VISIT WEBSITE FOR PATIENTS

The POMALYST safety profile was well established in a Phase 3 trial of 450 patients

Adverse reactions, n (%) (≥5% in POMALYST + low-dose dex arm, and at least 2% points higher than the high-dose dex arm)
System Organ Class/Preferred Term POMALYST +
low-dose dex
(n=300)
High-dose dex
(n=150)
Number (%) of patients with at least one adverse reaction 297 (99.0) 149 (99.3)
Blood and lymphatic system disorders
Neutropeniab 154 (51.3) 31 (20.7)
Thrombocytopenia 89 (29.7)a 44 (29.3)a
Leukopenia 38 (12.7) 8 (5.3)
Febrile neutropeniab 28 (9.3) 0 (0.0)
General disorders and administration site conditions
Fatigue and asthenia 140 (46.7) 64 (42.7)
Pyrexiab 80 (26.7) 35 (23.3)
Edema peripheral 52 (17.3) 17 (11.3)
Pain 11 (3.7)a 3 (2.0)a
Infections and infestations
Upper respiratory tract infectionb 93 (31.0) 19 (12.7)
Pneumoniab 58 (19.3) 20 (13.3)
Neutropenic sepsisb 3 (1.0)a 0 (0.0)a
Gastrointestinal disorders
Diarrhea 66 (22.0) 28 (18.7)
Constipation 65 (21.7) 22 (14.7)
Nausea 45 (15.0) 17 (11.3)
Vomiting 23 (7.7) 6 (4.0)
Musculoskeletal and connective tissue disorders
Back painb 59 (19.7) 24 (16.0)
Bone painb 54 (18.0) 21 (14.0)
Muscle spasms 46 (15.3) 11 (7.3)
Arthralgia 26 (8.7) 7 (4.7)
Pain in extremity 20 (6.7)a 9 (6.0)a
Respiratory, thoracic and mediastinal disorders
Dyspneab 76 (25.3) 25 (16.7)
Cough 60 (20.0) 15 (10.0)
Chronic obstructive pulmonary diseaseb 5 (1.7)a 0 (0.0)a
Nervous system disorders
Peripheral neuropathy 52 (17.3) 18 (12.0)
Dizziness 37 (12.3) 14 (9.3)
Headache 23 (7.7) 8 (5.3)
Tremor 17 (5.7) 2 (1.3)
Depressed level of consciousness 5 (1.7)a 0 (0.0)a
Metabolism and nutrition disorders
Decreased appetite 38 (12.7) 12 (8.0)
Hypokalemia 28 (9.3)a 12 (8.0)a
Hypocalcemia 12 (4.0)a 9 (6.0)a
Skin and subcutaneous tissue disorders
Rash 23 (7.7) 2 (1.3)
Pruritus 22 (7.3) 5 (3.3)
Hyperhidrosis 15 (5.0) 1 (0.7)
Investigations
Neutrophil count decreased 15 (5.0) 1 (0.7)
Platelet count decreased 10 (3.3)a 3 (2.0)a
White blood cell count decreased 8 (2.7)a 1 (0.7)a
Alanine aminotransferase increased 7 (2.3)a 2 (1.3)a
Aspartate aminotransferase increased 4 (1.3)a 2 (1.3)a
Lymphocyte count decreased 3 (1.0)a 1 (0.7)a
Renal and urinary disorders
Renal failure 31 (10.3)a 18 (12.0)a
Injury, poisoning and procedural complications
Femur fractureb 5 (1.7)a 1 (0.7)a
Reproductive system and breast disorders
Pelvic pain 6 (2.0)a 3 (2.0)a
Adverse reactions, n (%) (≥1% in POMALYST + low-dose dex arm, and at least 1% point higher than the high-dose dex arm)
System Organ Class/Preferred Term POMALYST +
low-dose dex
(n=300)
High-dose dex
(n=150)
Number (%) of patients with at least one adverse reaction 259 (86.3) 127 (84.7)
Blood and lymphatic system disorders
Neutropeniab 145 (48.3) 24 (16.0)
Thrombocytopenia 66 (22.0)a 39 (26.0)a
Leukopenia 27 (9.0) 5 (3.3)
Febrile neutropeniab 28 (9.3) 0 (0.0)
General disorders and administration site conditions
Fatigue and asthenia 26 (8.7)a 18 (12.0)a
Pyrexiab 9 (3.0)a 7 (4.7)a
Edema peripheral 4 (1.3)a 3 (2.0)a
Pain 5 (1.7) 1 (0.7)
Infections and infestations
Upper respiratory tract infectionb 9 (3.0) 1 (0.7)
Pneumoniab 47 (15.7) 15 (10.0)
Neutropenic sepsisb 3 (1.0) 0 (0.0)
Gastrointestinal disorders
Diarrhea 3 (1.0)a 2 (1.3)a
Constipation 7 (2.3) 0 (0.0)
Nausea 3 (1.0)a 2 (1.3)a
Vomiting 3 (1.0) 0 (0.0)
Musculoskeletal and connective tissue disorders
Back painb 15 (5.0) 6 (4.0)
Bone painb 22 (7.3) 7 (4.7)
Muscle spasms 1 (0.3)a 1 (0.7)a
Arthralgia 2 (0.7)a 1 (0.7)a
Pain in extremity 6 (2.0) 0 (0.0)
Respiratory, thoracic and mediastinal disorders
Dyspneab 17 (5.7) 7 (4.7)
Cough 2 (0.7)a 1 (0.7)a
Chronic obstructive pulmonary diseaseb 4 (1.3) 0 (0.0)
Nervous system disorders
Peripheral neuropathy 5 (1.7)a 2 (1.3)a
Dizziness 4 (1.3)a 2 (1.3)a
Headache 1 (0.3)a 0 (0.0)a
Tremor 2 (0.7)a 0 (0.0)a
Depressed level of consciousness 3 (1.0) 0 (0.0)
Metabolism and nutrition disorders
Decreased appetite 3 (1.0)a 2 (1.3)a
Hypokalemia 12 (4.0) 0 (0.0)
Hypocalcemia 5 (1.7) 1 (0.7)
Skin and subcutaneous tissue disorders
Rash 3 (1.0) 0 (0.0)
Pruritus 0 (0.0)a 0 (0.0)a
Hyperhidrosis 0 (0.0)a 0 (0.0)a
Investigations
Neutrophil count decreased 14 (4.7) 1 (0.7)
Platelet count decreased 8 (2.7) 2 (1.3)
White blood cell count decreased 8 (2.7) 0 (0.0)
Alanine aminotransferase increased 5 (1.7) 0 (0.0)
Aspartate aminotransferase increased 3 (1.0) 0 (0.0)
Lymphocyte count decreased 3 (1.0) 0 (0.0)
Renal and urinary disorders
Renal failure 19 (6.3) 8 (5.3)
Injury, poisoning and procedural complications
Femur fractureb 5 (1.7) 1 (0.7)
Reproductive system and breast disorders
Pelvic pain 4 (1.3) 0 (0.0)
a

