pomalidomide (Rx)

Brand and Other Names:Pomalyst
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

capsule

  • 1mg
  • 2mg
  • 3mg
  • 4mg

Multiple Myeloma

Indicated in combination with dexamethasone, for multiple myeloma (MM) 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

Kaposi Sarcoma

AIDS-related Kaposi sarcoma (KS)

  • Indicated for AIDS-related KS in patients who failed highly active antiretroviral therapy (HAART)
  • 5 mg PO qDay on Days 1-21 of each 28-day cycle
  • Continue until disease progression or unacceptable toxicity
  • Continue HAART as HIV treatment

KS in adults who are HIV-negative

  • Indicated for KS in adults who are HIV-negative
  • 5 mg PO qDay on Days 1-21 of each 28-day cycle
  • Continue until disease progression or unacceptable toxicity

Dosage Modifications

Neutropenia (MM)

  • ANC <500/mcL or febrile neutropenia (ie, fever >38.5ºC and ANC <1000/mcL): Withhold until ANC ≥500/mcL and follow CBC weekly; resume at 1 mg less than previous dose
  • For each subsequent ANC drop <500/mcL: Withhold until ANC ≥500/mcL; resume at 1 mg less than previous dose
  • Permanently discontinue if unable to tolerate 1 mg qDay

Neutropenia (KS)

  • ANC 500 to <1000/mcL
    • Day 1 of cycle: Withhold until ANC ≥1000/mcL, resume at the same dose
    • During cycle: Continue at the current dose
  • ANC <500/mcL
    • Withhold until ANC ≥1000/mcL, resume at the same dose

Febrile neutropenia (KS)

  • ANC <1000/mcL and single temperature ≥38.3ºC or sustained temperature ≥38.3ºC for >1 hr
  • Withhold until ANC ≥1000/mcL, resume at dose 1 mg less than the previous dose
  • Permanently discontinue if unable to tolerate 1 mg qDay

Thrombocytopenia (MM)

  • Platelet count <25,000/mcL: Withhold until platelets >50,000/mcL and follow CBC weekly, resume at 1 mg less than previous dose
  • For each subsequent drop <25,000/mcL: Withhold, resume at 1 mg less than previous dose if platelet count ≥50,000/mcL
  • Permanently discontinue if unable to tolerate 1 mg qDay

Thrombocytopenia (KS) H4

  • Platelet count 25,000 to <50,000/mcL
    • Day 1 of cycle: Withhold until platelet count ≥50,000/mcL, resume at the same dose
    • During cycle: Continue at the current dose
  • Platelet count <25,000/mcL
    • Permanently discontinue

Other toxicities

  • Angioedema, skin exfoliation, bullae, or any other severe dermatologic reaction: Permanently discontinue
  • Grade 3 or 4 toxicities: Withhold and resume at 1 mg less than the previous dose when toxicity has resolved to Grade ≤2 at the physician’s discretion

Dosage modification for strong CYP1A2 inhibitors

  • Avoid coadministration with strong CYP1A2 inhibitors
  • If unavoidable, reduce pomalidomide dose to 2 mg

Renal impairment

  • Severe
    • Severe requiring hemodialysis (MM): Reduce to 3 mg/day
    • Severe requiring hemodialysis (KS): Reduce to 4 mg/day
    • Hemodialysis: Take on days of hemodialysis once procedure has completed

Hepatic impairment

  • MM
    • Mild-to-moderate (Child-Pugh A or B): Reduce to 3 mg/day
    • Severe (Child-Pugh C): Reduce to 2 mg/day
  • KS
    • Mild-to-severe (Child-Pugh A to C): Reduce to 3 mg/day

Dosing Considerations

Prior to initiation

  • Females of reproductive potential: Obtain 2 negative pregnancy tests and use contraception methods
  • 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

Orphan sponsor

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

<18 years: Safety and efficacy not established

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Interactions

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              Serious - Use Alternative (96)

              • abametapir

                abametapir will increase the level or effect of pomalidomide by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. For 2 weeks after abametapir application, avoid taking drugs that are CYP3A4 substrates. If not feasible, avoid use of abametapir.

                abametapir will increase the level or effect of pomalidomide by affecting hepatic enzyme CYP1A2 metabolism. Avoid or Use Alternate Drug. For 2 weeks after abametapir application, avoid taking drugs that are CYP1A2 substrates. If not feasible, avoid use of abametapir.

              • abiraterone

                abiraterone increases levels of pomalidomide by P-glycoprotein (MDR1) efflux transporter. Avoid or Use Alternate Drug.

              • amiodarone

                amiodarone increases levels of pomalidomide by P-glycoprotein (MDR1) efflux transporter. Avoid or Use Alternate Drug.

              • apalutamide

                apalutamide will decrease the level or effect of pomalidomide by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Coadministration of apalutamide, a strong CYP3A4 inducer, with drugs that are CYP3A4 substrates can result in lower exposure to these medications. Avoid or substitute another drug for these medications when possible. Evaluate for loss of therapeutic effect if medication must be coadministered. Adjust dose according to prescribing information if needed.

