Thalidomide

Thalidomide is an oral medication prescribed only by licensed medical doctors to treat and prevent a painful skin disease that is associated with Hansen’s disease or leprosy called erythema nodosum leprosum as well as patients who have multiple myeloma cancer of the blood in conjunction with other medications.

Overview

What is Thalidomide?

Thalidomide is an antineoplastic and leprostatic agent medication that works on the immune system to reduce inflammation. It has also been proven to interfere with the growth of multiple myeloma cells so that they can eventually be destroyed by the body’s natural processes. Thalidomide is also known as the brand name Thalomid.

How does it work?

Research is still exploring how Thalidomide works specifically, but it is a type of cancer blocker that affects cell processes such as division and growth. By interfering with the chemicals that cause the cancer cells to grow, these cells become vulnerable to disposal by the body as they weaken, thus stopping the spread of the cancer. Thalidomide is also effective in stopping the cancerous tumors from making their own blood vessels, which are required for growth.

In patients who are diagnosed with Hansen’s disease, once known as leprosy, and are experiencing skin lesions as a result of erythema nodosum leprosum, Thalidomide treats and prevents the spread of these skin lesions and gives the patient some relief from their symptoms. Thalidomide also reduces the swelling and redness of the inflamed lesions.

What is multiple myeloma?

Multiple myeloma is a cancer of the blood that is related to lymphoma and leukemia. Multiple myeloma has no cure but there are treatments such as Thalidomide that slow down the disease and prevent it from spreading.

Blood is made up of red cells and white cells, and these cells multiply, divide and grow to do their work in the body. In multiple myeloma, a white plasma cell multiplies in an unusual fashion; instead of making antibodies that fight infections, multiple myeloma causes the plasma cell to release too much protein into the bones and blood. This immunoglobulin builds up throughout the body and damages the organs because of the higher than normal levels. Additionally, these mutated plasma cells crowd the normal blood cells found in the bones, releasing chemicals that dissolve and weaken bones, creating areas called lytic lesions.

As the multiple myeloma gets worse, the plasma cells spill out of the bone marrow and spread through the body, causing more damage as it goes. There are no known causes of multiple myeloma, but treatment with Thalidomide, in combination with a chemotherapy drug, is proven to stop the spread of these diseased plasma cells, slowing down the disease so that it can be managed. Again, there is no known cure for multiple myeloma, but stem cell therapy could be effective in some patients.

What is Hansen’s disease or leprosy?

Hansen’s disease or leprosy is a bacterial infection that develops symptoms in the nerves, respiratory tract, skin and eyes. The patient may be unable to feel pain and lose parts of their extremities because they are repeatedly injured or infected because of wounds they do not feel. Leprosy is spread between people through body fluid contact but it is not considered highly contagious. Multidrug therapy is effective in curing leprosy and includes a treatment regimen ranging from six to 12 months with a course of medications and antibiotics.

Patients diagnosed with Hansen’s disease or leprosy often also contract a skin infection known as erythema nodosum leprosum. Erythema nodosum leprosum is characterized as a leprosy complication or symptom and is characterized by multiple inflamed skin nodules and symptoms such as malaise, arthritis, fever, lymphadenitis, iritis, and neuritis. Some patients have episodes lasting a few years and some suffer longer; as much as to 7 years. It is estimated that erythema nodosum leprosum affects thirty to forty percent of leprosy patients which causes pain and severe disability.

In patients with severe symptoms of erythema nodosum leprosum, Thalidomide in doses of 200 to 400 milligrams per day are typically prescribed. Thalidomide works top stop the progress of erythema nodosum leprosum and ease symptoms.

Conditions treated

  • Multiple myeloma
  • erythema nodosum leprosum

Type of medicine

  • Antineoplastic and leprostatic agent

Side Effects

Thalidomide has been known to cause these side effects, in addition to the required effects of the drug, in some patients. Not all patients will experience side effects such as those shown below:

  • Anxiety
  • Cough
  • Pain in chest
  • Lightheadedness or dizziness
  • Rapid heartbeat
  • Passing out or feeling faint
  • Weak muscles
  • Painful, red or swollen arms or legs
  • Shortness of breath, trouble with breathing
  • Numb, tingling, burning or painful feet, legs, arms or hands

Patients who feel that the side effects from Thalidomide are severe or of a prolonged duration are urged to contact their physician, who could possibly suggest ways to lessen or eliminate these side effects.

