thalidomide (Rx)

Brand and Other Names:Thalomid
  • Print

Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

capsule

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

Erythema Nodosum Leprosum (ENL)

Indicated for acute treatment of cutaneous manifestations of moderate-to-severe erythema nodosum leprosum (ENL); also indicated as maintenance therapy for prevention and suppression of cutaneous recurrence

Also indicated as maintenance therapy for prevention and suppression of the cutaneous manifestations of ENL recurrence

Note: Not indicated as monotherapy for ENL in the presence of moderate-to-severe neuritis

Initial: 100-300 mg PO qDay with water, preferably at bedtime at least 1 hr after evening meal

Weight <50 kg: Initiate at low end of dose range

Severe cutaneous ENL or patient previously requiring higher doses: May start at 400 mg/day (qHS or in divided doses at least 1 hr pc)

Consider concomitant use of corticosteroids in patients with moderate-to-severe neuritis associated with a severe ENL reaction; taper steroid and discontinued when neuritis has ameliorated

Dose tapering

  • Continue thalidomide until active symptoms have subsided, usually at least 2 weeks, then titrate downward by 50-mg decrements q2-4 weeks
  • Patients who have a documented history of requiring prolonged maintenance treatment to prevent cutaneous ENL recurrence or who flare during tapering should be maintained on the minimum dose necessary to control the reaction; attempt tapering off medication should q3-6 months by 50-mg decrements q2-4 weeks

Multiple Myeloma

Indicated in combination with dexamethasone for newly diagnosed multiple myeloma (MM)

200 mg PO qHS in 28-day cycles PLUS

Dexamethasone 40 mg PO on Days 1-4, 9-12, and 17-20 of each 28-day cycle

Dosage Modifications

Interrupt Dosing: Constipation, somnolence, or peripheral neuropathy; consider dose reduction upon treatment resumption

Grade 3-4 adverse effects: Consider dose reduction, delay, or discontinuation

Permanently discontinue: Angioedema, anaphylaxis, Grade 4 rash, skin exfoliation, bullae, any other severe dermatologic reactions, or other reactions based on clinical judgment

Dosing Considerations

Drug prescribing to females of reproductive potential is contingent upon initial and continued negative results of pregnancy testing

Females of reproductive potential must avoid pregnancy for at least 4 weeks before beginning therapy, during therapy, during dose interruptions, and for at least 4 weeks after completing therapy

Must only be administered in compliance with all of the terms outlined in the Thalomid REMS program

May only be prescribed by prescribers certified and may only be dispensed by pharmacists certified with the Thalomid REMS program

Orphan Designations

Graft versus host disease (GVHD)

  • Orphan designation for prevention and treatment of GVHD
  • Orphan sponsor: Andrulis Research Corporation; 11800 Baltimore Avenue, Suite 113; Beltsville, MD 20705

Mycobacterial infection

  • Orphan designation for treatment of the clinical manifestations of mycobacterial infection caused by Mycobacterium tuberculosis and non-tuberculous mycobacteria
  • Orphan sponsor: Celgene Corporation; PO Box 4914; 7 Powder Horn Drive; Warren, NJ 07059

Recurrent aphthous ulcers

  • Orphan designation for treatment and prevention of recurrent aphthous ulcers in severely, terminally immunocompromised patients
  • Orphan sponsor: Andrulis Research Corporation; 11800 Baltimore Avenue, Suite 113; Beltsville, MD 20705

Severe recurrent aphthous stomatitis

  • Orphan designation for treatment of severe recurrent aphthous stomatitis in severely, terminally immunocompromised patients
  • Orphan sponsor: Celgene Corporation; PO Box 4914; 7 Powder Horn Drive; Warren, NJ 07059

Primary brain malignancies

  • Orphan designation for treatment of primary brain malignancies
  • Orphan sponsor: Celgene Corporation; 7 Powder Horn Dr; Warren, NJ 07059

HIV-associated wasting syndrome

  • Indicated for treatment of HIV-associated wasting syndrome
  • Orphan sponsor: Celgene Corporation; PO Box 4914; 7 Powder Horn Drive; Warren, NJ 07059

Crohn disease

  • Orphan designation for treatment of Crohn disease
  • Orphan sponsor: Celgene Corporation; 7 Powder Horn Dr; Warren, NJ 07059

Kaposi sarcoma

  • Orphan designation for treatment of Kaposi sarcoma
  • Orphan sponsor: Celgene Corporation; 7 Powder Horn Dr; Warren, NJ 07059

Myelodysplastic syndrome

  • Orphan designation for treatment of myelodysplastic syndrome
  • Orphan sponsor: Celgene Corporation; 86 Morris Avenue; Summit, NJ 07901

