Lenalidomide

What is Lenalidomide?

Lenalidomide (Revlimid) is a thalidomide analogue used to treat:

• Anemia caused by certain types of myelodysplastic syndromes
• Follicular lymphoma
• Mantle cell lymphoma
• Marginal zone lymphoma
• Multiple myeloma

Lenalidomide

Lenalidomide

What are the uses of this medicine?

• Lenalidomide (Revlimid) is used to treat adults with:

Multiple myeloma (MM):

• in combination with the medicine dexamethasone, or
• as maintenance treatment after autologous hematopoietic stem cell transplantation (a type of stem cell transplant that uses your own stem cells)

a condition called myelodysplastic syndromes (MDS). Revlimid is for the type of MDS with a chromosome problem where part of chromosome 5 is missing. This type of MDS is known as deletion 5q MDS. People with this type of MDS may have low red blood cell counts that require treatment with blood transfusions.

Lenalidomide3Dan

mantle cell lymphoma (MCL) when the disease comes back or becomes worse after treatment with 2 prior medicines, one of which included bortezomib. MCL is a cancer of a type of white blood cell called lymphocytes that are in the lymph nodes.

follicular lymphoma (FL) or marginal zone lymphoma (MZL)

• in combination with a rituximab product, and
• who have previously been treated for their FL or MZL
• FL and MZL are types of cancer of white blood cells called B-cell lymphocytes that are found in the lymph nodes and spleen.

Limitations of Use:

• Revlimid should not be used to treat people who have chronic lymphocytic leukemia (CLL) unless they are participants in a controlled clinical trial.

How does this medicine work?

• Lenalidomide is an analogue of thalidomide with immunomodulatory, antiangiogenic, and antineoplastic properties.
• Cellular activities of lenalidomide are mediated through its target cereblon, a component of a cullin ring E3 ubiquitin ligase enzyme complex.
• Lenalidomide inhibits proliferation and induces apoptosis of certain hematopoietic tumor cells including MM, mantle cell lymphoma, and del (5q) myelodysplastic syndromes, follicular lymphoma and marginal zone lymphoma.
• Immunomodulatory properties of lenalidomide include increased number and activation of T cells and natural killer (NK) cells leading to direct and enhanced antibody-dependent cell-mediated cytotoxicity (ADCC) via increased secretion of interleukin-2 and interferon-gamma, increased numbers of NKT cells, and inhibition of pro-inflammatory cytokines (e.g., TNF-α and IL-6) by monocytes.

Who Should Not Use this medicine ?

This medicine cannot be used in patients who:

• are pregnant, plan to become pregnant, or become pregnant during treatment with Revlimid.
• are allergic to lenalidomide or any of the ingredients in Revlimid.

What drug interactions can this medicine cause?

Tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, and nutritional supplements you are taking or plan to take. Be sure to mention any of the following:

• darbepoetin (Aranesp)
• epoetin alfa (Epogen, Procrit)
• medications containing estrogen such as hormone replacement therapy or hormonal contraceptives (birth control pills, patches, rings, implants, or injections)
• digoxin (Lanoxin)

Is this medicine FDA approved?

• Lenalidomide (len" a lid' oh mide) is a thalidomide derivative that was found to be more potent as an antineoplastic agent, and was approved for use in selected myelodysplastic syndromes in 2005 and for multiple myeloma (combined with dexamethasone) in 2006.
• Thalidomide has also been used on an experimental basis for graft vs host disease, Kaposi sarcoma, AIDS associated wasting syndrome and several forms of autoimmune disease.

How should this medicine be used?

Recommended dosage: Multiple myeloma (MM) combination therapy:

• 25 mg once daily orally on Days 1-21 of repeated 28-day cycles.

Multiple myeloma (MM) maintenance therapy following auto-HSCT:

• 10 mg once daily continuously on Days 1-28 of repeated 28-day cycles.

Myelodysplastic syndromes (MDS):

• 10 mg once daily.

Mantle cell lymphoma (MCL):

• 25 mg once daily orally on Days 1-21 of repeated 28-day cycles.

Follicular lymphoma (FL) or marginal zone lymphoma (MZL):

• 20 mg once daily orally on Days 1-21 of repeated 28-day cycles for up to 12 cycles.

Renal impairment: Adjust starting dose based on the creatinine clearance value

Administration:

• Swallow Revlimid capsules whole with water 1 time a day. Do not open, break, or chew your capsules.
• Revlimid may be taken with or without food.
• Take Revlimid at about the same time each day.
• Do not open or break Revlimid capsules or handle them any more than needed.
• If powder from the Revlimid capsule comes in contact with your skin, wash the skin right away with soap and water.
• If powder from the Revlimid capsule comes in contact with the inside of your eyes, nose, or mouth, flush well with water.
• If you miss a dose of Revlimid and it has been less than 12 hours since your regular time, take it as soon as you remember. If it has been more than 12 hours, just skip your missed dose. Do not take 2 doses at the same time.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Capsules: 2.5 mg, 5 mg, 10 mg, 15 mg, 20 mg, and 25 mg

This medicine is available in fallowing brand namesː

• Revlimid

What side effects can this medication cause?

