LENALIDOMIDE capsule

Land: Bandaríkin

Tungumál: enska

Heimild: NLM (National Library of Medicine)

Virkt innihaldsefni:

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

Fáanlegur frá:

Apotex Corp.

Stjórnsýsluleið:

ORAL

Gerð lyfseðils:

PRESCRIPTION DRUG

Ábendingar:

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

Vörulýsing:

2.5 mg: Hard gelatin capsule with white opaque body and blue green opaque cap. Imprinted “APO L2.5” in black ink. 2.5 mg bottles of 28 (NDC 60505-4532-2) 2.5 mg bottles of 100 (NDC 60505-4532-1) 5 mg: Hard gelatin capsule with white opaque body and white opaque cap. Imprinted “APO L5” in black ink. 5 mg bottles of 28 (NDC 60505-4533-2) 5 mg bottles of 100 (NDC 60505-4533-1) 10 mg: Hard gelatin capsule with ivory opaque body and blue green opaque cap. Imprinted “APO L10” in black ink. 10 mg bottles of 28 (NDC 60505-4534-2)   10 mg bottles of 100 (NDC 60505-4534-1) 15 mg: Hard gelatin capsule with white opaque body and powder blue opaque cap. Imprinted “APO L15” in black ink. 15 mg bottles of 21 (NDC 60505-4535-2) 15 mg bottles of 100 (NDC 60505-4535-1) 20 mg: Hard gelatin capsule with powder blue opaque body and blue green opaque cap. Imprinted “APO L20” in black ink. 20 mg bottles of 21 (NDC 60505-4536-2) 20 mg bottles of 100 (NDC 60505-4536-1) 25 mg: Hard gelatin capsule with white opaque body and white opaque cap. Imprinted “APO L25” in black ink.   25 mg bottles of 21 (NDC 60505-4537-2) 25 mg bottles of 100 (NDC 60505-4537-1) Store at 20°C to 25°C (68°F to 77°F); excursions permitted from 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 capsules 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.

Leyfisstaða:

Abbreviated New Drug Application

Upplýsingar fylgiseðill

LENALIDOMIDE- LENALIDOMIDE CAPSULE
Apotex Corp.
----------
MEDICATION GUIDE
Lenalidomide Capsules
(len” a lid’ oh mide)
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
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 capsules.
•
If you had unprotected sex o

Vara einkenni

LENALIDOMIDE- LENALIDOMIDE CAPSULE
APOTEX CORP.
----------
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).
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 capsules are 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 lymphom