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| | | POMALYST® (pomalidomide) is a thalidomide analogue indicated, in combination with dexamethasone, for patients with multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor and have demonstrated disease progression on or within 60 days of completion of the last therapy. | | | | POMALYST is only available through a restricted distribution program, POMALYST REMS®. | | | | Boxed WARNINGS: EMBRYO-FETAL TOXICITY and VENOUS AND ARTERIAL THROMBOEMBOLISM |
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| | | POMALYST® (pomalidomide) is a thalidomide analogue indicated, in combination with dexamethasone, for patients with multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor and have demonstrated disease progression on or within 60 days of completion of the last therapy. | | | | POMALYST is only available through a restricted distribution program, POMALYST REMS®. | | | | Boxed WARNINGS: EMBRYO-FETAL TOXICITY and VENOUS AND ARTERIAL THROMBOEMBOLISM | | | |
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| | Dear {{customText[Dr.|Mr.|Ms.|Mrs.|Prof.]}} {{accFname}} {{accLname}}, | | | | {{customText[It was a pleasure speaking with you today about POMALYST + dex for relapsed/refractory MM. POMALYST has convenient once-daily oral dosing and can be used in patients with all levels of renal impairment—including those on dialysis. I’ve enclosed additional dosing information that I thought you might find useful when considering treatment for patients with renal impairment.|As a follow-up to our conversation, I’ve included key renal dosing information for POMALYST, approved in combination with dex for relapsed/refractory MM patients, including patients with renal dysfunction. I look forward to hearing your thoughts on POMALYST, which has convenient once-daily oral dosing and straightforward starting dosage irrespective of level of renal impairment.|Finding an appropriate treatment for relapsed/refractory MM patients with renal impairment can be challenging. Below you will find dosing information for POMALYST, a once-daily oral therapy approved in combination with dex for RRMM patients. POMALYST can be used in patients with all levels of renal impairment—including patients on dialysis. I look forward to hearing how POMALYST may fit into the treatment plan for patients with relapsed/refractory multiple myeloma during our next discussion.|I’m sorry we didn’t have a chance to connect today. I’ve enclosed important dosing information for POMALYST, an oral RRMM therapy approved in combination with dex, and how it may be dose modified to adjust for renal dysfunction in patients on dialysis. I look forward to connecting again soon.]}} | | | | Regards, | | | {{userName}} | | | | Celgene Consultant | | | {{User.Phone}} | | |  |  | | | POMALYST:
Convenient once-daily oral dosing1 | | |  |  | | | | Capsules shown are not actual size. | | | | | | | | • | For patients with severe renal impairment requiring dialysis, patients should take POMALYST following hemodialysis on the day of dialysis
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| | | | • | Recommended starting dose for POMALYST is 4 mg/day on Days 1-21 of a 28-day cycle |
| | | – | 3 mg, 2 mg, and 1 mg doses are also available for dose modification | | | – | POMALYST should be given in combination with dexamethasone (dex) | | | |
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| | | | Important Dosing Information | | | | • | POMALYST may be taken with water, and with or without food. Inform patients not to break, chew, or open the capsules | | | | | • | Monitor CBCs every week for the first 8 weeks and monthly thereafter. Patients may require dose interruption and/or modification | | | | | • | Monitor liver function tests monthly. Stop POMALYST upon elevation of liver enzymes and evaluate. After return to baseline values, treatment at a lower dose may be considered | | | | | • | Reduce POMALYST dose by 25% in patients with mild to moderate hepatic impairment and 50% in patients with severe hepatic impairment | | | | | • | Avoid concomitant use of POMALYST with strong inhibitors of CYP1A2. Consider alternative treatments. If a strong CYP1A2 inhibitor must be used, reduce POMALYST dose by 50% | | | | | • | Reduce POMALYST dose by 25% in patients with severe renal impairment requiring dialysis. Take dose of POMALYST following hemodialysis on hemodialysis days | | | | | CBC, complete blood count; MM, multiple myeloma; RRMM, relapsed/refractory multiple myeloma. | | | |
