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Thalidomide: Drug information

Thalidomide: Drug information
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For additional information see "Thalidomide: Patient drug information" and "Thalidomide: Pediatric drug information"

For abbreviations, symbols, and age group definitions show table
ALERT: US Boxed Warning
Pregnancy:

If thalidomide is taken during pregnancy, it may cause severe birth defects or embryo-fetal death. Thalidomide should never be used by females who are pregnant or who could become pregnant while taking thalidomide. Even a single dose (1 capsule [regardless of strength]) taken by a pregnant woman during pregnancy may cause severe birth defects.

Because of this toxicity and in an effort to make the chance of embryo-fetal exposure to thalidomide as negligible as possible, thalidomide is approved for marketing only through a special restricted distribution program: Thalomid REMS program, approved by the Food and Drug Administration. Information about Thalomid and the Thalomid REMS program is available at https://www.thalomidrems.com or by calling the REMS Call Center at 1-888-423-5436.

Thromboembolic events:

The use of thalidomide in multiple myeloma results in an increased risk of venous thromboembolism, such as deep venous thrombosis and pulmonary embolism. This risk increases significantly when thalidomide is used in combination with standard chemotherapeutic agents including dexamethasone. In 1 controlled trial, the rate of venous thromboembolism was 22.5% in patients receiving thalidomide in combination with dexamethasone compared with 4.9% in patients receiving dexamethasone alone (P = 0.002). Patients and physicians are advised to be observant for the signs and symptoms of thromboembolism. Instruct patients to seek medical care if they develop symptoms such as shortness of breath, chest pain, or arm or leg swelling. Consider thromboprophylaxis based on an assessment of individual patients' underlying risk factors.

Brand Names: US
  • Thalomid
Brand Names: Canada
  • Thalomid
Pharmacologic Category
  • Angiogenesis Inhibitor;
  • Antineoplastic Agent
Dosing: Adult
AIDS-related aphthous stomatitis

AIDS-related aphthous stomatitis (off-label use): Oral: 200 mg once daily at bedtime for up to 8 weeks; if no response, then 200 mg twice daily for 4 weeks (Ref).

Erythema nodosum leprosum, acute cutaneous

Erythema nodosum leprosum, acute cutaneous: Oral: Initial: 100 to 300 mg once daily at bedtime, continue until signs/symptoms subside (usually ~2 weeks), then taper off in 50 mg decrements every 2 to 4 weeks. For severe cases with moderate to severe neuritis, corticosteroids may be initiated with thalidomide (taper off and discontinue corticosteroids when neuritis improves).

Patients weighing <50 kg: Initiate at lower end of the dosing range.

Severe cutaneous reaction or patients previously requiring high doses: May be initiated at up to 400 mg once daily at bedtime or in divided doses.

Erythema nodosum leprosum, maintenance

Erythema nodosum leprosum, maintenance (prevention/suppression, or with flares during tapering attempts): Oral: Maintain on the minimum dosage necessary to control the reaction; efforts to taper off should be attempted every 3 to 6 months, in decrements of 50 mg every 2 to 4 weeks.

Graft-versus-host disease, chronic, treatment

Graft-versus-host disease, chronic (refractory), treatment (off-label, second-line use; optimum dose not determined): Oral: Initial: 100 mg once daily at bedtime, with dose escalation up to 400 mg daily in 3 to 4 divided doses (Ref) or Initial: 50 to 100 mg 3 times daily; maximum dose: 600 to 1,200 mg daily (Ref) or 200 mg 4 times daily (dose adjusted to goal thalidomide concentration of ≥5 mcg/mL 2 hours postdose) (Ref) or 100 to 300 mg 4 times daily (Ref).

Multiple myeloma, newly diagnosed

Multiple myeloma, newly diagnosed: Oral: 200 mg once daily at bedtime (in combination with dexamethasone).

Multiple myeloma

Multiple myeloma (off-label dosing or combinations):

In combination with bortezomib and dexamethasone (off-label combination): Induction therapy: 100 mg once daily for the first 14 days, then 200 mg once daily for 3 (21-day) cycles (Ref) or 100 mg once daily for up to 8 (21-day) cycles (Ref).

In combination with daratumumab, bortezomib, and dexamethasone (off-label combination): DVTd regimen (in newly diagnosed transplant-eligible patients): 100 mg once daily for up to 4 pretransplant induction cycles and 2 posttransplant consolidation cycles; each cycle is 28 days (Ref).

In combination with melphalan and prednisone (off-label combination): 200 to 400 mg once daily (Ref) or 100 mg once daily (Ref) or 50 to 100 mg once daily, depending on patient tolerance (Ref).

Multiple myeloma, maintenance (following autologous stem cell transplant; off-label use): Oral: 200 mg once daily starting 3 to 6 months after transplant; continue until disease progression or unacceptable toxicity (Ref) or 100 mg once daily starting 42 to 60 days following transplant; increase to 200 mg once daily after 2 weeks if tolerated; continue for up to 12 months (in combination with prednisolone) (Ref).

Multiple myeloma, salvage therapy: Initial: 200 mg once daily at bedtime; may increase daily dose by 200 mg every 2 weeks for 6 weeks (if tolerated) to a maximum of 800 mg once daily at bedtime (Ref) or 100 mg once daily (in combination with dexamethasone) (Ref) or 200 mg once daily (in combination with bortezomib and dexamethasone) for 1 year (Ref) or 400 mg once daily at bedtime (in combination with dexamethasone, cisplatin, doxorubicin, cyclophosphamide and etoposide) (Ref).

Systemic light chain amyloidosis

Systemic light chain amyloidosis (off-label use): Oral: 200 mg once daily (starting dose 50 to 100 mg once daily; titrate at 4-week intervals) in combination with cyclophosphamide and dexamethasone (Ref).

Waldenström macroglobulinemia

Waldenström macroglobulinemia (off-label use): Oral: ≤200 mg once daily for up to 52 weeks (in combination with rituximab) (Ref).

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Dosing: Kidney Impairment: Adult

The renal dosing recommendations are based upon the best available evidence and clinical expertise. Senior Editorial Team: Kenar D. Jhaveri, MD; Bruce Mueller, PharmD, FCCP, FASN, FNKF; Jason A. Roberts, PhD, BPharm (Hons), B App Sc, FSHP, FISAC; Michael Heung, MD, MS.

Altered kidney function:

CrCl >30 mL/minute: Oral: No dosage adjustment necessary (Ref).

CrCl ≤30 mL/minute: Oral: No dosage adjustment necessary (Ref). Close monitoring for hyperkalemia is suggested (Ref). Note: May consider beginning with doses ≤100 mg/day and then titrate upward to indication-specific standard doses based on response and tolerability (Ref).