              • atazanavir

                atazanavir increases levels of pomalidomide by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.

              • atorvastatin

                atorvastatin increases levels of pomalidomide by P-glycoprotein (MDR1) efflux transporter. Avoid or Use Alternate Drug.

              • azithromycin

                azithromycin increases levels of pomalidomide by P-glycoprotein (MDR1) efflux transporter. Avoid or Use Alternate Drug.

              • bosentan

                bosentan decreases levels of pomalidomide by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.

              • carbamazepine

                carbamazepine decreases levels of pomalidomide by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.

                carbamazepine decreases levels of pomalidomide by affecting hepatic enzyme CYP1A2 metabolism. Avoid or Use Alternate Drug.

                carbamazepine decreases levels of pomalidomide by P-glycoprotein (MDR1) efflux transporter. Avoid or Use Alternate Drug.

              • carvedilol

                carvedilol increases levels of pomalidomide by P-glycoprotein (MDR1) efflux transporter. Avoid or Use Alternate Drug.

              • cigarette smoking

                cigarette smoking decreases levels of pomalidomide by increasing metabolism. Avoid or Use Alternate Drug.

              • ciprofloxacin

                ciprofloxacin increases levels of pomalidomide by affecting hepatic enzyme CYP1A2 metabolism. Avoid or Use Alternate Drug.

              • clarithromycin

                clarithromycin increases levels of pomalidomide by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.

                clarithromycin increases levels of pomalidomide by P-glycoprotein (MDR1) efflux transporter. Avoid or Use Alternate Drug.

              • conivaptan

                conivaptan increases levels of pomalidomide by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.

              • cyclosporine

                cyclosporine increases levels of pomalidomide by P-glycoprotein (MDR1) efflux transporter. Avoid or Use Alternate Drug.

              • darunavir

                darunavir increases levels of pomalidomide by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.

                darunavir increases levels of pomalidomide by P-glycoprotein (MDR1) efflux transporter. Avoid or Use Alternate Drug.

              • deferiprone

                deferiprone, pomalidomide. 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.

              • dipyridamole

                dipyridamole increases levels of pomalidomide by P-glycoprotein (MDR1) efflux transporter. Avoid or Use Alternate Drug.

              • doxorubicin liposomal

                doxorubicin liposomal decreases levels of pomalidomide by P-glycoprotein (MDR1) efflux transporter. Avoid or Use Alternate Drug.

              • dronedarone

                dronedarone increases levels of pomalidomide by P-glycoprotein (MDR1) efflux transporter. Avoid or Use Alternate Drug.

              • efavirenz

                efavirenz decreases levels of pomalidomide by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.

              • elvitegravir/cobicistat/emtricitabine/tenofovir DF

                elvitegravir/cobicistat/emtricitabine/tenofovir DF increases levels of pomalidomide by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.

              • enzalutamide

                enzalutamide decreases levels of pomalidomide by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.

              • eribulin

                eribulin increases levels of pomalidomide by P-glycoprotein (MDR1) efflux transporter. Avoid or Use Alternate Drug.

              • erythromycin base

                erythromycin base increases levels of pomalidomide by P-glycoprotein (MDR1) efflux transporter. Avoid or Use Alternate Drug.

              • erythromycin ethylsuccinate

                erythromycin ethylsuccinate increases levels of pomalidomide by P-glycoprotein (MDR1) efflux transporter. Avoid or Use Alternate Drug.

              • erythromycin lactobionate

                erythromycin lactobionate increases levels of pomalidomide by P-glycoprotein (MDR1) efflux transporter. Avoid or Use Alternate Drug.

              • erythromycin stearate

                erythromycin stearate increases levels of pomalidomide by P-glycoprotein (MDR1) efflux transporter. Avoid or Use Alternate Drug.

              • eslicarbazepine acetate

                eslicarbazepine acetate will decrease the level or effect of pomalidomide by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.

              • etravirine

                etravirine increases levels of pomalidomide by P-glycoprotein (MDR1) efflux transporter. Avoid or Use Alternate Drug.

                etravirine decreases levels of pomalidomide by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.

              • fexinidazole

                fexinidazole will increase the level or effect of pomalidomide by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Fexinidazole inhibits CYP3A4. Coadministration may increase risk for adverse effects of CYP3A4 substrates.

              • fluvoxamine

                fluvoxamine will increase the level or effect of pomalidomide by affecting hepatic enzyme CYP1A2 metabolism. Avoid or Use Alternate Drug.

              • fosamprenavir

                fosamprenavir increases levels of pomalidomide by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.

              • fosphenytoin

                fosphenytoin decreases levels of pomalidomide by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.

