Lenalidomide

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Lenalidomide

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  • For more information, please download leaflet.

    • The brand name of your medication is Lenoma® and the generic name is Lenalidomide.
    • Lenoma® is similar to Thalidomide and is an immunomodulatory with anticancer features.
    • This medication is a hard gelatin capsule in dosage of 5,10,15 and 25 mg packed in blisters with 7 capsules. Each box contains 21 capsules.

    1 Why is LENOMA® prescribed?

    LENOMA® is used to treat following diseases:

    • Multiple Myeloma in combination with Dexamethasone
    • In Myelodysplastic syndrome, there is a mutation in Chromosome No.5. This syndrome is called Deletion 5q MSD. In these patients red blood cells decrease and they need blood transfusion
    • Mantle cell Lymphoma (MCL), when the disease replaces or after progression when two courses of Bortezomib had been used. Mantle cell lymphoma is type of blood cancer which related to white blood cells (Lymphocytes) in lymphatic nodes.
    • Lenoma® may be used in other diseases which have not mentioned in this leaflet.

    2 How LENOMA® should be taken?

    • Take LENOMA® according to your doctor’s order. Your doctor will talk to you about amount and interval of using capsules.
    • Take drug at about the same time each day, with water. Food may not affect your medication.
    • Avoid chewing, crushing or opening Lenoma® capsules.
    • Avoid opening LENOMA® capsules. If you contact with medicine in capsule, wash contacted area with water and soap carefully.
    • Consult your doctor or pharmacist about the safe way to throw out your medication.
    • If you have any more question about LENOMA® talk to your doctor, pharmacist or other health care providers.

    3 What special precautions should you follow during your treatment with LENOMA®?

    • Talk to your doctor or dentist before any surgery when you are using LENOMA®
    • Taking LENOMA® may cause dizziness. Avoid driving or similar activities which may need high concentration.
    • LENOMA® may decrease blood platelets, avoid activities which may cause injury or bruising. If you see any bruising, unusual bleeding, dark stool or blood in your stool, contact with your doctor.
    • LENOMA® may take you in risk of infection. try to avoid contact with people who have colds, flu or infections. If you notice any symptom of an infection call your doctor immediately.
    • Patients who have cancer and are under treatment with LENOMA® are at risk of fatal Tumor lysis syndrome. IF you notice any symptoms like increasing in heart beat or irregular heartbeat, fainting, decrease in urination, nausea, vomiting, diarrhea or decrease in appetite contact your doctor immediately.
    • In Patients who are under treatment with LENOMA® sever liver problems had been reported. It had been fatal in some cases. IF you notice any symptoms like dark urination, pale stool, sever or chronic nausea, loss of appetite or pain in stomach, unusual tiredness, yellowish skin or eye contact your doctor immediately.
    • During using LENOMA® you may see serious skin reactions like Stevens Johnson syndrome or toxic epidermal necrosis. These reactions could be life-threatening or fatal. If you notice any redness, swallowing, blisters, skin scaling (with or without fever), red eye or any sore in mouth, throat, nose or eyes, contact your doctor immediately.
    • Patients who are under treatment with LENOMA® are susceptible to sever or in some cases fatal heart problems like irregular heartbeats, MI or heart failure. If you have any heart problem, take LENOMA only after your doctor’s approval.
    • In Patients who are under treatment with LENOMA®, the risk of other cancers like acute Myeloma and Hodgkin’s lymphoma may increase. In most cases it happens in patients who had bone marrow transplant or using LENOMA in combination of Melphalan. Discuss your doctor about advantage and disadvantage of using this medication.
    • Avoid blood donation during taking LENOMA® and at least 4 weeks after stop taking it.
    • During taking LENOMLA® avoid taking any oral contraceptive with following drugs; AIDS- treatment medications, Antibiotics, Carbamazepine, Modafenil, Etc. these medications can reduce effect of oral contraceptives. Consult with your doctor about possible drug interactions.
    • LENOMA® should be used with caution in old patients because this group are more susceptible to drug’s side effects.
    • During taking LENOMA® take all laboratory tests, prescribed by your doctor and give the reports back.
    • Taking LENOMA® during pregnancy and breast-feeding is abandoned. If you have any doubt about being pregnant like late periods, unusual bleeding or stop using pregnancy prevention contact your doctor immediately.

