Adcetris

Adcetris

brentuximab vedotin

Manufacturer:

Takeda

Distributor:

DKSH
Concise Prescribing Info
Contents
Brentuximab vedotin
Indications/Uses
Adults w/ previously untreated CD30+ stage IV Hodgkin lymphoma (HL) in combination w/ doxorubicin, vinblastine & dacarbazine (AVD). Adults w/ CD30+ HL at increased risk of relapse or progression following autologous stem cell transplant (ASCT). Adults w/ relapsed or refractory CD30+ HL following ASCT or at least 2 prior therapies when ASCT or multi-agent chemotherapy is not a treatment option. Adults w/ previously untreated systemic anaplastic large cell lymphoma (sALCL) in combination w/ cyclophosphamide, doxorubicin & prednisone (CHP). Adults w/ relapsed or refractory sALCL. Adults w/ CD30+ cutaneous T-cell lymphoma (CTCL) after at least 1 prior therapy.
Dosage/Direction for Use
Administer as IV infusion over 30 min. Adult Previously untreated HL In combination w/ AVD: 1.2 mg/kg as IV infusion over 30 min on days 1 & 15 of each 28-day cycle for 6 cycles. HL at increased risk of relapse or progression 1.8 mg/kg as IV infusion over 30 min every 3 wk. Patients following recovery from ASCT Receive treatment up to 16 cycles. Relapsed or refractory HL & sALCL 1.8 mg/kg as IV infusion over 30 min every 3 wk. Patients who have previously responded to treatment w/ Adcetris Retreatment: Initially 1.8 mg/kg as IV infusion over 30 min every 3 wk. Alternatively, start treatment at the last tolerated dose. Patients who achieve stable disease or better Treat w/ min of 8 cycles & up to max of 16 cycles (approx 1 yr). Previously untreated sALCL In combination w/ CHP: 1.8 mg/kg as IV infusion over 30 min every 3 wk for 6-8 cycles. CTCL 1.8 mg/kg as IV infusion over 30 min every 3 wk up to 16 cycles. Dose adjustments: Patients who develop new or worsening peripheral sensory or motor neuropathy Grade 2: Monotherapy: Withhold dose until toxicity returns to ≤ Grade 1 or baseline, then restart at 1.2 mg/kg up to max of 120 mg every 3 wk. Combination therapy w/ AVD: Reduce dose to 0.9 mg/kg up to max of 90 mg every 2 wk; w/ CHP: Motor neuropathy: Reduce dose to 1.2 mg/kg, up to max of 120 mg every 3 wk. Grade 3: Monotherapy: Withhold dose until toxicity returns to ≤ Grade 1 or baseline, then restart at 1.2 mg/kg up to max of 120 mg every 3 wk. Combination therapy w/ AVD: Withhold treatment until toxicity ≤Grade 2, then restart at 0.9 mg/kg up to max of 90 mg every 2 wk; w/ CHP: Sensory neuropathy: Reduce dose to 1.2 mg/kg, up to max of 120 mg every 3 wk. Patients w/ severe renal impairment (CrCl <30 mL/min) Monotherapy: 1.2 mg/kg up to a max of 120 mg every 3 wk, mild (CrCl >50-80 mL/min) & moderate (CrCl 30-50 mL/min) renal impairment Monotherapy: 1.8 mg/kg up to a max of 180 mg every 3 wk. Combination therapy w/ AVD: 1.2 mg/kg up to a max of 120 mg every 2 wk. Patients w/ severe (Child-Pugh C) or moderate (Child-Pugh B) hepatic impairment 1.2 mg/kg up to a max of 120 mg every 3 wk, mild (Child-Pugh A) hepatic impairment Monotherapy: 1.2 mg/kg up to a max of 120 mg every 3 wk. Combination therapy w/ AVD: 0.9 mg/kg up to a max of 90 mg every 2 wk; w/ CHP: 1.2 mg/kg as IV infusion over 30 min every 3 wk.
Contraindications
Hypersensitivity. Concomitant use w/ bleomycin.
Special Precautions
Do not administer as IV push or bolus. Closely monitor for new or worsening neurological, cognitive, or behavioural signs or symptoms, suggestive of progressive multifocal leukoencephalopathy (PML); abdominal pain suggestive of acute pancreatitis. Permanently discontinue if PML is confirmed. Discontinue if acute pancreatitis is confirmed. Perform prompt diagnostic evaluation in the event of new or worsening pulmonary (eg, cough, dyspnoea) & GI symptoms, & treat appropriately. Consider holding treatment during evaluation & until symptomatic improvement. Carefully monitor emergence of possible serious & opportunistic infections during treatment. Immediately & permanently discontinue if anaphylactic reaction occurs; carefully monitor during & after infusion. Premed w/ paracetamol, antihistamine & corticosteroid in prior infusion-related reactions experience. Tumor lysis syndrome. Patients w/ rapidly proliferating tumor & high tumour burden should be closely monitored. Delay & reduce dose or discontinue in patients experiencing new or worsening peripheral neuropathy & hepatotoxicity. Monitor complete blood counts prior to administration of each dose. Closely monitor patients if febrile neutropenia occurs. Administer primary prophylaxis w/ G-CSF in combination treatment w/ AVD or CHP. Discontinue use if Stevens-Johnson syndrome & toxic epidermal necrolysis occurs. Test liver function before initiating treatment & routinely monitor during treatment. Hyperglycemia in patients w/ elevated BMI w/ or w/o history of DM. Closely monitor serum glucose. Severe renal impairment, hepatic impairment & low serum albumin conc. Other CD30+ CTCL patients. Na-controlled diet. May have moderate influence on the ability to drive & use machines. Women of childbearing potential should use 2 methods of contraception during treatment & until 6 mth after treatment. Men are advised not to father a child during therapy & for up to 6 mth after the last dose. Pregnancy & lactation. Childn <18 yr.
Adverse Reactions
Infection, upper resp tract infection; neutropenia, anaemia, febrile neutropenia; decreased appetite; insomnia; peripheral sensory & motor neuropathy, dizziness; cough, dyspnoea; nausea, diarrhoea, vomiting, constipation, abdominal pain, stomatitis; rash, pruritus, alopecia; arthralgia, myalgia, bone pain, back pain; fatigue, pyrexia, infusion-related reactions; decreased wt. Herpes zoster, pneumonia, herpes simplex, oral candidiasis, sepsis/septic shock; anaemia, thrombocytopenia; hyperglycaemia; dizziness; increased ALT/AST; chills.
Drug Interactions
May increase the incidence of neutropenia w/ strong CYP3A4 & P-gp inhibitors. Reduced plasma conc of MMAE metabolites w/ strong CYP3A4 inducer eg, rifampicin. Unacceptable pulmonary toxicity may occur w/ bleomycin.
MIMS Class
Targeted Cancer Therapy
ATC Classification
L01XC12 - brentuximab vedotin ; Belongs to the class of monoclonal antibodies, other antineoplastic agents. Used in the treatment of cancer.
Presentation/Packing
Form
Adcetris powd for infusion 50 mg
Packing/Price
1's
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