Soliris (Alexion Pharmaceuticals)

Soliris (Alexion Pharmaceuticals) - General Information

Soliris is a formulation of eculizumab which is a recombinant humanized monoclonal IgG2/4;κ antibody produced by murine myeloma cell culture and purified by standard bioprocess technology. Soliris (Alexion Pharmaceuticals) 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. Soliris (Alexion Pharmaceuticals) 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.

Pharmacology of Soliris (Alexion Pharmaceuticals)

Soliris (Alexion Pharmaceuticals) is a monoclonal antibody directed against the complement protein C5. This antibody blocks the cleavage of C5 and halts the process of complement-mediated cell destruction. Soliris (Alexion Pharmaceuticals) is a product of Alexion Pharmaceuticals and has been shown to be effective in treating paroxysmal nocturnal hemoglobinuria. Soliris (Alexion Pharmaceuticals) was approved by the FDA in March, 2007.

Soliris (Alexion Pharmaceuticals) for patients

MEDICATION GUIDE

Soliris
(eculizumab) (so-leer-is)

Read the Medication Guide before you start Soliris and before each dose (infusion). This Medication Guide does not take the place of talking with your doctor about your condition or your treatment. Talk to your doctor if you have any questions about your treatment with Soliris.

What Is The Most Important Information I Should Know About Soliris?

Soliris is a medicine that affects your immune system. Soliris can lower the ability of your immune system to fight infections.

• Soliris increases your chance of getting serious and life-threatening meningococcal infections.
  1. You must receive a meningococcal vaccine at least 2 weeks before your first dose of Soliris unless you have already had this vaccine.
  2. If you had a meningococcal vaccine in the past, you might need a booster dose before starting Soliris. Your doctor will decide if you need another dose of a meningococcal vaccine.
  3. A meningococcal vaccine does not prevent all meningococcal infections. You must be aware of the following signs and symptoms of a meningococcal infection:
     • moderate to severe headache with nausea or vomiting
     • moderate to severe headache and a fever
     • moderate to severe headache with a stiff neck or stiff back
     • fever of 103° F (39.4° C) or higher
     • fever and a rash
     • confusion
     • severe muscle aches with flu-like symptoms, and eyes sensitive to light

Call your doctor or get emergency medical care right away if you have any of these symptoms.

You will receive a Patient Safety Card that lists these symptoms and what to do if you have them. Carry it with you at all times. You will need to show the card to any healthcare provider that treats you.

What Is Soliris?

Soliris is a medicine called a monoclonal antibody. Soliris is used for the treatment of patients with a disease that affects red blood cells called Paroxysmal Nocturnal Hemoglobinuria (PNH).

Soliris works by blocking part of your immune system. This can help your PNH symptoms but it can also increase your chance for infection. It is important that you:

• have all recommended immunizations and vaccines before you start Soliris
• stay up-to-date with all recommended immunizations and vaccines during treatment with Soliris

Who Should Not Receive Soliris?

Do not receive Soliris if you:

• have a meningococcal infection
• have not been vaccinated with, or you are not up-to-date with a meningococcal vaccine. See "What is the most important information about Soliris?"

Tell your doctor if you:

• have an infection or fever
• are pregnant, become pregnant, or are breastfeeding. Soliris has not been studied in pregnant or nursing women.

How Do I Receive Soliris?

• Soliris is given through a vein (I.V. infusion) over 35 minutes.
• You will usually receive a Soliris infusion:
  • every 7 days for five weeks,
  • then every 14 days
• Following each infusion, you may be monitored for one hour for allergic reactions.

What If I Miss a Dose or Stop Soliris Treatment?

• If you forget or miss a Soliris infusion, call your doctor right away.
• Stopping treatment with Soliris may cause a sudden and serious breakdown of your red blood cells. Symptoms or problems from red blood cell breakdown include:
  • a large drop in your red blood cell count causing anemia
  • confusion
  • chest pain
  • kidney problems
  • blood clots
• Your doctor will need to monitor you closely for at least 8 weeks after stopping Soliris.

What Are The Possible Side Effects With Soliris?

Serious side effects with Soliris include:

• serious and life-threatening infections. See "What is the most imortant information I should know about Soliris?"

Common side effects with Soliris include:

• headaches
• runny nose and colds
• sore throat
• back pain
• nausea

Call your doctor if you have any of these side effects. These are not all the side effects with Soliris. Ask your doctor for more information.

General Information About Soliris

Medicines are sometimes prescribed for conditions other than those listed in a Medication Guide. If you have any concerns about Soliris, ask your doctor. Your doctor or pharmacist can give you information about Soliris that was written for health care professionals.

Soliris contains eculizumab in a solution of water, polysorbate, sodium phosphate and sodium chloride.

This Medication Guide has been approved by the U.S. Food and Drug Administration

Soliris (Alexion Pharmaceuticals) Interactions

Drug interaction studies have not been performed with Soliris.

Soliris (Alexion Pharmaceuticals) Contraindications

Additional information about Soliris (Alexion Pharmaceuticals)

Soliris (Alexion Pharmaceuticals) Indication: For the treatment of patients with paroxysmal nocturnal hemoglobinuria (PNH) to reduce hemolysis.
Mechanism Of Action: Soliris (Alexion Pharmaceuticals), the active ingredient in Soliris, is a monoclonal antibody that specifically binds to the complement protein C5 with high affinity, thereby inhibiting its cleavage to C5a and C5b and preventing the generation of the terminal complement complex C5b-9. Soliris inhibits terminal complement mediated intravascular hemolysis in PNH patients. A genetic mutation in PNH patients leads to the generation of populations of abnormal RBCs (known as PNH cells) that are deficient in terminal complement inhibitors, rendering PNH RBCs sensitive to persistent terminal complement-mediated destruction. The destruction and loss of these PNH cells (intravascular hemolysis) results in low RBC counts (anemia), and also fatigue, difficulty in functioning, pain, dark urine, shortness of breath, and blood clots.
Drug Interactions: Not Available
Food Interactions: Not Available
Generic Name: Eculizumab
Synonyms: 5G1.1
Drug Category: Not Available
Drug Type: Biotech; Approved; Investigational

Other Brand Names containing Eculizumab: Soliris (Alexion Pharmaceuticals); Soliris;
Absorption: Not Available
Toxicity (Overdose): Not Available
Protein Binding: Not Available
Biotransformation: Not Available
Half Life: 272 ± 82 hrs (mean ± SD)
Dosage Forms of Soliris (Alexion Pharmaceuticals): Solution Intravenous drip
Chemical IUPAC Name: Not Available
Chemical Formula: Not Available
Eculizumab on Wikipedia: https://en.wikipedia.org/wiki/Eculizumab
Organisms Affected: Humans and other mammals