Pomalidomide Precautions

During treatment with Pomalidomide, patients should pay attention to the occurrence of venous and arterial thromboembolism, hematological toxicity, hepatotoxicity, severe skin reactions, dizziness and confusion, neuropathy, risk of secondary primary malignant tumors, tumor lysis syndrome, allergies and other events.

1. Venous and arterial thromboembolism: including arterial thromboembolic events, ischemic cerebrovascular disease and ischemic heart disease. Patients with known risk factors (including previous thrombosis) may be at greater risk and steps should be taken to minimize all modifiable factors (eg, hyperlipidemia, hypertension, smoking). Thromboprophylaxis is recommended, and the choice of regimen should be based on an assessment of the patient's potential risk factors.

2. Hematologic toxicity: Monitor patients for hematologic toxicity, especially neutropenia. Monitor complete blood count weekly for the first 8 weeks and monthly thereafter. Depending on the severity of the reaction, withhold, reduce the dose, or permanently discontinue pomalidomide.

3. Hepatotoxicity: Patients receiving pomalidomide have experienced liver failure, including fatal cases, and increased levels of alanine aminotransferase and bilirubin have also been observed. Monitor liver function tests monthly. Discontinue pomalidomide and evaluate if hepatic enzymes are elevated. After returning to baseline values, treatment at a lower dose may be considered.

4. Serious skin reactions: including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and drug reaction with eosinophilia and systemic symptoms (DRESS). Dressings may cause skin reactions (eg, rash or exfoliative dermatitis), eosinophilia, fever, and/or lymphadenopathy with systemic complications, such as hepatitis, nephritis, pneumonia, myocarditis, and/or pericarditis. Interruption or discontinuation of pomalidomide should be considered. ForSJS, TEN, or DRESS, pomalidomide should be permanently discontinued.

5. Dizziness and confusion: Dizziness and confusion may occur in clinical trials. Instruct patients to avoid dizziness or confusion and not to take other drugs that may cause dizziness or confusion without adequate medical advice.

6. Neuropathy: In trials 1 and 2, 18% of patients who received pomalidomide + low-dose dexamethasone developed neuropathy, and approximately 12% developed peripheral neuropathy. In Trial 2, 2% of patients experienced grade 3 neuropathy. No grade 4 neuropathy adverse reactions were reported in either trial.

7. Risk of secondary primary malignancy: Cases of acute myeloid leukemia have been reported in patients receiving pomalidomide as an investigational treatment other than multiple myeloma (MM).

8. Tumor lysis syndrome: Patients receiving pomalidomide may develop tumor lysis syndrome.(TLS). Patients at risk for TLS are those with high tumor burden prior to treatment. These patients should be monitored closely and appropriate precautions taken.

9. Allergy: There have been reports of allergic reactions, including angioedema, anaphylaxis, and allergic reaction to pomalidomide. Permanently discontinue pomalidomide in the event of angioedema or anaphylaxis.