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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). Darzalex is usually given after other cancer medicines have been tried without success.

Darzalex was approved by the US Food and Drug Administration (FDA) on an "accelerated" basis. In clinical studies, patients with multiple myeloma responded to this medicine. However, further studies are needed.

Important information

If you need to receive a blood transfusion, be sure to tell your caregivers 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 Darzalex is safe for you, tell your doctor if you have:

  • a breathing disorder; 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 plan to become pregnant. Use effective birth control to prevent pregnancy while you are using Darzalex 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 provider will give you this injection. This medicine must be injected slowly, and the IV infusion can take about 15 hours to complete.

Darzalex is usually given once per week for the first 8 weeks of treatment. Then it is given once every 2 weeks for the next 16 weeks, and then once every 4 weeks until your body no longer responds to the medicine. Your doctor will determine how long to treat you with Darzalex.

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

Darzalex 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 daratumumab.

Darzalex can affect blood-typing tests for up to 6 months after you stop using this medicine.

Darzalex dosing information

Usual Adult Dose of Darzalex for Multiple Myeloma:

Recommended dose:
16 mg/kg IV once a week on weeks 1 thru 8, then 16 mg/kg IV every 2 weeks on weeks 9 thru 24, then 16 mg/kg IV every 4 weeks from week 25 onwards until disease progression

Manufacturer recommended infusion rates:
-Dilution volume: 1000 mL
-Initial rate (first hour): 50 mL/hr
-Rate increment: 50 mL/hr every hour
-Maximum rate: 200 mL/hr
-Dilution volume: 500 mL
-Initial rate (first hour): 50 mL/hr
-Rate increment: 50 mL/hr every hour
-Maximum rate: 200 mL/hr
-COMMENT: Escalate only if there is no Grade 1 (mild) or greater infusion reactions during the first 3 hours of the first infusion.
-Dilution volume: 500 mL
-Initial rate (first hour): 100 mL/hr
-Rate increment: 50 mL/hr every hour
-Maximum rate: 200 mL/hr
-COMMENT: Escalate only if there is no Grade 1 (mild) or greater infusion reactions during a final infusion rate of 100 mL/hr or greater in the first 2 infusions.

-If a planned dose is missed, administer the dose as soon as possible and adjust the dosing schedule accordingly, maintaining the treatment interval.
-Pre-medicate with corticosteroids, antipyretics and antihistamines (consult manufacturer product information or local protocol).
-Administer an oral corticosteroid as post-infusion medication to reduce the risk of delayed infusion reactions (consult manufacturer product information or local protocol).
-Interrupt the infusion for reactions of any severity.
-Permanently discontinue the infusion in case of life-threatening infusion reactions. For patients with a history of obstructive pulmonary disorder, consideration should be given to prescribing post-infusion medications such as short and long-acting bronchodilators, and inhaled corticosteroids.
-Antiviral prophylaxis should be initiated to prevent herpes zoster reactivation within 1 week of starting therapy and continued for 3 months following treatment.

Use: For the treatment of patients with multiple myeloma who have received at least 3 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

See also: Dosage Information (in more detail)

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, cold, nauseated, or if you have a headache, stuffy nose, runny nose, 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;

  • numbness, tingling, or burning pain;

  • a red or blistering skin rash; or

  • low blood cell counts - 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;

  • feeling tired;

  • back pain; or

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

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.

See also: Side effects (in more detail)

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?

  • 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 is accurate, up-to-date, and complete, but no guarantee is made to that effect. 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 healthcare practitioners. 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 1996-2016 Cerner Multum, Inc. Version: 1.01. Revision Date: 2016-01-09, 4:08:51 PM.