Hematopoietic stem cell transplantation

  • Orphan designation for conditioning treatment prior to hematopoietic stem cell transplantation
  • Orphan sponsor: Adienne Srl; 24128 Bergamo; 64/B Broseta Street; Bergamo; ITALY

Telangiectasia

  • Orphan designation for hereditary hemorrhagic telangiectasia
  • Orphan sponsor: PlumeStars s.r.l.; Via Lago Scuro11 43124; Parma; Italy

Dosage Forms & Strengths

capsule

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

Erythema Nodosum Leprosum (ENL)

Indicated for acute treatment of cutaneous manifestations of moderate-to-severe erythema nodosum leprosum (ENL); also indicated as maintenance therapy for prevention and suppression of cutaneous recurrence

Also indicated as maintenance therapy for prevention and suppression of the cutaneous manifestations of ENL recurrence

Note: Not indicated as monotherapy for ENL in the presence of moderate-to-severe neuritis

<12 years: Safety and efficacy not established

≥12 years

  • Initial: 100-300 mg PO qDay with water, preferably at bedtime at least 1 hr after evening meal
  • Weight <50 kg: Initiate at low end of dose range
  • Severe cutaneous ENL or patient previously requiring higher doses: May start at 400 mg/day (qHS or in divided doses at least 1 hr pc)
  • Consider concomitant use of corticosteroids in patients with moderate-to-severe neuritis associated with a severe ENL reaction; taper steroid and discontinued when neuritis has ameliorated

Dose tapering

  • Continue thalidomide until active symptoms have subsided, usually at least 2 weeks, then titrate downward by 50-mg decrements q2-4 weeks
  • Patients who have a documented history of requiring prolonged maintenance treatment to prevent cutaneous ENL recurrence or who flare during tapering should be maintained on the minimum dose necessary to control the reaction; attempt tapering off medication should q3-6 months by 50-mg decrements q2-4 weeks

Dosage Modifications

Interrupt Dosing: Constipation, somnolence, or peripheral neuropathy; consider dose reduction upon treatment resumption

Grade 3-4 adverse effects: Consider dose reduction, delay, or discontinuation

Permanently discontinue: Angioedema, anaphylaxis, Grade 4 rash, skin exfoliation, bullae, any other severe dermatologic reactions, or other reactions based on clinical judgment

Dosing Considerations

Drug prescribing to females of reproductive potential is contingent upon initial and continued negative results of pregnancy testing

Females of reproductive potential must avoid pregnancy for at least 4 weeks before beginning therapy, during therapy, during dose interruptions, and for at least 4 weeks after completing therapy

Must only be administered in compliance with all of the terms outlined in the Thalomid REMS program

May only be prescribed by prescribers certified and may only be dispensed by pharmacists certified with the Thalomid REMS program

Next:

Interactions

Interaction Checker

and thalidomide

No Results

     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

            All Interactions Sort By:
             activity indicator 
            Previous
            Next:

            Adverse Effects

            >10% (MM All Grades)

            Fatigue (21-79%)

            Hypocalcemia (72%)

            Edema (13-56%)

            Constipation (50-55%)

            Neuropathy-sensory (54%)

            Dyspnea (42%)

            Muscle weakness (40%)

            Leukocytes decreased (35%)

            Peripheral edema (34%)

            Neutrophils decreased (31%)

            Rash/desquamation (30%)

            Confusion (28%)

            Anorexia (28%)

            Nausea (13-28%)

            Anxiety/agitation (26%)

            Tremor (26%)

            Fever (24%)

            Asthenia (24%)

            Weight loss (23%)

            Weight gain (22%)

            Thrombosis/embolism (22%)

            Neuropathy-motor (22%)

            Dry skin (21%)

            Dizziness/lightheadedness (20-23%)

            Myalgia (17%)

            Depressed level of consciousness (16%)

            Pneumonia (15%)

            Hyperglycemia (15%)

            Bilirubin (14%)

            Arthralgia (13%)

            Deep vein thrombosis (13%)

            Dry mouth (12%)

            Paresthesia (12%)

            Anxiety (12%)

            Dyspepsia (11%)

            >10% (ENL)

            Somnolence (36-38%)

            Rash (21-25%)

            Leukopenia (17-25%)

            Fever (17-22%)

            Asthenia (6-22%)

            Headache (13-19%)

            Diarrhea (11-19%)

            Dizziness (4-19%)

            Maculopapular rash (4-19%)

            Paresthesia (6-16%)

            Sweating (13%)

            Anemia (6-13%)

            Lymphadenopathy (6-13%)

            Nausea (4-13%)

            SGOT increased (3-13%)

            Hematuria (11%)

            Postmarketing Reports

            Blood and lymphatic: Decreased white blood cell counts including febrile neutropenia, changes in prothrombin time, pancytopenia, chronic myelogenous leukemia, nodular sclerosing Hodgkin disease, erythroleukemia, lymphedema, and lymphopenia

            Body as a whole: Hangover effect

            Cardiovascular System: Sick sinus syndrome, EKG abnormalities, pulmonary hypertension

            Digestive system: Intestinal perforation, gastrointestinal perforations, bile duct obstruction, stomach ulcer, aphthous, stomatitis

            Ear and labyrinthine disorders: Hearing impairment

            Immune system disorders: Hypersensitivity including anaphylaxis, solid organ transplant rejection

            Infections and infestations: Severe infections (eg, fatal sepsis including septic shock) and viral infections (including varicella zoster virus, cytomegalovirus, and hepatitis B virus reactivation)

            Metabolic and endocrine: Electrolyte imbalance including hypercalcemia, hyponatremia and hypomagnesemia, hypothyroidism, increased alkaline phosphatase, tumor lysis syndrome, myxedema

            Nervous system: Changes in mental status or mood including suicide attempts, disturbances in consciousness including lethargy, loss of consciousness or stupor, seizures including grand mal convulsions and status epilepticus, Parkinson disease, stroke, carpal tunnel, Raynaud syndrome, migraine, foot drop

            Renal and urinary disorders: Renal failure, acute renal failure, oliguria, enuresis

            Reproductive system and breast disorders: amenorrhea, sexual dysfunction, galactorrhea, gynecomastia, metrorrhagia

            Respiratory system: Pleural effusion, interstitial lung disease

            Skin and appendages: Erythema multiforme, erythema nodosum, toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS), purpura, petechiae

            Special senses: Diplopia, nystagmus

            Previous
            Next:

            Warnings

            Black Box Warnings

            Embryo-fetal toxicity

            • If taken during pregnancy, thalidomide can cause severe birth defects or embryo-fetal death
            • Never prescribe for females who are pregnant or who could be pregnant while taking the drug
            • Even a single dose (1 capsule, regardless of strength) taken by a pregnant woman during her pregnancy can cause severe birth defects
            • Pregnancy must be excluded before initiating treatment
            • Prevent pregnancy thereafter by the use of 2 reliable contraceptive methods
            • Prescribers must be certified with the THALOMID REMS program by enrolling and complying with the REMS requirements

            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

            Contraindications

            Hypersensitivity

            Pregnancy; highly teratogenic (even a single dose)

            Cautions

            Powerful human teratogen that induces a high frequency of severe and life-threatening birth defects, even after a single dose; mortality at or shortly after birth reported in ~40% of infants; when there is no satisfactory alternant treatment, females of reproductive potential may be treated with thalidomide provided adequate precautions are taken to avoid pregnancy; only available through the Thalomid REMS program (see Black Box Warnings, Contraindications, and Pregnancy)

            Do not donate blood during treatment and for 4 weeks following discontinuation of the drug because the blood might be given to a pregnant female patient whose fetus must not be exposed thalidomide

            Increased risk of venous thromboembolism reported in patients with multiple myeloma (MM) treatment (see Black Box Warnings)

            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 bradycardia and possible syncope; dose reduction or discontinuation may be required

            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 reported, including angioedema and anaphylaxis; signs and symptoms include the occurrence of erythematous macular rash, possibly associated with fever, tachycardia, and hypotension, and if severe, may necessitate therapy interruption; if the reaction recurs when dosing is resumed, discontinue thalidomide; do not resume treatment after angioedema and anaphylaxis

            Increased mortality was observed in 2 randomized clinical trials in patients with multiple myeloma when pembrolizumab was added to a thalidomide analogue and dexamethasone; treatment with a PD-1 or PD-L1 blocking antibody in combination with a thalidomide analogue plus dexamethasone is not recommended outside of controlled clinical trials

            Severe cutaneous reactions

            • Severe cutaneous reactions including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and drug reaction with eosinophilia and systemic symptoms (DRESS) reported
            • DRESS may present with cutaneous reaction (such as rash or exfoliative dermatitis), eosinophilia, fever, and/or lymphadenopathy with systemic complications such as hepatitis, nephritis, pneumonitis, myocarditis, and/or pericarditis; which can be fatal; consider interruption or discontinuation or therapy for Grade 2-3 skin rash
            • Discontinue therapy for Grade 4 rash, exfoliative or bullous rash, or for other severe cutaneous reactions such as SJS, TEN, or DRESS; do not resume therapy

            Drug interaction overview

            • Avoid coadministration with other drugs that may cause additive sedation (eg, opioids, antihistamines, antipsychotics, antianxiety agents, CNS depressants)
            • Additive effects may occur if coadministered with drugs that cause peripheral neuropathy (eg, bortezomib, amiodarone, cisplatin, docetaxel, paclitaxel, vincristine, disulfiram, phenytoin, metronidazole, alcohol); use cautiously
            • Hormonal contraceptives increase risk of thromboembolism; unknown if coadministration further increases this risk
            • Caution if erythropoietic agents or other agents that increase risk of thromboembolism (eg, estrogen containing therapies) are coadministered in patients receiving thalidomide with dexamethasone for multiple myeloma
            • Drugs that interfere with hormonal contraception
              • Concomitant use of HIV-protease inhibitors, griseofulvin, modafinil, penicillins, rifampin, rifabutin, phenytoin, carbamazepine, or certain herbal supplements (eg, St. John’s Wort) with hormonal contraceptive agents may reduce the effectiveness of the contraception up to 1 month after discontinuation of these concomitant therapies
              • Females requiring treatment with 1 or more of these drugs must use 2 OTHER effective or highly effective methods of contraception while taking thalidomide
            • Bradycardia
              • Drugs which slow cardiac conduction may cause an additive bradycardic effect if coadministered with thalidomide and should be used with caution
              • Cardiovascular medications which may cause bradycardia include calcium channel blockers, beta blockers, alpha/beta-adrenergic blockers, and digoxin
              • Noncardiac drugs that may cause bradycardia include H2 blockers, lithium, TCAs, and neuromuscular blockers
            Previous
            Next:

            Pregnancy & Lactation

            Pregnancy

            Potent teratogen; contraindicated during pregnancy (see Black Box Warnings; Contraindications, Cautions)

            Based on the mechanism of action, human and animal data, thalidomide can cause embryo-fetal harm when administered to pregnant female

            It is a powerful human teratogen, inducing a high frequency of severe and life-threatening birth defects, even after a single dose

            Mortality at or shortly after birth reported in ~40% of infants

            If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential risk to a fetus

            If pregnancy occurs during treatment, discontinue the drug immediately

            Contraception

            • Females
              • Females must commit either to abstain continuously from heterosexual sexual intercourse or to use 2 methods of reliable birth control, beginning 4 weeks before initiating treatment, during therapy, during dose interruptions, and continuing for 4 weeks following therapy discontinuation
              • 2 negative pregnancy tests must be obtained before initiating; the first test should be performed within 10-14 days and the second test within 24 hr before prescribing therapy and then weekly during the first month, then monthly thereafter in females with regular menstrual cycles or q2week in females with irregular menstrual cycles
            • Males
              • Thalidomide is present in the semen of patients; therefore, males must always use a latex or synthetic condom during any sexual contact with females of reproductive potential while taking thalidomide and for up to 4 weeks after discontinuing, even if they have undergone a successful vasectomy
              • Male patients taking thalidomide must not donate sperm

            Lactation

            There is no information regarding presence of thalidomide in human milk; effects of thalidomide on breastfed infant, or effects of thalidomide on milk production

            Because many drugs are excreted in human milk and because of potential for adverse reactions in breastfed infants from thalidomide advise women not to breastfeed during therapy

            Pregnancy Categories

            A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA: Information not available.

            Previous
            Next:

            Pharmacology

            Mechanism of Action

            Suppresses tumor necrosis factor alpha; down-modulates cell surface adhesion molecules involved in leukocyte migration

            Anticancer activity may be due to inhibition of angiogenesis

            Pharmacokinetics

            Bioavailability: 90%

            Protein bound: 55-66%

            Peak plasma time: 3-6 hr

            Half-life: 5-7 hr

            Peak plasma concentration: 1.15-3.2 mcg/mL

            Vd: 122 L

            Metabolism: Liver

            Clearance: 1.15 mL/min

            Excretion: Urine

            Previous
            Next:

            Administration

            Oral Administration

            Take with water at bedtime, at least 1 hr 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

            Previous
            Next:

            Images

            Previous
            Next:

            Formulary

            FormularyPatient Discounts

            Adding plans allows you to compare formulary status to other drugs in the same class.

            To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

            Adding plans allows you to:

            • View the formulary and any restrictions for each plan.
            • Manage and view all your plans together – even plans in different states.
            • Compare formulary status to other drugs in the same class.
            • Access your plan list on any device – mobile or desktop.

            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
            QL Quantity Limits
            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
            ST Step Therapy
            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
            OR Other Restrictions
            Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
            Additional Offers
            Email to Patient

            From:

            To:

            The recipient will receive more details and instructions to access this offer.

            By clicking send, you acknowledge that you have permission to email the recipient with this information.

            Email Forms to Patient

            From:

            To:

            The recipient will receive more details and instructions to access this offer.

            By clicking send, you acknowledge that you have permission to email the recipient with this information.

            Previous
            Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.