The most common side effects of this medicine include:

• diarrhea
• rash
• nausea
• constipation
• tiredness or weakness
• fever
• itching
• swelling of your arms, hands, legs, feet and skin
• sleep problems (insomnia)
• headache
• muscle cramps or spasms
• shortness of breath
• cough, sore throat, and other symptoms of a cold
• upper respiratory tract infection or bronchitis
• inflammation of the stomach and intestine ("stomach flu")
• nose bleed
• shaking or trembling (tremor)
• joint aches
• pain in your back or stomach-area (abdomen)

Revlimid can cause serious side effects, including:

• deformed babies
• neutropenia
• thrombocytopenia
• Blood clots
• Increased risk of death in people who have chronic lymphocytic leukemia
• malignancies
• Severe liver problems, including liver failure and death
• Severe skin reactions and severe allergic reactions
• Tumor lysis syndrome
• tumor flare reaction
• Thyroid problems
• Risk of Early Death in MCL

What special precautions should I follow? =

• serious and fatal cardiac adverse reactions occurred in patients with CLL treated with Revlimid. Revlimid is not indicated and not recommended for use in CLL outside of controlled clinical trials.
• Higher incidences of second primary malignancies (SPM) were observed in controlled trials of patients with MM receiving Revlimid. Monitor patients for the development of second primary malignancies.
• Increased Mortality observed in patients with MM when pembrolizumab was added to dexamethasone and a thalidomide analogue.
• Hepatic failure, including fatal cases, has occurred in patients treated with Revlimid in combination with dexamethasone. Monitor liver function. Stop Revlimid and evaluate if hepatotoxicity is suspected.
• Severe cutaneous reactions including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and drug reaction with eosinophilia and systemic symptoms (DRESS) have been reported.Discontinue Revlimid for severe reactions.
• Fatal instances of tumor lysis syndrome (TLS) have been reported during treatment with Revlimid. Monitor patients at risk of TLS (i.e., those with high tumor burden) and take appropriate precautions.
• Serious tumor flare reactions, including fatal reactions, have occurred during investigational use of Revlimid for chronic lymphocytic leukemia and lymphoma.
• A decrease in the number of CD34+ cells collected after treatment (> 4 cycles) with Revlimid has been reported. Consider early referral to transplant center.
• Higher rate of early deaths have occurred in patients with MCL.
• Hypersensitivity, including angioedema, anaphylaxis, and anaphylactic reactions to Revlimid has been reported. Monitor patients for potential hypersensitivity. Discontinue Revlimid for angioedema and anaphylaxis.
• Revlimid is a thalidomide analogue and is contraindicated for use during pregnancy. Females of reproductive potential must avoid pregnancy for at least 4 weeks before beginning Revlimid therapy, during therapy, during dose interruptions and for at least 4 weeks after completing therapy. Lenalidomide is present in the semen of patients receiving the drug. Male patients taking Revlimid must not donate sperm and for up to 4 weeks after discontinuing Revlimid.
• Revlimid is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS), the Lenalidomide REMS program.
• Revlimid can cause significant neutropenia and thrombocytopenia. Advise patients to observe for bleeding or bruising, especially with use of concomitant medication that may increase risk of bleeding.
• Both hypothyroidism and hyperthyroidism have been reported. Measure thyroid function before start of Revlimid treatment and during therapy.
• Both agents are associated with a low rate of serum aminotransferase elevations during therapy and both have been implicated in causing rare instances of clinically apparent liver injury which can be severe.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• Pruritus
• urticaria
• rash
• elevated liver transaminases
• neutropenia
• thrombocytopenia

Management of overdosage:

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.

Can this medicine be used in pregnancy?

• Based on the mechanism of action and findings from animal studies, Revlimid can cause embryo-fetal harm when administered to a pregnant female and is contraindicated during pregnancy.
• There is a pregnancy exposure registry that monitors the outcomes of females who take Revlimid during pregnancy, or if their male partner takes Revlimid and they are exposed during pregnancy.

Can this medicine be used in children?

• It is not known if Revlimid is safe and effective in children.

What are the active and inactive ingredients in this medicine?

Active ingredient:

• lenalidomide

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 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.

Who manufactures and distributes this medicine?

Manufactured for:

• Celgene Corporation, 86 Morris Avenue, Summit, NJ
• Revlimid® is a registered trademark of Celgene Corporation.

What should I know about storage and disposal of this medication?

• Store Revlimid at room temperature between 68°F to 77°F (20°C to 25°C).

• Dailymed label info on Lenalidomide
• FDA Lenalidomide

Lenalidomide Resources
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• Dailymed label info on Lenalidomide
• FDA Lenalidomide

Lenalidomide Resources
Need Help Finding a Doctor? Need help finding a doctor or specialist anywhere in the world? Explore our world directory. WikiMD's DocFinder can assist you in locating millions of physicians.	Medical Knowledge Access the latest research - Most recent articles Ongoing trials.

Translate to: East Asian 中文, 日本, 한국어, South Asian हिन्दी, Urdu, বাংলা, తెలుగు, தமிழ், ಕನ್ನಡ,
Southeast Asian Indonesian, Vietnamese, Thai, မြန်မာဘာသာ, European español, Deutsch, français, русский, português do Brasil, Italian, polski

Lenalidomide Resources
Need Help Finding a Doctor? Need help finding a doctor or specialist anywhere in the world? Explore our world directory. WikiMD's DocFinder can assist you in locating millions of physicians.	Medical Knowledge Access the latest research - Most recent articles Ongoing trials.

Translate to: East Asian 中文, 日本, 한국어, South Asian हिन्दी, Urdu, বাংলা, తెలుగు, தமிழ், ಕನ್ನಡ,
Southeast Asian Indonesian, Vietnamese, Thai, မြန်မာဘာသာ, European español, Deutsch, français, русский, português do Brasil, Italian, polski