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TRUSELTIQ offers patients once-daily oral dosing

TRUSELTIQ is taken on a 4-week treatment cycle with 3 weeks on and 1 treatment-free week until disease progression of unacceptable toxicity.
  • 125 mg once daily for 21 days, followed by 7 days off, in 28-day cycles
  • 100 mg, 75 mg, and 50 mg cartons are available for dose modifications

See full Prescribing Information for the recommended dose modifications for patients with mild or moderate renal or hepatic impairment, and for concomitant use with gastric acid-reducing agents. Additionally, avoid concomitant use of TRUSELTIQ with strong or moderate CYP3A inhibitors or inducers.

TRUSELTIQ capsules should be:


Copay Assistance Program

Taken orally,
once daily

QuickStart Program

Taken on an empty stomach at least 1 hour before or 2 hours after a meal

Patient Assistance Program

Taken at the same time every day

Patient Assistance Program

Swallowed whole with a glass of water–no chewing, crushing, or dissolving the capsules

Important reminders before initiating treatment with TRUSELTIQ

  • To initiate therapy, patients should have a confirmed presence of an FGFR2 fusion or rearrangement, as detected by an FDA-approved test
  • Verify negative pregnancy status in females of reproductive potential
  • Advise patients of reproductive potential of risk to fetus, to use effective contraception, and to not breastfeed during treatment with TRUSELTIQ and for 1 month after the final dose
  • Perform a comprehensive ophthalmic examination, including optical coherence tomography (OCT), prior to treatment initiation, at 1 month, at 3 months, and then every 3 months thereafter during treatment
  • Monitor for hyperphosphatemia within the first week of treatment and throughout treatment, as the median time to onset of hyperphosphatemia with TRUSELTIQ was 8 days
    • Manage with phosphate binders and dose interruption/modification as clinically indicated based on the duration and severity of hyperphosphatemia

FGFR2=fibroblast growth factor receptor 2.

Dose modification

Recommended dose reduction for TRUSELTIQ for adverse reactions

1st dose reduction

1st reduction: 100mg capsule

100 mg (one 100 mg capsule)

2nd dose reduction

2nd: three 25mg capsules

75 mg (three 25 mg capsules)

3rd dose reduction

3rd: two 25mg capsules

50 mg (two 25 mg capsules)

See Table 2 in the full Prescribing Information for a complete list of recommended dosage modifications for TRUSELTIQ adverse reactions. Click here to view or download the TRUSELTIQ Dosing Guide.

Packaging

TRUSELTIQ packaging was designed with patients in mind

The full treatment sequence is labeled throughout each blister card to help keep dosage and medication dates organized.

Each dose carton contains a full 28-day cycle, with 21 doses of 125 mg, provided as 100 mg and 25 mg capsules (42 capsules total)

Each dose carton contains a full 28-day cycle, with 21 doses of 125 mg, provided as 100 mg and 25 mg capsules (42 capsules total).

100 mg, 75 mg, and 50 mg cartons are available to support dose modification.

100 mg dose carton is available for TRUSELTIQ
75 mg dose cartons are available for TRUSELTIQ
50 mg dose carton is available for TRUSELTIQ

Advise patients to read the FDA-approved patient labeling (Patient Information), and remind them to report any adverse reactions they experience so that a mitigation strategy can be considered.

Get support and affordability access to TRUSELTIQ

Reference:
  1. TRUSELTIQ Prescribing Information. Brisbane, CA: QED Therapeutics, Inc.; May 2021.

INDICATION AND IMPORTANT
SAFETY INFORMATION

INDICATION

TRUSELTIQ is 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.

Accelerated approval was granted based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification of clinical benefit in confirmatory trial(s).

