Thalidomide
Introduction
Using thalidomide to treat myeloma* is a relatively new idea, but thalidomide itself has been studied for many decades. Much has been learned about how thalidomide works in the treatment of different diseases and how its side effects can be treated. Additionally, we now understand how important it is to
prevent women who may be pregnant from being exposed to thalidomide.
Thalidomide is currently approved for the treatment of erythema nodosum leprosum, an inflammatory condition seen in some patients with leprosy. However, thalidomide is actively being investigated for the treatment of myeloma. Many patients with myeloma have benefited from this therapy. This booklet is intended to provide a basic understanding of thalidomide therapy:
- What thalidomide is and how it works to treat myeloma
- How to handle thalidomide safely
- What side effects might be expected while taking thalidomide
- How doctors can minimize side effects
- How thalidomide may be used with other therapies.
The information in this booklet may be useful not only to patients, but also to friends, family, loved ones, and other caregivers. Please remember that myeloma, like all cancers, is a complicated disease. Specific questions about
treatment should be addressed by a doctor or nurse.
WHAT IS THALIDOMIDE?
Thalidomide is a drug that was first used in the late 1950s in Europe for the treatment of morning sickness. It was later withdrawn from use when it was reported that the drug produced severe, life-threatening birth defects.
Today, the medical community has a better understanding of this drug and how it works. Thalidomide is classified as an immunomodulatory agent, which means it affects the levels of certain chemicals in the body that control the activity of cells. We know that thalidomide can produce many other effects that are helpful, such as slowing or stopping the growth of new blood vessels, called angiogenesis. Today, a program called the System for Thalidomide Education and Prescribing Safety (S.T.E.P.S.®) helps to ensure that every effort is made to use the drug safely.
IS THALIDOMIDE THE SAME AS CHEMOTHERAPY?
Chemotherapy works by killing cells that are dividing. These cells include cancer cells as well as some normal cells in the body. Hair loss, nausea and vomiting, and gastric upset are common side effects that occur, because some healthy cells are affected by chemotherapy. Thalidomide is not considered a form of chemotherapy. It is instead considered a new kind of treatment, because it can affect the levels of certain proteins that the body normally uses to control the activity of cells.
WHO CAN BENEFIT FROM THALIDOMIDE THERAPY?
Today, thalidomide is approved for the treatment of erythema nodosum leprosum. However, thalidomide has also been studied in a number of other diseases, including cancer.
Clinical trials have shown that thalidomide is active against myeloma and can produce lasting complete or partial responses, as well as disease stabilization. In these trials, thalidomide has been found to be effective in patients with different stages of myeloma, including:
- Patients with newly diagnosed myeloma
- Patients who have not responded to other treatments
- Patients in whom myeloma has returned after initial successful treatment
Additionally, thalidomide has been successful in treating myeloma either when given alone or when given in combination with the drug dexamethasone, a type of steroid. Selection of an appropriate treatment is made on a case-by-case basis. The ideal daily dose of thalidomide is under investigation. In some cases, low doses have been found to be effective alone and in combination.
Response to thalidomide therapy takes time. Generally, improvement in the disease is seen after about 3 months of treatment; however, improvements have been noted as early as 2 weeks and as late as 8 months. Once a response is achieved, the physician will determine if ongoing, or maintenance,
therapy is needed. It is important to note, however, that not everyone who takes thalidomide will have a response, and other therapies may be considered.
HOW DOES THALIDOMIDE WORK?
Although scientists are still trying to understand exactly how thalidomide fights cancer, thalidomide is known to work on 2 important levels. First, thalidomide is believed to boost the body’s immune response to cancer. Second, it helps block the blood supply of cancerous tumors. Cancer cells, like normal cells, need to get nutrients and oxygen from the blood to survive and multiply. Some tumors send chemicals into the body that can
trigger the formation of new blood vessels. As more blood vessels grow into the tumor, it can become larger. It is thought that one way thalidomide may help to limit tumor growth is by hindering new blood vessel growth within tumors.
Thalidomide is also believed to act in several other ways against myeloma, including targeting the myeloma cells and the molecules that allow them to grow. However, these exact effects are not clear and scientists are actively studying them.
WHAT ARE THE POSSIBLE SIDE EFFECTS OF THALIDOMIDE?
The most common side effects associated with thalidomide are:
- Drowsiness – feelings of sleepiness or fatigue
- Peripheral neuropathy – tingling or numbness in the arms, hands, legs, and/or feet
- Dizziness – sensation of unsteadiness
- Constipation – delayed or infrequent passage of hardened feces
- Rash – an eruption on the skin
- Leukopenia – a low level of white blood cells.
Other side effects have been reported, although infrequently. Any side effects a patient experiences while receiving treatment should be discussed with a doctor or nurse as soon as possible. In addition, any changes in overall health or well-being should be reported to a health-care professional. Prescription medications and over-the-counter products that are being taken should also be reported.
Drowsiness
Thalidomide often causes feelings of drowsiness. These methods may help relieve this side effect:
- Taking thalidomide at bedtime
- Avoiding use of other drugs that may cause drowsiness while taking thalidomide
- At the discretion of a doctor or nurse, taking other drugs to help alleviate drowsiness
- Avoiding alcohol.
Situations in which drowsiness may be a problem should be avoided. Mental and physical abilities needed to perform dangerous tasks, such as driving a car, may be impaired.
