Vimizim Side Effects

Generic name: elosulfase alfa

Medically reviewed by Drugs.com. Last updated on Oct 31, 2024.

Note: This document provides detailed information about Vimizim Side Effects associated with elosulfase alfa. Some dosage forms listed on this page may not apply specifically to the brand name Vimizim.

Applies to elosulfase alfa: intravenous solution.

Important warnings This medicine can cause some serious health issues

Intravenous route (solution)

Life-threatening anaphylactic reactions have occurred in some patients during elosulfase alfa infusions. Anaphylaxis, presenting as cough, erythema, throat tightness, urticaria, flushing, cyanosis, hypotension, rash, dyspnea, chest discomfort, and gastrointestinal symptoms in conjunction with urticaria, have been reported to occur during infusions, regardless of duration of the course of treatment.

Closely observe patients during and after elosulfase alfa administration and be prepared to manage anaphylaxis Inform patients of the signs and symptoms of anaphylaxis and have them seek immediate medical care should symptoms occur.

Patients with acute respiratory illness may be at risk of serious acute exacerbation of their respiratory compromise due to hypersensitivity reactions, and require additional monitoring.

Serious side effects of Vimizim

Along with its needed effects, elosulfase alfa (the active ingredient contained in Vimizim) 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 while taking elosulfase alfa:

More common side effects

• chills
• cough
• difficulty with swallowing
• dizziness
• fast heartbeat
• fever
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• skin rash, hives, or itching
• tightness in the chest
• unusual tiredness or weakness

Other side effects of Vimizim

Some side effects of elosulfase alfa 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 side effects

• abdominal or stomach pain
• headache
• vomiting

For healthcare professionals

Applies to elosulfase alfa: intravenous solution.

General adverse events

The more commonly reported adverse reactions include pyrexia, vomiting, headache, nausea, abdominal pain, chills, and fatigue.

Hypersensitivity

• Very common (10% or more): Hypersensitivity reactions (including anaphylaxis; 18.7%)
• Common (1% to 10%): Anaphylaxis^[Ref]

During clinical trials, 7.5% of patients (n=18/235) experienced signs and symptoms of anaphylaxis. These 18 patients experienced 26 anaphylactic reactions. These cases occurred 30 to 180 minutes after the start of the infusion. Anaphylaxis occurred as late into treatment as the 47th infusion. Hypersensitivity reactions (including anaphylaxis) occurred in 18.7% (n=44/235) of patients.^[Ref]

Local

• Very common (10% or more): Infusion reaction (up to 96%)

In clinical trials, 96% of patients experienced infusion reactions (IRs). IRs may include allergic reactions. Thirty-five patients (15.2%) discontinued at least one infusion due to an IR. Sixty (0.66%) of the 9,126 infusions administered in the clinical trials were discontinued due to an IR. 17.3% of patients had an infusion reaction requiring medical intervention. In 13 out of 231 patients and less than 1% of the total infusions, the infusion was discontinued, and medical intervention was required.

Immunologic

• Very common (10% or more): Development of anti-drug antibodies (100%), tested positive for neutralizing antibodies (100%)^[Ref]

All patients tested positive at least once during the trial for neutralizing antibodies capable of inhibiting the drug from binding to the mannose-6-phosphate receptor; this receptor binding is needed for drug intake into cells.^[Ref]

Other

• Very common (10% or more): Pyrexia (33%), chills (10.3%), fatigue (10.3%)^[Ref]

Gastrointestinal

• Very common (10% or more): Vomiting (31%), nausea (24%), abdominal pain (21%)^[Ref]

Nervous system

• Very common (10% or more): Headache (26%)^[Ref]

Further information

Vimizim side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

Medical Disclaimer