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Thalidomide

Brand Name: Thalomid

Generic Name: Thalidomide

Drug Class: Antineoplastics, Other; Antineoplastics, Angiogenesis Inhibitor

What Is Thalidomide and How Does It Work?

Thalidomide is used to treat or prevent certain skin conditions related to Hansen's disease, once known as leprosy (erythema nodosum leprosum). Thalidomide is also used to treat a certain type of cancer (multiple myeloma). It works in Hansen's disease by reducing swelling and redness (inflammation). It also reduces the formation of blood vessels that feed tumors.

Thalidomide may also be used to treat certain conditions caused by cancer and HIV infection.

Thalidomide is available under the following different brand names: Thalomid.

Dosages of Thalidomide:

Dosage Forms and Strengths

Capsule

  • 50 mg
  • 100 mg
  • 150 mg
  • 200 mg

Dosage Considerations – Should be Given as Follows:

Erythema Nodosum Leprosum (ENL)

  • Initial: 100-300 mg orally at bedtime
  • More severe reaction may start at 400 mg
  • Continue until active symptoms subsided, at least 2 weeks, THEN
  • Titrate down by 50 mg increments every 2-4 weeks

Multiple Myeloma

  • 200 mg orally at bedtime in 28-day cycles
  • Take 40 mg of dexamethasone on days 1-4, 9-12, 17-20 of 28 days

Administration

  • Take with water at bedtime, at least 1 hour after evening meal
  • Consider dose reduction, delay, or discontinuation in patients who develop NCI CTC (National Cancer Institute Common Toxicity Criteria) Grade 3 or 4 adverse reactions and/or based on clinical judgment

Other Information

What Are Side Effects Associated with Using Thalidomide?

Common side effects of Thalidomide include:

Other side effects of thalidomide include:

Severe side effects of thalidomide include:

  • Severe nerve damage, which may be permanent (may occur during treatment or after treatment has stopped), symptoms include:
    • Numbness/tingling/pain/burning in the feet or hands
    • Muscle weakness or cramps
    • A feeling of tightness in the feet

Postmarketing side effects of thalidomide reported include:

This document does not contain all possible side effects and others may occur. Check with your physician for additional information about side effects.

What Other Drugs Interact with Thalidomide?

If your doctor has directed you to use this medication, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider or pharmacist first.

Severe interactions of thalidomide include:

  • anakinra

Serious interactions of thalidomide include:

  • tocilizumab
  • vedolizumab

Moderate interactions of thalidomide include:

Mild interactions of thalidomide include:

This information does not contain all possible interactions or adverse effects. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share this information with your doctor and pharmacist. Check with your health care professional or doctor for additional medical advice, or if you have health questions, concerns or for more information about this medicine.

What Are Warnings and Precautions for Thalidomide?

Warnings

Potential for human birth defects

  • If taken during pregnancy, can cause severe birth defects or fetal death
  • Major human fetal abnormalities with thalidomide include absence of bones, amelia (absence of limbs), congenital heart defects, external ear abnormalities (including anotia, micro pinna, small or absent external auditory canals), eye abnormalities (anophthalmos, microphthalmos), facial palsy, hypoplasticity of the bones, and phocomelia (short limbs); alimentary tract, urinary tract, and genital malformations also have been documented
  • 40% mortality at birth, or shortly afterwards
  • Avoid in pregnant women or women who could become pregnant while taking the drug; even a single dose (one 50, 100, or 200 mg capsule) taken by a pregnant woman can cause severe birth defects

