Generic Name: Lenalidomide Brand Name(s): Generics only. No brands available.

Uses

What is Lenalidomide used for?

Lenalidomide is used to treat certain cancers (multiple myeloma, mantle cell lymphoma-MCL). It works by slowing or stopping the growth of cancer cells. It is also used to treat anemia in patients with certain blood/bone marrow disorders (myelodysplastic syndromes-MDS). Lenalidomide may lessen the need for blood transfusions.

Lenalidomide is not recommended for the treatment of a certain type of cancer (chronic lymphocytic leukemia) because of the increased risk of serious heart-related side effects and death. If you have this type of cancer, talk to your doctor about the risks of using this medication.

How should I take Lenalidomide?

Take this medication by mouth with or without food as directed by your doctor, usually once daily. Swallow this medication whole with water. For treatment of certain conditions (multiple myeloma, MCL), you may be instructed to take this medication in cycles (once daily for 21 days, then stopping the medication for 7 days). The dosage is based on your medical condition, response to treatment, and laboratory test results. Be sure to follow your doctor’s directions carefully.

Do not open, chew, or break the capsules, or handle them any more than needed. If any of the powder from the capsule gets on your skin, wash the area with soap and water.

Since this drug can be absorbed through the skin and lungs and may harm an unborn baby, women who are pregnant or who may become pregnant should not handle this medication or breathe the dust from broken capsules. All people should wash their hands thoroughly after handling this drug.

Use this medication regularly to get the most benefit from it. Remember to take it at the same time each day.

Do not increase your dose or use this drug more often or for longer than prescribed. Your condition will not improve any faster, and your risk of side effects will increase.

How do I store Lenalidomide?

Lenalidomide is best stored at room temperature away from direct light and moisture. To prevent drug damage, you should not store Lenalidomide in the bathroom or the freezer. There may be different brands of Lenalidomide that may have different storage needs. It is important to always check the product package for instructions on storage, or ask your pharmacist. For safety, you should keep all medicines away from children and pets.

You should not flush Lenalidomide down the toilet or pour them into a drain unless instructed to do so. It is important to properly discard this product when it is expired or no longer needed. Consult your pharmacist for more details about how to safely discard your product.

Precautions & warnings

What should I know before using Lenalidomide?

Before taking lenalidomide, tell your doctor or pharmacist if you are allergic to it; or to thalidomide; or if you have any other allergies. This product may contain inactive ingredients (such as lactose), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease, liver disease (such as hepatitis B), thyroid disease, chicken pox and shingles (herpes zoster infection).

This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.

Lenalidomide can make you more likely to get infections or may worsen any current infections. Avoid contact with people who have infections that may spread to others (such as chickenpox, measles, flu). Consult your doctor if you have been exposed to an infection or for more details.

Do not have immunizations/vaccinations without the consent of your doctor. Avoid contact with people who have recently received live vaccines (such as flu vaccine inhaled through the nose).

To lower the chance of getting cut, bruised, or injured, use caution with sharp objects like razors and nail cutters, and avoid activities such as contact sports.

Do not donate blood or sperm while using lenalidomide and for 4 weeks after stopping this drug.

Older adults may be more sensitive to the side effects of this drug.

Since this drug can be absorbed through the skin and lungs and may harm an unborn baby, women who are pregnant or who may become pregnant should not handle this medication or breathe the dust from broken capsules.

Lenalidomide must not be used during pregnancy. It may harm an unborn baby. If you become pregnant or think you may be pregnant, stop taking lenalidomide and tell your doctor right away. If you are male and have had unprotected sex with a woman who is or can become pregnant, or if you think your sexual partner may be pregnant, tell both of your doctors right away.

It is unknown if lenalidomide passes into breast milk. Because of the possible risk to the infant, breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.

Is it safe during pregnancy or breast-feeding?

