COVID-19 Update

Updates on COVID-19 and STRENSIQ

Strensiq® dosages

Alexion understands our patients and healthcare providers may be concerned about the evolving COVID-19 situation and our products.

Alexion’s goal is to always manage a robust supply chain that delivers medicines that are secure, sterile and meet our rigorous quality standards. In addition, due to the seriousness of the diseases we treat, we strive to maintain sufficient inventory levels to ensure their supply to the patients who rely on them. We have taken proactive measures to mitigate the risk of potential interruptions in supply, and we are continuing to actively monitor this dynamic and rapidly evolving situation worldwide.

Alexion’s manufacturing is based in Ireland at our award-winning facility. In 2019, Alexion Ireland received Biotech Company of the Year at the Pharma Industry Awards, reflecting the talent, commitment and dedication of the manufacturing team.

We have several additional facilities located around the globe to ensure continued manufacturing operations beyond the Ireland campus. Alexion’s goal is to always manage a robust supply chain that delivers medicines that are secure, sterile, and meet our rigorous quality standards. In addition, due to the seriousness of the diseases we treat, we strive to maintain sufficient inventory levels to ensure their supply to the patients who rely on them. We have taken proactive measures to mitigate the risk of potential interruptions in supply, and we are continuing to actively monitor this dynamic and rapidly evolving situation worldwide.

Hypophosphatasia (HPP) is a genetic, metabolic disorder. Patients with HPP, especially infants and children with perinatal-infantile HPP, may have underlying respiratory/breathing problems.1 Therefore, having HPP may increase the risk of having a severe illness from COVID-19.2,3 To minimize exposure, handwashing and daily cleaning of frequently touched surfaces (including wheelchairs) are recommended measures to prevent illness.3,4

STRENSIQ® (asfotase alfa) is a type of medication known as an enzyme replacement therapy.5 STRENSIQ works in patients with hypophosphatasia (HPP) by replacing the deficient enzyme, known as alkaline phosphatase, which allows the body to build or mineralize bones. STRENSIQ works differently than medications known as immunosuppressants.5,6 Across the clinical trials for STRENSIQ, patients receiving STRENSIQ did not show a reduced immune system.3 Based on the way STRENSIQ works and safety data compiled, it does not appear that patients treated with STRENSIQ have a higher risk of developing a viral infection.5,7

We made the decision to move our U.S. teams to full-time, remote work, with the exception of essential manufacturing and research teams. While you won’t see your account manager or medical science liaison at the office or in the hospital, know that we are a phone or video call away to support you and the people living with rare diseases who rely on our medicines. Your primary contact at Alexion will be in touch to ensure we know what you need, how we can help, and any preferences you may have as it relates to contact from us during this difficult time.

  1. Whyte MP, Leung E, Wilcox WR, Liese J, Argente J, Martos-Moreno GA, on behalf of the Study 011-10 Investigators. Natural History of Perinatal and Infantile Hypophosphatasia: A Retrospective Study. J Pediatr. 2019;209:116-124.
  2. Centers for Disease Control and Prevention. People who are at higher risk for severe illness. https://www.cdc.gov/coronavirus/2019-ncov/specific-groups/people-at-higher-risk.html. Accessed March 27, 2020.
  3. European Centre for Disease Prevention and Control. Q&A on COVID-19. https://www.ecdc.europa.eu/en/novel-coronavirus-china/questions-answers. Accessed March 30, 2020.
  4. https://www.cdc.gov/coronavirus/2019-ncov/prepare/prevention.html. Accessed March 24, 2020.
  5. STRENSIQ® (asfotase alfa) US Full Prescribing Information. Alexion Pharmaceuticals, Inc.
  6. Carbone J, Del Pozo N, Gallego A, Sarmiento E. Immunological risk factors for infection after immunosuppressive and biologic therapies. Expert Rev Anti Infect Ther. 2011;9(4):405-413. doi:10.1586/eri.10.178.
  7. Data on file. Integrated Safety Summary (ISS). Alexion Pharmaceuticals, Inc.

