Darzalex

Darzalex is a prescription medication used to treat multiple myeloma.

It belongs to a group of drugs called monoclonal antibodies. These work by helping certain cells in the immune system attack cancer cells.

This medication is available as an injection to be infused by a healthcare professional.

Common side effects of Darzalex include infusion-related reactions and fatigue.

Darzalex is a prescription medication used to treat multiple myeloma:

• Can be given in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, in those who have received at least one prior medicine to treat multiple myeloma.

• Can be given combination with pomalidomide and dexamethasone in those who have received at least two prior medicines to treat multiple myeloma, including lenalidomide and a proteasome inhibitor.

• Can be given alone in those who have received at least three specific medicines to treat multiple myeloma or did not respond to a proteasome inhibitor and an immunomodulatory agent. 

• Can be given in combination with the medicines bortezomib, melphalan and prednisone, in people with newly diagnosed multiple myeloma who cannot receive a type of stem cell transplant that uses their own stem cells (autologous stem cell transplant). 

It is not known if Darzalex is safe and effective in children.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

• Janssen Biotech, Inc.

Serious side effects have been reported with Darzalex. See the “Darzalex Precautions” section.

Common side effects of Darzalex include the following:

• infusion-related reactions
• fatigue
• nausea/vomiting
• back and joint pain
• fever
• cough
• trouble slepping
• swollen hands, ankles, or feet
• cols-like symptoms such as respiratory infection
• low blood counts (low white blood cells, low red blood cells (anemia) and/or low levels of blood platelets 

This is not a complete list of Darzalex side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

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

No drug interactions studies have been performed by the manufacturer. However, you should tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Not all drug interactions are known or reported and new drug interactions are continually being reported.

Serious side effects have been reported with Darzalex including the following:

• Infusion reactions. Infusion reactions can occur with this medication. Your doctor may give you certain medications before and after the infusion to help prevent developing a reaction. Tell your doctor or get medical help right away if you get any of these symptoms during or after an infusion this medication:

  • rash or hives (red itchy welts)
  • itching
  • swelling of your lips, tongue, throat or face
  • sudden cough
  • shortness of breath, difficulty breathing, or wheezing
  • nausea or vomiting
  • dizziness or feel faint
  • headache
  • runny or stuffy nose
• Changes in blood tests. Darzalex can change the results of certain blood tests that determine your blood type. Darzalex can affect these results for up to 6 months after you finish taking it. Your doctor will perform blood tests to determine your blood type before starting you on treatment with Darzalex. Tell all of your healthcare providers that you are taking Darzalex prior to receiving any blood transfusions.
• Decreases in blood cell counts. This medication can decrease white blood cell counts which help fight infections and blood cells called platelets which help to clot blood. Your doctor will check your blood cell counts during treatment. Tell your doctor if you develop fever or have signs of bruising or bleeding.

Do not take Darzalex if you are allergic to Darzalex or any of its ingredients.

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Darzalex, there are no specific foods that you must exclude from your diet when receiving this medication.

Before taking Darzalex, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to this medication or to any of its ingredients 
• currently have or have previously had any problems with your breathing
• have had shingles (herpes zoster)
• are pregnant or plan to become pregnant
• are breastfeeding or plan to breastfeed

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

Although there have not been any studies in humans or animals with Darzalex and therefore it is not known how this medication can affect unborn babies, monoclonal antibodies such as Darzalex cross the placenta and may cause harm to an unborn baby.

Females who are able to become pregnant should use an effective method of birth control during treatment with Darzalex and for at least 3 months after you finish taking Darzalex. Talk to your healthcare provider about which birth control methods are right for you.

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known if Darzalex crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using Darzalex.

Use Darzalex exactly as prescribed.

Darzalex comes in an injectable form to be infused directly into a vein (IV) by a healthcare professional in a medical setting.

The dosing regimen can follow a 3-week cycle, 4-week cycle, or a 6-week cycle. 

Your healthcare provider will determine how many treatments you need to receive.

Your healthcare provider will give you medicines before each dose of Darzalex and on the first day after each dose of Darzalex to help reduce the risk of infusion reactions. 

Your doctor will give you other medicines before you receive Darzalex and for the first and second day after you receive Darzalex to help lower your risk of having a reaction to the infusion. If you experience a reaction, your doctor may slow down the infusion or stop Darzalex completely.

If you miss an appointment to receive a dose of Darzalex, call your doctor as soon as possible to reschedule. 

The dose of Darzalex you receive will be based on your weight.

The recommended dose of Darzalex is 16 mg per kg of body weight. 

The dosing regimen can follow a 3-week cycle, 4-week cycle, or a 6-week cycle. 

If Darzalex is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.

Make sure to keep all your appointments with your healthcare providers and laboratory.