Our History

Alexion Timeline: A Commitment to Breakthrough Innovation

Since our founding in 1992, Alexion has given hope to people who had none and shined a light on those who felt isolated and alone. We have remained steadfast in our pursuit of groundbreaking innovation, and have delivered solutions to challenges that once seemed impossible. Here are some of the milestones throughout our history.

Company Milestone Product Milestone Awards and Recognition
  • 2019
    ULTOMIRIS is approved in the U.S. for the treatment of adults and pediatric patients one month of age and older with atypical hemolytic uremic syndrome (aHUS) to inhibit complement-mediated thrombotic microangiopathy (TMA).
    SOLIRIS is approved in the U.S. for the treatment of adult patients with anti-aquaporin-4 (AQP4) antibody positive neuromyelitis optica spectrum disorder (NMOSD)
    Alexion and Zealand Pharma announce collaboration to discover and develop peptide therapies for complement-mediated diseases
    ULTOMIRIS is approved in Japan and the EU for the treatment of adult patients with paroxysmal nocturnal hemoglobinuria (PNH)
    Alexion and Affibody announce partnership to co-develop anti-FcRn Affibody molecule
  • 2018
    ULTOMIRIS is approved in the U.S. for the treatment of adult patients with paroxysmal nocturnal hemoglobinuria (PNH)
    Alexion acquires Syntimmune, a clinical-stage biotechnology company developing antibody therapeutics targeting the neonatal Fc receptor (FcRn)
    Alexion and Dicerna partner to discover and develop RNA interference (RNAi) therapies for complement-mediated diseases
    Alexion and Complement Pharma partner to co-develop pre-clinical complement inhibitor for neurodegenerative disorders
    Alexion acquires Wilson Therapeutics, strengthening its pipeline and expanding its focus on metabolic and neurologic disorders
    Forbes Logo
    Alexion is named one of the World's Most Innovative Companies by Forbes consecutively from 2012 to 2018
    Alexion’s data sciences work contributes to Rady Children’s Institute for Genomic Medicine scientists’ achievement of new GUINNESS WORLD RECORDS™ title for fastest genetic diagnosis
  • 2017
    SOLIRIS is approved in the U.S. and Japan for the treatment of adult patients with generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AchR) antibody-positive and in the European Union for the treatment of refractory generalized gMG in adult patients who are anti-AchR antibody-positive
  • 2016
    KANUMA is approved as a treatment for patients with lysosomal acid lipase deficiency (LAL-D) in Japan
    Alexion receives 2016 Rare Impact Award from the National Organization for Rare Disorders (NORD®) and is named as Industry Innovation Honoree for the Company’s work in bringing STRENSIQ and KANUMA to market
    KANUMA receives 2016 German Prix Galien Award in the Orphan Product category
    Science names Alexion as a Top Employer in both 2015 and 2016
    Alexion initiates two Phase 3 clinical trials of ALXN1210 in complement inhibitor treatment-naïve patients with PNH and aHUS, and receives ODD for ALXN1210 for the treatment of patients with PNH from the EC
  • 2015
    STRENSIQ is approved as a treatment for patients with hypophosphatasia (HPP) in the U.S., EU, Japan and Canada
    KANUMA is approved as a treatment for patients with lysosomal acid lipase deficiency (LAL-D) in the U.S. and EU
    Alexion is named one of Fortune Magazine’s Fastest Growing Companies in 2011, 2012, 2014 and 2015
  • 2014
    SOLIRIS receives orphan drug designation (ODD) for multiple potential indications:
    • Prevention of delayed graft function (DGF) in renal transplant patients from the FDA, and prevention of DGF after solid organ transplantation from the EMA
    • Treatment of refractory myasthenia gravis (MG) from the FDA and EMA
    Alexion initiates multinational registration trials of eculizumab as a potential treatment for patients with NMO, MG and DGF
    Connecticut Magazine names Alexion one of the top workplaces in the state in both 2010 and 2014
  • 2013
    Asfotase alfa receives Breakthrough Therapy Designation from the FDA for the treatment of HPP
    SOLIRIS is approved as a treatment for patients with aHUS in Japan
    SOLIRIS receives orphan drug designation (ODD) for the treatment of neuromyelitis optica (NMO) from the FDA and EMA
  • 2012
    Alexion acquires asfotase alfa, the first potential treatment for patients with hypophosphatasia (HPP)
    New England Journal of Medicine publishes data from Phase 2 study of asfotase alfa in
    life-threatening HPP
    Alexion is added to the S&P 500 Index of leading global companies
    Alexion presented with the Partners in Progress Award from the National Organization for Rare Diseases (NORD®)
  • 2011
    The FDA and the EMA approve SOLIRIS as the first and only treatment for adult and pediatric patients with aHUS
  • 2010
    U.S. Green Building Council (USGBC) twice recognizes Alexion with LEED® Certification Awards for constructing, operating and maintaining interiors that meet the highest green building and performance standards
  • 2009
    SOLIRIS receives the Prix Galien France Award for Drugs for Rare Diseases
  • 2008
    SOLIRIS is first used as a treatment for patients with atypical hemolytic uremic syndrome (aHUS) in France and Germany
    SOLIRIS receives the Prix Galien USA Award for Best Biotechnology Product
  • 2007
    SOLIRIS receives approval from the FDA and European Medicines Agency (EMA) as the first and only treatment for patients with PNH
    Alexion honored with the Corporate Leadership Award from the National Organization for Rare Disorders (NORD®)
    Alexion earns the Award of Excellence from Connecticut United for Research Excellence (CURE)
  • 2005
    Second pivotal Phase 3 study of eculizumab in patients with PNH begins (SHEPHERD)
  • 2002-2004
    Pilot study with eculizumab commences in Leeds, England in paroxysmal nocturnal hemoglobinuria (PNH)
    New England Journal of Medicine publishes positive results from pilot study of eculizumab in 11 patients with PNH
    First pivotal Phase 3 study of eculizumab commences in patients with PNH (TRIUMPH)
  • 1996-1998
    First in-human clinical trial of eculizumab begins
  • 1992-1994
    C5 complement inhibitor development program commences

