LENALIDOMIDE capsule

국가: 미국

언어: 영어

출처: NLM (National Library of Medicine)

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Download 환자 정보 전단 (PIL)
31-05-2022
Download 제품 특성 요약 (SPC)
31-05-2022

유효 성분:

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

제공처:

Teva Pharmaceuticals, Inc.

관리 경로:

ORAL

처방전 유형:

PRESCRIPTION DRUG

치료 징후:

Lenalidomide capsules in combination with dexamethasone are indicated for the treatment of adult patients with multiple myeloma (MM). 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 are not indicated and are not recommended for the treatment of patients with CLL outside of controlled clinical trials [see Warnings and Precautions (5.5)] . Lenalidomide capsules can cause fetal harm when administered to a pregnant female. Limb abnormalities were seen in the offspring of monkeys that were dosed with lenalidomide during organogenesis. This effect was seen at all

제품 요약:

Lenalidomide capsules are available as follows: 5 mg – Each size 2 capsule with white cap and body printed with “NAT” on cap and “5mg” on body in black ink contains 5 mg of lenalidomide.               5 mg bottles of 28 (NDC 0480‐1242‐28) 10 mg – Each size 2 capsule with white cap and body printed with “NAT” on cap and “10mg” on body in black ink contains 10 mg of lenalidomide.               10 mg bottles of 28 (NDC 0480‐1243‐28) 15 mg – Each size 2 capsule with white cap and body printed with “NAT” on cap and “15mg” on body in black ink contains 15 mg of lenalidomide.               15 mg bottles of 21 (NDC 0480‐1244‐21) 25 mg – Each size 2 capsule with white cap and body printed with “NAT” on cap and “25mg” on body in black ink contains 25 mg of lenalidomide.                25 mg bottles of 21 (NDC 0480‐1246‐21) Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [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.

승인 상태:

Abbreviated New Drug Application

환자 정보 전단

                                Teva Pharmaceuticals, 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. 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 cause severe
life-threatening birth defects. Lenalidomide capsules have not been
tested in pregnant females. Lenalidomide capsules have 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 capsules.
•
If you had unprotected sex or if you think y
                                
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제품 특성 요약

                                LENALIDOMIDE- LENALIDOMIDE CAPSULE
TEVA PHARMACEUTICALS, INC.
----------
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 CAPSULES 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 CAPSULES 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
Lenalidomide is a thalidomide analogue indicated for the treatment of
adult patients with:
Multiple myeloma (MM), in combination with dexamethasone (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 therapies, 
                                
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