pomalidomide (Rx)

Brand and Other Names:Pomalyst
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

capsule

  • 1mg
  • 2mg
  • 3mg
  • 4mg
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Multiple Myeloma

Thalidomide analogue, in combination with dexamethasone, is indicated for multiple myeloma in patients who have received at least 2 prior therapies (including lenalidomide and a proteasome inhibitor) and have disease progression on or within 60 days of completion of the last therapy

4 mg PO qDay on days 1-21 of repeated 28-day cycles until disease progression; give in combination with low-dose dexamethasone

Low-dose dexamethasone

  • Give PO only on Days 1, 8, 15, and 22 of each 28-day cycle
  • ≤75 years: 40 mg/day
  • >75 years: 20 mg/day

Dosage Modifications

Discontinue treatment if toxicities continue to occur after dose reductions to 1 mg

Neutropenia

  • ANC <500/mcL or febrile neutropenia (ie, fever ≤38.5°C and ANC <1,000/mcL): Interrupt treatment and follow CBC weekly, may resume at 3 mg/day if ANC returns to ≥500/mcL
  • For each subsequent drop <500/mcL: Interrupt treatment, may resume at 1 mg less than previous dose if ANC returns to ≥500/mcL

Thrombocytopenia

  • Platelets <25,000/mcL: Interrupt treatment and follow CBC weekly, may resume at 3 mg/day if platelets returns to ≥50,000/mcL
  • For each subsequent drop <25,000/mcL: Interrupt treatment, may resume at 1 mg less than previous dose if platelets returns to ≥50,000/mcL

Other

  • Permanently discontinue for angioedema, skin exfoliation, bullae, or any other severe dermatologic reaction
  • For other grade 3 or 4 toxicities, hold treatment and restart treatment at 1 mg less than the previous dose when toxicity has resolved to less than or equal to Grade 2 at the physician’s discretion

Renal & hepatic impairment

  • Avoid use if serum creatinine >3 mg/dL
  • Avoid use if serum bilirubin >2 mg/dL and AST/ALT >3x ULN

Dosing Considerations

Females of reproductive potential must have negative pregnancy testing and use contraception methods before initiating

To initiate a new cycle, the neutrophil count must be ≥500/mcL and the platelet count must be ≥50,000/mcL

Orphan Designations

Systemic sclerosis

Kaposi sarcoma

Orphan sponsor

  • Celgene Corporation; 86 Morris Avenue; Summit, NJ 07901

<18 years: Safety and efficacy not established

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Interactions

Interaction Checker

and pomalidomide

No Results

     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse Effects

            >10%

            Fatigue and asthenia (55-63%)

            Neutropenia (47-52%)

            Dyspnea (34-45%)

            Anemia (38-39%)

            Constipation (35-36%)

            Nausea (22-36%)

            Diarrhea (33-34%)

            Back pain (30-32%)

            Upper respiratory tract infection (25-32%)

            Pyrexia (19-30%)

            Pneumonia (23-29%)

            Thrombocytopenia (23-25%)

            Peripheral edema (16-23%)

            Musculoskeletal chest pain (20-22%)

            Decreased appetite (18-22%)

            Rash (16-22%)

            Cough (14-21%)

            Hypercalcemia (12-21%)

            Dizziness (17-20%)

            Muscle spasms (19%)

            Leukopenia (11-18%)

            Arthralgia (15-16%)

            Urinary tract infection (8-16%)

            Hyperhidrosis (6-16%)

            Hyperglycemia (12-15%)

            Musculoskeletal pain (11-15%)

            Epistaxis (11-15%)

            Pruritus (11-15%)

            Increased blood creatinine (11-15%)

            Renal failure (10-15%)

            Lymphopenia (4-15%)

            Vomiting (13-14%)

            Decreased weight (8-14%)

            Insomnia (7-14%)

            Pain in extremity (5-14%)

            Hyponatremia (10-13%)

            Confusional state (10-13%)

            Tremor (9-13%)

            Headache (8-13%)

            Night sweats (5-13%)

            Muscular weakness (12%)

            Hypocalcemia (6-12%)

            Bone pain (5-12%)

