Description
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 also used in combination with bortezomib, lenalidomide, and dexamethasone to treat newly diagnosed multiple myeloma in patients who cannot receive autologous stem cell transplant (transplant that uses their own stem cells).
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.
This product is available in the following dosage forms:
- Solution
Before Using
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.
Pediatric
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.
Geriatric
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.
Breastfeeding
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.
Drug Interactions
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
A nurse or other trained health professional will give you this medicine in a hospital. It is given through an IV placed into one of your veins. This medicine must be given slowly, so the IV 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
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 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 serious allergic reactions, including anaphylaxis and angioedema, which can be life-threatening and require immediate medical attention. Call your doctor right away if you have 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.
This medicine may cause serious infections. Check with your doctor right away if you have a cough or hoarseness, fever or chills, lower back or side pain, or painful or difficult urination.
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 skin cancer or solid tumors. 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, 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.
Side Effects
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
- blindness
- bloating or swelling of the face, arms, hands, lower legs, or feet
- blood in the urine or stools
- blurred vision
- body aches or pain
- bone pain
- burning, numbness, tingling, or painful sensations
- chest pain or tightness
- chills
- cough
- decreased vision
- diarrhea
- 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 taste or smell
- loss of voice
- lower back or side pain
- muscle aches
- nausea
- nervousness
- painful or difficult urination
- pale skin
- pinpoint red spots on the skin
- pounding in the ears
- rapid weight gain
- 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
- tingling of the hands or feet
- trouble breathing
- ulcers, sores, or white spots in the mouth
- unsteadiness or awkwardness
- unusual bleeding or bruising
- unusual tiredness or weakness
- unusual weight gain or loss
- vomiting
- weakness in the arms, hands, legs, or feet
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
- Constipation
- 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.
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