Daratumumab and hyaluronidase is used to treat multiple myeloma in adults.

Daratumumab and hyaluronidase can also be used to treat light chain amyloidosis in adults.

Daratumumab and hyaluronidase is sometimes used in combination with other medicines.

Daratumumab and hyaluronidase may also be used for purposes not listed in this medication guide.

daratumumab and hyaluronidase may harm an unborn baby. Use effective birth control to prevent pregnancy while using daratumumab and hyaluronidase and for at least 3 months after your last dose.

Carefully follow all instructions about the use of birth control while you are using daratumumab and hyaluronidase in combination with other medicines.

Daratumumab and hyaluronidase is injected under the skin. A healthcare provider will give you this injection.

You may be given other medications to help prevent serious side effects or an allergic reaction. Keep using these medicines for as long as your doctor has prescribed.

Daratumumab and hyaluronidase is usually given every 1 to 4 weeks until your body no longer responds to the medicine. Your doctor will determine how long to treat you with daratumumab and hyaluronidase, and how often you will receive an injection.

The injection is given under the skin of your stomach. Do not given any other injections (such as insulin) into the same place where your last daratumumab and hyaluronidase injection was given.

When used in combination with other medicines, the dosing schedules of the other medicines may be different from your daratumumab and hyaluronidase schedule.

You will need frequent medical tests, and your next dose may be delayed based on the results.

Daratumumab and hyaluronidase can have long lasting effects on your body, and can affect the results of certain medical tests for up to 6 months after your last dose. Make sure any doctor caring for you knows you were treated with this medicine.

If you've ever had hepatitis B, using daratumumab and hyaluronidase can cause this virus to become active or get worse. You may need frequent liver function tests while using this medicine and for several months after you stop.

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

Comments:
-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.

Uses:
For the treatment of adult 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.

You should not use this medicine if you are allergic to daratumumab or hyaluronidase.

Tell your doctor if you have ever had:

• heart problems (if you are being treated for light chain amyloidosis);

• breathing problems;

• hepatitis B; or

• herpes zoster (shingles).

Daratumumab and hyaluronidase may harm an unborn baby. Use effective birth control to prevent pregnancy while using this medicine and for at least 3 months after your last dose. Tell your doctor if you become pregnant.

Daratumumab and hyaluronidase is sometimes used in combination with lenalidomide. Both men and women using lenalidomide must use effective birth control. Even one dose can cause severe, life-threatening birth defects or death of a baby if the mother or the father is taking lenalidomide at the time of conception or during pregnancy.

Carefully follow all instructions about the use of birth control while you are using daratumumab and hyaluronidase in combination with other medicines.

Do not breastfeed. Ask a healthcare provider about how to feed your baby while using daratumumab and hyaluronidase.

Call your doctor for instructions if you miss an appointment for your daratumumab and hyaluronidase injection.

Try not to miss any doses of any other medicines you use in combination with daratumumab and hyaluronidase.

Since daratumumab and hyaluronidase is given by a healthcare professional in a medical setting, an overdose is unlikely to occur.

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Get emergency medical help if you have signs of an allergic reaction: itching, hives; runny or stuffy nose, fever, chills, headache, nausea, vomiting; throat irritation, cough, chest pain, fast heartbeats, wheezing, difficult breathing; swelling of your face, lips, tongue, or throat.

Some side effects may occur during or after the injection. Tell your medical caregiver if you feel dizzy, nauseated, light-headed, itchy, sweaty, or have a headache, chest tightness, back pain, trouble breathing, or swelling in your face.

Daratumumab and hyaluronidase may cause serious side effects. Call your doctor at once if you have:

• a light-headed feeling, like you might pass out;

• easy bruising, unusual bleeding, purple or red spots under your skin;

• right-sided upper stomach pain, vomiting, loss of appetite, yellowing of your skin or eyes, and not feeling well;

• heart problems--abnormal heart rhythm, chest pain, feeling faint, shortness of breath, or swollen legs;

• low blood cell counts--fever, easy bruising, unusual bleeding; or

• a lung infection--fever, chills, cough with mucus, chest pain, feeling short of breath.

Your cancer treatments may be delayed or permanently discontinued if you have certain side effects.

Common side effects of daratumumab and hyaluronidase may include:

• swollen hands, ankles, or feet;

• itching, swelling, bruising, or redness where the medicine was injected;

• nausea, vomiting, diarrhea, constipation;

• fever, low blood cell counts;

• severe headache, blurred vision, pounding in your neck or ears;

• trouble breathing, cough, lung infection;

• numbness, tingling, or burning pain in your hands or feet;

• tiredness;

• cold symptoms such as stuffy nose, sneezing, sore throat;

• muscle spasm, back pain; or

• sleep problems (insomnia).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Other drugs may affect daratumumab and hyaluronidase, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.