Adcetris

Adcetris Dosage/Direction for Use

brentuximab vedotin

Manufacturer:

Takeda

Distributor:

DKSH
Full Prescribing Info
Dosage/Direction for Use
ADCETRIS should be administered under the supervision of a physician experienced in the use of anti-cancer agents.
Posology: Previously Untreated HL: The recommended dose in combination with chemotherapy (doxorubicin [A], vinblastine [V] and dacarbazine [D] [AVD]) is 1.2 mg/kg administered as an intravenous infusion over 30 minutes on days 1 and 15 of each 28-day cycle for 6 cycles (see Pharmacology: Pharmacodynamics under Actions).
Primary prophylaxis with growth factor support (G-CSF) is recommended for all patients beginning with the first dose (see Precautions).
Refer to the product insert of chemotherapy agents given in combination with ADCETRIS for frontline treatment of patients with HL.
HL at increased risk of relapse or progression following ASCT: The recommended dose is 1.8 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. These patients should receive up to 16 cycles (see Pharmacology: Pharmacodynamics under Actions).
Relapsed or refractory HL: The recommended dose is 1.8 mg/kg administered as an intravenous infusion over 30 minutes every 3 weeks.
The recommended starting dose for the retreatment of patients with relapsed or refractory HL who have previously responded to treatment with ADCETRIS is 1.8 mg/kg administered as an intravenous infusion over 30 minutes every 3 weeks. Alternatively, treatment may be started at the last tolerated dose (see Pharmacology: Pharacodynamics under Actions).
Treatment should be continued until disease progression or unacceptable toxicity (see Precautions).
Patients who achieve stable disease or better should receive a minimum of 8 cycles and up to a maximum of 16 cycles (approximately 1 year) (see Pharmacology: Pharmacodynamics under Actions).
Frontline PTCL: The recommended dose in combination with chemotherapy (cyclophosphamide [C], doxorubicin [H], and prednisone [P]; [CHP]) is 1.8 mg/kg administered as an intravenous infusion over 30 minutes every 3 weeks for 6 to 8 cycles (see Pharmacology: Pharmacodynamics under Actions).
Primary prophylaxis with growth factor support (G-CSF) is recommended for all patients beginning with the first dose (see Precautions).
Refer to the product information of chemotherapy agents given in combination with ADCETRIS for treatment of patients with previously untreated PTCL.
Relapsed or refractory sALCL: The recommended dose is 1.8 mg/kg administered as an intravenous infusion over 30 minutes every 3 weeks.
The recommended starting dose for the retreatment of patients who have previously responded to treatment with ADCETRIS is 1.8 mg/kg administered as an intravenous infusion over 30 minutes every 3 weeks. Alternatively, treatment may be started at the last tolerated dose (see Pharmacology: Pharmacodynamics under Actions).
Treatment should be continued until disease progression or unacceptable toxicity (see Precautions).
Patients who achieve stable disease or better should receive a minimum of 8 cycles and up to a maximum of 16 cycles (approximately 1 year) (see Pharmacology: Pharmacodynamics under Actions).
CTCL: The recommended dose is 1.8 mg/kg administered as an intravenous infusion over 30 minutes every 3 weeks.
Patients with CTCL should receive up to 16 cycles.
General: Do not administer as an IV push or bolus.
If the patient's weight is more than 100 kg, the dose calculation should use 100 kg (see Special precautions on disposal and other handling under Cautions for Usage).
Complete blood counts should be monitored prior to administration of each dose of this treatment (see Precautions).
Patients should be monitored during and after infusion (see Precautions).
Dose adjustments: Neutropenia: If neutropenia develops during treatment it should be managed by dose delays. See Table 13 and Table 14 as follows for appropriate dosing recommendations for monotherapy and combination therapy, respectively (see also Precautions). (See Tables 13 and 14.)

Click on icon to see table/diagram/image


Click on icon to see table/diagram/image

Peripheral Neuropathy: If peripheral sensory or motor neuropathy emerges or worsens during treatment see Table 15 and Table 16 as follows for appropriate dosing recommendations for monotherapy and combination therapy, respectively (see Precautions). (See Tables 15 and 16.)

Click on icon to see table/diagram/image


Click on icon to see table/diagram/image

Special patient populations: Renal and hepatic impairment: Combination therapy: Patients with renal impairment should be closely monitored for adverse events. There is no clinical trial experience using ADCETRIS in combination with chemotherapy in patients with renal impairment, where serum creatinine is ≥ 2.0 mg/dL and/or creatinine clearance or calculated creatinine clearance is ≤ 40 mL/minute. Use of ADCETRIS in combination with chemotherapy should be avoided in patients with severe renal impairment.
Patients with hepatic impairment should be closely monitored for adverse events. The recommended starting dose in patients with mild hepatic impairment receiving ADCETRIS in combination with AVD is 0.9 mg/kg (up to a maximum of 90 mg) administered as an intravenous infusion over 30 minutes every 2 weeks. The recommended starting dose in patients with mild hepatic impairment receiving ADCETRIS in combination with CHP is 1.2 mg/kg administered as an intravenous infusion over 30 minutes every 3 weeks. There is no clinical trial experience using ADCETRIS in combination with chemotherapy in patients with hepatic impairment, where total bilirubin is > 1.5 times the upper limit of normal (ULN) (unless due to Gilbert syndrome), or aspartate aminotransferase (AST) or alanine aminotransferase (ALT) are > 3 times the ULN, or > 5 times the ULN if their elevation may be reasonably ascribed to the presence of HL in the liver. Use of ADCETRIS in combination with chemotherapy should be avoided in patients with moderate and severe hepatic impairment.
Monotherapy: The recommended starting dose in patients with severe renal impairment is 1.2 mg/kg administered as an intravenous infusion over 30 minutes every 3 weeks. Patients with renal impairment should be closely monitored for adverse events (see Pharmacology: Pharmacokinetics under Actions).
The recommended starting dose in patients with hepatic impairment is 1.2 mg/kg administered as an intravenous infusion over 30 minutes every 3 weeks. Patients with hepatic impairment should be closely monitored for adverse events (see Pharmacology: Pharmacokinetics under Actions).
Elderly patients: The dosing recommendations for patients aged 65 and older are the same as for adults. Currently available data are described in Adverse Reactions, Pharmacology: Pharmacodynamics and Pharmacokinetics under Actions.
Paediatric population: The safety and efficacy of children less than 18 years have not yet been established. Currently available data are described in Pharmacokinetics (see Pharmacology: Pharmacokinetics under Actions).
In nonclinical studies, thymus depletion has been observed (see Pharmacology: Toxicology: Preclinical safety data under Actions).
Method of administration: The recommended dose of ADCETRIS is infused over 30 minutes.
For instructions on reconstitution and dilution of the medicinal product before administration, see Special precautions on disposal and other handling under Cautions for Usage.
ADCETRIS must not be administered as an intravenous push or bolus. ADCETRIS should be administered through a dedicated intravenous line and it must not be mixed with other medicinal products (see Incompatibilities under Cautions for Usage).
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