            Hypokalemia (11%)

            Dry skin (9-11%)

            Chills (9-11%)

            Anxiety (7-11%)

            Increased weight (1-11%)

            1-10%

            Neuropathy, peripheral (7-10%)

            Pain (5-6%)

            Thromboembolism (3%)

            Febrile neutropenia (3%)

            Postmarketing reports

            Tumor lysis syndrome

            Hepatitis B virus reactivation

            Herpes zoster

            Gastrointestinal hemorrhage

            Basal cell carcinoma

            Squamous cell carcinoma of the skin

            Blood and lymphatic system disorders: Pancytopenia

            Gastrointestinal disorders: Gastrointestinal hemorrhage

            Hepatobiliary disorders: Hepatic failure (including fatal cases), elevated liver enzymes

            Immune system disorders: Allergic reactions (e.g., angioedema, urticaria)

            Infections and infestations: Hepatitis B virus reactivation, Herpes zoster

            Neoplasms benign, malignant and unspecified (incl cysts and polyps): Tumor lysis syndrome, basal cell carcinoma, and squamous cell carcinoma of the skin

            Skin and subcutaneous tissue disorders: Stevens-Johnson Syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS)

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            Warnings

            Black Box Warnings

            Only available from a restricted distribution program: 1-888-423-5436

            Embryo-fetal toxicity

            • Contraindicated in pregnancy
            • Pomalidomide is a thalidomide analog and is a known human teratogen that causes severe birth defects or embryo-fetal death
            • In females of reproductive potential, obtain 2 negative pregnancy tests before initiating treatment
            • Advise females of reproductive potential that they must avoid pregnancy 4 weeks before therapy
            • Women of reproductive potential must use 2 forms of contraception or continuously abstain from heterosexual sex during and for 4 weeks after stopping pomalidomide
            • Present in semen; males must always use a latex or synthetic condom during any sexual contact with females of reproductive potential while taking pomalidomide and for 4 weeks after stopping treatment
            • Male patients must not donate sperm during and for 4 weeks after stopping drug
            • Male and female patients must not donate blood during treatment and for 4 weeks after stopping drug

            Venous and thromboembolism

            • Deep venous thrombosis (DVT), pulmonary embolism (PE), myocardial infarction, and stroke occur in patients with multiple myeloma treated with pomalidomide; antithrombotic prophylaxis recommended
            • Prophylactic antithrombotic measures were employed in the clinical trials; thromboprophylaxis recommended, and the choice of regiment should be based on assessment of the individual patient’s underlying risk factors

            Contraindications

            Pregnancy

            Cautions

            Analog of known human teratogen, thalidomide, and is contraindicated during pregnancy in women, and during treatment and for 4 weeks after stopping therapy in both men and women (see Black Box Warnings and Contraindications)

            Venous and arterial thromboembolic events reported as serious adverse reactions; patients with known risk factors, including prior thrombosis, may be at greater risk, and actions should be taken to minimize all modifiable factors (e.g., hyperlipidemia, hypertension, smoking); in the trial, all patients were required to receive prophylaxis or antithrombotic treatment (eg, aspirin, warfarin, heparin, clopidogrel) (see Black Box Warnings)

            Hematologic toxicity reported, including neutropenia, anemia, and thrombocytopenia; monitor complete blood counts weekly for the first 8 weeks and monthly thereafter

            Angioedema and 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 a 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; discontinue therapy for angioedema, skin exfoliation, bullae, or any other severe cutaneous reactions such as SJS, TEN or DRESS, and do not resume therapy

            Hepatic failure, including fatalities, have occurred; monitor LFTs monthly and discontinue drug if increased LFTs occur; after LFTs return to baseline values, treatment at a lower dose may be considered

            Hypersensitivity and severe dermatologic reactions reported; discontinue for angioedema, skin exfoliation, bullae, or any other severe dermatologic reactions, and do not resume therapy

            Dizziness or confusional state reported

            Neuropathy reported

            Tumor lysis syndrome may occur; risk is increased in patients with high tumor burden prior to treatment

