Soliris

Soliris is a prescription medication used to treat Paroxysmal Nocturnal Hemoglobinuria (PNH), atypical Hemolytic Uremic Syndrome (aHUS), and generalized Myasthenia Gravis (gMG). These are diseases affecting red blood cells, blood vessels, kidneys, other organs, and nervous system. Soliris belongs to a group of drugs monoclonal antibodies. It works by blocking the activity of the part of the immune system that damages blood cells or causes clots.

This medication comes in an injectable form to be given directly into a vein (IV) by a healthcare provider. It is usually given once a week for 5 weeks, and then once every other week.

Common side effects of Soliris are headache, runny nose, and sore throat.

Soliris is a prescription medicine used to treat people with:

• a disease called Paroxysmal Nocturnal Hemoglobinuria (PNH). PNH affects red blood cells.
• a disease called atypical Hemolytic Uremic Syndrome (aHUS). aHUS affects the blood system, kidney, and sometimes other body organs.
• a disease called generalized Myasthenia Gravis (gMG) who are anti-acetylcholine receptor (AchR) antibody positive. gMG causes  weakness and rapid fatigue of muscles under voluntary control.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

• Alexion Pharmaceuticals, Inc.

Soliris can cause serious side effects, including:

• See "Drug Precautions"
• Serious allergic reactions. Serious allergic reactions can happen during your Soliris infusion. Tell your doctor or nurse right away if you get any of these symptoms during your Soliris infusion:
  • chest pain
  • trouble breathing or shortness of breath
  • swelling of your face, tongue, or throat
  • feel faint or pass out
  If you have an allergic reaction to Soliris, your doctor may need to infuse Soliris more slowly, or stop Soliris. 

Common side effects in people with PNH treated with Soliris include:

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

Common side effects in people with aHUS treated with Soliris include:

• high blood pressure
• common cold (upper respiratory infection)
• diarrhea
• headache
• nausea and vomiting
• low red blood cell count
• low white blood cell count
• urinary tract infection

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 Soliris. For more information, ask your doctor or pharmacist.

No significant drug interactions with Soliris have been reported, however, it is important you tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

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

• Soliris increases your risk 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 a meningococcal vaccine at least 2 weeks before your first dose of Soliris unless you have already had this vaccine. If your doctor decides that urgent treatment with Soliris is needed, you should receive a meningococcal vaccine as soon as possible.
  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. 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 a fever
     • headache with a stiff neck or stiff back
     • fever of 103° F (39.4° C) or higher
     • 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 3 months after your last Soliris dose. Your risk of meningococcal infection may continue for several weeks after your last dose of Soliris. It is important to show this card to any doctor or nurse who treats you. This will help them diagnose and treat you quickly.

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

• enroll in the 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

Soliris may also increase the risk of other types of serious infections. If your child is treated with Soliris, make sure that your child receives vaccinations against Streptococcus pneumoniae and Haemophilus influenza type b (Hib).

Do not receive Soliris if you:

• have a meningococcal infection
• have not been vaccinated against meningitis infection, unless your doctor decides that urgent treatment with Soliris is needed.

Medicines can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Soliris there are no specific foods that you must exclude from your diet when receiving Soliris.

Before receiving Soliris, tell your doctor if you:

• have an infection or fever
• are pregnant or plan to become pregnant. 
• are breastfeeding or plan to breastfeed. 

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.

Know the medicines you take. Keep a list of them to show your doctor and pharmacist when you get a new medicine.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

This medication falls into category C. In animal studies, pregnant animals were given this medication and had some babies born with problems. No well-controlled studies have been done in humans. Therefore, this medication may be used if the potential benefits to the mother outweigh the potential risks to the unborn child.

Tell your doctor if you are breastfeeding or plan to breastfeed. It is not known if Soliris is excreted in human breast milk or if it will harm your nursing baby.

• Soliris is given through a vein (I.V. or intravenous infusion) usually over 35 minutes. If you have an allergic reaction during your Soliris infusion, your doctor may decide to give Soliris more slowly or stop your infusion.
• If you are an adult, you will usually receive a Soliris infusion by your doctor:
  • weekly for five weeks, then
  • every 2 weeks
• If you are less than 18 years of age, your doctor will decide how often you will receive Soliris depending on your age and body weight.
• After each infusion, you should be monitored for one hour for allergic reactions. 
• If you forget or miss a Soliris infusion, call your doctor right away.
• If you have PNH, your doctor will need to monitor you closely for at least 8 weeks after stopping Soliris. Stopping treatment with Soliris 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 the number of your red blood cells
  • drop in your platelet count
  • confusion
  • chest pain
  • kidney problems
  • blood clots
  • difficulty breathing
• If you have aHUS, your doctor will need to monitor you closely during and for at least 12 weeks after stopping treatment for signs of worsening aHUS symptoms or problems related to abnormal clotting (thrombotic microangiopathy).
  Symptoms or problems that can happen with abnormal clotting may include:
  • stroke
  • confusion
  • seizures
  • chest pain (angina)
  • difficulty breathing
  • kidney problems
  • swelling in arms or legs
  • a drop in your platelet count

Your doctor will determine the best dose for you.

Paroxysmal Nocturnal Hemoglobinuria (PNH)

The recommended dosage regimen for PNH is:

• 600 mg weekly for the first 4 weeks, followed by
• 900 mg for the fifth dose 1 week later, then
• 900 mg every 2 weeks thereafter.

Soliris should be administered at the recommended dosage regimen time points, or within two days of these time points.

Atypical Hemolytic Uremic Syndrome (aHUS)

The recommended dosage regimen for aHUS is:

For patients 18 years of age and older, Soliris therapy consists of:

• 900 mg weekly for the first 4 weeks, followed by
• 1200 mg for the fifth dose 1 week later, then
• 1200 mg every 2 weeks thereafter.

For patients less than 18 years of age, administer Soliris based upon body weight. Soliris should be administered at the recommended dosage regimen time points, or within two days of these time points.

Generalized Myasthenia Gravis (gMG)

The recommended dosage regimen for gMG is:

• 900 mg weekly for the first 4 weeks, followed by
• 1200 mg for the fifth dose 1 week later, then
• 1200 mg every 2 weeks thereafter.

Supplemental dosing of Soliris is required in the setting of concomitant plasmapheresis or plasma exchange, or fresh frozen plasma infusion.

Soliris is usually administered by a healthcare provider in a medical setting making it unlikely for an overdose to occur. However, if overdose is suspected, seek emergency medical attention.

Keep all of your medical and laboratory appointments. If you miss a scheduled dose, contact your healthcare provider right away.

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 a meningococcal vaccine 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 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 this program, prescribers must enroll in the program. Enrollment in the REMS program and additional information are available by telephone.