Augmented renal clearance (measured urinary CrCl ≥130 mL/minute/1.73 m2): Note: Augmented renal clearance (ARC) is a condition that occurs in certain critically ill patients without organ dysfunction and with normal serum creatinine concentrations. Young patients (<55 years of age) admitted post trauma or major surgery are at highest risk for ARC, as well as those with sepsis, burns, or hematologic malignancies. An 8- to 24-hour measured urinary CrCl is necessary to identify these patients (Ref).

Oral: No dose adjustment necessary (Ref).

Hemodialysis, intermittent (thrice weekly): Dialyzability: Clearance is doubled during dialysis, but the percent of total dose removed is not clinically significant (Ref): Oral: No dose adjustment or supplemental doses are necessary (Ref). Close monitoring for hyperkalemia is suggested (Ref). Note: May consider beginning with doses ≤100 mg/day and then titrate upward to indication-specific standard doses based on response and tolerability (Ref).

Peritoneal dialysis: Dialyzability unknown: Oral: No dose adjustment necessary (Ref). Close monitoring for hyperkalemia is suggested (Ref). Note: May consider beginning with doses ≤100 mg/day and then titrate upward to indication-specific standard doses based on response and tolerability (Ref).

CRRT: Oral: No dose adjustment necessary (Ref).

PIRRT (eg, sustained, low-efficiency diafiltration): Oral: No dose adjustment necessary (Ref).

Dosing: Liver Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling (has not been studied). However, thalidomide does not appear to undergo significant hepatic metabolism.

Dosing: Adjustment for Toxicity: Adult

ANC ≤750/mm3: Withhold treatment if clinically appropriate.

Dermatologic reactions:

Grade 2 or 3 rash: Consider interruption or discontinuation of therapy.

Grade 4 rash, skin exfoliation, bullae, or any severe dermatologic reaction: Permanently discontinue therapy.

Grade 3 or 4 adverse reactions: Consider dose reduction, delay or discontinuation (based on clinical judgment).

Other reactions:

Angioedema or anaphylaxis: Permanently discontinue therapy.

Constipation, oversedation: Temporarily withhold and consider a reduced dose with resumption of therapy.

Peripheral neuropathy:

The manufacturer recommends to temporarily withhold and consider a reduced dose with resumption of therapy.

The following adjustments have also been recommended (Ref):

Grade 1: Reduce dose by 50%.

Grade 2: Temporarily interrupt therapy; once resolved to ≤ grade 1, resume therapy with a 50% dosage reduction (if clinically appropriate).

Grade 3 or higher: Discontinue therapy.

Dosing: Older Adult

Refer to adult dosing. A reduced initial dose may be appropriate (depending on patient tolerance) in patients ≥75 years (Ref).

Dosing: Pediatric

(For additional information see "Thalidomide: Pediatric drug information")

AIDS-related aphthous stomatitis

AIDS-related aphthous stomatitis: Limited data available: Adolescents ≥13 years: Oral: 200 mg once daily at bedtime for 4 weeks or sooner if resolution. May be increased to 200 mg twice daily if no improvement after 4 weeks. Dosing based on double-blind, placebo-controlled trial by AIDS Clinical Trials Group (n=57; age: ≥13 years) which showed 55% healing in treatment group vs 7% in placebo (Ref).

Erythema nodosum leprosum, cutaneous

Erythema nodosum leprosum (ENL), cutaneous: Children ≥12 years and Adolescents: Oral:

Acute: Initial: 100 to 300 mg once daily at bedtime; continue until signs/symptoms subside (usually ~2 weeks), then taper off in 50 mg decrements every 2 to 4 weeks. For severe cases with moderate to severe neuritis, corticosteroids may be initiated with thalidomide (taper off and discontinue corticosteroids when neuritis improves).

Patients weighing <50 kg: Initiate at lower end of dosage range.

Severe cutaneous reaction or patients previously requiring high doses: May be initiated or increased to 400 mg/day at bedtime or in divided doses.

Maintenance (prevention/suppression, or with flares during tapering attempts): Maintain on the minimum dosage necessary to control the reaction; efforts to taper should be repeated every 3 to 6 months in decrements of 50 mg every 2 to 4 weeks.

Graft-versus-host disease, chronic, treatment

Graft-versus-host disease, chronic (refractory), treatment: Limited data available: Children ≥2 years and Adolescents: Oral: Initial: 3 to 6 mg/kg/day (maximum initial daily dose: 100 mg/day) at bedtime or in 2 to 4 divided doses before meals; may be adjusted at ≥2 week intervals based on patient response up to 12 mg/kg/day in 3 to 4 divided doses (maximum daily dose: 800 mg/day) (Ref); one trial used initial doses of 3 mg/kg/dose every 6 hours with dose adjustment to attain thalidomide concentration of ≥5 mcg/mL 2 hours postdose (Ref).

Inflammatory bowel disease, refractory

Inflammatory bowel disease, refractory: Limited data available: Note: Use reserved for patients who do not tolerate or have lost response to anti-tumor necrosis factor agents (Ref).

Weight-based dosing (Ref):

Children ≥2 years and Adolescents: Oral: 1.5 to 2.5 mg/kg/dose once daily, usually dosed in the evening; doses as high as 3 mg/kg/dose were described in a small case series. Maximum reported dose in clinical trials is 150 mg/day. Taper to lowest effective dose after remission is achieved.

Fixed dosing:

Adolescents: Oral: Initial: 50 mg once daily; if needed, may titrate dose in 50 mg increments to a maximum of 150 mg daily. Taper to lowest effective dose after remission is achieved (Ref). Fixed initial dosing adjusted for patient weight has also been described in the literature; patients weighing <30 kg received 50 mg once daily, patients weighing 30 to 60 kg received 100 mg once daily, and patients weighing ≥60 kg received 150 mg once daily (Ref).

Dosing based on clinical trials and case reports. In the largest trial, pediatric patients with refractory Crohn disease received fixed thalidomide doses based on weight (n=28; mean age: 14 ± 3.5 years) or placebo (n=26; mean age: 15 ± 3 years); at 8 weeks, 46.4% of patients receiving thalidomide achieved clinical remission, compared to only 11.5% of those receiving placebo (Ref). In another randomized clinical trial, pediatric patients with severe, refractory ulcerative colitis received fixed thalidomide doses based on weight (n=12; mean age: 11.7 years) or placebo (n=11; mean age: 12.9 years). At 8 weeks, 83.3% of patients receiving thalidomide achieved clinical remission, compared to only 18.2% receiving placebo (Ref). In a retrospective study of severe refractory Crohn disease patients (n=12; ages: 8 to 19 years), thalidomide was initiated at 50 mg once daily and titrated by 50 mg increments to a maximum dose of 150 mg. Markers of disease severity significantly improved and long-term follow up found a lower rate of surgical resection from baseline (Ref).

