Daratumumab

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Other drugs may interact with daratumumab, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

Adverse reactions listed below are for any grade unless otherwise noted

>10%

Lymphopenia (72%)

Neutropenia (60%)

Infusion reaction (48%)

Thrombocytopenia (48%)

Anemia (45%)

Fatigue (39%)

Lymphopenia, grade 3 (30%)

Nausea (27%)

Back pain (23%)

Pyrexia (21%)

Cough (21%)

Upper respiratory tract infection (20%)

Anemia, grade 3 (19%)

Neutropenia, grade 3 (17%)

Nasal congestion (17%)

Arthralgia (17%)

Diarrhea (16%)

Constipation (15%)

Pain in extremity (15%)

Dyspnea (15%)

Nasopharyngitis (15%)

Decreased appetite (15%)

Vomiting (14%)

Musculoskeletal chest pain (12%)

Headache (12%)

Pneumonia (11%)

1-10%

Thrombocytopenia, grade 3 (10%)

Lymphopenia, grade 4 (10%)

Hypertension (10%)

Chills (10%)

Thrombocytopenia, grade 4 (8%)

Pneumonia, grade 3 (6%)

Hypertension, grade 3 (5%)

Neutropenia, grade 4 (3%)

Infusion reaction, grade 3 (3%)

Fatigue, grade 3 (2%)

Back pain, grade 3 (2%)

Pyrexia, grade 3 (1%)

Dyspnea, grade 3 (1%)

Pain in extremity, grade 3 (1%)

Musculoskeletal chest pain, grade 3 (1%)

Upper respiratory tract infection, grade 3 (1%)

Diarrhea, grade 3 (1%)

Decreased appetite, grade 3 (1%)

Headache, grade 3 (1%)

Daratumumab is part of the drug class:

• Monoclonal antibodies

Serious side effects have been reported with daratumumab 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. Daratumumab can change the results of certain blood tests that determine your blood type. Daratumumab 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 daratumumab. Tell all of your healthcare providers that you are taking this medication prior to receiving any blood transfusions.

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

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Other drugs may interact with daratumumab, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

Multiple Myeloma

Treatment of multiple myeloma in patients who have received ≥3 prior therapies, including proteasome inhibitor and immunomodulatory agent, or in those with disease refractory to proteasome inhibitor and immunomodulatory agent1 (designated an orphan drug by FDA for use in multiple myeloma).3

Accelerated approval based on overall response rate.1 Continued approval may be contingent on verification and description of clinical benefit in confirmatory studies.1

No formal drug interaction studies to date.1

• Importance of reading the manufacturer's patient information before beginning treatment and each time the drug is administered.1

• Risk of infusion-related reactions.1 Importance of immediately reporting signs or symptoms of such reactions (e.g., nasal itching, congestion, or rhinitis; chills, nausea, throat irritation, cough, headache, breathing difficulty, shortness of breath).1

• Importance of advising patients about the possibility for serologic test interference in the event of a planned blood transfusion and of the need to inform clinicians (e.g., blood center personnel) that they are receiving daratumumab.1

• Importance of advising patients that daratumumab may affect results of some tests used to determine complete response to the drug and that additional tests may be needed to evaluate the response.1

• Risk of fetal harm.1 Necessity of advising women of childbearing potential to use an effective method of contraception while receiving the drug and for at least 3 months after the last dose.1 If pregnancy occurs, advise women of potential fetal risk.1

• Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.1

• Importance of advising women who received daratumumab during pregnancy that infants exposed to the drug in utero should have hematologic evaluation performed before they receive live vaccines.1

• Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as any concomitant illnesses (e.g., respiratory problems, history of herpes zoster).1

• Importance of informing patients of other important precautionary information.1 (See Cautions.)

• It is used to treat multiple myeloma.

• Tell all of your health care providers that you take this medicine. This includes your doctors, nurses, pharmacists, and dentists.
• Infusion reactions have happened with daratumumab. Sometimes, these could be very bad or life-threatening. Talk with the doctor.
• Other drugs may be given to help with infusion side effects.
• You may need to take another drug to prevent herpes zoster (shingles). Talk with your doctor.
• This medicine may affect certain lab tests. This may last for up to 6 months after your last dose. Be sure your doctor and lab workers know you take this medicine.
• Have blood work checked as you have been told by the doctor. Talk with the doctor.
• You may have more of a chance of getting an infection. Wash hands often. Stay away from people with infections, colds, or flu. Some infections have been very bad and even deadly.
• You may bleed more easily. Be careful and avoid injury. Use a soft toothbrush and an electric razor.
• If you have taken daratumumab and you are getting a blood transfusion, talk with your doctor.
• If you have upset stomach, throwing up, loose stools (diarrhea), or are not hungry, talk with your doctor. There may be ways to lower these side effects.
• If you have high blood sugar (diabetes), you will need to watch your blood sugar closely.
• This medicine may cause harm to the unborn baby if you take it while you are pregnant.
• Use birth control that you can trust to prevent pregnancy while taking this medicine and for 3 months after care ends.
• If you get pregnant while taking daratumumab or within 3 months after your last dose, call your doctor right away.
• Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

• If you need to store daratumumab at home, talk with your doctor, nurse, or pharmacist about how to store it.

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
• Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Check with your pharmacist about how to throw out unused drugs.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about this medicine, please talk with your doctor, nurse, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take daratumumab or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to daratumumab. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.

Review Date: October 4, 2017

Daratumumab is an IgG1κ human monoclonal antibody directed against CD38. CD38 is a cell surface glycoprotein which is highly expressed on myeloma cells, yet is expressed at low levels on normal lymphoid and myeloid cells (Lokhorst 2015). By binding to CD38, daratumumab inhibits the growth of CD38 expressing tumor cells by inducing apoptosis directly through Fc mediated cross linking as well as by immune-mediated tumor cell lysis through complement dependent cytotoxicity, antibody dependent cell mediated cytotoxicity, and antibody dependent cellular phagocytosis.

Distribution

Central: Monotherapy: 4.7 ± 1.3 L; Combination therapy: 4.4 ± 1.5 L

Half-Life Elimination

Monotherapy: 18 ± 9 days; Combination therapy: 23 ± 12 days

Determine the appropriate dose and volume of daratumumab required (based on patient's actual body weight); daratumumab should be colorless to pale yellow (do not use if opaque particles, discoloration, or other foreign particles are observed). Remove the volume of 0.9% sodium chloride injection from the infusion bag that is equal to the required volume of the daratumumab dose. Add the appropriate daratumumab volume to a 1,000 mL (first infusion) or 500 mL (subsequent infusions) 0.9% sodium chloride bag; gently invert to mix (do not shake). Infusion bags/containers must be made of polyvinylchloride (PVC), polypropylene (PP), polyethylene (PE), or polyolefin blend (PP+PE). If the diluted solution is refrigerated prior to use, allow to come to room temperature before administration. After dilution, may develop very small translucent to white proteinaceous particles; do not use if discolored or if visibly opaque or foreign particles are observed.

Mild hepatic impairment: No adjustment recommended.
Moderate to severe hepatic impairment: Data not available

Data not available

Safety has not been established. Excreted into human milk: Unknown Excreted into animal milk: Data not available

There is no information regarding the presence of this drug in human milk, the effects on the breastfed infant, or the effects on milk production. Human IgG is known to be present in human milk. Data suggest antibodies in breast milk do not enter the neonatal and infant circulations in substantial amounts.