Pronunciation:

dar-a-TOOM-ue-mab, hye-al-ure-ON-i-dase - fihj

Brand Names:

• Darzalex Faspro

Dosage Forms:

• Solution

Classifications:

Therapeutic—

Antineoplastic Agent

Pharmacologic—

Monoclonal Antibody

Uses of This Medicine:

Daratumumab and hyaluronidase-fihj combination injection is used together with bortezomib, melphalan, and prednisone to treat newly diagnosed multiple myeloma (a type of bone marrow cancer) in patients who cannot receive autologous stem cell transplant (transplant that uses their own stem cells).

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

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

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

Daratumumab and hyaluronidase-fihj combination injection is used together with pomalidomide and dexamethasone to treat multiple myeloma in patients who have received at least 1 previous treatment (eg, lenalidomide and a proteasome inhibitor).

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

Daratumumab and hyaluronidase-fihj combination injection is also used alone to treat multiple myeloma in patients who have received at least 3 previous treatments or in patients who did not respond to previous treatments. These previous treatments include a proteasome inhibitor and an immunomodulatory agent.

Daratumumab and hyaluronidase-fihj combination injection is also used together with bortezomib, cyclophosphamide, and dexamethasone to treat newly diagnosed light chain amyloidosis.

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 and hyaluronidase-fihj combination 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 and hyaluronidase-fihj combination injection in the elderly. However, elderly patients are more likely to have unwanted side effects 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:

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

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

Proper Use of This Medicine:

Medicines used to treat cancer are very strong and can have many side effects. Before receiving this medicine, make sure you understand all the risks and benefits. It is important for you to work closely with your doctor during your treatment.

A nurse or other trained health professional will give you this medicine in a medical facility. This medicine is given as a shot under your skin, usually in the stomach area for at least 3 to 5 minutes.

This medicine is given alone or in combination with other medicines. Your doctor will decide on how often and how many treatments you will receive.

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 an antiviral medicine to prevent shingles at least 1 week after starting treatment with this medicine 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 this medicine 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 at regular visits to make sure this 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 serious allergic reactions, including anaphylaxis, which can be life-threatening and require immediate medical attention. Check with your doctor right away if you have chest pain, chills, cough, dizziness or lightheadedness, fast heartbeat, fever, itching, nausea or vomiting, runny or stuffy nose, sore throat, or trouble breathing after receiving this medicine.

This medicine may cause serious skin reactions at or near the injection site. Tell your doctor right away if you have bruising, itching, redness, or swelling of the skin after you receive the injection. These reactions may occur more than 24 hours after 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).

This medicine may cause serious heart problems (eg, cardiac toxicity) in patients with light chain amyloidosis (AL). Check with your doctor right away if you have chest pain or discomfort, fast or irregular heartbeat, swelling of the feet or lower legs, or trouble breathing.

This medicine 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 receiving daratumumab and hyaluronidase-fihj combination injection. This medicine may affect the results of certain medical tests (eg, tests to determine your blood type). These effects may last up to 6 months after your last dose. Tell your doctor or other trained health professional 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

Bladder pain

bleeding, blistering, burning, coldness, discoloration of skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site

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

bloody or cloudy urine

blue lips and fingernails

blurred vision

body aches or pain

burning, numbness, tingling, or painful sensations

chest pain, discomfort, or tightness

confusion

cough

coughing that sometimes produces a pink frothy sputum

difficult or labored breathing

difficult, burning, or painful urination

dizziness or lightheadedness

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

ear congestion

facial swelling

fainting

fast or irregular heartbeat

fever or chills

frequent urge to urinate

headache

increased sweating

itching

loss of voice

nausea or vomiting

nervousness

painful blisters on the trunk of the body

pale skin

pounding in the ears

rapid weight gain

runny or stuffy nose

sore throat

swelling in the legs, ankles, or feet

tingling of the hands or feet

trouble breathing

unsteadiness or awkwardness

unusual bleeding or bruising

unusual tiredness or weakness

unusual weight gain or loss

Incidence not known

Bloating

darkened urine

difficulty swallowing

hives

indigestion

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

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

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, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings

constipation

diarrhea

difficulty in moving

loss of appetite

muscle pain or stiffness

pain in the joints

rash

sleeplessness

stomach pain

trouble sleeping

unable to sleep

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.