LENALIDOMIDE capsule

Country: Amerika Syarikat

Bahasa: Inggeris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

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

Boleh didapati daripada:

Alvogen, Inc.

Laluan pentadbiran:

ORAL

Jenis preskripsi:

PRESCRIPTION DRUG

Tanda-tanda terapeutik:

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 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 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 doses tested. Due to the results of this developmental monkey study, and lenalidomide's structural similarities to thalidomide, a known human teratogen, lenalidomide is contraindicated in females who are pregnant [

Ringkasan produk:

A dark blue opaque cap/ light orange opaque body, capsule shell size No. 4 imprinted in black ink with “LP” on the cap and “637” on the body and filled with white powder. 2.5 mg bottles of 28 (NDC 47781-483-28) 2.5 mg bottles of 100 (NDC 47781-483-01) A green opaque cap/ light caramel opaque body, capsule shell size No. 2 imprinted in black ink with “LP” on the cap and “638” on the body and filled with white powder. 5 mg bottles of 28 (NDC 47781-484-28) 5 mg bottles of 100 (NDC 47781-484-01) A gold opaque cap/ gray opaque body, capsule shell size No. 0 imprinted in black ink with “LP” on the cap and “639” on the body and filled with white powder. 10 mg bottles of 28 (NDC 47781-485-28) 10 mg bottles of 100 (NDC 47781-485-01) A caramel opaque cap/ grey opaque body, capsule shell size No. 2 imprinted in black ink with “LP” on the cap and “640” on the body and filled with white powder. 15 mg bottles of 21 (NDC 47781-486-77) 15 mg bottles of 100 (NDC 47781-486-01) A warm brick red opaque cap/ light gray opaque body, capsule shell size No. 1 imprinted in black ink with “LP” on the cap and “641” on the body and filled with white powder. 20 mg bottles of 21 (NDC 47781-487-77) 20 mg bottles of 100 (NDC 47781-487-01) A white opaque cap/ white opaque body, capsule shell size No. 0 imprinted in black ink with “LP” on the cap and “642” on the body and filled with white powder. 25 mg bottles of 21 (NDC 47781-488-77) 25 mg bottles of 100 (NDC 47781-488-01) 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 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.

Status kebenaran:

Abbreviated New Drug Application

Risalah maklumat

Alvogen, Inc.
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MEDICATION GUIDE
This Medication Guide has been approved by the U.S. Food
and Drug Administration.
Revised: October 2022
PL483-00
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 capsules are 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 pr

Ciri produk

LENALIDOMIDE- LENALIDOMIDE CAPSULE
ALVOGEN, 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 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, 5.11)
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).
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).
Limitations of Use:
Lenalidomide capsules are not indicated and are not recommended for
the treatment of patients with
chronic lymphocytic le