Lena Janssen Model
Rachelle Kun
This protocol has been superseded as it is the consensus of the eviQ Haematology Reference Committee that subcutaneous daratumumab is the more commonly used route of administration of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. ID 4371 Multiple myeloma DRd (daratumumab subcutaneous lenalidomide dexamethasone) is the preferred regimen.
Interference with indirect antiglobulin tests may occur. Please notify your blood transfusion laboratory and send a blood sample for extended red blood cell phenotype and RBC antibody screen BEFORE the first dose of daratumumab.
The anticancer drug(s) in this protocol have been updated with the ADDIKD guideline recommendations (if applicable). Recommendations may differ from other protocols which have not been updated. For further information refer to the dedicated eviQ ADDIKD guideline webpage.
* Dexamethasone dose may be reduced to 20 mg/week for patients > 75 years, BMI < 18.5, poorly controlled diabetes mellitus or prior intolerance to steroid therapy. For patients on a reduced dexamethasone dose, the entire 20 mg dose was given as pre-infusion medication. After cycle 6, dexamethasone dose may be reduced to 20 mg/week for all patients.r
NB: patient registration into a pregnancy prevention risk management program is required.
Full prescribing information and Authority Application forms available from the Department of Human Services
Drug unit costs are taken directly from the Pharmaceutical Benefits Scheme (PBS) website (www.pbs.gov.au). These costs are reviewed and updated on eviQ at 6 monthly intervals. Anti-cancer drugs that are not included on the PBS do not have a cost included in eviQ protocols.
The supportive therapies (e.g. antiemetics, premedications, etc.), infusion times, diluents, volumes and routes of administration, if included, are listed as defaults. They may vary between institutions and can be substituted to reflect individual institutional policy.
Antiemetics if included in the treatment schedule are based upon recommendations from national and international guidelines. These are defaults only and may be substituted to reflect individual institutional policy. Select here for recommended doses of alternative antiemetics.
Infusion-Related Reactions (IRRs) can occur with administration of IV or SC daratumumab. Hypersensitivity risk is greatest with the first dose of daratumumab, and is higher in IV than SC administration.r
For patients with a history of chronic obstructive pulmonary disease, consider the use of post-treatment medications including short and long acting bronchodilators, and inhaled corticosteroids. Following the first four injections, if the patient experiences no major IRRs, these inhaled post-treatment medications may be discontinued at the discretion of the treating clinician.
All patients and partners of patients that can conceive a child must use at least one reliable contraceptive method for at least 4 weeks before starting treatment, during treatment (including dose interruptions), and for 4 weeks after stopping treatment.
Male patients should also use a condom when having sexual intercourse with a woman of childbearing potential during treatment (including dose interruptions), and for 4 weeks after stopping treatment.
In female patients and female partners of male patients, a pregnancy test should be carried out prior to initiating treatment (after 4 weeks of contraception use), weekly during the first month of treatment and monthly thereafter.
Effective contraception methods and adequate contraception timeframes should be discussed with all patients of reproductive potential.
Prescription of an IMiD requires patient registration with a pregnancy prevention program.
Use of a bone modifying agent (BMA) should be considered in all patients with symptomatic myeloma requiring treatment. For patients with newly diagnosed symptomatic myeloma, zoledronic acid, pamidronate or denosumab should be considered for monthly administration (adjust for kidney dysfunction where appropriate) for up to 2 years. A longer duration of therapy may be appropriate (MRC M IX trial).r
For more information, please see the following protocols:
ID 137 Multiple myeloma zoledronic acid
ID 147 Multiple myeloma pamidronate
ID 3964 Multiple myeloma denosumab - note denosumab is TGA approved but not PBS reimbursed for this indication.
Caution should be taken with prolonged use of bisphosphonates due to the risk of osteonecrosis of the jaw (ONJ). A dental review prior to treatment is recommended, and all dental issues treated before the initiation of bisphosphonates. Dental review 6 to 12 monthly during treatment is advisable to minimise risk of ONJ. Concurrent daily oral supplements of calcium 500 mg and vitamin D 400 International Units are recommended.
It is the consensus opinion of the Haematology Reference Committee that concomitant thromboprophylaxis is recommended: consider using low dose aspirin for patients without pre-existing risk factors, while patients with pre-existing risk factors should receive enoxaparin 40 mg subcut daily for the duration of treatment (unless contraindicated; reduce dose in kidney dysfunction).
Daratumumab may be detected on serum protein electrophoresis (SPE) and immunofixation
(IFE) assays used for monitoring disease monoclonal immunoglobulins (M protein), which can lead to false positive assay results in patients with IgG kappa myeloma protein. The initial assessment of complete responses by the International Myeloma Working Group (IMWG) criteria may be affected.
Diabetic patients should monitor their blood glucose levels closely. To minimise gastric irritation, advise patient to take immediately after food. Consider the use of a H2 antagonist or proton pump inhibitor if appropriate.
The drug interactions shown below are not an exhaustive list. For a more comprehensive list and for detailed information on specific drug interactions and clinical management, please refer to the specific drug product information and the following key resources:
eviQ provides safe and effective instructions on how to administer cancer treatments. However, eviQ does not provide every treatment delivery option, and is unable to provide a comprehensive list of cancer treatment agents and their required IV line giving set/filter. There may be alternative methods of treatment administration, and alternative supportive treatments that are also appropriate. Please refer to the individual product information monographs via the TGA and Australian Injectable Drugs Handbook websites for further information.
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