Daratumumab Test2

Daratumumab Test2
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: AKT

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Overview

Daratumumab Test2 is an antineoplastic agent that is FDA approved for the treatment of multiple myeloma. Common adverse reactions include fatigue, headache, nausea, diarrhea, constipation, decreased appetite, vomiting, lymphocytopenia, neutropenia, thrombocytopenia, anemia, back pain, arthralgia, leg pain, musculoskeletal chest pain, cough, nasal congestion, dyspnea, nasopharyngitis, pneumonia, and infusion-related reaction.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Daratumumab is indicated for, in combination with lenalidomide and dexamethasone or bortezomib and dexamethasone, treatment of patients with multiple myeloma who have received at least one prior therapy; for, in combination with pomalidomide and dexamethasone, treatment of patients with multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor; and as monotherapy, for the treatment of patients with multiple myeloma who have received at least three 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.

Multiple Myeloma

• Administer post-infusion medication to reduce the risk of delayed infusion reactions to all patients as follows:
  • Administer corticosteroids (monotherapy: methylprednisolone 100 mg, or equivalent, administered intravenously. Following the second infusion, the dose of corticosteroid may be reduced (oral or intravenous methylprednisolone 60 mg) or combination therapy: administer 20 mg dexamethasone prior to every daratumumab infusion. Dexamethasone is given intravenously prior to the first daratumumab infusion and oral administration may be considered prior to subsequent infusions), antipyretics (oral acetaminophen 650 to 1000 mg), and antihistamine (oral or intravenous diphenhydramine 25 to 50 mg or equivalent) to reduce the risk of infusion reactions to all patients 1–3 hours prior to every infusion of daratumumab.
• Administer post-infusion medication to reduce the risk of delayed infusion reactions to all patients as follows:
  • Monotherapy: Administer 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: Consider administering low-dose oral methylprednisolone (≤ 20 mg) or equivalent, the day after the daratumumab infusion. However, if a background regimen-specific corticosteroid (e.g. dexamethasone) is administered the day after the daratumumab infusion, additional post-infusion medications may not be needed.
  • In addition, for any patients with a history of chronic obstructive pulmonary disease, 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.
• Initiate antiviral prophylaxis to prevent herpes zoster reactivation within 1 week after starting daratumumab and continue for 3 months following treatment.
• Dosing Information
  • Administer only as an intravenous infusion after dilution in 0.9% Sodium Chloride Injection, USP. Daratumumab should be administered by a healthcare professional, with immediate access to emergency equipment and appropriate medical support to manage infusion reactions if they occur.
  • The recommended dose of daratumumab for monotherapy and combination therapy with lenalidomide or pomalidomide and low-dose dexamethasone (4-week cycle regimens) is 16 mg/kg actual body weight administered as an intravenous infusion according to the following dosing schedule

    

    This image is provided by the National Library of Medicine.

  • The recommended dose of daratumumab for combination therapy with bortezomib and dexamethasone (3-week cycle regimen) is 16 mg/kg actual body weight administered as an intravenous infusion according to the following dosing schedule

    

    This image is provided by the National Library of Medicine.

  • If a planned dose of daratumumab is missed, administer the dose as soon as possible and adjust the dosing schedule accordingly, maintaining the treatment interval.
  • Administer daratumumab infusion intravenously at the infusion rate described below. Consider incremental escalation of the infusion rate only in the absence of infusion reactions.

    

    This image is provided by the National Library of Medicine.

