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.

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.

Use Darzalex Faspro (Daratumumab and Hyaluronidase) exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.

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.

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 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.

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