What it is used for
- Treating bone manifestations of hypophosphatasia that began in childhood
- Improving bone mineralisation, growth and mobility according to specialist assessment
- Reducing skeletal and breathing complications related to poorly mineralised bone
How it is used
- Use it only under the skin and on the plan set by an experienced doctor; never change the amount or schedule yourself
- The team trains the patient or carer to prepare the injection, inspect the solution and inject safely
- Rotate among permitted injection areas and avoid red, hardened or damaged skin
- Do not mix it with another medicine or use a vial for more than one patient
- Attend growth, bone, dental, eye and kidney follow-up arranged by the team
Possible side effects
- Pain, redness, itching or swelling at the injection site
- Bruising, headache or limb pain
- Fatty lumps or loss of tissue under the skin after repeated injections
- Fever, irritability or nausea
- A rare severe allergic reaction
Who should not use it
- Do not use after a severe reaction to asfotase alfa or a product ingredient if the allergy cannot be controlled
- Do not inject it into a vein or muscle
- Do not use it for common osteoporosis or osteomalacia from other causes
Before and while using it
- Breathing difficulty, facial swelling or a widespread rash after injection may be a severe allergy and needs urgent help
- Repeated injections can cause lasting changes in fat under the skin; rotate sites and report every lump or hollow
- Calcium deposits can occur around the eyes or in the kidneys; regular checks are needed even without symptoms
- Early fusion of skull bones can occur in children with the disease; the team monitors head shape and pressure within the skull
- Treatment interferes with some alkaline-phosphatase laboratory tests and can give misleading results; tell the laboratory that you use it
- Choosing the wrong vial or calculating the amount incorrectly can cause harm; check the label and team plan before every injection
Medicine interactions
- No important medicine interactions are established, but tell the team about every medicine and supplement you use
- Asfotase alfa can interfere with laboratory tests that rely on alkaline phosphatase, so the laboratory must be informed
- Do not mix it with any other product in the same syringe
Pregnancy and breastfeeding
- Pregnancy data are limited; tell your team if you are pregnant or planning pregnancy so it can decide whether treatment need outweighs unknown risk
- It is not known whether it enters milk; the doctor discusses the benefit of breastfeeding and the mother's need for treatment
How to store it
- Keep vials refrigerated in the original carton, protected from light, and do not freeze or shake them
- Remove a vial when preparing to inject and follow the product leaflet for use and disposal of any remainder
Get medical help straight away if
- Your face, lips or tongue swell, or you find it hard to breathe.
- You get a severe rash, blistering or peeling skin.
- A side effect worries you or doesn’t go away: contact your doctor or pharmacist.
Questions about this medicine?
Talk to a doctor by video, or send your question by text.
Source: Standard international medicine references
This guide is general information and doesn’t replace advice from your doctor or pharmacist. Don’t start, stop or change a medicine without asking them, and always read the leaflet in the pack.