【Drug Name】

Name: Lenalidomide Capsules

Product Name: LENADX

【Specification】

10mg/25mg

【Indications】

LENADX is a prescription medicine used to treat people:

• with multiple myeloma (MM) who have received at least one prior medicine, taken along with the medicine dexamethasone.

• who have a condition called myelodysplastic syndromes (MDS). LENADX is for the type of MDS with a chromosome problem where part of chromosome 5 is missing. This type of MDS is known as deletion 5q MDS. People with this type of MDS may have low red blood cell counts that require treatment with blood transfusions.

• with mantle cell lymphoma (MCL) when the disease does not respond to or comes back after treatment with two prior medicines, one of which included bortezomib. Mantle cell lymphoma is a cancer of a type of white blood cell called lymphocytes that are in the lymph nodes.

It is not known if LENADX is safe and effective in people under 18 years of age.

【Recommended Dosage】

Before prescribing LENADX, your healthcare provider will:

• Swallow LENADX capsules whole with water 1 time a day. Do not break, chew, or open your capsules.

• Take LENADX at about the same time each day.

• Do not open the LENADX capsules or handle them any more than needed. If you touch a broken LENADX capsule or the medicine in the capsule, wash the area of your body with soap and water.

•  If you miss a dose of LENADX, and it has been less than 12 hours since your regular time, take it as soon as you remember. If it has been more than 12 hours, just skip your missed dose. Do not take 2 doses at the same time.

• If you take too much LENADX or overdose, call your healthcare provider right away.

【Side Effects】

· Serious skin reactions. Serious skin reactions can happen with LENADX and may cause death. Call your healthcare provider right away if you have any skin reaction while taking LENADX.

· Tumor lysis syndrome (TLS). TLS is caused by the fast breakdown of cancer cells. TLS can cause kidney failure and the need for dialysis treatment, abnormal heart rhythm, seizure and sometimes death. Your healthcare provider may do blood tests to check you for TLS.

· Severe liver problems, including liver failure and death. Tell your healthcare provider right away if you develop any of the following symptoms of liver problems:

· yellowing of your skin or the white part of your eyes (jaundice)

· dark or brown (tea colored) urine

· pain on the upper right side of your stomach area (abdomen)

· bleeding or bruising more easily than normal

· feeling very tired

Your healthcare provider will do blood tests to check your liver function during your treatment with LENADX.

· Risk of new cancers (malignancies). People with multiple myeloma who receive melphalan (a type of chemotherapy) and a blood stem cell transplant with the addition of LENADX have a higher risk of developing new cancers, including certain blood cancers (acute myelogenous leukemia or AML) and a

type of lymphoma called Hodgkin lymphoma. Talk with your healthcare provider about your risk of developing new cancers if you take LENADX. Your healthcare provider will check you for new cancers during your treatment with LENADX.

Common side effects of LENADX include:

diarrhea

itching

rash

Tiredness

These are not all the possible side effects of LENADX.

【Storage】

• Store at or below 86°F (30°C).

Keep all medicines out of reach of children.