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Home > PCN MM Relapsed - daratumumab [subcut]

PCN MM Relapsed - daratumumab [subcut]

Treatment Overview

Cycle 1 - 28 days

Cycle length:
28

In patients with chronic obstructive pulmonary disease (COPD): Also consider additional post-dose medication (e.g. inhaled corticosteroids, short- and long-acting bronchodilators) to manage respiratory complications should they occur. Post-dose inhaled medication may be discontinued following the first 4 administrations at the prescriber’s discretion if there has been no major administration reaction.

Cycle 2 - 28 days

Cycle length:
28

In patients with chronic obstructive pulmonary disease (COPD): Also consider additional post-dose medication (e.g. inhaled corticosteroids, short- and long-acting bronchodilators) to manage respiratory complications should they occur. Post-dose inhaled medication may be discontinued following the first 4 administrations at the prescriber’s discretion if there has been no major administration reaction.

Cycles 3 to 6 - 28 days

Cycle length:
28

In patients with chronic obstructive pulmonary disease (COPD): Also consider additional post-dose medication (e.g. inhaled corticosteroids, short- and long-acting bronchodilators) to manage respiratory complications should they occur. Post-dose inhaled medication may be discontinued following the first 4 administrations at the prescriber’s discretion if there has been no major administration reaction.

Cycle 7 (and all further cycles) - 28 days

Cycle length:
28

In patients with chronic obstructive pulmonary disease (COPD): Also consider additional post-dose medication (e.g. inhaled corticosteroids, short- and long-acting bronchodilators) to manage respiratory complications should they occur. Post-dose inhaled medication may be discontinued following the first 4 administrations at the prescriber’s discretion if there has been no major administration reaction.

Cycle details

Cycle 1 - 28 days

Medication Dose Route Days Max Duration
paracetamol * 1000 mg flat dosing oral administration 1, 8, 15,
22
loratadine * 10 mg oral administration 1, 8, 15,
22
dexamethasone 20 mg flat dosing oral administration 1, 8
dexamethasone 12 mg flat dosing oral administration 15, 22
montelukast * 10 mg oral administration 1, 8, 15,
22
daratumumab 1800 mg flat dosing subcutaneous injection 1, 8, 15,
22
dexamethasone 4 mg flat dosing oral administration 2, 3, 9,
10, 16, 17,
23, 24

In patients with chronic obstructive pulmonary disease (COPD): Also consider additional post-dose medication (e.g. inhaled corticosteroids, short- and long-acting bronchodilators) to manage respiratory complications should they occur. Post-dose inhaled medication may be discontinued following the first 4 administrations at the prescriber’s discretion if there has been no major administration reaction.

Cycle 2 - 28 days

Medication Dose Route Days Max Duration
paracetamol * 1000 mg flat dosing oral administration 1, 8, 15,
22
loratadine * 10 mg oral administration 1, 8, 15,
22
dexamethasone 12 mg flat dosing oral administration 1, 8, 15,
22
daratumumab 1800 mg flat dosing subcutaneous injection 1, 8, 15,
22
dexamethasone 4 mg flat dosing oral administration 2, 3, 9,
10, 16, 17,
23, 24

In patients with chronic obstructive pulmonary disease (COPD): Also consider additional post-dose medication (e.g. inhaled corticosteroids, short- and long-acting bronchodilators) to manage respiratory complications should they occur. Post-dose inhaled medication may be discontinued following the first 4 administrations at the prescriber’s discretion if there has been no major administration reaction.

Cycles 3 to 6 - 28 days

Medication Dose Route Days Max Duration
paracetamol * 1000 mg flat dosing oral administration 1, 15
loratadine * 10 mg oral administration 1, 15
dexamethasone 12 mg flat dosing oral administration 1, 15
daratumumab 1800 mg flat dosing subcutaneous injection 1, 15
dexamethasone 4 mg flat dosing oral administration 2, 3, 16,
17

In patients with chronic obstructive pulmonary disease (COPD): Also consider additional post-dose medication (e.g. inhaled corticosteroids, short- and long-acting bronchodilators) to manage respiratory complications should they occur. Post-dose inhaled medication may be discontinued following the first 4 administrations at the prescriber’s discretion if there has been no major administration reaction.

