Thalidomide capsules contain the active ingredient thalidomide, which is a type of medicine called an immunomodulating agent.
What is it used for?
- Cancer of the plasma cells in the bone marrow (multiple myeloma).
- This medicine is used in combination with melphalan (Alkeran) and prednisolone as a first-line treatment for people who are 65 years or older, or who can't be given high-dose chemotherapy.
How does it work?
- Thalidomide capsules contain the active ingredient thalidomide, which is a type of medicine called an immunomodulating agent.
- Thalidomide is used to treat multiple myeloma, which is a cancer of a type of white blood cell in the bone marrow. In multiple myeloma, white blood cells called plasma cells multiply in an uncontrolled way.
- The way in which thalidomide works in mutiple myeloma is not yet completely understood. However, it has several actions.
- In order to grow, cancerous cells need a blood supply that provides them with nutrients and oxygen.
They also need this blood supply to spread. Cancerous cells stimulate blood vessels to grow into the tumour. Thalidomide stops the growth and development of these new blood vessels. This stops the growth of the tumour and can cause it to shrink.
Thalidomide can also reduce some of the symptoms associated with multiple myeloma by its action on the immune system. The body naturally produces a substance called tumour necrosis factor (TNF), which is something that stimulates the immune system to attack abnormal cells. However, in multiple myeloma excessive production of TNF causes symptoms such as high temperatures, night sweats and severe weight loss. Thalidomide stops the excessive production of TNF and so helps to reduce these symptoms.
Thalidomide is only prescribed by specialist consultants. It is usually used in combination with a chemotherapy medicine called melphalan and a steroid called prednisolone for the treatment of multiple myeloma in people who have not had any previous therapy. You may hear this combination of drugs referred to as MPT.
Thalidomide is given in six week cycles, with melphalan and prednisolone taken on days one to four of each six week cycle.
How do I take it?
- Thalidomide capsules are taken once daily. Follow the instructions given by your doctor for how many capsules to take.
- Your dose should be taken at bedtime because the medicine is likely to make you sleepy. If you forget to take a dose at your usual time you can take it up to 12 hours after it was due, but be aware that if you have to take it in the morning that you may be sleepy that day.
- If you are more than 12 hours late taking a dose you should skip the missed dose and take your next dose at your usual time.
- The capsules should be swallowed whole with a glass of water. They should not be crushed, chewed or opened. The capsules can be taken with or without food.
Use with caution in
- Severely decreased liver function.
- Severely decreased kidney function.
- People with a history of blood clots in the veins (eg deep vein thrombosis (DVT) or pulmonary embolism).
- People with angina or a history of a heart attack.
- People with extra risk factors for blood clots, such as smoking, high blood pressure or high cholesterol.
- People with disease of the nerves or signs of nerve problems (peripheral neuropathy) - see warning section above.
- People with extensive cancer before the treatment is started.
Not to be used in
- Pregnancy.
- Women who could get pregnant.
- Breastfeeding.
- Rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption (thalidomide capsules contain lactose).
- The manufacturer has not studied this medicine in children and adolescents under 18 years of age. It is not recommended for this age group.
- This medicine should not be used if you are allergic to any of its ingredients. Please inform your doctor or pharmacist if you have previously experienced such an allergy.
If you feel you have experienced an allergic reaction, stop using this medicine and inform your doctor or pharmacist immediately.
Pregnancy and breastfeeding
Certain medicines should not be used during pregnancy or breastfeeding. However, other medicines may be safely used in pregnancy or breastfeeding providing the benefits to the mother outweigh the risks to the unborn baby. Always inform your doctor if you are pregnant or planning a pregnancy, before using any medicine.
- This medicine MUST NOT be used during pregnancy, as it can cause serious malformations of the developing foetus and result in the baby being born with major birth defects. Women who could get pregnant must use a highly effective method of contraception (such as an injected or implanted form) to prevent pregnancy. The pill is not a suitable option because of the increased risk of blood clots associated with multiple myeloma, thalidomide and the pill. Contraception should be started four weeks before your treatment begins and continued all the time you are taking this medicine. You should continue to use contraception to prevent pregnancy for at least four weeks after your treatment is finished. You will need to have a pregnancy test before treatment with this medicine is started, every four weeks throughout the treatment and four weeks after treatment is finished. You should consult your doctor immediately if you think you could be pregnant.