INDICATIONS & IMPORTANT SAFETY INFORMATION for
ULTOMIRIS® (ravulizumab-cwvz) FOR INTRAVENOUS USE [300 MG/30 ML VIAL]

INDICATIONS

What is ULTOMIRIS?

ULTOMIRIS is a prescription medicine called a monoclonal antibody. ULTOMIRIS is used to treat:

  • adults with a disease called Paroxysmal Nocturnal Hemoglobinuria (PNH).
  • adults and children 1 month of age and older with a disease called atypical Hemolytic Uremic Syndrome (aHUS). ULTOMIRIS is not used in treating people with Shiga toxin E. coli related hemolytic uremic syndrome (STEC-HUS).

It is not known if ULTOMIRIS is safe and effective in children with PNH.
It is not known if ULTOMIRIS is safe and effective in children younger than 1 month of age.

IMPORTANT SAFETY INFORMATION

What is the most important information I should know about ULTOMIRIS?
ULTOMIRIS is a medicine that affects your immune system. ULTOMIRIS can lower the ability of your immune system to fight infections.

  • ULTOMIRIS increases your chance of getting serious and life-threatening meningococcal infections. Meningococcal infections may quickly become life-threatening and cause death if not recognized and treated early.
    1. You must receive meningococcal vaccines at least 2 weeks before your first dose of ULTOMIRIS if you have not already had this vaccine.
    2. If your doctor decided that urgent treatment with ULTOMIRIS is needed, you should receive meningococcal vaccination as soon as possible.
    3. If you have not been vaccinated and ULTOMIRIS therapy must be initiated immediately, you should also receive 2 weeks of antibiotics with your vaccinations.
    4. If you had a meningococcal vaccine in the past, you might need additional vaccination before starting ULTOMIRIS. Your doctor will decide if you need additional meningococcal vaccination.
    5. Meningococcal vaccines reduce the risk of meningococcal infection but do not prevent all meningococcal infections. Call your doctor or get emergency medical care right away if you get any of these signs and symptoms of a meningococcal infection:
    • headache with nausea or vomiting
    • headache and fever
    • headache with a stiff neck or stiff back
    • fever
    • fever and a rash
    • confusion
    • muscle aches with flu-like symptoms
    • eyes sensitive to light

Your doctor will give you a Patient Safety Card about the risk of meningococcal infection. Carry it with you at all times during treatment and for 8 months after your last ULTOMIRIS dose. Your risk of meningococcal infection may continue for several months after your last dose of ULTOMIRIS. It is important to show this card to any doctor or nurse who treats you. This will help them diagnose and treat you quickly.

