LENALIDOMIDE- lenalidomide capsule 
Apotex Corp.



Lenalidomide Capsules

(len” a lid’ oh mide)

What is the most important information I should know about lenalidomide capsules?

Before you begin taking lenalidomide capsules, you must read and agree to all of the instructions in the Lenalidomide REMS program. Before prescribing lenalidomide capsules, your healthcare provider will explain the Lenalidomide REMS program to you and have you sign the Patient-Physician Agreement Form.

Lenalidomide capsules may cause serious side effects including:

Lenalidomide is similar to the medicine thalidomide. We know thalidomide can cause severe life-threatening birth defects. Lenalidomide capsules have not been tested in pregnant females. Lenalidomide has harmed unborn animals in animal testing. 

Females must not get pregnant:

Females who can become pregnant:

If you become pregnant while taking lenalidomide capsules, stop taking it right away and call your healthcare provider. If your healthcare provider is not available, you can call the REMS Call Center at 1-888-423-5436. Healthcare providers and patients should report all cases of pregnancy to:

ο FDA MedWatch at 1-800-FDA-1088, and

ο Lenalidomide REMS 1-888-423-5436

There is a pregnancy exposure registry that monitors the outcomes of females who take lenalidomide capsules during pregnancy, or if their male partner takes lenalidomide capsules and they are exposed during pregnancy. You can enroll in this registry by calling the Lenalidomide REMS at the phone number listed above.

Lenalidomide can pass into human semen:

Men, if your female partner becomes pregnant, you should call your healthcare provider right away.

Before taking lenalidomide capsules, tell your healthcare provider:

What are lenalidomide capsules?

Lenalidomide capsules are a prescription medicine, used to treat adults with:

Lenalidomide capsules should not be used to treat people who have chronic lymphocytic leukemia (CLL) unless they are participants in a controlled clinical trial.

It is not known if lenalidomide capsules are safe and effective in children.

Who should not take lenalidomide capsules? 

Do not take lenalidomide capsules if you:

What should I tell my healthcare provider before taking lenalidomide capsules?

Before you take lenalidomide capsules, tell your healthcare provider about all of your medical conditions, including if you:

Tell your healthcare provider about all the medicines you take, including prescription and over-the counter medicines, vitamins, and herbal supplements. Lenalidomide capsules and other medicines may affect each other, causing serious side effects. Talk with your healthcare provider before taking any new medicines. Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist.

How should I take lenalidomide capsules?

What should I avoid while taking lenalidomide capsules?

What are the possible side effects of lenalidomide capsules?

Lenalidomide capsules can cause serious side effects, including:

Get emergency medical help right away if you develop any of the following signs or symptoms during treatment with lenalidomide capsules:

Your healthcare provider may tell you to decrease your dose, temporarily stop or permanently stop taking lenalidomide capsules if you develop certain serious side effects during treatment with lenalidomide capsules.

These are not all the possible side effects of lenalidomide capsules. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

How should I store lenalidomide capsules?

Keep lenalidomide capsules and all medicines out of the reach of children  

General information about the safe and effective use of lenalidomide capsules. 

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not take lenalidomide capsules for conditions for which it was not prescribed. Do not give lenalidomide capsules to other people, even if they have the same symptoms you have. It may harm them and may cause birth defects. If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about lenalidomide capsules that is written for health professionals.

What are the ingredients in lenalidomide capsules?

Active ingredient: lenalidomide

Inactive ingredients: anhydrous lactose, croscarmellose sodium, magnesium stearate and microcrystalline cellulose.

The 5 mg and 25 mg capsule shell contains gelatin, titanium dioxide and black ink.

The 2.5 mg, 10 mg and 20 mg capsule shell contains FD&C blue #2, gelatin, iron oxide yellow, titanium dioxide and black ink.

The 15 mg capsule shell contains FD&C blue #2, gelatin, titanium dioxide and black ink.

The capsule imprinting black ink contains ammonium hydroxide 28%, iron oxide black, propylene glycol and shellac.  

For more information, call Apotex Corp. at 1-800-706-5575 or go to www.apotex.com.

This Medication Guide has been approved by the U.S. Food and Drug Administration.



2.5 mg, 5 mg, 10 mg, 15 mg 20 mg and 25 mg 

Manufactured byManufactured for
Apotex Inc. Apotex Corp.
Toronto, Ontario Weston, Florida,
Canada M9L1T9 USA 33326

Revised: December 2022

Revision: 16

Revised: 4/2023
Apotex Corp.