Darzalex

Uses of Darzalex

Darzalex (daratumumab) is commonly used for treating multiple myeloma, which is a type of blood cancer. Darzalex can be used in certain people who have or have not received prior treatment for their condition and who may or may not qualify for other treatments, such as a stem cell transplant. Depending on the specifics of your condition, Darzalex may be used by itself or in combination with other medicines.

Precautions and Warnings

Who should not use Darzalex?

Allergies to Ingredients. People who are allergic to any of the following should not use Darzalex.

• Darzalex
• Daratumumab
• Any of the ingredients in the specific product dispensed

Your pharmacist can tell you all of the ingredients in Darzalex.

What should I know about Darzalex before using it?

Do not use Darzalex unless it has been prescribed by a healthcare provider. Your healthcare provider will store and give you the medicine.

Darzalex will be given to you by your healthcare provider as an infusion through a vein over a period of time. Your healthcare provider may also instruct you to take certain medicines before or after you receive your Darzalex dose. These medicines can help to prevent infusion-related side effects.

What should I tell my healthcare provider before using Darzalex?

Tell your healthcare provider about all of your health conditions and any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. This will help them determine if Darzalex is right for you.

In particular, make sure that you discuss any of the following.

Current and Past Health Conditions. Tell your healthcare provider if you have any of the following.

• Breathing or lung problems
• Have had shingles (herpes zoster)
• Have ever had or may currently have a hepatitis B infection
• Hereditary fructose intolerance (HFI)

Pregnancy and Breastfeeding. Darzalex may cause harm to an unborn baby. Tell your healthcare provider if you are or plan to become pregnant. You must not be pregnant before starting Darzalex. If you can become pregnant, use effective birth control during treatment with Darzalex and for 3 months after your last dose. Do not undergo treatment with Darzalex while you are breastfeeding. It is not known if Darzalex passes into breast milk. Tell your healthcare provider if you are breastfeeding or plan to breastfeed.

Dosage

The first dose of Darzalex is usually given over a period of up to 8 hours. Especially with the first dose, the slower the rate of infusion, the less likely it is that a severe administration-related reaction (ARR) will occur.

If the first dose is well tolerated, subsequent doses may be given more rapidly at your doctor’s discretion. Medications can be given before and after each Darzalex infusion to help prevent a reaction.

Splitting the first infusion of Darzalex over two consecutive days, also called a “split-dosing regimen,” is approved in both the United States and Europe. The concentration of Darzalex in the body was found to be comparable regardless of whether the first dose was administered as a single infusion or a split-dosing infusion.

The dose of Darzalex, whether alone or as part of DRd or DPd regimens, is 16 mg/kg of body weight.

Side Effects

Common side effects:

• Infection in the nose or throat, sore throat, or common cold symptoms
• Blood disorders (see below)
• Infusion reactions (see below)
• Diarrhea
• Constipation
• Nerve problems
• Tiredness
• Fluid retention
• Nausea
• Cough
• Fever
• Shortness of breath
• Weakness