Cycle 7 (and all further cycles) - 28 days

Medication Dose Route Days Max Duration
paracetamol * 1000 mg flat dosing oral administration 1
loratadine * 10 mg oral administration 1
dexamethasone 12 mg flat dosing oral administration 1
daratumumab 1800 mg flat dosing subcutaneous injection 1
dexamethasone 4 mg flat dosing oral administration 2, 3

In patients with chronic obstructive pulmonary disease (COPD): Also consider additional post-dose medication (e.g. inhaled corticosteroids, short- and long-acting bronchodilators) to manage respiratory complications should they occur. Post-dose inhaled medication may be discontinued following the first 4 administrations at the prescriber’s discretion if there has been no major administration reaction.

Full details

Cycle 1 - 28 days

Day: 1

Medication Dose Route Max duration Details
paracetamol * 1000 mg flat dosing oral administration
Instructions:
ONE to THREE hours prior to daratumumab.
loratadine * 10 mg oral administration
Instructions:
ONE to THREE hours prior to daratumumab.
dexamethasone 20 mg flat dosing oral administration
Instructions:

ONE to THREE hours prior to daratumumab with food.
montelukast * 10 mg oral administration
Instructions:
ONE to THREE hours prior to daratumumab as per institutional policy.
daratumumab 1800 mg flat dosing subcutaneous injection Additional details:

Day: 2

Medication Dose Route Max duration Details
dexamethasone 4 mg flat dosing oral administration
Instructions:

Take in the morning with food.

Day: 3

Medication Dose Route Max duration Details
dexamethasone 4 mg flat dosing oral administration
Instructions:

Take in the morning with food.

Day: 8

Medication Dose Route Max duration Details
paracetamol * 1000 mg flat dosing oral administration
Instructions:
ONE to THREE hours prior to daratumumab.
loratadine * 10 mg oral administration
Instructions:
ONE to THREE hours prior to daratumumab.
dexamethasone 20 mg flat dosing oral administration
Instructions:

ONE to THREE hours prior to daratumumab with food.
montelukast * 10 mg oral administration
Instructions:
ONE to THREE hours prior to daratumumab as per institutional policy.
daratumumab 1800 mg flat dosing subcutaneous injection Additional details:

Day: 9

Medication Dose Route Max duration Details
dexamethasone 4 mg flat dosing oral administration
Instructions:

Take in the morning with food.

Day: 10

Medication Dose Route Max duration Details
dexamethasone 4 mg flat dosing oral administration
Instructions:

Take in the morning with food.

Day: 15

Medication Dose Route Max duration Details
paracetamol * 1000 mg flat dosing oral administration
Instructions:
ONE to THREE hours prior to daratumumab.
loratadine * 10 mg oral administration
Instructions:
ONE to THREE hours prior to daratumumab.
dexamethasone 12 mg flat dosing oral administration
Instructions:

ONE to THREE hours prior to daratumumab with food.
montelukast * 10 mg oral administration
Instructions:
ONE to THREE hours prior to daratumumab as per institutional policy.
daratumumab 1800 mg flat dosing subcutaneous injection Additional details:

Day: 16

Medication Dose Route Max duration Details
dexamethasone 4 mg flat dosing oral administration
Instructions:

Take in the morning with food.

Day: 17

Medication Dose Route Max duration Details
dexamethasone 4 mg flat dosing oral administration
Instructions:

Take in the morning with food.

