Vimizim Side Effects

Generic name: elosulfase alfa

Medically reviewed by Drugs.com. Last updated on Jun 2, 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.

Precautions

Your doctor will check your progress closely while you or your child are receiving this medicine. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to receive it.

This medicine may cause serious allergic reactions, including anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Call your doctor right away if you or your child have a rash, itching, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth while you are receiving this medicine.

Spinal or cervical cord compression (SCC) may occur while receiving this medicine. Check with your doctor right away if you or your child have back pain, loss of bladder or bowel control, or numbness or weakness in the legs.

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:

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:

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]

See also:

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