There are no adequate studies in women for determining risk when using this Lenalidomide during pregnancy or while breastfeeding. Please always consult with your doctor to weigh the potential benefits and risks before taking Lenalidomide. Lenalidomide is pregnancy risk category N according to the US Food and Drug Administration (FDA).

FDA pregnancy risk category reference below:

  • A=No risk,
  • B=No risk in some studies,
  • C=There may be some risk,
  • D=Positive evidence of risk,
  • X=Contraindicated,
  • N=Unknown

Side effects

What side effects can occur from Lenalidomide?

Diarrhea, stomach/abdominal pain, nausea/vomiting, loss of appetite, constipation, dizziness, dry skin, dry mouth, or trouble sleeping may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

People using this medication may have serious side effects. However, your doctor has prescribed this drug because he or she has judged that the benefit to you is greater than the risk ofside effects. Careful monitoring by your doctor may decrease your risk.

Tell your doctor right away if you have any serious side effects, including: mental/mood changes (such as depression), increased thirst/urination, shaking (tremor), numbness/tingling of arms/legs, fast/slow/irregular heartbeat, unusual tiredness, swelling ankles/feet.

People with multiple myeloma who are treated with this medication may rarely get other cancers (such as acute leukemia, lymphoma). Consult your doctor for more details.

Lenalidomide sometimes causes side effects due to the rapid destruction of cancer cells (tumor lysis syndrome). To lower your risk, your doctor may add a medication and tell you to drink plenty of fluids. Tell your doctor right away if you have symptoms such as: low back/side pain (flank pain), signs of kidney problems (such as painful urination, pink/bloody urine, change in the amount of urine), muscle spasms/weakness.

People taking lenalidomide for MCL sometimes have worsening of their MCL symptoms (tumor flare reaction). If you have tender/swollen lymph nodes, fever, pain, or rash, contact your doctor right away.

Lenalidomide may rarely cause serious (possibly fatal) liver disease. Get medical help right away if you have any symptoms of liver damage, such as: nausea/vomiting that doesn’t stop, loss of appetite, severe stomach/abdominal pain, yellowing eyes/skin, dark urine.

Lenalidomide can commonly cause a rash that is usually not serious. However, you may not be able to tell it apart from a rare rash that could be a sign of a severe reaction. Get medical help right away if you develop any rash.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

Not everyone experiences these side effects. There may be some side effects not listed above. If you have any concerns about a side-effect, please consult your doctor or pharmacist.

Interactions

What drugs may interact with Lenalidomide?

Lenalidomide may interact with other drugs that you are currently taking, which can change how your drug works or increase your risk for serious side effects. To avoid any potential drug interactions, you should keep a list of all the drugs you are using (including prescription drugs, nonprescription drugs and herbal products) and share it with your doctor and pharmacist. For your safety, do not start, stop, or change the dosage of any drugs without your doctor’s approval.

Does food or alcohol interact with Lenalidomide?

Lenalidomide may interact with food or alcohol by altering the way the drug works or increase the risk for serious side effects. Please discuss with your doctor or pharmacist any potential food or alcohol interactions before using this drug.

What health conditions may interact with Lenalidomide?

Lenalidomide may interact with your health condition. This interaction may worsen your health condition or alter the way the drug works. It is important to always let your doctor and pharmacist know all the health conditions you currently have.

Dosage

The information provided is not a substitute for any medical advice. You should ALWAYS consult with your doctor or pharmacist before using this Lenalidomide.

What is the dose of Lenalidomide for an adult?

Usual Adult Dose for Myelodysplastic Disease

10 mg orally once a day

Duration of Therapy: Treatment is continued or modified based upon clinical and laboratory findings.

Use: 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

-In combination with dexamethasone: 25 mg orally once a day on Days 1 to 21 of repeated 28-day cycles

-Maintenance therapy following autologous hematopoietic stem cell transplantation (auto-HSCT): 10 mg once a day continuously (Days 1 to 28 of repeated 28-day cycles) for 3 cycles, then increase to 15 mg once a day if tolerated.

