Your browser does not support JavaScript!

9th Floor, Empire Heights Tower A, Shuraa Gold Business Centre , Business Bay 79998 Dubai AE
JollyRX
9th Floor, Empire Heights Tower A, Shuraa Gold Business Centre , Business Bay Dubai, AE
+971585996347 //cdn1.storehippo.com/s/6052eead9e1cf8aa024c48c8/606ecab786617735b12707ae/webp/jollyrx-480x480.png" contact@jollyrx.com
61b457dcb39665817c4841e1 REVLIMID 25 MG 21 CAP. //cdn1.storehippo.com/s/6052eead9e1cf8aa024c48c8/61b457bfb39665817c483def/webp/revlimid-25-mg-21-cap-.jpg

What is Revlimid and how is it used?

Revlimid is a prescription medicine used to treat the symptoms of Myelodysplastic Syndromes (MDS), Multiple Myeloma, Mantle Cell Lymphoma, Follicular Lymphoma and Marginal Zone Lymphoma. Revlimid may be used alone or with other medications.

Revlimid belongs to a class of drugs called Antineoplastics, Angiogenesis Inhibitor.

It is not known if Revlimid is safe and effective in children younger than 18 years of age.

What are the possible side effects of Revlimid?

Revlimid may cause serious side effects including:

  • hives,
  • difficulty breathing,
  • swelling of your face, lips, tongue, or throat,
  • severe skin reaction,
  • fever,
  • sore throat,
  • burning in your eyes,
  • skin pain,
  • red or purple skin rash that spreads and causes blistering and peeling,
  • sudden numbness or weakness,
  • severe headache,
  • problems with speech or vision,
  • shortness of breath,
  • swelling or redness in your arm or leg,
  • chest pain or pressure,
  • pain spreading to your jaw or shoulder,
  • sweating,
  • chills,
  • swollen gums,
  • mouth sores,
  • skin sores,
  • easy bruising,
  • unusual bleeding,
  • swollen glands,
  • low fever,
  • rash,
  • pain,
  • lower back pain,
  • blood in your urine,
  • little or no urination,
  • numbness or tingly feeling around your mouth,
  • shortness of breath,
  • confusion, and
  • fainting

Get medical help right away, if you have any of the symptoms listed above.

The most common side effects of Revlimid include:

  • fever,
  • cough,
  • tiredness,
  • itching,
  • rash,
  • swelling,
  • nausea,
  • diarrhea, and
  • constipation

Tell the doctor if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of Revlimid. For more information, ask your doctor or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

DESCRIPTION

REVLIMID, a thalidomide analogue, is an immunomodulatory agent with antiangiogenic and antineoplastic properties. The chemical name is 3-(4-amino-1-oxo 1,3- dihydro-2H-isoindol-2-yl) piperidine-2,6-dione and it has the following chemical structure:

REVLIMID (lenalidomide) Structural Formula  - Illustration

3-(4-amino-1-oxo 1,3-dihydro-2H-isoindol-2-yl) piperidine-2,6-dione

The empirical formula for lenalidomide is C13H13N3O3, and the gram molecular weight is 259.3.

Lenalidomide is an off-white to pale-yellow solid powder. It is soluble in organic solvent/water mixtures, and buffered aqueous solvents. Lenalidomide is more soluble in organic solvents and low pH solutions. Solubility was significantly lower in less acidic buffers, ranging from about 0.4 to 0.5 mg/ml. Lenalidomide has an asymmetric carbon atom and can exist as the optically active forms S(-) and R(+), and is produced as a racemic mixture with a net optical rotation of zero.

REVLIMID is available in 2.5 mg, 5 mg, 10 mg, 15 mg, 20 mg and 25 mg capsules for oral administration. Each capsule contains lenalidomide as the active ingredient and the following inactive ingredients: lactose anhydrous, microcrystalline cellulose, croscarmellose sodium, and magnesium stearate. The 5 mg and 25 mg capsule shell contains gelatin, titanium dioxide and black ink. The 2.5 mg and 10 mg capsule shell contains gelatin, FD&C blue #2, yellow iron oxide, titanium dioxide and black ink. The 15 mg capsule shell contains gelatin, FD&C blue #2, titanium dioxide and black ink. The 20 mg capsule shell contains gelatin, FD&C blue #2, yellow iron oxide, titanium dioxide and black ink.

