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Daratumumab Dosage

Medically reviewed on August 28, 2018.

Applies to the following strengths: 20 mg/mL

Usual Adult Dose for Multiple Myeloma

NEWLY DIAGNOSED MULTIPLE MYELOMA: In combination with bortezomib, melphalan, and prednisone for patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant (6-week cycle dosing regimen):
-Weeks 1 to 6: 16 mg/kg IV weekly (total of 6 doses); first dose of the every-3-week dosing schedule is given at Week 7
-Weeks 7 to 54: 16 mg/kg IV every 3 weeks (total of 16 doses)
-Week 55 and onwards until disease progression: 16 mg/kg IV every 4 weeks; first dose of the every-4-week dosing schedule is given at Week 55

RELAPSED/REFRACTORY MULTIPLE MYELOMA: Monotherapy and combination therapy with lenalidomide or pomalidomide and low-dose dexamethasone (4-week cycle regimens):
-Weeks 1 to 8: 16 mg/kg IV weekly (total of 8 doses)
-Weeks 9 to 24: 16 mg/kg IV every 2 weeks (total of 8 doses); first dose of the every-2-week dosing schedule is given at Week 9
-Week 25 and onwards until disease progression: 16 mg/kg IV every 4 weeks; first dose of the every-4-week dosing schedule is given at Week 25

MULTIPLE MYELOMA: In combination with bortezomib and dexamethasone, for patients with multiple myeloma who have received at least 1 prior therapy (3-week cycle regimen):
-Weeks 1 to 9: 16 mg/kg IV weekly (total of 9 doses)
-Weeks 10 to 24: 16 mg/kg IV every 3 weeks (total of 5 doses); first dose of the every-3-week dosing schedule is given at Week 10
-Week 25 and onwards until disease progression: 16 mg/kg IV every 4 weeks; first dose of the every-4-week dosing schedule is given at Week 25

Comments:
-Pre-and post-infusion medications should be given prior to initiating therapy.
-For dosing instructions of combination agents administered with this drug see the manufacturer product information.
-If a planned dose is missed, administer the dose as soon as possible and adjust the dosing schedule accordingly, maintaining the treatment interval.

Manufacturer recommended infusion rates and management of infusion related reactions (IRRs):
FIRST INFUSION:
-Dilution volume: 1000 mL
-Initial rate (first hour): 50 mL/hr
-Rate increment: 50 mL/hr every hour
-Maximum rate: 200 mL/hr
SECOND INFUSION:
-Dilution volume: 500 mL
-Initial rate (first hour): 50 mL/hr
-Rate increment: 50 mL/hr every hour
-Maximum rate: 200 mL/hr
SUBSEQUENT INFUSIONS:
-Dilution volume: 500 mL
-Initial rate (first hour): 100 mL/hr
-Rate increment: 50 mL/hr every hour
-Maximum rate: 200 mL/hr
COMMENTS:
-Consider incremental escalation of the infusion rate only in the absence of IRRs.
-Use a dilution volume of 500 mL only if there were no Grade 1 (mild) or greater IRRs 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 and onward) only if there were no Grade 1 (mild) or greater IRRs during a final infusion rate of 100 mL/hr or greater in the first 2 infusions; otherwise, continue to use instructions for the second infusion.

Premedications:
Premedicate approximately 1 to 3 hours prior to every infusion:
1) Corticosteroid (long- or intermediate-acting);
-Monotherapy: Methylprednisolone (or equivalent) 100 mg IV; following the second infusion, the dose of corticosteroid may be reduced (oral or IV methylprednisolone 60 mg).
-Combination therapy: Administer 20 mg dexamethasone prior to every infusion (give IV prior to the first infusion and oral administration may be considered prior to subsequent infusions; additional background regimen-specific corticosteroids (e.g., prednisone) should not be taken on daratumumab infusion days when patients receive dexamethasone [or equivalent] as a premedication).
2) Antipyretic: Acetaminophen 650 to 1000 mg orally
3) Antihistamine: Diphenhydramine (or equivalent) 25 to 50 mg orally or IV

