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Treatment Name: Daratumumab (Darzalex®)

Daratumumab (Darzalex®) is an Immunotherapy Regimen for Multiple Myeloma (MM)

How does daratumumab work?
Daratumumab is an antibody (a type of targeted drug therapy) that attaches to a specific protein commonly found on the surface of myeloma cells. When daratumumab binds to this protein on myeloma cells it marks the cell for destruction by your immune system-- these immune cells are known as macrophages.

Goals of therapy:
Daratumumab is not usually given to cure multiple myeloma, but rather to slow the progression of the disease and to improve symptoms of myeloma.

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Schedule

  • Daratumumab intravenous (I.V.) infusion on Day 1, once per week for 8 weeks in the initial part of treatment

Estimated total infusion time for this treatment:

  • Because of the possibility of experiencing infusion reactions, the very first infusion is given slowly and may take up to 8 hours. If you do not experience any infusion reactions with the first dose, the second is usually given with less total fluid volume and may take only 6 hours. If you do not experience any infusion reactions during the first two infusions, the remaining doses may be given faster and take only 4 hours or less
  • Infusion times are based on clinical studies, but may vary depending on doctor preference or patient tolerability. Pre-medications and intravenous (I.V.) fluids, such as hydration, may add more time

Daratumumab is usually given in an outpatient infusion center, allowing the person to go home afterwards. Daratumumab is given every week for the first 8 weeks of treatment, then every-other-week for 16 weeks, then every 4 weeks (monthly)

Click here for the common starting dose.

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Side Effects

In clinical studies, the most commonly reported side effects with daratumumab are shown here:

  • Fatigue (40%)
  • Runny nose (24%)
  • Fever (17%)
  • Sinus infection (17%)
  • Diarrhea (14%)
  • Shortness of breath (14%)
  • Increased bleeding risk [low platelet count; thrombocytopenia] (10%)
  • Low white blood cell count [neutropenia] (5%)
  • Pneumonia (5%)
  • Anemia [low red blood cell count] (5%)

Approximately 4% of patients discontinued daratumumab due to unacceptable side effects.

Side effect videos Side Effect Videos
Fatigue Fatigue DiarrheaDiarrheaBleedingBleedingAnemiaAnemiaNeutropenic FeverNeutropenic Fever

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Monitoring

How often is monitoring needed?
Labs (blood tests) may be checked before treatment and periodically during treatment. Labs often include: Complete Blood Count (CBC), Comprehensive Metabolic Panel (CMP), plus any others your doctor may order.

How often is imaging needed?
Imaging may be checked during treatment. Imaging may include: bone scans or magnetic resonance imaging (MRI).

How might blood test results/imaging affect treatment?
Depending upon the results, your doctor may advise to continue daratumumab as planned, or delay or switch therapy.

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ChemoExperts Tips

  • Approximately 50% of patients experience an infusion reaction, which most commonly occurs during the first dose (infusion reactions during subsequent or "later" doses are less likely). Acetaminophen (Tylenol®), an antihistamine such as diphenhydramine (Benadryl®), and a corticosteroid such as methylprednisolone (Solu-Medrol®) may be given approximately one hour before each dose of daratumumab to decrease the chance of an infusion reaction (example of an infusion reaction: shortness of breath, chills, headache, or fever)
  • A corticosteroid drug, such as dexamethasone or methylprednisolone, may be recommended to be taken after each infusion for two days to decrease the chance of experiencing a delayed infusion reaction
  • If you have an obstructive lung disorder such as COPD or emphysema, you may be instructed to use an inhaler after your infusion
  • Therapy with daratumumab can increase your risk of experiencing herpes zoster (shingles). An anti-viral medication such as acyclovir (Zovirax®) or valacyclovir (Valtrex®) may be prescribed to lessen your risk. Acyclovir commonly starts one week before treatment and continued without interruption until three months after daratumumab is stopped
  • Daratumumab interferes with testing for a person's blood type. This effect can last up to 6 months after completing therapy. Before your first infusion, you may have a "type-and-cross" performed to help determine what type of blood you can receive in case you need it in the future. Inform your healthcare provider that you are taking daratumumab if any blood transfusions are planned. Blood compatibility and blood transfusion can still be performed after you receive this drug
  • Daratumumab can affect the results of a test used to assess response to therapy called serum protein electrophoresis (SPEP). Additional testing may be needed to assess your response to therapy with daratumumab
  • A pharmacist should ALWAYS review your medication list to ensure that drug interactions are prevented or managed appropriately
  • Clinical trials may exist for multiple myeloma. Ask your doctor if any studies are currently enrolling in your area. If not, go to clinicaltrials.gov to search for other centers offering study medications

