Isatuximab-irfc (Intravenous)

Isatuximab-irfc injection is used together with pomalidomide and dexamethasone to treat multiple myeloma (a type of bone marrow cancer) in patients who have had at least 2 previous treatments (for example, lenalidomide and a proteasome inhibitor).

Isatuximab-irfc injection is also used 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 had 1 to 3 previous treatments that did not work well.

Isatuximab-irfc injection is an antineoplastic agent (cancer medicine) that interferes with the growth of cancer cells, which are eventually destroyed by the body.

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

It is very important for your doctor to monitor your progress closely while you are receiving this medicine to ensure it is working properly. Blood tests may be necessary to check for side effects.

Receiving this medicine while you are pregnant can harm your unborn baby. If you are a woman who can get pregnant, your doctor may perform tests to confirm you are not pregnant before starting this medicine. Use an effective form of birth control while you are receiving this medicine and for at least 5 months after the last dose to prevent pregnancy. If you think you may be pregnant while receiving the medicine, inform your doctor immediately.

This medicine may cause serious infusion-related reactions, which can be life-threatening and need immediate medical attention. Notify your doctor right away if you experience fever, chills or shaking, cough, dizziness, a fast, irregular, pounding, or racing heartbeat or pulse, headache, nausea, runny or stuffy nose, trouble breathing, itching or skin rash, lightheadedness, or fainting after receiving this medicine.

This medicine may cause serious allergic reactions, including anaphylaxis and angioedema, which can be life-threatening and require immediate medical attention. Contact your doctor immediately if you develop a rash, itching, hoarseness, large hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or genitals, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth while you are receiving this medicine.

Isatuximab-irfc injection will lower the number of some types of blood cells in your body. Because of this, you may bleed or get infections more easily. To help prevent these problems, avoid close contact with people who are sick or have infections. Wash your hands frequently. Stay away from rough sports or other activities where you might be bruised, cut, or injured. Brush and floss your teeth gently. Be cautious when using sharp objects, including razors and fingernail clippers.

This medicine may increase your risk of developing secondary cancers, including bone marrow (myelodysplasia), breast, or skin cancer. Contact your doctor immediately if you notice any skin changes, including a new wart, changes in size or color of a mole, a skin sore or reddish bump that does not heal, bloody or black, tarry stools, clear or bloody discharge from the nipple, inverted nipple, dimpling of the breast, a lump in the breast or under the arm, redness or swelling of the breast, a sore on the skin of the breast that does not heal, or unusual bleeding, bruising, or weakness.

Make sure any doctor who treats you knows that you are receiving this medicine. This medicine may affect the results of certain medical tests.

Do not take other medicines unless you have discussed them with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal (e.g., St. John's wort) or vitamin supplements.

In deciding to use a medicine, you and your doctor need to think about the risks of taking the medicine compared to the benefits it will provide. Here are some important things to consider for this medicine:

Allergies

Let your doctor know if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also, inform your healthcare professional 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 appropriate studies on how isatuximab-irfc injection affects children. Its safety and effectiveness in this age group have not been established.

Geriatric

Studies done so far have not found any specific problems in elderly patients that would limit the use of isatuximab-irfc injection. However, older adults may be more sensitive to the effects of this medicine than younger adults.

Breast Feeding

There are not enough studies in women to determine the risk to infants when using this medicine during breastfeeding. Consider the potential benefits and risks before taking this medicine while breastfeeding.

Interactions with Medicines

Some medicines should not be used together at all, while others can be used together even if there might be an interaction. In these situations, your doctor may need to adjust the dose, or take other precautions. Inform your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be taken at mealtime or with specific foods due to possible interactions. Using alcohol or tobacco with some medicines may also lead to interactions. Talk to your healthcare professional about how to use your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical problems may affect how you can use this medicine. Make sure to tell your doctor about any other medical issues, especially:

• Infection (e.g., shingles)—Use with caution. This may increase the risk of more side effects and could worsen this condition.

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

• Back pain
• black, tarry stools
• bleeding gums
• blood in the urine or stools
• blurred vision
• body aches or pain
• chest pain or tightness
• chills
• cough
• difficulty in breathing
• dizziness
• ear congestion
• enlarged pupils
• feeling of warmth
• fever
• flushing
• headache
• hoarseness
• increased sensitivity of the eyes to light
• increased sweating, possibly with fever or cold, clammy skin
• loss of voice
• lower back or side pain
• nausea
• nervousness
• painful or difficult urination
• pale skin
• pinpoint red spots on the skin
• pounding in the ears
• redness of the face, neck, arms, and occasionally, upper chest
• runny or stuffy nose
• slow or fast heartbeat
• sneezing
• sore throat
• stiff or sore neck
• trouble breathing
• ulcers, sores, or white spots in the mouth
• unusual bleeding or bruising
• unusual tiredness or weakness
• vomiting

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

• Diarrhea
• trouble sleeping

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.

• Sarclisa

Available Dosage Forms:

• Solution

Therapeutic Class: Antineoplastic Agent

Pharmacologic Class: Isatuximab

Find detailed information on biosimilars for this medication.

A nurse or other trained health professional will give you this medicine in a hospital. It is given through a needle placed into one of your veins. This medicine must be given slowly, so the IV tube will need to stay in place for at least 30 minutes.

This medicine comes with a patient information leaflet. Read and follow the instructions carefully. Ask your doctor if you have any questions.

You may receive other medicines (eg, allergy medicine, fever medicine, steroids) before starting treatment with this medicine to help prevent infusion-related reactions. You may also receive an antiviral medicine to help prevent shingles from coming back (herpes zoster reactivation).

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.