Source: European Medicines Agency (EU) Revision Year: 2024 Publisher: SFL Pharmaceuticals Deutschland GmbH, Marie-Curie-Strasse 8, 79539 Loerrach, Germany
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
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, including serious and fatal cases, have occurred in patients receiving sugemalimab. Immune-related adverse reactions can occur after discontinuation of treatment. In clinical studies, most immune-related adverse reactions were reversible and managed with interruptions of sugemalimab treatment, administration of corticosteroids and/or supportive care. Immune-related adverse reactions affecting more than one body system can occur simultaneously.
For suspected immune-related adverse reactions, ensure adequate evaluation to confirm aetiology or exclude other causes. Based on the severity of the adverse reaction, withhold, or permanently discontinue sugemalimab and consider administration of corticosteroids. Upon improvement to Grade 1 or 0, initiate corticosteroid taper and continue to taper for at least 1 month. Restart sugemalimab if the adverse reaction remains at Grade 1 or 0 following corticosteroid tapering. If another episode of the severe adverse reaction occurs, permanently discontinue sugemalimab (see sections 4.2 and 4.4).
Immune-related pneumonitis has been reported in patients receiving sugemalimab (see section 4.8). Patients should be monitored for signs and symptoms of pneumonitis. Suspected pneumonitis should be confirmed with radiographic imaging to exclude other causes. For Grade 2 pneumonitis, treatment with sugemalimab should be withheld, and 1 to 2 mg/kg/day prednisone or equivalent should be administered. If symptoms improve to Grade 0 or 1, corticosteroids should be tapered for at least 1 month. Treatment with sugemalimab may be resumed if the event remains at Grade 0 to 1 following corticosteroid tapering. Sugemalimab should be permanently discontinued for severe (Grade 3), life-threatening (Grade 4) or recurrent moderate (Grade 2) pneumonitis (see section 4.2) and 1 to 2 mg/kg/day of methylprednisolone or equivalent should be administered.
Immune-related severe skin reactions have been reported in patients receiving sugemalimab (see section 4.8). Patients should be monitored for suspected severe skin reactions and other causes should be excluded. For Grade 3 skin reactions, sugemalimab should be withheld until recovery to Grade 0 to 1 and 1 to 2 mg/kg/day of prednisone or equivalent should be administered. Sugemalimab should be permanently discontinued for Grade 4 skin reactions, and corticosteroids should be administered.
Cases of Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) have been reported in patients receiving PD-1/PD-L1 immune checkpoint inhibitors. For suspected SJS or TEN, sugemalimab should be withheld and the patient should be referred to a specialised unit for assessment and treatment. For confirmed SJS or TEN, sugemalimab should be permanently discontinued (see section 4.2).
Caution should be used when considering the use of sugemalimab in a patient who has previously experienced a severe or life-threatening skin adverse reaction on prior treatment with other immune- stimulatory anti-cancer agents.
Immune-related colitis has been reported in patients receiving sugemalimab monotherapy (see section 4.8). Patients should be monitored for signs and symptoms of colitis and other causes should be excluded. For Grade 2 colitis, treatment with sugemalimab should be withheld, and 1 to 2 mg/kg/day prednisone or equivalent should be administered. For Grade 3 colitis, treatment with sugemalimab should be withheld, and 1 to 2 mg/kg/day methylprednisolone or equivalent should be administered. Treatment with sugemalimab may be resumed if the event remains at Grade 0 to 1 following corticosteroid tapering. Sugemalimab should be permanently discontinued for life-threatening (Grade 4) or recurrent Grade 3 colitis (see section 4.2), and 1 to 2 mg/kg /day methylprednisolone or equivalent should be administered.
Immune-related hepatitis has occurred in patients receiving sugemalimab (see section 4.8). Patients should be monitored for abnormal liver tests prior to and as clinically indicated during treatment with sugemalimab. For Grade 2 hepatitis, treatment with sugemalimab should be withheld, and 1 to 2 mg/kg/day prednisone or equivalent should be administered. Treatment with sugemalimab may be resumed if the event remains at Grade 0 or 1 following corticosteroid tapering. Sugemalimab should be permanently discontinued for severe (Grade 3) or life-threatening (Grade 4) hepatitis (see section 4.2), and 1 to 2 mg/kg/day methylprednisolone or equivalent should be administered.