Patient Assistance & Co-payment Coverage

Patients under the age of 65 years, or those with private insurance plans:
If you have insurance and are looking for patient assistance or copay assistance for Daratumumab (Darzalex®), we have provided links that may help.

Visit our Patient Assistance page and click the links to various patient assistance programs for help paying for Daratumumab (Darzalex®). Depending upon your income, they may be able to help cover the cost of:

  • Daratumumab

For Branded medications (may be available for generic medications too), check with the manufacturer to determine if a co-pay card is offered and if it could reduce your monthly copay.

  • If you are uninsured, check with the manufacturer to determine if you are eligible to receive medication at no cost.

Medicare and Medicaid patients (Patients 65 years or older):
The clinic providing treatment will likely pre-authorize medications and immune therapies such as Daratumumab (Darzalex®) and are the best source to help you understand drug cost.

  • Ask to speak with a patient assistance technician or financial counselor at the clinic or hospital administering this therapy.

Emotional Wellness

What is Emotional Wellness?
Emotional wellness is having a positive outlook balanced with a realistic understanding of current life events. This requires both an awareness and acceptance of your emotions. It is with this knowledge that you can develop a plan to take the necessary actions to positively impact your life.

Emotional wellness uses an ongoing process to continually reflect on the stressors of life in a constructive manner to move forward and create happiness.

Because emotional wellness is deeply connected with physical, social, and spiritual wellness, pursuing it often becomes particularly difficult in times of major illness. Despite this difficulty, working toward emotional wellness has been connected to improved treatment outcomes and a higher likelihood of achieving goals of therapy.

Learn more about pursuing emotional wellness while receiving treatment with Daratumumab (Darzalex®)

Individual Drug Label Information

Daratumumab (Darzalex®)

  • Daratumumab is an intravenous infusion
  • Acetaminophen (Tylenol®), diphenhydramine (Benadryl®), and a corticosteroid such as methylprednisolone (Solu-Medrol®) will be given approximately one hour before each dose
  • A corticosteroid such as methylprednisolone (Solu-Medrol®) is taken on the first and second days after each infusion
  • An inhaler may been used after each treatment if you have an obstructive lung disorder such as COPD or emphysema
  • May increase your risk of experiencing herpes zoster (shingles). Acyclovir (Zovirax®) or valacyclovir (Valtrex®) may be taken to lessen your risk
  • Daratumumab interferes with testing that is done to determine what type of blood you can receive if you need a blood transfusion. Inform your healthcare provider that you are taking daratumumab if any blood transfusion are planned
  • Daratumumab can affect the results of a test used to assess response to therapy
  • Females who are of reproductive potential should use contraception during therapy and for at least 3 months after completing therapy
General Daratumumab (Darzalex) Side Effects
  • May cause fatigue
  • Can cause allergy symptoms such as a runny nose
  • Can cause an upper respiratory tract infection or a sinus infection Fever 
  • Diarrhea
  • Shortness of breath
  • Click on the daratumumab (Darzalex) package insert below for reported side effects and possible drug interactions

Side Effect Videos
DiarrheaDiarrheaFatigue Fatigue BleedingBleedingAnemiaAnemiaNeutropenic FeverNeutropenic Fever

See DailyMed package insert.