              • givosiran

                givosiran will increase the level or effect of pomalidomide by affecting hepatic enzyme CYP1A2 metabolism. Avoid or Use Alternate Drug. Avoid coadministration of sensitive CYP1A2 substrates with givosiran. If unavoidable, decrease the CYP1A2 substrate dosage in accordance with approved product labeling.

              • grapefruit

                grapefruit increases levels of pomalidomide by P-glycoprotein (MDR1) efflux transporter. Avoid or Use Alternate Drug.

              • idelalisib

                idelalisib will increase the level or effect of pomalidomide by aldehyde dehydrogenase inhibition. Avoid or Use Alternate Drug. Idelalisib is a strong CYP3A inhibitor; avoid coadministration with sensitive CYP3A substrates

              • imatinib

                imatinib increases levels of pomalidomide by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.

              • indinavir

                indinavir increases levels of pomalidomide by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.

              • isoniazid

                isoniazid increases levels of pomalidomide by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.

              • ketoconazole

                ketoconazole increases levels of pomalidomide by affecting hepatic enzyme CYP1A2 metabolism. Avoid or Use Alternate Drug.

                ketoconazole increases levels of pomalidomide by P-glycoprotein (MDR1) efflux transporter. Avoid or Use Alternate Drug.

              • lapatinib

                lapatinib increases levels of pomalidomide by P-glycoprotein (MDR1) efflux transporter. Avoid or Use Alternate Drug.

              • lasmiditan

                lasmiditan increases levels of pomalidomide by P-glycoprotein (MDR1) efflux transporter. Avoid or Use Alternate Drug.

              • levoketoconazole

                levoketoconazole increases levels of pomalidomide by affecting hepatic enzyme CYP1A2 metabolism. Avoid or Use Alternate Drug.

                levoketoconazole increases levels of pomalidomide by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.

                levoketoconazole increases levels of pomalidomide by P-glycoprotein (MDR1) efflux transporter. Avoid or Use Alternate Drug.

              • lidocaine

                lidocaine increases levels of pomalidomide by affecting hepatic enzyme CYP1A2 metabolism. Avoid or Use Alternate Drug.

              • lopinavir

                lopinavir increases levels of pomalidomide by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.

                lopinavir increases levels of pomalidomide by P-glycoprotein (MDR1) efflux transporter. Avoid or Use Alternate Drug.

              • lovastatin

                lovastatin increases levels of pomalidomide by P-glycoprotein (MDR1) efflux transporter. Avoid or Use Alternate Drug.

              • mefloquine

                mefloquine increases levels of pomalidomide by P-glycoprotein (MDR1) efflux transporter. Avoid or Use Alternate Drug.

              • methoxsalen

                methoxsalen increases levels of pomalidomide by affecting hepatic enzyme CYP1A2 metabolism. Avoid or Use Alternate Drug.

              • mexiletine

                mexiletine increases levels of pomalidomide by affecting hepatic enzyme CYP1A2 metabolism. Avoid or Use Alternate Drug.

              • nafcillin

                nafcillin decreases levels of pomalidomide by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.

              • nefazodone

                nefazodone increases levels of pomalidomide by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.

                nefazodone will increase the level or effect of pomalidomide by P-glycoprotein (MDR1) efflux transporter. Avoid or Use Alternate Drug.

              • nelfinavir

                nelfinavir increases levels of pomalidomide by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.

                nelfinavir increases levels of pomalidomide by P-glycoprotein (MDR1) efflux transporter. Avoid or Use Alternate Drug.

              • nevirapine

                nevirapine decreases levels of pomalidomide by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.

              • nicardipine

                nicardipine increases levels of pomalidomide by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.

                nicardipine increases levels of pomalidomide by P-glycoprotein (MDR1) efflux transporter. Avoid or Use Alternate Drug.

              • nifedipine

                nifedipine increases levels of pomalidomide by P-glycoprotein (MDR1) efflux transporter. Avoid or Use Alternate Drug.

              • nilotinib

                nilotinib increases levels of pomalidomide by P-glycoprotein (MDR1) efflux transporter. Avoid or Use Alternate Drug.

              • ofloxacin

                ofloxacin increases levels of pomalidomide by affecting hepatic enzyme CYP1A2 metabolism. Avoid or Use Alternate Drug.

              • oxcarbazepine

                oxcarbazepine decreases levels of pomalidomide by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.

              • palifermin

                palifermin increases toxicity of pomalidomide 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.

              • paliperidone

                paliperidone increases levels of pomalidomide by P-glycoprotein (MDR1) efflux transporter. Avoid or Use Alternate Drug.

              • pentobarbital

                pentobarbital decreases levels of pomalidomide by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.

              • phenobarbital

                phenobarbital decreases levels of pomalidomide by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.

                phenobarbital decreases levels of pomalidomide by affecting hepatic enzyme CYP1A2 metabolism. Avoid or Use Alternate Drug.

              • phenytoin

                phenytoin decreases levels of pomalidomide by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.