Immune-related nephritis has been reported in patients receiving sugemalimab (see section 4.8). Patients should be monitored for abnormal renal function tests prior to and periodically during treatment with sugemalimab and managed as recommended. For Grade 2 nephritis, treatment with sugemalimab should be withheld, and 1 to 2 mg/kg/day prednisone or equivalent should be administered. For Grade 2 nephritis, treatment with sugemalimab may be resumed if the event remains at Grade 0 to 1 following corticosteroid tapering. Sugemalimab should be permanently discontinued for severe (Grade 3) or life-threatening (Grade 4) nephritis (see section 4.2) and 1 to 2 mg/kg/day methylprednisolone or equivalent should be administered.
Immune-related endocrinopathies including hyperthyroidism, hypothyroidism, thyroiditis, diabetes mellitus, adrenal insufficiency and hypophysitis have been reported in patients receiving sugemalimab treatment (see section 4.8).
Thyroid disorders have been reported in patients receiving sugemalimab, including hyperthyroidism, hypothyroidism and thyroiditis. These can occur at any time during treatment; therefore, patients should be monitored for changes in thyroid function and clinical signs and symptoms of thyroid disorders (at the start of treatment, periodically during treatment, and as indicated based on clinical evaluation).
For symptomatic hypothyroidism, sugemalimab should be withheld and thyroxine replacement therapy should be initiated as needed. For symptomatic hyperthyroidism sugemalimab should be withheld and an anti-thyroid medication should be initiated as needed. Treatment with sugemalimab may be resumed when symptoms are controlled, and thyroid function is improving. Sugemalimab should be permanently discontinued for life-threatening (Grade 4) hypothyroidism and hyperthyroidism (see section 4.2).
Type-1 diabetes mellitus has been reported in patients receiving sugemalimab. Patients should be monitored for hyperglycaemia or other signs and symptoms of diabetes and managed with insulin as clinically indicated. For type-1 diabetes mellitus associated with Grade 3 hyperglycaemia sugemalimab should be withheld. Treatment with sugemalimab may be resumed if metabolic control is achieved on insulin replacement therapy. Sugemalimab should be permanently discontinued for type-1 diabetes mellitus associated with life-threatening (Grade 4) hyperglycaemia (see section 4.2).
Adrenal insufficiency has been reported in patients receiving sugemalimab. Hypophysitis has also been reported in patients receiving sugemalimab. Patients should be monitored for signs and symptoms of adrenal insufficiency or hypophysitis (including hypopituitarism) and other causes should be excluded. For Grade 2 adrenal insufficiency or for Grade 2 or 3 hypophysitis, treatment with sugemalimab should be withheld (see section 4.2), and treatment with sugemalimab may be resumed if the event improves to Grade 0 to 1. Corticosteroids to treat adrenal insufficiency or hypophysitis and other hormone replacement therapy (such as thyroxine in patients with hypophystitis) should be administered as clinically indicated. Pituitary function and hormone levels should be monitored to ensure appropriate hormone replacement. Sugemalimab should be permanently discontinued for Grade 3 or 4 adrenal insufficiency and for Grade 4 hypophysitis.
Immune-related myositis has been reported in patients receiving sugemalimab at very low frequency or with delayed onset of symptoms (see section 4.8). Patients should be monitored for potential myositis and other causes should be excluded. If a patient develops signs and symptoms of myositis, close monitoring should be implemented, and the patient referred to a specialist for assessment and treatment without delay. Based on the severity of the adverse reaction, withhold, or permanently discontinue sugemalimab (see section 4.2). For Grade 2 myositis, 1 to 2 mg/kg/day prednisone or equivalent should be administered. For Grade 3 or 4 myositis, methylprednisolone 1 to 2 mg/kg/day or equivalents should be administered.
Immune-related myocarditis has been reported in patients receiving sugemalimab (see section 4.8). Monitor patients for suspected myocarditis and exclude other causes. If myocarditis is suspected, treatment with sugemalimab should be withheld, prompt initiation of systemic corticosteroids at a dose of 1 to 2 mg/kg bw/day of prednisone or equivalent should be started, and prompt cardiology consultation with diagnostic workup according to current clinical guidelines should be initiated. Once a diagnosis of myocarditis is established, sugemalimab should be permanently discontinued for Grade 2, 3 or 4 myocarditis (see section 4.2).
