Approximately half of the patients (54%) were male. Two multicenter, open-label clinical trials were conducted in 39 infantile-onset Pompe disease patients, ages 1 month to 3.5 years old. Clinical Trials In Infantile-Onset And Juvenile-Onset Pompe Disease In clinical trials, the most common adverse reactions (≥5%) following alglucosidase alfa treatment were hypersensitivity reactions, and included anaphylaxis, rash, pyrexia, flushing/feeling hot, urticaria, headache, hyperhidrosis, nausea, cough, decreased oxygen saturation, tachycardia, tachypnea, chest discomfort, dizziness, muscle twitching, agitation, cyanosis, erythema, hypertension/increased blood pressure, pallor, rigors, tremor, vomiting, fatigue, and myalgia. Anaphylaxis and hypersensitivity reactions.
The following serious adverse reactions are described below and elsewhere in the labeling: QUESTION About how much does an adult human brain weigh? See Answerīecause 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 clinical practice. You may report side effects to FDA at 1-80. Call your doctor for medical advice about side effects. This is not a complete list of side effects and others may occur.
tremor, shaking, increased sweating or.fast heart rate, rapid breathing, chest discomfort, cough.headache, dizziness, agitation, muscle twitching.
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skin rash, itching, flushing (warmth, redness, or tingly feeling).pale skin, blue lips, feeling hot or feverish.hives difficult breathing swelling of your face, lips, tongue, or throat.puffy eyes, swelling in your ankles or feet, weight gain, urine that looks foamy.skin changes (sores, lesions, ulcers, discoloring) or.fast heart rate, pounding in your neck or ears, anxiety, confusion.Īlso call your doctor at once if you have:.severe headache, nausea, feeling restless or nervous.warmth, redness, numbness, or tingly feeling under your skin.pale skin, cold or clammy skin, blue lips or fingernails, cold hands or feet.bronchospasm (wheezing, tight feeling in your chest or throat, trouble breathing).slow heart rate, weak pulse, fainting, slow breathing (breathing may stop).a feeling like you might pass out, even while lying down.Tell your caregivers or get emergency medical help right away if you have: Some allergic reactions may occur during the injection, or as long as 3 hours afterward. Get emergency medical help if you have signs of an allergic reaction: hives difficult breathing swelling of your face, lips, tongue, or throat. Our Lumizyme (alglucosidase alfa) for Injection Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication. Consult your doctor before breastfeeding. It is unknown if this drug passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. Lumizyme is not expected to harm a fetus. Lumizyme During Pregnancy and Breastfeeding Tell your doctor all medications and supplements you use. What Drugs, Substances, or Supplements Interact with Lumizyme? The recommended dosage of Lumizyme is 20 mg/kg body weight administered every 2 weeks as an intravenous infusion. high blood pressure/increased blood pressure.allergic reactions such as anaphylaxis (severe allergic reaction).infusion site reactions (pain, swelling, burning, or irritation).Lumizyme (alglucosidase alfa) for Injection is an enzyme used to treat a glycogen storage disorder called Pompe disease, (also called GAA deficiency) in adults and children who are at least 8 years old.
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