Efavirenz, Emtricitabine, and Tenofovir

(e FAV e renz, em trye SYE ta been, & te NOE fo veer)

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

• This drug may cause liver problems and a change in acid levels in the blood. Closely read the part in this leaflet which lists when to call your doctor. Obesity, and/or longer therapy, may raise the chance.
• Hepatitis B testing may be done in patients taking this drug for HIV infection. A hepatitis B infection may get worse after this drug is stopped.
• 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.

Is it safe for my child to take this drug?

• Not if your child has an allergy to efavirenz, emtricitabine, tenofovir, 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 HIV infection.

How does this drug work?

• Efavirenz, emtricitabine, and tenofovir works to harm the virus and fight the infection.

How is this drug given?

• To gain the most benefit, do not miss giving your child doses.
• Give as you have been told, even if your child is feeling better.
• Give on an empty stomach. Give 1 hour before or 2 hours after meals.
• Give at bedtime if it causes sleepiness.

How long does this drug take to work?

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

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

• 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?

• Keep a list of all your child's drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your child's doctor.
• Do not run out of this drug.
• If your child has kidney disease, talk with the doctor.
• If your child has liver disease, 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.
• This drug may cause your child to be less alert. Have your child avoid tasks or actions that call for alertness. These include playing (for example, riding a bicycle, rollerblading, sports) or using items that call for your child to have focus or coordination (for example, scissors, lawnmower, electric scooters, or toy cars). Your child's actions will be closely watched until you see how this drug affects him/her. School work may be hard for your child to focus on and get done.

What are some side effects of this drug?

• Feeling lightheaded, sleepy, having blurred eyesight, or a change in thinking clearly. Have your child avoid tasks or actions that call for him/her to be alert or have clear eyesight until you see how this drug works.
• Feeling dizzy. Have your child get up slowly over a few minutes when sitting or lying down. Have your child be extra careful climbing stairs.
• Headache.
• 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).
• Weak bones with long-term use.
• Change in color of skin.

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 trouble breathing.
• If your child has bad dizziness.
• If your child is feeling very cold.
• 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 is feeling very tired or weak.
• If your child has very bad belly pain.
• If your child has a very bad upset stomach or is throwing up.
• If your child is not able to eat.
• If your child has very loose stools (diarrhea).
• If your child has very bad muscle pain or weakness.
• If your child has dark urine or yellow skin or eyes.
• 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?

• Store at room temperature.
• Protect from water. Do not store in a bathroom or kitchen.

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.