LENALIDOMIDE capsule

Country: Amerika Syarikat

Bahasa: Inggeris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

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

Boleh didapati daripada:

Cipla USA 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 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

Ringkasan produk:

White to off white powder filled in size '2' hard gelatin White and White capsule printed in black ink with 'Cipla 5 mg' on the cap and '381' on the body. 5 mg bottles of 28                               (NDC 69097-381-73) White to off white powder filled in size '0' hard gelatin Blue green and Pale yellow capsule printed in black ink with 'Cipla 10 mg' on the cap and '382' on the body. 10 mg bottles of 28                             (NDC 69097-382-73) White to off white powder filled in size '0' hard gelatin pale blue and white capsule printed in black ink with 'Cipla 15 mg' on the cap and '383' on the body. 15 mg bottles of 21                             (NDC 69097-383-81) White to off white powder filled in size '0' hard gelatin Blue green and Pale blue capsule printed in black ink with 'Cipla 20 mg' on the cap and '384' on the body. 20 mg bottles of 21                             (NDC 69097-384-81) White to off white powder filled in size '0' hard gelatin white and white capsule printed in black ink with 'Cipla 25 mg 'on the cap and '385' on the body. 25 mg bottles of 21                             (NDC 69097-385-81) 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

LENALIDOMIDE - LENALIDOMIDE CAPSULE
Cipla USA 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 Capsule is similar to the medicine thalidomide. We know
thalidomide can cause severe
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:
o For at least 4 weeks before starting Lenalidomide Capsules
o While taking Lenalidomide Capsules
o During any breaks (interruptions) in your treatment with
Lenalidomide Capsules
o For at least 4 weeks after stopping Lenalidomide Capsules
Females who can become pregnant:
o 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.
o If you miss your period or have unusual bleeding, you will need to
have a pregnancy test and receive
counseling.
o 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.
o 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.
o If you had unprotected sex or if you think your birt

Ciri produk

LENALIDOMIDE - LENALIDOMIDE CAPSULE
CIPLA USA 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
------------------------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).
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