Daratumumab and hyaluronidase-fihj (Subcutaneous)

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

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

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

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

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

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

Daratumumab and hyaluronidase-fihj combination injection is also used alone to treat multiple myeloma in patients who have had 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 with bortezomib, cyclophosphamide, and dexamethasone to treat newly diagnosed light chain amyloidosis.

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

It is very important for your doctor to check your progress at regular visits to ensure this medicine is working properly. You may need blood tests 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 prevent pregnancy during treatment and for at least 3 months after your last dose. If you think you have become pregnant while receiving this medicine, tell your doctor immediately.

This medicine may cause serious allergic reactions, including anaphylaxis, which can be life-threatening and require immediate medical attention. Contact your doctor right away if you experience 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. Inform your doctor immediately if you notice 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.

Contact your doctor immediately if you experience blurred vision, difficulty in reading, or any other change in vision during or after treatment. Your doctor may want you to see an ophthalmologist (eye doctor) for an eye check.

This medicine may cause serious heart problems (e.g., cardiac toxicity) in patients with light chain amyloidosis (AL). Contact your doctor right away if you experience 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 risk of getting an infection. It can also lower the number of platelets, which are necessary for proper blood clotting. If this happens, there are certain precautions you can take, especially when your blood count is low, to reduce the risk of infection or bleeding:

• If possible, avoid people with infections. Contact your doctor immediately if you think you are getting an infection or if you experience fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.
• Contact 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 suggest 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 cautious when using sharp objects like a safety razor or fingernail or toenail clippers to avoid cuts.
• Avoid contact sports or other situations where bruising or injury could occur.

Make sure any doctor treating you knows that you are receiving daratumumab and hyaluronidase-fihj combination injection. This medicine may affect the results of certain medical tests (e.g., tests to determine your blood type). These effects may last up to 6 months after your last dose. Inform your doctor or other trained health professional that you are receiving this medicine before having a blood transfusion.

In deciding to use a medicine, you and your doctor need to think about the risks of the medicine against the benefits it might provide. For this medicine, consider the following:

Allergies

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

Pediatric

There have not been enough studies to understand how age affects the effects of daratumumab and hyaluronidase-fihj combination injection in children. Safety and effectiveness in this age group have not been established.

Geriatric

Studies conducted so far have not shown specific problems in older adults that would limit the use of daratumumab and hyaluronidase-fihj combination injection in this group. However, older patients may be more likely to experience unwanted side effects, which may require caution when using this medicine.

Breast Feeding

There are not enough studies in women to determine the risk to infants when using this medication while breastfeeding. Consider the potential benefits against the potential risks before using this medication while breastfeeding.

Interactions with Medicines

Some medicines should never be used together, while in other cases, two different medicines may be used together even if there is a possibility of interaction. In such cases, your doctor might adjust the dose or take other precautions. Inform your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicines.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be taken around the time of eating food or specific types of food due to possible interactions. Using alcohol or tobacco with certain medicines may also lead to interactions. Discuss with your healthcare professional about taking your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical problems may influence the use of this medicine. Be sure to tell your doctor if you have any other medical issues, 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 worsen these conditions.

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

Along with its required effects, a medicine may cause some unwanted effects. Not all of these side effects may happen, but if they do, you may need medical attention.

Contact your doctor or nurse right away if any of the following side effects occur:

More common

• Bladder pain
• bleeding, blistering, burning, coldness, skin discoloration, 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 happen that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Your health care professional may also have ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue, 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.

In the U.S.

• Darzalex Faspro

Available Dosage Forms:

• Solution

Therapeutic Class: Antineoplastic Agent

Pharmacologic Class: Monoclonal Antibody

Find detailed information on biosimilars for this medication.

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.

• What is Tecvayli plus Darzalex Faspro used for?
• What are the side effects of Tecvayli plus Darzalex Faspro?