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Pomalidomide is a brand name for Pomalidomide. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: 1 INDICATIONS AND USAGE Pomalidomide capsules are a thalidomide analogue indicated for the treatment of adult patients: in combination with dexamethasone, for patients with multiple myeloma (MM) who have received at least two prior therapies including lenalidomide and a proteasome inhibitor and have demonstrated…
Verbatim from this product's FDA label. Tap a section to expand.
2 ). 1 ). 3 ). 7 ). 3 )]. 2 Recommended Dosage for Multiple Myeloma The recommended dosage of pomalidomide capsules is 4 mg once daily orally with or without food on Days 1 through 21 of each 28-day cycle until disease progression. 1 )].
3 Recommended Dosage for Kaposi Sarcoma The recommended dosage of pomalidomide capsules is 5 mg once daily taken orally with or without food on Days 1 through 21 of each 28-day cycle until disease progression or unacceptable toxicity.
2)]. 4 Dosage Modifications for Hematologic Adverse Reactions Multiple Myeloma: Dosage Modifications for Hematologic Adverse Reactions Initiate a new cycle of pomalidomide capsules in patients with multiple myeloma (MM) when the neutrophil count is at least 500 per mcL and the platelet count is at least 50,000 per mcL.
Dosage modification for pomalidomide capsules for hematologic adverse reactions in patients with MM are summarized in Table 1.
Table 1:
Dosage Modifications for pomalidomide capsules for Hematologic in MM * Permanently discontinue pomalidomide capsules if unable to tolerate 1 mg once daily. 5°C and ANC less than 1,000 per mcL) Withhold pomalidomide capsules until ANC is greater than or equal to 500 per mcL; follow CBC weekly.
Resume pomalidomide capsules dose at 1 mg less than the previous dose. 5) ] For each subsequent drop of ANC less than 500 per mcL Withhold pomalidomide capsules until ANC is greater than or equal to 500 mcL. Resume pomalidomide capsules dose at 1 mg less than the previous dose.
* Platelets less than 25,000 per mcL Withhold pomalidomide capsules until platelets are greater than or equal to 50,000 per mcL; follow CBC weekly. Resume pomalidomide capsules dose at 1 mg less than the previous dose* For each subsequent drop of platelets less than 25,000 per mcL Withhold pomalidomide capsules until platelets are greater than or equal to 50,000 per mcL.
Resume pomalidomide capsules at 1 mg less than the previous dose* Kaposi Sarcoma:
Dosage Modifications for Hematologic Adverse Reactions Initiate a new cycle of pomalidomide capsules in patients with KS when the neutrophil count is at least 1000 per mcL and the platelet count is at least 75,000 per mcL. Dose modifications for pomalidomide capsules for hematologic adverse reactions in patients with KS are summarized in Table 2.
12 )]. 1 ). 1 ). To report SUSPECTED ADVERSE REACTIONS, contact Breckenridge Pharmaceutical Inc. gov/medwatch. 1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Multiple Myeloma (MM) In Trial 1, data were evaluated from 219 patients (safety population) who received treatment with Pomalidomide + Low-dose Dex (112 patients) or pomalidomide alone (107 patients). Median number of treatment cycles was 5.
Sixty-seven percent of patients in the study had a dose interruption of either drug due to adverse reactions. Forty-two percent of patients in the study had a dose reduction of either drug due to adverse reactions. The discontinuation rate due to adverse reactions was 11%.
In Trial 2, data were evaluated from 450 patients (safety population) who received treatment with Pomalidomide + Low-dose Dex (300 patients) or High-dose Dexamethasone (High-dose Dex) (150 patients). The median number of treatment cycles for the Pomalidomide + Low-dose Dex arm was 5.
1 weeks. 5 weeks. Eight percent of patients discontinued pomalidomide due to adverse reactions. Tables 3 and 4 summarize the adverse reactions reported in Trials 1 and 2, respectively.
Table 3:
Adverse Reactions in Any Pomalidomide Capsules Treatment Arm in Trial 1* * Regardless of attribution of relatedness to pomalidomide. a Pomalidomide alone arm includes all patients randomized to the pomalidomide alone arm who took study drug; 61 of the 107 patients had dexamethasone added during the treatment period.
b Serious adverse reactions were reported in at least 2 patients in any pomalidomide treatment arm. , all adverse events or Grade 3 or 4 adverse events). b Serious adverse reactions were reported in at least 3 patients in the POM + Low-dose Dex arm, AND at least 1% higher than the High-dose-Dex arm percentage.
4 ).
Hematologic Toxicity:
Neutropenia was the most frequently reported Grade 3/4 adverse event. 5 ). 6 ). 7 ). 11 ).