Immune-related pancreatitis has been reported in patients receiving sugemalimab (see section 4.8). Patients should be closely monitored for signs of symptoms suggestive of acute pancreatitis and for increases in serum amylase or lipase. For Grade 2 pancreatitis, treatment with sugemalimab should be withheld, and 1 to 2 mg/kg/day prednisone or equivalent should be administered. For Grade 2 pancreatitis, treatment with sugemalimab may be resumed if the event remains at Grade 0 to 1 following corticosteroid tapering. Sugemalimab should be permanently discontinued for severe (Grade 3) or life-threatening (Grade 4) pancreatitis (see section 4.2) and 1 to 2 mg/kg/day methylprednisolone or equivalent should be administered.
Immune-related ocular toxicities have been reported in patients receiving sugemalimab (see section 4.8). For Grade 2 ocular toxicities, treatment with sugemalimab should be withheld, and 1 to 2 mg/kg/day prednisone or equivalent should be administered. For Grade 2 ocular toxicities, treatment with sugemalimab may be resumed if the event remains at Grade 0 to 1 following corticosteroid tapering. Sugemalimab should be permanently discontinued for severe (Grade 3) or life-threatening (Grade 4) ocular toxicities (see section 4.2) and 1 to 2 mg/kg/day methylprednisolone or equivalent should be administered.
Other immune-related adverse reactions including immune-related upper gastrointestinal disorders, immune-related arthritis, immune-related pancytopenia/bicytopenia, immune-related meningoencephalitis/encephalitis, immune-related Guillain-Barre syndrome/demyelination, and immune-related rhabdomyolysis/myopathy were reported in patients receiving sugemalimab (see section 4.8).
Patients should be monitored for suspected immune-related adverse reactions, adequate evaluation should be performed to confirm aetiology or exclude other causes. Based on the severity of the adverse reaction, withhold, or permanently discontinue sugemalimab (see section 4.2). For Grade 2 immune-mediated adverse reactions, 1 to 2 mg/kg/day prednisone or equivalent should be administered. For Grade 3 or 4 adverse reactions, methylprednisolone 1 to 2 mg/kg/day or equivalents should be administered.
Infusion-related reactions including anaphylactic reaction, hyperhidrosis, pyrexia, chills, erythema and rash, have been reported in patients receiving sugemalimab (see section 4.8). Patients should be closely monitored for clinical signs and symptoms of an infusion reaction and managed as recommended in section 4.2.
Patients with the following conditions were excluded from clinical study: active autoimmune disease; receiving immunosuppressive treatment; live-virus vaccine administration within 28 days of the study treatment start; HIV infection, hepatitis B or hepatitis C infection; a history of interstitial lung disease or idiopathic pulmonary fibrosis.
This medicinal product contains 51.6 mg sodium per 1200 mg dose and 64.5 mg sodium per 1500 mg dose. The equivalent of 2.58% and 3.23% of the WHO recommended maximum daily intake of 2 grams for an adult.
All physicians administering sugemalimab must be familiar with the Physician Information and Management Guidelines. The physician must discuss the risks of sugemalimab therapy with the patient. The patient will be provided with the patient card and instructed by the physician to carry the card at all times.
No formal pharmacokinetic (PK) interaction studies have been conducted with sugemalimab. Since sugemalimab is cleared from the circulation through catabolism, no metabolic interactions with other medicinal products are expected.
The use of systemic corticosteroids or immunosuppressants before starting sugemalimab should be avoided because of their potential interference with the pharmacodynamic activity and efficacy of sugemalimab. However, systemic corticosteroids or other immunosuppressants can be used after starting sugemalimab to treat immune-related adverse reactions (see section 4.4).
Women of childbearing potential must be advised to avoid pregnancy during treatment with sugemalimab. Women of childbearing potential receiving sugemalimab should use reliable contraception methods during treatment and for at least 4 months after the last dose of sugemalimab (see below and section 5.3).