Systemic juvenile idiopathic arthritis, refractory

Systemic juvenile idiopathic arthritis, refractory: Limited data available: Children ≥3 years and Adolescents: Oral: Initial: 2 mg/kg/day rounded to the nearest 50 mg dose; if necessary, may increase at 2-week intervals to 3 to 5 mg/kg/day. Dosing based on a multicenter, open-labeled prospective study (n=13, age: 3 to 23 years); 11 of 13 patients showed sustained response with adequate disease control (Ref).

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Dosing adjustment for toxicity:

ENL, cutaneous:

Children ≥12 years and Adolescents:

ANC ≤750/mm3: Withhold treatment if clinically appropriate.

Angioedema or anaphylaxis: Permanently discontinue therapy.

Constipation, oversedation: Temporarily withhold; consider a reduced dose upon restarting therapy.

Dermatologic reactions:

Grade 2 or 3 rash: Consider interruption or discontinuation of therapy.

Grade 4 rash, skin exfoliation, bullae, or any severe dermatologic reaction: Permanently discontinue therapy.

Grade 3 or 4 adverse reactions: Consider dose reduction, delay, or discontinuation (based on clinical judgment).

Peripheral neuropathy: The manufacturer recommends to temporarily withhold or continue with a reduced dose.

The following adjustments have also been recommended for adult patients with multiple myeloma (Ref):

Grade 1: Reduce dose by 50%.

Grade 2: Temporarily interrupt therapy; once resolved to ≤ grade 1, resume therapy with a 50% dosage reduction (if clinically appropriate).

Grade 3 or higher: Discontinue therapy.

Dosing: Kidney Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer's labeling. Kidney impairment is not expected to alter drug exposure because <3.5% of dose is excreted as unchanged drug. In a study of 6 adult patients with end-stage renal disease on dialysis, although clearance was increased by dialysis, a supplemental dose was not needed (Ref).

Dosing: Liver Impairment: Pediatric

There are no dosage adjustments provided in manufacturer's labeling (has not been studied); however, thalidomide does not appear to undergo significant hepatic metabolism.

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Incidences of adverse reactions may include combination therapy with dexamethasone.

>10%:

Cardiovascular: Deep vein thrombosis (13%), edema (13%), ischemic heart disease (11%), peripheral edema (34%), venous thromboembolism (23%)

Endocrine & metabolic: Hyperglycemia (15%)

Gastrointestinal: Constipation (50%), dyspepsia (11%), nausea (13%)

Nervous system: Anxiety (12%), dizziness (23%), fatigue (21%), paresthesia (12%) peripheral neuropathy (≥10%; grade 3/4: 3%)

Neuromuscular & skeletal: Asthenia (24%), tremor (26%)

Respiratory: Pneumonia (15%)

1% to 10%:

Cardiovascular: Acute myocardial infarction (1%), atrial fibrillation (grade 3/4: 5%), bradycardia (≥3%), cerebrovascular accident (3%), hypotension (≥3%), orthostatic hypotension (≥3%), pulmonary embolism (grade 3/4: 7%), syncope (grade 3/4: 3%), transient ischemic attacks (≥3%)

Endocrine & metabolic: Hypokalemia (grade 3/4: 3%), weight gain (grade 3/4: 3%)

Gastrointestinal: Gastrointestinal perforation (≥3%; including diverticular and intestinal perforation), peritonitis (≥3%), vomiting (≥3%), xerostomia (≥3%)

Hematologic & oncologic: Neutropenia (grade 3/4: 3%)

Nervous system: Confusion (grade 3/4: 2%), depression (10%), drowsiness (≥3%), hypoesthesia (≥3%), mood changes (≥3%), peripheral sensory neuropathy (10%), polyneuropathy (≥3%), vertigo (grade 3/4: 2%)

Ophthalmic: Blurred vision (≥3%)

Respiratory: Bronchitis (≥3%), bronchopneumonia (grade 3/4: 3%)

Frequency not defined:

Cardiovascular: Facial edema

Dermatologic: Fungal dermatitis, maculopapular rash, nail disease, pruritus, skin rash

Gastrointestinal: Abdominal pain, diarrhea, oral candidiasis

Genitourinary: Impotence

Nervous system: Chills, headache, malaise, pain

Neuromuscular & skeletal: Back pain, neck pain, neck stiffness

Respiratory: Pharyngitis, rhinitis, sinusitis

Postmarketing:

Cardiovascular: ECG abnormality, myxedema, Raynaud’s disease, septic shock, sick sinus syndrome

Dermatologic: Erythema multiforme, erythema nodosum, Stevens-Johnson syndrome, toxic epidermal necrolysis

Endocrine & metabolic: Amenorrhea, galactorrhea not associated with childbirth, gynecomastia, hypercalcemia, hypomagnesemia, hyponatremia, hypothyroidism

Gastrointestinal: Aphthous stomatitis, biliary obstruction, gastric ulcer

Genitourinary: Oliguria, sexual disorder, urinary incontinence, uterine hemorrhage

Hematologic & Oncologic: Change in prothrombin time, chronic myelocytic leukemia, erythroleukemia, febrile neutropenia, Hodgkin’s lymphoma, lymphedema, lymphocytopenia, pancytopenia, petechia, purpuric disease, thrombocytopenia, tumor lysis syndrome

Hepatic: Increased serum alkaline phosphatase

Hypersensitivity: Anaphylaxis, angioedema, hypersensitivity reaction

Immunologic: Drug reaction with eosinophilia and systemic symptoms, organ transplant rejection

Infection: Cytomegalovirus disease, reactivation of HBV, sepsis, severe infection, varicella zoster infection, viral infection

Nervous system: Carpal tunnel syndrome, hangover effect, impaired consciousness, lethargy, loss of consciousness, mental status changes, migraine, Parkinson’s disease, progressive multifocal leukoencephalopathy, seizure (including tonic-clonic movements), status epilepticus, stupor, suicidal tendencies

Neuromuscular & skeletal: Foot-drop

Ophthalmic: Diplopia, nystagmus disorder

Otic: Auditory impairment

Renal: Acute kidney injury, renal failure syndrome

Respiratory: Interstitial pulmonary disease, pleural effusion, pulmonary hypertension

Contraindications

Hypersensitivity to thalidomide or any component of the formulation; pregnancy

Canadian labeling: Additional contraindications (not in the US labeling): Hypersensitivity to lenalidomide or pomalidomide; females at risk of becoming pregnant and male patients who are unable to follow or comply with conditions for use (refer to manufacturer labeling); breastfeeding

Warnings/Precautions

Concerns related to adverse effects:

• Bone marrow suppression: May cause leukopenia and neutropenia; avoid initiating therapy if ANC <750/mm3. Persistent neutropenia may require treatment interruption. Thrombocytopenia (including grades 3 and 4) has been reported; may require dose reduction, treatment delay, or discontinuation. Monitor for signs and symptoms of bleeding (including petechiae, epistaxis, and GI bleeding), especially if concomitant medication may increase the risk of bleeding. Monitor CBC with differential and platelets. Anemia has also been observed.