STEPS program

  • Available only under a special restricted distribution program called the System for Thalidomide Education and Prescribing Safety (STEPS)
  • Only prescribers and pharmacists registered with the program are allowed to prescribe and dispense thalidomide
  • Patients must be advised of, agree to, and comply with the requirements of STEPS to receive thalidomide
  • Effective contraception must be used by patients for at least 4 weeks before beginning thalidomide therapy, during therapy, during dose interruptions, and for 4 weeks after discontinuing
  • Reliable contraception is indicated even if the patient has a history of infertility, unless infertility is because of hysterectomy or because the patient has been postmenopausal naturally for at least 24 consecutive months
  • Two reliable forms of contraception must be used simultaneously unless continuous abstinence from heterosexual sexual contact is the chosen method; refer women of childbearing potential to a qualified provider of contraceptive methods, if needed
  • Sexually mature women who have not undergone a hysterectomy, have not had a bilateral oophorectomy, or who have not been postmenopausal naturally for at least 24 consecutive months are considered to be women of childbearing potential
  • Male patients: Because thalidomide is present in the semen of patients receiving the drug, men receiving thalidomide must always use a latex condom during any sexual contact with women of childbearing potential, even if he has undergone a successful vasectomy

Pregnancy testing

  • Before prescribing, women of childbearing potential should have 2 negative pregnancy test results (sensitivity of at least 50 milliunits/mL)
  • Perform first pregnancy test within 10-14 days and the second test within 24 hours prior to prescribing
  • A prescription for a woman of childbearing potential must not be issued until negative pregnancy test results have been verified by the health care provider, and the pharmacist must verify a negative pregnancy test result with the prescriber before dispensing
  • If pregnancy occurs, discontinue immediately
  • Report any suspected fetal exposure to the Food and Drug Administration (FDA) immediately via MedWatch at (800) FDA-1088 and also to the manufacturer
  • Refer the patient to an obstetrician/gynecologist experienced in reproductive toxicity for further evaluation and counseling

Patient education (females)

  • Female patients
    • Use in women of childbearing potential is advised only when the patient meets the following conditions: 1) She understands and can reliably carry out instructions
    • 2) She is capable of complying with the mandatory contraceptive measures, pregnancy testing, patient registration, and patient survey as described in STEPS program
    • 3) She has received both oral and written warnings of the risks of taking thalidomide during pregnancy and of exposing a fetus to the drug
    • 4) She has received both oral and written warnings of the risk of possible contraception failure and of the need to use 2 reliable forms of contraception simultaneously, unless continuous abstinence from heterosexual sexual intercourse is the chosen method
    • 5) Sexually mature women who have not undergone a hysterectomy or who have not been postmenopausal for at least 24 consecutive months (i.e., who have had menses at some time in the preceding 24 consecutive months) are considered to be women of childbearing potential
    • 6) She acknowledges, in writing, her understanding of these warnings and of the need for using 2 reliable methods of contraception for 4 weeks prior to initiating therapy, during therapy, and for 4 weeks after discontinuing therapy
    • 7) She has had a negative pregnancy test result, with a sensitivity of at least 50 milliunits/mL, within the 24 hours prior to beginning therapy
    • 8) If the patient is between 12-18 years of age, her parent or legal guardian must have read this material and agreed to ensure compliance

Patient education (males)

  • Male patients: Contraindicated in sexually mature men unless the patient meets all of the following conditions:
    • 1) He understands and can reliably carry out instructions
    • 2) He is capable of complying with the mandatory contraceptive measures that are appropriate for men, patient registration, and patient survey as described in STEPS program
    • 3) He has received both oral and written warnings of the risks of taking thalidomide and of exposing a fetus to the drug
    • 4) He has received both oral and written warnings of the risk of possible contraception failure and of the presence of thalidomide in semen
    • 5) He has been instructed that he must always use a latex condom during any sexual contact with women of childbearing potential, even if he has undergone a successful vasectomy
    • 6) He acknowledges, in writing, his understanding of these warnings and of the need to use a latex condom during any sexual contact with women of childbearing potential, even if he has undergone a successful vasectomy; women of childbearing potential are considered to be sexually mature women who have not undergone a hysterectomy, have not had a bilateral oophorectomy, or who have not been postmenopausal for at least 24 consecutive months (i.e., who have had menses at any time in the preceding 24 consecutive months)
    • 7) If the patient is between 12-18 years of age, his parent or legal guardian must have read this material and agreed to ensure compliance

Venous thromboembolic events

  • Significantly increases risk of deep vein thrombosis (DVT) and pulmonary embolism (PE) in patients treated for multiple myeloma; this risk increases significantly when used with standard chemotherapeutic agents, including dexamethasone
  • In one controlled trial, the rate of venous thromboembolic events was 22.5% in patients receiving thalidomide in combination with dexamethasone compared with 4.9% in patients receiving dexamethasone alone (P = 0.002)
  • Observe for signs and symptoms of thromboembolism and instruct patients to seek medical care if they develop shortness of breath, chest pain, or arm or leg swelling
  • Preliminary data suggest that patients who are appropriate candidates may benefit from concurrent prophylactic anticoagulation or aspirin treatment

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center immediately.

