Administer infusion solution immediately once prepared. If infusion solution is not administered immediately and needs to be stored, the total time from vial puncture to the start of the administration should not exceed:
•
24 hours in a refrigerator at 2°C to 8°C (36°F to 46°F)
•
4 hours at room temperature up to 25°C (77°F)
Do not freeze.
Do not shake.
Administration
•
Administer infusion solution intravenously over 60 minutes through an intravenous line containing a sterile, low-protein binding 0.2 or 0.22 micron in-line filter.
•
Do not co-administer other drugs through the same infusion line.
CLOSE
3 DOSAGE FORMS AND STRENGTHS
Injection: 120 mg/2.4mL (50 mg/mL) and 500 mg/10mL (50 mg/mL) clear to opalescent, colorless to slightly yellow solution in a single-dose vial.
4 CONTRAINDICATIONS
None.
5 WARNINGS AND PRECAUTIONS
5.1 Immune-Mediated Pneumonitis
Immune-mediated pneumonitis or interstitial lung disease occurred in patients receiving IMFINZI. Monitor patients for signs and symptoms of pneumonitis. eva luate patients with suspected pneumonitis with radiographic imaging and manage with treatment modifications and corticosteroids [see DOSAGE AND ADMINISTRATION (2.2)].
In Study 1 (n=182), one patient (0.5%) died from immune-mediated pneumonitis. In the combined safety database (n=1414), of patients treated with IMFINZI 10 mg/kg every 2 weeks, immune-mediated pneumonitis occurred in 32 (2.3%) patients including fatal pneumonitis in one (0.1%) patient and Grade 3-4 in six (0.4%) patients. The median time to onset was 55.5 days (range: 24-423 days). Seventeen (1.2%) patients received high-dose corticosteroid treatment (at least 40 mg prednisone or equivalent per day). IMFINZI was interrupted in 12 patients and discontinued in five (0.4%) patients. Resolution occurred in 18 (1.3%) patients.
5.2 Immune-Mediated Hepatitis
Immune-mediated hepatitis occurred in patients receiving IMFINZI. Monitor patients for abnormal liver tests each cycle during treatment with IMFINZI. Manage immune-mediated hepatitis with treatment modifications and corticosteroids [see DOSAGE AND ADMINISTRATION (2.2)].
In Study 1, one (0.5%) patient died from immune-mediated hepatitis. An additional two (1.1%) patients experienced immune-mediated hepatitis, including Grade 3 in one (0.5%) patient. In the combined safety database, immune-mediated hepatitis occurred in 16 (1.1%) patients including fatal hepatitis in one (<0.1%) patient and Grade 3 in nine (0.6%) patients. The median time to onset was 51.5 days (range: 15-312 days). Twelve (0.8%) of the 16 patients received high-dose corticosteroid treatment. One patient also received mycophenolate treatment. IMFINZI was interrupted in five (0.3%) patients and discontinued in three (0.2%) patients. Resolution occurred in nine (0.6%) patients. In the combined safety database, Grade 3 or 4 elevations in ALT occurred in 40/1342 (3.0%) of patients, AST in 58/1336 (4.3%), and total bilirubin in 37/1341 (2.8%) of patients.
5.3 Immune-Mediated Colitis
Immune-mediated colitis or diarrhea occurred in patients receiving IMFINZI. Monitor patients for signs and symptoms of colitis or diarrhea and manage with treatment modifications, anti-diarrheal agents, and corticosteroids [see DOSAGE AND ADMINISTRATION (2.2)].
In Study 1, colitis or diarrhea occurred in 23 (12.6%) patients including Gr |
