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Loqtorzi is a brand name for Toripalimab. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: LOQTORZI, in combination with cisplatin and gemcitabine, is indicated for the first-line treatment of adult patients with recurrent, not amenable to surgery or radiotherapy, or metastatic nasopharyngeal carcinoma. LOQTORZI, in combination with cisplatin and paclitaxel, is indicated for the first-line treatment of…
Verbatim from this product's EMA label. Tap a section to expand.
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. 3 See the Summary of Product Characteristics (SmPC) of other products to be used in combination with LOQTORZI. 5 and up to 3 times ULN Withhold2 AST or ALT increases to more than 5 times ULN or Total bilirubin increases to more than 3 times ULN Permanently discontinue Endocrinopathies Grade 2-4 adrenal insufficiency or hypophysitis Withhold until clinically stable on hormone replacement therapy2 Grades 3 or 4 hyperthyroidism or thyroiditis Withhold until clinically stable on appropriate medical management Grade 3-4 diabetes mellitus Withhold until clinically stable on antihyperglycemic (insulin) therapy Grade 1-4 hypothyroidism Manage with hormone replacement therapy without toripalimab interruption Nephritis with renal dysfunction Grade 2-3 increased blood creatinine Withhold2 Grade 4 increased blood creatinine Permanently discontinue Exfoliative dermatologic conditions Suspected Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), or drug rash with eosinophilia and systemic symptoms (DRESS) Withhold2 Confirmed SJS, TEN, or DRESS Permanently discontinue Myocarditis Grades 2, 3, or 4 Permanently discontinue Myositis Grade 2-3 Withhold or permanently discontinue depending on severity2 Grade 4 Permanently discontinue 4 Adverse reaction Severity1 Treatment modification Immune-related adverse reactions Other adverse reactions (including but not limited to neurologic toxicities, pancreatitis, iritis, uveitis, immune-related cystitis, and immune-related inflammatory arthritis) Grade 2-3 Withhold or permanently discontinue depending on type and severity2 Grade 4 Permanently discontinue Infusion-related reactions Infusion-related reactions Grade 1 or 2 Interrupt or slow the rate of infusion Grade 3 or 4 Stop infusion.
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.
2) The safety of toripalimab in combination with platinum containing chemotherapy has been evaluated in 403 patients with NPC or oesophageal squamous cell carcinoma (OSCC) receiving 240 mg toripalimab every 3 weeks in JUPITER-02 or JUPITER-06.
1 years). The frequencies included below and in Table 2 are based on all reported adverse drug reactions, regardless of the investigator assessment of causality. 2%). 6% for chemotherapy alone. Tabulated list of adverse reactions Adverse reactions observed in clinical studies of toripalimab as monotherapy or in combination with chemotherapy are listed in Table 2.
Adverse reactions are presented by system organ class and by frequency. Frequencies are defined as: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1 000 to < 1/100); rare (≥ 1/10 000 to < 1/1 000); very rare (< 1/10 000); not known (cannot be estimated from the available data).
Within each frequency grouping, adverse reactions are presented in the order of decreasing seriousness. Table 2 includes only treatment related adverse drug reactions. The adverse reaction frequencies from clinical studies are based on all-cause adverse event frequencies, where a proportion of the events for an adverse reaction may have other causes than the medicinal product such as the disease, other medicines or unrelated causes.
Adverse reactions reported in clinical studies are listed by system organ class and by frequency. 7 months) in 15 Phase 1, 2 or 3 clinical studies. 1 for information on the demographics and baseline characteristics of participants in the main clinical studies.
When toripalimab is administered in combination with chemotherapy, refer to the SmPCs for the respective combination therapy components prior to initiation of treatment.
Table 2:
Traceability In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded. Immune-related adverse reactions Immune-related adverse reactions, which may be severe or fatal, can occur in patients treated with antibodies blocking the programmed cell death protein-1 / programmed death-ligand 1 (PD-1/PD-L1) pathway, including toripalimab.
While immune-related adverse reactions usually occur during treatment with PD-1/PD-L1 blocking antibodies, symptoms can also manifest after discontinuation of treatment. Immune-related adverse reactions may occur in any organ or tissue and may affect more than one body system simultaneously.
Important immune-related adverse reactions listed in this section are not inclusive of all possible severe and fatal immune-related reactions. Early identification and management of immune-related adverse reactions are essential to ensure safe use of PD-1/PD-L1 blocking antibodies.
Patients should be monitored closely for symptoms and signs of immune-related adverse reactions. Clinical chemistries including liver enzymes, creatinine, and thyroid function should be evaluated at baseline and periodically during treatment.
In cases of suspected immune-related adverse reactions, appropriate workup should be initiated to exclude alternative aetiologies, including infection. Medical management should be instituted promptly, including specialty consultation as appropriate.
2). If treatment with toripalimab should be withheld or permanently discontinued, administer systemic corticosteroid therapy (1 to 2 mg/kg/day prednisone or equivalent) until improvement to Grade 1 or less. , methylprednisolone 1 g/day intravenously for 3–5 days).
Upon improvement to Grade 1 or less, initiate corticosteroid taper. Consider administration of other systemic immunosuppressants in patients whose immune-related adverse reactions are not controlled with corticosteroid therapy. Hormone replacement therapy for endocrinopathies should be instituted as warranted.
