Pomalidomide

About Pomalidomide

• Pomalidomide received approval for medical use in the United States in February 2013 and in the European Union in August 2013. 
• Pomalidomide is indicated for use in combination with dexamethasone, Pomalidomide is recommended for patients with multiple myeloma who have undergone at least two prior treatments, including lenalidomide and a proteasome inhibitor, and exhibit disease progression during or within 60 days of completing their last therapy. 
• Its mechanism involves the direct inhibition of angiogenesis and myeloma cell growth, distinguishing it from other pathways such as TNF alpha inhibition. Despite potent TNF inhibitors’ lack of impact on myeloma cell growth or angiogenesis, pomalidomide has demonstrated effectiveness. 
• Additionally, pomalidomide is associated with the upregulation of interferon-gamma, IL-2, and IL-10, as well as the downregulation of IL-6, contributing to its anti-angiogenic and anti-myeloma activities.

Strength: 

Pomalidomide capsules are available in strengths of 1 mg, 2 mg, 3 mg, and 4 mg

Recommended Dosage:

Before initiating Pomalidomide, females of reproductive potential must undergo negative pregnancy testing and utilize contraception methods. It is essential to implement strict administration precautions to ensure the safety and well-being of patients. 

• The suggested initial dosage for Pomalidomide is 4 mg administered orally once daily on Days 1-21 within a 28-day cycle, continuing until disease progression. 
• It is recommended to administer Pomalidomide in conjunction with dexamethasone. 
• Patients may take Pomalidomide with water, and it is crucial to instruct them not to break, chew, or open the capsules. 
• Furthermore, Pomalidomide can be taken with or without food, offering flexibility in its administration.

Important: 

Careful adherence to recommended protocols, including proper dosage administration and monitoring, is crucial throughout the treatment course. Additionally, healthcare providers should stay vigilant for any signs of adverse reactions or complications, promptly addressing and managing them as needed. Regular follow-up assessments and communication with patients about potential risks and benefits contribute to a comprehensive and responsible approach to Pomalidomide administration.

Warnings & Precaution:

• The utilization of Pomalidomide during pregnancy is strictly forbidden due to its thalidomide analog nature, a known human teratogen causing severe, life-threatening birth defects. 
• For females of reproductive potential, mandatory pregnancy testing is required before commencing treatment, and the use of two reliable contraceptive methods is essential throughout Pomalidomide treatment to prevent pregnancy. 
• Patients with multiple myeloma undergoing Pomalidomide treatment face an increased risk of deep venous thrombosis (DVT), pulmonary embolism (PE), myocardial infarction, and stroke, making antithrombotic prophylaxis highly recommended. 
• A rise in mortality risk was observed in multiple myeloma patients when pembrolizumab was added to dexamethasone and a thalidomide analog. 
• Frequent reports of neutropenia, particularly Grade 3/4 adverse events, underscore the need for vigilant monitoring of hematologic toxicities, with special attention to neutropenia. 
• Cases of hepatotoxicity, including fatal instances, have been documented, warranting regular monthly monitoring of liver function tests. 
• Instances of angioedema and severe dermatologic reactions have been noted, and in their presence, discontinuation of Pomalidomide is recommended. 
• A pivotal aspect involves the monitoring of patients at risk of Tumor Lysis Syndrome (TLS), especially those with a high tumor burden. 
• Implementing appropriate precautions, such as regular monitoring and preventive measures, is imperative.

Common Pomalidomide Side Effects:

• Fatigue
• Asthenia
• Neutropenia
• Anemia
• Constipation
• Nausea
• Diarrhea
• Dyspnea
• Upper respiratory tract infections
• Back Pain
• Pyrexia
• Mouth sores

Use in Specific Population

• Pomalidomide poses a risk of fetal harm if administered during pregnancy. Prior to initiating Pomalidomide therapy and for at least 4 weeks after completion, it is crucial to confirm the pregnancy status of females of reproductive potential. 
• Females of reproductive potential must be informed of the necessity to avoid pregnancy while using Pomalidomide. Before starting Pomalidomide, these females are required to undergo two negative pregnancy tests, with the first test within 10-14 days and the second within 24 hours before prescribing Pomalidomide.
• Pomalidomide excretion in the milk of lactating rats has been observed. Effective contraception is imperative, commencing four weeks before initiating Pomalidomide treatment, continuing during therapy, during dose interruptions, and persisting for four weeks post discontinuation of Pomalidomide therapy. 
• Semen of males taking Pomalidomide contains pomalidomide; therefore, consistent use of a latex or synthetic condom during any sexual contact with females of reproductive potential is essential while taking Pomalidomide and for up to four weeks after discontinuation, even after a successful vasectomy. 
• Male patients on Pomalidomide should refrain from sperm donation.
• Based on animal studies, female fertility may be impacted by Pomalidomide treatment. Safety and effectiveness in pediatric patients have not been established, and no dosage adjustment is necessary based on age.
• Cigarette smoking reduces pomalidomide AUC by 32% due to CYP1A2 induction; patients should be advised that smoking may diminish the efficacy of pomalidomide.
• Given the potential for adverse reactions in breastfed infants, nursing women are advised to discontinue breastfeeding during Pomalidomide treatment.
• For patients with severe renal impairment requiring dialysis, a Pomalidomide dose reduction of at least 25% is recommended. The dose should be administered following hemodialysis on hemodialysis days. 
• In patients with mild to moderate hepatic impairment, a 25% reduction in Pomalidomide dose is advised, while in those with severe hepatic impairment, a 50% dose reduction is recommended.

Storage and Handling

Keep Pomalidomide at a temperature of 20° to 25°C (68° to 77°F). Excursions within the range of 15°C to 30°C (59°F to 86°F) are permitted. Do not freeze the medicine. Keep the medicine away from pets and children. 

• 1 mg; 2 mg; 3 mg; 4mg bottles of 21
• 1 mg; 2 mg; 3 mg; 4mg bottles of 100