• Bradycardia: May cause bradycardia; use with caution when administering concomitantly with medications that may also decrease heart rate. May require thalidomide dose reduction or discontinuation.

• CNS effects: May cause dizziness, drowsiness, and/or somnolence; caution patients about performing tasks which require mental alertness (eg, operating machinery or driving). Avoid ethanol and concomitant medications that may exacerbate these symptoms; dose reductions may be necessary for excessive drowsiness or somnolence.

• Constipation: Constipation may commonly occur. May require treatment interruption or dosage reduction.

• Dermatologic reactions: Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and drug reaction with eosinophilia and systemic symptoms (DRESS) have been reported (may be fatal). Withhold or discontinue therapy for grade 2 or 3 rash. Permanently discontinue for grade 4 rash or if rash is exfoliative, bullous, or severe (eg, SJS, TEN, DRESS).

• Hepatotoxicity: Abnormal liver function tests, hepatitis, and cholestatic jaundice have been reported. Hepatotoxicity (including hepatocellular and cholestatic injury) has been observed rarely (case reports), with a mean time to development of 46 days; most events resolved after discontinuing thalidomide (Vilas-Boas 2012).

• Hypersensitivity: Hypersensitivity, including angioedema, anaphylactic reaction, and erythematous macular rash, possibly associated with fever, tachycardia, and hypotension, have been reported. Permanently discontinue for angioedema or anaphylaxis. May require treatment interruption for other severe reactions; discontinue if recurs with rechallenge.

• Orthostatic hypotension: May cause orthostatic hypotension; use with caution in patients who would not tolerate transient hypotensive episodes. When arising from a recumbent position, advise patients to sit upright for a few minutes prior to standing.

• Peripheral neuropathy: Thalidomide is commonly associated with peripheral neuropathy; may be irreversible. Neuropathy generally occurs following chronic use (over months), but may occur with short-term use; onset may be delayed. Use caution with other medications that may also cause peripheral neuropathy. Monitor for signs/symptoms of neuropathy monthly for the first 3 months of therapy and regularly thereafter. Electrophysiological testing may be considered at baseline and every 6 months to detect asymptomatic neuropathy. To limit further damage, immediately discontinue (if clinically appropriate) in patients who develop neuropathy. Reinitiate therapy only if neuropathy returns to baseline; may require dosage reduction or permanent discontinuation.

• Secondary malignancy: Increased incidence of second primary malignancies (SPMs), including acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS), has been observed in previously untreated multiple myeloma patients receiving thalidomide in combination with melphalan, and prednisone. In addition to AML and MDS, solid tumors have been reported with thalidomide maintenance treatment for multiple myeloma (Usmani 2012). Carefully evaluate patients for SPMs prior to and during treatment and manage as clinically indicated.

• Seizures: Seizures (including grand mal convulsions) have been reported in postmarketing data; monitor closely for clinical changes indicating potential seizure activity in patients with a history of seizures, concurrent therapy with drugs that alter seizure threshold, or conditions that predispose to seizures.

• Thromboembolic events: Thalidomide use for the treatment of multiple myeloma is associated with an increased risk for venous thromboembolism (VTE), including deep vein thrombosis (DVT) and pulmonary embolism. Ischemic heart disease, including MI and stroke, also occurred at a higher rate (compared to placebo) in myeloma patients receiving thalidomide plus dexamethasone who had not received prior treatment. Assess individual risk factors for thromboembolism and consider thromboprophylaxis. The American Society of Clinical Oncology guidelines for VTE prophylaxis and treatment recommend thromboprophylaxis for patients receiving thalidomide in combination with chemotherapy and/or dexamethasone; either aspirin or low molecular weight heparin (LMWH) is recommended for lower risk patient and LMWH is recommended for higher-risk patients (Lyman 2013; Lyman 2015). Anticoagulant prophylaxis should be individualized and selected based on the venous thromboembolism risk of the combination treatment regimen, using the safest and easiest to administer (Palumbo 2008). Monitor for signs/symptoms of thromboembolism and advise patients to seek immediate care if symptoms (shortness of breath, chest pain, arm/leg swelling) develop. Other medications that are also associated with thromboembolism should be used with caution.

• Tumor lysis syndrome: Patients with a high tumor burden may be at risk for tumor lysis syndrome; monitor closely; institute appropriate management for hyperuricemia.

Disease-related concerns:

• Heart failure: In a scientific statement from the American Heart Association, thalidomide has been determined to be an agent that may exacerbate underlying myocardial dysfunction (magnitude: minor) (AHA [Page 2016]).

• Multiple myeloma: An increase in mortality was noted in 2 clinical studies in patients with multiple myeloma who received pembrolizumab in combination with a thalidomide analogue and dexamethasone. Causes of death in the experimental arm (containing pembrolizumab, dexamethasone, and a thalidomide analogue [pomalidomide or lenalidomide]) included myocarditis, SJS, MI, pericardial hemorrhage, cardiac failure, respiratory tract infection, neutropenic sepsis, sepsis, multiple organ dysfunction, respiratory failure, intestinal ischemia, cardiopulmonary arrest, suicide, pulmonary embolism, cardiac arrest, pneumonia, sudden death, and large intestine perforation. Multiple myeloma is not an approved indication for PD-1 or PD-L1 blocking antibodies; pembrolizumab should not be used to treat multiple myeloma in combination with a thalidomide analogue and dexamethasone unless as part of a clinical trial.

Special populations:

• Older adult: Certain adverse reactions (constipation, fatigue, weakness, nausea, hypokalemia, hyperglycemia, DVT, pulmonary embolism, atrial fibrillation) are more likely in elderly patients.

• HIV-infected patients: Thalidomide is associated with increased viral loads in studies conducted prior to the use of antiretroviral therapy. Monitor viral load after the first and third months of therapy, and every 3 months thereafter.

Other warnings/precautions:

• Blood donation: Patients should not donate blood during thalidomide treatment and for 4 weeks after therapy discontinuation.

• REMS program: Prescribers and pharmacies must be certified with the program to prescribe or dispense thalidomide. Patients must sign an agreement and comply with the REMS program requirements.

