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Daratumumab Dosage

Applies to the following strength(s): 20 mg/mL

The information at Drugs.com is not a substitute for medical advice. Always consult your doctor or pharmacist.

Usual Adult Dose for:

Additional dosage information:

Usual Adult Dose for Multiple Myeloma

Recommended dose:
16 mg/kg IV once a week on weeks 1 thru 8, then 16 mg/kg IV every 2 weeks on weeks 9 thru 24, then 16 mg/kg IV every 4 weeks from week 25 onwards until disease progression

Manufacturer recommended infusion rates:
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
-COMMENT: Escalate only if there is no Grade 1 (mild) or greater infusion reactions during the first 3 hours of the first infusion.
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
-COMMENT: Escalate only if there is no Grade 1 (mild) or greater infusion reactions during a final infusion rate of 100 mL/hr or greater in the first 2 infusions.

Comments:
-If a planned dose is missed, administer the dose as soon as possible and adjust the dosing schedule accordingly, maintaining the treatment interval.
-Pre-medicate with corticosteroids, antipyretics and antihistamines (consult manufacturer product information or local protocol).
-Administer an oral corticosteroid as post-infusion medication to reduce the risk of delayed infusion reactions (consult manufacturer product information or local protocol).
-Interrupt the infusion for reactions of any severity.
-Permanently discontinue the infusion in case of life-threatening infusion reactions. For patients with a history of obstructive pulmonary disorder, consideration should be given to prescribing post-infusion medications such as short and long-acting bronchodilators, and inhaled corticosteroids.
-Antiviral prophylaxis should be initiated to prevent herpes zoster reactivation within 1 week of starting therapy and continued for 3 months following treatment.

Use: 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

For infusion reactions of any grade/severity, the infusion should be interrupted immediately and symptoms managed. Management of infusion reactions may further require reduction in the rate of infusion, or treatment discontinuation as outlined below:
-Grade 1 or 2 (mild to moderate) infusion reaction: Once reaction symptoms resolve, resume the infusion at no more than half the rate at which the reaction occurred. If the patient does not experience any further reaction symptoms, the infusion rate escalation may resume at increments and intervals as appropriate.
-Grade 3 (severe): If the intensity of the reaction decreases to Grade 2 or lower, consider restarting the infusion at no more than half the rate at which the reaction occurred. If the patient does not experience additional symptoms, resume infusion rate escalation at increments and intervals as appropriate. Repeat the procedure in the event of recurrence of Grade 3 symptoms. Permanently discontinue therapy upon the third occurrence of a Grade 3 or greater infusion reaction.
-Grade 4 (life threatening): Permanently discontinue therapy.

Precautions

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 infusion reactions if they occur.

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 healthcare providers including blood transfusion centers/personnel that they are taking this drug, in the event of a planned transfusion.

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