There are no data on the use of sugemalimab in pregnant women. Animal reproduction and developmental toxicity studies have not been conducted with sugemalimab. However, blockade of PD-L1 signalling in murine models of pregnancy has been shown to disrupt tolerance to the foetus and to increase foetal loss (see section 5.3).
Sugemalimab is not recommended during pregnancy and in women of childbearing potential not using contraception.
It is unknown whether sugemalimab is secreted in human milk. Since it is known that antibodies can be secreted in human milk, a risk to the newborns/infants cannot be excluded. A decision should be made whether to discontinue breast-feeding or to discontinue sugemalimab treatment, taking into account the benefit of breast-feeding for the child and the benefit of sugemalimab therapy for the woman.
No clinical data are available on the possible effects of sugemalimab on fertility. Animal data did not show notable effects on the male and female reproductive organs (see section 5.3).
Sugemalimab has minor influence on the ability to drive and use machines. In some patients, fatigue has been reported following administration of sugemalimab (see section 4.8). Patients experiencing fatigue should be advised not to drive and use machines until the symptoms resolved.
The safety of sugemalimab in combination with chemotherapy has been evaluated in 435 patients receiving 1200 mg every 3 weeks in clinical studies across tumour types.
The incidence of adverse reactions in this patient population was 95.6%. The most common adverse reactions (≥10%) were anaemia (77.5%), aspartate aminotransferase increased (34.0%), alanine aminotransferase increased (32.0%), rash (26.2%), hyperlipidaemia (21.6%), hyperglycaemia (18.4%), hyponatraemia (16.8%), hypokalaemia (15.6%), proteinuria (14.0%), abdominal pain (13.8%), fatigue (13.3%), arthralgia (12.2%), hypoaesthesia (11.5%), hypothyroidism (10.3%), and hypocalcaemia (10.1%).
The incidence of Grade ≥3 adverse reactions in these patients was 33.1%. The most common Grade ≥3 adverse reactions (>1%) were anaemia (17.5%), hyponatraemia (4.4%), hypokalaemia (3.0%), hyperlipidaemia (2.3%), amylase increased (2.1%), hepatic function abnormal (1.8%), hyperglycaemia (1.6%), fatigue (1.4%), rash (1.4%), blood alkaline phosphatase increased (1.1%), and pneumonitis (1.1%).
Adverse drug reactions observed in clinical studies of sugemalimab in combination with chemotherapy or sugemalimab monotherapy are listed in Table 2. These reactions are presented by system organ class and by frequency. Frequencies are defined as: very common (≥1/10); 10 common (≥1/100 to <1/10); uncommon (≥1/1 000 to <1/100); rare (≥1/10 000 to <1/1 000) and very rare (<1/10 000). Within each frequency grouping, adverse reactions are presented in the order of decreasing frequency.
Table 2. Adverse reactions:
| Blood and lymphatic system disorders | |
| Very common | anaemia |
| Uncommon | haemolytic anaemia#, immune-related pancytopenia/bicytopenia* |
| Immune system disorders | |
| Uncommon | anaphylactic reaction, anti-neutrophil cytoplasmic antibody positive vasculitis# |
| Injury, poisoning and procedural complications | |
| Common | infusion related reaction |
| Endocrine disorders | |
| Very common | hypothyroidism |
| Common | hyperthyroidism |
| Uncommon | immune-related hypophysitis*, adrenal insufficiency, immune-mediated thyroiditis |
| Metabolism and nutrition disorders | |
| Very common | hyperlipidaemiaa, hyperglycaemiab, hyponatraemia, hypokalaemia, hypocalcaemiac |
| Common | hyperuricaemiad, hypochloraemiae, hypomagnesaemia, diabetes |
| Uncommon | dyslipidaemia |
| Nervous system disorders | |
| Very common | hypoaesthesiaf |
| Common | neuropathy peripheral |
| Uncommon | immune-mediated encephalitis, immune-related Guillain-Barre syndrome/demyelination* |
| Cardiac disorders | |
| Common | tachycardiag |
| Uncommon | immune-mediated myocarditis |
| Eye disorders | |
| Common | conjunctivitis, dry eye |
| Respiratory, thoracic, and mediastinal disorders | |
| Common | pneumonitish |
| Gastrointestinal disorders | |
| Very common | abdominal paini |
| Common | stomatitisj, dry mouth |
| Uncommon | pancreatitis, proctitis, colitis# |
| Hepatobiliary disorders | |
| Common | hepatic function abnormal, hepatitisk |
| Skin and subcutaneous tissue disorders | |
| Very common | rashl |
| Common | skin hypopigmentationm |
| Musculoskeletal and connective tissue disorders | |
| Very common | arthralgia |
| Common | myalgia, bone pain |
| Uncommon | myositis#, immune-mediated arthritis |
| Renal and urinary disorders | |
| Very common | proteinurian |
| Common | nephritis° |
| General disorders and administration site conditions | |
| Very common | fatigue |
| Vascular disorders | |
| Common | hypertension |
| Investigations | |
| Very common | aspartate aminotransferase increased, alanine aminotransferase increased |
| Common | blood creatinine increased, blood alkaline phosphatase increased, amylase increased, blood bilirubin increasedp, blood thyroid stimulating hormone increased, blood thyroid stimulating hormone decreased, thyroxine increasedq, transaminases increased, blood creatine phosphokinase MB increased, thyroxine free decreased, tri- iodothyronine free increased, lipase increased |