- This medicine passes into semen. As it could potentially cause birth defects in a developing baby, men taking this medicine whose partner is pregnant or who could get pregnant must use a condom during their treatment and for one week after treatment is finished.
- It is not known if this medicine passes into breast milk. However, the medicine could potentially have serious side effects on a nursing baby if it did pass into the breast milk. For this reason, mothers who need treatment with this medicine should not breastfeed their babies during treatment. Seek further medical advice from your doctor.
Side effects
Very common
- Decrease in the number of white blood cells, red blood cells or platelets in the blood.
- Disorder of the peripheral nerves causing numbness, tingling or weakness in the hands or feet.
- Tremor.
- Dizziness.
- Sleepiness.
- Swollen ankles (peripheral oedema).
- Constipation.
Common
- Feeling weak or generally unwell.
- Fever (high temperature).
- Feeling sick or vomiting.
- Dry mouth.
- Problems with co-ordination.
- Slower than normal heart beat (bradycardia).
- Heart failure.
- Blood clots in the veins.
- Shortness of breath (dyspnoea).
- Pneumonia.
- Skin reactions, such as dry skin, rash.
- Mood changes.
- Depression.
- Anxiety.
- Confusion.
- Low blood pressure.
- Fainting.
- Spinning sensation.
- Blurred vision.
- Mini stroke (TIA), causing temporary difficulty in seeing or speaking.
Uncommon
- Bacterial infection inside the abdomen (peritonitis).
- Chest infection (bronchitis).
- Stroke.
- A drop in blood pressure that occurs when moving from a lying or sitting position to sitting or standing, which causes dizziness and lightheadedness (postural hypotension).
The frequency of these side effects is rare.
- Severe skin reactions (toxic epidermal necrolysis orStevens Johnson Syndrome). Tell your doctor straight away if you get a severe skin rash or peeling or blistering of the skin, genitals or inside of the mouth while taking this medicine.
- Blockage in the intestines (intestinal obstruction).
- Perforation of the gut.
- Hearing problems.
- Kidney failure.
- Heart attack.
- Underactive thyroid gland (hypothyroidism).
- Sexual problems.
- Tumour lysis syndrome, where the body is unable to cope with all the waste products of the cancer cells killed by this medicine. This may lead to abnormal levels of salts in your blood and possibly kidney failure.
The side effects listed above may not include all of the side effects reported by the medicine's manufacturer.
For more information about any other possible risks associated with this medicine, please read the information provided with the medicine or consult your doctor or pharmacist.
How can this medicine affect other medicines?
There may be an increased risk of drowsiness if this medicine is taken with any of the following (which can also cause drowsiness):
- alcohol
- antipsychotics, eg haloperidol
- barbiturates, eg phenobarbital
- benzodiazepines, eg diazepam, temazepam
- opioid painkillers, eg codeine, morphine, tramadol, fentanyl
- sedating antihistamines, eg chlorphenamine
- sleeping tablets, eg zopiclone
- tricyclic antidepressants, eg amitriptyline.
There may be an increased risk of blood clots in the veins or arteries if the following medicines are taken in combination with thalidomide:
- combined oral contraceptives (the pill)
- hormone replacement therapy (HRT)
- medicines that stimulate red blood cell production, eg erythropoietin (epoetin).
- There may be an increased risk of side effects on the nerves (peripheral neuropathy) if this medicine is used with other medicines that can cause this problem, such as vincristine and bortezomib.
There may be an increased chance of a slowed heart rate if thalidomide is used with other medicines that can have this effect, for example beta-blockers.
References:
https://www.ema.europa.eu/en/medicines/human/EPAR/thalidomide-celgene-previously-thalidomide-pharmion
https://www.netdoctor.co.uk/medicines/cancer-drugs/a8753/thalidomide/
https://en.wikipedia.org/wiki/Thalidomide
https://www.mayoclinic.org/diseases-conditions/cancer/in-depth/thalidomide/art-20046534
https://pmj.bmj.com/content/79/929/127
https://www.ema.europa.eu/en/documents/product-information/thalidomide-celgene-epar-product-information_en.pdf
Health Reference: Multiple myeloma
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