HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use LuciErda safely and effectively. See full prescribing information for LuciErda.

INDICATIONS AND USAGE

LuciErda is a kinase inhibitor indicated for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma (mUC) that has

 • susceptible FGFR3 or FGFR2 genetic alterations and

 •  progressed during or following at least one line of prior platinum-containing chemotherapy including within 12 months of neoadjuvant or adjuvant platinum-containing chemotherapy.

Select patients for therapy based on an FDA-approved companion diagnostic for LuciErda.

This indication is approved under accelerated approval based on tumor response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

DOSAGE AND ADMINISTRATION

• Confirm the presence of FGFR genetic alterations in tumor specimens prior to initiation of treatment with LuciErda.

• Recommended initial dosage: 8 mg orally once daily with a dose increase to 9 mg daily if criteria are met.

• Swallow whole with or without food.

DOSAGE FORMS AND STRENGTHS

Tablets: 3 mg×28 tablets

CONTRAINDICATIONS

None.

WARNINGS AND PRECAUTIONS

•  Ocular disorders: LuciErda can cause central serous retinopathy/retinal pigment epithelial detachment (CSR/RPED). Perform monthly ophthalmological examinations during the first four months of treatment, every 3 months afterwards, and at any time for visual symptoms. Withhold LuciErda when CSR/RPED occurs and permanently discontinue if it does not resolve within  4 weeks or if Grade 4 in severity.

•  Hyperphosphatemia: Increases in phosphate levels are a pharmacodynamic effect of LuciErda.  Monitor for hyperphosphatemia and manage with dose modifications when required.

•  Embryo-fetal toxicity: Can cause fetal harm. Advise patients of the potential risk to the fetus and to use effective contraception.

ADVERSE REACTIONS

The most common adverse reactions including laboratory abnormalities (≥20%) were phosphate increased, stomatitis, fatigue, creatinine increased, diarrhea, dry mouth, nail disorder, alanine aminotransferase increased, alkaline phosphatase increased, sodium decreased, decreased appetite, albumin decreased, dysgeusia, hemoglobin decreased, dry skin, aspartate aminotransferase increased, magnesium decreased, dry eye, alopecia, palmar-plantar erythrodysesthesia syndrome, constipation, phosphate decreased, abdominal pain, calcium increased, nausea, and musculoskeletal pain.

DRUG INTERACTIONS

•  Moderate CYP2C9 or strong CYP3A4 inhibitors: Consider alternative agents or monitor closely for adverse reactions.

•  Strong CYP2C9 or CYP3A4 inducers: Avoid concomitant use with LuciErda.

•  Moderate CYP2C9 or CYP3A4 inducers: Increase LuciErda dose up to 9 mg.  

•  Serum phosphate level-altering agents: Avoid concomitant use with agents that can alter serum phosphate levels before the initial dose modification period.

•  CYP3A4 substrates: Avoid concomitant use with sensitive CYP3A4 substrates with narrow therapeutic indices.

•  OCT2 substrates: Consider alternative agents or consider reducing the dose of OCT2 substrates based on tolerability.

•  P-gp substrates: Separate LuciErda administration by at least 6 hours before or after administration of P-gp substrates with narrow therapeutic indices.

USE IN SPECIFIC POPULATIONS

• Lactation: Advise not to breastfeed.

Storage

Store at 20℃ to 25℃ (68℉ to 77℉), excursions permitted between 15℃ and 30℃ (59℉ and 86℉) [see USP Controlled Room Temperature]. Protect from moisture.