Description
Apitegromab-mstn injection is used to treat spinal muscular atrophy (SMA) in patients who are currently receiving a survival motor neuron 2 (SMN2) targeted treatment. Spinal muscular atrophy is a rare neuromuscular disorder that is characterized by loss of lower motor neurons and progressive muscle wasting, often leading to early death.
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 apitegromab-mstn injection in children younger than 2 years of age. Safety and efficacy have not been established.
Geriatric
Appropriate studies on the relationship of age to the effects of apitegromab-mstn injection have not been performed in the geriatric population.
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:
- Low bone density, history of or
- Multiple fractures, history of—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 that is placed into one of your veins. The medicine must be given slowly, so the IV will have to stay in place for 60 to 120 minutes. It is usually given every 4 weeks.
This medicine comes with a patient information leaflet. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions.
Missed Dose
This medicine needs to be given on a fixed schedule. If you miss a dose or forget to use your medicine, call your doctor or pharmacist for instructions.
Precautions
It is very important that your doctor check you or your child's progress closely while receiving this medicine to make sure it is working properly. Blood tests are needed to check for unwanted effects.
This medicine may increase your risk for fractures. Check with your doctor right away if you have pain or swelling in the arms or legs without any injury.
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
- Arm or leg pain
- body aches or pain
- bruise
- chills
- collection of blood under the skin
- cough
- deep, dark purple bruise
- diarrhea
- difficulty in moving
- ear congestion
- fall
- fever
- headache
- hoarseness
- itching, pain, redness, or swelling
- loss of taste or smell
- loss of voice
- muscle or joint pain
- nausea or vomiting
- pain or swelling in the arms or legs without any injury
- skin itching, rash, or redness
- sneezing
- sore throat
- stuffy or runny nose
- swelling of the face, throat, or tongue
- tender, swollen glands in neck
- trouble breathing
- trouble swallowing
- unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness
- voice changes
Less common
- Blue lips, fingernails, or skin
- chest pain or tightness
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
- Bleeding, blistering, burning, coldness, discoloration of skin, 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
- loss of appetite
- stomach 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.
DRG-80012055
