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Generic Name: daratumumab (DAR a TOOM ue mab)
Brand Names: Darzalex

What is Darzalex?

Darzalex (daratumumab) is a monoclonal antibody that blocks a certain protein in the body that can affect tumor cell growth. Monoclonal antibodies are made to target and destroy only certain cells in the body. This may help to protect healthy cells from damage.

Darzalex is used to treat multiple myeloma (bone marrow cancer). It is usually given after other cancer medicines have been tried without success.

Darzalex is used alone when given to a person who has been treated with at least 3 prior cancer medicines.

For a person treated with only one prior cancer medicine, Darzalex may be given in combination with another cancer medicine (either lenalidomide or bortezomib) plus a steroid medicine called dexamethasone.

For a person treated with two prior cancer medicines, Darzalex may be given in combination with pomalidomide and dexamethasone.

Important information

If you need to receive a blood transfusion, be sure to tell your caregivers and the blood bank that you are being treated with Darzalex.

Before taking this medicine

You should not be treated with Darzalex if you are allergic to daratumumab.

To make sure this medicine is safe for you, tell your doctor if you have ever had:

  • a breathing disorder (chronic obstructive pulmonary disease - COPD); or

  • a history of herpes zoster (also called shingles).

Using Darzalex during pregnancy could harm the unborn baby. Tell your doctor if you are pregnant or if you become pregnant. Use effective birth control to prevent pregnancy while you are using this medicine and for at least 3 months after your last dose.

It is not known whether daratumumab passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

How is Darzalex given?

Darzalex is injected into a vein through an IV. A healthcare professional will give you this injection. This medicine must be injected slowly.

Darzalex is usually given every 1 to 3 weeks during the first several weeks of treatment. Then it is given once every 4 weeks until your body no longer responds to the medicine. How often you receive this medicine will depend on whether you are also receiving lenalidomide, pomalidomide or bortezomib.

Follow your doctor's dosing instructions very carefully. Your doctor will determine how long to treat you with this medicine.

You may be given medication to prevent certain side effects while you are receiving Darzalex.

While using this medicine, you may need frequent blood tests.

Daratumumab can affect blood tests that are used to match your blood type. If you need to receive a blood transfusion, be sure to tell your caregivers that you are being treated with Darzalex.

Daratumumab can affect blood type tests for up to 6 months after you stop using this medicine.

Darzalex dosing information

The recommended dose of daratumumab is 16 mg/kg actual body weight according to the following schedule.

Monotherapy and in combination with lenalidomide or pomalidomide and low-dose dexamethasone:

  • Weeks 1 to 8 - weekly (total of 8 doses)
  • Weeks 9 to 24 - every two weeks (total of 8 doses)
  • Week 25 onwards until disease progression - every four weeks

In combination with bortezomib and dexamethasone:

  • Weeks 1 to 9 - weekly (total of 9 doses)
  • Weeks 10 to 24 - every three weeks (total of 5 doses)
  • Week 25 onwards until disease progression - every four weeks

Dosage Information (comprehensive)

What happens if I miss a dose?

Call your doctor for instructions if you miss an appointment for your Darzalex injection.

What happens if I overdose?

Since this medicine is given by a healthcare professional in a medical setting, an overdose is unlikely to occur.

What should I avoid while receiving Darzalex?

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

Darzalex side effects

Get emergency medical help if you have signs of an allergic reaction to Darzalex: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Some side effects may occur during the injection. Tell your caregiver right away if you feel dizzy, itchy, nauseated, or if you have a headache, stuffy nose, runny nose, cough, throat irritation, fever, chills, wheezing, trouble breathing, or a tight feeling in your throat.

Call your doctor at once if you have:

  • fever, chills, cough with yellow or green mucus;

  • stabbing chest pain, wheezing, feeling short of breath;

  • a red or blistering skin rash;

  • nerve problems - numbness, tingling, burning pain; or

  • low count of blood cells - fever, chills, flu-like symptoms, swollen gums, mouth sores, skin sores, rapid heart rate, pale skin, easy bruising, unusual bleeding, feeling light-headed.

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

Common Darzalex side effects may include:

  • nausea, diarrhea;

  • shortness of breath;

  • nerve problems;

  • swelling in your hands or feet;

  • fever, feeling tired;

  • muscle spasms, back pain; or

  • cold symptoms such as stuffy nose, sneezing, cough, sore throat.

Daratumumab can cause severe infusion reactions. Approximately half of all patients experienced a reaction, most during the first infusion. Infusion reactions can also occur with subsequent infusions.

In data from three clinical studies including a total of 156 patients, four percent of patients discontinued treatment due to adverse reactions. The most frequently reported adverse reactions (incidence ≥20%) in clinical trials were: infusion reactions.

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 Janssen Biotech or the FDA at 1-800-FDA-1088.

Side Effects (complete list)

What other drugs will affect Darzalex?

Other drugs may interact with daratumumab, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

Where can I get more information?

  • Darzalex is manufactured by Janssen Biotech, Inc. Your doctor or pharmacist can provide more information about Darzalex.
  • Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use Darzalex only for the indication prescribed.
  • Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of health care professional. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of health care administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2017 Cerner Multum, Inc. Version: 4.01.

Date modified: August 03, 2017
Last reviewed: June 22, 2017