-Duration of Therapy (both indications): Until disease progression or unacceptable toxicity.

Comments:

-Following auto-HSCT, initiate maintenance therapy after adequate hematologic recovery (ANC 1000/mcL or more AND/OR platelet count 75,000/mcL or more).

-For patients who are eligible for auto-HSCT, hematopoietic stem cell mobilization should occur within 4 cycles of a treatment regimen containing this drug.

-Consult the manufacturer product information for dexamethasone dosing recommendations.

Uses:

-In combination with dexamethasone, treatment of patients with multiple myeloma (MM).

-Maintenance therapy in patients with MM following auto-HSCT.

Usual Adult Dose for Lymphoma

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

Duration of Therapy: Until disease progression or unacceptable toxicity; treatment is continued, modified, or discontinued based upon clinical and laboratory findings.

Use: Treatment of patients with mantle cell lymphoma (MCL) whose disease has relapsed or progressed after 2 prior therapies, one of which included bortezomib.

Renal Dose Adjustments

MULTIPLE MYELOMA (MM) and MANTLE CELL LYMPHOMA (MCL):

-CrCl greater than 60 mL/min: No adjustment recommended.

-CrCl 30 to 60 mL/min: 10 mg once a day; consider escalating the dose to 15 mg after 2 cycles if the patient tolerates the 10 mg dose without dose-limiting toxicity.

-CrCl less than 30 mL/min (Non-Dialysis): 15 mg every other day.

MYELODYSPLASTIC SYNDROMES (MDS):

-CrCl greater than 60 mL/min: No adjustment recommended.

-CrCl 30 to 60 mL/min: 5 mg once a day.

-CrCl less than 30 mL/min (Non-Dialysis): 2.5 mg once a day.

MAINTENANCE THERAPY FOLLOWING AUTO-HSCT (MM, MDS, MCL): Base subsequent dose adjustment(s) on individual patient treatment tolerance.

Liver Dose Adjustments

-IMPAIRED HEPATIC FUNCTION: There are no dose adjustments provided in the manufacturer product information; however, it has been observed that mild hepatic impairment does not influence drug clearance. Data not available for moderate to severe hepatic impairment.

-IF ABNORMAL LIVER FUNCTION TEST RESULTS/ELEVATED LIVER ENZYMES ARE REPORTED: Interrupt treatment; consider resuming treatment at a lower dose once parameters have returned to baseline.

Dose Adjustments

GRADE 3/4 NEUTROPENIA AND/OR THROMBOCYTOPENIA:

MULTIPLE MYELOMA (MM):

Neutropenia:

When Neutrophils:

-Fall to Less than 1000/mcL: Interrupt treatment and follow CBC weekly.

-Return to 1000/mcL or more AND Neutropenia is Only Toxicity: Resume treatment at 25 mg/day or initial starting dose.

-Return to 1000/mcL or more AND If Other Toxicity: Resume treatment at next lower dose; do not dose below 2.5 mg/day.

-Each Subsequent Drop Below 1000/mcL: Interrupt treatment.

-Each Subsequent Return to 1000/mcL or More: Resume treatment at next lower dose; do not dose below 2.5 mg/day.

Thrombocytopenia:

When Platelets:

-Fall to Less than 30,000/mcL: Interrupt treatment and follow CBC weekly.

-Return to 30,000/mcL or More: Resume treatment at next lower dose; do not dose below 2.5 mg/day.

-Each Subsequent Drop Below 30,000/mcL: Interrupt treatment.

-Each Subsequent Return to 30,000/mcL or More: Resume treatment at next lower dose; do not dose below 2.5 mg/day.

MAINTENANCE THERAPY FOLLOWING AUTO-HSCT:

Neutropenia:

When Neutrophils:

-Fall to Less than 500/mcL: Interrupt treatment and follow CBC weekly.

-Return to 500/mcL or More: Resume treatment at next lower dose continuously for Days 1 to 28 of repeated 28-day cycle.

