Lenalid5mg containing active substance known as Lenalidomide which is considered as thalidomide derivative and it is originated from Generic Revlimid.
Lenalidomide is a naturally established compound which plays important role in myeloma at first, later it is used for hematological disorders like myelodysplastic syndromes.
Lenalidomide is an Immuno modulatory agent which has both anti-angiogenic & anti-cancer activity.
Lenalid is available in the strength of 5mg
Trade name: Lenalid5mg
Active ingredient: Lenalidomide
Mfg: Natco pharma
Pack: 30 tablets in a container
Classified as: Anti-neoplastic drug
Prescribing information of Lenalid 5mg;
The most important therapeutic indication of Lenalidomide is given below as follows;
v In multiple myeloma
v In myelodysplastic syndrome
v In mantle cell lymphoma
Lenalid5mg (Generic Revlimid) is used in myeloma condition by combining with dexamethasone
In myeloma patients with autologous hematopoietic stem cell transplantation, Lenalid5mg is used as a continuation therapy.
Lenalid5mg (Generic Revlimid), is also used in the therapy of patients with transfusion vulnerable anemia expected low or moderate exposure of myelodysplastic syndrome related to deletion 5q cytogenetic aberrant.
Mantle cell lymphoma:
Lenalid5mg (Generic Revlimid) is used in mantle cell lymphoma as a second line therapy. The patient’s disease conditions are reoccurred or advanced after prior two therapies like Bortezomib.
Drawback of use;
Lenalid5mg is not suggested in chronic lymphocytic leukemia.
Mechanism of Lenalid 5mg;
Lenalid5mg (Generic Revlimid), is a thalidomide analogue.
The pharmacological activity of Lenalid5mg is;
Immuno modulatory effect by;
Elevates the counts and activates the effect of T-cells and natural killer cells
Elevates the count of natural killer T cells
Prohibits the pro-inflammatory cytokines like TNF-alpha & IL-6 monocytes
Anti-neoplastic activity by;
Prohibiting cell multiplication & activates apoptosis of cancer cells in vitro and causes prohibition of cell growth in vivo, prominently to reduce in tumor strain.
Postponing the growth of cancer cells
Combined effort of dexamethasone leads to inhibits cell replication and promotes apoptosis in myeloma cells.
Angiogenesis (cell development) is blocked by reducing the levels of VEGF, TNF-alpha & IL-6.
VEGF: Vascular Endothelial Growth Factor
Lenalidomide is expel its activity by inhibits the interpretation of cyclo oxygenase 2 (COX 2) in vitro, it may trigger the apoptosis directly by involving in prohibition of bone marrow stromal cell backing by anti-angiogenic and anti-osteoclastogenic activity & by Immuno modulatory effect
After an oral administration of Lenalid 5mg, the absorption occurs very quickly.
The peak plasma concentration time occurs between 0.5 to 6 hours after drug intake.
Lenalid5mg is bounds to human plasma protein at relatively 30%
Lenalidomide is occurs in semen after administration, at 2 hours & 24 hours after the dose of 25mg Lenalid 5mg.
The metabolism of Lenalidomide is occurs in limited range, mostly unchanged form of Lenalidomide is a major circulating substance present in the human body.
There are two major metabolites like;
Not more than 5% of parent form is present in the circulation.
The primary elimination of Lenalidomide is occurs via renally.
Nearly 82% of radioactive dose is eliminated in urine within 24 hours; the two metabolites are excreted in 4.6% & 1.8%.
Total excretion occurs within 10 days.
The terminal half life period of Lenalidomide in healthy person is 3 hours; whereas in myeloma & MDS or MCL is 3 to 5 hours
When to take the tablet Lenalid 5mg
Lenalid5mg (Generic Revlimid) should be taken with or without food.
Lenalid5mg capsules should not be opened, broken or chewed.
It should be administered with whole water.
Dosage regimens of Lenalid 5mg
The potency of Lenalidomide is not evaluated in pediatric patients with the age of <18 years.
In myelodysplastic syndrome:
The recommended dosage is 10mg of Lenalidomide should be taken as a single dose.
In renal damaged patients:
In CrCl 30 to 60ml/min: 5mg of Lenalidomide should be suggested for once a day.
In CrCl <30ml/min: 2.5mg PO as a single dose
In CrCl >60ml/min: No dosage adjustment is required
The therapy should be followed by combining of Lenalid5mg with dexamethasone as a single dose.
The recommended dose of Lenalid5mg is 25mg should be given as a single dose on day 1 to 21 of repeated 28 day cycles.
