thalidomide (redirected from Fetal thalidomide syndrome)

thalidomide /tha·lid·o·mide/ (thah-lid´o-mīd) a sedative and hypnotic, commonly used in Europe in the early 1960's, and discovered to cause serious congenital anomalies in the fetus, notably amelia and phocomelia, when taken during early pregnancy; now used in the treatment of erythema nodosum leprosum.

---

tha·lid·o·mide (th-ld-md)

n.

A sedative and hypnotic drug that was withdrawn from sale after it was found to cause severe birth defects when taken during pregnancy.

---

thalidomide

[thalid′əmīd]

a sedative-hypnotic sometimes prescribed for the treatment of leprosy. It is never given to women who are or who might become pregnant.

---

thalidomide

a sedative and hypnotic compound whose use during early pregnancy in women was frequently followed by the birth of infants with phocomelia.

---

thalidomide Warning - Hazardous drug!

Thalomid

Pharmacologic class: Synthetic glutamic acid derivative

Therapeutic class: Immunomodulator, angiogenesis inhibitor

Pregnancy risk category X

FDA Boxed Warning

• When taken during pregnancy, drug may cause severe, life-threatening birth defects or fetal death. Never administer to women who are pregnant or could become pregnant during therapy. Because of its toxicity and to reduce risk of fetal exposure, drug is approved for marketing only under special Food and Drug Administration-approved restricted distribution program, called System for Thalidomide Education and Prescribing Safety (S.T.E.P.S.) Only prescribers and pharmacists registered with program are allowed to prescribe and dispense drug. Also, patients must be advised of, agree to, and comply with program requirements. For special information about this distribution program for prescribers and patients, see complete boxed warnings in package insert.

Action

Suppresses excess levels of tumor necrosis factor-alpha in patients with erythema nodosum leprosum (ENL). Alters leukocyte migration by changing cell surface characteristics.

Availability

Capsules: 50 mg, 100 mg, 200 mg

⊘Indications and dosages

➣ Cutaneous manifestations of moderate to severe ENL; to prevent and suppress recurrent ENL

Adults weighing 50 kg (110 lb) or more: 100 to 300 mg P.O. daily, or up to 400 mg P.O. daily, depending on disease severity or previous response. Continue therapy until symptoms of active reactions subside (usually after 2 weeks); then may taper in 50-mg decrements q 2 to 4 weeks.

Adults weighing less than 50 kg (110 lb): Initially, 100 mg P.O. daily, or up to 400 mg P.O. daily, depending on disease severity or previous response. Continue therapy until symptoms of active reactions subside (usually after 2 weeks); then may taper in 50-mg decrements q 2 to 4 weeks.

Off-label uses

• Aphthous stomatitis
• Wasting syndrome associated with human immunodeficiency virus (HIV)
• Multiple myeloma
• Refractory Crohn's disease

Contraindications

• Hypersensitivity to drug or its components
• Pregnancy

Precautions

Use cautiously in:
• breastfeeding patients (use not recommended)
• children younger than age 12 (safety not established).

Administration

☞ Follow all instructions provided by System for Thalidomide Education and Prescribing Safety (S.T.E.P.S.^?) program, accessible at http://www.steps-info.com.
• Give with 8 oz of water just before bedtime, at least 1 hour after evening meal.
• Know that patients who need prolonged maintenance therapy to prevent cutaneous ENL recurrence and those who have flares during tapering should receive minimum effective dosage, with tapering attempted every 3 to 6 months. To taper, decrease dosage by 50 mg every 2 to 4 weeks.

Route	Onset	Peak	Duration
P.O.	48 hr	1-2 mo	Unknown

Adverse reactions

CNS: drowsiness, dizziness, vertigo, sedation, tremor, asthenia, peripheral neuropathy

CV: bradycardia, orthostatic hypotension, peripheral edema

EENT: rhinitis, sinusitis, pharyngitis

GI: nausea, constipation, diarrhea, abdominal pain, oral moniliasis

GU: erectile dysfunction

Hematologic: neutropenia

Musculoskeletal: back pain

Skin: exfoliative, purpuric, bullous, or maculopapular rash; pruritus; fungal dermatitis; nail disorder; photosensitivity; toxic epidermal necrolysis, Stevens-Johnson syndrome

Other: tooth pain, chills, accidental injury, hypersensitivity reactions, increased HIV viral load, severe birth defects, fetal death

Interactions

Drug-drug. Barbiturates, chlorpromazine, reserpine, sedative-hypnotics, and other CNS depressants: increased sedation

Drugs linked to peripheral neuropathy: increased risk of peripheral neuropathy

Drug-diagnostic tests. Alanine aminotransferase, aspartate aminotransferase, lactate dehydrogenase, lipids, liver function tests: increased values

Hemoglobin, neutrophils, white blood cells: decreased values

Drug-food. High-fat meal: interference with drug absorption

Drug-behaviors. Alcohol use: increased sedation

Patient monitoring

☞ Monitor for signs and symptoms of hypersensitivity reaction. If rash occurs, discontinue drug and contact prescriber immediately. Don't restart drug if Stevens-Johnson syndrome, toxic epidermal necrolysis, or exfoliative, purpuric, or bullous rash occurs.
• Watch for and report signs and symptoms of peripheral neuropathy.
• Assess CBC with white cell differential.
• Carefully monitor patient's reproductive status.

Patient teaching

• Instruct patient to take with 8 oz of water just before bedtime, at least 1 hour after dinner.
☞ Tell patient to immediately report signs and symptoms of hypersensitivity reaction, especially rash.
• Teach patient about risks of fetal exposure to drug. Carefully review relevant portions of S.T.E.P.S.^? program with patient.
• Instruct female of childbearing age to use two highly effective birth control methods simultaneously, from 1 month before first thalidomide dose until 1 month after last dose.
• Explain mandatory pregnancy testing schedule to female patient, and stress importance of compliance.
☞ Advise female patient to contact prescriber immediately if she suspects she's pregnant.
• Caution female patient not to breastfeed.
• Instruct male patient to use latex condoms during every sexual encounter.
• Tell patient to avoid alcohol during drug therapy.
• As appropriate, review all other significant and life-threatening adverse reactions and interactions, especially those related to the drugs, tests, foods, and behaviors mentioned above.

---

thalidomide

 Therapeutics A drug first marketed as a sedative and sleeping aid, which caused 12,000-15,000 cases of embryopathy, often in the form of phocomelia or 'flipper' extremities New indications Thalidomide may be effective in combating wasting in AIDS Pts–especially with oral ulcers, as well as rheumatoid arthritis, photodermatitis, Behçet's disease, SLE, GVHD, asbestosis, IBD, lepromatous leprosy–erythema nodosum leprosum, possibly TB; it is antiangiogenic, stops menstruation and may be useful for neoangiogenesis in macular degeneration and diabetic retinopathy. See Angiogenesis inhibitors GI disease Benefits Pts with refractory Crohn's disease, due to TNF-α inhibition Oncology Thalidomide has orphan drug status for treating refractory myeloma, possibly due to thalidomide's inhibition of angiogenesis and modulation of cytokines; it may be used for Pts with head & neck SCC., and as an ancillary therapy in KS, melanoma, brain, breast, prostate CAs.