HIGHLIGHT
Replagal

Replagal

agalsidase alfa

Manufacturer:

Takeda

Distributor:

Zuellig Pharma
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
Pre-treatment w/ antihistamines &/or corticosteroids from 1-24 hr prior to infusion to prevent subsequent reactions. Discontinue immediately if severe hypersensitivity or anaphylactic reactions occur. Idiosyncratic infusion related reactions. Not to infuse concomitantly in same IV line w/ other agents. May develop Abs to protein. Renal impairment. Pregnancy & lactation. Childn 0-6 yr. Elderly >65 yr.
Adverse Reactions
Peripheral oedema; headache, dizziness, neuropathic pain, tremor, hypoesthesia, paraesthesia; tinnitus; palpitations; dyspnoea, cough, nasopharyngitis, pharyngitis; vomiting, nausea, abdominal pain, diarrhoea; rash; arthralgia, limb & back pain, myalgia; chest pain, rigors, pyrexia, pain, asthenia, fatigue. Dysgeusia, hypersomnia; increased lacrimation; aggravated tinnitus; tachycardia, atrial fibrillation; HTN, hypotension, flushing; hoarseness, throat tightness, rhinorrhoea; abdominal discomfort; urticaria, erythema, pruritus, acne, hyperhidrosis; musculoskeletal discomfort, peripheral & joint swelling; hypersensitivity; chest tightness, aggravated fatigue, feeling hot & cold, flu-like illness, discomfort, malaise.
Drug Interactions
Inhibited intracellular α-galactosidase activity w/ chloroquine, amiodarone, Benoquin or gentamicin.
MIMS Class
Other Agents Affecting Metabolism
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 conc for soln for infusion 1 mg/mL
Packing/Price
3.5 mL x 1's
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