ULTOMIRIS is only available through a program called the ULTOMIRIS REMS. Before you can receive ULTOMIRIS, your doctor must:

  • enroll in the ULTOMIRIS REMS program
  • counsel you about the risk of meningococcal infection
  • give you information about the symptoms of meningococcal infection
  • give you a Patient Safety Card about your risk of meningococcal infection, as discussed above
  • make sure that you are vaccinated with a meningococcal vaccine

ULTOMIRIS may also increase the risk of other types of serious infections.

  • People who take ULTOMIRIS may have an increased risk of getting infections caused by Streptococcus pneumoniae and Haemophilus influenzae.
  • Certain people may also have an increased risk of gonorrhea infection. Talk to your doctor to find out if you are at risk for gonorrhea infection, about gonorrhea prevention, and regular testing.
  • Call your doctor right away if you have any new signs or symptoms of infection.

    Who should not receive ULTOMIRIS?

    Do not receive ULTOMIRIS if you:

    • have a meningococcal infection
    • Have not been vaccinated against meningococcal infection unless your doctor decides that urgent treatment with ULTOMIRIS is needed. See “What is the most important information I should know about ULTOMIRIS.”

    Before you receive ULTOMIRIS, tell your doctor about all of your medical conditions, including if you:

    • have an infection or fever.
    • are pregnant or plan to become pregnant. It is not known if ULTOMIRIS will harm your unborn baby.
    • are breastfeeding or plan to breastfeed. It is not known if ULTOMIRIS passes into your breast milk. You should not breastfeed during treatment and for 8 months after your final dose of ULTOMIRIS.

    Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. ULTOMIRIS and other medicines can affect each other causing side effects.
    Know the medicines you take and the vaccines you receive. Keep a list of them to show your doctor and pharmacist when you get a new medicine.

    How should I receive ULTOMIRIS?

    • ULTOMIRIS is given through a vein by intravenous (I.V.) infusion usually over about 2 hours in adults and up to 4 hours in children.
    • If you are an adult with PNH or aHUS, you will usually receive:
      • a starting dose of ULTOMIRIS as an infusion by your doctor, and then
      • 2 weeks later, you will start to receive an infusion of ULTOMIRIS every 8 weeks.
    • Children 1 month of age and older with aHUS will usually receive:
      • a starting dose of ULTOMIRIS as an infusion by your doctor, and then
      • your doctor will decide how often your child will receive ULTOMIRIS, either every 4 weeks or every 8 weeks, depending on their weight, starting 2 weeks after the starting dose.
    • Your doctor will decide how long you need to take ULTOMIRIS for your aHUS.
    • If you are changing treatment from SOLIRIS to ULTOMIRIS, you should receive your starting dose of ULTOMIRIS 2 weeks after your last dose of SOLIRIS.
    • After each infusion, you should be monitored for at least 1 hour for infusion reactions. See “What are the possible side effects of ULTOMIRIS?”
    • If you have PNH and you stop receiving ULTOMIRIS, your doctor will need to monitor you closely for at least 16 weeks after you stop ULTOMIRIS. Stopping ULTOMIRIS may cause breakdown of your red blood cells due to PNH. Symptoms or problems that can happen due to red blood cell breakdown include:
      • drop in your red blood cell count
      • tiredness
      • blood in your urine
      • stomach-area (abdomen) pain
      • shortness of breath
      • blood clots
      • trouble swallowing
      • erectile dysfunction (ED) in males
    • If you have aHUS, your doctor will need to monitor you closely for at least 12 months after stopping treatment for signs of worsening aHUS symptoms or problems related to a type of abnormal clotting and breakdown of your red blood cells called thrombotic microangiopathy (TMA). Symptoms or problems that can happen with TMA may include:
      • confusion or loss of consciousness
      • seizures
      • chest pain (angina)
      • difficulty breathing
      • blood clots or stroke
    • If you miss an ULTOMIRIS infusion, call your doctor right away.

