LENALIDOMIDE capsule

البلد: الولايات المتحدة

اللغة: الإنجليزية

المصدر: NLM (National Library of Medicine)

العنصر النشط:

Lenalidomide (UNII: F0P408N6V4) (Lenalidomide - UNII:F0P408N6V4)

متاح من:

Dr. Reddy's Laboratories Inc.

طريقة التعاطي:

ORAL

نوع الوصفة الطبية :

PRESCRIPTION DRUG

الخصائص العلاجية:

Lenalidomide capsules in combination with dexamethasone is indicated for the treatment of adult patients with multiple myeloma (MM). Lenalidomide capsules are indicated as maintenance therapy in adult patients with MM following autologous hematopoietic stem cell transplantation (auto-HSCT). Lenalidomide capsules are 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. Lenalidomide capsules are 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. Lenalidomide capsules in combination with a rituximab product, is indicated for the treatment of adult patients with previously treated follicular lymphoma (FL). Lenalidomide capsules in combination with a rituximab product, is indicated for the

ملخص المنتج:

2.5 mg capsules:  White to off-white colored powder filled in hard gelatin capsules with pale green opaque colored cap imprinted ‘RDY’ with black ink and pale green opaque colored body imprinted ‘2.5 mg’ with black ink. Free from physical defects. Bottles of 28: NDC 43598-516-63 Bottles of 100: NDC 43598-516-01  5 mg capsules:  White to off-white colored powder filled in hard gelatin capsules with opaque white colored cap imprinted ‘RDY’ with black ink and opaque white colored body imprinted ‘5 mg’ with black ink. Free from physical defects. Bottles of 28: NDC 43598-511-63 Bottles of 100: NDC 43598-511-01  10 mg capsules:  White to off-white colored powder filled in hard gelatin capsules with yellow opaque colored cap imprinted ‘RDY’ with black ink and yellow opaque colored body imprinted ‘10 mg’ with black ink. Free from physical defects. Bottles of 28: NDC 43598-512-63 Bottles of 100: NDC 43598-512-01  15 mg capsules:  White to off-white colored powder filled in hard gelatin capsules with blue opaque colored cap imprinted ‘RDY’ with black ink and blue opaque colored body imprinted ‘15 mg’ with black ink. Free from physical defects. Bottles of 21: NDC 43598-513-21 Bottles of 100: NDC 43598-513-01  20 mg capsules:  White to off-white colored powder filled in hard gelatin capsules with yellow opaque colored cap imprinted ‘RDY’ with black ink and blue opaque colored body imprinted ‘20 mg’ with black ink. Free from physical defects. Bottles of 21: NDC 43598-514-21 Bottles of 100: NDC 43598-514-01 25 mg capsules:  White to off-white colored powder filled in hard gelatin capsules with opaque white colored cap imprinted ‘RDY’ with black ink and opaque white colored body imprinted ‘25 mg’ with black ink. Free from physical defects. Bottles of 21: NDC 43598-515-21 Bottles of 100: NDC 43598-515-01 Store at 20ºC to 25ºC (68ºF to 77ºF); [See USP Controlled Room Temperature]. Care should be exercised in the handling of lenalidomide capsules. Lenalidomide capsules should not be opened or broken. If powder from lenalidomide capsules contacts the skin, wash the skin immediately and thoroughly with soap and water. If lenalidomide 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.

الوضع إذن:

Abbreviated New Drug Application

نشرة المعلومات

Dr. Reddy's Laboratories Inc.
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MEDICATION GUIDE
Lenalidomide (LEN a LID oh mide) Capsules
What is the most important information I should know about
lenalidomide capsules?
Before you begin taking lenalidomide capsules, 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 lenalidomide capsules,
your healthcare provider will
explain the Lenalidomide REMS program to you and have you sign the
Patient-Physician Agreement
Form.
Lenalidomide capsules 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 lenalidomide capsules.
Lenalidomide is similar to the medicine thalidomide. We know
thalidomide can causesevere life-
threatening birth defects. Lenalidomide has not been tested in
pregnant females. Lenalidomide has
harmed unborn animals in animal testing.
Females must not get pregnant:
•
For at least 4 weeks before starting lenalidomide capsules
•
While taking lenalidomide capsules
•
During any breaks (interruptions) in your treatment with lenalidomide
capsules
•
For at least 4 weeks after stopping lenalidomide capsules
Females who can become pregnant:
•
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.
•
If you miss your period or have unusual bleeding, you will need to
have a pregnancy test and
receive counseling.
•
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 lenalidomide capsules.
•
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 lenalidomide

خصائص المنتج

LENALIDOMIDE- LENALIDOMIDE CAPSULE
DR. REDDY'S LABORATORIES INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
LENALIDOMIDE CAPSULES
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
LENALIDOMIDE CAPSULES.
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
• 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).
LENALIDOMIDE CAPSULES ARE AVAILABLE ONLY THROUGH A RESTRICTED
DISTRIBUTION PROGRAM,
CALLED THE LENALIDOMIDE REMS PROGRAM (5.2, 17).
HEMATOLOGIC TOXICITY. LENALIDOMIDE 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 LENALIDOMIDE WITH DEXAMETHASONE. ANTI-THROMBOTIC
PROPHYLAXIS IS
RECOMMENDED (5.4).
INDICATIONS AND USAGE
Lenalidomide is a thalidomide analogue indicated for the treatment of
adult patients with:
• 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 abnormality with or without additional
cytogenetic abnormalities (1.2).
• Mantle cell lymphoma (MCL) whose disease has relapsed or
progressed after two prior therapi