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References

Lokhorst HM, Plesner T, Laubach JP, et al. Targeting CD38 with daratumumab monotherapy in multiple myeloma. N Engl J Med 2015;373:1207-1219.

Created: June 1, 2016 Updated: September 20, 2016

What is Multiple Myeloma (MM)?

Multiple Myeloma is a disease of the white blood cells, called plasma cells, found in the blood or bone marrow. Plasma cells are a type of white blood cell known as a B-lymphocyte.

Sometimes plasma cells form collections on bone and weaken or destroy it. These are known as "lytic lesions". Multiple Myeloma is a rare condition with an unknown cause. The stage can vary at diagnosis and throughout treatment. Staging is based on the international staging system (ISS). The type and effectiveness of the treatment may depend upon the stage.

NOTE: Treatment Options listed below are not all-inclusive. Other treatments may be available. ChemoExperts provides drug information and does not recommend any one treatment over another. Only your Doctor can choose which therapy is appropriate for you.

What does "Cure" mean?

The word “cure” means there are no cancer cells left in the body and cancer will never come back. Depending on the cancer type and stage, this may be the true goal of therapy. However, it is very difficult to prove all cancer cells are gone. Even though images, like X-rays and MRI’s, and blood tests may not show any signs of cancer, there can be a small amount of cancer cells still left in the body. Because of this, doctors use the word “remission” is used more often. This means there are no signs or symptoms of cancer. Patients in remission are followed closely for any signs of cancer returning. Sometimes, more chemotherapy may be given while in remission to prevent the cancer from coming back.

Doctors usually do not consider a patient “cured” until the chance of cancer returning is extremely low. If cancer does return, it usually happens within 5 years of having a remission. Because of this, doctors do not consider a patient cured unless the cancer has not come back within 5 years of remission. The five-year cutoff does not apply to all cancers.

Common Starting Dose

  • Daratumumab 16 mg/kg intravenous infusion every week for the first 8 weeks of treatment, then every other week for 16 weeks, then every 4 weeks (monthly) until the drug no longer works or is not tolerated

Note: Individual doses may vary based upon your doctor's recommendation, or drug availability.

What is a CBC?

A Complete Blood Count (CBC) is a frequently ordered blood test that tells clinicians the status of your: 1) White blood cell count, 2) Hemoglobin, and 3) Platelet count at the time the test was taken.

Common uses:
1) White blood cell count (WBC): is used to determine infection risk, or response to chemotherapy. Certain chemotherapy agents may harm our good infection-fighting cells. Sometimes chemotherapy may need to be delayed to allow these cells to recover.

2) Hemoglobin: is used to determine if someone is anemic. Anytime the hemoglobin is below 12 g/dL, the person is said to be anemic. Red blood cell transfusions, and sometimes iron can be given to restore the hemoglobin level, but anemia treatment should always aim at treating the underlying cause or condition.

3) Platelet count: is used to determine if the risk of bleeding is increased or if a platelet transfusion is required to prevent bleeding. Certain medications that increase bleeding risk, such as: aspirin, certain chemotherapy agents, and blood thinners, may need to be stopped temporarily until the platelet count is within a safe range.

What is a CMP?

A Comprehensive Metabolic Panel (CMP) is a frequently ordered blood test that tells clinicians the status of your: 1) Electrolytes & Acid/Base status2) Kidney function, 3) Liver function, 4) Blood sugar, and 5) Calcium at the time the test was taken. It is commonly used to monitor liver and kidney function when beginning new medications such as chemotherapy. A total of 14 tests are run simultaneously and are shown below.

Electrolytes & Acid/Base status:
1) Sodium, 2) Potassium, 3) Carbon dioxide, 4) Chloride

Kidney Function:
5) BUN (blood urea nitrogen), 6) Serum creatinine (Scr)

Liver Function:
7) AST, 8) ALT, 9) Total bilirubin, 10) Alk Phos, 11) Albumin, 12) Total protein

Blood sugar:
13) Serum glucose

Calcium:
14) Serum calcium