Non-small cell lung cancer

Active Ingredient: Tislelizumab

Indication for Tislelizumab

Population group: only adults (18 years old or older)
Therapeutic intent: Curative procedure

Tislelizumab as monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer after prior platinum-based therapy. Patients with EGFR mutant or ALK positive NSCLC should also have received targeted therapies before receiving tislelizumab.

For this indication, competent medicine agencies globally authorize below treatments:

200 mg once every 3 weeks

For:

Dosage regimens

Intravenous, 200 milligrams tislelizumab, once every 3 weeks.

Detailed description

The recommended dose of tislelizumab is 200 mg administered by intravenous infusion once every 3 weeks.

Duration of treatment

Patients should be treated with tislelizumab until disease progression or unacceptable toxicity.

Dose delay or discontinuation

No dose reductions of tislelizumab as monotherapy are recommended. Tislelizumab should be withheld or discontinued as described in Table 1.

Table 1. Recommended treatment modifications for tislelizumab:

Immune-related adverse
reaction
Severity1 Tislelizumab treatment modification
Pneumonitis Grade 2 Withhold2,3
Recurrent grade 2; grade 3 or 4 Permanently discontinue3
HepatitisALT or AST >3 to 8 x ULN or
total bilirubin >1.5 to 3 x ULN
Withhold2,3
ALT or AST >8 x ULN or total
bilirubin >3 x ULN
Permanently discontinue3
Rash Grade 3 Withhold2,3
Grade 4 Permanently discontinue3
Severe cutaneous adverse reactions
(SCARs)
Suspected SCARs, including SJS
or TEN
Withhold2,3
For suspected SJS or TEN, do not
resume unless SJS/TEN has been
ruled out in consultation with
appropriate specialist(s).
Confirmed SCARs, including SJS
or TEN
Permanently discontinue
Colitis Grade 2 or 3 Withold2,3
Recurrent grade 3; grade 4 Permanently discontinue3
Myositis/rhabdomyolysis Grade 2 or 3 Withhold2,3
Recurrent grade 3; grade 4 Permanently discontinue3
Hypothyroidism Grade 2, 3 or 4Hypothyroidism may be managed
with replacement therapy without
treatment interruption.
Hyperthyroidism Grade 3 or 4Withhold2
For grade 3 or 4 that has improved
to grade ≤2 and is controlled with
anti-thyroid therapy, if indicated
continuation of tislelizumab may be
considered after corticosteroid
taper. Otherwise, treatment should
be discontinued.
Adrenal insufficiencyGrade 2 Consider withholding treatment
until controlled by HRT.
Grade 3 or 4Withhold3
For grade 3 or 4 that has improved
to grade ≤2 and is controlled with
HRT, if indicated continuation of
tislelizumab may be considered after
corticosteroid taper. Otherwise,
treatment should be discontinued.3
HypophysitisGrade 2Consider withholding treatment
until controlled by HRT.
Grade 3 or 4Withhold2,3
For grade 3 or 4 that has improved
to grade ≤2 and is controlled with
HRT, if indicated continuation of
tislelizumab may be considered after
corticosteroid taper. Otherwise,
treatment should be discontinued.3
Type 1 diabetes mellitusType 1 diabetes mellitus
associated with grade ≥3
hyperglycaemia
(glucose >250 mg/dl
or >13.9 mmol/l) or associated
with ketoacidosis
Withhold
For grade 3 or 4 that has improved
to grade ≤2 with insulin therapy, if
indicated continuation of tislelizumab
may be considered once metabolic
control is achieved. Otherwise,
treatment should be discontinued.
Nephritis with renal dysfunctionGrade 2 (creatinine >1.5 to 3 x
baseline or >1.5 to 3 x ULN)
Withhold2,3
Grade 3 (creatinine >3 x baseline
or >3 to 6 x ULN) or grade 4
(creatinine >6 x ULN)
Permanently discontinue3
Myocarditis Grade 2, 3 or 4 Permanently discontinue3
Neurological toxicities Grade 2 Withhold2,3
Grade 3 or 4 Permanently discontinue3
PancreatitisGrade 3 pancreatitis or grade 3 or
4 serum amylase or lipase levels
increased (>2 x ULN)
Withhold2,3
Grade 4 Permanently discontinue3
Other immune-related adverse
reactions
Grade 3 Withhold2,3
Recurrent grade 3; grade 4 Permanently discontinue3
Infusion-related reactionsGrade 1Consider pre-medication for
prophylaxis of subsequent infusion
reactions.
Slow the rate of infusion by 50%.
Grade 2Interrupt infusion.
Resume infusion if resolved or
decreased to grade 1, and slow rate
of infusion by 50%.
Grade 3 or 4 Permanently discontinue

ALT = alanine aminotransferase, AST = aspartate aminotransferase, HRT= hormone replacement therapy, SJS = Stevens-Johnson syndrome, TEN = toxic epidermal necrolysis, ULN = upper limit normal
1 Toxicity grades are in accordance with National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (NCI-CTCAE v4.0). Hypophysitis grade is in accordance with NCI-CTCAE v5.0.
2 Resume in patients with complete or partial resolution (grade 0 to 1) after corticosteroid taper over at least 1 month. Permanently discontinue if no complete or partial resolution within 12 weeks of initiating corticosteroids or inability to reduce prednisone to ≤10 mg/day (or equivalent) within 12 weeks of initiating corticosteroids.
3 Initial dose of 1 to 2 mg/kg/day prednisone or equivalent followed by a taper to ≤10 mg/day (or equivalent) over at least 1 month is recommended, except for pneumonitis, where initial dose of 2 to 4 mg/kg/day is recommended.

Dosage considerations

It is to be administered as an infusion and must not be administered as an intravenous push or single bolus injection.

Active ingredient

Tislelizumab

Tislelizumab is a humanised immunoglobulin G4 (IgG4) variant monoclonal antibody against PD-1, binding to the extracellular domain of human PD-1. It competitively blocks the binding of both PD-L1 and PD-L2, inhibiting PD-1-mediated negative signalling and enhancing the functional activity in T cells in in vitro cell-based assays.

Read more about Tislelizumab

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