            Risk of second primary malignancies (ie, acute myelogenous leukemia) reported

            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

            Drug interaction overview

            • Strong CYP1A2, CYP3A4, or P-gp inhibitors may increase pomalidomide exposure
            • Cigarette smoking and strong inducers of CYP1A2, CYP3A4, and P-gp may decrease pomalidomide exposure
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            Pregnancy & Lactation

            Pregnancy

            A pregnancy exposure registry that monitors pregnancy outcomes in females exposed to drug during pregnancy as well as female partners of male patients who are exposed to drug established; registry is also used to understand the root cause for pregnancy; report any suspected fetal exposure to drug to FDA via MedWatch program at 1-800-FDA-1088 and also to Celgene Corporation at 1-888-4235436

            Based on mechanism of action and findings from animal studies, therapy can cause embryo-fetal harm when administered to a pregnant female and is contraindicated during pregnancy

            Pomalidiomide is a thalidomide analogue, which is a human teratogen, inducing a high frequency of severe and life-threatening birth defects such as amelia (absence of limbs), phocomelia (short limbs), hypoplasticity of the bones, absence of bones, external ear abnormalities (including anotia, micropinna, small or absent external auditory canals), facial palsy, eye abnormalities (anophthalmos, microphthalmos), and congenital heart defects; alimentary tract, urinary tract, and genital malformations also documented, and mortality at or shortly after birth reported in about 40% of infants

            If pregnancy does occur during treatment, immediately discontinue drug and refer patient to an obstetrician/ gynecologist experienced in reproductive toxicity for further evaluation and counseling

            Contraception

            • Females
              • Females of reproductive potential must commit either to abstain continuously from heterosexual sexual intercourse or to use 2 methods of reliable birth control simultaneously: one highly effective form of contraception – tubal ligation, IUD, hormonal (birth control pills, injections, hormonal patches, vaginal rings, or implants), or partner’s vasectomy, and 1 additional effective contraceptive method– male latex or synthetic condom, diaphragm, or cervical cap; contraception must begin 4 weeks prior to initiating treatment, during therapy, during dose interruptions, and continuing for 4 weeks following discontinuation of therapy; reliable contraception is indicated even where there has been a history of infertility, unless due to hysterectomy; females of reproductive potential should be referred to a qualified provider of contraceptive methods, if needed
            • Males
              • Drug is present in semen of males who take drug; males must always use a latex or synthetic condom during any sexual contact with females of reproductive potential while taking drug and for up to 4 weeks after discontinuing therapy, even if they have undergone a successful vasectomy; male patients taking drug must not donate sperm

            Lactation

            There is no information regarding presence of pomalidomide in human milk, effects on the breastfed child, or on milk production; drug is excreted in milk of lactating rats; because many drugs are excreted in human milk and because of potential for adverse reactions in a breastfed child from drug, advise women not to breastfeed during treatment

            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

            Thalidomide analog that elicits immunomodulatory and antineoplastic activity; it inhibits proliferation and induced apoptosis of hematopoietic tumor cells

            Additionally, it enhances T-cell and natural killer cell-mediated immunity and suppresses production of TNF-alpha and interleukin-6; down-modulates cell surface adhesion molecules involved in leukocyte migration

            Anticancer activity may be due to inhibition of angiogenesis

            Absorption

            Peak plasma time: 2-3 hr

            Peak plasma concentration: 75 ng/mL

            AUC: 400 ng•hr/mL

            Distribution

            Protein bound: 12-44%

            Vd: 62-138 L

            Semen concentration: 67% of plasma level at 4 hr post-dose

            Metabolism

            Metabolized in liver by CYP1A2 and CYP3A4 (primary enzymes involved the hydroxylation); minor contribution by CYP2C19 and CYP2D6

            Elimination

            Half-life: 7.5 hr

            Total body clearance: 7-10 L/hr

            Excretion: 73% urine (2% unchanged); 15% feces (8% unchanged)

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            Administration

            Oral Administration

            Swallow capsule whole with water; do not break, chew, or open the capsules

            Take without food, at least 2 hr before or 2 hr after a meal

            Use procedures for proper handling and disposal according to anticancer drug guidelines

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            Formulary

            FormularyPatient Discounts

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            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.
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            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.
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