LOQTORZI Concentrate for solution for infusion Ref.[115078] Active ingredients: Toripalimab

Treatment must be initiated and supervised by physicians experienced in the treatment of cancer.

Posology

The recommended dosing regimen of LOQTORZI is 240 mg every 3 weeks (Q3W) as an intravenous infusion over 60 minutes for the first infusion. If no significant infusion-related reactions occurred during the first infusion, the subsequent infusions may be administered over 30 minutes.

Treatment should continue until disease progression, unacceptable toxicity or up to a maximum duration of 24 months.

Dose modifications

Recommended modifications to manage adverse reaction are provided in Table 1.

See the Summary of Product Characteristics (SmPC) of other products to be used in combination with LOQTORZI.

Table 1. Recommended treatment modifications for LOQTORZI:

¹ Based on National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
² Resume LOQTORZI in patients with resolution to Grade 0-1 after corticosteroid taper. Permanently discontinue if not less than Grade 1 within 12 weeks of initiating steroids or inability to reduce prednisone to 10 mg per day or less (or equivalent) within 12 weeks of initiating steroids, or for endocrinopathies cannot be clinically stabilized on hormone replacement therapy.

Patient card

All prescribers of LOQTORZI should inform patients about the patient card, explaining what to do should they experience any symptom of immune-related adverse reactions. The physician will provide the patient card to each patient.

Special populations

Elderly

No dose adjustment is recommended for patients who are aged 65 years or over (see section 5.2).

Renal impairment

No dose adjustment is needed for patients with mild or moderate renal impairment. There are insufficient data in patients with severe renal impairment for dosing recommendations (see section 5.2).

Hepatic impairment

No dose adjustment is recommended for patients with mild hepatic impairment. There are insufficient data in patients with moderate or severe hepatic impairment for dosing recommendations (see section 5.2).

Paediatric population

The safety and efficacy of LOQTORZI in children and adolescents aged under 18 years have not been established. No data are available.

Method of administration

LOQTORZI is for intravenous use only and must be administered by infusion. The first infusion should be administered over 60 minutes via an infusion pump through an in-line filter (0.2 micron or 0.22 micron pore size). If no infusion-related reactions occurred during the first infusion, subsequent infusions may be administered over 30 minutes.

When administered on the same day as chemotherapy, LOQTORZI should be administered prior to chemotherapy through a different intravenous line.

For instructions on dilution of the medicinal product before administration, see section 6.6.

In case of overdose, patients should be closely monitored for signs or symptoms of adverse reactions and appropriate symptomatic treatment instituted.

Unopened vial:

3 years.

After dilution:

Chemical and physical in-use stability after dilution has been demonstrated for 24 hours at 2°C to 8°C or at 20°C to 25°C. From a microbiological point of view, unless the method of dilution precludes the risks of microbial contamination, the product should be used immediately. If not used immediately, in-use storage times and conditions are the responsibility of the user.

Store in a refrigerator (2°C–8°C).

Do not freeze.

Store in the original carton in order to protect from light.

For storage conditions after dilution of the medicinal product, see section 6.3.

Type 1 neutral borosilicate glass vial capped sealed with a chlorobutyl rubber stopper and sealed with a 20 mm flip-off seal (aluminium), containing 6 mL of concentrate for solution for infusion.

Each carton contains one vial.

Preparation:

• Visually inspect the solution for particulate matter and discoloration. The solution is clear to slightly opalescent, colourless to slightly yellow. Discard the vial if visible particles are observed.
• Dilute LOQTORZI prior to intravenous administration.
• Withdraw the required volume of LOQTORZI and inject slowly into a 100 mL or 250 mL infusion bag containing sodium chloride 9 mg/mL (0.9%) solution for injection. Mix the diluted solution by gentle inversion. Do not shake. The final concentration of the diluted solution should be between 1 mg/mL to 3 mg/mL.

Administration:

• Administer the diluted solution intravenously via an infusion pump using a sterile in-line filter (0.2 micron or 0.22 micron pore size).
• First infusion: infuse over at least 60 minutes.
• Subsequent infusions: if no infusion-related reactions occurred during the first infusion, subsequent infusions may be administered over 30 minutes.
• Do not co-administer other medicinal products through the same intravenous line.
• When administered on the same day as chemotherapy, LOQTORZI should be administered prior to chemotherapy.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.