INDICATIONS

Multiple Myeloma

REVLIMID in combination with dexamethasone is indicated for the treatment of adult patients with multiple myeloma (MM).

REVLIMID is indicated as maintenance therapy in adult patients with MM following autologous hematopoietic stem cell transplantation (auto-HSCT).

Myelodysplastic Syndromes

REVLIMID is 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.

Mantle Cell Lymphoma

REVLIMID is 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.

Follicular Lymphoma

REVLIMID in combination with a rituximab product, is indicated for the treatment of adult patients with previously treated follicular lymphoma (FL).

Marginal Zone Lymphoma

REVLIMID in combination with a rituximab product, is indicated for the treatment of adult patients with previously treated marginal zone lymphoma (MZL).

Limitations Of Use

REVLIMID is not indicated and is not recommended for the treatment of patients with CLL outside of controlled clinical trials [see WARNINGS AND PRECAUTIONS].

DOSAGE AND ADMINISTRATION

Recommended Dosage For Multiple Myeloma

REVLIMID Combination Therapy

The recommended starting dose of REVLIMID is 25 mg orally once daily on Days 1-21 of repeated 28-day cycles in combination with dexamethasone. Refer to Section 14.1 for specific dexamethasone dosing. For patients greater than 75 years old, the starting dose of dexamethasone may be reduced [see Clinical Studies]. Treatment should be continued until disease progression or unacceptable toxicity.

In patients who are not eligible for auto-HSCT, treatment should continue until disease progression or unacceptable toxicity. For patients who are auto-HSCT-eligible, hematopoietic stem cell mobilization should occur within 4 cycles of a REVLIMID-containing therapy [see WARNINGS AND PRECAUTIONS].

Dose Adjustments for Hematologic Toxicities During MM Treatment

Dose modification guidelines, as summarized in Table 1 below, are recommended to manage Grade 3 or 4 neutropenia or thrombocytopenia or other Grade 3 or 4 toxicity judged to be related to REVLIMID.

HOW SUPPLIED

Dosage Forms And Strengths

Capsules
  • 2.5 mg, white and blue-green opaque hard capsules imprinted "REV" on one half and "2.5 mg" on the other half in black ink
  • 5 mg, white opaque capsules imprinted "REV" on one half and "5 mg" on the other half in black ink
  • 10 mg, blue/green and pale yellow opaque capsules imprinted "REV" on one half and "10 mg" on the other half in black ink
  • 15 mg, powder blue and white opaque capsules imprinted "REV" on one half and "15 mg" on the other half in black ink
  • 20 mg, powder blue and blue-green opaque hard capsules imprinted "REV" on one half and "20 mg" on the other half in black ink
  • 25 mg, white opaque capsules imprinted "REV" on one half and "25 mg" on the other half in black ink

Storage And Handling

White and blue-green opaque hard capsules imprinted "REV" on one half and "2.5 mg" on the other half in black ink:

2.5 mg bottles of 28 (NDC 59572-402-28)
2.5 mg bottles of 100 (NDC 59572-402-00)

White opaque capsules imprinted "REV" on one half and "5 mg" on the other half in black ink:

5 mg bottles of 28 (NDC 59572-405-28)
5 mg bottles of 100 (NDC 59572-405-00)

Blue/green and pale yellow opaque capsules imprinted "REV" on one half and "10 mg" on the other half in black ink:

10 mg bottles of 28 (NDC 59572-410-28)
10 mg bottles of 100 (NDC 59572-410-00)

Powder blue and white opaque capsules imprinted "REV" on one half and "15 mg" on the other half in black ink:

15 mg bottles of 21 (NDC 59572-415-21)
15 mg bottles of 100 (NDC 59572-415-00)

Powder blue and blue-green opaque hard capsules imprinted "REV" on one half and "20 mg" on the other half in black ink.

