Adcetris

Adcetris

brentuximab vedotin

Manufacturer:

Takeda

Distributor:

DKSH
Concise Prescribing Info
Contents
Brentuximab vedotin
Indications/Uses
Frontline treatment of adult patients w/ previously untreated CD30+ advanced classical Hodgkin lymphoma (cHL) in combination w/ doxorubicin, vinblastine & dacarbazine (AVD). Adult patients w/ CD30+ Hodgkin lymphoma (HL) at increased risk of relapse or progression following autologous stem cell transplant (ASCT); relapsed or refractory CD30+ HL following ASCT or at least 2 prior therapies when ASCT or multi-agent chemotherapy is not a treatment option; relapsed or refractory systemic anaplastic large cell lymphoma (sALCL); CD30+ cutaneous T-cell lymphoma (CTCL) after at least 1 prior systemic therapy. Frontline sALCL or other CD30-expressing peripheral T-cell lymphomas (PTCL), in combination w/ chemotherapy.
Dosage/Direction for Use
Previously untreated HL In combination w/ chemotherapy AVD, 1.2 mg/kg IV infusion over 30 min on day 1 & 15 of each 28-day cycle for 6 cycles. HL at increased risk of relapse or progression following ASCT; CTCL 1.8 mg/kg IV infusion over 30 min every 3 wk, & should be given for up to 16 cycles. Relapsed or refractory HL/sALCL 1.8 mg/kg IV infusion over 30 min every 3 wk. Should be given for a min of 8 cycles & up to a max of 16 cycles (approx 1 yr), for patient who achieves stable disease. Frontline PTCL In combination w/ chemotherapy [cyclophosphamide, doxorubicin, & prednisone (CHP)]: 1.8 mg/kg IV infusion over 30 min every 3 wk for 6-8 cycles. Primary prophylaxis w/ growth factor support (G-SF) is recommended beginning w/ the 1st dose. Hepatic impairment Monotherapy: Initially 1.2 mg/kg IV infusion over 30 min every 3 wk. Mild hepatic impairment Combination therapy w/ AVD: Initially 0.9 mg/kg (max: 90 mg) IV infusion over 30 min every 2 wk. Combination therapy w/ CHP: Initially 1.2 mg/kg IV infusion over 30 min every 3 wk.  Severe renal impairment Monotherapy: Initially 1.2 mg/kg IV infusion over 30 min every 3 wk.
Contraindications
Hypersensitivity. Combined use w/ bleomycin causes pulmonary toxicity.
Special Precautions
Not to be administered as an IV push or bolus. Monitor complete blood counts prior to administration of each treatment dose. Monitor patients during & after infusion. Closely monitor for new or worsening neurological, cognitive or behavioural signs or symptoms suggestive of progressive multifocal leukoencephalopathy (PML); permanently discontinue if diagnosis of PML is confirmed. Potentially fatal acute pancreatitis; closely monitor for new or worsening abdominal pain suggestive of acute pancreatitis; discontinue if a diagnosis of acute pancreatitis is confirmed. Emergence of possible serious & opportunistic infections; immediate & delayed infusion-related reactions. Immediately & permanently discontinue if anaphylaxis occurs. Perform prompt diagnostic evaluation in the event of new or worsening pulmonary or GI symptoms. Patients w/ rapidly proliferating tumour & high tumour burden at risk of tumour lysis syndrome. Monitor for symptoms of neuropathy; consider dose modifications if neuropathy develops during treatment. Patients experiencing new or worsening peripheral neuropathy may require a delay & a change in dose or discontinuation of treatment. Manage as needed by dose modifications or discontinuation if Grade 3 or 4 neutropenia develops; primary prophylaxis w/ G-CSF is recommended for all patients beginning w/ the 1st dose, in the treatment of previously untreated PTCL. Febrile neutropenia. Discontinue use if Stevens-Johnson syndrome & toxic epidermal necrolysis occurs. Hepatotoxicity; routinely monitor liver function. Closely monitor serum glucose levels. Patient w/ elevated BMI w/ or w/o history of DM; on controlled Na-diet. Patients w/ CD30+ CTCL. May have a minor influence on the ability to drive & use machines. Avoid use in combination w/ chemotherapy in patients w/ severe renal impairment, or moderate & severe hepatic impairment. Renal & hepatic impairment. Women of childbearing potential should use 2 methods of contraception during & until 6 mth after treatment. Men should not father a child during therapy & for up to 6 mth after last dose. Pregnancy & lactation. Childn <18 yr.
Adverse Reactions
Infection, upper resp tract infection; neutropenia; peripheral sensory/motor neuropathy; cough, dyspnoea; nausea, vomiting, constipation, abdominal pain; rash; arthralgia, myalgia; fatigue, pyrexia; decreased wt. Pneumonia, herpes simplex, oral candidiasis; thrombocytopenia; hyperglycaemia; increased ALT/AST; chills. Anemia, pruritus, alopecia, dizziness, back pain, infusion related reactions. Diarrhoea, herpes zoster; febrile neutropenia, decreased appetite, stomatitis, increased ALT, bone pain, insomnia, sepsis/septic shock.
Drug Interactions
May increase the incidence of neutropenia w/ strong CYP3A4 & P-gp inhibitors. Reduced exposure to monomethyl auristatin E (MMAE) w/ strong CYP3A4 inducer eg, rifampicin. Co-administration w/ bleomycin is contraindicated.
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 conc for soln for infusion 50 mg
Packing/Price
1's
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