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Adcetris is a brand name for Brentuximab Vedotin. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Hodgkin lymphoma ADCETRIS is indicated for adult patients with previously untreated CD30+ Stage III or IV Hodgkin lymphoma (HL) in combination with doxorubicin, vinblastine and dacarbazine (AVD) (see sections 4.2 and 5.1). ADCETRIS is indicated for adult patients with previously untreated CD30+ Stage IIB with risk…
Verbatim from this product's EMA label. Tap a section to expand.
ADCETRIS should be administered under the supervision of a physician experienced in the use of anti-cancer agents. 1). 4). Refer to the summary of product characteristics (SmPC) of chemotherapy agents given in combination with ADCETRIS for patients with previously untreated HL.
1). 4). Pretreatment with dexamethasone for 4 days before the first cycle of chemotherapy is recommended for patients > 40 years of age or at physician’s discretion. An antibiotic prophylaxis must be given 3 x/week during the whole duration of chemotherapy.
Refer to Table 4 for dosing recommendations for chemotherapy agents given in combination with ADCETRIS for patients with previously untreated HL. 8 mg/kg administered as an intravenous infusion over 30 minutes every 3 weeks. ADCETRIS treatment should start following recovery from ASCT based on clinical judgment.
1). 8 mg/kg administered as an intravenous infusion over 30 minutes every 3 weeks. 8 mg/kg administered as an intravenous infusion over 30 minutes every 3 weeks. 1). 4). 1). 1). 4). Refer to the SmPCs of chemotherapy agents given in combination with ADCETRIS for patients with previously untreated sALCL.
8 mg/kg administered as an intravenous infusion over 30 minutes every 3 weeks. 8 mg/kg administered as an intravenous infusion over 30 minutes every 3 weeks. 1). 4). 1). 8 mg/kg administered as an intravenous infusion over 30 minutes every 3 weeks.
1). 6). 4). 4). 5 Dose adjustments Neutropenia If neutropenia develops during treatment it should be managed by dose delays or dose adjustment in subsequent cycles. 4). 0 x 109/L) Continue with the same dose and schedule. 5 x 109/L) Withhold dose until toxicity returns to ≤ Grade 2 or baseline then resume treatment at the same dose and scheduleb.
Consider G-CSF or GM-CSF in subsequent cycles for patients who develop Grade 3 or Grade 4 neutropenia. a. 0; see neutrophils/granulocytes; LLN = lower limit of normal. b. Patients who develop Grade 3 or Grade 4 lymphopenia may continue treatment without interruption.
5 x 109/L) Primary prophylaxis with G-CSF, beginning with the […]
Summary of the safety profile The safety profile of ADCETRIS is based on available clinical trial data, the Named Patient Program (NPP), and post-marketing experience to date. Frequencies of adverse reactions described below and in Table 7 have been determined based on data generated from clinical studies.
1) the most frequent adverse reactions (≥ 10%) were infections, peripheral sensory neuropathy, nausea, fatigue, diarrhoea, pyrexia, neutropenia, upper respiratory tract infection, arthralgia, rash, cough, vomiting, pruritus, peripheral motor neuropathy, infusion-related reactions, constipation, dyspnoea, myalgia, weight decreased, and abdominal pain.
Serious adverse drug reactions occurred in 12% of patients. The frequency of unique serious adverse drug reactions was ≤ 1%. Adverse events led to treatment discontinuation in 24% of patients receiving ADCETRIS. 1) were consistent with those observed in the combined pivotal phase 2 studies, with the exception of peripheral motor neuropathy, which had a higher incidence (28% vs.
9% in the pivotal phase 2 studies) and was primarily Grade 2. Patients also had a higher incidence of arthralgia, Grade 3 anaemia, and back pain compared to patients observed in the combined pivotal phase 2 studies. 1) were consistent with the safety profile of the pivotal clinical studies.
Combination therapy (AVD/CHP) For safety information of chemotherapy agents given in combination with ADCETRIS (doxorubicin, vinblastine and dacarbazine (AVD) or cyclophosphamide, doxorubicin and prednisone (CHP)), refer to their summary of product characteristics.