1.
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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.
2). Renal impairment No dose adjustment is needed for patients with mild or moderate renal impairment. 2). Hepatic impairment No dose adjustment is recommended for patients with mild hepatic impairment. 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. 22 micron pore size). 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 infusion line. When administered on the same day as chemotherapy, LOQTORZI should be administered prior to chemotherapy. 6.
Adverse reactions in patients treated with toripalimab Infections and infestations Very common upper respiratory tract infection Common pneumonia, urinary tract infection, infection (not specified by site or pathogen), ear infections1, dental and oral soft tissue infections2, herpes simplex/herpes zoster infection Uncommon conjunctivitis, gingivitis, skin and subcutaneous tissue infections3, skin infections, bacteraemia, toe infection, paronychia/dermatophytosis of nail, osteomyelitis, pulmonary tuberculosis Rare diverticulitis, hepatitis B reactivation, muscle abscess, urosepsis Neoplasms benign, malignant and unspecified (incl cysts and polyps) Common tumour pain Uncommon tumour haemorrhage, tumour rupture Rare myelodysplastic syndrome Blood and lymphatic system disorders Very common anaemia, leukopenia, neutropenia, thrombocytopenia Common leukocytosis, neutrophilia, lymphopenia Uncommon coagulopathy, bone marrow failure, myelosuppression Rare eosinopenia, pancytopenia Immune system disorders Uncommon hypersensitivity/serum sickness Endocrine disorders Very common hypothyroidism Common hyperthyroidism Uncommon thyroiditis, adrenal insufficiency/cortisol decreased, thyroid disorder (excluding hypothyroidism and hyperthyroidism), hypophysitis/empty sella syndrome Rare hyperparathyroidism, hypopituitarism Metabolism and nutrition disorders Very common decreased appetite, hyponatraemia, weight decreased, hypoproteinaemia, hyperglycaemia, hypokalaemia, hyperuricaemia/gout Common hypochloraemia, hypomagnesaemia, hypocalcaemia, hypophosphataemia, hyperkalaemia, hypercalcaemia, hypoglycaemia, dehydration Uncommon electrolyte imbalance, hyperphosphataemia, hypernatraemia, acid base disorder4, diabetes mellitus, malnutrition, hypovolaemia Rare hypolipidaemia Psychiatric disorders Common hypersomnia/insomnia Uncommon depression/dysphoria, anxiety Rare mental disorder, tic Nervous system disorders Very common neuropathy5 Common dizziness, headache, neurotoxicity, dysgeusia Uncommon somnolence, syncope, encephalopathy, epilepsy, tremor, memory impairment, dysarthria, nervous system disorder, speech disorder Rare disturbance in attention, haemorrhage intracranial, paraplegia 11 Eye disorders Common vision blurred Uncommon eye inflammation6, eye movement disorder, papilloedema Rare blepharochalasis, glaucomatocyclitic crises, hypermetropia, retinal haemorrhage Ear and labyrinth disorders Common ear disorder7 Uncommon vertigo, deafness Cardiac disorders Very common arrhythmia8 Uncommon pericardial effusion, cardiac failure/cardiac dysfunction, myocarditis/immune-mediated myocarditis, myocardial injury/myocardial ischaemia, cardiac discomfort Rare aortic valve disease, cardiac disorder Vascular disorders Common hypertension, hypotension/orthostatic hypotension, embolism and thrombosis Uncommon phlebitis Rare aortic aneurysm, flushing Respiratory, thoracic and mediastinal disorders Very common cough Common […]
Treatment with toripalimab may be restarted within 12 weeks after last dose of toripalimab if the adverse reaction recovers to Grade ≤1 and corticosteroid dose has been reduced to ≤ 10 mg prednisone or equivalent per day. 8). , endocrinopathies and skin reactions) are discussed below.
In patients with pre-existing autoimmune disease (AID), data from observational studies suggest that the risk of immune-mediated adverse reactions following immune-checkpoint inhibitor therapy may be increased as compared with the risk in patients without pre-existing AID.
In addition, flares of the underlying AID were frequent, but the majority were mild and manageable. 8). Patients should be monitored for signs and symptoms of pneumonitis. Suspected pneumonitis should be confirmed with radiographic imaging and other causes excluded.
4 above). 8). 4 above). In cases of corticosteroid-refractory colitis, consider repeating infectious workup to exclude alternative aetiologies. Cytomegalovirus (CMV) infection/reactivation has been reported in patients receiving other PD-1/PD-L1 blocking antibodies with corticosteroid-refractory immune-related colitis.
8). Patients should be monitored for changes in liver function periodically and as indicated, based on clinical evaluation. 4 above). 8). Patients should be monitored for clinical signs and symptoms of adrenal insufficiency. 2). 8). Hypophysitis can present with acute symptoms associated with mass effects such as headache, photophobia, or visual field defects.
Hypophysitis can cause hypopituitarism. Patients should be monitored for signs and symptoms of hypophysitis. 2). 8). Patients should be monitored for signs and symptoms of thyroid disorders prior to and periodically during treatment, and as indicated based on […]