pomalidomide (Rx)Brand and Other Names:Pomalyst

 
 
 

Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

capsule

  • 1mg
  • 2mg
  • 3mg
  • 4mg
more...

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

Systemic Sclerosis (Orphan)

Orphan designation for treatment of systemic sclerosis

Orphan sponsor

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

<18 years: Safety and efficacy not established

Next

Interactions

Interaction Checker

pomalidomide and

No Results

     
     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

            Sort by :  
             activity indicator 
            Previous
            Next

            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

            Previous
            Next

            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
            • 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

            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

            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

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

            Previous
            Next

            Pregnancy & Lactation

            Pregnancy Category: X

            Lactation: Unknown whether distributed in human breast milk; a decision should be made whether to discontinue nursing or discontinue the drug

            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.

            more...
            Previous
            Next

            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)

            Previous
            Next

            Administration

            Instructions

            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

            Previous
            Next

            Images

            Previous
            Next

            Formulary

            FormularyPatient Discounts

            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.
            Add or Remove Plans
            Plans for
            Select State:
            Non-Medicare PlansMedicare Plans

            Select a box to add or remove a plan.

            Select a class to view formulary status for similar drugs

            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
             
             
             
            All material on this website is protected by copyright, Copyright © 1994-2016 by WebMD LLC. This website also contains material copyrighted by 3rd parties.