Description
Tividenofusp alfa-eknm injection is used to treat Hunter syndrome (Mucopolysaccharidosis type II, MPS II). Hunter syndrome is a rare genetic disorder in which the body does not breakdown sugar.
This medicine is to be given only by or under the direct supervision of a doctor.
This product is available in the following dosage forms:
- Powder for 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 tividenofusp alfa-eknm injection in children weighing less than 5 kilograms (kg). Safety and efficacy have not been established.
Geriatric
Appropriate studies on the relationship of age to the effects of tividenofusp alfa-eknm injection have not been performed in the geriatric population.
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:
- Blood problem (eg, anemia)—Use with caution. May make this condition worse.
Proper Use
A doctor or other trained health professional will give your child this medicine in a medical facility. It is given through an IV catheter that is placed into one of your veins. This medicine must be injected slowly, so your IV will need to stay in place for 4 hours.
Tividenofusp alfa-eknm injection may sometimes be given at home to patients who do not need to be in the hospital or clinic. If your child is using this medicine at home, your child's doctor or nurse will teach you how to prepare and inject the medicine.
Your doctor may also give you other medicines (eg, allergy medicine, fever medicine, steroids) to help prevent unwanted effects.
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 your child's progress at regular visits to make sure that this medicine is working properly. Blood and urine tests may be needed to check for unwanted effects.
This medicine may cause serious allergic reactions, including anaphylaxis which can be life-threatening and require immediate medical attention. Check with your doctor right away if your child has blurred vision, confusion, cough, difficulty swallowing, dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position, fast, pounding, or irregular heartbeat or pulse, rash, itching, sweating, trouble breathing, or unusual tiredness or weakness after receiving this medicine.
This medicine may cause infusion-related reactions. Check with your doctor right away if your child has back pain, chest tightness, chills, diarrhea, fever, flushing, headache, large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs, nausea and vomiting, or trouble breathing.
Check with your doctor right away if you have pale skin, trouble breathing, unusual bleeding or bruising, or unusual tiredness or weakness. These may be symptoms of anemia.
This medicine may cause serious kidney problems. Check with your doctor right away if your child has bloody or cloudy urine, problems with urination, or swelling of the face, feet, or lower legs.
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
- chest tightness
- chills
- cough
- diarrhea
- ear congestion
- fever
- flushing
- headache
- loss of taste or smell
- loss of voice
- lower back or side pain
- muscle or body pain
- nausea and vomiting
- painful or difficult urination
- pale skin
- sneezing
- sore throat
- stuffy or runny nose
- trouble breathing
- ulcers, sores, or white spots in the mouth
- unusual bleeding or bruising
- unusual tiredness or weakness
Incidence not known
- Bloody or cloudy urine
- blurred vision
- confusion
- difficulty swallowing
- dizziness
- dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
- fast, pounding, or irregular heartbeat or pulse
- high blood pressure
- hives, itching, skin rash
- irritability
- large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
- lip and tongue swelling
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
- stomach pain
- sweating
- swelling of the face, feet, or lower legs
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
- Bruising
- change in hearing
- constipation
- earache
- ear drainage
- loss of appetite
- pain or redness at the in injection site
- pale skin at the injection site
- 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.
DRG-80010481