    What are the possible side effects of ULTOMIRIS?
    ULTOMIRIS can cause serious side effects including:

    • See “What is the most important information I should know about ULTOMIRIS?”
    • Infusion reactions. Infusion reactions may happen during your ULTOMIRIS infusion. Symptoms of an infusion reaction with ULTOMIRIS may include lower back pain, pain with the infusion, feeling faint or discomfort in your arms or legs. Tell your doctor or nurse right away if you develop these symptoms, or any other symptoms during your ULTOMIRIS infusion that may mean you are having a serious infusion reaction, including:
      • chest pain
      • trouble breathing or shortness of breath
      • swelling of your face, tongue, or throat
      • feel faint or pass out

    Your doctor will treat your symptoms as needed.

    The most common side effects of ULTOMIRIS in people treated for PNH are upper respiratory infection and headache.

    The most common side effects of ULTOMIRIS in people with aHUS are:

    • upper respiratory infections
    • diarrhea
    • nausea
    • vomiting
    • headache
    • high blood pressure
    • fever

    Tell your doctor about any side effect that bothers you or that does not go away. These are not all the possible side effects of ULTOMIRIS. For more information, ask your doctor or pharmacist.

    Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

    Please see the accompanying full Prescribing Information and Medication Guide for ULTOMIRIS, including Boxed WARNING regarding serious and life-threatening meningococcal infections/sepsis.

INDICATIONS & IMPORTANT SAFETY INFORMATION FOR
SOLIRIS® (eculizumab)

INDICATIONS

Paroxysmal Nocturnal Hemoglobinuria (PNH)
Soliris is indicated for the treatment of patients with paroxysmal nocturnal hemoglobinuria (PNH) to reduce hemolysis.

Atypical Hemolytic Uremic Syndrome (aHUS)
Soliris is indicated for the treatment of patients with atypical hemolytic uremic syndrome (aHUS) to inhibit complement-mediated thrombotic microangiopathy.

Limitation of Use

Soliris is not indicated for the treatment of patients with Shiga toxin E. coli related hemolytic uremic syndrome (STEC-HUS).

Generalized Myasthenia Gravis (gMG)
Soliris is indicated for the treatment of generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) antibody positive.

Neuromyelitis Optica Spectrum Disorder (NMOSD)
Soliris is indicated for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQP4) antibody positive.

IMPORTANT SAFETY INFORMATION

WARNING: SERIOUS MENINGOCOCCAL INFECTIONS

Life-threatening and fatal meningococcal infections have occurred in patients treated with Soliris. Meningococcal infection may become rapidly life-threatening or fatal if not recognized and treated early.

  • Comply with the most current Advisory Committee on Immunization Practices (ACIP) recommendations for meningococcal vaccination in patients with complement deficiencies.
  • Immunize patients with meningococcal vaccines at least 2 weeks prior to administering the first dose of Soliris, unless the risks of delaying Soliris therapy outweigh the risk of developing a meningococcal infection [see Warnings and Precautions for additional guidance on the management of the risk of meningococcal infection].
  • Vaccination reduces, but does not eliminate, the risk of meningococcal infections. Monitor patients for early signs of meningococcal infections and evaluate immediately if infection is suspected.

Soliris is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS). Under the Soliris REMS, prescribers must enroll in the program. Enrollment in the Soliris REMS program and additional information are available by telephone: 1-888-SOLIRIS (1-888-765-4747) or at www.solirisrems.com.

CONTRAINDICATIONS

Soliris is contraindicated in:

  • Patients with unresolved serious Neisseria meningitidis infection
  • Patients who are not currently vaccinated against Neisseria meningitidis, unless the risks of delaying Soliris treatment outweigh the risks of developing a meningococcal infection

WARNINGS AND PRECAUTIONS

Serious Meningococcal Infections

Risk and Prevention

See Boxed WARNING for additional information on serious meningococcal infections.

