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Indications & Uses
Pomalidomide is used together with dexamethasone in adults with multiple myeloma (MM). It is meant for people who have already had at least two earlier therapies, including lenalidomide and a proteasome inhibitor, and whose disease has progressed on or within 60 days of finishing the last therapy. Pomalidomide is also used to treat Kaposi sarcoma (KS). This covers adults with AIDS-related Kaposi sarcoma after highly active antiretroviral therapy (HAART) has failed, and adults with Kaposi sarcoma who are HIV-negative.
Pharmacology
Pomalidomide is an analogue of thalidomide. It has immunomodulatory, antiangiogenic and antineoplastic properties. Its effects in cells work through its target, cereblon, which is part of a cullin ring E3 ubiquitin ligase enzyme complex. In vitro, when the drug is present, substrate proteins (including Aiolos and Ikaros) are marked for ubiquitination and then broken down. This leads to direct cytotoxic and immunomodulatory effects. In in vitro cellular assays, pomalidomide stopped hematopoietic tumor cells from multiplying and induced apoptosis in them. It also stopped the growth of lenalidomide-resistant multiple myeloma (MM) cell lines. With dexamethasone, it worked together to induce tumor cell apoptosis in both lenalidomide-sensitive and lenalidomide-resistant cell lines. Pomalidomide strengthened T cell- and natural killer (NK) cell-mediated immunity, and it reduced the production of pro-inflammatory cytokines (e.g., TNF-α and IL-6) by monocytes. It showed anti-angiogenic activity in a mouse tumor model and in the in vitro umbilical cord model.
Pharmacodynamics
Exposure-response analyses found no relationship between systemic pomalidomide exposure and either efficacy or safety after a pomalidomide dose of 4 mg.
Pharmacokinetics
In patients with MM who took pomalidomide 4 mg daily, alone or with dexamethasone, steady-state exposure was an AUC (CV%) of 860 (37%) ng-h/mL and a Cmax (CV%) of 75 (32%) ng/mL. In patients with Kaposi sarcoma (KS) who took pomalidomide 5 mg daily, steady-state exposure was an AUC of 462.3 ng-h/mL (82%) and a Cmax of 53.1 ng/mL (50%).
Absorption
After single oral doses of pomalidomide, the maximum plasma concentration (Cmax) is reached 2 to 3 hours after the dose in patients with MM or KS.
Distribution
At steady state, pomalidomide has a mean apparent volume of distribution (Vd/F) of between 62 and 138 L in patients with MM or KS. It passes into semen in healthy subjects, reaching approximately 67% of the plasma level at 4 hours after the dose (~Tmax) following 4 days of 2 mg once-daily dosing. Human plasma protein binding of pomalidomide ranges from 12% to 44% and does not depend on concentration. Pomalidomide is a substrate for P-gp.
Metabolism
Pomalidomide is mainly metabolized in the liver by CYP1A2 and CYP3A4. In vitro, CYP2C19 and CYP2D6 were also seen to contribute in a minor way.
Elimination
In patients with MM or KS, pomalidomide has a mean total body clearance (CL/F) of 7 to 10 L/h. Its median plasma half-life is 9.5 hours in healthy subjects and 7.5 hours in patients with MM or KS.
Excretion
Healthy subjects were given a single oral dose of 14C-pomalidomide. Approximately 73% of the radioactive dose was eliminated in urine and 15% in feces. Of the radiolabeled dose, approximately 2% in urine and 8% in feces was eliminated unchanged as pomalidomide.
Dosage Reference
Reference Information Only
Dosages shown are general references from official sources. Always consult your doctor or pharmacist for personalized dosing.
Adults:
Pregnancy Testing Prior to Administration
Females of reproductive potential must have negative pregnancy testing and use contraception before initiating Pomalidomide.
Recommended Dosage for Multiple Myeloma
The recommended dosage of Pomalidomide is 4 mg once daily by mouth, with or without food, on Days 1 through 21 of each 28-day cycle until disease progression. Give it in combination with dexamethasone.
Recommended Dosage for Kaposi Sarcoma
For Kaposi sarcoma, the recommended dosage of Pomalidomide is 5 mg once daily by mouth, with or without food, on Days 1 through 21 of each 28-day cycle until disease progression or unacceptable toxicity. Patients with AIDS-related Kaposi sarcoma (KS) should continue HAART as their HIV treatment.
Dosage Modifications for Hematologic Adverse Reactions
Multiple Myeloma
Initiate a new cycle of Pomalidomide in patients with multiple myeloma (MM) when the neutrophil count is at least 500 per mcL and the platelet count is at least 50,000 per mcL.
Kaposi Sarcoma
In patients with KS, initiate a new cycle of Pomalidomide when the neutrophil count is at least 1000 per mcL and the platelet count is at least 75,000 per mcL.
