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      • This website is for UK Healthcare Professionals only

      Venclyxto logo
      VENCLYXTO PRESCRIBING INFORMATION [EXTERNAL LINK]
      VENCLYXTO SUMMARY OF PRODUCT CHARACTERISTICS
      VENCLYXTO PATIENT CARD
      banner

      Obinutuzumab dosing and administration

      Infusion-related reactions (IRRs) (including severe and life-threatening) can occur in patients treated with obinutuzumab2

      • Obinutuzumab, unlike rituximab, directly triggers apoptosis by inducing lysosomal membrane permeabilization. This in turn leads to a large release of cytokines from tumour cell lysis3

      Risk factors that increase the risk of IRRs include:2

      • High tumour burden and/or high circulating lymphocyte count in CLL (>25 x 109/L)
      • Renal impairment (CrCl <50 mL/min)
      • Both Cumulative Illness Rating Scale (CIRS) >6 and CrCl <70 mL/min

      Patients on antihypertensive treatments, or those with pre-existing cardiac or pulmonary conditions may experience hypotension during obinutuzumab administration2

      • Corticosteriod premedication is mandatory for CLL patients in the first cycle to reduce the risk of IRRs
      • Provide prophylactic hydration and anti-hyperuricemics to patients at risk of TLS
      • Administer only as an intravenous infusion through a dedicated line after dilution. Do not administer as an intravenous push or bolus
      • Obinutuzumab should be administered under the close supervision of an experienced physician and in an environment where full resuscitation facilities are immediately available

       

      Please refer to the obinutuzumab Summary of Product Characteristics for full details

      The following premedications are required before obinutuzumab infusion begins to reduce the risk of IRRs:

       

      Cycle 1,
      Days 1 and 2

      All subsequent infusions

      Complete before infusion

      All patients

      Patients with no IRR during previous infusion

      Patients with an IRR (Grade 1-2)
      with the previous infusion

      Patients with a Grade 3 IRR with the previous infusion or with a lymphocyte count >25 x 109/L prior to next treatment

      At least 60 minutes prior
      Intravenous corticosteriod*†

      ✓

      		  

      ✓

      At least 30 minutes prior
      Antihistamine‡

      ✓

      		 

      ✓

      ✓

      At least 30 minutes prior
      Oral analgesic/anti-pyretic§

      ✓

      ✓

      ✓

      ✓

       

      Cycle 1,
      Days 1 and 2

      Complete before infusion

      All patients

      At least 60 minutes prior
      Intravenous corticosteriod*†

      ✓

      At least 30 minutes prior
      Antihistamine‡

      ✓

      At least 30 minutes prior
      Oral analgesic/anti-pyretic§

      ✓

       

      All subsequent infusions

      Complete before infusion

      Patients with no IRR during previous infusion

      Patients with an IRR (Grade 1-2)
      with the previous infusion

      Patients with a Grade 3 IRR with the previous infusion or with a lymphocyte count >25 x 109/L prior to next treatment

      At least 60 minutes prior
      Intravenous corticosteriod*†

      		  

      ✓

      At least 30 minutes prior
      Antihistamine‡

      		 

      ✓

      ✓

      At least 30 minutes prior
      Oral analgesic/anti-pyretic§

      ✓

      ✓

      ✓

      *100 mg prednisone/prednisolone or 20 mg dexamethasone or 80 mg methylprednisolone. Hydrocortisone should not be used as it has not been effective in reducing rates of IRR.
      †If a corticosteroid-containing chemotherapy regimen is administered on the same day as obinutuzumab, the corticosteroid can be administered as an oral medicinal product if given at least 60 minutes prior to obinutuzumab, in which case additional IV corticosteroid as premedication is not required.
      ‡e.g. 50 mg diphenhydramine
      §e.g. 1,000 mg acetaminophen/paracetamol

       

      Please refer to the obinutuzumab Summary of Product Characteristics for full details

      Obinutuzumab is delivered as an intravenous infusion. Each dose of obinutuzumab is 1000 mg, with the exception of the first two infusions in cycle 1, which are administered as 100 mg on Day 1 and 900 mg on Day 2. If the first 100 mg is completed without modifications of the infusion rate or interruptions, the second infusion of 900 mg may be administered on the same day (no dose delay necessary, no repetition of premedication), provided that appropriate time, conditions, and medical supervision are available throughout the infusion. If there are any modifications to the infusion rate or interruptions during the first 100 mg infusion, the second bag must be administered the following day. This is in order to minimise the risk of IRRs, which predominantly occur early during the first infusion.

      Day of treatment cycle

      Dose

      Rate of infusion

      Cycle 1
      (loading doses)

      Day 1

      100 mg

      • Administer at 25 mg/hr over 4 hours
      • Do not increase the infusion rate

      Day 2
      (or day 1 continued)

      900 mg

      • If no infusion-related reaction occurred during the previous infusion, administer at 50 mg/hr. The rate of the infusion can be escalated in increments of 50 mg/hr every 30 minutes to a maximum rate of 400 mg/hr
      • If an infusion-related reaction occurred during the previous infusion, start with administration at 25 mg/hr. The rate of infusion can be escalated in increments of up to 50 mg/hr every 30 minutes to a maximum rate of 400 mg/hr

      Day 8

      1000 mg

      • If no infusion-related reaction occurred during the previous infusion and the final infusion rate was 100 mg/hr or faster, infusions can be started at a rate of 100 mg/hr and increased by 100 mg/hr increments every 30 minutes to a maximum of 400 mg/hr
      • If an infusion-related reaction occurred during the previous infusion, administer at 50 mg/hr. The rate of infusion can be escalated in increments of 50 mg/hr every 30 minutes to a maximum rate of 400 mg/hr