Day: 22

Medication Dose Route Max duration Details
paracetamol * 1000 mg flat dosing oral administration
Instructions:
ONE to THREE hours prior to daratumumab.
loratadine * 10 mg oral administration
Instructions:
ONE to THREE hours prior to daratumumab.
dexamethasone 12 mg flat dosing oral administration
Instructions:

ONE to THREE hours prior to daratumumab with food.
montelukast * 10 mg oral administration
Instructions:
ONE to THREE hours prior to daratumumab as per institutional policy.
daratumumab 1800 mg flat dosing subcutaneous injection Additional details:

Day: 23

Medication Dose Route Max duration Details
dexamethasone 4 mg flat dosing oral administration
Instructions:

Take in the morning with food.

May be omitted if the patient experiences no major administration-related reactions after the first 3 administrations of daratumumab.

Day: 24

Medication Dose Route Max duration Details
dexamethasone 4 mg flat dosing oral administration
Instructions:

Take in the morning with food.

May be omitted if the patient experiences no major administration-related reactions after the first 3 administrations of daratumumab.

Cycle 2 - 28 days

Day: 1

Medication Dose Route Max duration Details
paracetamol * 1000 mg flat dosing oral administration
Instructions:
ONE to THREE hours prior to daratumumab.
loratadine * 10 mg oral administration
Instructions:
ONE to THREE hours prior to daratumumab.
dexamethasone 12 mg flat dosing oral administration
Instructions:

ONE to THREE hours prior to daratumumab with food.
daratumumab 1800 mg flat dosing subcutaneous injection Additional details:

Day: 2

Medication Dose Route Max duration Details
dexamethasone 4 mg flat dosing oral administration
Instructions:

Take in the morning with food.

May be omitted if no previous daratumumab administration reactions.

Day: 3

Medication Dose Route Max duration Details
dexamethasone 4 mg flat dosing oral administration
Instructions:

Take in the morning with food.

May be omitted if no previous daratumumab administration reactions.

Day: 8

Medication Dose Route Max duration Details
paracetamol * 1000 mg flat dosing oral administration
Instructions:
ONE to THREE hours prior to daratumumab.
loratadine * 10 mg oral administration
Instructions:
ONE to THREE hours prior to daratumumab.
dexamethasone 12 mg flat dosing oral administration
Instructions:

ONE to THREE hours prior to daratumumab with food.
daratumumab 1800 mg flat dosing subcutaneous injection Additional details:

Day: 9

Medication Dose Route Max duration Details
dexamethasone 4 mg flat dosing oral administration
Instructions:

Take in the morning with food.

May be omitted if no previous daratumumab administration reactions.

Day: 10

Medication Dose Route Max duration Details
dexamethasone 4 mg flat dosing oral administration
Instructions:

Take in the morning with food.

May be omitted if no previous daratumumab administration reactions.

Day: 15

Medication Dose Route Max duration Details
paracetamol * 1000 mg flat dosing oral administration
Instructions:
ONE to THREE hours prior to daratumumab.
loratadine * 10 mg oral administration
Instructions:
ONE to THREE hours prior to daratumumab.
dexamethasone 12 mg flat dosing oral administration
Instructions:

ONE to THREE hours prior to daratumumab with food.
daratumumab 1800 mg flat dosing subcutaneous injection Additional details:

Day: 16

Medication Dose Route Max duration Details
dexamethasone 4 mg flat dosing oral administration
Instructions:

Take in the morning with food.

May be omitted if no previous daratumumab administration reactions.

Day: 17

Medication Dose Route Max duration Details
dexamethasone 4 mg flat dosing oral administration
Instructions:

Take in the morning with food.

May be omitted if no previous daratumumab administration reactions.

Day: 22

Medication Dose Route Max duration Details
paracetamol * 1000 mg flat dosing oral administration
Instructions:
ONE to THREE hours prior to daratumumab.
loratadine * 10 mg oral administration
Instructions:
ONE to THREE hours prior to daratumumab.
dexamethasone 12 mg flat dosing oral administration
Instructions:

ONE to THREE hours prior to daratumumab with food.
daratumumab 1800 mg flat dosing subcutaneous injection Additional details:

Day: 23

Medication Dose Route Max duration Details
dexamethasone 4 mg flat dosing oral administration
Instructions:

Take in the morning with food.

