Daratumumab

Generic name: daratumumab
Brand name: Darzalex
Dosage form: intravenous solution (20 mg/mL)
Drug class: CD38 monoclonal antibodies

Medically reviewed by  A Ras MD.

What is daratumumab?

Daratumumab is a prescription medicine that is used to treat multiple myeloma.

Description

Daratumumab is an immunoglobulin G1 kappa (IgG1κ) human monoclonal antibody that binds to CD38 antigen. It is produced in Chinese Hamster Ovary (CHO) cells using recombinant DNA technology. The molecular weight of daratumumab is approximately 148 kDa.

DARZALEX® (daratumumab) injection is supplied as a colorless to pale yellow preservative-free solution for intravenous use in a single-dose vial. The pH is 5.5.

Each DARZALEX 20 mL single-dose vial contains (NDC 57894-502-20) 400 mg daratumumab, glacial acetic acid (3.7 mg), mannitol (510 mg), polysorbate 20 (8 mg), sodium acetate trihydrate (59.3 mg), sodium chloride (70.1 mg), and Water for Injection, USP.

Each DARZALEX 5 mL single-dose vial contains (NDC 57894-502-05) 100 mg daratumumab, glacial acetic acid (0.9 mg), mannitol (127.5 mg), polysorbate 20 (2 mg), sodium acetate trihydrate (14.8 mg), sodium chloride (17.5 mg), and Water for Injection, USP.

Each DARZALEX 20 mL single-dose vial contains (NDC 57894-505-20) 400 mg daratumumab, L-histidine (7 mg), L-histidine hydrochloride monohydrate (32.6 mg), L-methionine (20 mg), polysorbate 20 (8 mg), sorbitol (1093 mg), and Water for Injection, USP.

Each DARZALEX 5 mL single-dose vial contains (NDC 57894-505-05) 100 mg daratumumab, L-histidine (1.8 mg), L-histidine hydrochloride monohydrate (8.2 mg), L-methionine (5 mg), polysorbate 20 (2 mg), sorbitol (273.3 mg), and Water for Injection, USP.

 Mechanism of Action

CD38 is a transmembrane glycoprotein (48 kDa) expressed on the surface of hematopoietic cells, including multiple myeloma and other cell types and tissues and has multiple functions, such as receptor mediated adhesion, signaling, and modulation of cyclase and hydrolase activity. Daratumumab is an IgG1κ human monoclonal antibody (mAb) that binds to CD38 and inhibits the growth of CD38 expressing tumor cells by inducing apoptosis directly through Fc mediated cross linking as well as by immune-mediated tumor cell lysis through complement dependent cytotoxicity (CDC), antibody dependent cell mediated cytotoxicity (ADCC) and antibody dependent cellular phagocytosis (ADCP). A subset of myeloid derived suppressor cells (CD38+MDSCs), regulatory T cells (CD38+Tregs) and B cells (CD38+Bregs) are decreased by daratumumab.

Before taking daratumumab, tell your doctor:

  • If you are allergic to daratumumab; any part of this medicine; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.

This medicine may interact with other drugs or health problems.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take daratumumab with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take daratumumab?

  • Tell all of your health care providers that you take daratumumab. This includes your doctors, nurses, pharmacists, and dentists.
  • Infusion reactions have happened with daratumumab. Sometimes, these could be very bad or life-threatening. Talk with the doctor.
  • Other drugs may be given to help with infusion side effects.
  • You may need to take another drug to prevent herpes zoster (shingles). Talk with your doctor.
  • This medicine may affect certain lab tests. This may last for up to 6 months after your last dose. Be sure your doctor and lab workers know you take daratumumab.
  • Have blood work checked as you have been told by the doctor. Talk with the doctor.
  • You may have more chance of getting an infection. Wash hands often. Stay away from people with infections, colds, or flu.
  • You may bleed more easily. Be careful and avoid injury. Use a soft toothbrush and an electric razor.
  • If you have taken daratumumab and you are getting a blood transfusion, talk with your doctor.
  • If you have had hepatitis B before or carry the virus, talk with your doctor. This medicine can cause the virus to become active again.
  • This medicine may cause harm to the unborn baby if you take it while you are pregnant.
  • Women must use birth control while taking daratumumab and for some time after the last dose. Ask your doctor how long to use birth control. If you get pregnant, call your doctor right away.
  • If you used daratumumab when you were pregnant, tell your baby’s doctor.
  • Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

How is daratumumab best taken?

Use daratumumab as ordered by your doctor. Read all information given to you. Follow all instructions closely.

  • It is given as an infusion into a vein over a period of time.

What do I do if I miss a dose?

  • Call your doctor to find out what to do.

What are the side effects of daratumumab that I need to call my doctor about immediately?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Signs of infection like fever, chills, very bad sore throat, ear or sinus pain, cough, more sputum or change in color of sputum, pain with passing urine, mouth sores, or wound that will not heal.
  • Any unexplained bruising or bleeding.
  • Feeling very tired or weak.
  • Shortness of breath.
  • Headache.
  • Dizziness or passing out.
  • Runny or stuffy nose.
  • Chest pain.
  • A burning, numbness, or tingling feeling that is not normal.
  • Swelling in the arms or legs.

What are some other side effects of daratumumab?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

  • Feeling tired or weak.
  • Back pain.
  • Joint pain.
  • Pain in arms or legs.
  • Signs of a common cold.
  • Nose or throat irritation.
  • Constipation.
  • Muscle spasm.
  • Trouble sleeping.
  • Diarrhea, throwing up, upset stomach, and feeling less hungry are common with daratumumab. If these happen, talk with your doctor about ways to lower these side effects. Call your doctor right away if any of these effects bother you, do not get better, or get very bad.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If overdose is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out daratumumab?

  • If you need to store daratumumab at home, talk with your doctor, nurse, or pharmacist about how to store it.

 

Label

PRINCIPAL DISPLAY PANEL – 100 MG/5 ML VIAL CARTON

  • NDC 57894-502-05
  • DARZALEX®
    (daratumumab)
    Injection
    100 mg/5 mL
    (20 mg/mL)
  • For Intravenous Infusion Only
    Dilute Before UseRx only

    Single-dose vial.
    Discard Unused Portion

  • janssen
PRINCIPAL DISPLAY PANEL - 100 mg/5 mL Vial Carton

 

SRC: NLM .