Elosulfase alfa Intravenous

Name: Elosulfase alfa Intravenous

Commonly used brand name(s)

In the U.S.

  • Vimizim

Available Dosage Forms:

  • Solution

Therapeutic Class: Endocrine-Metabolic Agent

Pharmacologic Class: Enzyme

Before Using elosulfase alfa

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For elosulfase alfa, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to elosulfase alfa or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of elosulfase alfa injection in children. However, safety and efficacy have not been established in children younger than 5 years of age.

Geriatric

Although appropriate studies on the relationship of age to the effects of elosulfase alfa injection have not been performed in the geriatric population, no geriatric-specific problems have been documented to date.

Pregnancy

Pregnancy Category Explanation
All Trimesters C Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of elosulfase alfa. Make sure you tell your doctor if you have any other medical problems, especially:

  • Fever or
  • Lung or breathing problems (including sleep apnea)—Use with caution. May increase risk for more serious side effects.

Precautions While Using elosulfase alfa

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

elosulfase alfa 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 elosulfase alfa.

Spinal or cervical cord compression (SCC) may occur while receiving elosulfase alfa. 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.

elosulfase alfa Side Effects

Along with its needed effects, a medicine 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:

More common
  • 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

Some side effects 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
  • Abdominal or stomach pain
  • headache
  • vomiting

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Overdose

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

Notes

No monograph available at this time.

Missed Dose

Consult your pharmacist.

Storage

Consult your pharmacist.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

Information last revised July 2016. Copyright(c) 2016 First Databank, Inc.

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