US/STQ-H/0076

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Important Safety Information and Indication for STRENSIQ® (asfotase alfa) 40mg/mL vial
Important Safety Information
WARNINGS AND PRECAUTIONS
  • Hypersensitivity Reactions, including anaphylaxis, have been reported in STRENSIQ-treated patients. Signs and symptoms consistent with anaphylaxis included difficulty breathing, choking sensation, nausea, periorbital edema, and dizziness. These reactions have occurred within minutes after subcutaneous administration of STRENSIQ and have been observed more than 1 year after treatment initiation. Other hypersensitivity reactions have also been reported in STRENSIQ-treated patients, including vomiting, fever, headache, flushing, irritability, chills, skin erythema, rash, pruritus and oral hypoesthesia.
    Inform patients and/or caregivers of the signs and symptoms of hypersensitivity reactions and have them seek immediate medical care should signs and symptoms occur. If a severe hypersensitivity reaction occurs, discontinue STRENSIQ treatment and initiate appropriate medical treatment. Consider the risks and benefits of re-administering STRENSIQ to individual patients following a severe reaction. If the decision is made to re-administer the product, monitor patients for a reoccurrence of signs and symptoms of a severe hypersensitivity reaction.
  • Lipodystrophy: Localized lipodystrophy, including lipoatrophy (depression in the skin) and lipohypertrophy (enlargement or thickening of tissue), has been reported at injection sites after several months in patients treated with STRENSIQ in clinical trials. Advise patients to follow proper injection technique and to rotate injection sites.
  • Ectopic Calcifications: Patients with HPP are at increased risk for developing ectopic calcifications. Events of ectopic calcification, including ophthalmic (conjunctival and corneal) and renal (nephrocalcinosis, nephrolithiasis), have been reported in the clinical trial experience with STRENSIQ. There was insufficient information to determine whether or not the reported events were consistent with the disease or due to STRENSIQ. No visual changes or changes in renal function were reported resulting from the occurrence of ectopic calcifications.
    Ophthalmology examinations and renal ultrasounds are recommended at baseline and periodically during treatment with STRENSIQ to monitor for signs and symptoms of ophthalmic and renal ectopic calcifications and for changes in vision or renal function.
  • Possible Immune-Mediated Clinical Effects: In clinical trials, most STRENSIQ-treated patients developed anti-asfotase alfa antibodies and neutralizing antibodies which resulted in reduced systemic exposure of asfotase alfa. In postmarketing reports, some STRENSIQ-treated patients with initial therapeutic response subsequently developed recurrence and worsening in disease-associated laboratory and radiographic biomarkers (some in association with neutralizing antibodies) suggesting possible immune-mediated effects on STRENSIQ’s pharmacologic action resulting in disease progression. The effect of anti-asfotase alfa antibody formation on the long-term efficacy of STRENSIQ is unknown. There are no marketed anti-asfotase alfa antibody tests. If patients experience progression of HPP symptoms or worsening of disease-associated laboratory and imaging biomarkers after a period of initial therapeutic response to STRENSIQ, consider obtaining anti-asfotase alfa antibody testing by contacting STRENSIQ Medical Information at Alexion at 1-888-765-4747 or by email at medinfo@alexion.com. Close clinical follow up is recommended.
ADVERSE REACTIONS
  • Overall, the most common adverse reactions (≥ 10%) reported were injection site reactions (63%). Other common adverse reactions included lipodystrophy (28%), ectopic calcifications (14%), and hypersensitivity reactions (12%). Possible immune-mediated clinical effects have been identified during post-approval use of STRENSIQ.
DRUG INTERACTIONS
    Drug Interference with Laboratory Tests:
  • Laboratory tests utilizing alkaline phosphatase (ALP) as a detection reagent could result in erroneous test results for patients receiving treatment due to the presence of asfotase alfa in clinical laboratory samples. Inform laboratory personnel that the patient is being treated with STRENSIQ and discuss use of an alternative testing platform which does not utilize an ALP-conjugated test system.
  • Elevated serum ALP measurements detected through clinical laboratory testing are expected in patients receiving STRENSIQ due to circulating concentrations of asfotase alfa and may be unreliable for clinical decision making.
SPECIAL POPULATIONS
  • Pregnancy & Lactation: There are no available data on STRENSIQ use in pregnant women, the presence of STRENSIQ in human milk, or the effects on the breastfed infant or on milk production, to inform a drug associated risk.
Indication

STRENSIQ® is indicated for the treatment of patients with perinatal/infantile- and juvenile-onset hypophosphatasia (HPP).

