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Daratumumab (Intravenous route)

Pronunciation:

dar-a-TOOM-ue-mab

Brand Names:

  • Darzalex

Dosage Forms:

  • Solution

Classifications:

Therapeutic

Antineoplastic Agent

Pharmacologic

Monoclonal Antibody

Uses of This Medicine:

Daratumumab injection is used to treat multiple myeloma (a type of bone marrow cancer). It is used in patients who have received at least 3 prior treatments that did not work well, including a proteasome inhibitor and an immunomodulatory agent, or who did not respond to both a proteasome inhibitor and an immunomodulatory agent.

This medicine is to be given only by or under the supervision of your doctor.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children

Appropriate studies have not been performed on the relationship of age to the effects of daratumumab injection in the pediatric population. Safety and efficacy have not been established.

Older adults

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of daratumumab injection in the elderly.

Breast-feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Other interactions

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

  • Breathing problems, history of Use with caution. May make this condition worse.
  • Herpes zoster infection (shingles) May reactivate this condition.

Proper Use of This Medicine:

A nurse or other trained health professional will give you this medicine in a hospital or cancer clinic. This medicine is given through a needle placed in a vein.

This medicine needs to be given on a fixed schedule. Be sure to keep all appointments.

This medicine should come with a patient information leaflet. It is very important that you read and understand this information. Be sure to ask your doctor about anything you do not understand.

You may receive medicine to prevent shingles within 1 week of starting treatment with daratumumab and continue for 3 months after treatment.

You may also receive medicines (eg, acetaminophen, diphenhydramine, methylprednisolone) to help prevent unwanted reactions to the injection.

Precautions While Using This Medicine:

It is very important that your doctor check you at regular visits while you are receiving this medicine to make sure that the medicine is working properly. Blood tests may be needed to check for unwanted effects.

Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant during treatment and for at least 3 months after your last dose. If you think you have become pregnant while using the medicine, tell your doctor right away.

This medicine may cause an infusion reaction, which can be life-threatening and requires immediate medical attention. Tell your doctor right away if you have chills, cough or wheezing, dizziness or lightheadedness, headache, itching, nausea or vomiting, runny or stuffy nose, a rash or hives, shortness of breath or trouble breathing, or sore throat while you are receiving this medicine.

Make sure any doctor who treats you knows that you are using daratumumab. This medicine may affect the results of certain medical tests including tests to determine your blood type. These effects may last up to 6 months after your last dose. Tell all of your healthcare providers that you are receiving this medicine before you receive a blood transfusion.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

More common
Blurred vision
body aches or pain
chest pain or tightness
dizziness
ear congestion
fever or chills
facial swelling
headache
loss of voice
nausea or vomiting
nervousness
pounding in the ears
shortness of breath
slow or fast heartbeat
sneezing
sore throat
stuffy or runny nose
trouble breathing
Less common
Confusion
dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
painful blisters on the trunk of body
skin rash, hives, or itching
sweating
unusual tiredness or weakness

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common
Back pain
constipation
cough
diarrhea
difficulty in moving
joint pain
loss of appetite
muscle pain or stiffness
nausea
pain in the arms or legs
vomiting

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.


Last Updated: 9/15/2016
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