If at 5 mg/day Dose:

-Subsequent Drop Below 500/mcL: Interrupt treatment; do not dose below 5 mg/day for Days 1 to 21 of 28-day cycle.

-Subsequent Return to Greater than 500/mcL: Resume treatment at 5 mg/day for Days 1 to 21 of 28-day cycle; do not dose below 5 mg/day.

Thrombocytopenia:

When Platelets:

-Fall to Less than 30,000/mcL: Interrupt treatment and follow CBC weekly.

-Return to 30,000/mcL or More: Resume treatment at next lower dose continuously for Days 1 to 28 of repeated 28-day cycle.

If at 5 mg/day Dose:

-Subsequent Drop Below 30,000/mcL: Interrupt treatment; do not dose below 5 mg/day for Days 1 to 21 of 28-day cycle.

-Subsequent Return to 30,000/mcL or More: Resume treatment at 5 mg/day for Days 1 to 21 of 28-day cycle; do not dose below 5 mg/day.

MYELODYSPLASTIC SYNDROMES (MDS):

WITHIN THE FIRST 4 WEEKS OF TREATMENT AT 10 MG DAILY:

Neutropenia:

Baseline ANC 1000/mcL or More:

When Neutrophils:

-Fall to Less than 750/mcL: Interrupt treatment.

-Return to 1000/mcL or More: Resume treatment at 5 mg/day.

Baseline ANC Less than 1000/mcL:

When Neutrophils:

-Fall to Less than 500/mcL: Interrupt treatment.

-Return to 500/mcL or More: Resume treatment at 5 mg/day.

Thrombocytopenia:

Baseline Platelets 100,000/mcL or More:

When Platelets:

-Fall to Less than 50,000/mcL: Interrupt treatment.

-Return to 50,000/mcL or More: Resume treatment at 5 mg/day.

Baseline Platelets Less than 100,000/mcL:

When Platelets:

-Fall to 50% of the Baseline Value: Interrupt treatment.

Baseline Platelets 60,000/mcL or More:

When Platelets:

-Return to 50,000/mcL or More: Resume treatment at 5 mg/day.

Baseline Platelets Less than 60,000/mcL:

When Platelets:

-Return to 30,000/mcL or More: Resume treatment at 5 mg/day.

AFTER 4 WEEKS OF STARTING TREATMENT AT 10 MG DAILY:

Neutropenia:

When Neutrophils:

-Fall to Less than 500/mcL for 7 Days or more OR Less than 500/mcL Associated with Fever (38.5 degrees Celsius or higher): Interrupt treatment.

-Return to 500/mcL or More: Resume treatment at 5 mg/day.

Thrombocytopenia:

When Platelets:

-Fall to Less than 30,000/mcL OR Less than 50,000/mcL with Platelet Transfusions: Interrupt treatment.

-Return to 30,000/mcL or More (without hemostatic failure): Resume treatment at 5 mg/day.

DURING TREATMENT AT 5 MG DAILY:

Neutropenia:

When Neutrophils:

-Fall to Less than 500/mcL for 7 Days or more OR Less than 500/mcL Associated with Fever (38.5 degrees Celsius or higher): Interrupt treatment.

-Return to 500/mcL or More: Resume treatment at 2.5 mg/day.

Thrombocytopenia:

When Platelets:

-Fall to Less than 30,000/mcL OR Less than 50,000/mcL with Platelet Transfusions: Interrupt treatment.

-Return to 30,000/mcL or More (without hemostatic failure): Resume treatment at 2.5 mg/day.

MANTLE CELL LYMPHOMA (MCL):

Neutropenia:

When Neutrophils

-Fall to Less than 1000/mcL for at least 7 Days OR Fall to Less than 1000/mcL with Associated Temperature (38.5 degrees or more Celsius) OR Fall to Less than 500/mcL: Interrupt treatment and follow CBC weekly.

-Return to 1000/mcL or More: Resume treatment at 5 mg less than the previous dose; do not dose below 5 mg/day.