              • ponatinib

                ponatinib increases levels of pomalidomide by P-glycoprotein (MDR1) efflux transporter. Avoid or Use Alternate Drug.

              • posaconazole

                posaconazole increases levels of pomalidomide by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.

                posaconazole increases levels of pomalidomide by P-glycoprotein (MDR1) efflux transporter. Avoid or Use Alternate Drug.

              • primaquine

                primaquine increases levels of pomalidomide by affecting hepatic enzyme CYP1A2 metabolism. Avoid or Use Alternate Drug.

              • primidone

                primidone decreases levels of pomalidomide by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.

                primidone decreases levels of pomalidomide by affecting hepatic enzyme CYP1A2 metabolism. Avoid or Use Alternate Drug.

              • progesterone micronized

                progesterone micronized increases levels of pomalidomide by P-glycoprotein (MDR1) efflux transporter. Avoid or Use Alternate Drug.

              • progesterone, natural

                progesterone, natural increases levels of pomalidomide by P-glycoprotein (MDR1) efflux transporter. Avoid or Use Alternate Drug.

              • propafenone

                propafenone increases levels of pomalidomide by P-glycoprotein (MDR1) efflux transporter. Avoid or Use Alternate Drug.

              • propranolol

                propranolol increases levels of pomalidomide by P-glycoprotein (MDR1) efflux transporter. Avoid or Use Alternate Drug.

              • quinidine

                quinidine increases levels of pomalidomide by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.

                quinidine increases levels of pomalidomide by P-glycoprotein (MDR1) efflux transporter. Avoid or Use Alternate Drug.

              • quinine

                quinine increases levels of pomalidomide by P-glycoprotein (MDR1) efflux transporter. Avoid or Use Alternate Drug.

              • ranolazine

                ranolazine increases levels of pomalidomide by P-glycoprotein (MDR1) efflux transporter. Avoid or Use Alternate Drug.

              • rifabutin

                rifabutin decreases levels of pomalidomide by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.

              • rifampin

                rifampin decreases levels of pomalidomide by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.

                rifampin decreases levels of pomalidomide by affecting hepatic enzyme CYP1A2 metabolism. Avoid or Use Alternate Drug.

                rifampin decreases levels of pomalidomide by P-glycoprotein (MDR1) efflux transporter. Avoid or Use Alternate Drug.

              • rifapentine

                rifapentine decreases levels of pomalidomide by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.

              • ritonavir

                ritonavir increases levels of pomalidomide by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.

                ritonavir increases levels of pomalidomide by P-glycoprotein (MDR1) efflux transporter. Avoid or Use Alternate Drug.

              • saquinavir

                saquinavir increases levels of pomalidomide by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.

                saquinavir increases levels of pomalidomide by P-glycoprotein (MDR1) efflux transporter. Avoid or Use Alternate Drug.

              • selinexor

                selinexor, pomalidomide. 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.

              • simvastatin

                simvastatin increases levels of pomalidomide by P-glycoprotein (MDR1) efflux transporter. Avoid or Use Alternate Drug.

              • sotorasib

                sotorasib will decrease the level or effect of pomalidomide by P-glycoprotein (MDR1) efflux transporter. Avoid or Use Alternate Drug. If use is unavoidable, refer to the prescribing information of the P-gp substrate for dosage modifications.

              • St John's Wort

                St John's Wort decreases levels of pomalidomide by P-glycoprotein (MDR1) efflux transporter. Avoid or Use Alternate Drug.

              • sunitinib

                sunitinib increases levels of pomalidomide by P-glycoprotein (MDR1) efflux transporter. Avoid or Use Alternate Drug.

              • tacrolimus

                tacrolimus increases levels of pomalidomide by P-glycoprotein (MDR1) efflux transporter. Avoid or Use Alternate Drug.

              • tamoxifen

                tamoxifen increases levels of pomalidomide by P-glycoprotein (MDR1) efflux transporter. Avoid or Use Alternate Drug.

              • tepotinib

                tepotinib will increase the level or effect of pomalidomide by P-glycoprotein (MDR1) efflux transporter. Avoid or Use Alternate Drug. If concomitant use unavoidable, reduce the P-gp substrate dosage if recommended in its approved product labeling.

              • tipranavir

                tipranavir increases levels of pomalidomide by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.

                tipranavir decreases levels of pomalidomide by P-glycoprotein (MDR1) efflux transporter. Avoid or Use Alternate Drug.

              • tolvaptan

                tolvaptan increases levels of pomalidomide by P-glycoprotein (MDR1) efflux transporter. Avoid or Use Alternate Drug.

              • trazodone

                trazodone decreases levels of pomalidomide by P-glycoprotein (MDR1) efflux transporter. Avoid or Use Alternate Drug.

              • tucatinib

                tucatinib will increase the level or effect of pomalidomide by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Avoid concomitant use of tucatinib with CYP3A substrates, where minimal concentration changes may lead to serious or life-threatening toxicities. If unavoidable, reduce CYP3A substrate dose according to product labeling.