Please see STRENSIQ (asfotase alfa) full Prescribing Information.
Important Safety Information and Indication for STRENSIQ® (asfotase alfa) 40mg/mL vial
Important Safety Information
WARNINGS AND PRECAUTIONS
  • Hypersensitivity Reactions, including anaphylaxis, have been reported in STRENSIQ-treated patients. Signs and symptoms consistent with anaphylaxis included difficulty breathing, choking sensation, nausea, periorbital edema, and dizziness. These reactions have occurred within minutes after subcutaneous administration of STRENSIQ and have been observed more than 1 year after treatment initiation. Other hypersensitivity reactions have also been reported in STRENSIQ-treated patients, including vomiting, fever, headache, flushing, irritability, chills, skin erythema, rash, pruritus and oral hypoesthesia.
    Inform patients and/or caregivers of the signs and symptoms of hypersensitivity reactions and have them seek immediate medical care should signs and symptoms occur. If a severe hypersensitivity reaction occurs, discontinue STRENSIQ treatment and initiate appropriate medical treatment. Consider the risks and benefits of re-administering STRENSIQ to individual patients following a severe reaction. If the decision is made to re-administer the product, monitor patients for a reoccurrence of signs and symptoms of a severe hypersensitivity reaction.
  • Lipodystrophy: Localized lipodystrophy, including lipoatrophy (depression in the skin) and lipohypertrophy (enlargement or thickening of tissue), has been reported at injection sites after several months in patients treated with STRENSIQ in clinical trials. Advise patients to follow proper injection technique and to rotate injection sites.
  • Ectopic Calcifications: Patients with HPP are at increased risk for developing ectopic calcifications. Events of ectopic calcification, including ophthalmic (conjunctival and corneal) and renal (nephrocalcinosis, nephrolithiasis), have been reported in the clinical trial experience with STRENSIQ. There was insufficient information to determine whether or not the reported events were consistent with the disease or due to STRENSIQ. No visual changes or changes in renal function were reported resulting from the occurrence of ectopic calcifications.
    Ophthalmology examinations and renal ultrasounds are recommended at baseline and periodically during treatment with STRENSIQ to monitor for signs and symptoms of ophthalmic and renal ectopic calcifications and for changes in vision or renal function.
  • Possible Immune-Mediated Clinical Effects: In clinical trials, most STRENSIQ-treated patients developed anti-asfotase alfa antibodies and neutralizing antibodies which resulted in reduced systemic exposure of asfotase alfa. In postmarketing reports, some STRENSIQ-treated patients with initial therapeutic response subsequently developed recurrence and worsening in disease-associated laboratory and radiographic biomarkers (some in association with neutralizing antibodies) suggesting possible immune-mediated effects on STRENSIQ’s pharmacologic action resulting in disease progression. The effect of anti-asfotase alfa antibody formation on the long-term efficacy of STRENSIQ is unknown. There are no marketed anti-asfotase alfa antibody tests. If patients experience progression of HPP symptoms or worsening of disease-associated laboratory and imaging biomarkers after a period of initial therapeutic response to STRENSIQ, consider obtaining anti-asfotase alfa antibody testing by contacting STRENSIQ Medical Information at Alexion at 1-888-765-4747 or by email at medinfo@alexion.com. Close clinical follow up is recommended.
ADVERSE REACTIONS
  • Overall, the most common adverse reactions (≥ 10%) reported were injection site reactions (63%). Other common adverse reactions included lipodystrophy (28%), ectopic calcifications (14%), and hypersensitivity reactions (12%). Possible immune-mediated clinical effects have been identified during post-approval use of STRENSIQ.
DRUG INTERACTIONS
    Drug Interference with Laboratory Tests:
  • Laboratory tests utilizing alkaline phosphatase (ALP) as a detection reagent could result in erroneous test results for patients receiving treatment due to the presence of asfotase alfa in clinical laboratory samples. Inform laboratory personnel that the patient is being treated with STRENSIQ and discuss use of an alternative testing platform which does not utilize an ALP-conjugated test system.
  • Elevated serum ALP measurements detected through clinical laboratory testing are expected in patients receiving STRENSIQ due to circulating concentrations of asfotase alfa and may be unreliable for clinical decision making.
SPECIAL POPULATIONS
  • Pregnancy & Lactation: There are no available data on STRENSIQ use in pregnant women, the presence of STRENSIQ in human milk, or the effects on the breastfed infant or on milk production, to inform a drug associated risk.
Indication

STRENSIQ® is indicated for the treatment of patients with perinatal/infantile- and juvenile-onset hypophosphatasia (HPP).

Please see STRENSIQ (asfotase alfa) full Prescribing Information.
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