IMPORTANT SAFETY INFORMATION

Warnings and precautions

  • Ocular toxicity: Retinal pigment epithelial detachment (RPED), which may cause blurred vision, occurred in 11% of 351 patients treated with TRUSELTIQ, including patients with asymptomatic RPED, with a median onset of 26 days. Perform comprehensive ophthalmological exam including optical coherence tomography prior to initiating, at 1 month, at 3 months, and then every 3 months during treatment with TRUSELTIQ. Urgently evaluate patients for onset of visual symptoms and follow up every 3 weeks until resolved or TRUSELTIQ is discontinued. Withhold TRUSELTIQ as recommended. Dry eye occurred in 29% of 351 patients; treat with ocular demulcents as needed
  • Hyperphosphatemia and soft tissue mineralization: Hyperphosphatemia, which can lead to soft tissue mineralization, cutaneous calcinosis, non-uremic calciphylaxis, vascular calcification, and myocardial calcification, occurred in 82% of 351 patients treated with TRUSELTIQ, with a median time to onset of 8 days (range 1-349); 83% of 351 patients treated with TRUSELTIQ received phosphate binders. Monitor for hyperphosphatemia throughout treatment. Initiate phosphate-lowering therapy for serum phosphate >5.5 mg/dL; withhold TRUSELTIQ and initiate phosphate-lowering therapy for serum phosphate >7.5 mg/dL; withhold, reduce the dose, or permanently discontinue TRUSELTIQ based on duration and severity of hyperphosphatemia
  • Embryo-fetal toxicity: TRUSELTIQ can cause fetal harm. Advise pregnant women of the potential risk to the fetus; advise females of reproductive potential and men who are partnered with women of reproductive potential to use effective contraception during treatment with TRUSELTIQ and for 1 month after the final dose

Adverse reactions

  • Most common adverse reactions (incidence ≥20%, all grades): nail toxicity, stomatitis, dry eye, fatigue, alopecia, palmar-plantar erythrodysesthesia syndrome, arthralgia, dysgeusia, constipation, abdominal pain, dry mouth, eyelash changes, diarrhea, dry skin, decreased appetite, blurred vision, and vomiting
  • Most common laboratory abnormalities (incidence ≥20%, all grades): increased creatinine, increased phosphate, decreased phosphate, increased alkaline phosphatase, decreased hemoglobin, increased alanine aminotransferase, increased lipase, increased calcium, decreased lymphocytes, decreased sodium, increased triglycerides, increased aspartate aminotransferase (AST), increased urate, decreased platelets, decreased leukocytes, decreased albumin, increased bilirubin, and decreased potassium

Drug interactions

  • CYP3A inhibitors: Avoid use with strong and moderate CYP3A inhibitors
  • CYP3A inducers: Avoid use with strong and moderate CYP3A inducers
  • Gastric acid–reducing agents: Avoid coadministration with proton pump inhibitors, histamine-2 receptor antagonists (H2RA), and locally acting antacids. If coadministration of H2RA or locally acting antacids cannot be avoided, separate TRUSELTIQ administration
    • H2RA: Take TRUSELTIQ 2 hours before or 10 hours after
    • Locally-acting antacid: Take TRUSELTIQ 2 hours before or 2 hours after

Dosage and administration

  • Prior to initiating TRUSELTIQ: Confirm FGFR2 fusion or rearrangement; perform comprehensive ophthalmic exam including OCT; confirm negative pregnancy test in females of reproductive potential
  • Starting dose: Take TRUSELTIQ orally once daily on Days 1-21 of 28-day cycles; continue treatment until disease progression or unacceptable toxicity. Take TRUSELTIQ on an empty stomach with a glass of water at least 1 hour before or 2 hours after food
    • No renal or hepatic impairment
      • 125 mg (one 100 mg capsule and one 25 mg capsule)
    • Mild and moderate renal impairment (creatinine clearance 30-89 mL/min)
      • 100 mg (one 100 mg capsule)
    • Mild hepatic impairment (total bilirubin >upper limit of normal [ULN] to 1.5 x ULN or AST > ULN)
      • 100 mg (one 100 mg capsule)
    • Moderate hepatic impairment (total bilirubin >1.5 to 3 x ULN with any AST)
      • 75 mg (three 25 mg capsules)
  • Dose modification: Consult the TRUSELTIQ full Prescribing Information for dose modifications and monitoring recommendations for RPED, hyperphosphatemia, and other Grades 3-4 adverse reactions

Please click here for full Prescribing Information.