Percentage did not meet the criteria to be considered as an adverse reaction for POMALYST for that category of event (i.e., all adverse events or Grade 3 or 4 adverse events).

b

Serious adverse reactions were reported in at least 3 patients in the POMALYST + low-dose dex arm, AND at least 1% higher than the high-dose dex arm percentage.

Data cutoff: March 1, 2013

Click here to help your patients learn more about POMALYST safety

Pomalidomide (POMALYST) is a National Comprehensive Cancer Network® (NCCN®) Category 1 Recommended Option When Used in Combination With Dexamethasone

Indicated for patients with multiple myeloma who have received at least two prior therapies, including an immunomodulatory agent and a proteasome inhibitor, and have demonstrated disease progression on or within 60 days of completion of the last therapy.

Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Multiple Myeloma, Version 3.2017. © National Comprehensive Cancer Network, Inc 2017. All rights reserved. Accessed January 2017. To view the most recent and complete version of the guideline, go online to NCCN.org. NATIONAL COMPREHENSIVE CANCER NETWORK®, NCCN®, NCCN GUIDELINES®, and all other NCCN Content are trademarks owned by the National Comprehensive Cancer Network, Inc.

Indication

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.

Important Safety Information

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.

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.

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 1 month following discontinuation of POMALYST therapy because the blood might be given to a pregnant female patient whose fetus must not be exposed to POMALYST.
  • 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.
  • 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.
  • 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.
  • Hypersensitivity Reactions: Angioedema and severe dermatologic reactions have been reported. Discontinue POMALYST for angioedema, skin exfoliation, bullae, or any other severe dermatologic reactions, and do not resume therapy.
  • 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.

ADVERSE REACTIONS

Nearly all patients treated with POMALYST + low-dose dex experienced at least one adverse reaction (99%). The most common adverse reactions 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 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 infant, 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 breastfed infants from POMALYST, advise a nursing woman to discontinue breastfeeding 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.

Indication

POMALYST® (pomalidomide) is a thalidomide analogue indicated, in combination with

Important Safety Information

WARNING: EMBRYO-FETAL TOXICITY and
VENOUS AND ARTERIAL THROMBOEMBOLISM

Embryo-Fetal Toxicity

  • POMALYST is contraindicated in pregnancy.