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Lenalidomide Dosage

Applies to the following strength(s): 2.5 mg ; 5 mg ; 10 mg ; 15 mg ; 20 mg ; 25 mg

The information at Drugs.com is not a substitute for medical advice. Always consult your doctor or pharmacist.

Usual Adult Dose for:

Additional dosage information:

Usual Adult Dose for Myelodysplastic Diseases

10 mg orally once daily

Approved indication: 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.

Usual Adult Dose for Multiple Myeloma

25 mg/day of lenalidomide with water orally as a single 25 mg capsule on days 1 through 21 of repeated 28 day cycles.

(The recommended dose of dexamethasone is 40 mg/day on days 1 through 4, 9 through 12, and 17 through 20 of each 28 day cycle for the first 4 cycles of therapy and then 40 mg/day orally on days 1 through 4 every 28 days.)

The effects of substituting lesser strengths of lenalidomide to equal a 25 mg capsule dose is unknown.

Usual Adult Dose for Lymphoma

25 mg orally once a day on Days 1 to 21 of repeated 28 day cycles.

Duration of therapy: Treatment should be continued until disease progression or unacceptable toxicity.

Approved indication: Treatment of mantle cell lymphoma (MCL) in patients whose disease has relapsed or progressed after two prior therapies, one of which included bortezomib.

Renal Dose Adjustments

Initial Starting Doses:

Moderate renal function impairment (CrCl 30 to less than 60 mL/min):
MM and MCL: 10 mg every 24 hours
MDS: 5 mg every 24 hours

Severe renal function impairment (CrCl 11 to less than 30 mL/min) not requiring dialysis:
MM and MCL: 15 mg every 48 hours
MDS: 5 mg every 48 hours

Non-dialysis patients with creatinine clearances less than 11 mL/min have not been studied.

Liver Dose Adjustments

Data not available

Dose Adjustments

Dosing is continued or modified or discontinued based upon clinical and laboratory findings.

MYELODYSPLASTIC SYNDROMES:

Patients who are dosed initially at 10 mg and who experience thrombocytopenia should have their dosage adjusted as follows:

1A) If thrombocytopenia develops WITHIN 4 weeks of starting treatment at 10 mg daily
If baseline platelet count is greater than or equal to 100,000/mcL
When platelets fall to less than 50,000/mcL, interrupt lenalidomide treatment.
When platelets return to greater than or equal to 50,000/mcL, resume lenalidomide at 5 mg daily.

If baseline platelet counts is less than 100,000/mcL
When platelets fall to 50% of the baseline value, interrupt lenalidomide treatment.
If baseline was greater than or equal to 60,000/mcL and returns to greater than or equal to 50,000/mcL, then resume lenalidomide at 5 mg daily.
If baseline was less than or equal to 60,000/mcL and returns to greater than or equal to 30,000/mcL, then resume lenalidomide at 5 mg daily.

1B) If thrombocytopenia develops AFTER 4 weeks of starting treatment at 10 mg daily
When platelets are less than 30,000/mcL or less than 50,000/mcL with platelet transfusions, then interrupt lenalidomide treatment.
When platelets return to greater than or equal to 30,000/mcL (without hemostatic failure), resume lenalidomide at 5 mg daily.

Patients who experience thrombocytopenia at 5 mg daily should have their dosage adjusted as follows:
1C) If thrombocytopenia develops during treatment at 5 mg daily
When platelets are less than 30,000/mcL or less than 50,000/mcL with platelet transfusions, then interrupt lenalidomide treatment.
When platelets return to greater than or equal to 30,000/mcL (without hemostatic failure), resume lenalidomide at 2.5 mg daily.

Patients who are dosed initially at 10 mg and experience neutropenia should have their dosage adjusted as follows:

2A) If neutropenia develops WITHIN 4 weeks of starting treatment at 10 mg daily
If baseline ANC is greater than or equal to 1,000/mcL
When neutrophils fall to less than 750/mcL, interrupt lenalidomide treatment.
When neutrophils return to greater than or equal to 1,000/mcL, resume lenalidomide at 5 mg daily.

If baseline ANC is less than 1,000/mcL
When neutrophils fall to less than 500/mcL, interrupt lenalidomide treatment.
When neutrophils return to greater than or equal to 500/mcL, resume lenalidomide at 5 mg daily.

2B) If neutropenia develops AFTER 4 weeks of starting treatment at 10 mg daily
When neutrophils fall to less than 500/mcL for 7 or more days or less than 500/mcL associated with fever greater than or equal to 38.5 degrees Celsius, then interrupt lenalidomide treatment.
When neutrophils return to greater than or equal to 500/mcL, then resume lenalidomide at 5 mg daily.

