running Elaprase (Intravenous) Generic Name: idursulfase (Intravenous route) eye-dur-SUL-fase Overview Side Effects Dosage Professional Pregnancy More User Reviews Support Group Q & A Pricing & Coupons Intravenous route(Solution) Life-threatening anaphylactic reactions, presenting as respiratory distress, hypoxia, hypotension, urticaria, and/or angioedema of throat or tongue have occurred in some patients during and up to 24 hours after idursulfase infusions, regardless of duration of the course of treatment. Closely observe patients during and after idursulfase 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 compromised respiratory function or acute respiratory disease may be at risk of serious acute exacerbation of their respiratory compromise due to hypersensitivity reactions, and require additional monitoring . Commonly used brand name(s) In the U.S. Elaprase Available Dosage Forms: Solution Therapeutic Class: Enzyme Replacement Pharmacologic Class: Enzyme Slideshow Binge Eating Disorder: Beyond Overeating Uses For Elaprase Idursulfase injection is used to treat Hunter syndrome (Mucopolysaccharidosis II, MPS II), a rare condition that is most often seen in males. Hunter syndrome is an inherited disease in which the breakdown of a certain chemical in the body (mucopolysaccharide) is defective due to the lack or absence of an enzyme called iduronate-2-sulfatase. Idursulfase improves signs and symptoms in patients, especially walking capacity, by replacing the missing enzyme in Hunter syndrome. This medicine is available only with your doctor's prescription. Before Using Elaprase 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 this medicine, the following should be considered: Allergies Tell your doctor if you have ever had any unusual or allergic reaction to this medicine 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 idursulfase injection in children. However, safety and efficacy have not been established in children younger than 16 months of age. Geriatric Appropriate studies have not been performed on the relationship of age to the effects of idursulfase injection in the geriatric population. Safety and efficacy have not been established. 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 this medicine. Make sure you tell your doctor if you have any other medical problems, especially: Fluid overload (too much fluid in the blood) or Heart disease or Illness with fever or Lung disease or breathing problems Use with caution. May increase risk of developing life-threatening complications. Proper Use of Elaprase A nurse or other trained health professional will give you or your child this medicine in a hospital. This medicine is given through a needle placed in one of your veins. This medicine is usually given one time each week. The medicine is given slowly, so the needle will remain in place for a few hours. You or your child may also receive medicines to help prevent possible allergic reactions to the injection. Precautions While Using Elaprase It is very important that your doctor check your or your child's progress at regular visits . This will allow your doctor to see if the medicine is working properly and check you for unwanted effects that may be caused by this medicine. This medicine may cause serious allergic reactions, including anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Tell your doctor or nurse right away if you or your child have a rash, itching, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth after you or your child get the injection. Elaprase 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 Bone or muscle pain chest pain chills cough fast, pounding, or irregular heartbeat or pulse feeling of warmth fever headache hives or welts itching rash redness of the face, neck, arms, and occasionally, upper chest redness of the skin sneezing sore throat tightness in the chest unusual tiredness or weakness Less common Blurred vision confusion dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position sweating Incidence not known Difficulty with swallowing dilated neck veins extreme fatigue heart stops irregular breathing no breathing no pulse or blood pressure puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue unconscious weight gain 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 Change in hearing diarrhea ear drainage earache or pain in the ear Less common Nausea 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. Side Effects (complete list) The information contained in the Truven Health Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you. The use of the Truven Health products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Truven Health and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, TRUVEN HEALTH MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Truven Health does not assume any responsibility or risk for your use of the Truven Health products. Copyright 2017 Truven Health Analytics, Inc. All Rights Reserved. Next Side Effects Print this page Add to My Med List More about Elaprase (idursulfase) Side Effects During Pregnancy Dosage Information Support Group Pricing & Coupons En Español 0 Reviews Add your own review/rating Drug class: lysosomal enzymes Consumer resources Elaprase Professional resources Elaprase (AHFS Monograph) Elaprase (FDA) Related treatment guides Mucopolysaccharidosis Type II} Drug Status Rx Availability Prescription only C Pregnancy Category Risk cannot be ruled out N/A CSA Schedule Not a controlled drug Approval History Drug history at FDA Manufacturer Shire US, Inc. Drug Class Lysosomal enzymes Related Drugs Mucopolysaccharidosis Type II n/a Elaprase Rating No Reviews - Be the first! No Reviews - Be the first! Not Rated - Be the first! Help and Support Looking for answers? Ask a question or go join the Elaprase support group to connect with others who have similar interests.} } generators
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