This document has been superseded as it is the consensus of the eviQ Haematology Reference Committee that subcutaneous daratumumab is the more commonly used route of administration of daratumumab.
This document is a quick and concise evidence-based summary to provide additional information, instruction, or guidance to complement a treatment protocol or clinical resource document.
Infusion related reactions (IRRs) can occur with administration of daratumumab. Hypersensitivity risk is greatest with the first dose of daratumumab, and is higher in intravenous (IV) than subcutaneous (SC) administration.r Patients who tolerate the first two infusions of daratumumab at the standard administration rates without experiencing any IRRs may be eligible to receive subsequent infusions at a faster rate.
Note:
The rapid infusion regimen is ONLY to be used in patients who are receiving their third or subsequent infusion of daratumumab and who received their previous infusions at the rates outlined in the infusion table without any grade ≥ 1 infusion-related reactions. The rapid infusion rate is currently unlicensed and is based on the demonstrated tolerability and safety outcomes from a prospective, single-centre and open label safety study where daratumumab infusion was administered over 90 minutes from the third infusion onwards in patients who tolerated the 500 mL daratumumab infusion at the manufacturer recommended rates.r
- for each dose administered via rapid infusion, measure and document baseline observations and repeat every 15 minutes during the first hour and then at the end of the infusion
- for the first dose administered via rapid infusion, patients must remain under observation for 30 minutes after infusion is completed to assess for delayed infusion related reactions
- in case of prolonged daratumumab interruption, consider resuming infusions at the standard subsequent infusion rate (3.5 hours) before switching to the rapid infusion.r
Administration
Close monitoring during and after administration is recommended.r
- administer the following premedications approximately 1 to 3 hours prior to every daratumumab infusion:
- paracetamol 1000 mg PO
- loratadine 10 mg PO (or similar antihistamine)
- corticosteroid:
- for daramutumab monotherapy: dexamethasone 20 mg IV (or an equivalent intermediate‑ or long‑acting corticosteroid) for the first two infusions, and dexamethasone 12 mg (oral or IV) thereafter in the absence of IRRs during the first two infusions.
- when daratumumab is part of combination therapy: dexamethasone 20 mg (oral or IV) prior to every daratumumab infusion.
- note that dexamethasone is given intravenously prior to the first daratumumab infusion and oral administration may be considered prior to subsequent infusions.r
- to prevent the occurrence of delayed IRRs after daratumumab administration, administer oral corticosteroids post-infusion:
- for daramutumab monotherapy: following each daratumumab infusion, administer dexamethasone 4 mg PO (or equivalent) for 2 days (beginning the day after the infusion).
- when daratumumab is part of combination therapy: consider administering dexamethasone 4 mg PO (or equivalent) the day after daratumumab infusion. However, if combination therapy includes corticosteroid the day after the daratumumab infusion as part of the treatment protocol, additional post-infusion medications may not be needed.
Infusion rates for daratumumab (16 mg/kg) administration
Practice points
- patient must be under constant visual observation during all rate increases
- consider incremental escalation of the infusion rate only in the absence of infusion reactions
- for the first infusion, the patient should remain under observation for 2 hours after infusion is completed to assess for delayed infusion related reactionsr
- dilution volume of 500 mL should only be used if there were no Grade 1 (mild) or greater infusion reactions during the first 3 hours of the first infusion, otherwise continue to use a dilution volume of 1000 mL and instructions for the first infusion
- use a modified initial rate for subsequent infusions (i.e. third infusion onwards) only if there were no Grade 1 (mild) or greater infusion reactions during a final infusion rate of ≥100 mL/hr in the first two infusions, otherwise continue to use instructions for the second infusion.
| Infusion time |
Volume |
1st hour |
2nd hour |
3rd hour |
4th hour |
5th hour |
6th hour |
| First infusion (7 hours) |
1000 mL |
50 mL/hr |
100 mL/hr |
150 mL/hr |
200 mL/hr (MAX RATE) |
> |
| Second infusion (4.5 hours) |
500 mL |
50 mL/hr |
100 mL/hr |
150 mL/hr |
200 mL/hr (MAX RATE) |
|
| Subsequent infusions (3.5 hours) |
500 mL |
100 mL/hr |
150 mL/hr |
200 mL/hr (MAX RATE) |
|
|
|
Rapid infusion - third or subsequent infusions (1.5 hours) - see Note above
|
500 mL |
First 30 mins:
200 mL/hr
Second 30 mins:
450 ml/hr (MAX RATE)
|
450 mL/hr (MAX RATE) |
|
|
|
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https://www.eviq.org.au/p/3393
19 Apr 2024