- Dosages
- Side effects in children
- Warnings & precautions in children
- Contra-indications in children
-
Interactions - PK
- Renal impairment
- References
Pharmacokinetics in children
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dose recommendation of formulary compared to licensed use (on-label versus off-label)
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Available formulations
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Dosages
| Enzyme replacement therapy in hypophosphatasia |
|---|
|
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Renal impaiment in children > 3 months
No information available on dose adjustment in renal impairment.
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The complete list of all undesirable drug reactions can be found in the national Summary of Product Characteristics (SmPC) – click here
Side effects in children
Very common (> 10%): headache. Erythema. Pain in extremity. Injection site reaction (including atrophy, abscess, erythema, pain, itching, swelling, lipodystrophy, induration, nodule, rash, papula, hematoma, inflammation, urticaria, calcification, heat, haemorrhage, injection site vesicles), fever, irritability. Bruise.
Common (1-10%): anaphylactoid reactions, hypersensitivity. Injection site cellulite. Increased tendency to bruise. Hypocalcaemia. Hot flashes. Oral hypoaesthesia, nausea. Skin discoloration, stretched skin. Nephrolithiasis. Myalgia. Cold shivers. Scar.
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The complete list of all contra-indications can be found in the national Summary of Product Characteristics (SmPC) – click here
Contra-indications in children
Severe or life-threatening hypersensitivity to asfotase alfa if the hypersensitivity cannot be controlled
The complete list of all warnings and precautions can be found in the national Summary of Product Characteristics (SmPC) – click here
Warnings & precautions in children
Hypersensitivity reactions may include anaphylactoid reactions (difficulty breathing, choking sensation, periorbital edema and dizziness), nausea, vomiting, fever, headache, flushing, irritability, chills, erythema, rash, itching and oral hypoaesthesia; These side effects occur within minutes of administration and can still occur after 1 year of treatment. If these reactions occur, discontinue administration immediately. Balance the risks and benefits of re-administration after treatment of a severe reaction. Re-administration should take place under medical supervision, with subsequent administrations depending on the physician's judgment.
Injection-related reactions usually occur within the first 12 weeks of treatment, but can still occur up to 1 or more years after starting treatment. Discontinue administration in case of a severe injection-related reaction.
Events of craniostenosis (associated with increased intracranial pressure), including exacerbation of pre-existing craniostenosis and occurrence of Arnold-Chiari malformation, have been reported in patients <5 years of age. There are insufficient data to establish a causal relationship to asfotase alfa exposure. Craniostenosis can also be a manifestation of hypophosphatasia. Periodic monitoring (including fundoscopy to check for signs of papilledema) is recommended in patients <5 years of age.
Ectopic calcification (ophthalmic calcification and nephrocalcinosis) have been reported. There are insufficient data to establish a causal relationship to asfotase alfa exposure. Ophthalmic calcification and nephrocalcinosis can also be manifestations of hypophosphatasia. Eye examination and ultrasound scan of the kidneys are recommended at baseline and periodically.
Serum parathyroid hormone levels may increase during treatment (especially during the first 12 weeks). Monitoring of parathyroid hormone and serum calcium is recommended. Calcium and oral vitamin D supplementation may be required.
Patients may experience disproportionate weight gain. Dietary supervision is recommended.
If the patient is to receive laboratory testing, inform the laboratory that the patient is being treated with medication that affects AF concentration.
Efficacy and safety have not been established in renal or hepatic impairment
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Interactions
The complete list of all interactions can be found in the national Summary of Product Characteristics (SmPC) – click here
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| Amino acids and derivatives | ||
|---|---|---|
| A16AA06 | ||
| A16AA05 | ||
| A16AA01 | ||
| A16AA04 | ||
| Enzymes | ||
|---|---|---|
| A16AB03 | ||
| A16AB04 | ||
| A16AB07 | ||
| A16AB22 | ||
| A16AB17 | ||
| A16AB08 | ||
| A16AB09 | ||
| A16AB02 | ||
| A16AB05 | ||
| A16AB14 | ||
| A16AB10 | ||
| Various alimentary tract and metabolism products | ||
|---|---|---|
| A16AX10 | ||
| A16AX09 | ||
| A16AX | ||
| A16AX18 | ||
| A16AX06 | ||
| A16AX04 | ||
| A16AX07 | ||
| A16AX | ||
| A16AX08 | ||
| A16AX07 | ||
| A16AX05 | ||
| AMINO ACIDS AND DERIVATIVES | ||
|---|---|---|
| A16AA06 | ||
| A16AA05 | ||
| A16AA01 | ||
| A16AA04 | ||
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Reference
- Alexion Europe SAS, SmPC Strensiq ( EU/1/15/1015) 08-05-2020, www.geneesmiddeleninformatiebank.nl
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Changes
Changes
