TM Owner Coherus Oncology, Inc.
Loqtorzi 240mg/6ml Injection
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Indications & Clinical Uses
- Loqtorzi is toripalimab-tpzi, a programmed death receptor-1 (PD-1)-blocking monoclonal antibody given as an intravenous infusion by a healthcare professional in a hospital or clinic.
- In the United States it is approved in combination with cisplatin and gemcitabine for the first-line treatment of adults with metastatic or recurrent locally advanced nasopharyngeal carcinoma, and as a single agent for adults with recurrent unresectable or metastatic nasopharyngeal carcinoma whose disease has progressed on or after platinum-containing chemotherapy.
- In the European Union it is additionally approved with cisplatin and paclitaxel for first-line unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma.
- The supplied presentation is a single-dose vial of 240 mg in 6 mL (40 mg/mL).
- The combination dose is 240 mg every three weeks; the single-agent dose is 3 mg/kg every two weeks.
Side Effects
- With cisplatin and gemcitabine, the most common side effects of Loqtorzi (toripalimab-tpzi) are nausea (71%), vomiting (68%), reduced appetite (55%), constipation (39%), an underactive thyroid (38%) and rash (36%); used alone, the commonest are tiredness (22%), underactive thyroid (20%) and musculoskeletal pain (20%).
- The US label carries no boxed warning.
- Because Loqtorzi switches on the immune system, it can cause immune-mediated inflammation of almost any organ: pneumonitis, colitis, hepatitis, endocrine disorders including adrenal insufficiency, hypophysitis, thyroid disease and diabetes, nephritis, skin reactions, myocarditis and nerve problems.
- Tell your care team at once about a new cough or breathlessness, diarrhoea or blood in the stool, yellow skin or eyes, severe tiredness, chest pain, palpitations, muscle weakness, unusual thirst or a blistering rash, even weeks after an infusion.
Precautions & Warnings
- Loqtorzi is for intravenous infusion only after dilution; it must never be given as an intravenous push or bolus.
- The first infusion runs over 60 minutes, and later infusions may run over 30 minutes if the first was tolerated.
- Treatment must be supervised by a specialist experienced in cancer immunotherapy, with thyroid function, liver enzymes, kidney function and blood glucose checked before and during therapy.
- Immune-mediated reactions usually require the antibody to be withheld and corticosteroids started, and severe reactions may require permanent discontinuation.
- Tell your care team if you have an autoimmune disease, have had a solid organ or stem cell transplant, or take immunosuppressants.
- Loqtorzi can harm an unborn baby: effective contraception is needed during treatment and for four months after the last dose, and breastfeeding should be avoided.
- Vials are refrigerated at 2°C to 8°C; do not freeze.
Avoid Interactions
- The US prescribing information for Loqtorzi (toripalimab-tpzi) has no drug-interaction section, because monoclonal antibodies are cleared by protein breakdown rather than liver enzymes, so CYP-mediated interactions are not expected.
- The main practical concern is that systemic corticosteroids or other immunosuppressants taken before treatment may reduce how well the intended immune response works; they are, however, the correct treatment for immune-mediated side effects once these appear, so never start or stop steroids yourself.
- Live vaccines are generally avoided during checkpoint-inhibitor therapy, and any vaccination should be discussed with your oncology team first.
- Tell the team about every prescription medicine, over-the-counter product, herbal remedy and supplement, since some can add to liver injury.
- In the pharmacy, dilute only as the label directs, do not mix Loqtorzi with other medicines in the same line, and do not freeze.
References
Frequently Asked Questions
Loqtorzi (toripalimab-tpzi) treats nasopharyngeal carcinoma in adults: with cisplatin and gemcitabine as first-line therapy for metastatic or recurrent locally advanced disease, and alone after platinum chemotherapy has stopped working. It is a PD-1 blocking antibody. In the EU it is also approved for oesophageal squamous cell carcinoma.
Loqtorzi (toripalimab-tpzi) is given as an intravenous infusion by a healthcare professional: 240 mg every three weeks with chemotherapy, or 3 mg/kg every two weeks when used alone. The first infusion takes 60 minutes; later ones can be given over 30 minutes if the first was tolerated.
Common Loqtorzi (toripalimab-tpzi) side effects with chemotherapy are nausea, vomiting, poor appetite, constipation, an underactive thyroid and rash. Because it activates the immune system it can inflame the lungs, bowel, liver, hormone glands, kidneys, skin, heart or nerves. Report new cough, diarrhoea, yellow skin or chest pain immediately.
Avoid live vaccines during Loqtorzi (toripalimab-tpzi) treatment unless your oncology team approves, and never start or stop steroids or herbal supplements on your own. Pregnancy must be avoided: use effective contraception during treatment and for four months after the last dose, and do not breastfeed.
Before and during Loqtorzi (toripalimab-tpzi) therapy your team checks thyroid function, liver enzymes, kidney function and blood glucose, and asks about new symptoms at every visit. Immune-mediated side effects often show up on blood tests before you feel them. Scans assess how the cancer is responding.
Loqtorzi (toripalimab-tpzi) is diluted by the pharmacy and infused into a vein over 60 minutes the first time, then over 30 minutes if there was no reaction. It is never given as a rapid injection. Staff watch for fever, chills, flushing, rash or breathlessness during and after the infusion.
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