In the studies of ADCETRIS as combination therapy in 662 patients with previously untreated advanced HL (C25003) and 223 patients with previously untreated CD30+ peripheral T-cell lymphoma (PTCL) (SGN35-014), the most common adverse reactions (≥ 10%) were: infections, neutropenia, peripheral sensory neuropathy, nausea, constipation, vomiting, diarrhoea, fatigue, pyrexia, alopecia, anaemia, weight decreased, stomatitis, febrile neutropenia, abdominal pain, decreased appetite, insomnia, bone pain, rash, cough, dyspnoea, arthralgia, myalgia, back pain, peripheral motor neuropathy, upper respiratory tract infection, and dizziness.
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. 10 Progressive multifocal leukoencephalopathy John Cunningham virus (JCV) reactivation resulting in progressive multifocal leukoencephalopathy (PML) and death can occur in ADCETRIS-treated patients.
PML has been reported in patients who received this treatment after receiving multiple prior chemotherapy regimens. PML is a rare demyelinating disease of the central nervous system that results from reactivation of latent JCV and is often fatal.
Patients should be closely monitored for new or worsening neurological, cognitive, or behavioural signs or symptoms, which may be suggestive of PML. ADCETRIS should be held for any suspected case of PML. Suggested evaluation of PML includes neurology consultation, gadolinium-enhanced magnetic resonance imaging of the brain and cerebrospinal fluid analysis for JCV DNA by polymerase chain reaction or a brain biopsy with evidence of JCV.
A negative JCV PCR does not exclude PML. Additional follow up and evaluation may be warranted if no alternative diagnosis can be established. ADCETRIS dosing should be permanently discontinued if a diagnosis of PML is confirmed. , cognitive, neurological, or psychiatric symptoms).
Pancreatitis Acute pancreatitis has been observed in patients treated with ADCETRIS. Fatal outcomes have been reported. Patients should be closely monitored for new or worsening abdominal pain, which may be suggestive of acute pancreatitis.
Patient evaluation may include physical examination, laboratory evaluation for serum amylase and serum lipase, and abdominal imaging, such as ultrasound and other appropriate diagnostic measures. ADCETRIS should be held for any suspected case of acute pancreatitis.
ADCETRIS should be discontinued if a diagnosis of acute pancreatitis is confirmed. Pulmonary toxicity Cases of pulmonary toxicity, including pneumonitis, interstitial lung disease, and acute respiratory distress syndrome (ARDS), some with fatal outcomes, have been reported in patients receiving ADCETRIS.
1. 5).
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In patients receiving ADCETRIS combination therapy, serious adverse reactions occurred in 34% of patients. Serious adverse reactions occurring in ≥ 3% of patients included febrile neutropenia (15%), pyrexia (5%), and neutropenia (3%).
Adverse events led to treatment discontinuation in 10% of patients. Adverse events that led to treatment discontinuation in ≥ 2% of patients included peripheral sensory neuropathy, and peripheral neuropathy. Tabulated list of adverse reactions Adverse reactions for ADCETRIS are listed by MedDRA System Organ Class and Preferred Term (see Table 7).
