Description
Sutimlimab-jome injection is used to treat the breakdown of red blood cells (hemolysis) in patients with cold agglutinin disease (CAD).
This medicine is to be given only by or under the 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 sutimlimab-jome 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 sutimlimab-jome 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:
- Hepatitis B or C or
- HIV infection or
- Serious infections or
- Systemic lupus erythematosus (SLE)—Use with caution. May make these conditions worse.
Proper Use
A nurse or other trained health professional will give you this medicine in a medical facility. It is given through an IV catheter placed into one of your veins. The medicine must be injected slowly, so your IV will need to stay in place for 1 to 2 hours.
You will usually receive a starting dose of this medicine, followed by a second dose one week later. Then 2 weeks after your second dose, you will receive this medicine every 2 weeks.
This medicine should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor if you have questions.
Missed Dose
Call your doctor or pharmacist for instructions.
Precautions
It is very important that your doctor check your progress closely and at regular visits to make sure this medicine is working properly and to decide if you should continue to receive it. Blood tests may be needed to check for unwanted effects.
This medicine may cause serious infections (eg, meningitis, pneumonia, influenza). You will need to be vaccinated against bacterial infections at least 2 weeks before you start treatment with this medicine. You may also receive additional vaccines during treatment with this medicine. Check with your doctor right away if you have chest pain or tightness, chills, confusion, cough, drowsiness, fever, general feeling of illness, joint pain, loss of appetite, muscle aches and pains, nausea, runny nose, severe headache, sore throat, stiff neck, sweating, trouble breathing, unusual tiredness or weakness, or vomiting.
This medicine may cause infusion-related reactions, which can be life-threatening and require immediate medical attention. Tell your doctor right away if you have back pain, chest tightness, chills, fast heartbeat, fever, flushing, headache, nausea, trouble breathing, or weakness.
Using this medicine may increase your risk of having autoimmune disease (eg, systemic lupus erythematosus). Check with your doctor right away if you have blisters or itching, chest pain, fever and chills, general feeling of discomfort or illness, hair loss, headache, muscle or joint pain, skin rash, sore throat, swollen glands, or trouble breathing.
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
- Bladder pain
- bloody or cloudy urine
- bluish color of the fingernails, lips, skin, palms, or nail beds
- blurred vision
- chest pain
- chills
- cough
- diarrhea
- difficult, burning, or painful urination
- dizziness
- ear congestion or pain
- fever
- frequent urge to urinate
- head congestion
- hoarseness or other voice changes
- loss of appetite
- lower back or side pain
- muscle aches
- nausea
- nervousness
- pounding in the ears
- slow or fast heartbeat
- stomach pain
- stuffy or runny nose
- sneezing
- sore throat
- swelling of the hands, ankles, feet, or lower legs
- weakness
Incidence not known
- Back pain
- blisters or itching
- dark urine
- decreased urination
- general feeling of discomfort or illness
- hair loss
- skin rash
- swollen glands
- tiredness
- yellow eyes or skin
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
- Acid or sour stomach
- belching
- difficulty in moving
- heartburn
- indigestion
- muscle pain or stiffness
- pain, swelling, or redness in the joints
- stomach discomfort, upset, or pain
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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