| Uncommon | troponin T increased, cortisol decreased |
# Frequency estimate based on incidence in sugemalimab monotherapy study.
* Grouped terms which refer to a class effect of immune-related adverse reaction. In clinical studies of sugemalimab in combination with chemotherapy, only myelosuppression, blood corticotrophin decreased, and neuritis were observed respectively under immune-related pancytopenia/bicytopenia, hypophysitis, and Guillain-Barre syndrome/demyelination.
The following terms represent a group of related events that describe a medical condition rather than a single event:
a Hyperlipidaemia (hyperlipidaemia, hypercholesterolaemia, hypertriglyceridaemia, blood triglycerides increased)
b Hyperglycaemia (hyperglycaemia, blood glucose increased)
c Hypocalcaemia (hypocalcaemia, blood calcium decreased)
d Hyperuricaemia (hyperuricaemia, blood uric acid increased)
e Hypochloraemia (hypochloraemia, blood chloride decreased)
f Hypoaesthesia (hypoaesthesia, anaesthesia)
g Tachycardia (tachycardia, sinus tachycardia, supraventricular tachycardia, atrial tachycardia, atrial fibrillation, ventricular fibrillation)
h Pneumonitis (pneumonitis, immune-mediated lung disease, interstitial lung disease)
i Abdominal pain (abdominal pain, abdominal discomfort, abdominal distension, abdominal pain upper)
j Stomatitis (stomatitis, mouth ulceration)
k Hepatitis (hepatitis, immune-mediated hepatic disorder, immune-mediated hepatitis, drug-induced liver injury, hepatic failure)
l Rash (rash, rash maculo-papular, eczema, erythema, dermatitis, dermatitis acneiform, rash erythematous, rash pruritic, urticaria, pruritus, immune-mediated dermatitis)
m Skin hypopigmentation (skin hypopigmentation, skin depigmentation, leukoderma)
n Proteinuria (proteinuria, protein urine present)
° Nephritis (nephritis, renal impairment, renal failure, acute kidney injury)
p Blood bilirubin increased (blood bilirubin unconjugated increased, bilirubin conjugated increased)
q Thyroxine increased (thyroxine increased, thyroxine free increased))
Data for the following immune-related adverse reactions are based on information from 435 patients treated with sugemalimab in combination with chemotherapy in clinical studies. The management guidelines for these adverse reactions are described in section 4.4.
Immune-related hypothyroidism was reported in 14.3% of patients treated with sugemalimab in combination with chemotherapy. The majority of events were Grade 1 or 2 in severity reported in 9.2% and 4.8% of patients, respectively. Grade 3 hypothyroidism was reported in 0.2% of patients. No serious hypothyroidism was reported. Events led to treatment interruption and discontinuation were reported in 0.9% and 0.2% of patients, respectively. The median time to onset was 112 days (range:16 to 607 days), and the median duration was 83 days (range:1+ to 857+ days).
Immune-related hyperthyroidism was reported in 9.4% of patients treated with sugemalimab in combination with chemotherapy. All events were Grade 1 and 2 in severity reported in 8.7% and 0.7% of patients, respectively. There were no serious events, or events led to treatment interruption or discontinuation. The median time to onset was 91 days (range: 20 to 620 days), and the median duration was 44 days (range: 10 to 484+ days).
