What Is Thalidomide (Thalomid)?
Thalidomide is the generic form of the brand-name drug Thalomid, prescribed along with a corticosteroid (dexamethasone) to treat multiple myeloma - a malignancy in plasma cells - when a person is newly diagnosed with the disease.
Doctors also prescribe thalidomide to treat and prevent acute skin symptoms of moderate to severe erythema nodosum leprosum (ENL), an inflammatory complication of leprosy (Hansen's disease).
Thalidomide is in a class of drugs called immunomodulatory agents. They affect the immune system in several ways to reduce inflammation. The drug is also an angiogenesis inhibitor that can stop the growth of new blood vessels in tumors.
It's not clear how thalidomide works to fight cancer, but it may be through its immunomodulatory effects and angiogenesis inhibition, or by reducing the production and activity of substances in the body that promote growth and survival of some cancer cells.
Thalidomide may treat ENL through its anti-inflammatory effects.
Thalidomide is also sometimes prescribed off-label to treat a wide range of other conditions. These conditions include:
- Aphthous stomatitis, recurrent canker sores, especially in people with HIV/AIDS
- Behcet's disease, inflammation of the blood vessels that causes symptoms throughout your body
- Chronic graft-versus-host disease, a persistent condition that follows stem cell or organ transplantation
- Systemic lupus erythematosus (SLE), a condition in which your immune system is overactive, causing inflammation
- Crohn's disease or inflammation of your digestive tract, especially your bowels
- Sarcoidosis, inflammation that may involve several of your organs
- Kaposi sarcoma, a malignancy, common in AIDS, in which tumors develop on the skin and other organs
The Food and Drug Administration (FDA) approved Thalomid in 1998. Celgene Corporation manufactures the drug.
In 2014, Celgene was the target of multiple, separate lawsuits. The Mylan pharmaceutical company filed an antitrust lawsuit against Celgene for its attempts to block the sale of generic versions of its Thalomid and Revlimid drugs. A former Celgene sales representative also filed a lawsuit against the company for marketing (off-label) uses of Thalomid and Revlimid that aren't approved by the FDA.
Thalidomide and Birth Defects
The German pharmaceutical company Chemie Grünenthal (now Grünenthal GmbH) developed thalidomide In the 1950s and marketed it as a mild sleeping pill safe for pregnant women.
It was also highly effective against nausea, such as morning sickness, during pregnancy. It quickly became widely used in Europe.
By the early 1960s, it was discovered that thalidomide causes a wide range of severe birth defects, including cleft lip or palate and abnormalities of other body parts, such as the arms and legs, ears, heart, kidney, genitals, and digestive organs.
Thalidomide caused more than 10,000 cases of birth defects in 46 countries.
Pregnancy and Thalidomide
Today, thalidomide is considered a Pregnancy Category X drug, meaning that it should never be used during pregnancy because it can cause severe and life-threatening birth defects.
The package insert that comes with your thalidomide prescription has a black-box warning - the strongest warning possible - that it can cause birth defects. Do not take the drug if you are pregnant or plan to become pregnant while taking it.
It's not known if thalidomide is secreted in breast milk. Talk to your doctor before taking the drug if you are breastfeeding.
Because of its danger to the developing baby, thalidomide is tightly regulated through a restrictive distribution program called Thalomid REMS. This program requires that a doctor prescribing the drug must enroll in the Thalomid REMS and be certified with Celgene.
You must avoid pregnancy - by remaining abstinent or taking two forms of reliable birth control -while taking thalidomide and during dose interruptions, as well as at least four weeks before and after using the drug.
Because thalidomide is present in semen, men must always use condoms during heterosexual sex while taking the drug and up to 28 days after taking it, even if the man has had a vasectomy. He also shouldn't donate sperm.
Regardless of your gender, do not donate blood while taking thalidomide.
Thalidomide carries a black-box warning regarding an increased risk of thromboembolism (a blood clot that blocks a vein in an arm, leg, or lungs). This risk is significantly higher when the drug is used in combination with dexamethasone and other chemotherapy medications.
Seek immediate medical care if you have any symptoms of a blood clot, such as:
- Sudden shortness of breath
- Chest pain
- Coughing up blood
- Swelling, pain, or warmth in the arms or legs
You shouldn't take thalidomide if you are hypersensitive to the drug. Symptoms of hypersensitivity include the following:
- Skin rash
- Low blood pressure (hypotension)
- Rapid heart rate
Don't take drive or operate heavy machinery while taking thalidomide, as it frequently causes drowsiness.
Be aware that thalidomide is associated with numerous, potentially serious health effects, including:
- Increase in the amount of human immunodeficiency virus (HIV) in your body (i.e., your viral load), if you have HIV infection
- Stevens-Johnson syndrome, a rare immune disorder that causes a variety of symptoms throughout the body
- Toxic epidermal necrolysis, a potentially fatal skin disease
- Abnormally slow heartbeat (bradycardia)
- Increased susceptibility to infection because of a decrease in the number of white blood cells
- Damage to the nerves of your hands or feet or both that causes pain (peripheral neuropathy)
- Dizziness and low blood pressure when you stand up too quickly from a sitting or lying position
- Increased side effects of some hormonal contraceptives
Thalidomide Side Effects
Common Side Effects of Thalidomide
If you have multiple myeloma and are also taking dexamethasone, the most common side effects of the combination are:
- Calcium deficiency
- Swelling from excess fluid buildup
- Constipation, anorexia, and nausea
- Nerve damage (neuropathy)
- Labored breathing
- Muscle weakness
- Low white blood cell counts
- Skin rash
- Dry and scaly skin
- Confusion, anxiety, and agitation
- Weight gain or loss
- Obstruction of a blood vessel by a blood clot
If you are taking thalidomide to treat ENL, the most common side effects are:
- Skin rash
- Severe itching
Contact your doctor if any of your side effects are severe.
You should always tell your doctor about any prescription, non-prescription, illegal, and recreational drugs; herbal remedies; and nutritional and dietary supplements you're taking, especially the following types:
Drugs that suppress the central nervous system, such as:
Drugs that cause bradycardia, such as:
Drugs that cause nerve damage in hands or legs or both (peripheral neuropathy), such as:
Drugs that interfere with hormonal contraceptives, such as
Drugs that may increase the risk of thromboembolism:
Thalidomide and Alcohol
Drinking alcohol while taking thalidomide may increase the drug's sedating effects.
Thalidomide comes in capsules of 50 milligrams (mg), 100 mg, 150 mg, and 200 mg, which should be taken with water before bed and at least an hour after an evening meal.
The dosage for people with multiple myeloma is 200 mg a day. People with moderate ENL usually take 100 to 300 mg a day, while people with severe ENL can take up to 400 mg a day.
Contact a poison control center or emergency room if you suspect you've taken too much thalidomide. You can get in touch with a poison control center at (800) 222-1222.
Call all 911 if someone has collapsed or is unconscious from a thalidomide overdose.
Missed Dose of Thalidomide
Take your missed dose of thalidomide as soon as possible unless it's less than 12 hours until your next dose.
If it's near the time of your next dose (less than 12 hours), skip the missed dose and continue on your regular dosing schedule. Don't double up on doses to make up for a missed one.
Video: Children of Thalidomide
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