Elosulfase Alfa

Elosulfase Alfa is a prescription medicine used for the treatment of Morquio A syndrome. 

• Elosulfase Alfa is available under the following different brand names: Vimizim

Common side effects of Elosulfase Alfa include:

• nausea,
• vomiting,
• stomach pain,
• headache,
• fever,
• chills, and
• tiredness.

Serious side effects of Elosulfase Alfa include:

• hives,
• difficulty breathing,
• swelling of the face, lips, tongue, or throat,
• lightheadedness (even while lying down),
• cough,
• chest discomfort,
• shortness of breath,
• skin rash or redness,
• sudden warmth,
• tingly feeling,
• nausea,
• vomiting,
• pale skin,
• blue lips or fingernails,
• back pain,
• loss of movement in any part of the body,
• loss of bowel control, and
• loss of bladder control.

Rare side effects of Elosulfase Alfa include:

• none

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors;
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out. 

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult and pediatric dosage

Concentrated intravenous solution

• 1 mg/mL (in 5 mg/5 mL single-use vials [requires dilution])

Morquio A Syndrome

Adult dosage

• 2 mg/kg IV infused over a minimum of 3.5-4.5 hours

Pediatric dosage

• Aged below 5 years: Safety and efficacy not established
• Aged above 5 years: 2 mg/kg IV infused over a minimum of 3.5-4.5 hours

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Elosulfase Alfa has no noted severe interactions with any other drugs.
• Elosulfase Alfa has no noted serious interactions with any other drugs.
• Elosulfase Alfa has no noted moderate interactions with any other drugs.
• Elosulfase Alfa has no noted minor interactions with any other drugs.

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all your products. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, or if you have health questions or concerns.

Contraindications

• None

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Elosulfase Alfa?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Elosulfase Alfa?”

Cautions

• Anaphylaxis is reported and may occur as early as 30 minutes from the start of infusion and up to 3 hours after completing the infusion (see Black Box Warnings)
• Increased risk of acute respiratory complications; monitor patients with acute febrile or respiratory illness at the time of infusion (higher risk of life-threatening complications from hypersensitivity reaction)
• Sleep apnea is common in patients with MPS IVA, evaluate airway patency before initiating treatment with elosulfase Alfa

Pregnancy and Lactation

• There is a Morquio A Registry that collects data on pregnant women with MPS IVA who are treated with elosulfase Alfa; contact [email protected] or call 1-800-983-4587 for information and enrollment
• Available data from published case reports and postmarketing experience in pregnant women are insufficient to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes
• Clinical considerations
  • Pregnancy can exacerbate preexisting clinical manifestations of MPS and lead to adverse outcomes for both mother and fetus
• Lactation
  • Data are not available on the presence of elosulfase Alfa in human milk or the effects on milk production
  • Elosulfase Alfa is present in milk from treated rats; when a drug is present in animal milk, the drug will likely be present in human milk