Pronunciation:

dar-a-TOOM-ue-mab

Brand Names:

• Darzalex

Dosage Forms:

• Solution

Classifications:

Therapeutic—

Antineoplastic Agent

Pharmacologic—

Monoclonal Antibody

Uses of This Medicine:

Daratumumab injection is used alone or together with other medicines to treat multiple myeloma (a type of bone marrow cancer). It is used alone in patients who have received at least 3 prior treatments that did not work well, including a proteasome inhibitor and an immunomodulatory agent, or who did not respond to both a proteasome inhibitor and an immunomodulatory agent.

Daratumumab injection is also used in combination with lenalidomide and dexamethasone to treat patients with newly diagnosed multiple myeloma who cannot receive autologous stem cell transplant and patients with relapsed (cancer that has come back) or refractory (cancer that did not respond to treatment) multiple myeloma who have received at least 1 previous treatment.

Daratumumab injection is also used together with bortezomib, melphalan, and prednisone to treat patients with newly diagnosed multiple myeloma who cannot receive autologous stem cell transplant.

Daratumumab injection is also used together with bortezomib, thalidomide, and dexamethasone to treat patients with newly diagnosed multiple myeloma who can receive autologous stem cell transplant.

Daratumumab injection is also used in combination with bortezomib and dexamethasone to treat patients with multiple myeloma who have received at least 1 previous treatment.

Daratumumab injection is also used in combination with carfilzomib and dexamethasone to treat patients with relapsed (cancer that has come back) or refractory (cancer that did not respond to treatment) multiple myeloma who have received 1 to 3 previous treatments.

Daratumumab injection is also used in combination with pomalidomide and dexamethasone to treat patients with multiple myeloma who have received at least two treatments (including lenalidomide and a proteasome inhibitor).

This medicine is to be given only by or under the supervision of your doctor.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of daratumumab injection in the pediatric population. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of daratumumab injection in the elderly. However, elderly patients are more likely to have serious unwanted effects (eg, pneumonia, sepsis), which may require caution in patients receiving this medicine.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Hepatitis B infection, active or history of or
• Herpes zoster infection (shingles), history of—May reactivate these conditions.

• Hereditary fructose intolerance (HFI)—This medicine contains sorbitol, which can cause serious side effects in patients with this condition.

• Lung or breathing problems (eg, COPD), or history of or
• Neutropenia (low number of white blood cells) or
• Thrombocytopenia (low number of platelets)—Use with caution. May make these conditions worse.

Proper Use of This Medicine:

A nurse or other trained health professional will give you this medicine in a medical facility. It is given through a needle placed into one of your veins.

This medicine needs to be given on a fixed schedule. Be sure to keep all appointments.

This medicine should come with a patient information leaflet. Read and follow these instructions carefully. Ask your doctor if you have questions.

You may receive antiviral medicine to prevent shingles within 1 week of starting treatment with daratumumab and continue for 3 months after treatment.

You may also receive other medicines (eg, allergy medicine, fever medicine, steroid) 1 to 3 hours before receiving daratumumab and after treatment to help prevent unwanted reactions to the injection.

Missed dose—

This medicine needs to be given on a fixed schedule. If you miss a dose, call your doctor, home health caregiver, or treatment clinic for instructions.

Precautions While Using This Medicine:

It is very important that your doctor check your progress closely while you are receiving this medicine to make sure that the medicine is working properly. Blood tests may be needed to check for unwanted effects.

Receiving this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant during treatment and for at least 3 months after your last dose. If you think you have become pregnant while receiving the medicine, tell your doctor right away.

This medicine may cause an infusion reaction, including anaphylaxis, which can be life-threatening and requires immediate medical attention. Tell your doctor right away if you have chest tightness, chills, cough, dizziness or lightheadedness, fast heartbeat, headache, hoarseness, itching, nausea or vomiting, runny or stuffy nose, a rash or hives, sore throat, swelling of the eyes, hands, face, or mouth, trouble breathing or swallowing, or unusual tiredness or weakness while you are receiving this medicine.

Check with your doctor immediately if blurred vision, difficulty in reading, or any other change in vision occurs during or after treatment. Your doctor may want you to have your eyes checked by an ophthalmologist (eye doctor).

Daratumumab can temporarily lower the number of white blood cells in your blood, increasing the chance of getting an infection. It can also lower the number of platelets, which are necessary for proper blood clotting. If this occurs, there are certain precautions you can take, especially when your blood count is low, to reduce the risk of infection or bleeding:

• If you can, avoid people with infections. Check with your doctor immediately if you think you are getting an infection or if you get a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.
• Check with your doctor immediately if you notice any unusual bleeding or bruising, black, tarry stools, blood in the urine or stools, or pinpoint red spots on your skin.
• Be careful when using a regular toothbrush, dental floss, or toothpick. Your medical doctor, dentist, or nurse may recommend other ways to clean your teeth and gums. Check with your medical doctor before having any dental work done.
• Do not touch your eyes or the inside of your nose unless you have just washed your hands and have not touched anything else in the meantime.
• Be careful not to cut yourself when you are using sharp objects such as a safety razor or fingernail or toenail cutters.
• Avoid contact sports or other situations where bruising or injury could occur.

Make sure any doctor who treats you knows that you are using daratumumab. This medicine may affect the results of certain medical tests including tests to determine your blood type. These effects may last up to 6 months after your last dose. Tell all of your healthcare providers that you are receiving this medicine before you receive a blood transfusion.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

More common

Bloating or swelling of the face, arms, hands, lower legs, or feet

blurred vision

body aches or pain

chest pain or tightness

chills

confusion

cough

difficulty swallowing

dizziness

ear congestion

facial swelling

fast heartbeat

fever

headache

hoarseness

loss of voice

nausea

nervousness

pounding in the ears

puffiness or swelling of the eyelids or around the eyes, lips, or tongue

rapid, shallow breathing

skin rash, hives, or itching

slow or fast heartbeat

sneezing

sore throat

stuffy or runny nose

tingling of the hands or feet

trouble breathing

unusual tiredness or weakness

unusual weight gain or loss

vomiting

Less common

Dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position

painful blisters on the trunk of body

sweating

Incidence not known

Black, tarry stools

bleeding gums

blood in the urine or stools

constipation

coughing that sometimes produce a pink frothy sputum

darkened urine

lower back or side pain

pains in the stomach, side, or abdomen, possibly radiating to the back

painful or difficult urination

pale skin

pinpoint red spots on the skin

swelling in the legs and ankles

ulcers, sores, or white spots in the mouth

unusual bleeding or bruising

yellow eyes or skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Back pain

burning, numbness, tingling, or painful sensations

diarrhea

difficulty with moving

joint pain

loss of appetite

muscle pain or stiffness

pain in the arms or legs

unsteadiness or awkwardness

weakness in the arms, hands, legs, or feet

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.