Usual Adult Dose for Multiple Myeloma

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

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

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

• Consult the manufacturer product information for dosing as part of other combination therapies.
• 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.
• Consult manufacturers prescribing information for pre-medication and post-medication recommendations when used as part of a combination therapy.

• 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.

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

Precautions

CONTRAINDICATIONS:

• Hypersensitivity to the active component or any of the ingredients

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 IV.
• Administer medications before and after administration of this drug to minimize administration-related reactions.
• Type and screen patients prior to starting this drug.

• Store in the refrigerator at 2C to 8C (36F to 46F).
• If not used immediately, store the solution for up to 4 hours at ambient temperature and ambient light.
• Discard after 4 hours, if not used.

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

• 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 pain is not alleviated by pausing or slowing down 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.

• 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 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.