looking forward to Zavesca Side Effects Generic Name: miglustat Overview Side Effects Dosage Professional Interactions More Pregnancy Warnings User Reviews Support Group Q & A Pricing & Coupons Note: This document contains side effect information about miglustat. Some of the dosage forms listed on this page may not apply to the brand name Zavesca. For the Consumer Applies to miglustat: oral capsule Along with its needed effects, miglustat (the active ingredient contained in Zavesca) 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 immediately if any of the following side effects occur while taking miglustat: More common Black, tarry stools bleeding gums blood in the urine or stools burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings diarrhea pinpoint red spots on the skin trembling or shaking in the hands unsteadiness or awkwardness unusual bleeding or bruising weakness in the arms, hands, legs, or feet weight loss Some side effects of miglustat 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 Back pain bloated or full feeling blurred or loss of vision difficulty having a bowel movement (stool) disturbed color perception dizziness double vision dry mouth excess air or gas in the stomach or intestines halos around lights headache heartburn heaviness in the limbs indigestion leg cramps loss of appetite memory loss menstrual changes nausea pain or discomfort in the chest, upper stomach, or throat passing gas stomach discomfort, upset or pain swelling of the abdominal or stomach area tunnel vision unsteady walk vomiting For Healthcare Professionals Applies to miglustat: oral capsule General The most commonly reported adverse reactions included diarrhea, flatulence, abdominal pain, weight loss, and tremor; the most common serious adverse reaction was peripheral neuropathy; diarrhea and tremor were the side effects that most commonly required intervention. [ Ref ] Gastrointestinal Osmotic diarrhea appears to be due to inhibitory activity of miglustat (the active ingredient contained in Zavesca) on intestinal disaccharidases leading to reduced absorption of dietary disaccharides in the small intestine. Diarrhea decreased over time with continued therapy. [ Ref ] Very common (10% or more): Diarrhea (including osmotic diarrhea; up to 100%), abdominal pain (up to 67%), flatulence (up to 50%), nausea (up to 22%), vomiting (up to 11%) Common (1% to 10%): Constipation, dry mouth, dyspepsia, epigastric pain not food-related, bloating, stomach pain, gas, abdominal distension/discomfort Frequency not reported: Dysphagia, indigestion, dry mouth [ Ref ] Metabolic Weight loss has been observed in approximately 55% to 65% of patients. Peak weight loss occurs between 6 and 12 months, with a mean weight loss of 6% to 7% of body weight. It is unclear if weight loss results from the diarrhea and associated gastrointestinal complaints, a decrease in food intake, or a combination of these or other factors. There is a trend to return to baseline weight after the first year. [ Ref ] Very common (10% or more): Weight decrease (up to 67%) Common (1% to 10%): Anorexia [ Ref ] Nervous system Very common (10% or more): Tremor/exacerbation of existing tremor (about 30%), headache (up to 22%), tremor (up to 17%), dizziness (up to 11%) Common (1% to 10%): Unsteady gait, paresthesia, migraine, peripheral neuropathy, ataxia, hypoesthesia Frequency not reported: Gait abnormal, gait spastic, hyperreflexia [ Ref ] The most common serious adverse reaction in clinical trials was peripheral neuropathy. Tremor, and worsening tremor were very commonly reported. Compared to the general population, patients with type 1 Gaucher disease are more likely to have peripheral neuropathy. A patient should be evaluated for tremor and neuropathy prior to starting therapy. [ Ref ] Other Very common (10% or more): Generalized weakness (up to 17%) Common (1% to 10%):Fatigue, asthenia, chills, malaise, pain Frequency not reported: Fatigue, lacerations [ Ref ] Ocular Very common (10% or more): Visual disturbances (up to 17%) [ Ref ] Musculoskeletal Very common (10% or more): Cramps (up to 11%) Common (1% to 10%): Muscle spasms Frequency not reported: Leg cramps, muscle cramps, back pain, heaviness in arms and legs [ Ref ] Psychiatric Common (1% to 10%): Memory loss Frequency not reported: Insomnia, decreased appetite, depression, decreased libido [ Ref ] Hematologic Common (1% to 10%): Thrombocytopenia Frequency not reported: Mild reduction in platelet count [ Ref ] Genitourinary Common (1% to 10%): Menstrual disorder [ Ref ] Respiratory Frequency not reported: Nasopharyngitis, cough, sinusitis [ Ref ] References 1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0 2. Cerner Multum, Inc. "Australian Product Information." O 0 3. "Product Information. Zavesca (miglustat)." Acetelion Pharmaceuticals US, Inc, South San Francisco, CA. Some side effects of Zavesca 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 Zavesca (miglustat) Side Effects During Pregnancy Dosage Information Drug Interactions Support Group Pricing & Coupons En Español 0 Reviews Add your own review/rating Drug class: miscellaneous metabolic agents Consumer resources Zavesca Zavesca (Advanced Reading) Professional resources Zavesca (AHFS Monograph) Zavesca (FDA) Related treatment guides Gaucher Disease 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 Actelion Pharmaceuticals US, Inc. Drug Class Miscellaneous metabolic agents Related Drugs Gaucher Disease eliglustat , Cerezyme , taliglucerase alfa , VPRIV , Elelyso , imiglucerase , More... Zavesca Rating No Reviews - Be the first! No Reviews - Be the first! Not Rated - Be the first! normal
starting up Zavesca Side Effects responsibilities
EmoticonEmoticon