Soliris

DRUG DESCRIPTION

Soliris, a complement inhibitor, is a formulation of eculizumab which is a
recombinant humanized monoclonal IgG2/4κ antibody produced by murine myeloma
cell culture and purified by standard bioprocess technology. Eculizumab contains
human constant regions from human IgG2 sequences and human IgG4 sequences and
murine complementarity-determining regions grafted onto the human framework
light- and heavy-chain variable regions. Eculizumab is composed of two 448 amino
acid heavy chains and two 214 amino acid light chains and has a molecular weight
of approximately 148 kDa.

Soliris is a sterile, clear, colorless, preservative-free 10 mg/mL solution
for intravenous infusion and is supplied in 30-mL single-use vials. The product
is formulated at pH 7 and each vial contains 300 mg of eculizumab, 13.8 mg sodium
phosphate monobasic, 53.4 mg sodium phosphate dibasic, 263.1 mg sodium chloride,
6.6 mg polysorbate 80 (vegetable origin) and Water for Injection, USP.

What are the possible side effects of eculizumab (Soliris)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

• severe headache with fever, confusion, purple spots on the skin, nausea or vomiting, and/or seizure (convulsions);


• stiffness in your neck or back;


• sensitivity to bright light;


• high fever (103 degrees or higher), chills, body aches, flu symptoms;


• any signs...

Read All Potential Side Effects and See Pictures of Soliris »

What are the precautions when taking eculizumab (Soliris)?

Before using eculizumab, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: current meningitis or other infection caused by the bacteria Neisseria meningitidis, no vaccination for meningitis.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: current/recent infection.

Before having surgery, tell your doctor or dentist that you are using this medication.

Do not have...

Read All Potential Precautions of Soliris »

Soliris Consumer (continued)

SIDE EFFECTS: See also Warning section.

Headache, tiredness, nausea, or muscle pain may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: signs of infection (e.g., fever, persistent sore throat).

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

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

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before using eculizumab, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: current meningitis or other infection caused by the bacteria Neisseria meningitidis, no vaccination for meningitis.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: current/recent infection.

Before having surgery, tell your doctor or dentist that you are using this medication.

Do not have immunizations/vaccinations without the consent of your doctor, and avoid contact with people who have recently received oral polio vaccine or flu vaccine inhaled through the nose.

Wash your hands well to prevent the spread of infections.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is not known whether this drug passes into breast milk. Consult your doctor before breast-feeding.

Soliris Patient Information Including Side Effects

Brand Names: Soliris

Generic Name: eculizumab (Pronunciation: E kue LIZ oo mab)

• What is eculizumab (Soliris)?


• What are the possible side effects of eculizumab (Soliris)?


• What is the most important information I should know about eculizumab (Soliris)?


• What should I discuss with my health care provider before taking eculizumab (Soliris)?


• How is eculizumab given (Soliris)?


• What happens if I miss a dose (Soliris)?


• What happens if I overdose (Soliris)?


• What should I avoid while taking eculizumab (Soliris)?


• What other drugs will affect eculizumab (Soliris)?


• Where can I get more information?

What is eculizumab (Soliris)?

Eculizumab is a monoclonal antibody that binds to proteins in the blood that can destroy red blood cells in people with a genetic condition that affects the natural defenses of red blood cells.

Eculizumab is used to prevent the breakdown of red blood cells in people with paroxysmal nocturnal hemoglobinemia (PNH).

Eculizumab may also be used for other purposes not listed in this medication guide.

What are the possible side effects of eculizumab (Soliris)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

• severe headache with fever, confusion, purple spots on the skin, nausea or vomiting, and/or seizure (convulsions);


• stiffness in your neck or back;


• sensitivity to bright light;


• high fever (103 degrees or higher), chills, body aches, flu symptoms;


• any signs of a new illness or injection; or


• signs that the medication is not working (pale skin, easy bruising, weakness, dark urine, feeling short of breath, or sudden numbness, severe headache, deep leg pain, or problems with vision, speech, or balance).

Less serious side effects may include:

• nausea;


• constipation;


• mild headache;


• runny nose, sore throat; or


• back pain.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about eculizumab (Soliris)?

Eculizumab affects your immune system, and using this medication may increase your risk of serious infection such as meningitis. Get emergency medical help if you have any signs of meningitis, such as severe headache with fever, confusion, purple spots on the skin, and/or seizure (convulsions) and nausea or vomiting, stiffness in your neck or back, sensitivity to bright light, or a very high fever (103 degrees or higher), chills, body aches, or other flu-like symptoms.

With your medication you will receive a Patient Safety Card listing the symptoms of meningitis. Carry this card with you at all times. Seek emergency medical attention or call your doctor right away if you notice any of these symptoms.

You must be vaccinated against meningococcal infection at least 2 weeks before you start treatment with eculizumab. If you have been vaccinated in the past, you may need a booster dose. It is best to stay current on all of your vaccinations before you receive eculizumab, and your doctor may recommend other vaccines before or during treatment.

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• Soliris