REVLIMID is a daily oral capsule, not a traditional chemotherapy, that is only available through a special distribution program called REVLIMID REMS. If you experience any side effects while taking REVLIMID, tell your doctor right away.

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

• have liver problems
• have kidney problems or receive kidney dialysis treatment
• have thyroid problems
• have had a serious skin rash with thalidomide treatment. You should not take REVLIMID.
• are lactose intolerant. REVLIMID contains lactose.
• are breastfeeding. Do not breastfeed during treatment with REVLIMID. It is not known if REVLIMID passes into your breast milk and can harm your baby.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. REVLIMID 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.

• Take REVLIMID exactly as prescribed and follow all the instructions of the REVLIMID REMS program.
• Swallow REVLIMID capsules whole with water 1 time a day. Do not open, break, or chew your capsules
• REVLIMID may be taken with or without food
• Take REVLIMID at about the same time each day
• Do not open the REVLIMID capsules or handle them any more than needed.
  • If powder from the REVLIMID capsule comes in contact with your skin, wash the skin right away with soap and water
  • If powder from the REVLIMID capsule comes in contact with the inside of your eyes, nose, or mouth, flush well with water
• If you miss a dose of REVLIMID 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 REVLIMID, call your healthcare provider right away
• Do not share REVLIMID with other people. It may cause birth defects and other serious problems

If you miss a dose of REVLIMID 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, skip your missed dose. Do not take 2 doses at the same time. Please see accompanying full Prescribing Information, including Boxed WARNINGS and Medication Guide, and Important Safety Information.

• Store REVLIMID at room temperature between 68^○F to 77^○F (20^○C to 25^○C)
• Return any unused REVLIMID to Bristol Myers Squibb or your healthcare provider

Keep REVLIMID and all medicines out of reach of children.

Tell your healthcare team immediately about any side effects you are experiencing, and do not stop taking REVLIMID unless directed. Your doctor can adjust your dose to help reduce side effects. In the case of a severe side effect, your doctor may tell you to discontinue treatment.

A stem cell transplant (SCT) is effective in helping patients with multiple myeloma significantly reduce myeloma cells and restore the bone marrow’s ability to produce healthy blood cells. But after an SCT, 100 million myeloma cells can remain in your body, even with a complete response. Many doctors recommend maintenance therapy following an SCT because it plays an important part in extending the response from a transplant as long as possible.

If you have had an autologous hematopoietic stem cell transplant (auto-HSCT) you might want to ask your doctor about REVLIMID maintenance therapy. Maintenance therapy is a proven strategy to extend the response from an SCT. Maintenance therapy may control the growth of residual myeloma cells. An SCT is effective in helping multiple myeloma patients significantly reduce myeloma cells and restore the bone marrow’s ability to produce healthy blood cells. Many doctors recommend maintenance therapy following an SCT because it plays an important part in extending the response from a transplant as long as possible. So you can both make an informed decision, ask your doctor for more information about REVLIMID maintenance therapy.

In clinical trials, patients took REVLIMID maintenance therapy every day, until their disease progressed or they experienced intolerable side effects. In studies, low white blood cells (neutropenia) and low platelets (thrombocytopenia) were the most common adverse events that led to discontinuation of REVLIMID maintenance therapy in a small percentage (less than 3%) of patients.

The standard dosing for maintenance therapy with REVLIMID is one 10-mg pill, taken once every day by itself (without dexamethasone). If tolerated, your doctor may increase your dose to 15 mg of REVLIMID once daily.

Study 1 and Study 2 were both designed to evaluate the safety and effectiveness of REVLIMID as maintenance therapy after a stem cell transplant, but there were many differences in how the studies were conducted. Some differences between the studies include:

• Study location: Study 1 took place in the United States; Study 2 took place in France, Belgium, and Switzerland
• Different therapy regimens before transplant (also called induction therapy). Study 1 included the use of REVLIMID-based induction therapy in some patients; Study 2 did not
• Use of a short course of additional therapy after transplant (also called consolidation therapy). Study 1 did not use consolidation therapy; Study 2 used consolidation therapy

These are not all of the differences between the studies. Talk to your doctor to understand what the study results may mean for you.