ZIAGEN- abacavir sulfate tablet, film coated
REMEDYREPACK INC.
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MEDICATION GUIDE
ZIAGEN ® (ZY-uh- jen)
(abacavir sulfate)
Tablets and Oral Solution
Read this Medication Guide before you start taking ZIAGEN and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or your treatment. Be sure to carry your ZIAGEN Warning Card with you at all times.
What is the most important information I should know about ZIAGEN?
1.Serious allergic reaction (hypersensitivity reaction). ZIAGEN contains abacavir (also contained in EPZICOM ® and TRIZIVIR ®). Patients taking ZIAGEN may have a serious allergic reaction (hypersensitivity reaction) that can cause death. Your risk of this allergic reaction is much higher if you have a gene variation called HLA-B*5701. Your healthcare provider can determine with a blood test if you have this gene variation.
If you get a symptom from 2 or more of the following groups while taking ZIAGEN, call your healthcare provider right away to find out if you should stop taking ZIAGEN.
Symptom(s) |
|
Group 1 |
Fever |
Group 2 |
Rash |
Group 3 |
Nausea, vomiting, diarrhea, abdominal (stomach area) pain |
Group 4 |
Generally ill feeling, extreme tiredness, or achiness |
Group 5 |
Shortness of breath, cough, sore throat |
A list of these symptoms is on the Warning Card your pharmacist gives you. Carry this Warning Card with you at all times.
If you stop ZIAGEN because of an allergic reaction, never take ZIAGEN (abacavir sulfate) or any other abacavir-containing medicine (EPZICOM and TRIZIVIR) again. If you take ZIAGEN or any other abacavir-containing medicine again after you have had an allergic reaction, within hours you may get life-threatening symptoms that may include very low blood pressure or death. If you stop ZIAGEN, for any other reason, even for a few days, and you are not allergic to ZIAGEN, talk with your healthcare provider before taking it again. Taking ZIAGEN again can cause a serious allergic or life-threatening reaction, even if you never had an allergic reaction to it before.
If your healthcare provider tells you that you can take ZIAGEN again, start taking it when you are around medical help or people who can call a healthcare provider if you need one.
2. Lactic Acidosis (buildup of acid in the blood). Some human immunodeficiency virus (HIV) medicines, including ZIAGEN, can cause a rare but serious condition called lactic acidosis. Lactic acidosis is a serious medical emergency that can cause death and must be treated in the hospital.
Call your healthcare provider right away if you get any of the following signs or symptoms of lactic acidosis:
3. Serious liver problems. Some people who have taken medicines like ZIAGEN have developed serious liver problems called hepatotoxicity, with liver enlargement (hepatomegaly) and fat in the liver (steatosis). Hepatomegaly with steatosis is a serious medical emergency that can cause death.Call your healthcare provider right away if you get any of the following signs or symptoms of liver problems:
You may be more likely to get lactic acidosis or serious liver problems if you are female, very overweight, or have been taking nucleoside analogue medicines for a long time.
What is ZIAGEN?
ZIAGEN is a prescription medicine used to treat HIV infection. ZIAGEN is a medicine called a nucleoside analogue reverse transcriptase inhibitor (NRTI). ZIAGEN is always used with other anti-HIV medicines. When used in combination with these other medicines, ZIAGEN helps lower the amount of HIV in your blood.
Who should not take ZIAGEN?
Do not take ZIAGEN if you:
What should I tell my healthcare provider before taking ZIAGEN?
Before you take ZIAGEN, tell your healthcare provider if you:
Tell your healthcare provider about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements.
Especially tell your healthcare provider if you take:
Ask your healthcare provider if you are not sure if you take one of the medicines listed above.
ZIAGEN may affect the way other medicines work, and other medicines may affect how ZIAGEN works.
Know the medicines you take. Keep a list of your medicines with you to show to your healthcare provider and pharmacist when you get a new medicine.
How should I take ZIAGEN?
What are the possible side effects of ZIAGEN?
These changes may include:
The most common side effects of ZIAGEN in adults include:
The most common side effects of ZIAGEN in children include:
Tell your healthcare provider if you have any side effect that bothers you or that does not go away.
These are not all the possible side effects of ZIAGEN. For more information, ask your healthcare provider or pharmacist.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
How should I store ZIAGEN?
General information for safe and effective use of ZIAGEN
Avoid doing things that can spread HIV infection to others.
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use ZIAGEN for a condition for which it was not prescribed. Do not give ZIAGEN to other people, even if they have the same symptoms that you have. It may harm them.
This Medication Guide summarizes the most important information about ZIAGEN. If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for the information that is written for healthcare professionals.
For more information go to www.ZIAGEN.com or call 1-877-844-8872.
What are the ingredients in ZIAGEN?
Tablets
Active ingredient: abacavir sulfate
Inactive ingredients: colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate, and afilm‑coating made of hypromellose, polysorbate 80, synthetic yellow iron oxide, titanium dioxide, and triacetin.
Oral Solution
Active ingredient: abacavir sulfate
Inactive ingredients: artificial strawberry and banana flavors, citric acid (anhydrous), methylparaben and propylparaben (added as preservatives), propylene glycol, saccharin sodium, sodium citrate (dihydrate), sorbitol solution, and water.
This Medication Guide has been approved by the US Food and Drug Administration.
EPZICOM and TRIZIVIR are registered trademarks of ViiV Healthcare.
Manufactured for:
ViiV Healthcare
Research Triangle Park, NC 27709
by:
GlaxoSmithKline
Research Triangle Park, NC 27709
©2012, ViiV Healthcare. All rights reserved.
May 2012
ZGN:5MG