Pronunciation:

eye-sa-TUX-i-mab - irfc

Brand Names:

• Sarclisa

Dosage Forms:

• Solution

Classifications:

Therapeutic—

Antineoplastic Agent

Pharmacologic—

Isatuximab

Uses of This Medicine:

Isatuximab-irfc injection is used in combination with pomalidomide and dexamethasone to treat multiple myeloma (a type of bone marrow cancer) in patients who have received at least 2 previous treatments (eg, lenalinomide and a proteasome inhibitor).

Isatuximab-irfc injection is also used in combination 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 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 is to be given only by or under the direct 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 isatuximab-irfc 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 isatuximab-irfc injection in the elderly. However, elderly patients are more sensitive to the effects of this medicine than younger adults.

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:

• Infection (eg, shingles)—Use with caution. May increase risk for more side effects. May also make this condition worse.

Proper Use of This Medicine:

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.

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 it 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. If you are a woman who can get pregnant, your doctor may do tests to make sure 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 keep from getting pregnant. If you think you have become pregnant while receiving the medicine, tell your doctor right away.

This medicine may cause serious infusion-related reactions, which can be life-threatening and require immediate medical attention. Tell your doctor right away if you start to have a fever, chills or shaking, cough, dizziness, 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 a serious type of allergic reaction called anaphylaxis, which can be life-threatening and requires immediate medical attention. Call your doctor right away if you have a rash, itching, hoarseness, 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 with these problems, avoid being near people who are sick or have infections. Wash your hands often. Stay away from rough sports or other situations where you could be bruised, cut, or injured. Brush and floss your teeth gently. Be careful when using sharp objects, including razors and fingernail clippers.

This medicine may increase your risk of having secondary cancers, including bone marrow (myelodysplasia), breast, or skin cancer. Check with your doctor right away if you develop any skin changes, including a new wart, change 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 nipple, inverted nipple, dimpling of the breast, skin lump in the breast or under the arm, redness or swelling of the breast, 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 they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal (eg, St. John's wort) or vitamin supplements.

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

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.