Sugemalimab interacts in the following cases:
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.
Sugemalimab has not been studied in patients with severe renal impairment. Sugemalimab must be administered with caution in patients with severe renal impairments.
Sugemalimab has not been studied in patients with moderate or severe hepatic impairment. Sugemalimab must be administered with caution in patients with moderate or severe hepatic impairment.
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.
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.
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.
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.
Sugemalimab has minor influence on the ability to drive and use machines. In some patients, fatigue has been reported following administration of sugemalimab. 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 the table below. 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.
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.
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.
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