Within each System Organ Class, adverse reactions are listed under frequency categories of: 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 7:
Adverse reactions to ADCETRIS System organ class Adverse reactions (monotherapy) Adverse reactions (combination therapy) Infections and infestations Very common: Infectiona, upper respiratory tract infection Infectiona, upper respiratory tract infection Common: Herpes zoster, pneumonia, herpes simplex, oral candidiasis Pneumonia, oral candidiasis, sepsis/septic shock, herpes zoster Uncommon: Pneumocystis jiroveci pneumonia, staphylococcal bacteraemia, cytomegalovirus infection or reactivation, sepsis/septic shock Herpes simplex, Pneumocystis jiroveci pneumonia 16 System organ class Adverse reactions (monotherapy) Adverse reactions (combination therapy) Not known: Progressive multifocal leukoencephalopathy Blood and lymphatic system disorders Very common: Neutropenia Neutropeniaa, anaemia, febrile neutropenia Common: Anaemia, thrombocytopenia Thrombocytopenia Uncommon: Febrile neutropenia Immune system disorders Uncommon: Anaphylactic reaction Anaphylactic reaction Metabolism and nutrition disorders Very common: Decreased appetite Common: Hyperglycaemia Hyperglycaemia Uncommon: Tumour lysis syndrome Tumour lysis syndrome Psychiatric disorders Very common: Insomnia Nervous system disorders Very common: Peripheral sensory neuropathy, peripheral motor neuropathy Peripheral sensory neuropathya, peripheral motor neuropathya, dizziness Common: Dizziness Uncommon: Demyelinating polyneuropathy Respiratory, thoracic and mediastinal disorders Very common: Cough, dyspnoea Cough, dyspnoea Gastrointestinal disorders Very common: Nausea, diarrhoea, vomiting, constipation, abdominal pain Nausea, constipation, vomiting, diarrhoea, abdominal pain, stomatitis Uncommon: Pancreatitis acute Pancreatitis acute Hepatobiliary disorders Common: Alanine aminotransferase/aspartate aminotransferase (ALT/AST) increased Alanine aminotransferase/aspartate aminotransferase (ALT/AST) increased Skin and subcutaneous tissue disorders Very common: Rasha, pruritus Alopecia, rasha Common: Alopecia Pruritus Uncommon: Stevens-Johnson syndrome/toxic epidermal necrolysis Stevens-Johnson syndromeb Not known: Drug reaction with eosinophilia and systemic symptoms […]
Although a causal association with ADCETRIS has not been established, the risk of pulmonary toxicity cannot be ruled out. g. cough, dyspnoea), a prompt diagnostic evaluation should be performed and patients should be treated appropriately.
Consider holding ADCETRIS dosing during evaluation and until symptomatic improvement. Serious infections and opportunistic infections Serious infections such as pneumonia, staphylococcal bacteraemia, sepsis/septic shock (including fatal outcomes) and herpes zoster, cytomegalovirus (CMV) (reactivation) and opportunistic infections such as Pneumocystis jiroveci pneumonia and oral candidiasis have been reported in patients treated with ADCETRIS.
Patients should be carefully monitored during treatment for the emergence of possible serious and opportunistic infections. Infusion-related reactions Immediate and delayed infusion-related reactions (IRR), as well as anaphylactic reactions, have been reported.
Patients should be carefully monitored during and after infusion. If an anaphylactic reaction occurs, administration of ADCETRIS should be immediately and permanently discontinued and appropriate medical therapy should be administered.
11 If an IRR occurs, the infusion should be interrupted and appropriate medical management instituted. The infusion may be restarted at a slower rate after symptom resolution. Patients who have experienced a prior IRR should be premedicated for subsequent infusions.
Premedication may include paracetamol, an antihistamine and a corticosteroid. 8). Tumour lysis syndrome Tumour lysis syndrome (TLS) has been reported with ADCETRIS. Patients with rapidly proliferating tumour and high tumour burden are at risk of tumour lysis syndrome.
These patients should be monitored closely and managed according to best medical practice. Management of TLS may include aggressive hydration, monitoring of renal function, correction of electrolyte abnormalities, anti-hyperuricaemic therapy, and supportive care.
Peripheral neuropathy ADCETRIS may cause peripheral neuropathy, both sensory and motor. ADCETRIS-induced peripheral neuropathy is typically an effect of cumulative exposure to this medicinal product and is reversible in most cases. 8).
Patients should be monitored for symptoms of neuropathy, such as hypoesthesia, hyperesthesia, paraesthesia, discomfort, a burning sensation, neuropathic pain or weakness. 2). Haematological toxicities Grade 3 or Grade 4 anaemia, thrombocytopenia, and prolonged (≥ 1 week) Grade 3 or Grade 4 neutropenia can occur with ADCETRIS.
Complete blood counts should be monitored prior to administration of each dose. 2. 5 °C; ref CTCAE v3) has been reported with treatment with ADCETRIS. Complete blood counts should be monitored prior to administration of each dose of treatment.
Patients should be monitored closely for fever and managed according to best medical practice if febrile neutropenia develops. In combination therapy with AVD, CHP or as the BrECADD regimen, advanced age was a risk factor for febrile neutropenia.
When ADCETRIS is […]