These side effects are rare and could be the sign of underlying health issues caused by Thalidomide that may be long term. Contact your doctor immediately if you experience any of the side effects below:

  • Blood in the urine
  • Decreased urination
  • Fever, alone or with chills and sore throat
  • Irregular heartbeat
  • Low blood pressure
  • Skin rash
  • Black, tarry stools
  • Bleeding gums
  • Blistering of the skin
  • Blood in the stools
  • Confusion
  • Convulsions
  • Difficulty with speaking
  • Double vision
  • Inability to move the arms, legs, or facial muscles
  • Inability to speak
  • Itching skin
  • Muscle jerking of the arms and legs
  • Peeling and loosening of the skin
  • Pinpoint red spots on the skin
  • Red skin lesions, often with a purple center
  • Red, irritated eyes
  • Slow speech
  • Sores, ulcers, or white spots in the mouth or on the lips
  • Sudden loss of consciousness
  • Unusual bleeding or bruising
  • Constipation
  • Diarrhea
  • Drowsiness
  • Nausea
  • Stomach pain
  • Dry skin
  • Dryness of the mouth
  • Headache
  • Increased appetite
  • Mood changes

Again, notify your health care professional if you experience extreme, prolonged side effects.

Dosage

The prescription of Thalidomide is very strictly regulated and it is likely that you will have to read and sign legal documents that you understand the risks involved and how the medication is used when you pick up your prescription from the doctor or pharmacy. Read all accompanying information and, if you have any questions, contact your doctor or pharmacist immediately.

This oral medication is to be taken with water, preferably at bedtime and at least one hour after eating. The capsules should remain packaged until you are ready to take it; if a capsule is broken and comes into contact with your skin, wash the area with soap and water immediately.

Your doctor has determined your dosage including the frequency and duration based on your particular health situation and set of symptoms, among other factors. Do not change the dosage size, frequency or duration from what your doctor has prescribed.

For erythema nodosum leprosum

Adults and children 12 years and older will first be prescribed a 100 to 300 milligram dose to be taken once per day. Dose adjustment will be done by your physician if required. Children younger than 12 years must have their dose determined by their doctor.

For multiple myeloma

Adults and children 12 years and older are, on average, prescribed with a dose of 200 milligrams to be taken once per day together with dexamethasone, for a duration of 28 days. Children who are younger than 12 years of age will have their dosage prescribed specifically for them by their health care provider.

If a dose of Thalidomide is missed, take it as soon as you remember unless it is close to the time for the next dose; in that case, skip the missing dose rather than double-dosing. Get back to your regular dosing schedule as soon as possible.

Interactions

Inform your health care provider if you have ever had an allergic reaction to Thalidomide or any other medications or if you are allergic to any foods, dyes, preservatives or animals.

There have been no appropriate studies on the effectiveness of Thalidomide on pediatric patients, nor has it been proven safe for this age group. Geriatric patients, to date, have not demonstrated specific age-related problems that would limit the effectiveness or safety of treatment with Thalidomide.

Prescription of Thalidomide for pregnant women is completely forbidden. Prescribing Thalidomide to women who are of child bearing age is done with extreme caution. Patients of child bearing age are urged to use two effective forms of birth control and undergo pregnancy testing on a regular basis. Birth control methods should be started at least four weeks before starting therapy with Thalidomide and continue at least four weeks after stopping. Consult your doctor about the most effective methods of birth control before starting treatment with Thalidomide.

Further, men who are sexually active must protect their female partners from getting pregnant, as Thalidomide will travel through the semen of male patients undergoing treatment. Barrier methods of birth control are mandatory, even for those men who have had vasectomy surgery, during treatment with Thalidomide and for 4 weeks after your last dose. If you partner may be pregnant, contact your health care provider immediately.

