BMA Concise Guide to Medicine & Drugs

Thalidomide

Brand name Celgene

Used in the following combined preparations None

QUICK REFERENCE

Drug group Drug for leprosy and multiple myeloma

Overdose danger rating Medium

Dependence rating Low

Prescription needed Yes

Available as generic No

GENERAL INFORMATION

Thalidomide was originally introduced in the 1950s as a sedative and became popular for treating morning sickness in pregnancy. By 1961, it was realized thalidomide caused severe birth defects and was withdrawn. However, it was subsequently found to be effective in treating leprosy and in blocking blood vessel growth to tumours. Currently in the UK thalidomide has strict controls on prescribing and is used only to treat multiple myeloma (a type of bone marrow cancer) in combination with other drugs, and, very rarely, leprosy (also known as Hansen’s disease). Because the drug can cause severe birth defects when taken during pregnancy and can also be present in semen, women of childbearing age and men must ensure reliable contraception is used. Thalidomide also increases the risk of developing peripheral nerve damage and venous thromboembolism (deep vein thrombosis and pulmonary embolism).

INFORMATION FOR USERS

Follow instructions on the label. Your drug prescription is tailored for you. Do not alter dosage without checking with your doctor.

How taken/used Capsules.

Frequency and timing of doses Once daily at bedtime for up to 72 weeks.

Adult dosage range 200mg daily.

Onset of effect 2–5 hours.

Duration of action 7–8 hours.

Diet advice None.

Storage Keep in original container out of the reach of children.

Missed dose Take the missed dose as soon as you remember unless your next dose is due within 12 hours, in which case omit the missed dose and take the next dose as scheduled.

Stopping the drug Do not stop the drug without consulting your doctor; your condition may worsen.

Exceeding the dose An occasional unintentional extra dose is unlikely to cause problems. However, a large overdose may cause serious side effects; consult your doctor or go to hospital immediately.

POSSIBLE ADVERSE EFFECTS

Thalidomide frequently causes drowsiness and nerve damage. The latter may be mild, causing numbness and tingling in the hands or feet, or more severe and painful; in some cases, the nerve damage may be irreversible. If you experience numbness or tingling in the extremities, consult your doctor. Other side effects include constipation, dizziness, blurred vision, unusual bleeding or bruising, rash, blisters, mouth ulcers, and palpitations. Discuss with your doctor if constipation, drowsiness, or dizziness are severe. If you experience blurred vision, you should stop taking the drug and consult your doctor. With the other side effects, you should stop taking the drug and contact your doctor immediately. Thalidomide also carries a significant risk of venous thromboembolism, which may cause pain or swelling in a limb, chest pain, breathlessness, or, rarely, collapse. If any of these occur, stop taking the drug and seek urgent medical help. The risks of nerve damage and thromboembolism are greater with long-term use (see Prolonged use).

INTERACTIONS

Sedative drugs Thalidomide increases the drowsiness caused by other sedative drugs, such as antihistamines, anticholinergics, opioids, benzodiazepines, and alcohol.

SPECIAL PRECAUTIONS

Be sure to tell your doctor if:

· You are sexually active, pregnant, or intend to become pregnant.

· You have lactose intolerance.

· You have kidney or liver problems.

· You have a history of thromboembolism.

· You have problems with sensation in your hands or feet.

· You are taking other medicines.

Pregnancy Must not be used; it causes severe birth defects. Women of childbearing age must use contraception. The drug is present in semen; men taking it must ensure that they and/or their partner use contraception. Women who think they may have become pregnant should stop the drug and consult their doctor immediately.

Breast-feeding Avoid as it is not known whether thalidomide passes into breast milk.

Infants and children Not recommended under 18 years.

Over 60 The elderly are at increased risk of potentially serious adverse effects. Discuss with your doctor.

Driving and hazardous work Avoid such activities if you experience side effects such as dizziness, tiredness, sleepiness, or blurred vision.

Alcohol Avoid. Alcohol increases the sedative effect of thalidomide.

PROLONGED USE

Prolonged use increases the risk of nerve damage and venous thromboembolism. If you are at high risk of thromboembolism, you may be prescribed preventive drugs.

Monitoring You will have regular checks of your reflexes and nerve function.