    4 What are some side effects that you need to call your doctor about right away?

    • If you notice any sign of blood clotting in lungs, feet or hands like shortness of breathing, chest discomfort or swallowing in feel or hands,
    • If you notice any sign of heart attack contact your doctor immediately. Following list are the signs: chest discomfort that spread through hands, neck, jaw, back or stomach, sweating, shortness of breathing, tiredness or vomiting,
    • If you see any sensitivity symptoms like any redness, swallowing, blisters, skin scaling with or without fever, wheezing, difficulty in breathing or talking, roughness in voice, swelling in mouth, face, lips, tongue or throat, contact your doctor immediately.
    • If you notice any sign of infection like fever more than 38 C or higher, shivering, sever sore throat, pain in sinuses or ears, cough, increase or color change in sputum, pain in urination, mouth sores, any chronic wound, pain or itching in anus, contact your doctor immediately.

    5 What is the storage condition of LENOMA®?

    Store LENOMA® away from light and moisture and at 15-30°C.

  • For more information, please download leaflet.

    • LENALIDOMIDE a thalidomide analogue, is an immunomodulatory agent with antiangiogenic and antineoplastic properties.
    • Lenoma® is available in 10 mg and 25 mg capsules for oral administration.
    • Each capsule contains LENALIDOMIDE as the active ingredient.

    1 INDICATIONS AND USAGE

    1.1. Multiple Myeloma:

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

    1.2. Myelodysplastic Syndromes:

    LENALIDOMIDE is indicated for the treatment of 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.

    1.3. Mantle Cell Lymphoma:

    LENALIDOMIDE is indicated for the treatment of patients with mantle cell lymphoma (MCL) whose disease has relapsed or progressed after two prior therapies, one of which included Bortezomib.

    1.4. Limitations of Use:

    LENALIDOMIDE is not indicated and is not recommended for the treatment of patients with CLL outside of controlled clinical trials.

    2 DOSAGE AND ADMINISTRATION

    LENALIDOMIDE should be taken orally at about the same time each day, either with or without food. LENALIDOMIDE capsules should be swallowed whole with water. The capsules should not be opened, broken, or chewed.

    2.1. Multiple Myeloma

    The recommended starting dose of LENALIDOMIDE is 25 mg orally once daily on Days 1-21 of repeated 28-day cycles in combination with dexamethasone. For patients > 75 years old, the starting dose of dexamethasone may be reduced. Treatment should be continued until disease progression or unacceptable toxicity.

    2.2. Myelodysplastic Syndromes

    The recommended starting dose of LENALIDOMIDE is 10 mg daily. Treatment is continued or modified based upon clinical and laboratory findings.

    2.3. Mantle Cell Lymphoma

    The recommended starting dose of LENALIDOMIDE is 25 mg/day orally on Days 1-21 of repeated 28-day cycles for relapsed or refractory mantle cell lymphoma. Treatment should be continued until disease progression or unacceptable toxicity. Treatment is continued, modified or discontinued based upon clinical and laboratory findings.

    2.4. Starting Dose for Renal Impairment in MM, MDS or MCL

    Since LENALIDOMIDE is primarily excreted unchanged by the kidney, adjustments to the starting dose of LENALIDOMIDE are recommended to provide appropriate drug exposure in patients with moderate or severe renal impairment and in patients on dialysis. Based on a pharmacokinetic study in patients with renal impairment due to non-malignant conditions, LENALIDOMIDE starting dose adjustment is recommended for patients with CLcr < 60 mL/min.

    3 CONTRAINDICATIONS:

    3.1. Pregnancy

    LENALIDOMIDE can cause fetal harm when administered to a pregnant female. If this drug is used during pregnancy or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus.

    3.2 Allergic Reactions

    LENALIDOMIDE is contraindicated in patients who have demonstrated hypersensitivity (e.g., angioedema, Stevens-Johnson syndrome, toxicepidermal necrolysis) to LENALIDOMIDE.

    4 USE IN SPECIAL POPULATIONS

      4.1. Pregnancy:

      Pregnancy Risk Factor: X

      Pregnancy Implications: LENALIDOMIDE is an analogue of thalidomide (a human teratogen) and could potentially cause birth defects in humans; do not use during pregnancy (contraindication); avoid pregnancy while taking LENALIDOMIDE. Obtain 2 negative pregnancy tests prior to initiation of treatment; 2 forms of contraception (or abstain from sexual intercourse) must be used at least 4 weeks prior to, during and for 4 weeks after LENALIDOMIDE treatment (and during treatment interruptions). Males taking LENALIDOMIDE (even those vasectomized) must use a latex or synthetic condom during any sexual contact with women of childbearing potential and for up to 28 days following discontinuation of therapy. Males taking LENALIDOMIDE must not donate sperm.

      4.2. NURSING MOTHERS:

      Excretion in breast milk unknown/not recommended It is not known if LENALIDOMIDE is excreted in breast milk. Due to the potential for serious adverse reactions in the infant, a decision should be made to discontinue nursing or discontinue treatment.

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