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DARZALEX FASPRO is the brand name for daratumumab and hyaluronidase-fihj and is available as a subcutaneous injection.

DARZALEX FASPRO is available as a subcutaneous injection that contains 1,800 mg daratumumab and 30,000 units hyaluronidase per 15 mL (120 mg and 2,000 units/mL).

DARZALEX FASPRO is an anti-CD38 monoclonal antibody and is used for the following:

Multiple myeloma:

• Given alone or in combination with certain other medications for people who haven’t responded well to previous treatments
• Given in combination with certain medications (other medications differ for people who can and can’t receive a stem-cell transplant)
• Light chain amyloidosis with certain other medications

DARZALEX FASPRO is an anti-CD38 monoclonal antibody. It treats multiple myeloma by targeting a specific protein called CD38 on the cells’ surface. Many cells, including healthy cells, have this protein. But multiple myeloma cells just have more of them. By binding to this protein, Darzalex Faspro attacks and kills the cancer cells, and also signals to the immune system to do the same. As a result, multiple myeloma cells can’t grow and spread as well. The hyaluronidase works by helping the active medication (daratumumab) get absorbed under the skin.

DARZALEX FASPRO is dosed as follows:

Multiple myeloma:

• When Darzalex Faspro is given alone, the typical dose is 1 injection once a week for 8 doses, then every 2 weeks for 8 doses, then every 4 weeks thereafter
• When Darzalex Faspro is given together with other anticancer medications, your provider will determine your dose and how often you receive it based on what medication combination you’re takin

Light chain amyloidosis:

• The typical dose is 1 injection once a week for 8 doses, then every 2 weeks for 8 doses, then every 4 weeks thereafter for a maximum of 2 years

DARZALEX FASPRO is a safe and effective treatment when used for FDA licensed indications. However, like all medications, they may give you unwanted side effects. You should always discuss potential side effects with your physician to ensure the medication is suitable and right for you.

Common side effects of DARZALEX FASPRO:

• Lower white blood cell counts
• Lower platelet counts
• Lower red blood cell counts
• Upper respiratory tract infections
• Tiredness
• Diarrhea
• Hypersensitivity reactions
• Fever
• Back pain

Serious side effects are rare with DARZALEX FASPRO. Contact your healthcare provider immediately if you experience any of the following.

• Serious reaction during infusion: fever, headache, stuffy nose, sore throat, cough, trouble breathing, fast heart beat, changes in blood pressure, chills, itching, rash, blurry or changes in vision
• Serious infections (from low white blood cell levels): fever, headache, sore throat, cough, body aches, chills, weakness, tiredness
• Heart problems (in people with amyloidosis): trouble breathing, swelling in legs, chest pain

• There are no major drug interactions listed for Darzalex Faspro. However, always let your physician and pharmacist know about any other medications or supplements (including prescribed and over-the-counter medications, vitamins, and dietary or herbal supplements) that you are currently taking

Janssen Pharmaceuticals

Based on the mechanism of action, Darzalex Faspro can cause fetal harm when administered to a pregnant woman. Women should use effective contraception during treatment with Darzalex Faspro and for 3 months after the last dose.

• Daratumumab And Hyaluronidase-FIHJ