). REVLIMID in combination with a rituximab product, is indicated for the treatment of adult patients with previously treated marginal zone lymphoma (MZL)

Product summary:

White and blue-green opaque hard capsules imprinted "REV" on one half and "2.5 mg" on the other half in black ink: 2.5 mg bottles of 28 (NDC 59572-402-28) 2.5 mg bottles of 100 (NDC 59572-402-00) White opaque capsules imprinted "REV" on one half and "5 mg" on the other half in black ink: 5 mg bottles of 28 (NDC 59572-405-28) 5 mg bottles of 100 (NDC 59572-405-00) Blue/green and pale yellow opaque capsules imprinted "REV" on one half and "10 mg" on the other half in black ink: 10 mg bottles of 28 (NDC 59572-410-28) 10 mg bottles of 100 (NDC 59572-410-00) Powder blue and white opaque capsules imprinted "REV" on one half and "15 mg" on the other half in black ink: 15 mg bottles of 21 (NDC 59572-415-21) 15 mg bottles of 100 (NDC 59572-415-00) Powder blue and blue-green opaque hard capsules imprinted "REV" on one half and "20 mg" on the other half in black ink. 20 mg bottles of 21 (NDC 59572-420-21) 20 mg bottles of 100 (NDC 59572-420-00) White opaque capsules imprinted "REV" on one half and "25 mg" on the other half in black ink: 25 mg bottles of 21 (NDC 59572-425-21) 25 mg bottles of 100 (NDC 59572-425-00) Store at 20°C - 25°C (68°F - 77°F); excursions permitted to 15°C - 30°C (59°F - 86°F) [See USP Controlled Room Temperature]. Care should be exercised in the handling of REVLIMID. REVLIMID capsules should not be opened or broken. If powder from REVLIMID contacts the skin, wash the skin immediately and thoroughly with soap and water. If REVLIMID contacts the mucous membranes, flush thoroughly with water. Procedures for the proper handling and disposal of anticancer drugs should be considered. Several guidelines on the subject have been published.1 Dispense no more than a 28-day supply.

Authorization status:

New Drug Application

Patient Information leaflet

Celgene Corporation
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MEDICATION GUIDE
REVLIMID® (rev-li-mid)
(lenalidomide) capsules
What is the most important information I should know about REVLIMID?
Before you begin taking REVLIMID, you must read and agree to all of
the instructions in the
Lenalidomide REMS program. For more information, call 1-888-423-5436
or go to
www.lenalidomiderems.com. Before prescribing REVLIMID, your healthcare
provider will explain the
Lenalidomide REMS program to you and have you sign the
Patient-Physician Agreement Form.
REVLIMID may cause serious side effects including:
•
Possible birth defects (deformed babies) or death of an unborn baby.
Females who are pregnant or
who plan to become pregnant must not take REVLIMID.
REVLIMID is similar to the medicine thalidomide. We know thalidomide
can cause severe life-
threatening birth defects. REVLIMID has not been tested in pregnant
females. REVLIMID has
harmed unborn animals in animal testing.
Females must not get pregnant:
o
For at least 4 weeks before starting REVLIMID
o
While taking REVLIMID
o
During any breaks (interruptions) in your treatment with REVLIMID
o
For at least 4 weeks after stopping REVLIMID
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 REVLIMID.
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 REVLIMID.
o
If you had unprotected sex or if you think your birth control has
failed, stop taking REVLIMID
immediately and call your healthcare provider right away.
If you be

Summary of Product characteristics

REVLIMID- LENALIDOMIDE CAPSULE
CELGENE CORPORATION
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
REVLIMID SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR REVLIMID.
REVLIMID (LENALIDOMIDE) CAPSULES, FOR ORAL USE
INITIAL U.S. APPROVAL: 2005
WARNING: EMBRYO-FETAL TOXICITY, HEMATOLOGIC TOXICITY, AND VENOUS AND
ARTERIAL THROMBOEMBOLISM
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
EMBRYO-FETAL TOXICITY
•
•
REVLIMID IS AVAILABLE ONLY THROUGH A RESTRICTED DISTRIBUTION PROGRAM,
CALLED THE
LENALIDOMIDE REMS PROGRAM (5.2, 17).
HEMATOLOGIC TOXICITY.REVLIMID CAN CAUSE SIGNIFICANT NEUTROPENIA AND
THROMBOCYTOPENIA (5.3).
VENOUS AND ARTERIAL THROMBOEMBOLISM
SIGNIFICANTLY INCREASED RISK OF DEEP VEIN THROMBOSIS (DVT) AND
PULMONARY EMBOLISM
(PE), AS WELL AS RISK OF MYOCARDIAL INFARCTION AND STROKE IN PATIENTS
WITH MULTIPLE
MYELOMA RECEIVING REVLIMID WITH DEXAMETHASONE. ANTI-THROMBOTIC
PROPHYLAXIS IS
RECOMMENDED (5.4).
RECENT MAJOR CHANGES
Warnings and Precautions (5.1, 5.2)
8/2021
Warnings and Precautions (5.1, 5.11)
5/2022
INDICATIONS AND USAGE
REVLIMID is a thalidomide analogue indicated for the treatment of
adult patients with:
•
•
•
•
•
•
Limitations of Use:
•
DOSAGE AND ADMINISTRATION
•
•
•
•
•
•
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DOSAGE FORMS AND STRENGTHS
®
LENALIDOMIDE, A THALIDOMIDE ANALOGUE, CAUSED LIMB ABNORMALITIES IN A
DEVELOPMENTAL MONKEY STUDY SIMILAR TO BIRTH DEFECTS CAUSED BY
THALIDOMIDE IN
HUMANS. IF LENALIDOMIDE IS USED DURING PREGNANCY, IT MAY CAUSE BIRTH
DEFECTS OR
EMBRYO-FETAL DEATH.
PREGNANCY MUST BE EXCLUDED BEFORE START OF TREATMENT. PREVENT
PREGNANCY DURING
TREATMENT BY THE USE OF TWO RELIABLE METHODS OF CONTRACEPTION (5.1).
Multiple myeloma (MM), in combination with dexamethasone (1.1).
MM, as maintenance following autologous hematopoietic stem cell
transplantation (auto-HSCT) (1.1).
Transfusion-dependent anemia due to low- or intermediate-1-risk
myelodysplastic syndromes (MDS)
associated with a deletion 5q