Peripheral neuropathy
Impairment of the nerves in the extremities (hands, arms, legs, feet) is known as peripheral neuropathy. This side effect can be mild, causing tingling in the hands and feet; more rarely, it can be severe and painful. It typically occurs after a long period of taking thalidomide, but it can sometimes occur sooner. These strategies may help alleviate symptoms of peripheral neuropathy:
- Walking and other forms of exercising
- Avoiding tight shoes and socks with elastic
- At the discretion of a doctor, reducing the dose of thalidomide
- At the discretion of a doctor or nurse, taking additional medications.
A physician should be notified if any symptoms of peripheral neuropathy occur. If side effects are severe, thalidomide therapy may need to be stopped altogether.
Dizziness
Dizziness may occur while taking thalidomide. Sitting up and waiting a few minutes before getting out of bed may help reduce dizziness.
Constipation
Constipation may occur during treatment with thalidomide; however, constipation is rarely severe. Prevention is the key to management. These strategies may help alleviate constipation:
- Drinking at least 8 glasses of fluid daily
- Adding plenty of dietary fiber every morning, such as prune juice, apple juice, and bran
- Exercising
- At the recommendation of a doctor or nurse, taking stool softeners and laxatives.
If constipation becomes severe, the dose of thalidomide may be lowered or temporarily discontinued.
Rash
In some cases, a rash may develop while taking thalidomide. A mild rash (red or discolored skin, with or without raised bumps) usually begins on the trunk and spreads to the arms and legs. Mild rashes may be relieved in the following ways:
- At the recommendation of a doctor or nurse, taking antihistamines and topicalcorticosteroids
- To alleviate dry skin, using Calendra lotion, cocoa butter cream, oatmeal soap, Eucerin® cream, and Acid Mantle® cream.
Rashes often resolve spontaneously after about 10 to 14 days of treatment. Some rashes are a potentially serious reaction to thalidomide treatment. Rare reactions include Stevens-Johnson syndrome and toxic epidermal necrolysis (TEN). Systems of Stevens-Johnson syndrome include persistent fever, rash, blisters, or red splotches on the skin and blisters in the mouth, eyes, ears, nose, and genital area. TEN is characterized by
blistering and peeling of large sections of skin.
A doctor should be contacted immediately if a fever and/or drop in blood pressure occur.
Leukopenia
Thalidomide can sometimes cause a decrease in white blood cells. This condition is called leukopenia. Because of this possibility, blood tests need to be done regularly. If the white blood cell count becomes too low, the dose of thalidomide may have to be changed or the treatment may need to be interrupted.
WHO SHOULD NOT TAKE THALIDOMIDE?
If thalidomide is taken during pregnancy, it can cause severe birth defects or death to an unborn baby. Thalidomide should never be used by women who are pregnant or who could become pregnant while taking the drug. Thalidomide may be detected in male sperm. Therefore, both men and women are required to follow strict rules for birth control while taking thalidomide.
Only physicians and pharmacists who are registered with the special program called S.T.E.P.S.® can prescribe or dispense thalidomide. Physicians and pharmacists may register with the S.T.E.P.S.® program by calling Celgene Corporation, the manufacturer of thalidomide, at 888-4-CELGENE (888-423-5436). Both men and women must agree to follow this program before receiving thalidomide. To minimize the risk of exposing an unborn child to thalidomide, the S.T.E.P.S.® program includes the following elements:
* Patients must provide informed consent, complete confidential enrollment, and complete follow-up surveys throughout treatment
* Women of childbearing age must have pregnancy tests every week during the first month of thalidomide therapy and monthly afterwards (every 2 weeks for women with irregular menstrual cycles)
* Women of childbearing age must receive contraceptive counseling and use 2 methods of birth control 4 weeks before, during, and at least 4 weeks after completing therapy
* Men who are sexually involved with women of childbearing age must use a latex condom during and at least 4 weeks after completing thalidomide therapy.
HOW IS THALIDOMIDE GIVEN?
Thalidomide is available as a capsule. The dose, or number of capsules to be taken every day, will be determined by whether thalidomide is being given alone or in combination with other drugs. How the drug is tolerated by the body will also determine the dose.
The dose may be gradually increased over time. A gradual increase ensures the most effective dose is given as safely as possible.
If side effects occur, a doctor or nurse should be notified immediately. The dose may need to be lowered, or even discontinued, if the side effects are severe. The dose should only be changed under the direction of a doctor.
CAN THALIDOMIDE BE TAKEN WITH OTHER CANCER TREATMENTS?
Yes, thalidomide can be taken alone or in combination with chemotherapy, radiation therapy, or biologic treatments. A doctor will advise on the appropriate treatment for each individual.
WILL INSURANCE COVER THE COST OF THALIDOMIDE?
Insurance coverage varies. Individual insurance companies can provide information regarding thalidomide coverage. Celgene Corporation also offers a therapy assistance program. For more information about this program, call 888-4-CELGENE (888-423-5436).
A FINAL NOTE
Thalidomide is an important treatment for a number of diseases. However, like any drug, it can cause harm if misused. It is important that all advice from health care professionals be followed while taking this drug. Any questions should be promptly addressed by a doctor or nurse.
Questions and concerns regarding thalidomide treatment may arise once treatment begins. Some of these concerns may be about thalidomide itself. Others may be about the outcome of treatment and its side effects. Still other concerns may be more emotional or financial in nature.
Many resources are available. Concerns should be shared with the treatment team so that assistance can be provided. Communication will help lead to the active management of side effects, minimize symptoms, and help alleviate fears and concerns during treatment. Involvement in personal
care will ultimately lead to confidence and a sense of control regarding treatment choices.
Published with kind permission by the International Myeloma Foundation: www.myeloma.org
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