Big Bear PEMIDX Pemigatinib 4.5mg

Product Information

• Product name: PEMIDX Pemigatinib 4.5mg
• Manufacturer / brand: Laos BigBear Pharma
• Active ingredient: Pemigatinib
• Current strength: 4.5mg
• SKU: BB-ITEM-57
• Site category: FGFR2 target, other cancer

Product Summary

PEMIDX Pemigatinib 4.5mg is an AISTIKA-listed product supplied by Laos BigBear 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

Pemigatinib is the active ingredient used for this product page. Public prescribing information for Pemigatinib 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

Pemigatinib is a small molecule kinase inhibitor that targets FGFR1, 2 and 3 with IC 50 values of less than 2 nM. Pemigatinib also inhibited FGFR4 in vitro at a concentration approximately 100 times higher than those that inhibit FGFR1, 2, and 3. Pemigatinib inhibited FGFR1-3 phosphorylation and signaling and decreased cell viability in cancer cell lines with activating FGFR amplifications and fusions that resulted in constitutive activation of FGFR signaling. Constitutive FGFR signaling can support the proliferation and survival of malignant cells.

Reference Indications

Pemigatinib is a kinase inhibitor indicated: for the treatment of adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or other rearrangement as detected by an FDA-approved test. ( 1 , 2.1 ) This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). ( 1 , 2.1 ) For the treatment of adults with relapsed or refractory myeloid/lymphoid neoplasms (MLNs) with FGFR1 rearrangement.

Reference Dosage and Administration

The public label should be checked for the indication-specific recommended dosage. Available administration instructions note that the medicine may be taken Recommended dosage is 13. Swallow tablet whole, with or without food.

Dose conversion must be confirmed by a physician because the reference dose may vary by indication, organ function, toxicity, or interacting medicines.

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

Important Safety Information

Ocular Toxicity : Pemigatinib can cause retinal pigment epithelial detachment. Perform ophthalmological examination including optical coherence tomography (OCT) prior to initiation of therapy, every 2 months for the first 6 months of treatment and every 3 months thereafter, and urgently at any time for visual symptoms. ( 2.3 , 5.1 ) Hyperphosphatemia and Soft Tissue Mineralization : Pemigatinib can cause hyperphosphatemia leading to soft tissue mineralization, cutaneous calcification, calcinosis, and non-uremic calciphylaxis. Monitor for hyperphosphatemia and withhold, reduce the dose, or permanently discontinue based on duration and severity of hyperphosphatemia. ( 2.3 , 5.2 ) Embryo-Fetal Toxicity : Can cause fetal harm. Advise patients of reproductive potential of the potential risk to the fetus and use effective contraception.

Common Adverse Reactions and Monitoring

The pooled safety population described in the section reflects exposure to Pemigatinib at a starting dose of 13.5 mg orally once daily (intermittent or continuous administration) in 635 patients with advanced malignancies. Among the 635 patients, 31% were exposed for 6 months or longer and 11% were exposed greater than one year, including patients with previously treated, advanced, or metastatic cholangiocarcinoma in FIGHT-202 and patients with MLNs with FGFR1 rearrangement in FIGHT-203. Cholangiocarcinoma FIGHT-202 The safety of Pemigatinib was evaluated in FIGHT-202, which included 146 patients with previously treated, locally advanced or metastatic cholangiocarcinoma .

Drug Interactions and Special Populations

Strong and Moderate CYP3A Inducers: Avoid concomitant use of Pemigatinib. Strong and Moderate CYP3A Inhibitors: Avoid concomitant use. If concomitant use cannot be avoided, reduce Pemigatinib dosage. ( 2.4 , 7.1 ) 7.1 Effect of Other Drugs on Pemigatinib Strong and Moderate CYP3A Inducers Concomitant use of Pemigatinib with a strong or moderate CYP3A inducer decreases pemigatinib plasma concentrations , which may reduce the efficacy of Pemigatinib. Avoid concomitant use of strong and moderate CYP3A inducers with Pemigatinib. Avoid concomitant use of strong and moderate CYP3A inhibitors with Pemigatinib. Reduce Pemigatinib dosage if concomitant use of strong and moderate CYP3A inhibitors cannot be avoided . Lactation: Advise not to breastfeed. There are no available data on the use of Pemigatinib in pregnant women.

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: PEMAZYRE 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.