Daratumumab and Hyaluronidase-fihj Injection

Daratumumab and hyaluronidase-fihj injection is used alone or in combination with other medications or treatments to treat multiple myeloma (a type of cancer of the bone marrow) in newly diagnosed people and in people who have not improved with treatment or who have improved after treatment with other medications but the condition returned. It is also approved for use with other medications in patients newly diagnosed with multiple myeloma who are eligible to undergo a stem cell transplant to prepare them for the procedure.

Daratumumab and hyaluronidase-fihj injection is also used in combination with other medications to treat a certain kind of amyloidosis (a disease in which abnormal proteins build up in tissues and organs in the body) in newly diagnosed adults. Daratumumab is in a class of medications called monoclonal antibodies.

Daratumumab and hyaluronidase-fihj works by helping the body to slow or stop the growth of cancer cells. Hyaluronidase-fihj is an endoglycosidase. It helps to keep daratumumab in the body longer so that the medication will have a greater effect.

Daratumumab and hyaluronidase-fihj injection comes as a solution (liquid) to be injected subcutaneously (just under the skin) into the abdomen (stomach) over 3 to 5 minutes. The time between your injections and the length of your treatment will depend on your condition and how well your body responds to treatment.

A doctor or nurse will watch you closely while you are receiving the medication and afterwards to be sure you are not having a serious reaction to the medication. You will be given other medications to help prevent and treat reactions to daratumumab and hyaluronidase-fihj before and after you receive your medication. Tell your doctor or nurse immediately if you experience any of the following symptoms: difficulty breathing or shortness of breath, chest pain, wheezing, throat tightness and irritation, cough, runny or stuffy nose, headache, itching, nausea, vomiting, fever, chills, rash, hives, eye pain, blurred vision, or dizziness or lightheadedness.

Your doctor may temporarily or permanently stop your treatment. This depends on how well the medication works for you and the side effects you experience. Be sure to tell your doctor how you are feeling during your treatment with daratumumab and hyaluronidase-fihj. Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

Before receiving daratumumab and hyaluronidase-fihj injection,

• tell your doctor and pharmacist if you are allergic to daratumumab, hyaluronidase-fihj, any other medications, or any of the ingredients in daratumumab and hyaluronidase-fihj injection. Ask your pharmacist for a list of the ingredients.
• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• tell your doctor if you have or have ever had shingles (a painful rash that occurs after infection with herpes zoster or chickenpox), hepatitis B (a virus that infects the liver and may cause severe liver damage), or breathing problems. If you are being treated for amyloidosis, tell your doctor if you have heart failure or heart disease.
• tell your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. You should use birth control to prevent pregnancy during your treatment with daratumumab and hyaluronidase-fihj and for at least 3 months after your final dose. Talk to your doctor about types of birth control that will work for you. If you become pregnant while receiving daratumumab and hyaluronidase-fihj injection, call your doctor.
• tell your doctor if you are breastfeeding. You should not breastfeed while you are receiving daratumumab and hyaluronidase-fihj injection.
• if you are having surgery, including dental surgery, tell the doctor or dentist that you are receiving daratumumab and hyaluronidase-fihj injection.

Unless your doctor tells you otherwise, continue your normal diet.

Daratumumab and hyaluronidase-fihj injection may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• constipation
• diarrhea
• vomiting
• nausea
• stomach pain
• loss of appetite
• fatigue
• difficulty falling asleep or staying asleep
• pain, burning, or tingling in the hands or feet
• swelling of the hands, ankles, or feet
• joint or back pain
• muscle spasms
• headache
• itching, swelling, bruising, or redness of the skin at the injection site

Some side effects can be serious. If you experience any of these symptoms or those listed in the HOW section, call your doctor immediately or get emergency medical treatment:

• fever, cough, sore throat, or signs of infection
• unusual bruising or bleeding
• pale skin, fatigue, or shortness of breath
• yellow eyes or skin; dark urine; or pain or discomfort in right upper stomach area
• chest pain, feeling faint, swollen legs, fast or irregular heartbeat, or shortness of breath (especially if you are being treated for amyloidosis)

Daratumumab and hyaluronidase-fihj injection may cause other side effects. Call your doctor if you have any unusual problems while receiving this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (https://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests before and during your treatment to check your body's response to daratumumab and hyaluronidase-fihj.

Daratumumab and hyaluronidase-fihj can affect blood matching test results during your treatment and for up to 6 months after your final dose. Before having a blood transfusion, tell your doctor and the laboratory personnel that you are receiving or received daratumumab and hyaluronidase-fihj injection. Your doctor will do blood tests to match your blood type before you start treatment with daratumumab and hyaluronidase-fihj.

Ask your pharmacist any questions you have about daratumumab and hyaluronidase-fihj.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

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