20 mg bottles of 21 (NDC 59572-420-21)
20 mg bottles of 100 (NDC 59572-420-00)

White opaque capsules imprinted "REV" on one half and "25 mg" on the other half in black ink:

25 mg bottles of 21 (NDC 59572-425-21)
25 mg bottles of 100 (NDC 59572-425-00)

Storage

Store at 20°C - 25°C (68°F - 77°F); excursions permitted to 15°C - 30°C (59°F - 86°F) [See USP Controlled Room Temperature].

SIDE EFFECTS

The following clinically significant adverse reactions are described in detail in other sections of the prescribing information:

  • Embryo-Fetal Toxicity [see BOXED WARNING, WARNINGS AND PRECAUTIONS]
  • Hematologic Toxicity [see BOXED WARNING, WARNINGS AND PRECAUTIONS]
  • Venous and Arterial Thromboembolism [see BOXED WARNING, WARNINGS AND PRECAUTIONS]
  • Increased Mortality in Patients with CLL [see WARNINGS AND PRECAUTIONS]
  • Second Primary Malignancies [see WARNINGS AND PRECAUTIONS]
  • Increased Mortality in Patients with MM When Pembrolizumab Is Added to a Thalidomide Analogue and Dexamethasone [see WARNINGS AND PRECAUTIONS]
  • Hepatotoxicity [see WARNINGS AND PRECAUTIONS]
  • Severe Cutaneous Reactions[see WARNINGS AND PRECAUTIONS]
  • Tumor Lysis Syndrome [see WARNINGS AND PRECAUTIONS]
  • Tumor Flare Reactions [see WARNINGS AND PRECAUTIONS]
  • Impaired Stem Cell Mobilization [see WARNINGS AND PRECAUTIONS]
  • Thyroid Disorders [see WARNINGS AND PRECAUTIONS]
  • Early Mortality in Patients with MCL [see WARNINGS AND PRECAUTIONS]
  • Hypersensitivity [see WARNINGS AND PRECAUTIONS]

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

SKU-V8ZSNDDUOH34
in stock INR
1 1

REVLIMID 25 MG 21 CAP.


Product Enquiry

Sold By: jollyrx
VARIANT SELLER PRICE QUANTITY

Description of product

What is Revlimid and how is it used?

Revlimid is a prescription medicine used to treat the symptoms of Myelodysplastic Syndromes (MDS), Multiple Myeloma, Mantle Cell Lymphoma, Follicular Lymphoma and Marginal Zone Lymphoma. Revlimid may be used alone or with other medications.

Revlimid belongs to a class of drugs called Antineoplastics, Angiogenesis Inhibitor.

It is not known if Revlimid is safe and effective in children younger than 18 years of age.

What are the possible side effects of Revlimid?

Revlimid may cause serious side effects including:

  • hives,
  • difficulty breathing,
  • swelling of your face, lips, tongue, or throat,
  • severe skin reaction,
  • fever,
  • sore throat,
  • burning in your eyes,
  • skin pain,
  • red or purple skin rash that spreads and causes blistering and peeling,
  • sudden numbness or weakness,
  • severe headache,
  • problems with speech or vision,
  • shortness of breath,
  • swelling or redness in your arm or leg,
  • chest pain or pressure,
  • pain spreading to your jaw or shoulder,
  • sweating,
  • chills,
  • swollen gums,
  • mouth sores,
  • skin sores,
  • easy bruising,
  • unusual bleeding,
  • swollen glands,
  • low fever,
  • rash,
  • pain,
  • lower back pain,
  • blood in your urine,
  • little or no urination,
  • numbness or tingly feeling around your mouth,
  • shortness of breath,
  • confusion, and
  • fainting

Get medical help right away, if you have any of the symptoms listed above.

