LENALID 15MG

Lenalid 15mg Drug profile

Lenalid 15mg consist of an active substance known as Lenalidomide which is considered as thalidomide derivative and it is originated from Generic Revlimid.

Lenalid 15mg belongs to Immunomodulatory agent which has both anti-angiogenic & anti-cancer activity.

Lenalid 15mg is a naturally established compound which plays important role in myeloma at first, later it is used for hematological disorders like myelodysplastic syndromes.

Usage of Lenalid 15mg

The most important therapeutic indication of Lenalid 15mg is given below as follows;

• In multiple myeloma
• In myelodysplastic syndrome
• In mantle cell lymphoma

Drawback of use

Lenalid 15mg is not suggested in chronic lymphocytic leukemia.

Mechanism of Lenalid 15mg

Lenalid 15mg (Generic Revlimid), is a thalidomide analogue.

Pharmacological action of lenalidomide remains to be fully characterized, however it has been described that lenalidomide prohibits the expression of cyclooxygenase-2 (COX-2), but not COX-1, in vitro. In vivo it activates tumor cell apoptosis directly and indirectly by prevention of bone marrow stromal cell support, by anti-angiogenic and anti-osteoclastogenic effects, and by immunomodulatory activity

Absorption

The absorption occurs very quickly.

The high plasma concentration time occurs between 0.5 to 6 hours after drug intake.

Distribution

Lenalid 15mg is bounds to human plasma protein at relatively 30%

Metabolism

The metabolism of Lenalidomide is appears in limited range, mostly unchanged form of Lenalidomide is a major circulating substance present in the human body.

There are two major metabolites like;

5-hydroxy Lenalidomide

N-acetyl Lenalidomide

Not more than 5% of parent form is present in the circulation.

Excretion

The mainly elimination of Lenalidomide is occurs through renally.

Nearly 82% of radioactive dose is eliminated in urine within 24 hours; the two metabolites are excreted in 4.6% & 1.8%.

The half-life period of Lenalidomide in healthy person is 3 hours; whereas in myeloma & MDS or MCL is 3 to 5 hours

Dosage regimens of Lenalid 15mg

The potency of Lenalidomide is not evaluated in pediatric patients with the age of <18 years.

In adults

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

Multiple myeloma:

The therapy should be followed by combining of Lenalid 15mg with dexamethasone as a single dose.

The recommended dose of Lenalid 15mg 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 Lenalid 15mg 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

Administration

Lenalid 15mg (Generic Revlimid) should be taken with or without food.

Lenalid 15mg capsules should not be opened, broken or chewed.

It should be administered with whole water.

Overdosage

There is no special treatment for overdosage of Lenalidomide; In case of this condition patient must be provided with adjuvant therapy and monitor the signs & symptoms frequently.

Lenalid 15mg caused side effects

common side effects

• Neck pain
• Respiratory infection
• Pneumonia
• Influenza
• Rhinitis
• Cellulitis
• Fatigue
• Asthenia
• Pyrexia
• Chest pain
• Diarrhea
• Abdominal pain
• Dyspepsia
• Back pain
• Muscle spasms
• Arthralgia
• Bone pain
• Pain in extremity
• Musculoskeletal pain

Lab abnormalities

• Anemia
• Thrombocytopenia
• Neutropenia
• Pancytopenia
• Hypokalemia
• Hyperglycemia
• Hypocalcaemia
• Hypophosphatemia
• Hyponatremia

Other effects

• Rash
• Pruritus
• Deep vein thrombosis
• Loss of appetite, weight
• Insomnia
• Squamous cell cancer
• Basal cell cancer

Drug-Drug interaction of Lenalid 15mg

Lenalid 15mg is concomitant use with digoxin causes higher the plasma concentration of Lenalidomide lead to increase the adverse effects. 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.

Contraindications of Lenalid 15mg caused

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 Lenalid 15mg tablets.

Precaution of Lenalid 15mg

In embryo fetal harm:

Lenalidomide is contraindicated to pregnancy conditions.

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 flare reaction:

This condition may occur in patients who undergone Lenalidomide therapy, in CLL & lymphoma have chance of getting inflammation on lymph nodes, fever, pain, & rash

In tumor lysis syndrome:

In this condition, patients must be monitored carefully, and precaution should be providing.

In allergic conditions:

Lenalid 15mg treatment should be withheld or discontinue in case of angioedema, rash, bullous rashes.

In venous thromboembolism:

In MDS, Lenalid 15mg is used as a monotherapy, in this condition there is a chance of getting increased exposure of DVT & PE.

In hematological risk:

Lenalid 15mg causes thrombocytopenia and neutropenia, patients receiving Lenalid 15mg 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.

Pregnancy

Pregnancy category: X

Lenalid 15mg should not be recommended in pregnancy condition

Lactation

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

Lenalid 15mg tablets should be stores at 20^oC to 25^oC; excursion between 15^oC to 30^oC.

Keep the container away from heat, moisture & light

Missed dose

The missed dose of Lenalid 15mg should be avoided and follow the regular dosing schedule. Must consult the doctor.