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Capsule, Oral:

Thalomid: 50 mg, 100 mg

Thalomid: 150 mg [DSC], 200 mg [DSC] [contains fd&c blue #2 (indigotine,indigo carmine)]

Generic Equivalent Available: US

No

Pricing: US

Capsules (Thalomid Oral)

50 mg (per each): $205.08

100 mg (per each): $332.89

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Dosage Forms: Canada

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Capsule, Oral:

Thalomid: 50 mg, 100 mg

Thalomid: 200 mg [DSC] [contains fd&c blue #2 (indigotine,indigo carmine)]

Prescribing and Access Restrictions

Canada: Access to thalidomide is restricted through a controlled distribution program called RevAid. Only physicians and pharmacists enrolled in this program are authorized to prescribe or dispense thalidomide. Patients must be enrolled in the program by their physicians. Further information is available at www.RevAid.ca or by calling 1-888-738-2431.

Administration: Adult

Administer orally, preferably at bedtime once daily, at least 1 hour after the evening meal. Doses >400 mg/day may be given in divided doses at least 1 hour after meals. Swallow capsules whole with water. Capsules should not be opened or crushed.

Capsules should remain in blister pack until ingestion. If exposed to the powder content from broken capsules or body fluids from patients receiving thalidomide, the exposed area should be washed immediately and thoroughly with soap and water.

Missed doses: For missed doses, if <12 hours patient may receive dose; if >12 hours wait until next dose due.

Administration: Pediatric

Oral: Wear gloves to prevent cutaneous exposure. Do not open or crush capsules. Avoid extensive handling of capsules; capsules should remain in blister pack until ingestion. If skin exposure to the powder content from broken capsules or body fluids from patients receiving thalidomide, wash the exposed area with soap and water; if mucous membranes are exposed flush thoroughly with water. Administer with water, preferably at bedtime, once daily on an empty stomach, at least 1 hour after the evening meal. Doses at the higher end of the range (ie, 400 mg/day) may be given in divided doses. For missed doses, if <12 hours have passed, patient may receive dose; if >12 hours have passed, wait until next dose is due.

Hazardous Drugs Handling Considerations

Hazardous agent (NIOSH 2024 [table 1]).

Use appropriate precautions for receiving, handling, storage, preparation, dispensing, transporting, administration, and disposal. Follow NIOSH and USP 800 recommendations and institution-specific policies/procedures for appropriate containment strategy (NIOSH 2023; NIOSH 2024; USP-NF 2020).

Note: Facilities may perform risk assessment of some hazardous drugs to determine if appropriate for alternative handling and containment strategies (USP-NF 2020). Refer to institution-specific handling policies/procedures.

Medication Guide and/or Vaccine Information Statement (VIS)

An FDA-approved patient medication guide, which is available with the product information and at https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/020785s071lbl.pdf#page=21, must be dispensed with this medication.

Use: Labeled Indications

Erythema nodosum leprosum: Acute treatment of cutaneous manifestations of moderate to severe erythema nodosum leprosum; maintenance treatment for prevention and suppression of cutaneous manifestations of erythema nodosum leprosum recurrence.

Limitation of use: Thalidomide is not indicated as monotherapy for erythema nodosum leprosum treatment in the presence of moderate to severe neuritis.

Multiple myeloma: Treatment of newly diagnosed multiple myeloma (in combination with dexamethasone).

Use: Off-Label: Adult

AIDS-related aphthous stomatitis; Chronic graft-versus-host disease, refractory; Multiple myeloma, maintenance; Multiple myeloma, salvage; Systemic light chain amyloidosis; Waldenström macroglobulinemia

Medication Safety Issues
Sound-alike/look-alike issues:

Thalidomide may be confused with flutamide, lenalidomide, pomalidomide

Thalomid may be confused with Revlimid, thiamine

High alert medication:

The Institute for Safe Medication Practices (ISMP) includes this medication among its list of drugs (contraindicated in pregnancy) which have a heightened risk of causing significant patient harm when used in error (High-Alert Medications in Community/Ambulatory Care Settings).

International issues:

Thalomid [US, Canada] may be confused with Thilomide brand name for lodoxamide [Greece, Turkey]

Metabolism/Transport Effects

None known.

Drug Interactions

Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the drug interactions program by clicking on the “Launch drug interactions program” link above.

5-Aminosalicylic Acid Derivatives: May increase myelosuppressive effects of Myelosuppressive Agents. Risk C: Monitor

Abatacept: Anti-TNF Agents may increase immunosuppressive effects of Abatacept. Risk X: Avoid

Alizapride: May increase CNS depressant effects of CNS Depressants. Risk C: Monitor

Amisulpride (Oral): May increase CNS depressant effects of CNS Depressants. Risk C: Monitor

Anakinra: Anti-TNF Agents may increase adverse/toxic effects of Anakinra. An increased risk of serious infection during concomitant use has been reported. Risk X: Avoid

Antithyroid Agents: Myelosuppressive Agents may increase neutropenic effects of Antithyroid Agents. Risk C: Monitor

Articaine: May increase CNS depressant effects of CNS Depressants. Management: Consider reducing the dose of articaine if possible when used in patients who are also receiving CNS depressants. Monitor for excessive CNS depressant effects with any combined use. Risk D: Consider Therapy Modification

Azelastine (Nasal): May increase CNS depressant effects of CNS Depressants. Risk X: Avoid

BCG (Intravesical): Myelosuppressive Agents may decrease therapeutic effects of BCG (Intravesical). Myelosuppressive Agents may increase adverse/toxic effects of BCG (Intravesical). Risk X: Avoid

Benperidol: May increase CNS depressant effects of CNS Depressants. Risk C: Monitor

Bisphosphonate Derivatives: Angiogenesis Inhibitors (Systemic) may increase adverse/toxic effects of Bisphosphonate Derivatives. Specifically, the risk for osteonecrosis of the jaw may be increased. Risk C: Monitor

Blonanserin: CNS Depressants may increase CNS depressant effects of Blonanserin. Management: Use caution if coadministering blonanserin and CNS depressants; dose reduction of the other CNS depressant may be required. Strong CNS depressants should not be coadministered with blonanserin. Risk D: Consider Therapy Modification

Bradycardia-Causing Agents: May increase bradycardic effects of Bradycardia-Causing Agents. Risk C: Monitor

Brimonidine (Topical): May increase CNS depressant effects of CNS Depressants. Risk C: Monitor

Bromopride: May increase CNS depressant effects of CNS Depressants. Risk C: Monitor

Bromperidol: May increase CNS depressant effects of CNS Depressants. Risk X: Avoid

Buclizine: May increase CNS depressant effects of CNS Depressants. Risk C: Monitor

BusPIRone: May increase CNS depressant effects of CNS Depressants. Risk C: Monitor

Canakinumab: Anti-TNF Agents may increase adverse/toxic effects of Canakinumab. Specifically, the risk for serious infections and/or neutropenia may be increased. Risk X: Avoid