Immune-related thyroiditis was reported in 0.5% of patients treated with sugemalimab in combination with chemotherapy. All events were Grade 1 in severity. There were no serious events, or events led to treatment interruption or discontinuation. The median time to onset was 136 days (range: 105 to 167 days), and the median duration was not reached (range: 736+ to 835+ days).
Immune-related diabetes mellitus was reported in 2.8% of patients treated with sugemalimab in combination with chemotherapy. The majority of events were Grade 1 in severity reported in 2.3% of patients. Grade 2 and Grade 3 events were reported in 0.2% of patients, respectively. There were no serious events, or events led to treatment interruption or discontinuation. The median time to onset was 154 days (range: 43 to 635 days), and the median duration was 41 days (range: 2 to 307+ days).
Immune-related hypophysitis was reported in 0.9% of patients treated with sugemalimab in combination with chemotherapy. All events were Grade 1 in severity. There were no serious events, or events leading to treatment interruption or discontinuation. The median time to onset was 240.5 days (range: 112 to 754 days), and the median duration was not reached (range: 13+ to 478+ days).
Immune-related adrenal insufficiency was reported in 0.2% of patients treated with sugemalimab in combination with chemotherapy. The event occurred in a single patient, was Grade 1 in severity, and did not lead to treatment interruption nor discontinuation.
Immune-related skin adverse reactions (excluding severe) were reported in 10.6% of patients treated with sugemalimab in combination with chemotherapy. All events were Grade 1 and 2 in severity and were reported in 7.1% and 3.4% of patients, respectively. Immune-related skin adverse reaction (excluding severe) leading to treatment interruption were reported in 0.9% of patients. There were no serious events or events leading to treatment discontinuation. The median time to onset was 158 days (range: 3 to 990 days), and the median duration was 31 days (range: 1 to 950+ days).
Immune-related severe skin adverse reaction was reported in 1.6% of patients treated with sugemalimab in combination with chemotherapy. Serious events were reported in 0.5% of patients, events leading to treatment interruption were reported in 0.9% of patients, and events leading to treatment discontinuation were reported in 0.5% of patients. The median time to onset was 312 days (range: 19 to 738 days), and the median duration was 95 days (range: 12 to 522+ days).
Immune-related hepatitis was reported in 9.7% of patients treated with sugemalimab in combination with chemotherapy. Grade 1, 2, 3 and 4 events were reported in 5.7%, 1.4%, 2.3% and 0.2% of patients, respectively. Serious events were reported in 2.5% of patients. Events leading to treatment interruption and discontinuation were reported in 2.3% and 1.6% of patients, respectively. The median time to onset was 53 days (range: 1 to 717 days), and the median duration was 25 days (range: 2 to 777+ days).
Immune-related pancreatitis was reported in 3.4% of patients treated with sugemalimab in combination with chemotherapy. Grade 1, 2, 3 and 4 events were reported in 1.6%, 0.7%, 0.9% and 0.2% of patients, respectively. Serious events were reported in 0.2% of patients. Events leading to treatment interruption were reported in 0.5% of patients. No events leading to treatment discontinuation were reported. The median time to onset was 42 days (range: 20 to 629 days), and the median duration was 53 days (range: 2 to 958+ days).
Immune-related pneumonitis was reported in 3.0% of patients treated with sugemalimab in combination with chemotherapy. Grade 1, 2, 3 and 5 events were reported in 0.2%, 1.6%, 0.9% and 0.2% of patients, respectively. Serious events were reported in 2.1% of patients. Events led to treatment interruption and discontinuation were reported in 1.1% and 1.8% of patients, respectively. The median time to onset was 165 days (range: 6 to 903 days), and the median duration was 229 days (range: 18 to 558+ days).
Immune-related myositis was reported in 2.5% of patients treated with sugemalimab in combination with chemotherapy. All events were Grade 1 and 2 in severity and were reported in 0.9% and 1.6% of patients, respectively. Events led to treatment interruption were reported in 0.2% of patients. There were no serious events or events that led to treatment discontinuation. The median time to onset was 135 days (range: 3 to 649 days), and the median duration was 42 days (range: 2 to 655+ days).