              • verapamil

                verapamil increases levels of pomalidomide by P-glycoprotein (MDR1) efflux transporter. Avoid or Use Alternate Drug.

              • vinblastine

                vinblastine decreases levels of pomalidomide by P-glycoprotein (MDR1) efflux transporter. Avoid or Use Alternate Drug.

              • voriconazole

                voriconazole increases levels of pomalidomide by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.

              • voxelotor

                voxelotor will increase the level or effect of pomalidomide by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Voxelotor increases systemic exposure of sensitive CYP3A4 substrates. Avoid coadministration with sensitive CYP3A4 substrates with a narrow therapeutic index. Consider dose reduction of the sensitive CYP3A4 substrate(s) if unable to avoid.

              Monitor Closely (32)

              • amobarbital

                amobarbital will decrease the level or effect of pomalidomide by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              • berotralstat

                berotralstat will increase the level or effect of pomalidomide by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor. Monitor or titrate P-gp substrate dose if coadministered.

              • brexanolone

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

              • cannabidiol

                cannabidiol, pomalidomide. affecting hepatic enzyme CYP1A2 metabolism. Modify Therapy/Monitor Closely. Owing to the potential for both CYP1A2 induction and inhibition with the coadministration of CYP1A2 substrates and cannabidiol, consider reducing dosage adjustment of CYP1A2 substrates as clinically appropriate.

              • cenobamate

                cenobamate will decrease the level or effect of pomalidomide by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Increase dose of CYP3A4 substrate, as needed, when coadministered with cenobamate.

              • cholera vaccine

                pomalidomide 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.

              • dabrafenib

                dabrafenib will decrease the level or effect of pomalidomide by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely.

              • dexamethasone

                dexamethasone decreases levels of pomalidomide by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Coadministration of multiple doses of 4 mg pomalidomide with 20 mg to 40 mg dexamethasone (a weak-to-moderate inducer of CYP3A4) to patients with multiple myeloma had no effect on the pharmacokinetics of pomalidomide compared with pomalidomide administered alone. .

              • dichlorphenamide

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

              • elagolix

                elagolix will increase the level or effect of pomalidomide by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor.

                elagolix decreases levels of pomalidomide by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Elagolix is a weak-to-moderate CYP3A4 inducer. Monitor CYP3A substrates if coadministered. Consider increasing CYP3A substrate dose if needed.

              • eliglustat

                eliglustat increases levels of pomalidomide by P-glycoprotein (MDR1) efflux transporter. Modify Therapy/Monitor Closely. Monitor therapeutic drug concentrations, as indicated, or consider reducing the dosage of the P-gp substrate and titrate to clinical effect.

              • esketamine intranasal

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

              • fedratinib

                fedratinib will increase the level or effect of pomalidomide by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Adjust dose of drugs that are CYP3A4 substrates as necessary.

              • fexinidazole

                fexinidazole will increase the level or effect of pomalidomide by affecting hepatic enzyme CYP1A2 metabolism. Use Caution/Monitor.

              • ganaxolone

                pomalidomide and ganaxolone both increase sedation. Use Caution/Monitor.

              • glecaprevir/pibrentasvir

                glecaprevir/pibrentasvir will increase the level or effect of pomalidomide by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor.

              • istradefylline

                istradefylline will increase the level or effect of pomalidomide by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Istradefylline 40 mg/day increased peak levels and AUC of CYP3A4 substrates in clinical trials. This effect was not observed with istradefylline 20 mg/day. Consider dose reduction of sensitive CYP3A4 substrates.

                istradefylline will increase the level or effect of pomalidomide by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor. Istradefylline 40 mg/day increased peak levels and AUC of P-gp substrates in clinical trials. Consider dose reduction of sensitive P-gp substrates.

              • lasmiditan

                lasmiditan, pomalidomide. 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, pomalidomide. Either increases effects of the other by sedation. Modify Therapy/Monitor Closely. Dosage adjustment may be necessary if lemborexant is coadministered with other CNS depressants because of potentially additive effects.

              • lonafarnib

                lonafarnib will increase the level or effect of pomalidomide by P-glycoprotein (MDR1) efflux transporter. Modify Therapy/Monitor Closely. Lonafarnib is a weak P-gp inhibitor. Monitor for adverse reactions if coadministered with P-gp substrates where minimal concentration changes may lead to serious or life-threatening toxicities. Reduce P-gp substrate dose if needed.

              • mitotane

                mitotane decreases levels of pomalidomide by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Mitotane is a strong inducer of cytochrome P-4503A4; monitor when coadministered with CYP3A4 substrates for possible dosage adjustments.

              • ofatumumab SC

                ofatumumab SC, pomalidomide. 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.

              • rucaparib

                rucaparib will increase the level or effect of pomalidomide by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              • sarecycline

                sarecycline will increase the level or effect of pomalidomide by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor. Monitor for toxicities of P-gp substrates that may require dosage reduction when coadministered with P-gp inhibitors.