Cannabinoid-Containing Products: CNS Depressants may increase CNS depressant effects of Cannabinoid-Containing Products. Risk C: Monitor

Ceritinib: Bradycardia-Causing Agents may increase bradycardic effects of Ceritinib. Management: If this combination cannot be avoided, monitor patients for evidence of symptomatic bradycardia, and closely monitor blood pressure and heart rate during therapy. Risk D: Consider Therapy Modification

Certolizumab Pegol: Anti-TNF Agents may increase immunosuppressive effects of Certolizumab Pegol. Risk X: Avoid

Cetirizine (Systemic): May increase CNS depressant effects of CNS Depressants. Management: Consider avoiding this combination if possible. If required, monitor for excessive sedation or CNS depression, limit the dose and duration of combination therapy, and consider CNS depressant dose reductions. Risk D: Consider Therapy Modification

Chloramphenicol (Ophthalmic): May increase adverse/toxic effects of Myelosuppressive Agents. Risk C: Monitor

Chloramphenicol (Systemic): Myelosuppressive Agents may increase myelosuppressive effects of Chloramphenicol (Systemic). Risk X: Avoid

Chlorphenesin Carbamate: May increase adverse/toxic effects of CNS Depressants. Risk C: Monitor

Cladribine: May increase myelosuppressive effects of Myelosuppressive Agents. Risk X: Avoid

CNS Depressants: May increase CNS depressant effects of Thalidomide. Risk X: Avoid

Deferiprone: Myelosuppressive Agents may increase neutropenic effects of Deferiprone. Management: Avoid the concomitant use of deferiprone and myelosuppressive agents whenever possible. If this combination cannot be avoided, monitor the absolute neutrophil count more closely. Risk D: Consider Therapy Modification

DexAMETHasone (Systemic): May increase dermatologic adverse effects of Thalidomide. DexAMETHasone (Systemic) may increase thrombogenic effects of Thalidomide. Management: Consider using venous thromboembolism prophylaxis (eg, low-molecular-weight heparin or warfarin [INR 2.0 to 3.0]) in patients with multiple myeloma receiving both thalidomide and dexamethasone. Monitor for increased dermatologic adverse effects (eg, rash) Risk D: Consider Therapy Modification

Difelikefalin: May increase CNS depressant effects of CNS Depressants. Risk C: Monitor

Dihydralazine: CNS Depressants may increase hypotensive effects of Dihydralazine. Risk C: Monitor

Dimethindene (Topical): May increase CNS depressant effects of CNS Depressants. Risk C: Monitor

Dothiepin: May increase CNS depressant effects of CNS Depressants. Risk C: Monitor

DroPERidol: May increase CNS depressant effects of CNS Depressants. Management: Consider dose reductions of droperidol or of other CNS agents (eg, opioids, barbiturates) with concomitant use. Risk D: Consider Therapy Modification

Emedastine (Systemic): May increase CNS depressant effects of CNS Depressants. Management: Consider avoiding this combination if possible. If required, monitor for excessive sedation or CNS depression, limit the dose and duration of combination therapy, and consider CNS depressant dose reductions. Risk C: Monitor

Entacapone: May increase CNS depressant effects of CNS Depressants. Risk C: Monitor

Erythropoiesis-Stimulating Agents: May increase thrombogenic effects of Thalidomide. Risk C: Monitor

Estrogen Derivatives: May increase thrombogenic effects of Thalidomide. Risk C: Monitor

Etrasimod: May increase bradycardic effects of Bradycardia-Causing Agents. Risk C: Monitor

Fexinidazole: Bradycardia-Causing Agents may increase arrhythmogenic effects of Fexinidazole. Risk X: Avoid

Fexinidazole: Myelosuppressive Agents may increase myelosuppressive effects of Fexinidazole. Risk X: Avoid

Fingolimod: Bradycardia-Causing Agents may increase bradycardic effects of Fingolimod. Management: Consult with the prescriber of any bradycardia-causing agent to see if the agent could be switched to an agent that does not cause bradycardia prior to initiating fingolimod. If combined, perform continuous ECG monitoring after the first fingolimod dose. Risk D: Consider Therapy Modification

Flunarizine: CNS Depressants may increase CNS depressant effects of Flunarizine. Risk X: Avoid

Hormonal Contraceptives: May increase thrombogenic effects of Thalidomide. Risk C: Monitor

Ivabradine: Bradycardia-Causing Agents may increase bradycardic effects of Ivabradine. Risk C: Monitor

Ixabepilone: May increase CNS depressant effects of CNS Depressants. Risk C: Monitor

Kava Kava: May increase CNS depressant effects of CNS Depressants. Risk C: Monitor

Ketotifen (Systemic): May increase CNS depressant effects of CNS Depressants. Risk C: Monitor

Kratom: May increase CNS depressant effects of CNS Depressants. Risk X: Avoid

Landiolol: Bradycardia-Causing Agents may increase bradycardic effects of Landiolol. Risk X: Avoid

Levocetirizine: May increase CNS depressant effects of CNS Depressants. Risk C: Monitor

Linezolid: May increase myelosuppressive effects of Myelosuppressive Agents. Risk C: Monitor

Lisuride: May increase CNS depressant effects of CNS Depressants. Risk C: Monitor

Lofexidine: May increase CNS depressant effects of CNS Depressants. Risk C: Monitor

Magnesium Sulfate: May increase CNS depressant effects of CNS Depressants. Risk C: Monitor

Mequitazine: May increase CNS depressant effects of CNS Depressants. Risk C: Monitor

Metergoline: May increase CNS depressant effects of CNS Depressants. Risk C: Monitor

Metoclopramide: May increase CNS depressant effects of CNS Depressants. Risk C: Monitor

MetyroSINE: CNS Depressants may increase sedative effects of MetyroSINE. Risk C: Monitor

Midodrine: May increase bradycardic effects of Bradycardia-Causing Agents. Risk C: Monitor

Minocycline (Systemic): May increase CNS depressant effects of CNS Depressants. Risk C: Monitor

Moxonidine: May increase CNS depressant effects of CNS Depressants. Risk C: Monitor

Nabilone: May increase CNS depressant effects of CNS Depressants. Risk X: Avoid

Noscapine: CNS Depressants may increase adverse/toxic effects of Noscapine. Risk X: Avoid

Olaparib: Myelosuppressive Agents may increase myelosuppressive effects of Olaparib. Risk C: Monitor

Olopatadine (Nasal): May increase CNS depressant effects of CNS Depressants. Risk X: Avoid

Opicapone: May increase CNS depressant effects of CNS Depressants. Risk C: Monitor

Opioid Agonists: CNS Depressants may increase CNS depressant effects of Opioid Agonists. Management: Avoid concomitant use of opioid agonists and benzodiazepines or other CNS depressants when possible. These agents should only be combined if alternative treatment options are inadequate. If combined, limit the dosages and duration of each drug. Risk D: Consider Therapy Modification

