Darzalex

The initial dose of Darzalex (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. Darzalex (Daratumumab) is usually injected into a vein through a specially prepared site on your skin.

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 Darzalex (Daratumumab) be given exactly as recommended by your doctor. If you miss an appointment to receive Darzalex (Daratumumab), contact your doctor as soon as possible to reschedule your appointment.

Darzalex (Daratumumab) must be handled very carefully. Darzalex (Daratumumab) should only be given by health care 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.

Each 1 mL of sterile, colourless-to-yellow, preservative-free, liquid concentrate contains 20 mg of Darzalex (Daratumumab). Nonmedicinal ingredients: glacial acetic acid, sodium acetate trihydrate, sodium chloride, mannitol, polysorbate 20, and water for injection.

Do not take Darzalex (Daratumumab) if you are allergic to Darzalex (Daratumumab) or any ingredients of the medication.

There may be an interaction between Darzalex (Daratumumab) and any of the following:

• BCG
• Clozapine

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 Darzalex (Daratumumab). 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.

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 Darzalex (Daratumumab).

HEALTH CANADA ADVISORY

March 25, 2019

Health Canada has issued information concerning the use of Darzalex (Daratumumab). To read the full Health Canada Advisory, visit Health Canada's web site at www.hc-sc.gc.ca.

Anemia: Darzalex (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: Darzalex (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.

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 Darzalex (Daratumumab) 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, Darzalex (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: Darzalex (Daratumumab) 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 COPD (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.

Pregnancy: Darzalex (Daratumumab) should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking Darzalex (Daratumumab), contact your doctor immediately. Women who may become pregnant who are taking Darzalex (Daratumumab) should use an effective method of birth control, such as condoms, during treatment and for 3 months after the last dose of Darzalex (Daratumumab).

Breast-feeding: It is not known if Darzalex (Daratumumab) passes into breast milk. If you are a breast-feeding mother and are taking Darzalex (Daratumumab), it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: The safety and effectiveness of using Darzalex (Daratumumab) have not been established for children.