              • secobarbital

                secobarbital will decrease the level or effect of pomalidomide by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              • siponimod

                siponimod and pomalidomide 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.

              • stiripentol

                stiripentol, pomalidomide. affecting hepatic enzyme CYP1A2 metabolism. Modify Therapy/Monitor Closely. Stiripentol is a CYP1A2 inhibitor and inducer. Monitor CYP1A2 substrates coadministered with stiripentol for increased or decreased effects. CYP1A2 substrates may require dosage adjustment.

                stiripentol, pomalidomide. affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Stiripentol is a CYP3A4 inhibitor and inducer. Monitor CYP3A4 substrates coadministered with stiripentol for increased or decreased effects. CYP3A4 substrates may require dosage adjustment.

                stiripentol will increase the level or effect of pomalidomide by P-glycoprotein (MDR1) efflux transporter. Modify Therapy/Monitor Closely. Consider reducing the dose of P-glycoprotein (P-gp) substrates, if adverse reactions are experienced when administered concomitantly with stiripentol.

              • tazemetostat

                tazemetostat will decrease the level or effect of pomalidomide by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              • tecovirimat

                tecovirimat will decrease the level or effect of pomalidomide by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Tecovirimat is a weak CYP3A4 inducer. Monitor sensitive CYP3A4 substrates for effectiveness if coadministered.

              • trastuzumab

                trastuzumab, pomalidomide. 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, pomalidomide. 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.

              • tucatinib

                tucatinib will increase the level or effect of pomalidomide by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor. Consider reducing the dosage of P-gp substrates, where minimal concentration changes may lead to serious or life-threatening toxicities.

              Minor (2)

              • itraconazole

                itraconazole increases levels of pomalidomide by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

                itraconazole increases levels of pomalidomide by P-glycoprotein (MDR1) efflux transporter. Minor/Significance Unknown.

              • ribociclib

                ribociclib will increase the level or effect of pomalidomide by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

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              Adverse Effects

              >10% (MM)

              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%)

              >10% (KS)

              All grades

              • Decreased ANC (96%)
              • Elevated creatinine (86%)
              • Decreased WBC (79%)
              • Maculopapular rash (71%)
              • Constipation (71%)
              • Fatigue (68%)
              • Elevated glucose (57%)
              • Decreased albumin (54%)
              • Decreased phosphate (54%)
              • Decreased hemoglobin (54%)
              • Decreased platelets (54%)
              • Decreased calcium (50%)
              • Nausea (36%)
              • Diarrhea (32%)
              • Increased ALT (32%)
              • Cough (29%)
              • Dyspnea (29%)
              • Peripheral edema (29%)
              • Upper respiratory tract infection (29%)
              • Increased AST (25%)
              • Muscle spasms (25%)
              • Elevated creatine kinase (25%)
              • Hypothyroidism (21%)
              • Dry skin (21%)
              • Chills (21%)
              • Decreased magnesium (14%)
              • Elevated alkaline phosphate (14%)

              Grade 3 or 4

              • Decreased ANC (50%)
              • Decreased phosphate (25%)

              1-10% (MM)

              Neuropathy, peripheral (7-10%)

              Pain (5-6%)

              Thromboembolism (3%)

              Febrile neutropenia (3%)

              1-10% (KS)

              Grade 3 or 4

              • Elevated creatine kinase (7%)
              • Elevated alkaline phosphate (3.6%)
              • Maculopapular rash (3.6%)
              • Diarrhea (3.6%)
              • Peripheral edema (3.6%)
              • Decreased WBC (3.6%)
              • Elevated creatinine (3.6%)

              Postmarketing reports

              Blood and lymphatic system disorders: Pancytopenia

              Endocrine disorders: Hypothyroidism, hyperthyroidism

              Gastrointestinal disorders: Gastrointestinal hemorrhage

              Hepatobiliary disorders: Hepatic failure, elevated liver enzymes

              Immune system disorders: Allergic reactions (eg, angioedema, anaphylaxis, urticaria), solid organ transplant rejection

              Infections and infestations: Hepatitis B virus reactivation, Herpes zoster, progressive multifocal leukoencephalopathy (PML)

              Neoplasms benign, malignant and unspecified: 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

              Embryofetal toxicity

              • Contraindicated in pregnancy
              • Pomalidomide is a thalidomide analog and is a known human teratogen that causes severe birth defects or embryofetal 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
              • REMS program
                • Only available through POMALYST REMS program; additional information is available at www.celgeneriskmanagement.com or by calling at 1-888-423-5436

              Venous and thromboembolism

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

              Contraindications

              Pregnancy

              Hypersensitivity (eg, angioedema, anaphylaxis) to drug or excipients

              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

              Consider therapy interruption or discontinuation for Grade 2-3 skin rash;.permanently discontinue therapy for Grade 4 rash, exfoliative or bullous rash, or for other severe cutaneous reactions such as SJS, TEN or DRESS

