Darzalex

Generic name: Daratumumab
Dosage form: infusion solution (100 mg/5 mL, 400 mg/20 mL)
Drug class: CD38 monoclonal antibodies

Usage of Darzalex

Darzalex (​​daratumumab) is used to treat multiple myeloma, which is a cancer of white blood cells called plasma cells. Darzalex can be used alone as a single therapy but is often used together with other medicines, Depending on your clinical situation. Darzalex is given as an infusion.

Darzalex works by blocking a protein called CD38 on myeloma cells, which reduces the growth of cancer.  Darzalex is from a class of medicines called CD38 monoclonal antibodies. 

Darzalex (​​daratumumab) is an infusion that is given into a vein over a period of hours by your healthcare provider. Darzalex Faspro is a different product. It contains both daratumumab and Hyaluronidase-fihj and is given suBCUTAneously over 3 to 5 minutes.

Darzalex side effects

Common Darzalex side effects of may include nausea, constipation, diarrhea, fever, shortness of breath, nerve problems causing tingling, numbness, or pain, feeling tired or weak, swelling in your hands, ankles, or feet and also cold symptoms such as stuffy nose, sneezing, cough, sore throat.

Serious Darzalex side effects

Get emergency medical help if you have signs of an allergic Reaction: hives, difficulty 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, or nauseated or if you have a headache, stuffy nose, runny nose, cough, fever, chills, wheezing, trouble breathing, or a tight feeling in your throat.

Darzalex may cause other serious side effects. 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.

    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 the FDA at 1-800-FDA-1088.

    Before taking Darzalex

    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:

  • a breathing disorder; or
  • herpes zoster (also called shingles) you may be prescribed antiviral medicine to prevent reactivation of shingles.
  • hepatitis B as hepatitis B virus may become active again. Tell your healthcare provider right away if you get worsening tiredness or yellowing of your skin or the white part of your eyes.
  • have hereditary fructose intolerance (HFI). This medicine contains sorbitol which is a source of fructose. People with HFI cannot break down fructose, which may cause serious side effects.

    • Pregnancy

    Darzalex

  • Daratumumab may harm an unborn baby.
  • Tell your healthcare provider right away if you become pregnant or think that you may be pregnant during treatment with this medicine.
  • Females who are able to become pregnant should use an effective method of birth control during treatment and for 3 months after their last dose of Darzalex. Talk to your healthcare provider about birth control methods that you can use during this time.

    • Darzalex 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.
  • Before starting Darzalex in combination with lenalidomide, pomalidomide, or thalidomide, females and males must agree to the instructions in the lenalidomide, pomalidomide, or thalidomide REMS program.
  • The lenalidomide, pomalidomide, and thalidomide REMS have more information about effective methods of birth control, pregnancy testing, and blood donation for females who can become pregnant.
  • For males who have female partners who can become pregnant, there is information in the lenalidomide, pomalidomide, and thalidomide REMS about sperm donation and how lenalidomide, pomalidomide, and thalidomide can pass into human semen.
  • Carefully follow all instructions about the use of birth control while you are using Darzalex in combination with other medicines.

    • Breastfeeding

    If you are breastfeeding or plan to breastfeed. It is not known if this medicine passes into your breast milk. You should not breastfeed during treatment with this medicine. Talk to your healthcare provider about the best way to feed your baby during treatment with Darzalex.

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    How to use Darzalex

    Usual Adult Dose for Multiple Myeloma

    Dosing schedule in combination with lenalidomide or pomalidomide (4-week cycle) and low-dose Dexamethasone and for monotherapy: 

  • Weeks 1 to 8: 16 mg/kg IV weekly (total of 8 doses).
  • Weeks 9 to 24: 16 mg/kg IV every 2 weeks (total of 8 doses); first dose of the every-2-week dosing schedule is given at Week 9.
  • Week 25 and onwards until disease progression: 16 mg/kg IV every 4 weeks; first dose of the every-4-week dosing schedule is given at Week 25.

    • Dosing schedule in combination with Bortezomib, melphalan, and prednisone 6-week cycle:

  • Weeks 1 to 6: 16 mg/kg IV weekly (total of 6 doses).
  • Weeks 7 to 54: 16 mg/kg IV every 3 weeks (total of 16 doses); first dose of the every-3-week dosing schedule is given at Week 7.
  • Week 55 onwards until disease progression: 16 mg/kg IV every 4 weeks; first dose of the every-4-week dosing schedule is given at Week 55.

    • Dosing schedule in combination with bortezomib, thalidomide, and dexamethasone 4-week cycle:

    Induction

  • Weeks 1 to 8: 16 mg/kg IV weekly (total of 8 doses).
  • Weeks 9 to 16: 16 mg/kg IV every 2 weeks (total of 4 doses); first dose of every-2-week dosing schedule is given at Week 9.
  • Stop for high dose chemotherapy and ASCT.

    • Consolidation

  • Weeks 1 to 8: 16 mg/kg IV every 2 weeks; first dose of the every-2-week dosing schedule is given at Week 1 upon reinitiation of therapy following ASCT.

    • Dosing schedule in combination with bortezomib and dexamethasone 3-week cycle: 

  • Weeks 1 to 9: 16 mg/kg IV weekly (total of 9 doses).
  • Weeks 10 to 24: 16 mg/kg IV every 3 weeks (total of 5 doses); first dose of every-3-week dosing schedule is given at Week 10.
  • Week 25 onwards until disease progression: 16 mg/kg IV every 4 weeks; first dose of the every-4-week dosing schedule is given at Week 25.

    • Dosing schedule with Carfilzomib and dexamethasone 4-week cycle:

  • Week 1: 8 mg/kg IV on Days 1 and 2 (total of 2 doses)
  • Weeks 2 to 8: 16 mg/kg IV weekly (total of 7 doses).
  • Weeks 9 to 24: 16 mg/kg IV every 2 weeks (total of 8 doses); first dose of the every-2-week dosing schedule is given at Week 9.
  • Week 25 onwards until disease progression: 16 mg/kg every 4 weeks; first dose of the every-4-week dosing schedule is given at Week 25.

    • Comments:

  • Dosing is based on actual body weight.
  • The first 16 mg/kg dose at Week 1 may be split over 2 consecutive days (i.e., 8 mg/kg on Day 1 and Day 2, respectively.
  • Pre-and post-infusion medications should be given prior to initiating therapy.

    • Warnings

    If you need to receive a blood transfusion, be sure to tell your caregivers that you are being treated with Darzalex as it can affect blood tests that are used to match your blood type. Darzalex can affect blood-typing tests for up to 6 months after you stop using this medicine.

    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. You may need frequent liver function tests while using this medicine and for several months after you stop.

    Men and women should carefully follow all instructions about the use of birth control while you are using Darzalex in combination with other medicines. See Pregnancy information below.

    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.

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