Generic name: Daratumumab 100mg in 5mL
Dosage form: injection, solution, concentrate
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Recommended Dose and Schedule
- Administer pre-infusion and post-infusion medications [see Dosage and Administration (2.2)].
- Administer only as an intravenous infusion after dilution [see Dosage and Administration (2.4)].
- DARZALEX should be administered by a healthcare professional, with immediate access to emergency equipment and appropriate medical support to manage infusion reactions if they occur [see Warnings and Precautions (5.1)].
The recommended dose of DARZALEX is 16 mg/kg body weight administered as an intravenous infusion according to the following dosing schedule.
|Weekly||Weeks 1 to 8|
|Every two weeks||Weeks 9 to 24|
|Every four weeks||Week 25 onwards until disease progression|
If a planned dose of DARZALEX is missed, administer the dose as soon as possible and adjust the dosing schedule accordingly, maintaining the treatment interval.
Administer DARZALEX infusion intravenously at the appropriate infusion rate. Consider incremental escalation of the infusion rate only in the absence of infusion reactions with the previous infusion of DARZALEX as defined in Table 2.
|Dilution volume||Initial rate (first hour)||Rate increment||Maximum rate|
|First infusion||1000 mL||50 mL/hour||50 mL/hour every hour||200 mL/hour|
|Second infusion*||500 mL||50 mL/hour||50 mL/hour every hour||200 mL/hour|
|Subsequent infusions†||500 mL||100 mL/hour||50 mL/hour every hour||200 mL/hour|
For infusion reactions of any grade/severity, immediately interrupt the DARZALEX infusion and manage symptoms. Management of infusion reactions may further require reduction in the rate of infusion, or treatment discontinuation of DARZALEX as outlined below [see Warnings and Precautions (5.1)].
- Grade 1–2 (mild to moderate): 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, infusion rate escalation may resume at increments and intervals as appropriate (Table 2).
- 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 outlined in Table 2. Repeat the procedure above in the event of recurrence of Grade 3 symptoms. Permanently discontinue DARZALEX upon the third occurrence of a Grade 3 or greater infusion reaction.
- Grade 4 (life threatening): Permanently discontinue DARZALEX treatment.
Recommended Concomitant Medications
Administer pre-infusion medications to reduce the risk of infusion reactions to all patients approximately 1 hour prior to every infusion of DARZALEX as follows:
- intravenous corticosteroid (methylprednisolone 100 mg, or equivalent dose of an intermediate-acting or long-acting corticosteroid), plus
- oral antipyretics (acetaminophen 650 to 1000 mg), plus
- oral or intravenous antihistamine (diphenhydramine 25 to 50 mg or equivalent).
Following the second infusion, the dose of corticosteroid may be reduced (methylprednisolone 60 mg intravenously).
Administer post-infusion medication to reduce the risk of delayed infusion reactions to all patients as follows:
- oral corticosteroid (20 mg methylprednisolone or equivalent dose of a corticosteroid in accordance with local standards) on the first and second day after all infusions.
For patients with a history of obstructive pulmonary disorder, consider prescribing post-infusion medications such as short and long-acting bronchodilators, and inhaled corticosteroids. Following the first four infusions, if the patient experiences no major infusion reactions, these additional inhaled post-infusion medications may be discontinued.
Prophylaxis for Herpes Zoster Reactivation
Initiate antiviral prophylaxis to prevent herpes zoster reactivation within 1 week of starting DARZALEX and continue for 3 months following treatment [see Adverse Reactions (6.1)].
Preparation for Administration
DARZALEX is for single use only.
Prepare the solution for infusion using aseptic technique as follows:
- Calculate the dose (mg), total volume (mL) of DARZALEX solution required and the number of DARZALEX vials needed based on patient actual body weight.
- Check that the DARZALEX solution is colorless to pale yellow. Do not use if opaque particles, discoloration or other foreign particles are present.
- Using aseptic technique, remove a volume of 0.9% Sodium Chloride Injection, USP from the infusion bag/container that is equal to the required volume of DARZALEX solution.
- Withdraw the necessary amount of DARZALEX solution and dilute to the appropriate volume by adding to the infusion bag/container containing 0.9% Sodium Chloride Injection, USP as specified in Table 2 [see Dosage and Administration (2.1)]. Infusion bags/containers must be made of polyvinylchloride (PVC), polypropylene (PP), polyethylene (PE) or polyolefin blend (PP+PE). Dilute under appropriate aseptic conditions. Discard any unused portion left in the vial.
- Gently invert the bag/container to mix the solution. Do not shake.
- Following dilution the infusion bag/container may be stored for up to 24 hours in a refrigerator at 2°C to 8°C (36°F to 46°F), protected from light. Do not freeze. After allowing the bag/container to come to room temperature, use immediately since DARZALEX solutions do not contain a preservative.
- Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. The diluted solution may develop very small, translucent to white proteinaceous particles, as daratumumab is a protein. Do not use if visibly opaque particles, discoloration or foreign particles are observed.
- Administer the diluted solution by intravenous infusion using an infusion set fitted with a flow regulator and with an in-line, sterile, non-pyrogenic, low protein-binding polyethersulfone (PES) filter (pore size 0.22 or 0.2 micrometer). Polyurethane (PU), polybutadiene (PBD), PVC, PP or PE administration sets must be used.
- Infusion should be completed within 15 hours.
- Do not store any unused portion of the infusion solution for reuse. Any unused product or waste material should be disposed of in accordance with local requirements.
- Do not infuse DARZALEX concomitantly in the same intravenous line with other agents.
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