• Cutaneous manifestations of moderate to severe erythema nodosum leprosum.
• Prevention (maintenance) and suppression of recurrent erythema nodosum leprosum.
• Newly diagnosed multiple myeloma (in combination with dexamethasone).

Unlabeled Uses:

• Bechet’s syndrome.
• HIV-associated wasting syndrome.
• Aphthous stomatitis (including HIV associated).
• Crohn’s disease.

Contraindicated in:

• Hypersensitivity
• Seizure disorders
• Concurrent use of pembrolizumab in patients with multiple myeloma (↑ risk of mortality)
• OB: Pregnancy
• Lactation: Lactation.

Use Cautiously in:

• Women of reproductive potential and men with female sexual partners of reproductive potential
• Pedi: Children <12 yr (safety and effectiveness not established).

CV: bradycardia, edema, orthostatic hypotension, thromboembolic events (↑ risk with dexamethasone in multiple myeloma).

Derm: drug reaction with eosinophilia and systemic symptoms (dress), rash, stevens-johnson syndrome, toxic epidermal necrolysis, photosensitivity.

GI: constipation.

Hemat: neutropenia, thrombocytopenia.

Neuro: dizziness, drowsiness, peripheral neuropathy, seizures.
Misc: (INCLUDING ANAPHYLAXIS AND ANGIOEDEMA)HYPERSENSITIVITY REACTIONS , TUMOR LYSIS SYNDROME.

Drug-Drug:

• ↑CNS depression with concurrent use of barbiturates, sedative/hypnotics, alcohol, chlorpromazine, or other CNS depressants.
• Concurrent use of agents that may cause peripheral neuropathy↑ risk of peripheral neuropathy.

Drug-Natural Products:

• Concurrent use with echinacea and melatonin may interfere with immunosuppression.

• Capsules: 50 mg; 100 mg; 150 mg; 200 mg;

Erythema Nodosum Leprosum

• PO (Adults 50 kg): 100–300 mg once daily initially; up to 400 mg/day has been used, depending on previous response. Every 3–6 mo, attempts should be made to taper and discontinue in decrements of 50 mg every 2–4 wk.
• PO (Adults <50 kg): 100 mg once daily initially; up to 400 mg/day has been used, depending on previous response. Every 3–6 mo, attempts should be made to taper and discontinue in decrements of 50 mg every 2–4 wk.

Multiple Myeloma

• PO (Adults): 200 mg once daily in 28-day treatment cycles.

Thalomid

• May suppress excess levels of tumor necrosis factor-alpha and alter leukocyte migration by altering characteristics of cell surfaces.

• Decreased skin lesions in erythema nodosum leprosum and prevention of recurrence.
• Slowed progression of multiple myeloma.

Therapeutic Classification: Immunosuppressant agents

Absorption: 67–93% absorbed following oral administration.

Distribution: Well distributed to tissues.

Metabolism/Excretion: Hydrolyzed in plasma to multiple metabolites. Primarily excreted in the urine (92%; <4% as unchanged drug).

Half-life: 5–7 hr.

(plasma concentrations)

• Instruct patient to take thalidomide as directed. Do not discontinue without notifying health care professional; dose should be tapered gradually. Explain Thalomid REMS program to patient.
• Advise patient that thalidomide should not be shared with others.
• Frequently causes drowsiness or dizziness. Caution patient to avoid driving or other activities requiring alertness until response to medication is known.
• Advise patient to change positions slowly to minimize orthostatic hypotension.
• Caution patient to use sunscreen and protective clothing to prevent photosensitivity reactions.
• Advise patient to notify health care professional immediately if pain, numbness, tingling, or burning in hands or feet or shortness of breath, chest pain, swelling of arms or legs occur.
• Instruct patient not to donate blood and male patients not to donate sperm while taking thalidomide and for 1 mo following discontinuation.
• May cause fetal harm. Inform females of reproductive potential that they must use one highly effective method (IUD, hormonal contraceptive, tubal ligation, partner's vasectomy) and one additional method (latex condom, diaphragm, cervical cap) AT THE SAME TIME for at least 4 wk before, during therapy and interruptions of therapy, and for 4 wk following discontinuation of therapy, even with a history of infertility, unless due to a hysterectomy or patient has been postmenopausal naturally for 24 consecutive mo. Advise female patients to avoid breastfeeding during therapy. Males receiving thalidomide with female partners of reproductive potential must always use a latex condom during and for up to 4 wk following discontinuation, even if they have undergone a successful vasectomy. Thalidomide must be discontinued if pregnancy is suspected or confirmed. Suspected fetal exposure must be reported to FDA via MedWatch at 1-800-FDA-1088 and to manufacturer at 1-888-668-2528. Inform females there is a Pregnancy Exposure Registry that monitors pregnancy outcomes in females exposed to thalidomide during pregnancy and that they can contact the Pregnancy Exposure Registry by calling 1-888-423-5436. May impair male fertility.
  • Advise patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and to consult with health care professional before taking other medications. Concomitant use of HIV-protease inhibitors, modafinil, penicillins, rifampin, rifabutin, phenytoin, carbamazepine, or certain herbal supplements such as St. John's wort with hormonal contraceptive agents may reduce the effectiveness of contraception during and for up to one mo after discontinuation of these concomitant therapies. Women requiring treatment with one or more of these drugs must use two other effective or highly effective methods of contraception or abstain from heterosexual sexual contact while taking thalidomide.

tha-LID-oh-mide