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How does this medication work? What will it do for me?
Daratumumab is a monoclonal antibody that belongs specifically to the class of medications called antineoplastic agents. It is used alone or in combination with other medications to treat multiple myeloma. Multiple myeloma is a type of blood cancer that affects plasma cells, a type of white blood cell. Daratumumab works by recognizing and attaching to these cancer cells. This may slow down or stop the cancer from growing and dividing.
The subcutaneous (injected under the skin) form of daratumumab is also used to treat light chain amyloidosis. This condition occurs when abnormal blood cells produce excess amounts of proteins that collect in organs such as the heart and kidneys. Daratumumab treats this condition by attaching to the abnormal blood cells so that the immune system can destroy them.
This medication may be available under multiple brand names and/or in several different forms. Any specific brand name of this medication may not be available in all of the forms or approved for all of the conditions discussed here. As well, some forms of this medication may not be used for all of the conditions discussed here.
Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are taking this medication, speak to your doctor. Do not stop taking this medication without consulting your doctor.
Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take this medication if their doctor has not prescribed it.
What form(s) does this medication come in?
Each 1 mL of sterile, colourless-to-yellow, preservative-free, liquid concentrate contains 20 mg of daratumumab. Nonmedicinal ingredients: glacial acetic acid, sodium acetate trihydrate, sodium chloride, mannitol, polysorbate 20, and water for injection.
Each 1 mL of colourless-to-yellow, clear-to-opalescent, preservative-free solution for subcutaneous administration contains 120 mg of daratumumab. Nonmedicinal ingredients: hyaluronidase human, L-histidine, L-histidine hydrochloride monohydrate, L-methionine, polysorbate 20, sorbitol, and water for injection.
How should I use this medication?
Daratumumab may be injected intravenously (into a vein) through a specially prepared site on your skin or injected subcutaneously (under the skin).
When given intravenously, the initial dose of daratumumab depends on body size and is usually 16 mg per kilogram of body weight. The treatment schedule varies depending on whether or not it is a newly diagnosed or a previously treated multiple myeloma.
The usual dose of daratumumab given subcutaneously is 1,800 mg injected slowly under the skin, in the stomach area, usually over a period of about 3 to 5 minutes. The treatment schedule varies depending the condition being treated, other medications being used and how far along you are in your treatment schedule.
Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, discuss any concerns with your doctor.
It is important this medication be given exactly as recommended by your doctor. If you miss an appointment to receive daratumumab, contact your doctor as soon as possible to reschedule your appointment.
This medication must be handled very carefully. Daratumumab should only be given by healthcare professionals familiar with the use of chemotherapy medications used to treat cancer. It is always given under the supervision of a doctor in a hospital or similar setting with access to sterile equipment for preparation.
Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.
Who should NOT take this medication?
Do not take this medication if you are allergic to daratumumab or any ingredients of the medication.
What side effects are possible with this medication?
Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.
The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.
The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.
Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.
- altered sense of taste
- back pain
- cold symptoms (e.g., nasal congestion, runny nose, sore throat)
- flu-like symptoms (sudden lack of energy, fever, cough, sore throat)
- itching, swelling, or skin irritation at the site of injection
- itchy skin
- joint, arm, or leg pain
- loss of appetite
- muscle spasms
- numbness or tingling
- sore mouth
- stomach ache
- trouble sleeping
- weight loss
Although most of the side effects listed below don’t happen very often, they could lead to serious problems if you do not seek medical attention.
Check with your doctor as soon as possible if any of the following side effects occur:
- blood pressure changes
- blurred vision
- chest pain
- feeling very tired, weak, or dizzy
- high fever
- irregular or fast heart beat
- mild infusion reaction (e.g., chills, nasal congestion, cough, headache, nausea, difficulty breathing)
- severe diarrhea (e.g., increased number of bowel movements, watery or bloody stool, stomach pain or cramps)
- signs of anemia (low red blood cells; e.g., dizziness, pale skin, unusual tiredness or weakness, shortness of breath)
- signs of clotting problems (e.g., unusual nosebleeds, bruising, blood in urine, coughing blood, bleeding gums, cuts that don’t stop bleeding)
- signs of depression (e.g., poor concentration, changes in weight, changes in sleep, decreased interest in activities, thoughts of suicide)
- signs of electrolyte imbalance (e.g., muscle pain or cramps, weakness, irregular heartbeat, lack of coordination, thirst, confusion)
- signs of infection (symptoms may include fever or chills, severe diarrhea, shortness of breath, prolonged dizziness, headache, stiff neck, weight loss, or listlessness)
- signs of kidney problems (e.g., increased urination at night, decreased urine production, blood in the urine, change of urine colour)
- signs of pneumonia (e.g., fever, chills, shortness of breath, cough)
- symptoms of high blood sugar (e.g., frequent urination, increased thirst, excessive eating, unexplained weight loss, poor wound healing, infections, fruity breath odour)
- urinary tract infection (e.g. pain when urinating, urinating more often than usual, low back or flank pain)
- wheezing or shortness of breath
Stop taking the medication and seek immediate medical attention if any of the following occur:
- severe infusion reaction (e.g., wheezing, throat tightness, difficulty breathing, high blood pressure)
- signs of bleeding in the stomach (e.g., bloody, black, or tarry stools; spitting up of blood; vomiting blood or material that looks like coffee grounds)
- signs of a serious allergic reaction (e.g., abdominal cramps, difficulty breathing, nausea and vomiting, or swelling of the face and throat)
- signs of pancreatitis (e.g., abdominal pain on the upper left side, back pain, nausea, fever, chills, rapid heartbeat, swollen abdomen)
- symptoms of sepsis (blood infection; high fever, rapid heartbeat, rapid breathing, confusion)
Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.