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| | | | | | | | WARNING: EMBRYO-FETAL TOXICITY and VENOUS AND
ARTERIAL THROMBOEMBOLISM | | | | Embryo-Fetal Toxicity | | • | POMALYST is contraindicated in pregnancy. POMALYST is a thalidomide analogue. Thalidomide 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 starting POMALYST treatment. |
| | • | Females of reproductive potential must use 2 forms of contraception or continuously abstain from heterosexual sex during and for 4 weeks after stopping POMALYST treatment. |
| | | | POMALYST is only available through a restricted distribution program called POMALYST REMS®. | | | | Venous and Arterial Thromboembolism | | • | Deep venous thrombosis (DVT), pulmonary embolism (PE), myocardial infarction, and stroke occur in patients with multiple myeloma treated with POMALYST. Prophylactic antithrombotic measures were employed in clinical trials. Thromboprophylaxis is recommended, and the choice of regimen should be based on assessment of the patient’s underlying risk factors. |
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| | | | CONTRAINDICATIONS | | | | • | Pregnancy: POMALYST can cause fetal harm and is contraindicated in females who are pregnant. If POMALYST is used during pregnancy or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential risk to a fetus. | | • | Hypersensitivity: POMALYST is contraindicated in patients who have demonstrated severe hypersensitivity (e.g., angioedema, anaphylaxis) to pomalidomide or any of the excipients. |
| | | | WARNINGS AND PRECAUTIONS | | | | • | Embryo-Fetal Toxicity & Females of Reproductive Potential: See Boxed WARNINGS | | | | – | Males: Pomalidomide is present in the semen of patients receiving the drug. Males must always use a latex or synthetic condom during any sexual contact with females of reproductive potential while taking POMALYST and for up to 4 weeks after discontinuing POMALYST, even if they have undergone a successful vasectomy. Males must not donate sperm. | | | | | – | Blood Donation: Patients must not donate blood during treatment with POMALYST and for 4 weeks following discontinuation of POMALYST therapy because the blood might be given to a pregnant female patient whose fetus must not be exposed to POMALYST. |
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| | | | • | POMALYST REMS ® Program: See Boxed WARNINGS | | | | – | Prescribers and pharmacies must be certified with the POMALYST REMS program by enrolling and complying with the REMS requirements; pharmacies must only dispense to patients who are authorized to receive POMALYST. Patients must sign a Patient-Physician Agreement Form and comply with REMS requirements; female patients of reproductive potential who are not pregnant must comply with the pregnancy testing and contraception requirements and males must comply with contraception requirements. | | | | | – | Further information about the POMALYST REMS program is available at www.CelgeneRiskManagement.com or by telephone at 1-888-423-5436. |
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| | | | • | Venous and Arterial Thromboembolism: See Boxed WARNINGS. Patients with known risk factors, including prior thrombosis, may be at greater risk, and actions should be taken to try to minimize all modifiable factors (e.g., hyperlipidemia, hypertension, smoking). Thromboprophylaxis is recommended, and the choice of regimen should be based on assessment of the patient’s underlying risk factors. | | | | | • | Increased Mortality With Pembrolizumab: In clinical trials in patients with multiple myeloma, the addition of pembrolizumab to a thalidomide analogue plus dexamethasone resulted in increased mortality. Treatment of patients with multiple myeloma 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. | | | | | • | Hematologic Toxicity: Neutropenia (46%) was the most frequently reported Grade 3/4 adverse reaction in patients taking POMALYST in clinical trials, followed by anemia and thrombocytopenia. Monitor complete blood counts weekly for the first 8 weeks and monthly thereafter. Patients may require dose interruption and/or modification. | | | | | • | Hepatotoxicity: Hepatic failure, including fatal cases, has occurred in patients treated with POMALYST. Elevated levels of alanine aminotransferase and bilirubin have also been observed in patients treated with POMALYST. Monitor liver function tests monthly. Stop POMALYST upon elevation of liver enzymes. After return to baseline values, treatment at a lower dose may be considered. | | | | | • | 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 POMALYST interruption or discontinuation for Grade 2-3 skin rash. Permanently discontinue POMALYST for Grade 4 rash, exfoliative or bullous rash, or any other severe cutaneous reactions such as SJS, TEN or DRESS. | | | | | • | Dizziness and Confusional State: In patients taking POMALYST in clinical trials, 14% experienced dizziness (1% Grade 3 or 4) and 7% a confusional state (3% Grade 3 or 4). 