Important Safety Information

  • WARNING: SERIOUS MENINGOCOCCAL INFECTIONS

    See full prescribing information for complete boxed warning

    Life-threatening and fatal meningococcal infections have occurred in patients treated with Soliris and 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 a meningococcal vaccine at least 2 weeks prior to administering the first dose of Soliris, unless the risks of delaying Soliris therapy outweigh the risks of developing a meningococcal infection. (See Serious Meningococcal Infections for additional guidance on the management of the risk of meningococcal infection.)
    • 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.

Glossary

Acquired

An acquired disease is not contagious or inherited from a family member. It's a disease you develop over time.

Allergic reaction

An overreaction after a substance is introduced into the body.

Anemia

A condition in which your body does not have enough hemoglobin (the part of your blood that carries oxygen). With anemia, you may have fewer whole red blood cells. This may cause you to feel weak and tired.

Aplastic anemia (AA)

"Aplastic" means that bone marrow can't produce new blood cells properly. As a result, patients with aplastic anemia have fewer red blood cells, white blood cells, and platelets. PNH is often found along with aplastic anemia.

atypical Hemolytic Uremic Syndrome (aHUS)

A disease of the blood that causes low red blood cell and platelet counts, kidney failure, and damage to other vital organs, such as the heart and brain.

Blood clot

Blood clots form when parts of your body's blood clump together. In a healthy body, this can stop bleeding when you're cut or injured. But in certain conditions, these clumps can block blood flow in the veins and arteries, which can be dangerous. In PNH, a clot can happen at any time and can cause serious health problems.

Bone marrow

The soft tissue inside your large bones. It works to create the cells in your blood: red blood cells, white blood cells, and platelets.

Bone marrow failure disorder

A disorder that causes bone marrow to decrease or stop making blood cells. AA and MDS are bone marrow failure disorders.

Clone size

The percentage of blood cells in your body affected by PNH.

Complement

Components in the blood that interact as part of the body’s immune system to destroy disease-causing substances.

Complete blood count (CBC)

A lab test that gives the amounts of different cells in your blood.

Dialysis

A treatment for kidney failure. Normally, the kidneys work to filter the blood and remove waste, excess salt, and water. Kidney failure, also called “end-stage renal disease,” occurs when the kidneys stop working completely. During hemodialysis, a machine takes over the job of the kidneys by filtering the blood outside of the body and then returning the filtered blood back to the body.

Enzyme

A type of protein that helps reactions/processes happen in the body.

Erectile dysfunction (ED)

A condition found in men that affects their ability to achieve an erection.

FDA

Food and Drug Administration.

Genetic

Relating to genes, which are units in cells that are passed down through families.

Hemoglobin (Hgb)

The reddish-brown material found inside red blood cells. It carries oxygen throughout your body. When it gets outside of your cells, it is harmful and can lead to serious health problems.

Hemoglobinuria

Hemoglobin in the urine. About 25% of patients with PNH have it at diagnosis, but most will experience it at some time. Because of the reddish-brown color of hemoglobin, it results in dark, sometimes "cola-colored" urine.

Hemolysis

When red blood cells burst. Hemolysis is the main cause of the major health problems in PNH.

Immune system

A complex group of cells, proteins, and other molecules that work together to identify foreign organisms and substances, such as bacteria; the main role of the system is to protect the body against these foreign organisms.

Inflammation

An immune system reaction from the body as a result of some type of injury. Signs of inflammation may be redness, swelling, pain, and/or heat.

Infusion

A process during which fluid is introduced into the body through a vein.

Lactate dehydrogenase (LDH)

An enzyme found in red blood cells, released during hemolysis. Testing for LDH can help show how much hemolysis is happening in your body.

Meningococcal infection

An infection caused by a group of bacteria called Neisseria meninigitidis. The most common forms of meningococcal infections include meningitis (infection of the membranes that surround the brain and spinal cord) and meningococcernia (blood stream infections).

Myelodysplastic syndromes (MDS)

A condition in which there's a problem with the way bone marrow makes blood cells. About 2% of PNH patients also have MDS.

Natural inhibitors

The body’'s natural protective immune system that regulates the body's immune response.

Paroxysmal nocturnal hemoglobinuria (PNH)

A disease where red blood cells are created without proteins. This causes red blood cells to burst (a process called hemolysis) and can result in serious health problems. Signs and symptoms include stomach pain, difficulty swallowing, anemia, shortness of breath, and tiredness. Life-threatening complications from PNH include blood clots, kidney failure, and damage to organs.

Plasma

The pale yellow liquid part of whole blood, in which the red and white blood cells and various other elements are floating.

Plasma exchange/plasma infusion (PE/PI)

A process of removing, treating, and returning, or infusing plasma to the body.

Platelet

A small, irregular, disc-shaped element in the blood that assists in blood clotting.

Progressive

A progressive disease is one that gets worse over time.

Pulmonary hypertension

High blood pressure in the arteries that deliver blood to the lungs. This means that blood has a hard time getting to the lungs, causing your heart to pump harder.

Red blood cells (RBCs)

A type of cell found in your blood that delivers oxygen and removes waste (carbon dioxide) in your body. Red blood cells affected by PNH are attacked and destroyed because they are missing a protective protein.

Transfusion

A transfusion is a painless procedure in which a person is given blood or other vital fluids directly into the vein.

Thrombotic microangiopathy (TMA)

Formation of clots in small blood vessels throughout the body; this is an underlying cause of the clinical signs and symptoms of aHUS.

Vaccine

A preparation that is used to increase the body's natural defense against a disease.

White blood cells (WBCs)

A type of cell found in your blood that helps your immune system fight disease and infection.

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Important Safety Information

CLOSE

WARNING: SERIOUS MENINGOCOCCAL INFECTIONS

See full prescribing information for complete boxed warning

Life-threatening and fatal meningococcal infections have occurred in patients treated with Soliris and 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 a meningococcal vaccine at least 2 weeks prior to administering the first dose of Soliris, unless the risks of delaying Soliris therapy outweigh the risks of developing a meningococcal infection. (See Serious Meningococcal Infections for additional guidance on the management of the risk of meningococcal infection.)
  • 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.

Indications and Usage

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).

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

Other Infections

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 influenza type b (Hib). Administer vaccinations for the prevention of Streptococcus pneumoniae and Haemophilus influenza 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 two, 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

As with all protein products, administration of Soliris may result in infusion reactions, including anaphylaxis or other hypersensitivity reactions. In clinical trials, no patients experienced an infusion reaction which 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.

Please see full Prescribing Information for Soliris, including Boxed WARNING regarding serious meningococcal infection.