Contraindications

  • Hypersensitivity
  • Pregnancy: highly teratogenic (even single dose)
    • Women of childbearing age MUST be on two reliable forms of contraception
    • Discontinue immediately if pregnancy occurs
    • Report any suspected fetal exposure to thalidomide to FDA MedWatch program 1-800-FDA-1088

Males must use latex condoms during any sexual contact with women of childbearing potential even after undergoing successful vasectomy

Effects of Drug Abuse

Short-Term Effects

  • Drowsiness and somnolence may occur; instruct patients to avoid situations where drowsiness may be a problem and not to take other medications that may cause drowsiness.
  • Peripheral neuropathy reported; examine patients at monthly intervals for the first 3 months of therapy and periodically thereafter; consider electrophysiological testing, consisting of measurement of sensory nerve action potential (SNAP) amplitudes at baseline and thereafter every 6 months in an effort to detect asymptomatic neuropathy.
  • Dizziness and orthostatic hypotension may occur; advise patients to sit upright for a few minutes prior to standing up from a recumbent position.
  • See "What Are Side Effects Associated with Using Thalidomide?"

Long-Term Effects

  • See "What Are Side Effects Associated with Using Thalidomide?"

Cautions

  • Increased risk of venous thromboembolism reported in patients with multiple myeloma treatment
  • Ischemic heart disease (including myocardial infarction) and stroke observed
  • Drowsiness and somnolence may occur; instruct patients to avoid situations where drowsiness may be a problem and not to take other medications that may cause drowsiness
  • Peripheral neuropathy reported; examine patients at monthly intervals for the first 3 months of therapy and periodically thereafter; consider electrophysiological testing, consisting of measurement of sensory nerve action potential (SNAP) amplitudes at baseline and thereafter every 6 months in an effort to detect asymptomatic neuropathy
  • Dizziness and orthostatic hypotension may occur; advise patients to sit upright for a few minutes prior to standing up from a recumbent position
  • Neutropenia may require dose interruption and/or dose reduction
  • Thrombocytopenia, including Grade 3 or 4 occurrences, reported in association with the clinical use of thalidomide; monitor blood counts, including platelet counts; dose reduction, delay, or discontinuation may be required; monitor for signs and symptoms of bleeding including petechiae, epistaxis, and gastrointestinal bleeding, especially if concomitant medication may increase the risk of bleeding
  • May increased HIV viral load when used in HIV-seropositive patients; clinical significance unknown, measure viral load after the first and third months of treatment and every 3 months thereafter
  • Monitor for slow heart rate (bradycardia) and possible fainting (syncope); dose reduction or discontinuation may be required Stevens-Johnson syndrome and toxic epidermal necrolysis reported; do not resume following discontinuation for these reactions
    • Monitor patients with a history of seizures or at risk for the development of seizures closely for clinical changes that could precipitate acute seizure activity Tumor lysis syndrome may occur; monitor patients at risk (eg, those with high tumor burden prior to treatment) and take appropriate precautions Hypersensitivity to the drug and its components reported

Pregnancy and Lactation

  • Based on the mechanism of action, human and animal data, thalidomide can cause embryo-fetal harm when administered to pregnant females; it is contraindicated during pregnancy.
  • There is no information regarding presence of thalidomide in human milk, the effects of thalidomide on breastfed infants, or the effects of thalidomide on milk production. Because many drugs are excreted in human milk and because of the potential for adverse reactions in breastfed infants from thalidomide, advise women not to breastfeed during therapy.