Patients who experience neutropenia at 5 mg daily should have their dosage adjusted as follows:
2C) If neutropenia develops during treatment at 5 mg daily
When neutrophils fall to less than 500/mcL for 7 or more days or less than 500/mcL associated with fever greater than or equal to 38.5 degrees Celsius, then interrupt lenalidomide treatment.
When neutrophils return to greater than or equal to 500/mcL, then resume lenalidomide at 2.5 mg daily.

MULTIPLE MYELOMA:
When platelets fall to less than 30,000/mcL, interrupt lenalidomide treatment and follow the CBC count weekly.
When platelets return to greater than or equal to 30,000/mcL, resume lenalidomide at 15 mg daily.
For each subsequent drop below 30,000/mcL interrupt lenalidomide treatment.
For each subsequent time the platelets return to greater than or equal to 30,000/mcL, resume lenalidomide at 5 mg daily less than previous dose. Do not dose below 5 mg daily.

When neutrophils fall to less than 1000/mcL, interrupt lenalidomide treatment. Add G-CSF and follow the CBC count weekly.
When neutrophils return to greater than or equal to 1000/mcL and neutropenia is the only toxicity, resume lenalidomide at 25 mg daily.
For each subsequent return to greater than or equal to 1000/mcL and if other toxicity is present, resume lenalidomide at 15 mg daily.
For each subsequent time the neutrophils drop below 1000/mcL, interrupt lenalidomide treatment.
For each subsequent return to greater than or equal to 1000/mcL, resume lenalidomide at 5 mg daily less than previous dose. Do not dose below 5 mg daily.

MANTLE CELL LYMPHOMA:
Thrombocytopenia:
-When platelets fall below 50,000/mcL: Interrupt treatment and follow CBC weekly.
-When platelets return to 50,000/mcL or greater: Resume treatment at 5 mg less than the previous dose. Do not dose below 5 mg daily.

Neutropenia
-When neutrophils fall to below 1000/mcL for at least 7 days OR fall to below 1000/mcL with an associated temperature of 38.5 degrees Celsius or greater OR fall to below to below 500/mcL: Interrupt treatment and follow CBC weekly.
-When neutrophils return to 1000/mcL or greater: Resume treatment at 5 mg less than previous dose. Do not dose below 5 mg daily.

Other Grade 3 or 4 toxicities: Hold treatment and consider restarting at next lower dose level when toxicity has resolved to Grade 2 or less.

Precautions

US REMS: The US FDA requires a Risk Evaluation and Mitigation Strategy (REMS) for lenalidomide. It includes elements to assure safe use and an implementation system. For additional information: www.fda.gov/REMS.

US BOXED WARNING:
EMBRYO-FETAL TOXICITY:
-Do not use this drug during pregnancy as it may cause birth defects or embryo-fetal death.
-This drug is an analogue of thalidomide, a know human teratogen that causes life-threatening human birth defects.
-This drug has caused limb abnormalities in animal studies.
-Females of reproductive potential must have 2 negative pregnancy tests before treatment initiation and must use 2 forms of contraception or continuously abstain from heterosexual sex during and for 4 weeks after treatment discontinuation.

HEMATOLOGIC TOXICITY:
-This drug can cause significant neutropenia and thrombocytopenia.
-Grade 3 or 4 hematologic toxicity was seen in 80% of study patients.
-Patients on therapy for del 5q myelodysplastic syndromes should have their CBCs monitored weekly for the first 8 weeks of treatment and at least monthly thereafter.
-Patients may require dose interruption and/or reduction, and use of blood product support and/or growth factors.

VENOUS and ARTERIAL THROMBOEMBOLISM:
-This drug has demonstrated a significantly increased risk of deep vein thrombosis and pulmonary embolism, as well as risk of myocardial infarction and stroke in patients with multiple myeloma who were treated with this drug and dexamethasone.
-Advise patients to seek immediate medical care if they develop symptoms such as shortness of breath, chest pain, or arm/leg swelling.
-Thromboprophylaxis is recommended.

Consult WARNINGS section for dosing related precautions.

Dialysis

Initial starting dose:

End stage renal disease (CrCl less than 30 mL/min) requiring hemodialysis:
MM or MCL: 5 mg once daily. On hemodialysis days the dose should be administered following dialysis.
MDS: 2.5 mg once daily. On hemodialysis days the dose should be administered following dialysis.

Hemodialysis patients with a creatinine clearances less than 7 mL/min have not been studied.
Peritoneal dialysis: No data available

Other Comments

The capsules should not be broken, chewed, or opened.

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