Lucius LuciPoma Pomalidomide 4mg

Product Information

• Product name: LuciPoma Pomalidomide 4mg
• Manufacturer / brand: Laos Lucius Pharma
• Active ingredient: Pomalidomide
• Current strength: 4mg
• SKU: LU-ITEM-90
• Site category: myeloma, other cancer

Product Summary

LuciPoma Pomalidomide 4mg is an AISTIKA-listed product supplied by Laos Lucius Pharma. This page summarizes the product identity, strength, SKU, site category, and public medical reference information. Product name, manufacturer, packaging, and strength follow this AISTIKA product page.

Active Ingredient and Reference Data

Pomalidomide is the active ingredient used for this product page. Public prescribing information for Pomalidomide was used for the medical reference sections. Medical details are provided for reference and must be interpreted by a qualified healthcare professional.

Mechanism of Action

Pomalidomide is an analogue of thalidomide with immunomodulatory, antiangiogenic, and antineoplastic properties. Cellular activities of Pomalidomide are mediated through its target cereblon, a component of a cullin ring E3 ubiquitin ligase enzyme complex. Additionally, Pomalidomide inhibited the proliferation of lenalidomide-resistant multiple myeloma (MM) cell lines and synergized with dexamethasone in both lenalidomide-sensitive and lenalidomide-resistant cell lines to induce tumor cell apoptosis.

Reference Indications

Pomalidomide capsules are a thalidomide analogue indicated for the treatment of adult patients: in combination with dexamethasone, for patients with multiple myeloma (MM) 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 . This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s) . Kaposi sarcoma (KS) in adult patients who are HIV-negative. This indication is approved under accelerated approval based on overall response rate .

Reference Dosage and Administration

Recommended dosage of Pomalidomide capsules is 4 mg once daily orally with or without food on Days 1 through 21 of each 28-day cycle until disease progression. taken orally on Days 1 through 21 of repeated 28-day cycles until disease progression .

With this 4mg product, that corresponds to 1 x 4mg tablet when that reference dose is clinically appropriate.

This reference dosage is not an individualized prescription. Dose changes, treatment interruptions, or discontinuation must be directed by a physician.

Important Safety Information

BOXED WARNING WARNING: EMBRYO-FETAL TOXICITY and VENOUS AND ARTERIAL THROMBOEMBOLISM Embryo-Fetal Toxicity Pomalidomide capsules are contraindicated in pregnancy. Pomalidomide capsules are a thalidomide analogue. Thalidomide is a known human teratogen that causes severe birth defects or embryo-fetal death. Females of reproductive potential must use 2 forms of contraception or continuously abstain from heterosexual sex during and for 4 weeks after stopping Pomalidomide capsules treatment . Pomalidomide capsules are only available through a restricted distribution program called PS-Pomalidomide REMS . Information about PS-Pomalidomide REMS is available at www.PS-PomalidomideREMS.com or by calling the REMS Call Center at 1-888-423-5436.

Common Adverse Reactions and Monitoring

Multiple Myeloma (MM) In Trial 1, data were evaluated from 219 patients (safety population) who received treatment with Pomalidomide + Low-dose Dex (112 patients) or Pomalidomide alone (107 patients). Median number of treatment cycles was 5. The median number of treatment cycles for the Pomalidomide + Low-dose Dex arm was 5. Twenty-seven percent of patients had a dose reduction of Pomalidomide, the median time to the first dose reduction of Pomalidomide was 4.5 weeks. a Pomalidomide alone arm includes all patients randomized to the Pomalidomide alone arm who took study drug; 61 of the 107 patients had dexamethasone added during the treatment period.

Drug Interactions and Special Populations

Strong CYP1A2 Inhibitors: Avoid concomitant use of strong CYP1A2 inhibitors. If concomitant use of a strong CYP1A2 inhibitor is unavoidable, reduce Pomalidomide capsules dose to 2 mg ( 2.6 , 7.1 , 12.3 ). Increased Pomalidomide exposure may increase the risk of exposure related toxicities. Avoid co-administration of strong CYP1A2 inhibitors (e.g. ciprofloxacin and fluvoxamine). If co-administration is unavoidable, reduce the Pomalidomide capsules dose . Lactation: Advise women not to breastfeed . This registry is also used to understand the root cause for the pregnancy. Report any suspected fetal exposure to Pomalidomide capsules to the FDA via the MedWatch program at 1-800-FDA-1088 and also to the REMS Call Center at 1-888-423-¬5436.

Storage and Purchase Notes

Store according to the package or pharmacist instructions and keep out of reach of children. Before ordering, confirm product name, strength, quantity, price, shipping details, and payment method. After receipt, check packaging, batch number, expiration date, and storage conditions.

Sources

Sources: Pomalidomide public prescribing information; openFDA/DailyMed public label data. These sources are used for public medical reference. Product information follows this AISTIKA product page.

DisclaimerThis page is for product information and public-label reference only. It does not provide diagnosis, prescription, or individualized medical advice. Consult a physician for treatment decisions.