The most common side effects of Revlimid include:

  • fever,
  • cough,
  • tiredness,
  • itching,
  • rash,
  • swelling,
  • nausea,
  • diarrhea, and
  • constipation

Tell the doctor if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of Revlimid. For more information, ask your doctor or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

DESCRIPTION

REVLIMID, a thalidomide analogue, is an immunomodulatory agent with antiangiogenic and antineoplastic properties. The chemical name is 3-(4-amino-1-oxo 1,3- dihydro-2H-isoindol-2-yl) piperidine-2,6-dione and it has the following chemical structure:

REVLIMID (lenalidomide) Structural Formula  - Illustration

3-(4-amino-1-oxo 1,3-dihydro-2H-isoindol-2-yl) piperidine-2,6-dione

The empirical formula for lenalidomide is C13H13N3O3, and the gram molecular weight is 259.3.

Lenalidomide is an off-white to pale-yellow solid powder. It is soluble in organic solvent/water mixtures, and buffered aqueous solvents. Lenalidomide is more soluble in organic solvents and low pH solutions. Solubility was significantly lower in less acidic buffers, ranging from about 0.4 to 0.5 mg/ml. Lenalidomide has an asymmetric carbon atom and can exist as the optically active forms S(-) and R(+), and is produced as a racemic mixture with a net optical rotation of zero.

REVLIMID is available in 2.5 mg, 5 mg, 10 mg, 15 mg, 20 mg and 25 mg capsules for oral administration. Each capsule contains lenalidomide as the active ingredient and the following inactive ingredients: lactose anhydrous, microcrystalline cellulose, croscarmellose sodium, and magnesium stearate. The 5 mg and 25 mg capsule shell contains gelatin, titanium dioxide and black ink. The 2.5 mg and 10 mg capsule shell contains gelatin, FD&C blue #2, yellow iron oxide, titanium dioxide and black ink. The 15 mg capsule shell contains gelatin, FD&C blue #2, titanium dioxide and black ink. The 20 mg capsule shell contains gelatin, FD&C blue #2, yellow iron oxide, titanium dioxide and black ink.

INDICATIONS

Multiple Myeloma

REVLIMID in combination with dexamethasone is indicated for the treatment of adult patients with multiple myeloma (MM).

REVLIMID is indicated as maintenance therapy in adult patients with MM following autologous hematopoietic stem cell transplantation (auto-HSCT).

Myelodysplastic Syndromes

REVLIMID is 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.

Mantle Cell Lymphoma

REVLIMID is 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.

Follicular Lymphoma

REVLIMID in combination with a rituximab product, is indicated for the treatment of adult patients with previously treated follicular lymphoma (FL).

Marginal Zone Lymphoma

REVLIMID in combination with a rituximab product, is indicated for the treatment of adult patients with previously treated marginal zone lymphoma (MZL).

Limitations Of Use

REVLIMID is not indicated and is not recommended for the treatment of patients with CLL outside of controlled clinical trials [see WARNINGS AND PRECAUTIONS].

DOSAGE AND ADMINISTRATION

Recommended Dosage For Multiple Myeloma

REVLIMID Combination Therapy

The recommended starting dose of REVLIMID is 25 mg orally once daily on Days 1-21 of repeated 28-day cycles in combination with dexamethasone. Refer to Section 14.1 for specific dexamethasone dosing. For patients greater than 75 years old, the starting dose of dexamethasone may be reduced [see Clinical Studies]. Treatment should be continued until disease progression or unacceptable toxicity.

In patients who are not eligible for auto-HSCT, treatment should continue until disease progression or unacceptable toxicity. For patients who are auto-HSCT-eligible, hematopoietic stem cell mobilization should occur within 4 cycles of a REVLIMID-containing therapy [see WARNINGS AND PRECAUTIONS].

Dose Adjustments for Hematologic Toxicities During MM Treatment

Dose modification guidelines, as summarized in Table 1 below, are recommended to manage Grade 3 or 4 neutropenia or thrombocytopenia or other Grade 3 or 4 toxicity judged to be related to REVLIMID.