May be omitted if no previous daratumumab administration reactions.

Day: 24

Medication Dose Route Max duration Details
dexamethasone 4 mg flat dosing oral administration
Instructions:

Take in the morning with food.

May be omitted if no previous daratumumab administration reactions.

Cycles 3 to 6 - 28 days

Day: 1

Medication Dose Route Max duration Details
paracetamol * 1000 mg flat dosing oral administration
Instructions:
ONE to THREE hours prior to daratumumab.
loratadine * 10 mg oral administration
Instructions:
ONE to THREE hours prior to daratumumab.
dexamethasone 12 mg flat dosing oral administration
Instructions:

ONE to THREE hours prior to daratumumab with food.
daratumumab 1800 mg flat dosing subcutaneous injection Additional details:

Day: 2

Medication Dose Route Max duration Details
dexamethasone 4 mg flat dosing oral administration
Instructions:

Take in the morning with food.

May be omitted if no previous daratumumab administration reactions.

Day: 3

Medication Dose Route Max duration Details
dexamethasone 4 mg flat dosing oral administration
Instructions:

Take in the morning with food.

May be omitted if no previous daratumumab administration reactions.

Day: 15

Medication Dose Route Max duration Details
paracetamol * 1000 mg flat dosing oral administration
Instructions:
ONE to THREE hours prior to daratumumab.
loratadine * 10 mg oral administration
Instructions:
ONE to THREE hours prior to daratumumab.
dexamethasone 12 mg flat dosing oral administration
Instructions:

ONE to THREE hours prior to daratumumab with food.
daratumumab 1800 mg flat dosing subcutaneous injection Additional details:

Day: 16

Medication Dose Route Max duration Details
dexamethasone 4 mg flat dosing oral administration
Instructions:

Take in the morning with food.

May be omitted if no previous daratumumab administration reactions.

Day: 17

Medication Dose Route Max duration Details
dexamethasone 4 mg flat dosing oral administration
Instructions:

Take in the morning with food.

May be omitted if no previous daratumumab administration reactions.

Cycle 7 (and all further cycles) - 28 days

Day: 1

Medication Dose Route Max duration Details
paracetamol * 1000 mg flat dosing oral administration
Instructions:
ONE to THREE hours prior to daratumumab.
loratadine * 10 mg oral administration
Instructions:
ONE to THREE hours prior to daratumumab.
dexamethasone 12 mg flat dosing oral administration
Instructions:

ONE to THREE hours prior to daratumumab with food.
daratumumab 1800 mg flat dosing subcutaneous injection Additional details:

Day: 2

Medication Dose Route Max duration Details
dexamethasone 4 mg flat dosing oral administration
Instructions:

Take in the morning with food.

May be omitted if no previous daratumumab administration reactions.

Day: 3

Medication Dose Route Max duration Details
dexamethasone 4 mg flat dosing oral administration
Instructions:

Take in the morning with food.

May be omitted if no previous daratumumab administration reactions.

Additional details

Section 1: Patients with COPD

In patients with chronic obstructive pulmonary disease (COPD): Also consider additional post-dose medication (e.g. inhaled corticosteroids, short- and long-acting bronchodilators) to manage respiratory complications should they occur. Post-dose inhaled medication may be discontinued following the first 4 administrations at the prescriber’s discretion if there has been no major administration reaction

Supportive Care Factors

Factor Value
Antiviral prophylaxis for herpes virus: Routine antiviral prophylaxis may be considered
Emetogenicity: Minimal
Gastroprotection: Gastroprotection may be considered
Hypersensitivity / Infusion related reaction risk: High - routine premedication recommended
Pneumocystis jirovecii pneumonia (PJP) prophylaxis: Routine antibiotic prophylaxis may be considered
Tumour lysis syndrome prophylaxis: Tumour lysis syndrome prophylaxis may be considered

Anti CD-38 monoclonal antibody red cell phenotyping and red blood cell antibody screen: Mandatory before starting treatment.