Life-threatening and fatal meningococcal infections have occurred in patients treated with Soliris. The use of Soliris increases a patient's susceptibility to serious meningococcal infections (septicemia and/or meningitis).

Vaccinate for meningococcal disease according to the most current ACIP recommendations for patients with complement deficiencies. Revaccinate patients in accordance with ACIP recommendations, considering the duration of Soliris therapy.

Immunize patients without a history of meningococcal vaccination at least 2 weeks prior to receiving the first dose of Soliris. If urgent Soliris therapy is indicated in an unvaccinated patient, administer meningococcal vaccine(s) as soon as possible and provide patients with 2 weeks of antibacterial drug prophylaxis.

The benefits and risks of antibiotic prophylaxis for prevention of meningococcal infections in patients receiving Soliris have not been established.

Vaccination reduces, but does not eliminate, the risk of meningococcal infections.

Closely monitor patients for early signs and symptoms of meningococcal infection and evaluate patients immediately if an infection is suspected. Meningococcal infection may become rapidly life-threatening or fatal if not recognized and treated early. Discontinue Soliris in patients who are undergoing treatment for serious meningococcal infections.

REMS

Because of the risk of meningococcal infections, Soliris is available only through a restricted program under a REMS. Under the Soliris REMS, prescribers must enroll in the program.

Prescribers must counsel patients about the risk of meningococcal infection, provide the patients with the REMS educational materials, and ensure patients are vaccinated with meningococcal vaccine(s).

Other Infections

Serious infections with Neisseria species (other than N. meningitidis), including disseminated gonococcal infections, have been reported.

Soliris blocks terminal complement activation; therefore patients may have increased susceptibility to infections, especially with encapsulated bacteria. Additionally, Aspergillus infections have occurred in immunocompromised and neutropenic patients. Children treated with Soliris may be at increased risk of developing serious infections due to Streptococcus pneumoniae and Haemophilus influenzae type b (Hib). Administer vaccinations for the prevention of Streptococcus pneumoniae and Haemophilus influenzae type b (Hib) infections according to ACIP guidelines. Use caution when administering Soliris to patients with any systemic infection.

Monitoring Disease Manifestations After Soliris Discontinuation

Treatment Discontinuation for PNH

Monitor patients after discontinuing Soliris for at least 8 weeks to detect hemolysis.

Treatment Discontinuation for aHUS

After discontinuing Soliris, monitor patients with aHUS for signs and symptoms of thrombotic microangiopathy (TMA) complications for at least 12 weeks. In aHUS clinical trials, 18 patients (5 in the prospective studies) discontinued Soliris treatment. TMA complications occurred following a missed dose in 5 patients, and Soliris was reinitiated in 4 of these 5 patients.

Clinical signs and symptoms of TMA include changes in mental status, seizures, angina, dyspnea, or thrombosis. In addition, the following changes in laboratory parameters may identify a TMA complication: occurrence of 2, or repeated measurement of any one of the following: a decrease in platelet count by 25% or more compared to baseline or the peak platelet count during Soliris treatment; an increase in serum creatinine by 25% or more compared to baseline or nadir during Soliris treatment; or, an increase in serum LDH by 25% or more over baseline or nadir during Soliris treatment.

If TMA complications occur after Soliris discontinuation, consider reinstitution of Soliris treatment, plasma therapy [plasmapheresis, plasma exchange, or fresh frozen plasma infusion (PE/PI)], or appropriate organ-specific supportive measures.

Thrombosis Prevention and Management

The effect of withdrawal of anticoagulant therapy during Soliris treatment has not been established. Therefore, treatment with Soliris should not alter anticoagulant management.

Infusion Reactions

Administration of Soliris may result in infusion reactions, including anaphylaxis or other hypersensitivity reactions. In clinical trials, no patients experienced an infusion reaction that required discontinuation of Soliris. Interrupt Soliris infusion and institute appropriate supportive measures if signs of cardiovascular instability or respiratory compromise occur.

Adverse Reactions

The most frequently reported adverse reactions in the PNH randomized trial (≥10% overall and greater than placebo) are: headache, nasopharyngitis, back pain, and nausea.