Studies on breastfeeding women to determine the effects of Thalidomide on infants have not been done. Breastfeeding women should discuss the risks and potential benefits of this drug while they are breastfeeding.

Use of Thalidomide with the following medications is not recommended:

  • Dexamethasone
  • Docetaxel
  • Oxycodone
  • Prednisone
  • Zometa

Your doctor will discuss the effects of using Thalidomide with certain types of food, alcohol or tobacco products, including any risks associated.

Patients who are diagnosed with the following medical conditions may find that Thalidomide is not as effective or that it causes worsening symptoms or health when used:

  • Blood clots
  • Bradycardia (slow heartbeat)
  • HIV infection
  • Neutropenia (low white blood cells)
  • Peripheral neuropathy (nerve problem)
  • Seizures
  • Thrombocytopenia (low platelets in the blood)
  • Deep vein thrombosis (blood clot in leg)
  • Heart attack, history of
  • Pulmonary embolism (blood clot in lung)
  • Stroke

It is of critical importance that your disclose your full medical history as well as details of any drugs you are currently taking or have taken in the recent past before you begin a course of treatment with Thalidomide or any other drug. Include all prescription as well as non-prescription medications you may be taking as well as the details of any herbal, holistic or vitamin supplements or treatments.

Warnings

Prescriptions of Thalidomide are under tightly controlled conditions only due to the history of the drug. Discovered in the 1950’s and initially prescribed for multiple uses, including a remedy for morning sickness, the drug eventually proved to cause severe birth defects. World-wide, over 10,000 infants were born with phocomelia, which is a malformation of the limbs, due to Thalidomide. Only forty percent of these children survived into adulthood. Consequently use of Thalidomide is highly restricted and development of the drug for treatment of other diseases is tightly regulated.

For this reason, prescribing Thalidomide to women who are of child bearing age is done with caution. Patients of child bearing age are urged to use two effective forms of birth control and undergo pregnancy testing on a regular basis. Birth control methods should be started at least four weeks before starting therapy with Thalidomide and continue at least four weeks after stopping. Consult your doctor about the most effective methods of birth control before starting treatment with Thalidomide.

Further, men who are sexually active must protect their female partners from getting pregnant, as Thalidomide will travel through the semen of male patients undergoing treatment. Barrier methods of birth control are mandatory, even for those men who have had vasectomy surgery, during treatment with Thalidomide and for 4 weeks after your last dose. If you partner may be pregnant, contact your health care provider immediately.

Blood and sperm donation by patients who are taking Thalidomide are forbidden as well as for four weeks after your last dose. Do not share this medication with anyone, even those with similar symptoms or similar diagnoses.

Thalidomide has been associated with an increased risk of blood clots, heart attack and stroke in certain patients. Patients under treatment with Talidomide who are experiencing symptoms such as shortness of breath, chest pain, leg pain or swelling, which are signs of blood clots, should contact their doctor immediately. Those experiencing confusion, difficulty speaking, double vision, paralysis or slow speech could be having symptoms that indicate stroke. Contact your doctor immediately if you have any of these symptoms while taking Thalidomide.

Use of Thalidomide may cause patients to feel dizzy, drowsy or lightheaded; for this reason, operation of heavy machinery, driving or using power tools is to be avoided.

While taking a course of Thalidomide, your white blood cell count will be lowered as the drug performs the necessary actions of destroying cells that are symptoms of your disease. This increases your chance of getting an infection. To avoid potential infections, avoid people who are infected and contact your doctor immediately if you feel like you are coming down with an infection. Avoid touching your eyes or the inside of your nose unless you have just washed your hands. If you have the following symptoms of infection, contact your doctor immediately:

  • Fever, chills, cough, hoarseness
  • Lower back or side pain
  • Painful or difficult urination
  • Unusual bleeding or bruising

The number of blood platelets found in your blood will also decrease during treatment with Thalidomide, which will affect your blood to clot. Avoid dangerous situations and contact sports. Use caution when brushing your teeth, using a razor or fingernail clippers. If you have any of the following signs of bleeding, contact your doctor immediately:

  • Black, tarry stools
  • Blood in urine or stools
  • Pinpoint red spots on your skin

Your doctor or dentist may suggest alternative ways to clean your teeth and gums during your treatment with Thalidomide.