Are there any other precautions or warnings for this medication?
Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.
HEALTH CANADA ADVISORY
March 25, 2019
Health Canada has issued information concerning the use of daratumumab. To read the full Health Canada Advisory, visit Health Canada’s web site at www.hc-sc.gc.ca.
Anemia: Daratumumab may cause low levels of red blood cells. If you experience symptoms of reduced red blood cell count (anemia) such as shortness of breath, feeling unusually tired, or pale skin, contact your doctor as soon as possible. Your doctor will order routine blood tests to make sure potential problems are caught early.
Bleeding: Daratumumab may cause a reduced number of platelets in the blood, which can make it difficult to stop cuts from bleeding. If you notice any signs of bleeding, such as frequent nosebleeds, unexplained bruising, or black and tarry stools, notify your doctor as soon as possible. Your doctor will order routine blood tests to make sure potential problems are caught early.
Heart problems: Amyloidosis can affect multiple organs in the body, including the heart. Some people who have used daratumumab with chemotherapy medications to treat this condition have experienced serious and sometimes fatal heart problems. People with heart conditions may have an increased risk of serious heart problems. If you have a history of heart problems, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this mediation, and whether any special monitoring is needed.
Hepatitis B reactivation: People who have a hepatitis B infection that is dormant may experience the infection returning, causing liver dysfunction or liver failure. If you have a history of hepatitis B, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this mediation, and whether any special monitoring is needed.
If you experience symptoms of worsening liver function, such as fatigue, feeling unwell, loss of appetite, nausea, yellowing of the skin or whites of the eyes, dark urine, pale stools, abdominal pain or swelling, and itchy skin, contact your doctor immediately.
Infection: As well as killing cancer cells, daratumumab can reduce the number of cells that fight infection in the body (white blood cells). If possible, avoid contact with people with contagious infections. Tell your doctor immediately if you notice signs of an infection, such as fever or chills, severe diarrhea, shortness of breath, prolonged dizziness, headache, stiff neck, weight loss, or listlessness. Your doctor will do blood tests regularly to monitor the number of specific types of blood cells in your blood.
Infusion reactions: This medication can cause a hypersensitivity or infusion reaction. Your doctor will prescribe a corticosteroid, an antihistamine, and a fever-reducing medication to help reduce the risk of this type of reaction. People who have breathing problems such as asthma or chronic obstructive pulmonary disease (COPD) may require inhalers if breathing problems develop after the infusion. Infusion reactions generally appear during the infusion of the medication and may include flushing, chest pain, shortness of breath, and a dramatic drop in blood pressure. In rare instances, these reactions can cause death, so it is important to let your nurse or doctor know immediately if you notice any unusual reactions.
Viral infections: Although unusual, people using daratumumab can develop a type of viral infection called cytomegalovirus (CMV) infection. An infection caused by CMV can cause fever, sore throat, tiredness, and swollen glands. It may also affect other parts of the body, causing cough or breathing problems, vision changes, eye pain, diarrhea, or stomach pain. If you experience any unusual symptoms, let your doctor know as soon as possible.
Pregnancy: This medication should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking this medication, contact your doctor immediately. Women who may become pregnant who are taking daratumumab should use an effective method of birth control, such as condoms, during treatment and for 3 months after the last dose of this medication.
Breast-feeding: It is not known if daratumumab passes into breast milk. If you are breast-feeding and are taking this medication, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.
Children: The safety and effectiveness of using this medication have not been established for children.
What other drugs could interact with this medication?
There may be an interaction between daratumumab and any of the following:
- 5-ASA medications (e.g., mesalamine, sulfasalazine)
If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:
- stop taking one of the medications,
- change one of the medications to another,
- change how you are taking one or both of the medications, or
- leave everything as is.
An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.
Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.
All material copyright MediResource Inc. 1996 – 2022. Terms and conditions of use. The contents herein are for informational purposes only. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. Source: www.medbroadcast.com/drug/getdrug/Darzalex