What is Elosulfase Alfa?
Elosulfase alfa is a type of enzyme that is naturally present in the bodies of healthy individuals. Certain people are deficient in this enzyme due to an inherited disorder. Elosulfase Alfa can replace the enzyme that is missing in these individuals. Elosulfase alfa is used to alleviate some symptoms associated with mucopolysaccharidosis (MYOO-koe-pol-ee-SAK-a-rye-DOE-sis) IV type A or Morquio A syndrome. MPS-IVA is a metabolic disorder that occurs when the body does not have the enzymes required to break down natural substances. The substances can accumulate within the body, leading to an increase in organs and bones, a change in the structures of bones, changes to the facial appearance, breathing difficulties, as well as heart problems, vision loss or loss of hearing, and changes in physical or mental capabilities. Elosulfase may help increase the speed of walking and stair-climbing for those suffering from this condition. It is important to note that it isn't an effective treatment for IVA MPS. Elosulfase Alfa can also be used to treat conditions not covered in this medication guideline.
Side effects of Elosulfase Alfa
Contact a medical professional immediately. If you are experiencing symptoms that indicate an allergic reaction, like hives, trouble breathing, or swelling of your lips, face, and tongue,
An allergic reaction can happen within or just after an infusion of elosulfase (up to 3 hours later). Contact your doctor or seek emergency medical assistance immediately if you exhibit any indication of a reaction to an allergic substance, such as:
- The feeling that you are about to feel like you're going to pass out, even while you're lying down;
- Cough and chest pain, feeling breathless;
- Skin eruption with redness or itchiness, an abrupt sensation of warmth or tingling;
- Nausea, vomiting;
- Pale skin; or
- Fingernails or blue lips
The most common adverse effects of elosulfase could be:
- Nausea, vomiting, and stomach pain;
- Headache;
- Fever chills;
- Feeling exhausted.
Although it might not cause a problem with elosulfase alfa, an increase in stress on the spine can be a complication of MPS IVA that can develop during the course of taking this drug. Inform your doctor promptly if you experience any signs of spinal cord compression.
- Back pain;
- Loss of movement in the body
- Loss of bladder or bowel control.
This list does not encompass every potential side effect and others could occur; please seek medical advice for advice regarding potential medical effects. Report any adverse reactions directly to the FDA at 1-800-FDA-1088.
Warnings
A reaction to an allergen can occur during or just after the infusion of this medication. Inform your healthcare providers or seek emergency medical assistance immediately if you notice any symptoms of a severe allergy, such as chest discomfort, coughing, trouble breathing and vomiting, skin rashes or redness, pale skin and lips, blue fingernails or blue lips, or feeling as if you're going to be ill. You are more likely to experience a reaction to the elosulfase-alfa compound if you suffer from breathing issues or if you're sick and have a fever at the moment of your infusion. You will be monitored closely following the treatment with elosulfase to ensure that you don't suffer from the reaction of an allergy.
Before you take this drug
The infusion of elosulfase can be delayed if you are suffering from a cold or fever. the symptoms of a cold.
Inform your doctor if you have ever suffered from:
- Breathing issues
- Sleep apnea, which is caused by an airway continuous pressure (CPAP) machine.
Notify your doctor immediately if you are breastfeeding or pregnant. It isn't known if the elosulfase-alfa compound can affect the unborn baby. The symptoms of MPS may become more severe in pregnancy and could cause medical issues for both the mother and baby. The advantages of treating MPS could outweigh the risk for the baby. Your name could have to be included on the Morquio A Registry while you are taking elosulfase. The aim of this register is to keep track of the development of this disorder as well as the impact that elosulfase can have on the long-term treatment of Morquio A disorder. The registry also monitors its effects on elosulfase in a baby in the event that you are nursing or pregnant.
How to take Elosulfase Alfa?
Elosulfase Alfa is administered as an injection into the vein. Your healthcare provider will offer the injection. It is recommended to administer Elosulfase alfa slowly, and the infusion could last as long as 4 hours or even longer to finish. The drug is typically administered every week. Follow the instructions of your physician. Doses of elosulfase alfa are determined by weight (especially in teenagers and children). Your dose needs may change if you gain or lose weight. Between 30 and 60 minutes prior to the injection, you'll be administered other medicines to help you avoid a severe allergic reaction. You will be monitored closely after receiving elosulfase Alfa to ensure that there aren't any allergic reactions.
Details on dosage
Usual Adult Dose for Mucopolysaccharidosis Type IV:
2 mg/kg intravenous infusions once per week
Comments:
Pretreatment using the antihistamines and/or antipyretics is suggested 30 to 60 minutes prior to commencing the infusion.
See Other Comments/Administration Advice for recommended dilution volume and infusion rates
Use: For patients with mucopolysaccharidosis, IVA (MPS IVA; Morquio A syndrome)
Usual Pediatric Dose for Mucopolysaccharidosis Type IV:
5 years old or older 2 mg/kg or more via IV infusion every week
Comments:
Pretreatment with antihistamines and/or antipyretics is suggested 30 to 60 minutes prior to commencing the infusion.
See Other Comments/Administration Advice for recommended dilution volume and infusion rates
Use: For patients with mucopolysaccharidosis, IVA (MPS IVA; Morquio A syndrome)
What happens if I miss the dose?
Consult your physician for treatment. If you do not make an appointment for an elosulfase injection,
What happens if I overdose?
Because this medication is administered by a health specialist in a medical setting, it is highly unlikely for an overdose to occur.
What should be avoided?
Follow the instructions of your physician regarding any restrictions on your food, drink, or activities
Interaction with other drug
Other medications may interact with elosulfase, which includes prescription and non-prescription medicines, vitamins, and herbal products. Discuss with your physician all the medications you currently use and any medication you begin or stop taking.
