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Replagal

Replagal

Manufacturer:

Takeda

Distributor:

Zuellig
Concise Prescribing Info
Contents
Agalsidase α
Indications/Uses
Long-term enzyme replacement therapy in patients w/ confirmed diagnosis of Fabry disease (α-galactosidase A deficiency).
Dosage/Direction for Use
0.2 mg/kg every other wk by IV infusion over 40 min.
Contraindications
Special Precautions
Hypersensitivity & idiosyncratic infusion-related reactions. IgG Abs may develop. Presence of extensive renal damage may limit the renal response to enzyme replacement therapy. Patients w/ hepatic impairment. Pregnancy & lactation. Elderly >65 yr. Childn <6 yr.
Adverse Reactions
Headache; flushing; nausea; rigors, pyrexia, pain & discomfort, fatigue. Peripheral oedema; dizziness, dysgeusia, neuropathic pain, tremor, hypersomnia, hypoesthesia, paraesthesia; decreased corneal reflex, increased lacrimation; tinnitus, tinnitus aggravated; tachycardia, palpitations; HTN; cough, hoarseness, throat tightness, dyspnoea, nasopharyngitis, pharyngitis, increased throat secretion, rhinorrhoea; diarrhoea, vomiting, abdominal pain/discomfort; acne, erythema, pruritus, rash, livedo reticularis; musculoskeletal discomfort, myalgia, back/limb pain, peripheral/joint swelling, arthralgia; fatigue aggravated, feeling hot/cold, asthenia, chest pain/tightness, flu-like illness, inj site rash, malaise.
Drug Interactions
Potential inhibition of intra-cellular α-galactosidase activity w/ chloroquine, amiodarone, benoquin or gentamicin.
ATC Classification
A16AB03 - agalsidase alfa ; Belongs to the class of enzymes. Used in the treatment of alimentary tract and metabolism problems.
Presentation/Packing
Form
Replagal concentrate for soln for infusion 3.5 mg/3.5 mL
Packing/Price
1's
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