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daratumumab

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

What is daratumumab?

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.

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

Daratumumab 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 1 prior cancer medicine, daratumumab may be given in combination with another cancer medicine (either lenalidomide or bortezomib) plus a steroid medicine called dexamethasone.

Daratumumab 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.

Daratumumab may also be used for purposes not listed in this medication guide.

What is the most important information I should know about daratumumab?

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

What should I discuss with my healthcare provider before receiving daratumumab?

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

To make sure daratumumab is safe for you, tell your doctor if you have:

  • a breathing disorder; or

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

Using daratumumab 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 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 daratumumab given?

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

Daratumumab 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 daratumumab will depend on whether you are also receiving lenalidomide or bortezomib.

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

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

While using daratumumab, 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 daratumumab.

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

What happens if I miss a dose?

Call your doctor for instructions if you miss an appointment for your daratumumab 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 daratumumab?

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

Daratumumab side effects

Get emergency medical help if you have signs of an allergic reaction: 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, cough, throat irritation, 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 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 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.

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)

Daratumumab dosing information

Usual Adult Dose for Multiple Myeloma:

Monotherapy and combination therapy with lenalidomide and low-dose dexamethasone (4-week cycle regimen):
-Weeks 1 to 8: 16 mg/kg once a week
-Weeks 9 to 24: 16 mg/kg once every 2 weeks
-Weeks 25 and beyond: 16 mg/kg once every 4 weeks until disease progression

Combination therapy with bortezomib and dexamethasone (3-week cycle regimen):
-Weeks 1 to 9: 16 mg/kg once a week (total of 9 doses)
-Weeks 10 to 24: 16 mg/kg every 3 weeks (total of 5 doses)
-Weeks 25 and beyond: 16 mg/kg every 4 weeks

Comments:
-Pre-and post-infusion medications should be given prior to initiating therapy with this drug.
-For dosing instructions of combination agents administered with this drug see the manufacturer product information.
-If a planned dose is missed, administer the dose as soon as possible and adjust the dosing schedule accordingly, maintaining the treatment interval.

Manufacturer recommended infusion rates and management of infusion related reactions (IRRs):
FIRST INFUSION:
-Dilution volume: 1000 mL
-Initial rate (first hour): 50 mL/hr
-Rate increment: 50 mL/hr every hour
-Maximum rate: 200 mL/hr
SECOND INFUSION:
-Dilution volume: 500 mL
-Initial rate (first hour): 50 mL/hr
-Rate increment: 50 mL/hr every hour
-Maximum rate: 200 mL/hr
SUBSEQUENT INFUSIONS:
-Dilution volume: 500 mL
-Initial rate (first hour): 100 mL/hr
-Rate increment: 50 mL/hr every hour
-Maximum rate: 200 mL/hr
COMMENTS:
-Consider incremental escalation of the infusion rate only in the absence of IRRs.
-Use a dilution volume of 500 mL only if there were no Grade 1 (mild) or greater IRRs during the first 3 hours of the first infusion; otherwise, continue to use a dilution volume of 1000 mL and instructions for the first infusion.
-Use a modified initial rate for subsequent infusions (i.e., third infusion and onward) only if there were no Grade 1 (mild) or greater IRRs during a final infusion rate of 100 mL/hr or greater in the first 2 infusions; otherwise, continue to use instructions for the second infusion.

Premedications:
Premedicate approximately 1 to 3 hours prior to every infusion:
1) Corticosteroid (long- or intermediate-acting);
-Monotherapy: Methylprednisolone (or equivalent) 100 mg IV; following the second infusion, the dose of corticosteroid may be reduced (oral or IV methylprednisolone 60 mg).
-Combination therapy: Administer 20 mg dexamethasone prior to every infusion (give IV prior to the first infusion and oral administration may be considered prior to subsequent infusions).
2) Antipyretic: Acetaminophen 650 to 1000 mg orally
3) Antihistamine: Diphenhydramine (or equivalent) 25 to 50 mg orally or IV

Post-infusion medication (administer post-infusion medication to reduce the risk of delayed IRRs to all patients):
-Monotherapy: Administer an oral corticosteroid (20 mg methylprednisolone) or equivalent, on each of the 2 days following all infusions (beginning the day after the infusion).
-Combination therapy: Administer low-dose oral methylprednisolone (20 mg or less) or equivalent, the day after the infusion; however, if a background regimen-specific corticosteroid (e.g., dexamethasone) is administered the day after the infusion, additional post-infusion medications may not be needed.

Comments:
-For dosing instructions of combination agents administered with this drug see the manufacturer product information.
-If a planned dose is missed, administer the dose as soon as possible and adjust the dosing schedule accordingly, maintaining the treatment interval.
-For any patients with a history of chronic obstructive pulmonary disease, post-infusion medications such as short and long-acting bronchodilators and inhaled corticosteroids should be prescribed; following the first 4 infusions, if the patient experiences no major IRRs, these additional inhaled post-infusion medications may be discontinued.
-Initiate antiviral prophylaxis to prevent herpes zoster reactivation within 1 week after starting this drug and continue for 3 months following discontinuation of therapy.

Uses:
-In combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of patients with multiple myeloma who have received at least one prior therapy
-As monotherapy, 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

What other drugs will affect daratumumab?

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 daratumumab.
  • Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication 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 healthcare practitioners. 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 healthcare 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 1996-2012 Cerner Multum, Inc. Version: 2.01.

Date modified: May 03, 2017
Last reviewed: December 09, 2016

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