The dosage of dexamethasone;
For first 4 cycles;
40mg of dexamethasone should be recommended on days 1 to 4; 9 to 12; & 17 to 20 of each 28 day cycles.
Then followed by 40mg should be given as single dose, days 1 to 4 every 28 days
Age >75 years: 20mg of dexamethasone is recommend, on day 1, 8, 15 & 22 of each 28 cycle.
Mantle cell lymphoma:
The recommended dosage of Lenalid5mg is 25mg should be administered orally as a single dose.
CrCl 30 to 60ml/min: 10mg PO single dose
CrCl <30ml/min: 15mg should be recommend as a single dose.
In ESRD: 5mg should be given
Lenalid5mg caused side effects
The major adverse effects;
Embryo fetal damage
Venous & arterial thromboembolism
Elevation in mortality with CLL
Serious cutaneous reactions
Tumor lysis syndrome
Tumor flare syndrome
Damaged stem cell mobilization
Increased extinct rate in MCL
The most common side effects;
Pain in extremity
Deep vein thrombosis
Loss of appetite, weight
Squamous cell cancer
Basal cell cancer
Drug - drug interaction of Lenalid 5mg
Lenalid5mg is combined used with digoxin causes increasing the plasma concentration of Lenalidomide lead to increase the adverse effects.
To avoid this problem, monitor the digoxin plasma concentration periodically during this concomitant.
There is no pharmacokinetic changes occurs during this concomitant of Lenalidomide with warfarin, but patients may get alteration in prothrombin time & INR. To avoid this condition, monitor the values frequently during this combinational therapy.
Some combination treatment may increase the exposure of thrombosis:
Erythropoietic drugs or some other medicines that may elevate the exposure of thrombosis like estrogen containing treatment.
This type of concomitant treatment should be used cautiously to reduce the risk factors.
Food drug interaction of Lenalid 5mg
Food should be avoided during chemotherapy of multiple myeloma;
Lenalid5mg cause renal impairment;
Food rich in potassium
Avocados, bananas, spinach, citrus, tomatoes should be avoided
Rich in phosphorus
Whole grains, oats, bran cereals, sunflower seeds
Food avoid during therapy;
Raw meats, sea foods, poultry
Possible contraindications of Lenalid 5mg;
Lenalidomide is contraindicated to pregnancy condition, may cause fetal damage
Some hyper sensitivity reactions like Stevens Johnsons syndrome, angioedema may occur, due to patients may contraindicate to the components present in Lenalid5mg tablets.
Safety measures of Lenalid 5mg;
During Lenalid5mg therapy, some life threatening conditions may occur like;
v Embryo fetal damage
v Hematological toxicity
v Venous & arterial thromboembolism
In tumor flare reaction:
This condition may occurs in patients who undergone Lenalidomide therapy, in CLL & lymphoma have chance of getting inflammation on lymph nodes, fever, pain, & rash
In liver toxicity:
Constant hepatic function test should be done, before and during the therapies.
In this condition, treatment should be postponed and continue if required.
In tumor lysis syndrome:
In this condition, patients must be monitored carefully and precaution should be provide.
In allergic conditions:
Lenalid5mg treatment should be withheld or discontinue in case of angioedema, rash, bullous rashes.
In venous thromboembolism:
In MDS, Lenalid5mg is used as a monotherapy, in this condition there is a chance of getting increased exposure of DVT & PE.
In hematological risk:
Lenalid5mg causes thrombocytopenia and neutropenia, patients receiving Lenalid5mg for MDS should be completely examine by investigating blood counts weekly for first 8 weeks.
In MM patients should be monitored with counting blood cells for every 2 weeks for first 12 weeks and then monthly afterwards.
In this condition, dose reduction is applicable.
In embryo fetal harm:
Lenalidomide is contraindicated to pregnancy conditions.
Pregnancy and lactation
Pregnancy category: X
Lenalid5mg should not be recommended in pregnancy condition
Breast feeding should not be recommended.
The initial dose of Lenalidomide is depending upon the creatinine clearance value and for the patients in dialysis.
Storage and handling
Lenalid5mg tablets should be stores at 20oC to 25oC; excursion between 15oC to 30oC.
Keep the container away from heat, moisture & light
The missed dose of Lenalid5mg should be avoided, and follow the regular dosing schedule.
There is no special treatment for over dosage of Lenalidomide; In case of this condition patient must be provided with adjuvant therapy and monitor the signs & symptoms frequently.