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Darzalex (Intravenous)

Generic Name: daratumumab (Intravenous route)

dar-a-TOOM-ue-mab

Commonly used brand name(s)

In the U.S.

  • Darzalex

Available Dosage Forms:

  • Solution

Therapeutic Class: Antineoplastic Agent

Pharmacologic Class: Monoclonal Antibody

Uses For Darzalex

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 also used in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, to treat patients with multiple myeloma who have received at least 1 previous treatment.

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

Before Using Darzalex

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.

Pediatric

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.

Geriatric

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.

Interactions with 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.

Interactions with Food/Tobacco/Alcohol

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 (eg COPD), history of or
  • Neutropenia (low number of white blood cells) or
  • Thrombocytopenia (low number of platelets)—Use with caution. May make this condition worse.
  • Herpes zoster infection (shingles)—May reactivate this condition.

Proper Use of Darzalex

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, dexamethasone, diphenhydramine, methylprednisolone) to help prevent unwanted reactions to the injection.

Precautions While Using Darzalex

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, 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.

Daratumumab can temporarily lower the number of white blood cells in your blood, increasing the chance of getting an infection. It can also lower the number of platelets, which are necessary for proper blood clotting. If this occurs, there are certain precautions you can take, especially when your blood count is low, to reduce the risk of infection or bleeding:

  • If you can, avoid people with infections. Check with your doctor immediately if you think you are getting an infection or if you get a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.
  • Check with your doctor immediately if you notice any unusual bleeding or bruising, black, tarry stools, blood in the urine or stools, or pinpoint red spots on your skin.
  • Be careful when using a regular toothbrush, dental floss, or toothpick. Your medical doctor, dentist, or nurse may recommend other ways to clean your teeth and gums. Check with your medical doctor before having any dental work done.
  • Do not touch your eyes or the inside of your nose unless you have just washed your hands and have not touched anything else in the meantime.
  • Be careful not to cut yourself when you are using sharp objects such as a safety razor or fingernail or toenail cutters.
  • Avoid contact sports or other situations where bruising or injury could occur.

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.

Darzalex Side Effects

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
Incidence not known
  • Black, tarry stools
  • bleeding gums
  • blood in the urine or stools
  • cough
  • lower back or side pain
  • painful or difficult urination
  • pale skin
  • pinpoint red spots on the skin
  • sore throat
  • ulcers, sores, or white spots in the mouth
  • unusual bleeding or bruising

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
  • diarrhea
  • difficulty with moving
  • joint pain
  • loss of appetite
  • muscle pain or stiffness
  • pain in the arms or legs

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.

Side Effects (complete list)

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