Antiviral prophylaxis for hepatitis B virus: Guidance is limited to high-risk anti-cancer medicines. Clinicians will need to assess individual patient risk for other anti-cancer medicines.

References

Quach, H., S. Benson, H. Haysom, et al. 2018. "Considerations for pre-transfusion immunohaematology testing in patients receiving the anti-CD38 monoclonal antibody daratumumab for the treatment of multiple myeloma." Intern Med J 48(2):210-220. , PMID: 29415351

Morgan, G. J., J. A. Child, W. M. Gregory, et al. 2011. "Effects of zoledronic acid versus clodronic acid on skeletal morbidity in patients with newly diagnosed multiple myeloma (MRC Myeloma IX): secondary outcomes from a randomised controlled trial." Lancet Oncol 12(8):743-752., PMID: 21771568

Usmani, S. Z., B. M. Weiss, T. Plesner, et al. 2016. "Clinical efficacy of daratumumab monotherapy in patients with heavily pretreated relapsed or refractory multiple myeloma." Blood 128(1):37-44. , PMID: 27216216

Usmani, S., T. Ahmadi, Y. Ng, et al. 2016. "Analysis of Real-World Data on Overall Survival in Multiple Myeloma Patients With >/=3 Prior Lines of Therapy Including a Proteasome Inhibitor (PI) and an Immunomodulatory Drug (IMiD), or Double Refractory to a PI and an IMiD." Oncologist. , PMID: 27486203

Usmani,S., H. Nahi, B. Weiss et al 2017. “Safety and Efficacy of Daratumumab Monotherapy in Patients with Heavily Pretreated Relapsed and Refractory Multiple Myeloma: Final Results from GEN501 and Sirius.” Blood 130: 3107., PMID: 32470437

Mateos MV, Nahi H, Legiec W et al., Subcutaneous versus intravenous daratumumab in patients with relapsed or refractory multiple myeloma (COLUMBA): a multicentre, open-label, non-inferiority, randomised, phase 3 trial. Lancet Haematol. 2020 May;7(5):e370-e380. doi: 10.1016/S2352-3026(20)30070-3. Epub 2020 Mar 23. Erratum in: Lancet Haematol. 2020 Oct;7(10):e710., PMID: 32213342

Janssen-Cilag (New Zealand) Ltd Daralex SC New Zealand Medicine Datasheet 27 May 2021 https://www.medsafe.govt.nz/profs/datasheet/d/darzalexscinj.pdf (Accessed 4 April 2022).

Ajai Chari, Tomer M Mark, Amrita Krishnan, et al., Use of Montelukast to Reduce Infusion Reactions in an Early Access Treatment Protocol of Daratumumab in United States Patients with Relapsed or Refractory Multiple Myeloma. Blood 2016; 128 (22): 2142. doi: https://doi.org/10.1182/blood.V128.22.2142.2142

Regimen details sometimes vary slightly from the published literature after recommendation by expert committee consensus.

* The medicines, doses, combinations, and schedule in this treatment regimen have been carefully reviewed against international best practice guidelines by specialists in medical oncology around New Zealand and this advice has been accepted for publication by Te Aho o Te Kahu (the Cancer Control Agency). Sometimes medicines that are used in routine clinical practice have not been through a formal review process by the NZ Medicines Regulator Medsafe and are therefore considered unapproved or off-label. These medicines are legally able to be prescribed through sections 25 and 29 of the Medicines Act and by obtaining informed consent from patients. All treatment regimens listed on this website have been through robust peer review and are considered an accepted standard of care, whether prescribed through sections 25 or 29 or carrying formal Medsafe Approval.

s29: This symbol indicates that some formulations of the associated medicine are legally only able to be prescribed under section 29 of the Medicines Act. You can see which formulations are section 29 by hovering over the s29 symbol. You can access full medication details from the New Zealand Formulary by clicking on the medication name. Each clinician retains full responsibility for ensuring they have complied with all relevant obligations and requirements of section 29 including obtaining informed patient consent prior to prescribing the applicable medicine.