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Adverse reactions (≥15%) in patients with advanced CCA receiving TRUSELTIQ (N=108)

Adverse Reaction All Grades
(%)
Grade 3
or 4a (%)
Skin and subcutaneous tissue disorders
Nail toxicityb 57 2*
Alopecia 38 0
Palmar-plantar erythrodysesthesia syndrome 33 7*
Dry skin 23 0
Gastrointestinal disorders
Stomatitisc 56 15*
Constipation 30 1*
Abdominal paind 26 5*
Dry mouth 25 0
Diarrhea 24 3*
Vomiting 21 1*
Nausea 19 1*
Dyspepsia 17 0
Eye disorderse
Dry eyef 44 0
Eyelash changesg 25 0
Vision blurred 21 0
Adverse Reaction All Grades
(%)
Grade 3
or 4a (%)
General disorders and administrative site conditions
Fatigueh 44 4*
Edemai 17 1*
Pyrexia 15 1*
Musculoskeletal and connective tissue disorders
Arthralgia 32 0
Pain in extremity 17 2*
Nervous system disorders
Dysgeusia 32 0
Headache 17 1*
Metabolism and nutrition disorders
Decreased appetite 22 1*
Respiratory, thoracic, and mediastinal disorders
Epistaxis 18 0
Investigations
Weight decreased 15 2*

Graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE 4.03).

aEvents of Grade 3 only (no Grade 4 occurred) are marked with an asterisk.

bIncludes ingrown nail, nail bed bleeding, nail bed disorder, nail bed inflammation, nail bed tenderness, nail discoloration, nail disorder, nail dystrophy, nail hypertrophy, nail infection, nail ridging, onychalgia, onychoclasis, onycholysis, onychomadesis, onychomycosis, and paronychia.

cIncludes mouth ulceration and stomatitis.

dIncludes abdominal pain, abdominal pain upper, abdominal discomfort, and abdominal pain lower.

eSeverity of eye disorders is not represented by CTCAE Grading.

fIncludes dry eye, keratitis, lacrimation increased, pinguecula, and punctate keratitis.

gIncludes blepharitis, eyelash changes, eyelash discoloration, growth of eyelashes, trichiasis, and trichomegaly.

hIncludes asthenia and fatigue.

iIncludes edema peripheral and edema.


Clinically relevant adverse reactions occurring in ≤15% of patients included cataracts (12%) and fractures (1%).

Mitigation strategies are available for patients with adverse reactions such as RPED and hyperphosphatemia

Select laboratory abnormalities (≥10%) worsening from baseline in patients with advanced CCA receiving TRUSELTIQ (N=108)

Laboratory Abnormality All Grades
(%)
Grade 3
or 4 (%)
Chemistry
Increased creatinine 93 7
Increased phosphatea 90 13
Decreased phosphate 64 31
Increased alkaline phosphatase 54 8
Increased alanine aminotransferase 51 6
Increased lipase 44 7
Increased calcium 43 7
Decreased sodium 41 20
Increased triglycerides 38 3
Increased aspartate aminotransferase 38 4
Increased urate 37 37
Decreased albumin 24 1
Increased bilirubin 24 6
Decreased potassium 21 3
Increased cholesterol 18 1
Increased potassium 17 3
Decreased calcium 10 2
Laboratory Abnormality All Grades
(%)
Grade 3
or 4 (%)
Hematology
Decreased hemoglobin 53 5
Decreased lymphocytes 43 9
Decreased platelets 37 4
Decreased leukocytes 26 3
Decreased neutrophils 14 2

The denominator used to calculate the rate varied from 104 to 107 based on the number of patients with a baseline value and at least one post-treatment value.
These laboratory abnormalities are values that reflect worsening from baseline.
Graded per NCI CTCAE 4.03.

aNCI CTCAE 4.03 does not define grades for increased phosphate. Laboratory value shift table categories were used to assess increased phosphorus levels (Grades ≥3 defined as ≥9 mg/dL).

TRUSELTIQ has a large safety database of patients across advanced malignancies. Among the 351 patients in the pooled safety database, 27% were exposed for ≥6 months, and 10% were exposed for >1 year

FGFR=fibroblast growth factor receptor; RPED=retinal pigment epithelial detachment.

Dose reductions for adverse reaction management

Table of dose reductions for adverse reaction management with TRUSELTIQ.

See Table 2 in the full Prescribing Information for a complete list of recommended dosage modifications for TRUSELTIQ adverse reactions.

How patients should take 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.