Introduction

Pemitinib 13.5 mg (Pemigatinib) is a highly specific, small molecule kinase inhibitor targeting FGFR1, FGFR2, and FGFR3. Manufactured by Everest Pharmaceuticals Ltd and supplied globally by Onco Solution, this oral cancer medication is indicated for advanced or metastatic cholangiocarcinoma and myeloid/lymphoid neoplasms (MLNs) with FGFR rearrangements.

Key Benefits

• Targeted inhibition of FGFR1, FGFR2, and FGFR3
• Proven efficacy in treating cholangiocarcinoma with FGFR2 fusions or rearrangements
• Also indicated for relapsed/refractory MLNs with FGFR1 rearrangement
• Oral administration for ease of use
• Worldwide delivery through Onco Solution

Indications

1. Cholangiocarcinoma:
Used in adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma harboring FGFR2 fusions or rearrangements.

2. Myeloid/Lymphoid Neoplasms (MLNs) with FGFR1 rearrangement:
Indicated for adults with relapsed or refractory MLNs.

Dosage & Administration

Cholangiocarcinoma:

• Dose: 13.5 mg orally once daily
• Cycle: 14 consecutive days followed by 7 days off (21-day cycle)

MLNs with FGFR1 Rearrangement:

• Dose: 13.5 mg once daily on a continuous basis

General Instructions:

• Take at the same time each day, with or without food
• Swallow tablets whole; do not crush or chew
• Modify dosage for renal/hepatic impairment or CYP3A interactions

Pharmacology

Pemigatinib inhibits FGFR1–3 with sub-nanomolar potency, thereby suppressing phosphorylation and tumor-promoting FGFR signaling. It demonstrates antitumor effects in cell lines and xenograft models with FGFR alterations.

• Bioavailability: Median Tmax ~1.13 hours
• Half-life: ~15.4 hours
• Protein Binding: ~90.6%
• Metabolism: Mainly by CYP3A4
• Elimination: 82.4% via feces; 12.6% via urine

Contraindications

There are currently no known contraindications.

Drug Interactions

• CYP3A Inhibitors (e.g., Itraconazole): May increase exposure—reduce dose
• CYP3A Inducers (e.g., Rifampin): May reduce exposure—avoid use
• Transporters (P-gp, BCRP, OCT2, MATE1): Inhibitors may affect renal excretion and elevate serum creatinine

Side Effects

Common side effects include:

• Hair loss
• Diarrhea
• Nail abnormalities
• Fatigue
• Nausea and vomiting
• Mouth sores
• Joint pain
• Hyperphosphatemia
• Dry eyes and dry mouth
• Decreased appetite
• Taste alterations

Serious risks include retinal disorders, soft tissue mineralization, and embryo-fetal toxicity.

Special Warnings & Precautions

• Ocular Toxicity: Risk of RPED and visual disturbances
• Hyperphosphatemia: Monitor and manage to avoid calcification
• Embryo-Fetal Toxicity: Use effective contraception; avoid in pregnancy

Use in Special Populations

• Pregnancy & Lactation: Not recommended due to fetal harm potential
• Pediatric Use: Not established
• Geriatric Use: No major safety differences observed
• Renal/Hepatic Impairment: Adjust dose for severe cases

Overdose

No specific antidote available. In case of overdose, provide supportive care.

Storage Conditions

Store below 30°C in a dry, cool place away from sunlight and children. Keep tablets in the original container with desiccants.

Manufacturer & Supplier Information

Manufactured by:
Everest Pharmaceuticals Ltd
Website: www.everestpharmabd.com

Global Oncology Supplier:
Onco Solution
Website: www.oncosolution.com

Conclusion

Pemitinib 13.5 mg (Pemigatinib) is a critical innovation in targeted oncology treatment, particularly for FGFR-altered cholangiocarcinoma and MLNs. Trusted by oncologists globally, it is supplied by Onco Solution with assurance of authenticity, timely delivery, and dedicated support.