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. 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 SOLIRIS unless you have already had this vaccine. If your doctor decided that urgent treatment with SOLIRIS is needed, you should receive meningococcal vaccination as soon as possible.

  2. If you had a meningococcal vaccine in the past, you might need additional vaccination before starting SOLIRIS. Your doctor will decide if you need additional meningococcal vaccination.

  3. Meningococcal vaccines 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 with a stiff neck or stiff back

  • fever and a rash

  • muscle aches with flu-like symptoms

  • headache and a fever

  • fever

  • confusion

  • 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 SOLIRIS REMS.  Before you can receive SOLIRIS, your doctor must:

  • enroll in the SOLIRIS 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 Haemophilis influenza type b (Hib).

What is SOLIRIS?

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

  • adults with a disease called generalized Myasthenia Gravis (gMG) who are anti-acetylcholine receptor (AchR) antibody positive

It is not known if SOLIRIS is safe and effective in children with gMG.

Who should not receive SOLIRIS?

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. See “What is the most important information I should know about SOLIRIS?”

Before you receive SOLIRIS, 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 SOLIRIS will harm your unborn baby.

  • are breastfeeding or plan to breastfeed. It is not known if SOLIRIS passes into your breast milk.

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. SOLIRIS and other medicines can affect each other causing side effects.

It is important that you:

  • have all recommended vaccinations before you start SOLIRIS.

  • stay up-to-date with all recommended vaccinations during treatment with SOLIRIS.

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

What are the possible side effects of SOLIRIS?

SOLIRIS can cause serious side effects including:

  • See “What is the most important information I should know about SOLIRIS?”

  • 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.

The most common side effects in people with gMG treated with SOLIRIS include:

  • muscle and joint (musculoskeletal) pain

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.

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

NOW APPROVED for the treatment of adult patients with generalized Myasthenia Gravis (gMG) who are anti-acetylcholine receptor (AchR) antibody positive.

Soliris is indicated for the treatment of adult patients with generalized Myasthenia Gravis (gMG) who are anti-acetylcholine receptor (AchR) antibody positive.

 

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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. 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 SOLIRIS unless you have already had this vaccine. If your doctor decided that urgent treatment with SOLIRIS is needed, you should receive meningococcal vaccination as soon as possible.

  2. If you had a meningococcal vaccine in the past, you might need additional vaccination before starting SOLIRIS. Your doctor will decide if you need additional meningococcal vaccination.

  3. Meningococcal vaccines 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 with a stiff neck or stiff back

  • fever and a rash

  • muscle aches with flu-like symptoms

  • headache and a fever

  • fever

  • confusion

  • 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 SOLIRIS REMS. Before you can receive SOLIRIS, your doctor must:

  • enroll in the SOLIRIS 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 Haemophilis influenza type b (Hib).

What is SOLIRIS?

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

  • adults with a disease called generalized Myasthenia Gravis (gMG) who are anti-acetylcholine receptor (AchR) antibody positive

It is not known if SOLIRIS is safe and effective in children with gMG.

Who should not receive SOLIRIS?

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. See “What is the most important information I should know about SOLIRIS?”

Before you receive SOLIRIS, 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 SOLIRIS will harm your unborn baby.

  • are breastfeeding or plan to breastfeed. It is not known if SOLIRIS passes into your breast milk.

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. SOLIRIS and other medicines can affect each other causing side effects.

It is important that you:

  • have all recommended vaccinations before you start SOLIRIS.

  • stay up-to-date with all recommended vaccinations during treatment with SOLIRIS.

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

What are the possible side effects of SOLIRIS?

SOLIRIS can cause serious side effects including:

  • See “What is the most important information I should know about SOLIRIS?”

  • 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.

 

The most common side effects in people with gMG treated with SOLIRIS include:

  • muscle and joint (musculoskeletal) pain

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.

 

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