Multikinase inhibitors
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Truseltiq Dosage

Drug Detail:Truseltiq (Infigratinib)

Generic Name: INFIGRATINIB 100mg

Dosage Form: capsule

Drug Class: Multikinase inhibitors

Contents
Uses Warnings Before Taking Dosage Side effects Interactions

Patient Selection

Select patients for the treatment of unresectable locally advanced or metastatic cholangiocarcinoma with TRUSELTIQ based on the presence of an FGFR2 fusion or rearrangement, as detected by an FDA-approved test [ seeClinical Studies ( 14.1) ].

Information on FDA-approved test(s) for the detection of FGFR2 fusions or rearrangements in cholangiocarcinoma is available at: http://www.fda.gov/CompanionDiagnostics.

Recommended Dosage

The recommended dosage of TRUSELTIQ is 125 mg (one 100 mg capsule and one 25 mg capsule) orally once daily for 21 consecutive days followed by 7 days off therapy, in 28-day cycles. Continue treatment until disease progression or unacceptable toxicity.

Instruct patients to take TRUSELTIQ on an empty stomach at least 1 hour before or 2 hours after food [ seeClinical Pharmacology(12.3) ], at approximately the same time each day. Instruct patients to swallow capsules whole with a glass of water. Advise patients to not crush, chew, or dissolve capsules.

If a dose of TRUSELTIQ is missed by ≥4 hours or if vomiting occurs, instruct patients to resume the regular daily dose schedule for TRUSELTIQ the next day.

Dose Modification for Adverse Reactions

The recommended dose reductions for adverse reactions are listed in Table 1.

Table 1: Recommended Dose Reduction for TRUSELTIQ for Adverse Reactions
1 st dose reduction 2 nd dose reduction 3 rd dose reduction
100 mg (one 100 mg capsule) 75 mg (three 25 mg capsules) 50 mg (two 25 mg capsules)

The recommended dosage modifications for adverse reactions are provided in Table 2 .

Table 2: Recommended Dosage Modifications for TRUSELTIQ Adverse Reactions
Adverse Reaction Severity a TRUSELTIQ Dose Modifications

Retinal Pigment Epithelial Detachment (RPED) [ see Warnings and Precautions (5.1) ]

 Not Applicable

Continue TRUSELTIQ at the current dose and continue periodic ophthalmic evaluation:

  • If resolving within 14 days, continue TRUSELTIQ at the current dose.
    • If not resolving within 14 days, withhold TRUSELTIQ until resolving; then resume TRUSELTIQ at previous or a lower dose.
Hyperphosphatemia [ see Warnings and Precautions ( 5.2) ] Serum phosphate >5.5 – ≤7.5 mg/dL Continue TRUSELTIQ at the current dose and initiate or dose adjust phosphate binder according to respective label. Monitor serum phosphate weekly. Phosphate binder dosing should be held during the week off TRUSELTIQ therapy each cycle (Days 22-28) and during TRUSELTIQ dose interruptions for non-hyperphosphatemia adverse events.

Serum phosphate >7.5 mg/dL

Or

Single serum phosphate >9 mg/dL regardless of duration or dose of phosphate lowering therapy.

Withhold TRUSELTIQ until level returns to serum phosphate ≤5.5 mg/dL.

Resume TRUSELTIQ as below, with maximal phosphate binder dosing:

  • If serum phosphate >7.5 mg/dL occurred for less than 7 days: Restart TRUSELTIQ at the same dose.
    • If serum phosphate >7.5 mg/dL for >7 days or if patient had a one-time serum phosphate of >9 mg/dL: Resume TRUSELTIQ at the next lower dose level.
Serum phosphate with life-threatening consequences; urgent intervention indicated (e.g., dialysis) Permanently discontinue TRUSELTIQ.
Other Adverse Reactions Grade 3 Withhold dose of TRUSELTIQ until resolved to Grade ≤1, then resume at the next lower dose level of TRUSELTIQ. If not resolved within ≤14 days, permanently discontinue TRUSELTIQ.
Grade 4 Permanently discontinue TRUSELTIQ.

a Severity as defined by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE version 4.03).

Dose Modification for Moderate Hepatic Impairment

Avoid coadministration of a proton pump inhibitor (PPI), a histamine-2 (H2) receptor antagonist, or a locally-acting antacid with TRUSELTIQ [ see Drug Interactions ( 7.1) ]. If coadministration cannot be avoided:

  • H2-antagonist: Separate administration of TRUSELTIQ by 2 hours before or 10 hours after.
  • Locally-acting antacid: Separate administration of TRUSELTIQ by 2 hours before or after.

Recommended Dosage for Mild and Moderate Renal Impairment

The recommended dosage of TRUSELTIQ for patients with mild to moderate renal impairment (creatinine clearance 30 to 89 mL/min, estimated by Cockcroft-Gault) is 100 mg once daily for 21 consecutive days followed by 7 days off therapy, in 28-day cycles [ see Use in Specific Population( 8.6), Clinical Pharmacology ( 12.3) ].

Recommended Dosage for Mild and Moderate Hepatic Impairment

The recommended dosage of TRUSELTIQ for patients with mild (total bilirubin > upper limit of normal [ULN] to 1.5 × ULN or AST > ULN ) or moderate hepatic impairment (total bilirubin >1.5 to 3 × ULN with any AST) is as follows [ see Use in Specific Population ( 8.7), Clinical Pharmacology ( 12.3) ].

  • Mild Hepatic Impairment: 100 mg once daily for 21 consecutive days followed by 7 days off therapy, in 28-day cycles.
  • Moderate Hepatic Impairment: 75 mg once daily for 21 consecutive days followed by 7 days off therapy, in 28-day cycles.
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