Thalidomide has been known to cause nerve damage in some patients during treatment. If you experience tingling, burning, numbness or pain in your hands and feet, contact your doctor immediately as these could be symptoms of a nerve condition known as peripheral neuropathy.

Treatment with Thalidomide can cause serious reactions in the skin. Your doctor should be contacted immediately if you experience loose or peeling skin, blistering, red lesions on the skin, sores, ulcers, fever chills or severe ache.

Tumor lysis syndrome has been known to occur in multiple myeloma patients in treatment with a course of Thalidomide medication. If you experience the following symptoms, contact your health care professional immediately:

  • Low urine amounts
  • Joint pain
  • Stiffness or swelling
  • Lower back, side or stomach pain
  • Rapid weight gain
  • Swollen feet or lower legs
  • Unusual fatigue or weakness

Use of alcohol and other depressants while on a course of treatment with Thalidomide is not advised as this drug will add to the drowsy effects of these substances. Medications such as antihistamines, allergy medication, sedatives, tranquilizers or sleep aids should be avoided when on Thalidomide.

If you fear you have overdosed on Thalidomide, are experiencing trouble breathing or are passing out, get immediate emergency help.

Storage

Thalidomide should be stored at room temperature, away from heat, light and moisture and out of sight and reach of children. Capsules should be kept in their protective blister pack until ready to use. If a capsule is broken and the medication gets on your skin, wash the area immediately with clear water.

Dispose of Thalidomide properly as advised by your doctor or pharmacist. Unused or expired Thalidomide should be disposed of. Never share this drug or any other with other people.

Summary

Thalidomide is an oral medication prescribed by doctors for treatment, in addition to a chemotherapy drug, of multiple myeloma cancer as well as for treatment of a painful skin disease that is associated with Hansen’s disease or leprosy called erythema nodosum leprosum. Thalidomide works by binding with the cells causing the mutation found in these conditions and stopping them from growing, weakening them and causing them to die and be disposed of by the body’s natural processes. While there is no cure for multiple myeloma, medications such as Thalidomide can slow down the spread of cancer to give the patient a longer potential life. Patients who are being treated for erythema nodosum leprosum find that Thalidomide stops the pain and slows the growth of the infected skin areas so that healing can begin.

Doses of Thalidomide are in capsule form and should be taken with water, preferably one hour after consuming any food and just before bedtime to reduce potential unwanted side effects. Do not take this drug with alcohol or other depressants, which could multiply their effects of drowsiness and lethargy to dangerous levels. Do not drive, operate heavy equipment or use power tools until the effects of Thalidomide on your alertness are determined.

Use of Thalidomide is highly restricted due to the complications it is known to cause unborn babies during all stages of pregnancy. For this reason, women who are of child bearing age and men who are sexually active are required to use effective forms of birth control before, during and for at least four weeks after treatment by Thalidomide.

Thalidomide is known to prevent blood from clotting and inhibit the body’s ability to fight off infections. Patients are advised to avoid dangerous situations and contact sports and to use caution when brushing their teeth, using dental floss or kitchen equipment. It is advised that patients under treatment with Thalidomide avoid people who are infected with viruses and other health compromises.

Patients who exhibit side effects thought to be severe or of a prolonged nature are urged to contact their health care providers immediately. Special attention should be paid to patients who exhibit symptoms of tumor lysis symptoms or any skin reactions, as these conditions could prove long term.

Thalidomide should be stored at room temperature, away from heat, light and moisture and out of sight and reach of children. Capsules should be kept in their protective blister pack until ready to use. If a capsule is broken and the medication gets on your skin, wash the area immediately with clear water.

Resources
Last Reviewed:
December 22, 2017
Last Updated:
December 22, 2017
Content Source: