thalidomide (Rx)

Brand and Other Names:Thalomid
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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

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Interactions

Interaction Checker

and thalidomide

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    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

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            Contraindicated (1)

            • anakinra

              anakinra increases toxicity of thalidomide by Other (see comment). Contraindicated. Comment: Avoid concomitant use due to increased risk of infection.

            Serious - Use Alternative (10)

            • clonidine

              clonidine, thalidomide. Either increases toxicity of the other by pharmacodynamic synergism. Avoid or Use Alternate Drug. Enhanced CNS depressant effects.

            • deferiprone

              deferiprone, thalidomide. Either increases toxicity of the other by pharmacodynamic synergism. Avoid or Use Alternate Drug. Avoid use of deferiprone with other drugs known to be associated with neutropenia or agranulocytosis; if an alternative is not possible, monitor absolute neutrophil count more frequently.

            • metoclopramide intranasal

              thalidomide, metoclopramide intranasal. Either increases effects of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: Avoid use of metoclopramide intranasal or interacting drug, depending on importance of drug to patient.

            • nivolumab

              thalidomide increases toxicity of nivolumab by Other (see comment). Avoid or Use Alternate Drug. Comment: Immunosuppression diminishes therapeutic effect of nivolumab; combination also increases mortality in patients with multiple myeloma when thalidomide and dexamethasone added to therapy.

            • palifermin

              palifermin increases toxicity of thalidomide by Other (see comment). Avoid or Use Alternate Drug. Comment: Palifermin should not be administered within 24 hr before, during infusion of, or within 24 hr after administration of antineoplastic agents. Coadministration of palifermin within 24 hr of chemotherapy resulted in increased severity and duration of oral mucositis.

            • ponesimod

              ponesimod, thalidomide. Either increases effects of the other by pharmacodynamic synergism. Avoid or Use Alternate Drug. Consult cardiologist if considering treatment. Coadministration of ponesimod with drugs that decrease HR may have additive effects on decreasing HR and should generally not be initiated in these patients.

            • selinexor

              selinexor, thalidomide. unspecified interaction mechanism. Avoid or Use Alternate Drug. Patients treated with selinexor may experience neurological toxicities. Avoid taking selinexor with other medications that may cause dizziness or confusion.

            • stiripentol

              stiripentol, thalidomide. Either increases effects of the other by sedation. Avoid or Use Alternate Drug. Concurrent use of medications with CNS depressant effects together with thalidomide should be avoided due to the risk for additive sedative effects.

            • tocilizumab

              tocilizumab, thalidomide. Either increases effects of the other by pharmacodynamic synergism. Avoid or Use Alternate Drug. Additive immunosuppression; risk of serious infection.

            • vedolizumab

              vedolizumab and thalidomide both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Avoid coadministration of vedolizumab with TNF blockers because of the potential for increased risk of infections

            Monitor Closely (25)

            • amobarbital

              thalidomide increases effects of amobarbital by unspecified interaction mechanism. Use Caution/Monitor. Increased sedative effects.

            • brexanolone

              brexanolone, thalidomide. Either increases toxicity of the other by sedation. Use Caution/Monitor.

            • butabarbital

              thalidomide increases effects of butabarbital by unspecified interaction mechanism. Use Caution/Monitor. Increased sedative effects.

            • butalbital

              thalidomide increases effects of butalbital by unspecified interaction mechanism. Use Caution/Monitor. Increased sedative effects.

            • cenobamate

              cenobamate, thalidomide. Either increases effects of the other by sedation. Use Caution/Monitor.

            • chlorpromazine

              thalidomide increases effects of chlorpromazine by unspecified interaction mechanism. Use Caution/Monitor. Increased sedative effects.

            • cholera vaccine

              thalidomide decreases effects of cholera vaccine by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Immunosuppressive therapies, including irradiation, antimetabolites, alkylating agents, cytotoxic drugs and corticosteroids (used in greater than physiologic doses), may reduce the immune response to cholera vaccine.

            • dichlorphenamide

              dichlorphenamide and thalidomide both decrease serum potassium. Use Caution/Monitor.

            • esketamine intranasal

              esketamine intranasal, thalidomide. Either increases toxicity of the other by sedation. Modify Therapy/Monitor Closely.

            • ethanol

              thalidomide increases effects of ethanol by unspecified interaction mechanism. Use Caution/Monitor. Increased sedative effects.

            • fingolimod

              thalidomide increases effects of fingolimod by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Concomitant therapy is expected to increase the risk of immunosuppression. Use caution when switching patients from long-acting therapies with immune effects. .

            • lasmiditan

              lasmiditan, thalidomide. Either increases effects of the other by sedation. Use Caution/Monitor. Coadministration of lasmiditan and other CNS depressant drugs, including alcohol have not been evaluated in clinical studies. Lasmiditan may cause sedation, as well as other cognitive and/or neuropsychiatric adverse reactions.

            • lemborexant

              lemborexant will increase the level or effect of thalidomide by sedation. Modify Therapy/Monitor Closely. Dosage adjustment may be necessary if lemborexant is coadministered with other CNS depressants because of potentially additive effects.

            • lurasidone

              lurasidone, thalidomide. Either increases toxicity of the other by Other (see comment). Use Caution/Monitor. Comment: Potential for increased CNS depressant effects when used concurrently; monitor for increased adverse effects and toxicity.

            • mechlorethamine

              mechlorethamine, thalidomide. Either increases toxicity of the other by pharmacodynamic synergism. Use Caution/Monitor. Coadministration with mechlorethamine may increase the risk of immunosuppression and myelosuppression.

            • midazolam intranasal

              midazolam intranasal, thalidomide. Either increases toxicity of the other by pharmacodynamic synergism. Modify Therapy/Monitor Closely. Concomitant use of barbiturates, alcohol, or other CNS depressants may increase the risk of hypoventilation, airway obstruction, desaturation, or apnea and may contribute to profound and/or prolonged drug effect.

            • ofatumumab SC

              ofatumumab SC, thalidomide. Either increases effects of the other by immunosuppressive effects; risk of infection. Use Caution/Monitor. Consider the risk of additive immune system effects when coadministering immunosuppressive therapies with coadministration. When switching from therapies with immune effects, take into account the duration and mechanism of action of these therapies when initiating ofatumumab SC.

            • pentobarbital

              thalidomide increases effects of pentobarbital by unspecified interaction mechanism. Use Caution/Monitor. Increased sedative effects.

            • phenobarbital

              thalidomide increases effects of phenobarbital by unspecified interaction mechanism. Use Caution/Monitor. Increased sedative effects.

            • primidone

              thalidomide increases effects of primidone by unspecified interaction mechanism. Use Caution/Monitor. Increased sedative effects.

            • secobarbital

              thalidomide increases effects of secobarbital by unspecified interaction mechanism. Use Caution/Monitor. Increased sedative effects.

            • siponimod

              siponimod and thalidomide both increase immunosuppressive effects; risk of infection. Use Caution/Monitor. Caution if coadministered because of additive immunosuppressive effects during such therapy and in the weeks following administration. When switching from drugs with prolonged immune effects, consider the half-life and mode of action of these drugs to avoid unintended additive immunosuppressive effects.

            • sipuleucel-T

              thalidomide decreases effects of sipuleucel-T by pharmacodynamic antagonism. Modify Therapy/Monitor Closely.

            • trastuzumab

              trastuzumab, thalidomide. Either increases toxicity of the other by immunosuppressive effects; risk of infection. Use Caution/Monitor. Neutropenia or febrile neutropenia incidence were increased when trastuzumab was coadministered with myelosuppressive chemotherapy.

            • trastuzumab deruxtecan

              trastuzumab deruxtecan, thalidomide. Either increases toxicity of the other by immunosuppressive effects; risk of infection. Use Caution/Monitor. Neutropenia or febrile neutropenia incidence were increased when trastuzumab was coadministered with myelosuppressive chemotherapy.

            Minor (4)

            • benazepril

              thalidomide, benazepril. Either increases effects of the other by pharmacodynamic synergism. Minor/Significance Unknown. May increase risk of hypotension.

            • captopril

              thalidomide, captopril. Either increases effects of the other by pharmacodynamic synergism. Minor/Significance Unknown. May increase risk of hypotension.

            • food

              food decreases levels of thalidomide by inhibition of GI absorption. Applies only to oral form of both agents. Minor/Significance Unknown. Esp. high fat foods.

            • shark cartilage

              thalidomide, shark cartilage. Either increases effects of the other by pharmacodynamic synergism. Minor/Significance Unknown. Enhanced anti angiogenesis (theoretical interaction).

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            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), progressive and multifocal leukoencephalopathy

            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

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            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
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            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.

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            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

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            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

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            Images

            BRAND FORM. UNIT PRICE PILL IMAGE
            Thalomid oral
            -
            50 mg capsule
            Thalomid oral
            -
            200 mg capsule
            Thalomid oral
            -
            100 mg capsule

            Copyright © 2010 First DataBank, Inc.

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            Patient Handout

            Patient Education
            thalidomide oral

            THALIDOMIDE - ORAL

            (tha-LID-oh-mide)

            COMMON BRAND NAME(S): Thalomid

            WARNING: Women who are pregnant must not use thalidomide. Women must avoid becoming pregnant while taking this medication. Even a single dose of thalidomide has caused severe (often fatal) birth defects when used during pregnancy. You must have 2 negative pregnancy tests before you start treatment with thalidomide (within 10 to 14 days before and 24 hours before starting), repeating the test at least monthly. Do not start or continue thalidomide treatment unless you have a negative pregnancy test result.Female patients must use 2 effective forms of birth control (or completely avoid sexual intercourse) for 1 month before starting thalidomide, during use, and for 1 month after stopping this drug. Talk to your doctor about reliable birth control choices. If your period is late, or if you have sexual intercourse at any time without using 2 effective forms of birth control, stop taking this medication and contact your doctor right away. (See also Precautions section.)Because thalidomide also passes into semen, men who use this drug and have sex with women must use a latex condom during all sexual contact, even if they have had a vasectomy. Continue using condoms and other birth control as directed until 1 month after thalidomide treatment has been stopped.Only patients who have signed an informed consent and agree to the requirements of the REMS program may obtain and use thalidomide. Only physicians enrolled in REMS may prescribe thalidomide, and only pharmacies enrolled in the program may dispense it. Consult your doctor or pharmacist for more details about the REMS program and for more information about the risks and benefits of using this medication. These requirements apply in the United States. If you live in Canada or any other country, consult your doctor and pharmacist for your country's regulations.When used to treat a certain type of cancer (multiple myeloma), thalidomide can increase the risk of serious blood clots in the legs or lungs, as well as heart attacks and strokes. Seek immediate medical attention if you develop shortness of breath, chest pain, jaw/neck/left arm pain, weakness on one side of your body, trouble speaking, sudden vision changes, or arm/leg swelling. While you are taking thalidomide, your doctor may also direct you to take aspirin or other "blood thinners" (e.g., warfarin) to lessen the risk of these types of blood clots. Talk to your doctor for more information, and tell him/her if you have diabetes, high blood pressure or high cholesterol, kidney problems, or if you smoke. (See also Side Effects section.)

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

            HOW TO USE: Read the Medication Guide provided by your pharmacist before you start using thalidomide and each time you get a refill. If you have any questions, ask your doctor or pharmacist.Take this medication by mouth, usually once daily at bedtime at least 1 hour after the evening meal or as directed by your doctor. Swallow this medication whole with water.Dosage is based on your medical condition and response to treatment. Do not increase your dose or take this medication more often than prescribed. Your condition will not improve any faster, and the risk of serious side effects may be increased.Keep the capsules in their blister pack until ready to use. Do not open or break the capsules, or handle them any more than needed. If any of the powder from the capsule gets on your skin, wash the area with soap and water.Since this drug can be absorbed through the skin and lungs and may harm an unborn baby, women who are pregnant or who may become pregnant should not handle this medication or breathe the dust from broken capsules. All people should wash their hands thoroughly after handling this drug.This medication passes into body fluids (e.g., urine). Avoid contact with body fluids from people taking this drug. Therefore, wear protective clothing (e.g., gloves) when handling these body fluids (e.g., during cleanup). If contact occurs, wash skin with soap and water.Use this medication regularly to get the most benefit from it. To help you remember, take it at the same time each day. If you are taking this medication for Hansen's disease, your skin condition may become worse when the drug is suddenly stopped. Your dose may need to be gradually decreased.Tell your doctor if your condition does not improve or if it worsens after 2 weeks.

            SIDE EFFECTS: See also Warning section.Drowsiness, dizziness, lightheadedness, constipation, weakness, and dry skin may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.To reduce the risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.Thalidomide may cause possibly severe nerve damage, which may be permanent. This may occur during treatment or after treatment has stopped. Tell your doctor right away if you develop any of the following symptoms: numbness/tingling/pain/burning in the feet or hands, muscle weakness/cramps, feeling of tightness in the feet.Tell your doctor right away if you have any serious side effects, including: mental/mood changes (e.g., confusion, anxiety), shaking (tremor), shortness of breath, arm/leg swelling, fast/slow heartbeat, easy bruising/bleeding, black/bloody stools, vomit that contains blood or looks like coffee grounds.People with multiple myeloma who are treated with this medication may rarely get other cancers (such as acute leukemia). Consult your doctor for more details.Get medical help right away if you have any very serious side effects, including: seizures.A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: fever, swollen lymph nodes, rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

            PRECAUTIONS: Before taking thalidomide, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history, especially of: certain blood disorders (low platelet/white blood cell count), numbness/tingling of arms/legs, seizures.Caution is advised when using this drug in people with HIV because they may be more sensitive to the effects of the drug. While thalidomide is used to treat muscle wasting and other HIV-related conditions, the drug might affect the amount of HIV in your system (viral load). Therefore, the manufacturer recommends having HIV tests from time to time.This drug may make you dizzy or drowsy. Alcohol or marijuana (cannabis) can make you more dizzy or drowsy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Avoid alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).Since this drug can be absorbed through the skin and lungs and may harm an unborn baby, women who are pregnant or who may become pregnant should not handle this medication or breathe the dust from broken capsules.Thalidomide must not be used during pregnancy due to the risk of severe birth defects and other serious, sometimes fatal harm to an unborn baby. If you are female and become pregnant or think you may be pregnant, if your period is late or you have unusual menstrual bleeding, or if you stop using 2 forms of birth control, stop taking thalidomide and tell your doctor right away. If you are male and have had unprotected sex with a woman who can become pregnant, or if you think your sexual partner may be pregnant, tell both of your doctors right away. (See also Warning section.)It is not known whether this drug passes into breast milk. Because of the possible risk to the infant, breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.

            DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.Tell your doctor or pharmacist if you also take drugs that cause drowsiness such as: alcohol, marijuana (cannabis), certain antihistamines (e.g., diphenhydramine), medicine for sleep or anxiety (e.g., alprazolam, diazepam, zolpidem), muscle relaxants, opioid pain relievers (e.g., codeine), psychiatric medicines (e.g., chlorpromazine, risperidone, amitriptyline, trazodone).Check the labels on all your medicines (e.g., cough-and-cold products) because they may contain ingredients that cause drowsiness. Ask your pharmacist about using those products safely.It is very important for women to use 2 forms of effective birth control while taking this medication. Some drugs may cause hormonal birth control (such as pills, patch, ring) to work less well by decreasing the amount of birth control hormones in your body. This effect can result in pregnancy. Examples include griseofulvin, modafinil, rifamycins (such as rifampin, rifabutin), St. John's wort, drugs used to treat seizures (such as barbiturates, carbamazepine, felbamate, phenytoin, primidone, topiramate), HIV drugs (such as nelfinavir, nevirapine, ritonavir), among others.Tell your doctor when you start any new drug, and discuss if you should use additional reliable birth control while using the new drug and for 1 month after stopping the drug.

            OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: prolonged sleep.

            NOTES: Do not share this medication with others. Do not donate blood, organs, eggs, or sperm while taking thalidomide.Laboratory and/or medical tests (e.g., pregnancy tests, white blood cell/platelet count) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.

            MISSED DOSE: If you miss a dose, take it as soon as you remember if it is less than 12 hours after the time you would usually take it. If more than 12 hours have passed, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.

            STORAGE: Store at room temperature away from light and moisture. Keep capsules in the original blister pack until ready to use. Do not store in the bathroom. Keep all medications away from children and pets.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

            MEDICAL ALERT: Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).

            Information last revised September 2020. Copyright(c) 2021 First Databank, Inc.

            IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

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