              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

              Contraindicated in pregnancy

              Based on mechanism of action and findings from animal studies, embryofetal harm may occur when administered to a pregnant female

              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

              Verify pregnancy status of females of reproductive potential prior to initiation and during therapy

              Animal data

              • Teratogenic in both rats and rabbits when administered during organogenesis
              • Crossed the placenta after administration to pregnant rabbits
              • If used during pregnancy or if patient becomes pregnant while taking this drug, advise patient of the potential risk to a fetus

              Pregnancy exposure registry

              • Registry monitors pregnancy outcomes in females exposed to drug during pregnancy as well as female partners of male patients who are exposed to drug established
              • Report any suspected fetal exposure to drug to FDA via MedWatch program at 1-800-FDA-1088 and also to Celgene Corporation at 1-888-423-5436

              Contraception

              • 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
                • Contraception is indicated even where there has been a history of infertility, unless due to hysterectomy; refer to a qualified provider of contraceptive methods, if needed
              • Males with female partner of reproductive potential
                • Drug is present in semen of males who take drug
                • 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

              Infertility

              • Based on findings in animals, female fertility may be compromised by treatment

              Lactation

              No information available

              Pomalidomide excreted in milk of lactating rats

              Advise females 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 postdose in MM or KS patients

              Peak plasma concentration

              • MM: 75 ng/mL
              • KS: 53.1 ng/mL

              AUC

              • MM: 860 ng⋅hr/mL
              • KS: 462.3 ng⋅hr/mL

              Smoking

              • Cigarette smoking reduces pomalidomide AUC due to CYP1A2 induction
              • Advise patients that smoking may reduce its efficacy

              Distribution

              Protein bound: 12-44%

              Vd (steady-state): 62-138 L

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

              Substrate of P-gp

              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 (MM or KS patients); 9.5 hr (healthy subjects)

              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

              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

              Storage

              Store at 20-25ºC (68-77ºF); excursions permitted to 15-30ºC (59-86ºF)

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              Images

              No images available for this drug.
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              Patient Handout

              Patient Education
              pomalidomide oral

              POMALIDOMIDE - ORAL

              (POE-ma-LID-oh-mide)

              COMMON BRAND NAME(S): Pomalyst

              WARNING: Pomalidomide can cause severe birth defects or death in unborn babies if taken during pregnancy. It is important to prevent pregnancy while taking this medication. Women must use 2 reliable forms of birth control or avoid sexual intercourse for 4 weeks before starting treatment, during treatment and breaks, and for at least 4 weeks after stopping treatment. Women must also have 2 negative pregnancy tests before starting treatment, the first test 10 to 14 days before the first dose and the second test within 24 hours before the first dose. Women must also continue to have pregnancy tests regularly during treatment. (See also Notes section.) If you become pregnant or think you may be pregnant, stop taking pomalidomide and tell your doctor right away. Consult your doctor or pharmacist for more information.Men who are taking pomalidomide must use latex or synthetic condoms during any sexual contact with female partners while on treatment, during breaks, and for at least 4 weeks after stopping treatment even if they have had a vasectomy. If your partner becomes pregnant or thinks she may be pregnant, tell your doctor right away.For patients to receive this medication, all doctors, pharmacists, and patients must agree to, understand, and carefully follow the requirements of the Pomalyst REMS Program. 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.Although unlikely, pomalidomide may cause very serious blood clots (such as heart attack, stroke, blood clots in the legs/lungs). Get medical help right away if you develop symptoms of blood clots, including chest/jaw/left arm pain, unusual sweating, weakness on one side of the body, vision changes, trouble speaking/breathing, or sudden pain/swelling/redness in the groin/calf. Your doctor should prescribe you medications such as "blood thinners" (examples include aspirin, warfarin) to prevent blood clots.

              USES: Pomalidomide is used to treat certain types of cancers (such as multiple myeloma, Kaposi sarcoma). It works by slowing or stopping the growth of cancer cells.

              HOW TO USE: This medication must be used only within the Pomalyst REMS guidelines in order to avoid any possible exposure of an unborn baby to the drug. Consult your doctor or pharmacist for more information. See also Warning section.Read the Medication Guide provided by your pharmacist before you start taking pomalidomide and each time you get a refill. If you have any questions, ask your doctor or pharmacist.Take this medication by mouth with or without food as directed by your doctor, usually once daily for 21 days, then stopping the medication for 7 days. This is one cycle of treatment. Continue taking the medication this way as directed by your doctor.Swallow the capsules whole with water. Do not open, break, crush or chew the capsules or handle them more than needed. If any of the powder from the capsule gets on your skin, wash the area with soap and water.The dosage is based on your medical condition, response to treatment, laboratory test results, and other medications you may be taking. Be sure to tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).Take this medication regularly to get the most benefit from it. Remember to take it at the same time each day that you are scheduled to take it.Do not increase your dose or take this drug more often or for longer than prescribed. Your condition will not improve any faster, and your risk of side effects will increase.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 the capsules.

