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Adcetris

Adcetris Dosage/Direction for Use

brentuximab vedotin

Manufacturer:

Takeda

Distributor:

DKSH
Full Prescribing Info
Dosage/Direction for Use
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: CLINICAL STUDIES under Actions).
Primary prophylaxis with growth factor support (G-CSF) is recommended for all patients with previously untreated HL receiving combination therapy beginning with the first dose (see Precautions).
Refer to the package insert (PI) of chemotherapy agents given in combination with Adcetris for patients with previously untreated HL.
HL at increased risk of relapse or progression: 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: CLINICAL STUDIES 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 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: CLINICAL STUDIES 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: CLINICAL STUDIES under Actions).
Previously untreated sALCL or other CD30-expressing 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: CLINICAL STUDIES under Actions).
Primary prophylaxis with growth factor support (G-CSF) beginning with the first dose, is recommended for all patients with previously untreated sALCL or other CD30-expressing PTCL, receiving combination therapy (See Precautions).
Refer to the product information of chemotherapy agents given in combination with Adcetris for treatment of patients with previously untreated sALCL or other CD30-expressing 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: CLINICAL STUDIES 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: CLINICAL STUDIES 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 (see Pharmacology: Pharmacodynamics: CLINICAL STUDIES under Actions).
General: If the patient's weight is more than 100 kg, the dose calculation should use 100 kg.
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 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 for appropriate recommendations for monotherapy and combination therapy, respectively. (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 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: 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: CLINICAL STUDIES and Pharmacokinetics under Actions.
Paediatric population: The safety and efficacy of Adcetris in children less than 18 years have not yet been established.
Currently available data are described in ADVERSE REACTIONS, Pharmacology: Pharmacodynamics: CLINICAL STUDIES and Pharmacokinetics under Actions but no recommendation on a posology can be made.
Instructions for Reconstitution: General Precautions: Follow proper aseptic technique throughout the handling of Adcetris.
Recommended safety measures for handling and preparation include protective clothing, gloves and vertical laminar airflow safety cabinets.
Adcetris vials are single-use containers. Any partially used vials or diluted dosing solutions are to be discarded using appropriate institutional drug disposal procedures.
Instructions for reconstitution: Each 50mg single use vial must be reconstituted with 10.5 ml of Water for Injection only. Direct the stream toward the wall of the vial and not directly at the cake. Gently swirl the vial to aid dissolution. DO NOT SHAKE. The reconstituted solution in the vial is a clear to slightly opalescent, colorless solution with a final pH of 6.6. The reconstituted solution should be inspected visually for any particulate matter or discoloration. If any discoloration or particulate matter is observed, the reconstituted solution must be discarded. If not used immediately, the reconstituted solution may be stored at 2 - 8°C (DO NOT FREEZE) for no more than 24 hours. Adcetris contains no bacteriostatic preservatives. Discard any unused portion left in the vial.
Preparations of Infusion Solution: There are no known incompatibilities between Adcetris and polyvinylchloride bags, ethylene vinyl acetate (EVA), polyolefin, polyethylene (PE) or polypropylene (PP).
The appropriate amount of reconstituted Adcetris will be withdrawn from the vial(s) and added to an infusion bag containing 0.9% Sodium Chloride Injection in order to achieve a final concentration of 0.4-1.8 mg/mL Adcetris. The already reconstituted Adcetris can also be diluted into 5% dextrose in water (D5W), or Lactated Ringers Solution. Gently invert the bag to mix the solution containing Adcetris. DO NOT SHAKE. Excess agitation may cause aggregate formation.
Do not add other medications to the prepared Adcetris infusion solution or IV infusion set. Infusion line should be flushed following administration with 0.9% Sodium Chloride Injection, 5% dextrose in water (D5W), or Lactated Ringers Solution.
Following dilution, infuse the Adcetris solution immediately at the recommended infusion rate, or store the solution at 2 - 8°C (DO NOT FREEZE) and use within 24 hours. Total storage time of the solution from reconstitution to infusion must not exceed 24 hours.
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