Active Ingredient: Amivantamab
Amivantamab as monotherapy is indicated for treatment of adult patients with advanced non-small cell lung cancer (NSCLC) with activating epidermal growth factor receptor (EGFR) Exon 20 insertion mutations, after failure of platinum-based therapy.
For this indication, competent medicine agencies globally authorize below treatments:
Intravenous
1,050 - 1,400 mg
From 1,050 To 1,400 mg once every 7 day(s)
Premedications should be administered to reduce the risk of IRRs with amivantamab.
The recommended dose of amivantamab is provided in Table 1, and the dosing schedule is provided in Table 2 (see below “Infusion rates”).
Table 1. Recommended dose of amivantamab:
| Body weight of patient (at baseline*) | Recommended dose | Number of vials |
|---|---|---|
| Less than 80 kg | 1,050 mg | 3 |
| Greater than or equal to 80 kg | 1,400 mg | 4 |
* Dose adjustments not required for subsequent body weight changes
Table 2. Dosing schedule for amivantamab:
| Weeks | Schedule |
|---|---|
| Weeks 1 to 4 | Weekly (total of 4 doses) |
| Week 5 onwards | Every 2 weeks starting at Week 5 |
It is recommended that patients are treated with amivantamab until disease progression or unacceptable toxicity.
If a planned dose is missed, the dose should be administered as soon as possible and the dosing schedule should be adjusted accordingly, maintaining the treatment interval.
Dosing should be interrupted for Grade 3 or 4 adverse reactions until the adverse reaction resolves to ≤ Grade 1 or baseline. If an interruption is 7 days or less, restart at the current dose. If an interruption is longer than 7 days, it is recommended restarting at a reduced dose as presented in Table 3. See also specific dose modifications for specific adverse reactions below Table 3.
Table 3. Recommended dose modifications for adverse reactions:
| Body weight (at baseline) | Initial dose | 1st dose modification | 2nd dose modification | 3rd dose modification |
|---|---|---|---|---|
| Less than 80 kg | 1,050 mg | 700 mg | 350 mg | Discontinue amivantamab |
| Greater than or equal to 80 kg | 1,400 mg | 1,050 mg | 700 mg |
Interrupt infusion at the first sign of IRRs. Additional supportive medicinal products (e.g., additional glucocorticoids, antihistamine, antipyretics and antiemetics) should be administered as clinically indicated.
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