• For infusion reactions of any grade/severity, immediately interrupt the daratumumab infusion and manage symptoms. Management of infusion reactions may further require reduction in the rate of infusion, or treatment discontinuation of daratumumab as outlined below:
  • 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 clinically appropriate up to the maximum rate of 200 mL/hour (Table 3).
  • Grade 3 (severe): Once reaction symptoms resolve, 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 3. Repeat the procedure above in the event of recurrence of Grade 3 symptoms. Permanently discontinue daratumumab upon the third occurrence of a Grade 3 or greater infusion reaction.
  • Grade 4 (life threatening): Permanently discontinue daratumumab treatment.
• 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.
• Daratumumab is for single use only. Prepare the solution for infusion using aseptic technique as follows:
  • Calculate the dose (mg), total volume (mL) of daratumumab solution required and the number of daratumumab vials needed based on patient actual body weight.
  • Check that the daratumumab solution is colorless to pale yellow. Do not use if opaque particles, discoloration or other foreign particles are present.
  • Remove a volume of 0.9% Sodium Chloride Injection, USP from the infusion bag/container that is equal to the required volume of daratumumab solution.
  • Withdraw the necessary amount of daratumumab 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 3. Infusion bags/containers must be made of either polyvinyl chloride (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.
  • 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.
  • Since daratumumab does not contain a preservative, administer the diluted solution immediately at room temperature 15°C–25°C (59°F–77°F) and in room light. Diluted solution may be kept at room temperature for a maximum of 15 hours (including infusion time).
  • If not used immediately, the diluted solution can be stored prior to administration for up to 24 hours at refrigerated conditions 2°C – 8°C (36°F–46°F) and protected from light. Do not freeze.
• Administer daratumumab as follows:
  • If stored in the refrigerator, allow the solution to come to room temperature. 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). Administration sets must be made of either polyurethane (PU), polybutadiene (PBD), PVC, PP or PE.
  • 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 daratumumab concomitantly in the same intravenous line with other agents.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Daratumumab Test2 in adult patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Daratumumab Test2 in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

There is limited information regarding Daratumumab Test2 FDA-Labeled Indications and Dosage (Pediatric) in the drug label.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Daratumumab Test2 in pediatric patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Daratumumab Test2 in pediatric patients.

Contraindications

There is limited information regarding Daratumumab Test2 Contraindications in the drug label.

Warnings

There is limited information regarding Daratumumab Test2 Warnings' in the drug label.

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Daratumumab Test2 Clinical Trials Experience in the drug label.

Postmarketing Experience

There is limited information regarding Daratumumab Test2 Postmarketing Experience in the drug label.

Drug Interactions

There is limited information regarding Daratumumab Test2 Drug Interactions in the drug label.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): There is no FDA guidance on usage of Daratumumab Test2 in women who are pregnant.
Pregnancy Category (AUS): There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Daratumumab Test2 in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Daratumumab Test2 during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Daratumumab Test2 in women who are nursing.

Pediatric Use

There is no FDA guidance on the use of Daratumumab Test2 in pediatric settings.

Geriatic Use

There is no FDA guidance on the use of Daratumumab Test2 in geriatric settings.

Gender

There is no FDA guidance on the use of Daratumumab Test2 with respect to specific gender populations.

Race

There is no FDA guidance on the use of Daratumumab Test2 with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Daratumumab Test2 in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Daratumumab Test2 in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Daratumumab Test2 in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Daratumumab Test2 in patients who are immunocompromised.

Administration and Monitoring

Administration

There is limited information regarding Daratumumab Test2 Administration in the drug label.

Monitoring

There is limited information regarding Daratumumab Test2 Monitoring in the drug label.

IV Compatibility

There is limited information regarding the compatibility of Daratumumab Test2 and IV administrations.

Overdosage

There is limited information regarding Daratumumab Test2 overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.

Pharmacology

There is limited information regarding Daratumumab Test2 Pharmacology in the drug label.

Mechanism of Action

There is limited information regarding Daratumumab Test2 Mechanism of Action in the drug label.

Structure

There is limited information regarding Daratumumab Test2 Structure in the drug label.

Pharmacodynamics

There is limited information regarding Daratumumab Test2 Pharmacodynamics in the drug label.

Pharmacokinetics

There is limited information regarding Daratumumab Test2 Pharmacokinetics in the drug label.

Nonclinical Toxicology

There is limited information regarding Daratumumab Test2 Nonclinical Toxicology in the drug label.

Clinical Studies

There is limited information regarding Daratumumab Test2 Clinical Studies in the drug label.

How Supplied

There is limited information regarding Daratumumab Test2 How Supplied in the drug label.

Storage

There is limited information regarding Daratumumab Test2 Storage in the drug label.

Images

Drug Images

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Patient Counseling Information

There is limited information regarding Daratumumab Test2 Patient Counseling Information in the drug label.

Precautions with Alcohol

Alcohol-Daratumumab Test2 interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

There is limited information regarding Daratumumab Test2 Brand Names in the drug label.

Look-Alike Drug Names

There is limited information regarding Daratumumab Test2 Look-Alike Drug Names in the drug label.

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.