Immune-related colitis was reported in 2.5% of patients treated with sugemalimab in combination with chemotherapy. All events were Grade 1 and 2 in severity and were reported in 1.1% and 1.4% of patients, respectively. Events leading to treatment interruption were reported in 0.2% of patients. No serious events or events leading to treatment discontinuation were reported. The median time to onset was 103 days (range: 1 to 682 days), and the median duration was 9 days (range: 2 to 445+ days).
Immune-related myocarditis was reported in 2.1% of patients treated with sugemalimab in combination with chemotherapy. All events were Grade 1 and 2 in severity and were reported in 1.1% and 0.9% of patients, respectively. Serious events were reported in 0.7% of patients. Events leading to treatment interruption and discontinuation were reported in 1.1% and 0.2% of patients, respectively. The median time to onset was 221 days (range: 41 to 442 days), and the median duration was 23 days (range: 1 to 429+ days).
Immune-related nephritis (including renal failure) was reported in 1.8% of patients treated with sugemalimab in combination with chemotherapy. Grade 1, 2 and 3 events were reported in 0.9%, 0.2% and 0.7% of patients, respectively. Serious events were reported in 0.9% of patients. Events leading to treatment interruption and discontinuation were reported in 0.5% and 0.2% of patients, respectively.
The median time to onset was 227.5 days (range: 26 to 539 days), and the median duration was 51.5 days (range: 5 to 543+ days).
Immune-related ocular toxicities were reported in 1.4% of patients treated with sugemalimab in combination with chemotherapy. All events were Grade 1 and 2 in severity and were reported in 0.7% and 0.7%, respectively. No serious events were reported. Events leading to treatment interruption and discontinuation were reported in 0.5% and 0.2% of patients, respectively. The median time to onset was 235.5 days (range: 137 to 482 days), and the median duration was 9.5 days (range: 1 to 181 days).
Immune-related upper gastrointestinal disorder was reported in 0.9% of patients treated with sugemalimab in combination with chemotherapy. Grade 1, 2 and 3 events were reported in 0.5%, 0.2% and 0.2% of patients, respectively. Serious events were reported in 0.2% of patients. No events leading to treatment interruption or discontinuation were reported. The median time to onset was 146 days (range: 82 to 204 days), and the median duration was 385 days (range: 42 to 710 days).
Immune-related arthritis was reported in 0.9% of patients treated with sugemalimab in combination with chemotherapy. All events were Grade 1 and 2 in severity and were reported in 0.2% and 0.7% of patients, respectively. No serious events were reported. Events leading to treatment interruption were reported in 0.5% of patients. No events led to treatment discontinuation were reported. The median time to the onset was 173.5 days (range: 96 to 257 days), and the median duration was 98 days (range: 50 to 958+ days).
Immune-related pancytopenia/bicytopenia was reported in 0.2% of patients treated with sugemalimab in combination with chemotherapy. The event occurred in a single patient, was Grade 4 in severity and serious, and did not lead to treatment interruption or discontinuation.
Immune-related meningoencephalitis/encephalitis was reported in 0.2% of patients treated with sugemalimab in combination with chemotherapy. The event occurred in a single patient, was of Grade 2 in severity and led to treatment discontinuation.
Immune-related Guillain-Barre syndrome/demyelination was reported in 0.2% of patients treated with sugemalimab in combination with chemotherapy. The event occurred in a single patient, was of Grade 2 in severity and serious, and did not lead to treatment interruption or discontinuation.
Immune-related rhabdomyolysis/myopathy was reported in 0.2% of patients treated with sugemalimab in combination with chemotherapy. The event occurred in a single patient, was of with Grade 2 in severity and led to treatment interruption.
Infusion-related adverse reactions were reported in 4.4% of patients treated with sugemalimab in combination with chemotherapy. Reported events were infusion related reaction (0.9%), anaphylactic reaction (0.7%), hyperhidrosis (0.5%), pyrexia (0.5%), erythema, rash, rash maculo-papular, skin depigmentation, skin disorder, skin swelling, chills, oedema peripheral, tenderness, nausea, breath holding and throat irritation (0.2% each), respectively.
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products in the same intravenous line except those mentioned in section 6.6.
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