Class: Biological Therapy

Generic Name: daratumumab

Trade Name: Darzalex®

How is this drug used? Darzalex is indicated for the treatment of patients with multiple myeloma who have received at least three prior lines of therapy; or in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, in patients who have received at least one prior therapy.

What is the mechanism of action? Multiple myeloma cells overexpress the protein called CD38. Therefore, researchers have designed daratumumab to specifically target and bind to CD38. Daratumumab binds to the cancer cells, and through multiple pathways, the cancer cells are killed once the binding occurs.

How is Darzalex given (administered)? Darzalex is given by intravenous infusion.

How are patients monitored? Patients will be pre-medicated with antihistamines, antipyretics, and corticosteroids and monitored during the entire infusion. To reduce the risk of delayed infusion reactions, all patients will be administered oral corticosteroids the first and second day after all infusions. Also, patients will be administered an antiviral medication to prevent herpes zoster reactivation. Your doctor will decide how many treatments you will receive.

What are the most common side effects of treatment with Darzalex?

• Infusion reactions
• Fatigue
• Nausea
• Back pain
• Pyrexia
• Cough
• Upper respiratory tract infection

What are some of the less common but potentially serious side effects of Darzalex?

• Pneumonia
• General physical health deterioration
• Pyrexia

This is not a complete list of side effects. Some patients may experience other side effects that are not listed here. Patients may wish to discuss with their physician the other less common side effects of this drug, some of which may be serious.

Some side effects may require medical attention. Other side effects do not require medical attention and may go away during treatment. Patients should check with their physician about any side effects that continue or are bothersome.

What can patients do to help alleviate or prevent discomfort and side effects?

Alert your doctor at the first sign of reactions or discomfort during the infusion. If you miss any appointments, call your healthcare provider as soon as possible to reschedule your appointment.

Are there any special precautions patients should be aware of before starting treatment? Tell your doctor about all of your medical conditions, including if you:

• Have a history of breathing problems
• Have had shingles (herpes zoster)
• Are pregnant or plan to be pregnant
• Are breastfeeding or plan to breastfeed

Tell your doctor about any medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

When should patients notify their physician?

Infusion reactions are common with Darzalex and can be severe. Tell your healthcare provider right away if you get any of the following symptoms:

• Shortness of breath or trouble breathing
• Dizziness or lightheadedness
• Cough
• Wheezing
• Throat tightness
• Runny or stuffy nose
• Headache
• Rash or hives
• Itching
• Nausea
• Vomiting
• Chills

Darzalex causes interference with cross-matching and red blood cell antibody screening. Tell all of your healthcare providers that you are being treated with Darzalex before receiving blood transfusions.

What is a package insert?

A package insert is required by the FDA and contains a summary of the essential scientific information needed for the safe and effective use of the drug for healthcare providers and consumers. A package insert typically includes information regarding specific indications, administration schedules, dosing, side effects, contraindications, results from some clinical trials, chemical structure, pharmacokinetics and metabolism of the specific drug. By carefully reviewing the package insert, you will get the most complete and current information about how to safely use this drug. If you do not have the package insert for the drug you are using, your pharmacist or physician may be able to provide you with a copy.

Last updated on 011/16.

Important Limitations of Use

The information provided above on the drug you have selected is provided for your information only and is not a substitute for consultation with an appropriate medical doctor. We are providing this information solely as a courtesy and, as such, it is in no way a recommendation as to the safety, efficacy or appropriateness of any particular drug, regimen, dosing schedule for any particular cancer, condition or patient nor is it in any way to be considered medical advice. Patients should discuss the appropriateness of a particular drug or chemotherapy regimen with their physician.

As with any printed reference, the use of particular drugs, regimens and drug dosages may become out-of-date over time, since new information may have been published and become generally accepted after the latest update to this printed information. Please keep in mind that health care professionals are fully responsible for practicing within current standards, avoiding use of outdated regimens, employing good clinical judgment kin selecting drugs and/or regimens, in calculating doses for individual patients, and verifying all dosage calculations.

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