      Day 15

      1000 mg

      Cycles 2-6

      Day 1

      1000 mg

      Day of treatment cycle

      Dose

      Rate of infusion

      Cycle 1
      (loading doses)

      Day 1

      100 mg

      • Administer at 25 mg/hr over 4 hours
      • Do not increase the infusion rate

      Day 2
      (or day 1 continued)

      900 mg

      • If no infusion-related reaction occurred during the previous infusion, administer at 50 mg/hr. The rate of the infusion can be escalated in increments of 50 mg/hr every 30 minutes to a maximum rate of 400 mg/hr
      • If an infusion-related reaction occurred during the previous infusion, start with administration at 25 mg/hr. The rate of infusion can be escalated in increments of up to 50 mg/hr every 30 minutes to a maximum rate of 400 mg/hr

      Day 8

      1000 mg

      • If no infusion-related reaction occurred during the previous infusion and the final infusion rate was 100 mg/hr or faster, infusions can be started at a rate of 100 mg/hr and increased by 100 mg/hr increments every 30 minutes to a maximum of 400 mg/hr
      • If an infusion-related reaction occurred during the previous infusion, administer at 50 mg/hr. The rate of infusion can be escalated in increments of 50 mg/hr every 30 minutes to a maximum rate of 400 mg/hr

      Day 15

      1000 mg

      Cycles 2-6

      Day 1

      1000 mg

      If a planned dose is missed, administer the missed dose as soon as possible; do not wait until the next planned dose. Adjust dosing schedule to maintain the time interval between doses

       

      Please refer to the obinutuzumab Summary of Product Characteristics for full details

      The following premedications are recommended before obinutuzumab infusion begins to reduce the risk of IRRs:

      IRRs

      Recommendations per prescribing information

      Grade 4
      (life-threatening)      		Stop infusion immediately and permanently discontinue obinutuzumab therapy

      Grade 3
      (severe)

      Interrupt infusion and manage symptoms.

      • Upon resolution of symptoms, consider restarting obinutuzumab infusion at no more than half the previous rate (the rate being used at the time that the IRR occurred) and, if patient does not experience any further IRR symptoms, infusion rate escalation may resume at the increments and intervals as appropriate for the treatment cycle dose
      • The Day 1 infusion rate may be increased back up to 25 mg/hr after 1 hour but not increased further
      • Permanently discontinue treatment if patients experience a Grade 3 IRR at rechallenge

      Reduce infusion rate or interrupt infusion and manage symptoms.

      • Upon resolution of symptoms, continue obinutuzumab infusion and, if patient does not experience any further IRR symptoms, infusion rate escalation may resume at the increments and intervals as appropriate for the treatment cycle dose
      • The Day 1 infusion rate may be increased back up to 25 mg/hr after 1 hour but not increased further

      Grades 1-2
      (mild to moderate)

      IRRs

      Recommendations per prescribing information

      Grade 4
      (life-threatening)      		Stop infusion immediately and permanently discontinue obinutuzumab therapy

      Grade 3
      (severe)

      Interrupt infusion and manage symptoms.

      • Upon resolution of symptoms, consider restarting obinutuzumab infusion at no more than half the previous rate (the rate being used at the time that the IRR occurred) and, if patient does not experience any further IRR symptoms, infusion rate escalation may resume at the increments and intervals as appropriate for the treatment cycle dose
      • The Day 1 infusion rate may be increased back up to 25 mg/hr after 1 hour but not increased further
      • Permanently discontinue treatment if patients experience a Grade 3 IRR at rechallenge

      Reduce infusion rate or interrupt infusion and manage symptoms.

      • Upon resolution of symptoms, continue obinutuzumab infusion and, if patient does not experience any further IRR symptoms, infusion rate escalation may resume at the increments and intervals as appropriate for the treatment cycle dose
      • The Day 1 infusion rate may be increased back up to 25 mg/hr after 1 hour but not increased further

      Grades 1-2
      (mild to moderate)

       

      Please refer to the obinutuzumab Summary of Product Characteristics for full details

      CIRS, Cumulative illness rating scale; CLL, Chronic lymphocytic leukemia; CrCl, Creatine clearance; IRRs, Infusion-related reactions; IV, Intravenous; TLS, Tumour lysis syndrome.

      References

      1. VENCLYXTO (venetoclax) Summary of Product Characteristics (accessed January 2025).
      2. GAZYVARO (obinutuzumab) Summary of Product Characteristics (accessed January 2025).
      3. Bourrier, et al. BMC Cancer 2022.

       

      VENCLYXTO PRESCRIBING INFORMATION

      By clicking the link above you will leave the AbbVie Pro website and be taken to the eMC PI portal website.

      Adverse events should be reported. Reporting forms and information can be found at yellowcard.mhra.gov.uk.

      Adverse events should also be reported to AbbVie on GBPV@abbvie.com

      Some patients may not be suitable for VENCLYXTO. You are advised to read the prescribing information and summary of product characteristics to evaluate patient suitability for VENCLYXTO.

      UK-VNCCLL-240489. Date of preparation: January 2025.

      Resources
      Contact us

      Adverse events should be reported. Reporting forms and information can be found at https://yellowcard.mhra.gov.uk or via the MHRA Yellow Card app, available in the Google Play or Apple App Stores. Adverse events should also be reported to AbbVie on GBPV@abbvie.com

       

      This website is for UK Healthcare Professionals only

      UK-ABBV-230225. Date of preparation June 2023. This website has been developed and funded by AbbVie Ltd.

      © 2023 AbbVie Ltd. All rights reserved. Registered Number: 08004972 England.