Hypersensitivity:
Monitor patients for potential hypersensitivity. 12 ). 1 Embryo-Fetal Toxicity Pomalidomide capsules are a thalidomide analogue and are contraindicated for use during pregnancy. 1) ]. 2 )]. Females of Reproductive Potential Females of reproductive potential must avoid pregnancy for at least 4 weeks before beginning Pomalidomide Capsules therapy, during therapy, during dose interruptions and for at least 4 weeks after completing therapy.
Females must commit either to abstain continuously from heterosexual sexual intercourse or to use 2 methods of reliable birth control, beginning 4 weeks prior to initiating treatment with pomalidomide capsules, during therapy, during dose interruptions, and continuing for 4 weeks following discontinuation of pomalidomide capsules therapy.
Two negative pregnancy tests must be obtained prior to initiating therapy. 3 )]. Males Pomalidomide is present in the semen of patients receiving the drug. Therefore, males must always use a latex or synthetic condom during any sexual contact with females of reproductive potential while taking pomalidomide capsules and for up to 4 weeks after discontinuing pomalidomide capsules, even if they have undergone a successful vasectomy.
3) ]. Blood Donation Patients must not donate blood during treatment with pomalidomide capsules and for 4 weeks following discontinuation of the drug because the blood might be given to a pregnant female patient whose fetus must not be exposed to pomalidomide capsules.
1) ], pomalidomide capsules are available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS), “PS-Pomalidomide REMS”.
1 Pregnancy Pomalidomide capsules are contraindicated in females who are pregnant. 1 )]. Pomalidomide is a thalidomide analogue and is teratogenic in both rats and rabbits when administered during the period of organogenesis. If the patient becomes pregnant while taking this drug, the patient should be apprised of the potential risk to a fetus.
7 ), Description (11) ].
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Table 2:
Dosage Modifications for Pomalidomide Capsules for Hematologic Adverse Reactions in KS * Permanently discontinue pomalidomide capsules if unable to tolerate 1mg once daily. 5 )] ANC 500 to less than1,000 per mcL Day 1 of cycle Withhold pomalidomide capsules until ANC is greater than or equal to 1,000 per mcL.
Resume pomalidomide capsules at the same dose. During cycle Continue pomalidomide capsules at the current dose. ANC less than 500 per mcL Withhold pomalidomide capsules until ANC is greater than or equal to 1,000 per mcL. Resume pomalidomide capsules at the same dose.
3°C or ANC less than 1,000 per mcL and sustained temperature greater than or equal to 38°C for more than 1 hour Withhold pomalidomide capsules until ANC is greater than or equal to 1,000 per mcL. 5) ] Platelet count 25,000 to less than 50,000 per mcL Day 1 of cycle Withhold pomalidomide capsules until platelet count is greater than or equal to 50,000 per mcL.
Resume pomalidomide capsules at the same dose.
During cycle:
Continue pomalidomide capsules at the current dose. Platelet count less than 25,000 per mcL Permanently discontinue pomalidomide capsules. 12) ]. 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.
6 Dosage Modifications for Strong CYP1A2 Inhibitors Avoid concomitant use of pomalidomide capsules with strong CYP1A2 inhibitors. 3) ]. 3) ]. For patients with MM with severe renal impairment requiring dialysis, reduce the recommended dosage to 3 mg orally daily.
For patients with KS with severe renal impairment requiring dialysis, reduce the recommended dosage to 4 mg orally daily. 8 Dosage Modification for Hepatic Impairment Multiple Myeloma For patients with MM with mild or moderate hepatic impairment (Child-Pugh A or B), reduce the recommended dosage to 3 mg orally daily.
3) ]. 3) ]. 9 Administration Swallow capsules whole with water. Do not break, chew, or open the capsules. Pomalidomide capsules may be taken with or without food
2 )]. Twenty-eight patients received pomalidomide capsules 5 mg taken orally once daily on Days 1 through 21 of repeated 28- day cycles. The study excluded patients with procoagulant disorders or a history of venous or arterial thromboembolism.
Patients received DVT prophylaxis with daily low dose aspirin. Across all patients treated on Trial 12-C-0047, 75% were exposed to pomalidomide for 6 months or longer and 25% were exposed for greater than one year. Serious adverse reactions occurred in 18% (5/28) of patients who received pomalidomide capsules.
The following serious adverse reactions each occurred in 1 patient: anemia, decreased neutrophil count, and hematuria. Permanent discontinuation due to an adverse reaction occurred in 11% (3/28) of patients who received pomalidomide capsules.
Dosage interruptions due to an adverse reaction occurred in 14% (4/28) of patients who received pomalidomide capsules. The most frequent adverse reaction requiring dosage interruption was decreased neutrophil count, which occurred in 3 patients.
