pomalidomide

Action and Spectrum

Actions and Spectrum 

pomalidomide suppresses the growth of cancer cells and modifies the immune system to work. Numerous strategies, including as anti-angiogenic, immunomodulatory, and anti-inflammatory actions, are used to achieve its effects. Multiple myeloma, a form of malignancy that affects plasma cells in the bone marrow, is typically treated with pomalidomide.  

Drug Interaction

Adverse Reaction

Frequency defined  

1-10% (Multiple Myeloma) 

Neuropathy, peripheral (7-10%) 

Pain (5-6%) 

Febrile neutropenia (3%) 

Thromboembolism (3%) 

1-10% (Kaposi Sarcoma) 

Grade 3 or 4 

Peripheral edema (3.6%) 

Decreased WBC (3.6%) 

Elevated creatine kinase (7%) 

Maculopapular rash (3.6%) 

Elevated creatinine (3.6%) 

Diarrhea (3.6%) 

Elevated alkaline phosphate (3.6%) 

>10% (Kaposi Sarcoma) 

All grades 

Decreased WBC (79%) 

Elevated glucose (57%) 

Dry skin (21%) 

Elevated alkaline phosphate (14%) 

Cough (29%) 

Dyspnea (29%) 

Peripheral edema (29%) 

Decreased hemoglobin (54%) 

Nausea (36%) 

Decreased platelets (54%) 

Constipation (71%) 

Decreased albumin (54%) 

Increased ALT (32%) 

Muscle spasms (25%) 

Hypothyroidism (21%) 

Upper respiratory tract infection (29%) 

Increased AST (25%) 

Elevated creatine kinase (25%) 

Chills (21%) 

Decreased magnesium (14%) 

Maculopapular rash (71%) 

Diarrhea (32%) 

Decreased phosphate (54%) 

Decreased calcium (50%) 

Fatigue (68%) 

Decreased ANC (96%) 

Elevated creatinine (86%) 

Grade 3 or 4 

Decreased phosphate (25%) 

Decreased ANC (50%) 

>10% (Multiple Myeloma) 

Dyspnea (34-45%) 

Constipation (35-36%) 

Rash (16-22%) 

Cough (14-21%) 

Musculoskeletal chest pain (20-22%) 

Peripheral edema (16-23%) 

Decreased appetite (18-22%) 

Musculoskeletal pain (11-15%) 

Increased blood creatinine (11-15%) 

Upper respiratory tract infection (25-32%) 

Pneumonia (23-29%) 

Hypercalcemia (12-21%) 

Tremor (9-13%) 

Chills (9-11%) 

Anxiety (7-11%) 

Headache (8-13%) 

Leukopenia (11-18%) 

Epistaxis (11-15%) 

Pruritus (11-15%) 

Back pain (30-32%) 

Dry skin (9-11%) 

Increased weight (1-11%) 

Thrombocytopenia (23-25%) 

Pyrexia (19-30%) 

Renal failure (10-15%) 

Decreased weight (8-14%) 

Anemia (38-39%) 

Dizziness (17-20%) 

Muscle spasms (19%) 

Night sweats (5-13%) 

Muscular weakness (12%) 

Arthralgia (15-16%) 

Hypokalemia (11%) 

Urinary tract infection (8-16%) 

Hyponatremia (10-13%) 

Confusional state (10-13%) 

Hypocalcemia (6-12%) 

Fatigue and asthenia (55-63%) 

Hyperglycemia (12-15%) 

Lymphopenia (4-15%) 

Bone pain (5-12%) 

Neutropenia (47-52%) 

Vomiting (13-14%) 

Nausea (22-36%) 

Insomnia (7-14%) 

Pain in extremity (5-14%) 

Hyperhidrosis (6-16%) 

Diarrhea (33-34%) 

Post marketing reports 

Endocrine disorders: Hyperthyroidism, hypothyroidism 

Subcutaneous tissue disorders and skin: drug reaction with eosinophilia and systemic symptoms, Stevens-Johnson syndrome, toxic epidermal necrolysis 

Immune system disorders: solid organ transplant rejection, Allergic reactions 

Neoplasms benign, malignant and unspecified: basal cell carcinoma, Tumor lysis syndrome and squamous cell carcinoma of the skin 

Blood and lymphatic system disorders: Pancytopenia 

Hepatobiliary disorders: elevated liver enzymes, Hepatic failure 

Infections and infestations: progressive multifocal leukoencephalopathy (PML), Herpes zoster, Hepatitis B virus reactivation 

Gastrointestinal disorders: Gastrointestinal hemorrhage 

Black Box Warning

Black Box Warning 

If used during pregnancy, pomalidomide can result in serious birth abnormalities or foetal death. It is not advised for usage by those who are pregnant or trying to conceive.  