Thrombocytopenia:

When Platelets:

-Fall to Less than 50,000/mcL: Interrupt treatment and follow CBC weekly.

-Return to 50,000/mcL or More: Resume treatment at 5 mg less than the previous dose; do not dose below 5 mg/day.

ALLERGIC REACTION:

-Grade 2 to 3 Skin Rash Occurs: Consider treatment interruption or discontinuation.

-Angioedema, Grade 4 Rash, Exfoliative or Bullous Rash Occurs, or Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis is Suspected: Permanently discontinue use of this drug.

TUMOR FLARE REACTION (TFR):

-Grade 1 or 2 TFR: Consider continuing use of this drug without interruption or modification.

-Grade 3 or 4 TFR: Withhold treatment until TFR resolves to Grade 1 or less.

-Comments: After careful clinical assessment of the individual patient, consider managing TFR symptoms with corticosteroids, non-steroidal anti-inflammatory drugs, and/or narcotic analgesics.

OTHER GRADE 3/4 TOXICITY IN MM, MDS, and MCL: Hold treatment and consider restarting at next lower dose level when toxicity has resolved to Grade 2 or less.

Dialysis

Dialysis Patients with CrCl less than 30 mL/min: 5 mg (MM and MCL) OR 2.5 mg (MDS) once a day.

Comments: On dialysis days, administer the dose following dialysis.

Other Comments

Administration Advice:

-Administer this drug at about the same time on the scheduled days, preferably with water and either with or without food.

-Instruct patients to swallow capsules whole; capsules should not be opened, broken, or chewed.

-Consult the manufacturer product information for instructions on administering this drug to patients with swallowing difficulties.

-Advise patients that in the event of a missed dose, the dose can be taken if less than 12 hours have elapsed since missing the dose; if more than 12 hours have elapsed, that dose should be skipped and the next dose should be taken at the normal time on the following day.

-If the powder from drug capsules makes contact with skin or mucous membranes, direct patients to wash affected skin immediately and thoroughly with soap and water and to flush affected membranes with water.

Storage Requirements:

-Store below 25 degrees Celsius.

-Keep drug in the original package.

Monitoring:

CARDIOVASCULAR: Signs/symptoms of thromboembolism

EMBRYOFETAL TOXICITY: Pregnancy (in females of reproductive potential)

ENDOCRINE: ENDOCRINE: Thyroid function

HEMATOLOGICAL: Signs/symptoms of neutropenia and thrombocytopenia:

-MM: CBC (weekly for the first 2 cycles, on Days 1 and 15 of cycle 3, and every 28 days thereafter)

-MDS: CBC (weekly for the first 8 weeks and at least monthly thereafter)

-MCL: CBC (weekly for the first 28-day cycle, every 2 weeks during Cycles 2 to 4, and monthly thereafter)

HEPATIC: Liver enzymes

OCULAR: Visual ability

ONCOLOGIC: Second primary malignancies

Patient Advice:

-Avoid potentially dangerous activities such as driving and operating machinery until you know how this drug affects you.

-Consult your healthcare provider on recommended methods of birth control to use while taking this drug.

-When removing a drug capsule from a blister pack, press only on one end of the capsule to reduce the risk of breaking the capsule.

What is the dose of Lenalidomide for a child?

The dosage has not been established in pediatric patients. It may be unsafe for your child. It is always important to fully understand the safety of the drug before using. Please consult with your doctor or pharmacist for more information.

How is Lenalidomide available?

Lenalidomide is available in the following dosage forms and strengths:

  • Oral Capsule

What should I do in case of an emergency or overdose?

In case of an emergency or an overdose, call your local emergency services or go to your nearest emergency room.

What should I do if I miss a dose?

If you miss a dose of Lenalidomide, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and take your regular dose as scheduled. Do not take a double dose.

 

Hello Health Group does not provide medical advice, diagnosis or treatment.

Sources

Review Date: March 14, 2018 | Last Modified: March 14, 2018

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