Vimizim

Last updated on RxList: 5/24/2021
Vimizim Side Effects Center

What Is Vimizim?

Vimizim (elosulfase alfa) Injection is a form of an enzyme used for patients with Mucopolysaccharidosis type IVA (MPS IVA; Morquio A syndrome).

What Are Side Effects of Vimizim?

Common side effects of Vimizim include:

  • fever
  • vomiting
  • headache
  • nausea
  • abdominal pain
  • chills, and
  • fatigue.
Serious side effects of Vimizim include hypersensitivity and allergic reactions such as:
  • hives
  • swelling
  • cough
  • shortness of breath, and
  • flushing

Dosage for Vimizim

The recommended dose of Vimizim is 2 mg per kg given intravenously over a minimum range of 3.5 to 4.5 hours, based on infusion volume, once every week.

What Drugs, Substances, or Supplements Interact with Vimizim?

Vimizim may interact with other drugs. Tell your doctor all medications and supplements you use.

Vimizim During Pregnancy and Breastfeeding

There is a Morquio A Registry that collects data on pregnant and breastfeeding women with MPS IVA who are treated with Vimizim. During pregnancy, Vimizim should be used only if prescribed. It is unknown if this drug passes into breast milk. Consult your doctor before breast feeding.

Additional Information

Our Vimizim (elosulfase alfa) Injection, Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Vimizim Consumer Information

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

An allergic reaction may occur during or shortly after infusion of this medicine (up to 3 hours later). Tell your caregivers or get emergency medical help right away if you have any signs of a severe allergic reaction, such as:

  • feeling like you might pass out, even while lying down;
  • cough, chest discomfort, feeling short of breath;
  • skin rash or redness, sudden warmth or tingly feeling;
  • nausea, vomiting;
  • pale skin; or
  • blue lips or fingernails.

Common side effects of elosulfase alfa may include:

  • nausea, vomiting, stomach pain;
  • headache;
  • fever, chills; or
  • feeling tired.

Even though it may not be a side effect of elosulfase alfa, increased pressure on the spinal cord is a complication of MPS IVA that may occur while you are using this medicine. Tell your doctor right away if you have any symptoms of spinal cord compression:

  • back pain;
  • loss of movement in any part of your body; or
  • loss of bowel or bladder control.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Vimizim (Elosulfase Alfa Injection for Intravenous Use)

Vimizim Professional Information

SIDE EFFECTS

The following serious adverse reactions are described below and elsewhere in the labeling:

  • Anaphylaxis and hypersensitivity reactions [see WARNINGS AND PRECAUTIONS].
  • Risk of acute respiratory complications [see WARNINGS AND PRECAUTIONS].
  • Spinal or cervical cord compression [see WARNINGS AND PRECAUTIONS].

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

A 24-week, randomized, double-blind, placebo-controlled clinical trial of Vimizim was conducted in 176 patients with MPS IVA, ages 5 to 57 years old. Approximately half of the patients (49%) were male. Of the 176 patients, 65% were White, 23% Asian, 3% Black, and 10% Other race. The majority of patients (78%) were non-Hispanic. Patients were randomized to three treatment groups: Vimizim 2 mg/kg once per week (n=58), Vimizim 2 mg/kg once every other week (n=59), or placebo (n=59). All patients were treated with antihistamines prior to each infusion.

Table 1 summarizes the most common adverse reactions that occurred in the placebo-controlled trial with an incidence of ≥ 10% in patients treated with Vimizim 2 mg/kg once per week and with a higher incidence than in the placebo-treated patients.

Table 1: Adverse Reactions That Occurred in the Placebo-Controlled Trial in At Least 10% of Patients in the Vimizim 2 mg/kg Once Per Week Group and with a Higher Incidence than in the Placebo Group

Adverse Reaction Vimizim 2 mg/kg once per week
N= 58
n (%)
Placebo
N= 59
n (%)
Pyrexia 19 (33%) 8 (14%)
Vomiting 18 (31%) 4 (7%)
Headache 15 (26%) 9 (15%)
Nausea 14 (24%) 4 (7%)
Abdominal pain 12 (21%) 1 (2%)
Chills 6 (10%) 1 (2%)
Fatigue 6 (10%) 2 (3%)

Extension Trial

An open-label extension trial was conducted in 173 patients who completed the placebo-controlled trial [see Clinical Studies]. No new adverse reactions were reported.

Immunogenicity

As with all therapeutic proteins, there is potential for immunogenicity. The detection of antibody formation is highly dependent on the sensitivity and specificity of the assay. Additionally, the observed incidence of antibody (including neutralizing antibody) positivity in an assay may be influenced by several factors including assay methodology, sample handling, timing of sample collection, concomitant medications, and underlying disease. For these reasons, comparison of the incidence of antibodies in other studies or to other elosulfase alfa products may be misleading.

All patients treated with Vimizim 2 mg/kg once per week in the placebo-controlled trial developed anti-drug antibodies by Week 4. Anti-drug antibody titers were sustained or increased for the duration of Vimizim treatment. Because all patients developed anti-drug antibodies, associations between antibody titers and reductions in treatment effect or the occurrence of anaphylaxis or other hypersensitivity reactions could not be determined.

All patients treated with Vimizim 2 mg/kg once per week tested positive for neutralizing antibodies capable of inhibiting the drug from binding to the mannose-6-phosphate receptor at least once during the trial. Binding to this receptor is required for Vimizim to be taken into cells where it is active. Neutralizing antibody titers were not determined in the patients. Therefore, the possibility of an association between neutralizing antibody titer and treatment effect cannot be assessed.

DRUG INTERACTIONS

No Information provided

Read the entire FDA prescribing information for Vimizim (Elosulfase Alfa Injection for Intravenous Use)

© Vimizim Patient Information is supplied by Cerner Multum, Inc. and Vimizim Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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