Agalsidase Alfa

(aye GAL si days AL fa)

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

• Unsafe allergic effects may happen. Tell your child's doctor about any fever, rash, feeling tired, upset stomach, throwing up, loose stools, belly pain, flu-like signs, sore throat, cough, or trouble breathing. Do not restart this drug if your child has had an allergic effect.
• Sometimes drugs are not safe when your child takes them with other drugs. Taking them together 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.

Is it safe for my child to take this drug?

• Not if your child has an allergy to agalsidase alfa 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.

Why does my child need this drug?

• It is used to treat Fabry disease.

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 up to 12 months to see the full effect.

What do I do if my child misses a dose?

• Call your doctor for an office visit.

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.
• Check all drugs your child is taking with your child's doctor. This drug may not mix well with some other drugs.

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.
• Upset stomach or throwing up. Many small meals and good mouth care may help. Older children may suck hard, sugar-free candy.
• Flushing.
• High blood pressure during infusion.
• Runny nose.
• Sore throat.
• Swelling in the arms or legs.
• Cough.
• Feeling tired or weak.

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 has been an overdose, call 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org), or emergency room (ER) right away.http://www.aapcc.org), or emergency room (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 signs of low mood (depression), thoughts of killing him/herself, nervousness, emotional ups and downs, thinking that is not normal, anxiety, or lack of interest in life.
• If your child has chest pain or pressure.
• If your child has trouble breathing.
• If your child has a very bad upset stomach or is throwing up.
• 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.

How do I store and/or throw out this drug?

• This drug will be given to your child in a hospital or doctor's office. You will not store it at home.

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.
• If you have any questions about this drug, please talk with your doctor, pharmacist, or other health care provider.
• 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.
• These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.
• 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.

This information should not be used to decide whether or not to take this medicine or any other medicine. Only your healthcare provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your healthcare provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.

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