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Loqtorzi Generic Name & Formulations
Legal Class
General Description
Pharmacological Class
How Supplied
Single-dose vial (6mL)—1
Manufacturer
Generic Availability
NO
Mechanism of Action
Toripalimab-tpzi is a humanized IgG4 monoclonal antibody that binds to the PD-1 receptor and blocks its interaction with PD-L1 and PD-L2, releasing PD-1 pathway-mediated inhibition of the immune response, including the anti-tumor immune response. In syngeneic mouse tumor models, blocking PD-1 activity resulted in decreased tumor growth.
Loqtorzi Indications
Indications
In combination with cisplatin and gemcitabine, for the first-line treatment of adults with metastatic or with recurrent, locally advanced nasopharyngeal carcinoma (NPC). As a single agent, for adults with recurrent unresectable or metastatic NPC with disease progression on or after platinum-containing chemotherapy.
Loqtorzi Dosage and Administration
Adult
First infusion: infuse over ≥60mins. Subsequent infusions: may give over 30mins if no infusion-related reactions occurred during the first infusion. First-line NPC: 240mg once every 3 weeks; continue until disease progression, unacceptable toxicity, or up to 24 months. Recurrent NPC: 3mg/kg every 2 weeks; continue until disease progression or unacceptable toxicity. Dose modifications for adverse reactions: see full labeling.
Children
Not established.
Renal impairment
Nephritis with renal dysfunction
- Grade 2 or 3 increased blood creatinine: Withhold.
- Grade 4 increased blood creatinine: Permanently discontinue.
Hepatic Impairment
Hepatitis with no tumor involvement of the liver
- AST/ALT increases to >3 to 8xULN or total bilirubin increases to >1.5 and up to 3xULN: Withhold.
- AST or ALT increased to >8xULN or total bilirubin increases to >3xULN: Permanently discontinue.
Hepatitis with tumor involvement of the liver
- Baseline AST or ALT is >1 to 3xULN and increases >5 to 10xULN or Baseline AST or ALT is >3 to 5xULN and increases to >8 to 10xULN: Withhold.
- Baseline AST or ALT is >ULN and increases to >10xULN or Total bilirubin increases to >3xULN: Permanently discontinue.
Other Modifications
Pneumonitis
- Grade 2: Withhold.
- Grades 3 or 4: Permanently discontinue.
Colitis
- Grade 2 or 3: Withhold.
- Grade 4: Permanently discontinue.
Endocrinopathies
- Grade 3 or 4: Withhold until clinically stable or permanently discontinue depending on severity.
Exfoliative dermatologic conditions
- Suspected SJS, TEN or DRESS: Withhold.
- Confirmed SJS, TEN or DRESS: Permanently discontinue.
Myocarditis
- Grades 2, 3, or 4: Permanently discontinue.
Neurological toxicities
- Grade 2: withhold.
- Grade 3 or 4: Permanently discontinue.
Infusion-related reactions
- Grade 1 or 2: Interrupt or slow the rate of infusion.
- Grade 3 or 4: Permanently discontinue the infusion.
Administration
Preparation
- Visually inspect the solution for particulate matter and discoloration. The solution is clear to slightly opalescent, colorless to slightly yellow. Discard the vial if visible particles are observed.
- Withdraw the required volume of Loqtorzi and inject slowly into a 100 mL or 250 mL infusion bag containing 0.9% Sodium Chloride Injection, USP. Mix 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.
- Loqtorzi is compatible with polypropylene infusion bags and infusion sets with 0.2 or 0.22 micron in-line filter.
Administration
- Administer diluted solution intravenously via an infusion pump using an in-line aseptic filter (0.2 or 0.22 micron).
- 1st Infusion: Infuse over at least 60 minutes.
- Subsequent infusions: may administer over 30 minutes if no infusion-related reactions occurred during the first infusion.
- Do not use other drugs through the same IV line.
- If Loqtorzi is administer on the same day as chemotherapy, give Loqtorzi prior to chemotherapy.
Loqtorzi Contraindications
Not Applicable
Loqtorzi Boxed Warnings
Not Applicable
Loqtorzi Warnings/Precautions
Warnings/Precautions
Severe and fatal immune-mediated adverse reactions can develop. Monitor closely for immune-related pneumonitis, hepatitis (with or without liver tumor involvement), colitis, endocrinopathies (thyroid disorders, adrenal insufficiency, diabetes, hypophysitis/hypopituitarism), nephritis/renal dysfunction, dermatologic reactions, myocarditis, neurological toxicities, others. Withhold or permanently discontinue based on severity and type of adverse reaction; see full labeling for management guidelines. Obtain liver enzymes, creatinine and thyroid function at baseline and periodically during therapy. Monitor for infection. Evaluate for Vogt-Koyanagi-Harada-like syndrome if uveitis in combination with other immune-mediated reactions occur. Interrupt, slow the infusion rate, or permanently discontinue based on severity of infusion-related reactions. Monitor closely for allogeneic HSCT-related complications (eg, graft-versus-host-disease, hepatic veno-occlusive disease, steroid-requiring febrile syndrome) and manage promptly. Embryo-fetal toxicity. Advise females of reproductive potential to use effective contraception during and for 4 months after the last dose. Pregnancy: exclude status prior to initiation. Nursing mothers: not recommended (during and for 4 months after the last dose).
Loqtorzi Pharmacokinetics
Distribution
Mean volume of distribution at steady state: 3.7 L (27%).
Elimination
Half-life: 10±1.5 days (after the first dose); 18±9.4 days (at steady state).
Loqtorzi Interactions
Not Applicable
Loqtorzi Adverse Reactions
Adverse Reactions
Nausea, vomiting, decreased appetite, constipation, hypothyroidism, rash, pyrexia, diarrhea, peripheral neuropathy, cough, musculoskeletal pain, upper RTI, insomnia, dizziness, and malaise, fatigue; other immune-mediated adverse reactions (eg, ocular, gastrointestinal, musculoskeletal/connective tissue, hematologic/immune), infusion-related reactions.
Loqtorzi Clinical Trials
Loqtorzi Note
Not Applicable
Loqtorzi Patient Counseling
Cost Savings Program
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