Sirolimus

(sir OH li mus)

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

• This drug may add to your child's chance of getting lymphoma or other cancers.
• Very bad infections have happened in patients who take this drug. Talk with the doctor.
• Sirolimus may have very bad effects if used for liver or lung transplant.
• 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.
• This drug comes with an extra patient fact sheet called a Medication Guide. Read it with care. Read it again each time this drug is refilled.

Is it safe for my child to take this drug?

• Not if your child has an allergy to sirolimus 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 keep the body from harming the organ after an organ transplant.

How is this drug given?

• All products:
• This drug is used with other drugs to help the body accept the new organ.
• To gain the most benefit, do not miss giving your child doses.
• Give this drug with or without food. Always give with food or always give on an empty stomach.
• Oral solution:
• Put
• Measure this drug in the oral dose syringe. Empty drug from syringe into cup. Mix well and have your child drink.
• Fill container again with
• Tablet:
• Have your child swallow whole. Do not let your child chew, break, or crush.

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?

• Give a missed dose as soon as you think about it.
• If it is close to the time for your child's next dose, skip the missed dose and go back to your child's normal time.
• Do not give 2 doses or extra doses.
• Do not change the dose or stop your child's drug. Talk with your child's doctor.

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

• If your child has high cholesterol, talk with the doctor.
• If your child has liver disease, talk with the doctor.
• If your child has lung disease, talk with the doctor.
• If your child has skin cancer, talk with the doctor.
• Have your child's blood work checked often. 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.
• Keep a list of all your child's drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your child's doctor.
• If your child drinks grapefruit juice or eats grapefruit often, talk with your child's doctor.
• Do not have other household members get the oral polio vaccine while your child is taking this drug.
• 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.
• Do not give cyclosporine capsules (Neoral®, Gengraf®) or oral solution (Neoral®) within 4 hours of this drug.
• Tell dentists, surgeons, and other doctors that your child is using this drug.
• Your child may get sunburned more easily. Avoid lots of sun, sunlamps, and tanning beds. Use sunscreen and dress your child in clothing and eyewear that protects him/her from the sun.

What are some side effects of this drug?

• High blood pressure. Have your child's checked before starting this drug.
• High cholesterol level. Check level before starting this drug.
• Your child may have more chance of getting infections. Avoid crowds and people with infections, colds, or flu.
• Anemia and low platelet count.
• Feeling tired or weak.
• Belly pain.
• Hard stools (constipation). Drinking more liquids, working out, or adding fiber to your diet may help. Talk with your doctor about a stool softener or laxative.
• Upset stomach or throwing up. Many small meals and good mouth care may help. Older children may suck hard, sugar-free candy.
• Loose stools (diarrhea).
• Headache.
• Joint pain.
• Pimples (acne).
• Swelling in the arms or legs.
• Kidney function that gets worse.
• Harm to the lungs 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 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 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 trouble breathing.
• If your child has very loose stools (diarrhea).
• If your child has very bad skin irritation.
• If your child has swelling.
• If your child has a skin wound that will not heal.
• If your child is not able to pass urine.
• If your child has any bruising or bleeding.
• 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?

• Tablet:
• Store at room temperature.
• Protect from light.
• Store in a dry place. Do not store in a bathroom.
• Liquid:
• Store liquid (solution) at room temperature or in a refrigerator. Throw away any part not used after 15 days if stored at room temperature. Throw away any part not used after 1 month if refrigerated.
• Liquid (solution) may look hazy when refrigerated. Bring to room temperature and shake gently until haze goes away.
• Store liquid (solution) in a syringe at room temperature for 24 hours.
• Protect from light.

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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