Deep vein thrombosis (DVT) and pulmonary embolism (PE) are two blood clots that are more likely to form in patients on pomalidomide. 

Contraindication / Caution

Contraindication/Caution: 

Contraindication: 

• People with history of hypersensitivity or allergic to its component should not take pomalidomide. 

Caution: 

• Hematologic toxicity from pomalidomide can result in anaemia, thrombocytopenia, and neutropenia. Blood cell counts must be regularly monitored, and depending on the results, dose modifications or interruptions may be necessary. 
• Hepatotoxicity from pomalidomide can result in increased levels of liver enzymes. Regular liver function checks are advised, and patients with liver damage may need medication adjustments. 
• Patients with mild to severe renal impairment should use pomalidomide with caution. Depending on renal function, dose modifications can be required. 

Pregnancy / Lactation

Pregnancy warnings:     

Pregnancy category: N/A 

Lactation: Excretion into human milk is unknown  

Pregnancy Categories:         

Category A: well-controlled and Satisfactory studies show no risk to the fetus in the first or later trimester. 

Category B: there was no evidence of risk to the fetus in animal studies, and there were not enough studies on pregnant women.  

Category C: there was evidence of risk of adverse effects in animal reproduction studies, and no adequate evidence in human studies must take care of potential risks in pregnant women. 

Category D: adequate data with sufficient evidence of human fetal risk from various platforms, but despite the potential risk, and used only in emergency cases for potential benefits. 

Category X: Drugs listed in this category outweigh the risks over benefits. Hence these categories of drugs need to be avoided by pregnant women. 

Category N: There is no data available for the drug under this category. 

Pharmacology

Pharmacology  

pomalidomide increases the activity of T-cells and natural killer cells, two immune system components involved in the fight against cancer cells. It influences cytokine synthesis, stimulating interferon-gamma release, which has anticancer effects. It prevents the establishment of new blood vessels, a procedure known as angiogenesis, which is essential for the development and survival of tumors. 

Pharmacodynamics 

pomalidomide’s pharmacodynamics involve interactions with numerous cellular and molecular targets, which result in immunomodulatory, anti-angiogenic, and anti-inflammatory effects.  

pomalidomide has anti-angiogenic characteristics, which means it prevents the generation of new blood vessels that facilitate the development of tumors. The growth and development of tumors depend heavily on the process of angiogenesis. 

Pharmacokinetics 

Absorption   

pomalidomide is taken by mouth and readily absorbed from the digestive tract. Following oral treatment, it absorbs quickly and effectively, reaching peak plasma concentrations in about two hours. 

Distribution 

pomalidomide’s unusually high volume of distribution suggests that it has reached tissues other than the circulation. It demonstrates strong affinity for albumin and other plasma proteins. 

Metabolism 

pomalidomide undergoes extensive metabolism in the liver. Hepatic enzymes, particularly cytochrome P450 enzymes, such as CYP1A2 and CYP3A4, are involved in the main metabolic pathways. pomalidomide is changed by these enzymes into several metabolites. 

Elimination and excretion 

pomalidomide is expelled both through metabolism and excretion. Hepatic metabolism is a key method of elimination, and the body then eliminates the metabolites. A small amount of the drug is eliminated in the feces unchanged. 

Adminstartion

Administration 

pomalidomide is taken orally and available in the form of capsules. 

Patient Information Leaflet

Patient information leaflet 

Generic Name: pomalidomide   

Why do we use pomalidomide? 

pomalidomide is used in the treatment of multiple myeloma, a type of cancer that affects plasma cells in the bone marrow.