The most frequently reported adverse reactions in aHUS single arm prospective trials (≥20%) are: headache, diarrhea, hypertension, upper respiratory infection, abdominal pain, vomiting, nasopharyngitis, anemia, cough, peripheral edema, nausea, urinary tract infections, pyrexia.

The most frequently reported adverse reaction in the gMG placebo-controlled clinical trial (≥10%) is: musculoskeletal pain.

The most frequently reported adverse reactions in the NMOSD placebo-controlled trial (≥10%) are: upper respiratory infection, nasopharyngitis, diarrhea, back pain, dizziness, influenza, arthralgia, pharyngitis, and contusion.

Please see accompanying full prescribing information for Soliris® , including BOXED WARNING regarding serious meningococcal infections.

IMPORTANT SAFETY INFORMATION FOR KANUMA® (SEBELIPASE ALFA)

Indications and Usage

KANUMA® is indicated for the treatment of patients with a diagnosis of lysosomal acid lipase deficiency (LAL-D).  

WARNINGS AND PRECAUTIONS

Hypersensitivity Reactions Including Anaphylaxis

Hypersensitivity reactions, including anaphylaxis, have been reported in KANUMA® -treated patients. In clinical trials, 3 of 106 (3%) patients treated with KANUMA® experienced signs and symptoms consistent with anaphylaxis. These patients experienced reactions during infusion with signs and symptoms including chest discomfort, conjunctival injection, dyspnea, generalized and itchy rash, hyperemia, swelling of eyelids, rhinorrhea, severe respiratory distress, tachycardia, tachypnea, and urticaria. Anaphylaxis has occurred as early as the sixth infusion and as late as 1 year after treatment initiation.

In clinical trials, 21 of 106 (20%) KANUMA® -treated patients, including 9 of 14 (64%) infants and 12 of 92 (13%) pediatric patients, 4 years and older, and adults experienced signs and symptoms either consistent with or that may be related to a hypersensitivity reaction. Signs and symptoms of hypersensitivity reactions, occurring in two or more patients, included abdominal pain, agitation, fever, chills, diarrhea, eczema, edema, hypertension, irritability, laryngeal edema, nausea, pallor, pruritus, rash, and vomiting. The majority of reactions occurred during or within 4 hours of the completion of the infusion. Patients were not routinely pre-medicated prior to infusion of KANUMA® in these clinical trials.

Due to the potential for anaphylaxis, appropriate medical support should be readily available when KANUMA®  is administered.

Consider the risks and benefits of re-administering KANUMA® following a severe reaction. Monitor patients, with appropriate resuscitation measures available, if the decision is made to re-administer the product.

Hypersensitivity to Eggs or Egg Products

Patients with a known history of egg allergies were excluded from the clinical trials. Consider the risks and benefits of treatment with KANUMA®  in patients with known systemic hypersensitivity reactions to eggs or egg products.

ADVERSE REACTIONS

The most common adverse reactions are:

  • In Patients with Rapidly Progressive Disease Presenting within the First 6 Months of Life (>30%): diarrhea, vomiting, fever, rhinitis, anemia, cough, nasopharyngitis, and urticaria.
  • In Pediatric and Adult Patients (≥8%): headache, fever, oropharyngeal pain, nasopharyngitis, asthenia, constipation, and nausea.

Please see full prescribing information for Kanuma® .

IMPORTANT SAFETY INFORMATION FOR STRENSIQ® (ASFOTASE ALFA)

Indications and Usage

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

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 can occur in patients on treatment for more than one year. 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.  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. 

Localized lipodystrophy, including lipoatrophy and lipohypertrophy, has been reported at injection sites after several months in patients treated with STRENSIQ® . Advise patients to follow proper injection technique and to rotate injection sites.

Patients with HPP are at increased risk for developing ectopic calcifications. In clinical trials, 14 cases (14%) of ectopic calcification of the eye including the cornea and conjunctiva, and the kidneys (nephrocalcinosis) were reported. 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.  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.

Adverse Reactions

The most common adverse reactions (≥ 10%) are injection site reactions, lipodystrophy, ectopic calcifications and hypersensitivity reactions.

Please see full prescribing information for Strensiq® .

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