hard earned Elaprase Side Effects Generic Name: idursulfase Overview Side Effects Dosage Professional Pregnancy More User Reviews Support Group Q & A Pricing & Coupons Note: This document contains side effect information about idursulfase. Some of the dosage forms listed on this page may not apply to the brand name Elaprase. For the Consumer Applies to idursulfase: intravenous solution Along with its needed effects, idursulfase (the active ingredient contained in Elaprase) 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 idursulfase: 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 of idursulfase 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 For Healthcare Professionals Applies to idursulfase: intravenous solution General The most frequently reported adverse effects in all clinical trials were hypersensitivity reactions and included rash, urticaria, pruritus, flushing, pyrexia, and headache. The most frequently reported adverse effects following treatment were hypoxia, pyrexia, rash, vomiting, diarrhea, cough, musculoskeletal pain, headache, pruritus, and urticaria. [ Ref ] Hypersensitivity In clinical trials, the most common adverse effects were hypersensitivity reactions and included rash, urticaria, pruritus, flushing, pyrexia, and headache. Most reactions were resolved with slowing the infusion rate or temporarily stopping the infusion, with or without additional treatments including antihistamines and/or corticosteroids prior to or during infusions. [ Ref ] Very common (10% or more): Hypersensitivity reaction Frequency not reported: Anaphylactoid/anaphylactic reaction Postmarketing reports: Late-emergent anaphylactoid reaction [ Ref ] Immunologic In clinical trials, 32 out of 63 patients 5 years and older tested positive for antidrug antibodies at least 1 time; of the 32 patients, 23 tested positive for antidrug antibodies 3 or more times. The incidence of hypersensitivity reactions was higher in positive antidrug antibody patients than those who tested negative. Out of 32 antidrug antibody positive patients, 13 also tested positive for neutralizing antibodies. There was no clear relationship between presence of either type of antibody and therapeutic response. [ Ref ] Very common (10% or more): Antidrug antibody development (50%), neutralizing antibody development (24.3%) [ Ref ] Nervous system Very common (10% or more): Headache (up to 65.6%) Common (1% to 10%): Dizziness, tremor [ Ref ] Dermatologic Very common (10% or more): Rash (up to 34.4%), pruritus (up to 31.3%), urticaria (up to 16%) Common (1% to 10%): Erythema [ Ref ] Other Very common (10% or more): Infusion-related reaction (68.8%), pyrexia (up to 62.5%), chest pain (up to 15.6%), infusion site swelling (12.5%) Common (1% to 10%): Face edema, peripheral edema [ Ref ] The most serious infusion-related reactions included anaphylactoid/anaphylactic reactions. The most common infusion-related reactions included cutaneous reactions (rash, pruritus, urticaria), pyrexia, headache, hypertension, flushing, wheezing, hypoxia, dyspnea, abdominal pain, nausea, dyspepsia, chest pain, and infusion site swelling. Treatment/amelioration of infusion-related reactions included slowing the infusion rate, interrupting the infusion, or drug therapy (e.g., antihistamines, antipyretics, low-dose corticosteroids [prednisone, methylprednisolone], beta-agonist nebulization). [ Ref ] Musculoskeletal Very common (10% or more): Musculoskeletal pain (13%) Common (1% to 10%): Arthralgia [ Ref ] Gastrointestinal Very common (10% or more): Abdominal pain (up to 53.1%), nausea (up to 28.1%), dyspepsia (12.5%), vomiting, diarrhea Common (1% to 10%): Swollen tongue [ Ref ] Cardiovascular Very common (10% or more): Hypertension (up to 25%), flushing (15.6%) Common (1% to 10%): Cyanosis, arrhythmia, tachycardia, hypotension Postmarketing reports: Cardiac failure, cardiorespiratory arrest [ Ref ] Respiratory Very common (10% or more): Wheezing (15.6%), dyspnea (up to 12.5%) Common (1% to 10%): Cough, bronchospasm, tachypnea, hypoxia Frequency not reported: Pulmonary embolism Postmarketing reports: Respiratory failure, respiratory distress, pneumonia [ Ref ] References 1. Cerner Multum, Inc. "Australian Product Information." O 0 2. "Product Information. Elaprase (idursulfase)." Shire US Inc, Florence, KY. 3. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0 Some side effects of Elaprase may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA . Next Dosage Print this page 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 Elaprase (Advanced Reading) Professional resources Elaprase (AHFS Monograph) Elaprase (FDA) Related treatment guides Mucopolysaccharidosis Type II Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist. 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! recently
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