Daratumumab / Hyaluronidase Dosage

Medically reviewed by Drugs.com. Last updated on Oct 3, 2022.

Applies to the following strengths: fihj 1800 mg-30,000 units/15 mL

Usual Adult Dose for:

Multiple Myeloma
Amyloidosis

Additional dosage information:

Renal Dose Adjustments
Liver Dose Adjustments
Dose Adjustments
Precautions
Dialysis
Other Comments

Usual Adult Dose for Multiple Myeloma

1800 mg/30,000 units (1800 mg daratumumab and 30,000 units hyaluronidase) (15 mL) administered subcutaneously over approximately 3 to 5 minutes

Duration of therapy:
For monotherapy or in combination with lenalidomide/dexamethasone, pomalidomide/dexamethasone or carfilzomib/dexamethasone:

Weeks 1 to 8: weekly (8 doses)
Weeks 9 to 24: every 2 weeks
Week 25 onward until disease progression: every 4 weeks

Comments:

Consult the manufacturer product information for dosing as part of other combination therapies.
Administer medications before and after administration of this drug to minimize administration-related reactions.
Consult manufacturers prescribing information for pre-medication and post-medication recommendations when used as part of a combination therapy.

Uses:

For the treatment of patients with multiple myeloma:
As monotherapy, in patients 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
In combination with lenalidomide and dexamethasone in newly diagnosed patients who are ineligible for autologous stem cell transplant and in patients with relapsed or refractory multiple myeloma who have received at least one prior therapy
In combination with bortezomib, melphalan and prednisone in newly diagnosed patients who are ineligible for autologous stem cell transplant
In combination with bortezomib and dexamethasone in patients who have received at least one prior therapy
In combination with bortezomib, thalidomide, and dexamethasone in newly diagnosed patients who are eligible for autologous stem cell transplant
In combination with pomalidomide and dexamethasone in patients who have received at least one prior line of therapy including lenalidomide and a proteasome inhibitor
In combination with carfilzomib and dexamethasone in patients with relapsed or refractory multiple myeloma who have received one to three prior lines of therapy

Usual Adult Dose for Amyloidosis

1800 mg/30,000 units (1800 mg daratumumab and 30,000 units hyaluronidase) (15 mL) administered subcutaneously over approximately 3 to 5 minutes

Duration of therapy:
In combination with bortezomib, cyclophosphamide, and dexamethasone:

Weeks 1 to 8: weekly (8 doses)
Weeks 9 to 24: every 2 weeks
Week 25 onward until disease progression or a maximum of 2 years: every 4 weeks

Comments:

This drug is not indicated and is not recommended for the treatment of patients with light chain (AL) amyloidosis who have NYHA Class IIIB or Class IV cardiac disease or Mayo Stage IIIB outside of controlled clinical trials.
Consult the manufacturer product information for dosing as part of other combination therapies.
Administer medications before and after administration of this drug to minimize administration-related reactions.
Consult manufacturers prescribing information for pre-medication and post-medication recommendations when used as part of a combination therapy.

Use: In combination with bortezomib, cyclophosphamide, and dexamethasone for the treatment of patients with newly diagnosed light chain (AL) amyloidosis

Renal Dose Adjustments

No adjustment recommended

Liver Dose Adjustments

Mild liver dysfunction: No adjustment recommended
Moderate liver dysfunction: Data not available
Severe liver dysfunction: Data not available

Dose Adjustments

No dose reductions are recommended.

Consider withholding dose to allow recovery of blood cell counts in the event of myelosuppression.

Precautions

CONTRAINDICATIONS:

Hypersensitivity to the active component or any of the ingredients

Safety and efficacy have not been established in children.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:

This drug should be administered by a healthcare provider.
This drug is for subcutaneous use only. Do not administer intravenously.
Type and screen patients prior to starting this drug.
Administer medications before and after administration of this drug to minimize administration-related reactions.
Premedicate patients with acetaminophen 650 to 1000 mg orally, diphenhydramine 25 to 50 mg (or equivalent) orally or IV, and a corticosteroid (long- or intermediate-acting) such as methylprednisolone 100 mg (or equivalent) oral or IV. Consider reducing the dose of methylprednisolone to 60 mg (or equivalent) following the second dose of this drug.
Post medicate patients with methylprednisolone 20 mg (or an equivalent dose of an intermediate- or long-acting corticosteroid) orally for 2 days, starting the day after the administration of this drug.

Storage requirements:

If not used immediately, store in the refrigerator at 2C to 8C (36F to 46F) for up to 24 hours or at room temperature at 15C to 25C (59F to 77F) for up to 12 hours under ambient light.
Do not freeze or shake.
Discard if storage time exceeds these limits.

Reconstitution/preparation techniques:

This drug is ready to use. It is not necessary to reconstitute.
The manufacturer product information should be consulted.

General:

Inject into the subcutaneous tissue of the abdomen approximately 3 inches [7.5 cm] to the right or left of the navel over approximately 3 to 5 minutes. No data are available on performing the injection at other sites of the body.
Rotate injection sites.
Never inject into areas where the skin is red, bruised, tender, hard or where there are scars.
Pause or slow down delivery rate if the patient experiences pain. In the event that pain is not alleviated by pausing or slowing down the delivery rate, a second injection site may be chosen on the opposite side of the abdomen to deliver the remainder of the dose.
Do not administer other subcutaneous medications at the same site.
Use of this drug for the treatment of light chain (AL) amyloidosis is approved under accelerated approval based on response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

Patient advice:

Read patient labeling for this drug initially and at the time of each refill.
Seek immediate medical attention for any of the following signs and symptoms of systemic administration-related reactions: itchy, runny, or blocked nose; chills, nausea, throat irritation, cough, headache, shortness of breath or difficulty breathing.
Contact your healthcare provider if you have a fever.
Contact your healthcare provider if you have bruising or bleeding.
Female patients should avoid becoming pregnant during treatment and for 3 months after.
Inform your healthcare provider of a known or suspected pregnancy.
If you need a blood transfusion, inform your healthcare provider and personnel at blood transfusion centers that you are taking this drug.
Inform your healthcare provider if you have ever had or might have a hepatitis B infection.