Pemitinib 13.5 mg Tablet

Generic Name: Pemigatinib
Brand Name: Pemitinib
Strength: 13.5 mg
Form: Oral Tablets
Pack Size: Varies (commonly 14 or 21 tablets per bottle)
Manufacturer: Everest Pharmaceuticals
Distributed by: NP Molecule

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Indications:

Pemitinib (Pemigatinib) is indicated for the treatment of:

• Unresectable locally advanced or metastatic cholangiocarcinoma (bile duct cancer) with an FGFR2 gene fusion or rearrangement, as confirmed by FDA-approved diagnostic testing.

• May also be studied or used off-label in other FGFR-altered solid tumors under clinical guidance.

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Pharmacology:

Pemigatinib is a selective fibroblast growth factor receptor (FGFR) inhibitor. It works by blocking FGFR1, FGFR2, and FGFR3 signaling pathways that drive tumor cell growth and survival in FGFR-altered cancers, especially intrahepatic cholangiocarcinoma.

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Dosage & Administration:

• Recommended dose: 13.5 mg once daily for 14 consecutive days, followed by 7 days off in a 21-day treatment cycle.

• Taken orally with or without food.

• Dose adjustments may be required based on side effects or lab findings (especially phosphate levels).

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Drug Interactions:

• Caution with strong CYP3A4 inhibitors/inducers.

• Drugs affecting phosphate levels should be monitored.

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Contraindications:

• Hypersensitivity to Pemigatinib or any formulation component.

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Side Effects:

• Common: Hyperphosphatemia, alopecia, fatigue, dry mouth, nail toxicity, diarrhea.

• Serious: Retinal pigment epithelial detachment, electrolyte imbalances, kidney dysfunction.

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Pregnancy & Lactation:

• Not recommended during pregnancy due to risk of fetal harm.

• Breastfeeding should be avoided during treatment and for 1 week after the last dose.

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Precautions & Warnings:

• Monitor serum phosphate and ocular health regularly.

• May require phosphate-lowering agents.

• Risk of serious eye toxicity—regular eye exams are advised.

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Overdose Effects:

• May increase the severity of side effects like hyperphosphatemia and gastrointestinal issues.

• Provide symptomatic and supportive care.

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Therapeutic Class:

• FGFR Inhibitor

• Targeted Oncology Therapy

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Storage Conditions:

• Store below 30°C.

• Keep dry and protect from light.

• Keep out of reach of children.