Eculizumab

(e kue LIZ oo mab)

What key warnings do I need to know about before giving this drug to my child?

• Very bad meningococcal infections have happened in patients who have taken this drug. Get a meningococcal vaccine at least 2 weeks before starting this drug.
• Sometimes drugs are not safe when your child takes them with other drugs. They can cause bad side effects. This is one of those drugs. Be sure to talk to your child’s doctor about all the drugs your child takes.
• You may get this drug only from the Soliris REMS Program.
• Please read the medication guide.

Is it safe for my child to take this drug?

• Not if your child has an allergy to eculizumab or any other part of this drug.
• Be sure to let the doctor know if your child has any allergies or side effects to drugs, foods, or dyes. Make sure to tell about the allergy and what signs your child had. This includes telling about rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
• If your child did not get a meningococcal vaccine.
• If your child has a meningococcal infection.

Why does my child need this drug?

• It is used to treat a blood and kidney disease called atypical hemolytic uremic syndrome (aHUS).

How does this drug work?

• It blocks the immune system when it gets out of check.

How is this drug given?

• It is given as a shot into a vein over a period of time.

How long does this drug take to work?

• It may take a few weeks to see the full effect.

What do I do if my child misses a dose? (does not apply to patients in the hospital)

• Call your child's doctor to find out what to do.

What safety measures do I need to take when my child is using this drug?

• Keep a list of all your child's drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your child's doctor.
• Very bad infections have been reported with use of this drug. If your child has any infection, has many infections, or is taking antibiotics, talk with the doctor.
• Have your child’s patient safety card with you at all times and for 3 months after drug is stopped.
• Have your child's blood work checked. Talk with your child's doctor.
• Check all drugs your child is taking with your child's doctor. This drug may not mix well with some other drugs.
• Make sure your child is up to date with all vaccines.
• Talk with the doctor before your child gets any vaccines. Use with this drug may either raise the chance of very bad infection or make the vaccine not work as well.

What are some side effects of this drug?

• Flu-like signs. These include headache, weakness, fever, shakes, aches, pains, and sweating. Mild pain drugs may help.
• Chance of getting an infection. Avoid people with infections, colds, or flu.
• Upset stomach or throwing up.
• Loose stools (diarrhea).
• Cough.
• Runny nose.
• Fast heartbeat.
• High blood pressure.
• Swelling.
• Headache.
• Sore throat.
• Brain infection may rarely happen.

When do I need to call my child's doctor?

• If any of this news causes you to be worried, any of the unwanted side effects happen, or if your child is not better after taking this drug.
• If you think there was an overdose, call your local poison control center or ER right away.
• If your child shows signs of a very bad reaction, call your child's doctor or the ER right away. These include wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; swelling of face, lips, tongue, or throat; or if your child is not acting normal.
• If your child shows any signs of infection. These include a fever of 100.5°F (38°C) or higher, chills, very bad sore throat, ear or sinus pain, cough, more sputum or change in color or sputum, pain with passing urine, mouth sores, wound that will not heal, or anal itching or pain.
• If your child has chest pain or pressure or a fast heartbeat.
• If your child has a very bad headache.
• If your child has a change in thinking clearly and with logic.
• If your child has neck stiffness.
• If your child has a sudden change in eyesight.
• If your child has a very bad upset stomach or is throwing up.
• If your child has very bad muscle pain.
• If your child has dark urine.
• If your child has cloudy or pink-red urine.
• If your child gets a rash.
• If your child’s health problem does not get better or if you believe your child’s health problem is worse.

General drug facts

• If your child has a very bad allergy, he/she needs to wear an allergy ID at all times.
• You may get this drug by drug order only. If there are refills, call your pharmacy. If your child does not have refills left, you may need to call your child's doctor.
• Get rid of this drug when your child no longer needs it or if the drug is outdated.
• Most drugs may be thrown away in household trash after mixing with coffee grounds or kitty litter and sealing in a plastic bag.
• In Canada, take any unused drugs to the pharmacy. Also, visit http://www.hc-sc.gc.ca/hl-vs/iyh-vsv/med/disposal-defaire-eng.php#th to learn about the right way to get rid of unused drugs.http://www.hc-sc.gc.ca/hl-vs/iyh-vsv/med/disposal-defaire-eng.php#th to learn about the right way to get rid of unused drugs.
• Do not share your child's drug with others and do not give anyone else's drug to your child.
• Keep all drugs out of the reach of children and pets.
• Keep a list of all your child's drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your child's doctor.
• Call your doctor for help with any side effects. If in the U.S., you may also call the FDA at 1-800-FDA-1088 or if in Canada, you may also call Health Canada's Vigilance Program at 1-866-234-2345.
• Talk with the doctor before giving your child any new drug, including OTC, natural products, or vitamins.
• If you do not use a drug the right way, it may not be safe. Follow what your child’s doctor tells you.

Copyright © 1978- Lexi-Comp Inc., The Children's Hospital, Denver, CO., and Pediatric Pharmacy Advocacy Group, Inc. All Rights Reserved. This information is protected under US and international copyright law. Unauthorized use or reproduction is prohibited.