Opipramol: May increase CNS depressant effects of CNS Depressants. Risk C: Monitor

Orphenadrine: CNS Depressants may increase CNS depressant effects of Orphenadrine. Risk X: Avoid

Oxomemazine: May increase CNS depressant effects of CNS Depressants. Risk X: Avoid

Ozanimod: May increase bradycardic effects of Bradycardia-Causing Agents. Risk C: Monitor

Pamidronate: Thalidomide may increase nephrotoxic effects of Pamidronate. Risk C: Monitor

Paraldehyde: CNS Depressants may increase CNS depressant effects of Paraldehyde. Risk X: Avoid

Pembrolizumab: May increase adverse/toxic effects of Thalidomide Analogues. Specifically, mortality may be increased when this combination is used for treatment of refractory multiple myeloma. Risk X: Avoid

Periciazine: May increase CNS depressant effects of CNS Depressants. Risk C: Monitor

Pipamperone: May increase adverse/toxic effects of CNS Depressants. Risk C: Monitor

Piribedil: CNS Depressants may increase CNS depressant effects of Piribedil. Risk C: Monitor

Ponesimod: Bradycardia-Causing Agents may increase bradycardic effects of Ponesimod. Management: Avoid coadministration of ponesimod with drugs that may cause bradycardia when possible. If combined, monitor heart rate closely and consider obtaining a cardiology consult. Do not initiate ponesimod in patients on beta-blockers if HR is less than 55 bpm. Risk D: Consider Therapy Modification

Pramipexole: CNS Depressants may increase sedative effects of Pramipexole. Risk C: Monitor

Procarbazine: May increase CNS depressant effects of CNS Depressants. Risk C: Monitor

Promazine: May increase myelosuppressive effects of Myelosuppressive Agents. Risk C: Monitor

Rilmenidine: May increase CNS depressant effects of CNS Depressants. Risk C: Monitor

Rilonacept: Anti-TNF Agents may increase adverse/toxic effects of Rilonacept. Risk X: Avoid

Ropeginterferon Alfa-2b: CNS Depressants may increase adverse/toxic effects of Ropeginterferon Alfa-2b. Specifically, the risk of neuropsychiatric adverse effects may be increased. Management: Avoid coadministration of ropeginterferon alfa-2b and other CNS depressants. If this combination cannot be avoided, monitor patients for neuropsychiatric adverse effects (eg, depression, suicidal ideation, aggression, mania). Risk D: Consider Therapy Modification

Ropeginterferon Alfa-2b: Myelosuppressive Agents may increase myelosuppressive effects of Ropeginterferon Alfa-2b. Management: Avoid coadministration of ropeginterferon alfa-2b and other myelosuppressive agents. If this combination cannot be avoided, monitor patients for excessive myelosuppressive effects. Risk D: Consider Therapy Modification

ROPINIRole: CNS Depressants may increase sedative effects of ROPINIRole. Risk C: Monitor

Rotigotine: CNS Depressants may increase sedative effects of Rotigotine. Risk C: Monitor

Siponimod: Bradycardia-Causing Agents may increase bradycardic effects of Siponimod. Management: Avoid coadministration of siponimod with drugs that may cause bradycardia. If combined, consider obtaining a cardiology consult regarding patient monitoring. Risk D: Consider Therapy Modification

Valerian: May increase CNS depressant effects of CNS Depressants. Risk C: Monitor

Vedolizumab: Anti-TNF Agents may increase adverse/toxic effects of Vedolizumab. Risk X: Avoid

Zoledronic Acid: Thalidomide may increase adverse/toxic effects of Zoledronic Acid. Specifically, the risk for ONJ or renal impairment may be increased. Risk C: Monitor

Reproductive Considerations

[US Boxed Warning]: Thalidomide should never be used by females who could become pregnant while taking thalidomide. When alternative treatments are not available, females of reproductive potential may be treated when adequate precautions are taken to avoid pregnancy. [US Boxed Warning]: In an effort to make the chance of embryo-fetal exposure to thalidomide as negligible as possible, thalidomide is approved for marketing only through a special restricted distribution program: Thalomid REMS program, approved by the Food and Drug Administration. Information about Thalomid and the Thalomid REMS program is available at https://www.thalomidrems.com or by calling the REMS Call Center 1-888-423-5436.

Females of reproductive potential must avoid pregnancy beginning 4 weeks prior to therapy, during therapy, during therapy interruptions, and for ≥4 weeks after therapy is discontinued. A negative pregnancy test (sensitivity of ≥50 milliunits/mL) 10 to 14 days prior to therapy, within 24 hours prior to beginning therapy, weekly during the first 4 weeks, and every 4 weeks (every 2 weeks for females with irregular menstrual cycles) thereafter is required for women of childbearing potential. Two forms of reliable contraception must be used simultaneously in females of reproductive potential (unless they commit to total abstinence from heterosexual intercourse): One highly effective method (eg, tubal ligation, IUD, hormonal birth control methods) or partners vasectomy; plus one additional effective method (eg, male latex or synthetic condom, diaphragm, or cervical cap). Contraception is required even in cases of infertility (unless due to hysterectomy). Thalidomide must be immediately discontinued for a missed period, abnormal pregnancy test, or abnormal menstrual bleeding. Some forms of contraception may not be appropriate in certain patients. An intrauterine device or implantable contraceptive may increase the risk of infection or bleeding; estrogen-containing products may increase the risk of thromboembolism.

Females of reproductive potential (including health care workers and caregivers) must also avoid contact with thalidomide capsules.

Thalidomide is also present in the semen of males. Males taking thalidomide (even those vasectomized) must use a latex or synthetic condom during any sexual contact with women of childbearing potential and for up to 28 days following discontinuation of therapy. Males taking thalidomide must not donate sperm.

Pregnancy Considerations

Use is contraindicated in pregnant females. [US Boxed Warning]: If thalidomide is taken during pregnancy, it can cause severe birth defects or embryo-fetal death. Thalidomide should never be used by females who are pregnant or who could become pregnant while taking thalidomide. Even a single dose (1 capsule [regardless of strength]) taken by a pregnant woman during pregnancy may cause severe birth defects. Thalidomide induces a high frequency of severe and life-threatening birth defects. Anomalies observed in humans include amelia, phocomelia, bone defects, ear and eye abnormalities, facial palsy, congenital heart defects, urinary and genital tract malformations; mortality in ~40% of infants at or shortly after birth has also been reported. Discontinue thalidomide immediately if pregnancy occurs during treatment and refer patient to a reproductive toxicity specialist.