              SIDE EFFECTS: See also Warning section.Dizziness, confusion, tiredness, weakness, constipation, diarrhea, back/bone pain, muscle pain/cramps, nausea, vomiting, and loss of appetite may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.People using this medication may have serious side effects. However, you have been prescribed this drug because your doctor has judged that the benefit to you is greater than the risk of side effects. Careful monitoring by your doctor may decrease your risk.Tell your doctor right away if you have any serious side effects, including: numbness/tingling/swelling of the arms/legs/hands/feet, shortness of breath.This medication decreases bone marrow function, an effect that may lead to a low number of blood cells such as red cells, white cells, and platelets. This effect can cause anemia, decrease your body's ability to fight an infection, or cause easy bruising/bleeding. Get medical help right away if you have any of the following symptoms: unusual tiredness, pale skin, easy bruising/bleeding, signs of infection (such as sore throat that doesn't go away, fever, chills, swollen lymph nodes, cough).Pomalidomide sometimes causes side effects due to the rapid destruction of cancer cells (tumor lysis syndrome). To lower your risk, your doctor may add a medication and tell you to drink plenty of fluids. Tell your doctor right away if you have symptoms such as: low back/side pain (flank pain), signs of kidney problems (such as painful urination, pink/bloody urine, change in the amount of urine), muscle spasms/weakness.This medication may increase your risk of getting a rare but very serious (possibly fatal) brain infection (progressive multifocal leukoencephalopathy-PML). Get medical help right away if you have any of these side effects: clumsiness, loss of coordination/balance, weakness, sudden change in your thinking (such as confusion, difficulty concentrating, memory loss), difficulty talking/walking, seizure, vision changes.Pomalidomide has rarely caused very serious (possibly fatal) liver disease. Get medical help right away if you develop symptoms of liver disease, including: nausea/vomiting that doesn't stop, severe stomach/abdominal pain, dark urine, yellowing eyes/skin.People who are treated with this medication may rarely get other cancers (such as leukemia). Consult your doctor for more details.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: 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 pomalidomide, tell your doctor or pharmacist if you are allergic to it; or to thalidomide or lenalidomide; 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: kidney disease, liver disease, cigarette smoking, heart disease (such as heart attack), blood clots, stroke.Pomalidomide can make you more likely to get infections or may worsen any current infections. Avoid contact with people who have infections that may spread to others (such as chickenpox, measles, flu). Consult your doctor if you have been exposed to an infection or for more details.Tell your health care professional that you are using pomalidomide before having any immunizations/vaccinations. Avoid contact with people who have recently received live vaccines (such as flu vaccine inhaled through the nose).To lower the chance of getting cut, bruised, or injured, use caution with sharp objects like razors and nail cutters, and avoid activities such as contact sports.This drug may make you dizzy or confused. Alcohol or marijuana (cannabis) can make you more dizzy or confused. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).Because pomalidomide can cause severe birth defects or death to an unborn baby, several precautions are noted below.Do not donate blood during treatment and for at least 1 month after stopping treatment.Men: Do not donate sperm during treatment and for at least 4 weeks after stopping treatment because pomalidomide passes into semen.Women: Tell your doctor right away if your period is late or if you have abnormal vaginal (menstrual) bleeding. Use reliable forms of birth control even if you were unable to get pregnant in the past.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 the capsules.This medication must not be used during pregnancy. It may harm an unborn baby. See also Warning section.It is unknown if 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 are taking other products that cause dizziness or confusion including alcohol, marijuana (cannabis), antihistamines (such as diphenhydramine), drugs for sleep or anxiety (such as alprazolam, zolpidem), muscle relaxants, and opioid pain relievers (such as codeine).Check the labels on all your medicines (such as allergy or cough-and-cold products) because they may contain ingredients that cause dizziness. Ask your pharmacist about using those products safely.Cigarette smoking decreases blood levels of this medication. Tell your doctor if you smoke or if you have recently stopped smoking.

              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.

              NOTES: Do not share this medication with others.Laboratory and/or medical tests (such as pregnancy tests, blood counts, liver function) must be performed before you start treatment and periodically to monitor your progress or check for side effects. Consult your doctor for more details.Test for pregnancy before treatment, and weekly during the first 4 weeks of treatment. If you have regular periods, then test every 4 weeks thereafter. If you have irregular periods, you should test every 2 weeks thereafter.

              MISSED DOSE: If you miss a dose and it has been less than 12 hours since your usual dose time, take it as soon as you remember. If it has been more than 12 hours since your usual dose time, then 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. 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 October 2022. Copyright(c) 2022 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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              Formulary

              FormularyPatient Discounts

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

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              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.
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              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.
              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.
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              Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
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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.