LENALIDOMIDE- lenalidomide capsule

Land: USA

Språk: engelska

Källa: NLM (National Library of Medicine)

Aktiva substanser:

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

Tillgänglig från:

Camber Pharmaceuticals, Inc.

Administreringssätt:

ORAL

Receptbelagda typ:

PRESCRIPTION DRUG

Terapeutiska indikationer:

Lenalidomide capsules in combination with dexamethasone are 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

Produktsammanfattning:

Lenalidomide Capsules 2.5 mg: Pink opaque cap and white opaque body, size ‘4’ hard gelatin capsules imprinted with ‘H’ on cap and ‘L1’ on body, filled with off white to pale yellow color powder.                                                        Bottles of 28                                                 NDC 31722-257-28                                                        Bottles of 100                                               NDC 31722-257-01 Lenalidomide Capsules 5 mg: White opaque cap and white opaque body, size ‘2’ hard gelatin capsules imprinted with ‘H’ on cap and ‘L2’ on body, filled with off white to pale yellow color powder.                                                        Bottles of 28                                                 NDC 31722-258-28                                                        Bottles of 100                                               NDC 31722-258-01 Lenalidomide Capsules 10 mg: Orange opaque cap and white opaque body, size ‘0’ hard gelatin capsules imprinted with ‘H’ on cap and ‘L4’ on body, filled with off white to pale yellow color powder.                                                       Bottles of 28                                                  NDC 31722-259-28                                                       Bottles of 100                                                NDC 31722-259-01 Lenalidomide Capsules 15 mg: Red opaque cap and white opaque body, size ‘0’ hard gelatin capsules imprinted with ‘H’ on cap and ‘L5’ on body, filled with off white to pale yellow color powder.                                                       Bottles of 21                                                   NDC 31722-260-21                                                       Bottles of 100                                                 NDC 31722-260-01 Lenalidomide Capsules 20 mg: Brown opaque cap and white opaque body, size ‘0’ hard gelatin capsules imprinted with ‘H’ on cap and ‘L6’ on body, filled with off white to pale yellow color powder.                                                       Bottles of 21                                                   NDC 31722-261-21                                                       Bottles of 100                                                 NDC 31722-261-01 Lenalidomide Capsules 25 mg: White opaque cap and white opaque body, size ‘0’ hard gelatin capsules imprinted with ‘H’ on cap and ‘L7’ on body, filled with off white to pale yellow color powder.                                                       Bottles of 21                                                   NDC 31722-262-21                                                       Bottles of 100                                                 NDC 31722-262-01 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.

Bemyndigande status:

Abbreviated New Drug Application

Bipacksedel

Camber Pharmaceuticals, Inc.
----------
MEDICATION GUIDE
MEDICATION GUIDE
Lenalidomide (LEN a LID oh mide) Capsules
What
is
the
most
important
information
I
should
know
aboutlenalidomide
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 capsulesare 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, duri

Produktens egenskaper

LENALIDOMIDE - LENALIDOMIDE CAPSULE
CAMBER 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 IS 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, 5.11) 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).
• 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) who