A pregnancy exposure registry has been created to monitor outcomes in females exposed to thalidomide during pregnancy and female partners of male patients and to understand the root cause for the pregnancy. The pregnancy exposure registry may be contacted at 1-888-423-5436. If pregnancy occurs during treatment, thalidomide must be immediately discontinued and the patient referred to a reproductive toxicity specialist. Any suspected fetal exposure to thalidomide must be reported to the FDA via the MedWatch program (1-800-FDA-1088) and to the REMS Call Center (1-888-423-5436).

Breastfeeding Considerations

It is not known if thalidomide is present in breast milk. Due to the potential for serious adverse reactions in the breastfed infant, breastfeeding is not recommended by the manufacturer.

Monitoring Parameters

CBC with differential, platelets; thyroid function tests (TSH at baseline then every 2 to 3 months during thalidomide treatment [Hamnvik 2011]). Hepatic function tests (periodic; particularly with preexisting hepatic dysfunction or concomitant use of drugs associated with hepatotoxicity). In HIV-seropositive patients: viral load after 1 and 3 months, then every 3 months. Pregnancy testing (sensitivity of at least 50 milliunits/mL) is required 10 to 14 days prior to therapy, within 24 hours prior to initiation of therapy, weekly during the first 4 weeks, then every 4 weeks in females with regular menstrual cycles or every 2 weeks in females with irregular menstrual cycles. Monitor for signs of neuropathy monthly for the first 3 months, then periodically during treatment; consider monitoring of sensory nerve application potential amplitudes (at baseline and every 6 months) to detect asymptomatic neuropathy. Monitor for signs and symptoms of thromboembolism (shortness of breath, chest pain, arm/leg swelling), tumor lysis syndrome, bradycardia, and syncope; monitor for clinical changes indicating potential seizure activity (in patients with a history of seizure). Monitor adherence.

The American Society of Clinical Oncology hepatitis B virus (HBV) screening and management provisional clinical opinion (ASCO [Hwang 2020]) recommends HBV screening with hepatitis B surface antigen, hepatitis B core antibody, total Ig or IgG, and antibody to hepatitis B surface antigen prior to beginning (or at the beginning of) systemic anticancer therapy; do not delay treatment for screening/results. Detection of chronic or past HBV infection requires a risk assessment to determine antiviral prophylaxis requirements, monitoring, and follow-up.

Reference Range

Graft-vs-host disease: Therapeutic plasma thalidomide levels are 5 to 8 mcg/mL, although it has been suggested that lower plasma levels (0.5 to 1.5 mcg/mL) may be therapeutic; peak serum thalidomide level after a 200 mg dose: 1.8 mcg/mL

Mechanism of Action

Thalidomide exhibits immunomodulatory and antiangiogenic characteristics; immunologic effects may vary based on conditions. Thalidomide may suppress excessive tumor necrosis factor-alpha production in patients with erythema nodosum leprosum, yet may increase plasma tumor necrosis factor-alpha levels in HIV-positive patients. In multiple myeloma, thalidomide is associated with an increase in natural killer cells and increased levels of interleukin-2 and interferon gamma. Other proposed mechanisms of action include suppression of angiogenesis, prevention of free-radical-mediated DNA damage, increased cell mediated cytotoxic effects, and altered expression of cellular adhesion molecules.

Pharmacokinetics (Adult Data Unless Noted)

Absorption: Slow, good

Distribution: Vd: 1.1 L/kg

Protein binding: 55% to 66%

Metabolism: Minimal (unchanged drug is the predominant circulating component)

Half-life elimination: 5.5 to 7.3 hours

Time to peak, plasma: ~2 to 5 hours

Excretion: Urine (~92%; <4% of the dose as unchanged drug); feces (<2%)

Pharmacokinetics: Additional Considerations (Adult Data Unless Noted)

Hansen disease: Based on data from a small study, in relation to healthy subjects, patients with Hansen disease may have increased thalidomide bioavailability, manifested as increased area under the curve and peak plasma levels.

Brand Names: International
International Brand Names by Country
For country code abbreviations (show table)

  • (AT) Austria: Thalidomide celgene | Thalidomide pharmion;
  • (BD) Bangladesh: Midothal;
  • (BE) Belgium: Thalidomide celgene | Thalidomide pharmion;
  • (CH) Switzerland: Thalidomide pharmion;
  • (CI) Côte d'Ivoire: Thalide;
  • (CZ) Czech Republic: Thalidomide celgene;
  • (DE) Germany: Thalidomide celgene;
  • (DO) Dominican Republic: Tadomid;
  • (EE) Estonia: Sauramide | Thalidomide celgene;
  • (EG) Egypt: Thalidomide pharmion;
  • (ES) Spain: Talidomida accord | Thalidomide celgene;
  • (FR) France: Thalidomide accord | Thalidomide bms | Thalidomide celgene | Thalidomide laphal;
  • (GB) United Kingdom: Thalidomide pharmion;
  • (GR) Greece: Thalidomide celgene | Thalix;
  • (HR) Croatia: Thalidomide celgene;
  • (HU) Hungary: Thalidomide accord | Thalidomide celgene;
  • (IN) India: Mythal | Thaangio | Thaldo | Thalide | Thaliglob | Thalinat | Thalix | Thaloda | Thalogen | Thaloma | Thycad;
  • (IT) Italy: Talidomide accord | Thalidomide celgene;
  • (JP) Japan: Thaled;
  • (KR) Korea, Republic of: Celgene thalidomide | Thalide | Thaliglob | Thaloma;
  • (LB) Lebanon: Thalidomide pharmion;
  • (LT) Lithuania: Thalidomide celgene;
  • (LU) Luxembourg: Thalidomide celgene;
  • (LV) Latvia: Thalidomide celgene;
  • (MY) Malaysia: Domide | Thado | Thalix;
  • (NL) Netherlands: Thalidomide milstein;
  • (NO) Norway: Sauramide | Thalidomide bms | Thalidomide celgene;
  • (NZ) New Zealand: Thalomid;
  • (PE) Peru: Thalidokem;
  • (PH) Philippines: Thalidomide Invida;
  • (PK) Pakistan: Bludomide | Medomide | Thalimid | Tld;
  • (PL) Poland: Sauramide | Thalidomide celgen | Thalivax | Thalix;
  • (PT) Portugal: Talidomida | Talidomida accord | Talidomida Celgene;
  • (PY) Paraguay: Talidomida imedic;
  • (QA) Qatar: Talidex;
  • (RO) Romania: Talidomida accord;
  • (RU) Russian Federation: Thalidomide celgen;
  • (SE) Sweden: Thalidomide celgene | Thalidomide pharmion;
  • (SG) Singapore: Domide;
  • (SI) Slovenia: Talidomid accord;
  • (TH) Thailand: Thado;
  • (TW) Taiwan: Thado | Thali
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