TM Owner Coherus BioSciences
Toripalimab IV 240mg/6mL Injection
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Indications & Clinical Uses
- Toripalimab IV, as listed here under its active-substance name with a route suffix, is marketed in the US under the approved brand name LOQTORZI (toripalimab-tpzi), a PD-1 immune checkpoint inhibitor antibody supplied as 240 mg/6 mL (40 mg/mL) solution in a single-dose vial.
- LOQTORZI is approved, in combination with cisplatin and gemcitabine chemotherapy, for first-line treatment of adults with metastatic or with recurrent, locally advanced nasopharyngeal carcinoma (NPC); and as a single agent for adults with recurrent, unresectable or metastatic NPC whose disease has progressed on or after platinum-containing chemotherapy.
- It was FDA-approved in October 2023, based on the JUPITER-02 and POLARIS-02 trials.
- LOQTORZI is given only by intravenous infusion in a hospital or oncology clinic, on a schedule set by the oncology team; it is never self-administered.
Side Effects
- LOQTORZI (toripalimab-tpzi) has no boxed warning, but its label carries a strong warning that immune-mediated adverse reactions - inflammation the drug's activated immune system directs at the patient's own organs - can occur in almost any organ, may be severe or fatal, and can appear at any time during or after treatment.
- These include pneumonitis (cough, breathlessness), colitis (diarrhoea, abdominal pain), hepatitis (yellowing skin or eyes, dark urine), thyroid and other endocrine problems (fatigue, weight change), kidney inflammation, and skin reactions.
- Very common effects include fatigue, nausea, decreased appetite, constipation, vomiting, rash and anaemia.
- Infusion reactions, sometimes serious, can occur, especially with early doses.
- Report any new or worsening symptom promptly, since immune-related reactions are treated by pausing the drug and often starting corticosteroids.
Precautions & Warnings
- Before and during LOQTORZI treatment, liver enzymes, kidney function (creatinine) and thyroid function are checked regularly to catch immune-mediated organ inflammation early; blood glucose is also monitored for immune-related diabetes.
- Infusion-related reactions are monitored for, particularly during and shortly after each infusion, and the infusion may be slowed, interrupted or stopped if they occur.
- LOQTORZI can cause harm to a developing baby, so effective contraception is required for females of reproductive potential during treatment and for 4 months after the last dose; it should not be used in pregnancy unless clearly needed, and is not recommended while breastfeeding.
- People who have had an allogeneic stem cell transplant may be at higher risk of transplant-related complications with checkpoint inhibitors such as this one.
- LOQTORZI is prepared and given only under specialist oncology supervision, never as a take-home medicine.
Avoid Interactions
- No specific pharmacokinetic drug-drug interactions have been established for LOQTORZI (toripalimab-tpzi), since it is a large antibody rather than a small-molecule drug metabolised by liver enzymes.
- Corticosteroids and other immunosuppressants given before starting treatment may blunt LOQTORZI's anti-tumour immune effect, so their use is generally avoided unless needed to manage an immune-mediated side effect that has already occurred.
- When LOQTORZI is given on the same day as chemotherapy such as cisplatin or gemcitabine, LOQTORZI is infused first, before the chemotherapy.
- It should not be mixed with, or infused through the same line as, other medicines.
- Tell your oncology team about every prescription, over-the-counter medicine, herbal remedy, vaccine and supplement you use before and during treatment.
References
Frequently Asked Questions
Toripalimab IV is marketed as Loqtorzi (toripalimab-tpzi), a PD-1 immunotherapy for nasopharyngeal carcinoma. It's used with cisplatin and gemcitabine as first-line treatment, or alone if the cancer has progressed after platinum chemotherapy. It was FDA-approved in October 2023.
Toripalimab IV (Loqtorzi) is given as an intravenous infusion in a hospital or cancer clinic, on a schedule your oncology team sets around your chemotherapy cycles or, if used alone, roughly every 2 to 3 weeks. You never give it to yourself.
Toripalimab IV (Loqtorzi) can cause immune-mediated reactions in almost any organ, including lung, bowel, liver, thyroid and kidney inflammation, which can be serious. Common effects include fatigue, nausea, low appetite and anaemia. Report new breathlessness, diarrhoea, yellowing skin or unusual tiredness right away.
Before and during Toripalimab IV (Loqtorzi) treatment, you'll have regular blood tests checking liver enzymes, kidney function, thyroid hormones and blood sugar, since the drug can trigger immune inflammation in these organs, sometimes without early symptoms.
You're monitored closely during and shortly after each Toripalimab IV infusion for infusion reactions, such as fever, chills or breathing changes, which can occur especially with the first few doses. The infusion may be slowed or paused if a reaction happens.
No. Toripalimab IV (Loqtorzi) can harm a developing baby, so effective contraception is required during treatment and for 4 months after the last dose. It is avoided in pregnancy unless clearly needed and is not recommended while breastfeeding.
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