The pomalidomide capsules dose was reduced due to an adverse reaction in 1 patient due to gout. Tables 5 and 6 summarize the adverse reactions and select laboratory abnormalities reported in Trial 12-C-0047. 6 * Denominator is the number of patients for whom there is a baseline and at least one post baseline assessment for the laboratory parameter.
2 Postmarketing Experience The following adverse reactions have been identified during post approval use of pomalidomide capsules. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
, 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 (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)
Required components of PS-Pomalidomide REMS include the following:
Prescribers must be certified with PS-Pomalidomide REMS by enrolling and complying with the REMS requirements. Patients must sign a Patient-Physician Agreement Form and comply with the REMS requirements. 3) ]. Pharmacies must be certified with PS-Pomalidomide REMS, must only dispense to patients who are authorized to receive pomalidomide capsules and comply with REMS requirements.
com or by telephone at 1-888-423-5436. 3 Venous and Arterial Thromboembolism Venous thromboembolic events (deep venous thrombosis and pulmonary embolism) and arterial thromboembolic events (myocardial infarction and stroke) have been observed in patients treated with pomalidomide capsules.
3% of patients treated with high-dose dexamethasone. 3% of patients treated with high-dose dexamethasone. Arterial thromboembolic events include terms for arterial thromboembolic events, ischemic cerebrovascular conditions, and ischemic heart disease.
3% of patients treated with high-dose dexamethasone. , hyperlipidemia, hypertension, smoking). Thromboprophylaxis is recommended, and the choice of regimen should be based on assessment of the patient's underlying risk factors. 4 Increased Mortality in Patients with Multiple Myeloma When Pembrolizumab Is Added to a Thalidomide Analogue and Dexamethasone In two randomized clinical trials in patients with MM, the addition of pembrolizumab to a thalidomide analogue plus dexamethasone, a use for which no PD-1 or PD-L1 blocking antibody is indicated, resulted in increased mortality.
Treatment of patients with MM 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. 5 Hematologic Toxicity Multiple Myeloma In trials 1 and 2 in patients who received pomalidomide + Low-dose Dex, neutropenia was the most frequently reported Grade 3 or 4 adverse reaction, followed by anemia and thrombocytopenia.
Neutropenia of any grade was reported in 51% of patients in both trials. The rate of Grade 3 or 4 neutropenia was 46%. The rate of febrile neutropenia was 8%. Monitor patients for hematologic toxicities, especially neutropenia. Monitor complete blood counts weekly for the first 8 weeks and monthly thereafter.
4) ]. 1) ]. Fifty percent of patients had Grade 3 or 4 neutropenia. Monitor patients for hematologic toxicities, especially decreased neutrophils. Monitor complete blood counts every 2 weeks for the first 12 weeks and monthly thereafter.
4) ]. 6 Hepatotoxicity Hepatic failure, including fatal cases, has occurred in patients treated with pomalidomide capsules. Elevated levels of alanine aminotransferase and bilirubin have also been observed in patients treated with pomalidomide capsules.
Monitor liver function tests monthly. Stop pomalidomide capsules upon elevation of liver enzymes and evaluate. After return to baseline values, treatment at a lower dose may be considered. 7 Severe Cutaneous Reactions Severe cutaneous reactions including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and drug reaction with eosinophilia and systemic symptoms (DRESS) have been 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.
These reactions can be fatal. Consider pomalidomide capsules interruption or discontinuation for Grade 2 or 3 skin rash. 5) ]. 8 Dizziness and Confusional State In trials 1 and 2 in patients who received pomalidomide capsules + Low-dose Dex, 14% of patients experienced dizziness and 7% of patients experienced a confusional state; 1% of patients experienced Grade 3 or 4 dizziness, and 3% of patients experienced Grade 3 or 4 confusional state.
Instruct patients to avoid situations where dizziness or confusional state may be a problem and not to take other medications that may cause dizziness or confusional state without adequate medical advice. 9 Neuropathy In trials 1 and 2 in patients who received pomalidomide capsules + Low-dose Dex, 18% of patients experienced neuropathy, with approximately 12% of the patients experiencing peripheral neuropathy.
Two percent of patients experienced Grade 3 neuropathy in trial 2. There were no cases of Grade 4 neuropathy adverse reactions reported in either trial. 10 Risk of Second Primary Malignancies Cases of acute myelogenous leukemia have been reported in patients receiving pomalidomide capsules as an investigational therapy outside of MM.
11 Tumor Lysis Syndrome Tumor lysis syndrome (TLS) may occur in patients treated with pomalidomide. Patients at risk for TLS are those with high tumor burden prior to treatment. These patients should be monitored closely and appropriate precautions taken.
12 Hypersensitivity Hypersensitivity, including angioedema, anaphylaxis, and anaphylactic reactions to pomalidomide capsules have been reported. 5) ].