Generic name:  daratumumab  [ DAR-a-TOOM-ue-mab ]
Drug class:  CD38 monoclonal antibodies

What is Darzalex?

Darzalex 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 sometimes given after other cancer treatments did not work or have stopped working.

Darzalex is sometimes used in combination with other cancer medicines plus a steroid medicine called  dexamethasone .

Warnings

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

If you’ve ever had hepatitis B, using daratumumab can cause this virus to become active or get worse. Tell your doctor if you don’t feel well and you have right-sided upper stomach pain, vomiting, loss of appetite, or yellowing of your skin or eyes.

Carefully follow all instructions about the use of birth control while you are using Darzalex in combination with other medicines.

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, nauseated, or if you have a  headache , stuffy nose,  runny nose , cough, fever, chills, wheezing, trouble breathing, or a tight feeling in your throat.

Call your doctor at once if you have:

• cough with yellow or green mucus;
• stabbing chest pain, wheezing, feeling short of breath;
• numbness, tingling, burning pain; or
• low blood cell counts – fever, chills, tiredness, mouth sores, skin sores, easy bruising, unusual bleeding, pale skin,  cold hands  and feet, feeling light-headed or short of breath.

Your cancer treatments may be delayed or permanently discontinued if you have certain side effects.

Common Darzalex side effects may include:

• nausea ,  diarrhea ,  constipation ;
• fever;
• shortness of breath;
• nerve problems causing tingling, numbness, or pain;
• feeling tired or weak;
• swelling in your hands, ankles, or feet; 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.

Darzalex side effects  (more detail)

Before taking this medicine

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

To make sure this medicine is safe for you, tell your doctor if you have ever had:

• hepatitis B;
• a breathing disorder; or
• herpes zoster  (also called  shingles ).

Daratumumab may harm an unborn baby. Tell your doctor if you are pregnant or if you 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.

Darzalex is sometimes used in combination with lenalidomide, pomalidomide, or thalidomide. Both men and women using these other drugs must use effective birth control. Even one dose can cause severe, life-threatening birth defects or death of a baby if the mother or the father is taking lenalidomide, pomalidomide, or thalidomide at the time of conception or during pregnancy.

Carefully follow all instructions about the use of birth control while you are using Darzalex in combination with other medicines.

It may not be safe to breastfeed while using this medicine. Ask your doctor about any risk.

How is Darzalex given?

Darzalex is given as an infusion into a vein. A healthcare provider will give you this injection.

Darzalex 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. Your doctor will determine how long to treat you with this medicine.

You may be given other medications to help prevent serious side effects or an allergic reaction. Keep using these medicines for as long as your doctor has prescribed.

You will need frequent medical 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 Darzalex.

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

If you’ve ever had hepatitis B, using Darzalex can cause this virus to become active or get worse. You may need frequent liver function tests while using this medicine and for several months after you stop.

Dosing information

The recommended dose of daratumumab is 16 mg/kg actual body weight according to the following schedule.

Monotherapy and in combination with lenalidomide or pomalidomide and low-dose dexamethasone:

• Weeks 1 to 8 – weekly (total of 8 doses)
• Weeks 9 to 24 – every two weeks (total of 8 doses)
• Week 25 onwards until disease progression – every four weeks

In combination with bortezomib and dexamethasone:

• Weeks 1 to 9 – weekly (total of 9 doses)
• Weeks 10 to 24 – every three weeks (total of 5 doses)
• Week 25 onwards until disease progression – every four weeks

Detailed Darzalex dosage information

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.

What other drugs will affect Darzalex?

Other drugs may interact with daratumumab, including prescription and over-the-counter medicines,  vitamins , and  herbal products . Tell your doctor about all your current medicines and any medicine you start or stop using.

source :: https://www.drugs.com/darzalex.html