capability [10%::<1% (Limited to important or life-threatening): Diarrhea Warnings/Precautions Concerns related to adverse effects: Antibody formation: The development of IgG anti-drug antibodies (ADA) has been reported; the clinical significance is unknown. Patients who develop immune or infusion reactions to taliglucerase alfa or who have had an immune response to other enzyme replacement therapies and who are switching to taliglucerase alfa should be monitored for antibody development; it is unknown if presence of antibodies is related to a higher risk of infusion reactions. CNS effects: Dizziness and fatigue have been observed with therapy; caution patients about performing dangerous tasks (eg, driving, operating machinery). Hypersensitivity/anaphylactoid reactions: Serious hypersensitivity reactions, including anaphylaxis, may occur; these reactions have occurred up to 3 hours after start of infusion. Appropriate medical support should be readily available. Base management of reaction on severity; may include slowing or temporary interruption of infusion and/or premedication (eg, antihistamine, antipyretics, corticosteroids) for mild reactions. Pretreatment may prevent subsequent reactions. Observe patient during and after infusion. If severe reactions occur, immediately discontinue infusion and initiate appropriate treatment; rechallenge with caution. Monitoring Parameters Hemoglobin, platelet count, angiotensin converting enzyme, tartrate-resistant acid phosphatase, chitotriosidase, IgG anti-drug antibody formation (in patients who experience, or previously experienced, immune or infusion reactions to enzyme replacement therapy); liver volume, spleen volume; bone density; ECG, echocardiogram, chest x-ray Pregnancy Considerations Adverse effects were not observed in animal reproduction studies. Pregnancy may exacerbate existing type I Gaucher disease or result in new symptoms. Women with type I Gaucher disease have an increased risk of spontaneous abortion if disease is not well controlled. Adverse pregnancy outcomes, including hepatosplenomegaly and thrombocytopenia (which may result in increased bleeding and postpartum hemorrhage requiring transfusion), may occur. Patient Education Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?) Patient may experience headache, diarrhea, joint pain, loss of strength and energy, abdominal pain, painful extremities, or back pain. Have patient report immediately to prescriber severe dizziness, passing out, flushing, cough, nausea, vomiting, or pharyngitis (HCAHPS). Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions. Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients. Next Pregnancy Warnings Print this page Add to My Med List More about taliglucerase alfa Side Effects During Pregnancy or Breastfeeding Dosage Information Support Group En Español 0 Reviews Add your own review/rating Drug class: lysosomal enzymes Consumer resources Taliglucerase alfa Taliglucerase alfa Intravenous (Advanced Reading) Professional resources Taliglucerase Alfa (AHFS Monograph) Other brands: Elelyso Related treatment guides Gaucher Disease> ] Drug Status Rx Availability Prescription only B Pregnancy Category No proven risk in humans N/A CSA Schedule Not a controlled drug Approval History Drug history at FDA Taliglucerase alfa Rating No Reviews - Be the first! No Reviews - Be the first! Not Rated - Be the first! Drug Class Lysosomal enzymes Related Drugs lysosomal enzymes Fabrazyme , Lumizyme , Myozyme , Elaprase , Aldurazyme , alglucosidase alfa Gaucher Disease eliglustat , Cerezyme , Zavesca , VPRIV , Elelyso , imiglucerase , More... in good shape
statistics Taliglucerase Alfa as a result of
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