HOW SUPPLIED

Dosage Forms And Strengths

Capsules
  • 2.5 mg, white and blue-green opaque hard capsules imprinted "REV" on one half and "2.5 mg" on the other half in black ink
  • 5 mg, white opaque capsules imprinted "REV" on one half and "5 mg" on the other half in black ink
  • 10 mg, blue/green and pale yellow opaque capsules imprinted "REV" on one half and "10 mg" on the other half in black ink
  • 15 mg, powder blue and white opaque capsules imprinted "REV" on one half and "15 mg" on the other half in black ink
  • 20 mg, powder blue and blue-green opaque hard capsules imprinted "REV" on one half and "20 mg" on the other half in black ink
  • 25 mg, white opaque capsules imprinted "REV" on one half and "25 mg" on the other half in black ink

Storage And Handling

White and blue-green opaque hard capsules imprinted "REV" on one half and "2.5 mg" on the other half in black ink:

2.5 mg bottles of 28 (NDC 59572-402-28)
2.5 mg bottles of 100 (NDC 59572-402-00)

White opaque capsules imprinted "REV" on one half and "5 mg" on the other half in black ink:

5 mg bottles of 28 (NDC 59572-405-28)
5 mg bottles of 100 (NDC 59572-405-00)

Blue/green and pale yellow opaque capsules imprinted "REV" on one half and "10 mg" on the other half in black ink:

10 mg bottles of 28 (NDC 59572-410-28)
10 mg bottles of 100 (NDC 59572-410-00)

Powder blue and white opaque capsules imprinted "REV" on one half and "15 mg" on the other half in black ink:

15 mg bottles of 21 (NDC 59572-415-21)
15 mg bottles of 100 (NDC 59572-415-00)

Powder blue and blue-green opaque hard capsules imprinted "REV" on one half and "20 mg" on the other half in black ink.

20 mg bottles of 21 (NDC 59572-420-21)
20 mg bottles of 100 (NDC 59572-420-00)

White opaque capsules imprinted "REV" on one half and "25 mg" on the other half in black ink:

25 mg bottles of 21 (NDC 59572-425-21)
25 mg bottles of 100 (NDC 59572-425-00)

Storage

Store at 20°C - 25°C (68°F - 77°F); excursions permitted to 15°C - 30°C (59°F - 86°F) [See USP Controlled Room Temperature].

SIDE EFFECTS

The following clinically significant adverse reactions are described in detail in other sections of the prescribing information:

  • Embryo-Fetal Toxicity [see BOXED WARNING, WARNINGS AND PRECAUTIONS]
  • Hematologic Toxicity [see BOXED WARNING, WARNINGS AND PRECAUTIONS]
  • Venous and Arterial Thromboembolism [see BOXED WARNING, WARNINGS AND PRECAUTIONS]
  • Increased Mortality in Patients with CLL [see WARNINGS AND PRECAUTIONS]
  • Second Primary Malignancies [see WARNINGS AND PRECAUTIONS]
  • Increased Mortality in Patients with MM When Pembrolizumab Is Added to a Thalidomide Analogue and Dexamethasone [see WARNINGS AND PRECAUTIONS]
  • Hepatotoxicity [see WARNINGS AND PRECAUTIONS]
  • Severe Cutaneous Reactions[see WARNINGS AND PRECAUTIONS]
  • Tumor Lysis Syndrome [see WARNINGS AND PRECAUTIONS]
  • Tumor Flare Reactions [see WARNINGS AND PRECAUTIONS]
  • Impaired Stem Cell Mobilization [see WARNINGS AND PRECAUTIONS]
  • Thyroid Disorders [see WARNINGS AND PRECAUTIONS]
  • Early Mortality in Patients with MCL [see WARNINGS AND PRECAUTIONS]
  • Hypersensitivity [see WARNINGS AND PRECAUTIONS]

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

User reviews

  0/5