Dosage Modifications for Non-Hematologic Adverse Reactions
Permanently discontinue Pomalidomide for angioedema, anaphylaxis, Grade 4 rash, skin exfoliation, bullae, or any other severe dermatologic reaction. For other Grade 3 or 4 toxicities, hold treatment. Restart at 1 mg less than the previous dose once the toxicity has resolved to less than or equal to Grade 2, at the physician's discretion.
Dosage Modifications for Strong CYP1A2 Inhibitors
Avoid using Pomalidomide together with strong CYP1A2 inhibitors. If a strong CYP1A2 inhibitor can't be avoided, reduce the Pomalidomide dose to 2 mg.
Pediatric Use
The safety and effectiveness of POMALYST have not been established in pediatric patients.
Side Effects
In multiple myeloma, the most common side effects of Pomalidomide (more than 30% of people) were fatigue and asthenia, neutropenia, anemia, constipation, nausea, diarrhea, dyspnea, upper-respiratory tract infections, back pain and pyrexia. In Kaposi sarcoma, the most common side effects, counting laboratory abnormalities (more than 30%), were a decreased absolute neutrophil count or white blood cells, elevated creatinine or glucose, rash, constipation, fatigue, and decreased hemoglobin, platelets, phosphate, albumin or calcium. Increased ALT, nausea and diarrhea were also common.
Cautions & Contraindications
Warnings & Precautions
Increased mortality: This was seen in patients with MM when pembrolizumab was added to dexamethasone and a thalidomide analogue. Hematologic toxicity: Neutropenia was the most frequently reported Grade 3/4 adverse event. Monitor patients for hematologic toxicities, especially neutropenia. Hepatotoxicity: Hepatic failure, including fatalities, has occurred. Monitor liver function tests monthly. Severe cutaneous reactions: Stop Pomalidomide if a reaction is severe. Tumor Lysis Syndrome (TLS): Monitor patients at risk of TLS (that is, those with high tumor burden) and take appropriate precautions. Hypersensitivity: Monitor patients for possible hypersensitivity. Stop Pomalidomide for angioedema and anaphylaxis.
Pregnancy & Breastfeeding
Pregnancy: Pomalidomide must not be used by women who are pregnant. It can harm an unborn baby when given to a pregnant woman. Pomalidomide is an analogue of thalidomide, and it caused birth defects in both rats and rabbits when given during the period of organogenesis. If a patient becomes pregnant while taking this medicine, she should be told about the possible risk to the baby.
Lactation: There is no information on whether pomalidomide passes into human milk, what effect it has on a breastfed child, or whether it changes milk production. It did pass into the milk of lactating rats (see Data). Many drugs pass into human milk, and Pomalidomide could cause adverse reactions in a breastfed child, so women are advised not to breastfeed during treatment with Pomalidomide.
⚠️ Talk to your doctor before taking any medicine during pregnancy or while breastfeeding.
Storage
Store Pomalidomide below 30°C, and keep it away from light and moisture. Keep it out of the reach of children.
Common questions about Pomide 4 mg
What is Pomide 4 mg Capsule?
Pomide 4 mg Capsule is a medicine that contains Pomalidomide. It is made by Beacon Pharmaceuticals PLC.
What is Pomide used for?
Pomalidomide is used together with dexamethasone in adults with multiple myeloma (MM). It is meant for people who have already had at least two earlier therapies, including lenalidomide and a proteasome inhibitor, and whose disease has progressed on or within 60 days of finishing the last therapy.
What are the side effects of Pomide?
In multiple myeloma, the most common side effects of Pomalidomide (more than 30% of people) were fatigue and asthenia, neutropenia, anemia, constipation, nausea, diarrhea, dyspnea, upper-respiratory tract infections, back pain and pyrexia. In Kaposi sarcoma, the most common side effects, counting laboratory abnormalities (more than 30%), were a decreased absolute neutrophil count or white blood cells, elevated creatinine or glucose, rash, constipation, fatigue, and decreased hemoglobin, platelets, phosphate, albumin or calcium.
Can I take Pomide during pregnancy or while breastfeeding?
Pregnancy: Pomalidomide must not be used by women who are pregnant. It can harm an unborn baby when given to a pregnant woman. Talk to your doctor before taking any medicine during pregnancy or while breastfeeding.
How should I store Pomide?
Store Pomalidomide below 30°C, and keep it away from light and moisture. Keep it out of the reach of children.
Is there a cheaper medicine with the same ingredient?
Pomide is already among the lowest-priced brands of Pomalidomide at this strength.
Do I need a prescription for Pomide?
Pomide is a prescription (Rx) medicine. Take it as your doctor advises.