Post-infusion medication (administer post-infusion medication to all patients to reduce the risk of delayed IRRs):
-Monotherapy: Administer an oral corticosteroid (20 mg methylprednisolone or equivalent dose of an intermediate-acting or long-acting corticosteroid in accordance with local standards), on each of the 2 days following all daratumumab infusions (beginning the day after the infusion).
-Combination therapy: Administer low-dose oral methylprednisolone (20 mg or less) or equivalent, the day after the infusion; however, if a background regimen-specific corticosteroid (e.g., dexamethasone) is administered the day after the daratumumab infusion; however, if a background regimen-specific corticosteroid (e.g. dexamethasone, prednisone) is administered the day after the daratumumab infusion, additional post-infusion medications may not be needed.

Comments:
-For dosing instructions of combination agents administered with this drug see the manufacturer product information.
-If a planned dose is missed, administer the dose as soon as possible and adjust the dosing schedule accordingly, maintaining the treatment interval.
-For any patients with a history of chronic obstructive pulmonary disease, post-infusion medications such as short and long-acting bronchodilators and inhaled corticosteroids should be prescribed; following the first 4 infusions, if the patient experiences no major IRRs, these additional inhaled post-infusion medications may be discontinued.
-Initiate antiviral prophylaxis to prevent herpes zoster reactivation within 1 week after starting this drug and continue for 3 months following discontinuation of therapy.

Uses:
-In combination with bortezomib, melphalan, and prednisone for patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant.
-In combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for patients with multiple myeloma who have received at least 1 prior therapy.
-In combination with pomalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received at least 2 prior therapies including lenalidomide and a proteasome inhibitor.
-As monotherapy, for the treatment of patients with multiple myeloma who have received at least 3 prior lines of therapy including a proteasome inhibitor (PI) and an immunomodulatory agent or who are double-refractory to a PI and an immunomodulatory agent.

Renal Dose Adjustments

No adjustment recommended.

Liver Dose Adjustments

Mild hepatic impairment: No adjustment recommended.
Moderate to severe hepatic impairment: Data not available

Dose Adjustments

No dose reductions of daratumumab are recommended. Dose delay may be required to allow recovery of blood cell counts in the event of hematological toxicity. For information concerning drugs given in combination, refer to the manufacturer prescribing information.

For infusion related reactions (IRRs) of any grade/severity, interrupt the infusion and manage symptoms (this may require further reduction in the rate of infusion or discontinuation of therapy):
-Grade 1 to 2 (mild to moderate): After symptoms resolve, resume the infusion at no more than half the rate at which the IRR occurred; if the patient experiences no further IRRs, infusion rate escalation may resume at increments up to the maximum rate of 200 mL/hour.
-Grade 3 (severe): After symptoms resolve, restart the infusion at no more than half the rate at which the IRR occurred; if the patient experiences no further IRRs, resume infusion rate escalation as outlined above in the "Manufacturer recommended infusion rates and management of IRRs". Repeat this procedure in the event of recurrence of Grade 3 symptoms. Permanently discontinue therapy upon the third occurrence of a Grade 3 or greater IRR.
-Grade 4 (life threatening): Permanently discontinue therapy.

Precautions

CONTRAINDICATIONS:
-None

Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration information:
-This drug should be administered by a healthcare professional, with immediate access to emergency equipment and appropriate medical support to manage IRRs.
-Administer only as an IV infusion after dilution.

Reconstitution/preparation/storage advice:
-The manufacturer product information should be consulted.

Patient advice:
-The patient should be instructed to read the patient labeling.
-Patients should be advised to seek immediate medical attention for any signs of infusion reactions (i.e., itchy, runny or blocked nose, chills, nausea, throat irritation, cough, headache, shortness of breath, or difficulty breathing).
-Patients should be advised to inform healthcare providers including blood transfusion centers/personnel that they are taking this drug, in the event of a planned transfusion.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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