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. | | | | | • | Neuropathy: In patients taking POMALYST in clinical trials, 18% experienced neuropathy (2% Grade 3 in one trial) and 12% peripheral neuropathy. | | | | | • | Second Primary Malignancies: Cases of acute myelogenous leukemia have been reported in patients receiving POMALYST as an investigational therapy outside of multiple myeloma. | | | | | • | Tumor Lysis Syndrome (TLS): TLS may occur in patients treated with POMALYST. Patients at risk are those with high tumor burden prior to treatment. These patients should be monitored closely and appropriate precautions taken. | | | | | • | Hypersensitivity: Hypersensitivity, including angioedema, anaphylaxis, and anaphylactic reactions to POMALYST have been reported. Permanently discontinue POMALYST for angioedema or anaphylaxis. |
| | | | ADVERSE REACTIONS | | | | The most common adverse reactions for POMALYST (≥30%) included fatigue and asthenia, neutropenia, anemia, constipation, nausea, diarrhea, dyspnea, upper-respiratory tract infections, back pain, and pyrexia. | | | | In the phase III trial, nearly all patients treated with POMALYST + low-dose dex experienced at least one adverse reaction (99%). Adverse reactions (≥15% in the POMALYST + low-dose dex arm and ≥2% higher than control) included neutropenia (51.3%), fatigue and asthenia (46.7%), upper respiratory tract infection (31%), thrombocytopenia (29.7%), pyrexia (26.7%), dyspnea (25.3%), diarrhea (22%), constipation (21.7%), back pain (19.7%), cough (20%), pneumonia (19.3%), bone pain (18%), edema peripheral (17.3%), peripheral neuropathy (17.3%), muscle spasms (15.3%), and nausea (15%). Grade 3 or 4 adverse reactions (≥15% in the POMALYST + low-dose dex arm and ≥1% higher than control) included neutropenia (48.3%), thrombocytopenia (22%), and pneumonia (15.7%). | | | | DRUG INTERACTIONS | | | | Avoid concomitant use of POMALYST with strong inhibitors of CYP1A2. Consider alternative treatments. If a strong CYP1A2 inhibitor must be used, reduce POMALYST dose by 50%. | | | | USE IN SPECIFIC POPULATIONS | | | | • | Pregnancy: See Boxed WARNINGS. If pregnancy does occur during treatment, immediately discontinue the drug and refer patient to an obstetrician/gynecologist experienced in reproductive toxicity for further evaluation and counseling. There is a POMALYST pregnancy exposure registry that monitors pregnancy outcomes in females exposed to POMALYST during pregnancy as well as female partners of male patients who are exposed to POMALYST. This registry is also used to understand the root cause for the pregnancy. Report any suspected fetal exposure to POMALYST to the FDA via the MedWatch program at 1-800-FDA-1088 and also to Celgene Corporation at 1-888-423-5436. |
| | | | • | Lactation: There is no information regarding the presence of pomalidomide in human milk, the effects of POMALYST on the breastfed child, or the effects of POMALYST on milk production. Pomalidomide was excreted in the milk of lactating rats. Because many drugs are excreted in human milk and because of the potential for adverse reactions in a breastfed child from POMALYST, advise women not to breastfeed during treatment with POMALYST. |
| | | | • | Pediatric Use: Safety and effectiveness have not been established in pediatric patients. |
| | | | • | Geriatric Use: No dosage adjustment is required for POMALYST based on age. Patients >65 years of age were more likely than patients ≤65 years of age to experience pneumonia. |
| | | | • | Renal Impairment: Reduce POMALYST dose by 25% in patients with severe renal impairment requiring dialysis. Take dose of POMALYST following hemodialysis on hemodialysis days. |
| | | | • | Hepatic Impairment: Reduce POMALYST dose by 25% in patients with mild to moderate hepatic impairment and 50% in patients with severe hepatic impairment. |
| | | | • | Smoking Tobacco: Advise patients that smoking may reduce the efficacy of POMALYST. Cigarette smoking reduces the AUC of pomalidomide by 32% by CYP1A2 induction. |
| | | | Please see full Prescribing Information, including Boxed WARNINGS. | | | | Reference: 1. POMALYST [package insert]. Summit, NJ; Celgene Corp; 2019. |
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