▼This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Please report any adverse events via your national reporting system. Adverse events can also be reported to Alexion Pharmaceuticals by contacting: https://contactazmedical.astrazeneca.com.
Please refer to the Summary of Product Characteristics for further information.
healthcare professional
HPP (age at enrolment from day 1 to 66.5 years) treated with STRENSIQ®, with a treatment duration range from 1 day to 391.9 weeks (7.5 years). The most common adverse reactions observed were injection site reactions (74%).1
Please refer to the STRENSIQ® Summary of Product Characteristics for further safety information.
Injection site reactions
- STRENSIQ® may result in local injection site reactions defined as any related adverse event occuring during the injection or until the end of the injection day1
- Most ISRs were mild and self-limiting, and the majority (> 99%) were reported as non-serious. In the clinical trial setting, the majority of patients who experienced an ISR had the first occurrence within the first 12 weeks of treatment with STRENSIQ®, and some patients continued to experience ISRs until 1 of more years after initiating STRENSIQ® dosing1
- One patient withdrew from the clinical trial due to injection site hypersensitivity1
- Injection sites should be rotated and carefully monitored for signs and potential reactions1
- STRENSIQ® administration should be interrupted in any patient experiencing severe injection reactions of appropriate medical therapy administered1
Hypersensitivity
Hypersensitivity reactions include erythema/redness, pyrexia/fever, rash, pruritis, irritability, nausea, vomiting, pain, rigor/chills, hypoaesthesia oral, headache, flushing, tachycardia, cough, and signs and symptoms consistent with anaphylaxis1
- A few case reports of anaphylactoid/hypersensitivity reaction have also been received and were associated with signs and symptoms of difficulty breathing, choking sensation, periorbital oedema and dizziness1
Contraindications
- Severe or life-threatening hypersensitivity to the active substance or to any of the excipients if hypersensitivity is not controllable1
Other adverse events have been reported in patients treated with STRENSIQ®, such as localised lipodystrophies at injection sites, ectopic calcifications, craniosynostosis in patients < 5 years of age, disproportionate weight gain and increase in serum parathyroid hormone concentration.1
For full safety information, please refer to the Summary of Product Characteristics.
Injection sites should be rotated and carefully monitored for signs of potential reactions1
- There is a potential for immunogenicity with STRENSIQ®1
- Among 109 patients with HPP enrolled in the clinical studies who have post-baseline antibody data available, 89.0% (97/109) tested positive for anti-drug antibodies at some point after starting STRENSIQ® treatment1
- Among those 97 patients 56.7% (55) also showed the presence of neutralising antibodies at some point post-baseline1
- The antibody response (with or without the presence of neutralising antibodies) was time variant in nature1
- In clinical trials, the development of antibodies has not been shown to affect clinical efficacy or safety1
- Data from post-marketing cases suggest that the development of antibodies may affect clinical efficacy1
- No trends in adverse events based on antibody status were observed in clinical trials1
- Some patients confirmed positive for anti-drug antibodies experienced ISR and/or hypersensitivity; however, there was no consistent trend in the frequency of these reactions over time noted between anti-drug antibodies ever-positive and anti-drug antibody always negative patients1
HPP, hypophosphatasia; ISR, injection site reaction.
This medicinal product has been authorised under ‘exceptional circumstances’. This means that due to the rarity of the disease it has not been possible to obtain complete information on this medicinal product.
▼This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Please report any adverse events via your national reporting system. Adverse events can also be reported to Alexion Pharmaceuticals by the following link: https://contactazmedical.astrazeneca.com/
▼This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Please report any adverse events via your national reporting system. Adverse events can also be reported to Alexion Pharmaceuticals by the following link: https://contactazmedical.astrazeneca.com/