Ziagen. What is that?
Ziagen(Abacavir sulfate) is an antiviral medication that prevents human immunodeficiency virus (HIV) cells from multiplying in your body.Ziagen was approved by the FDA on December 17, 1998, for use with other antiretroviral drugs in the treatment of HIV infection in adults and children 3 months of age or older. Preparations: Tablets: 300 mg; oral solution 20 mg/ml
Some people who take the medicine Ziagen may develop hypersensitivity reactions which can be fatal. These reactions usually occur within the first six weeks of taking Ziagen but can happen anytime during treatment. Make sure you tell your prescriber if you have previously had a reaction to Ziagen as it is important you do not take Ziagen or any preparation that contains the medicine Ziagen.
Re-starting treatment with Ziagen may lead to a more serious reaction.It is important you take Ziagen regularly. If you repeatedly stop treatment with Ziagen, you increase the chances of having a hypersensitivity reaction. If you have stopped taking Ziagen for any reason, seek advice from your prescriber before you start taking Ziagen again.
Daily Dose for Ziagen
The recommended dosage of Ziagen for adults is 300 mg twice a day. For children and adolescents age 3 months to 16 years, the recommended dosage is 8 mg/kg twice a day (up to a maximum of 300 mg twice a day).
Individuals with decreased liver function should take the liquid form of Ziagen sulfate; the recommended dosage for these patients is 10 ml twice a day.
Some individuals may benefit from different doses of Ziagen. Individuals should always take Ziagen as prescribed by their doctors.
Drug and Food Interactions with Ziagen
Ziagen may be taken with or without food. There are no specific foods that you must exclude from your diet when taking Ziagen. Alcohol competes with Ziagen for elimination from the body. Therefore, alcohol consumption may increase the concentration of Ziagen in the body and this could lead to increased frequency or severity of side effects from Ziagen. Ziagen does not affect the elimination of alcohol. Alcohol may increase your risk of liver damage.
The following drugs may interact with Ziagen:
- methadone
- phenobarbital
- phenytoin
- rifampicin
The following types of drugs may interact with Ziagen:
- liver enzyme inducers
- medicines that damage the skin such as non-nucleoside reverse transcriptase inhibitors
- retinoids
What should I discuss with my doctor before taking Ziagen
Do not take Ziagen if you have ever had an allergic reaction to it, or to any medicine that contains Ziagen, such as Epzicom or Trizivir. Once you have had an allergic reaction to Ziagen, you must never use it again. Some people have developed a life-threatening condition called lactic acidosis while taking Ziagen. You may be more likely to develop lactic acidosis if you are overweight or have liver disease, if you are a woman, or if you have taken certain HIV or AIDS medications for a long time.
Talk with your doctor about your individual risk. Ziagen can also cause severe or life-threatening effects on the liver. Call your doctor at once if you have any of these liver symptoms while taking Ziagen: nausea, stomach pain, loss of appetite, low fever, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes). Do not use Ziagen if you have moderate or severe liver disease, or if you are also taking any other medication that contains Ziagen, such as Epzicom, or Trizivir.
If you have any of these other conditions, you may need a dose adjustment or special tests to safely take Ziagen:
- liver disease;
- if you have used a medicine similar to Ziagen in the past, such as didanosine (Videx), lamivudine (Combivir, Epzicom, Trizivir), stavudine (Zerit), tenofovir (Viread), zalcitabine (Hivid), or zidovudine (Retrovir).
You may need a blood test before you start taking Ziagen for the first time, or if you are restarting the medication after stopping for reasons not related to an allergic reaction.
Whether this medicine is suitable for you
Ziagen is not suitable for everyone and some people should never use it. Other people should only use it with special care. It is important that the person prescribing this medicine knows your full medical history.
Your prescriber may only prescribe this medicine with special care or may not prescribe it at all if you:
- are aged over 65 years
- are allergic or sensitive to or have had a bad reaction to Ziagen in the past
- are allergic or sensitive to or have had a reaction to any of the ingredients in the medicine
- have kidney problems
- have liver problems or have risk factors for developing liver problems such as if you have hepatitis B or C infection, if you drink alcohol heavily or if you are a female and are overweight
- have metabolic problems
- have risk factors for developing a heart attack such as: raised blood pressure, hyperlipidaemia or smoking
- have risk factors for developing lipodystrophy syndrome
Furthermore the prescriber may only prescribe this medicine with special care or may not prescribe it at all for an infant under three months of age.
As part of the process of assessing suitability to take this medicine a prescriber may also arrange tests:
- to determine whether or not the medicine is suitable and whether it must be prescribed with extra care
- to check that this medicine is not having any undesired effects
Over time it is possible that Ziagen can become unsuitable for some people, or they may become unsuitable for it. If at any time it appears that Ziagen has become unsuitable, it is important that the prescriber is contacted immediately.
Ziagen and Pregnancy
FDA pregnancy category C. It is not known whether Ziagen is harmful to an unborn baby. HIV can be passed to the baby if the mother is not properly treated during pregnancy. Tell your doctor if you are pregnant or plan to become pregnant during treatment. Take all of your HIV medicines as directed to control your infection while you are pregnant. Your name may need to be listed on a pregnancy registry if you become pregnant while taking this medication.
The purpose of this registry is to track the outcome of the pregnancy and delivery to evaluate whether Ziagen had any effect on the baby.Before you have your baby you should discuss breast-feeding with your doctor or midwife. They will help you decide what is best for you and your baby based on the benefits and risks associated with this medicine. If you wish to breast-feed you should discuss with your prescriber whether there are any other medicines you could take which would also allow you to breast-feed. You should not stop this medicine without taking advice from your doctor.
Possible Side Effects
Along with its desired effects, Ziagen can cause some serious unwanted effects. In some individuals, Ziagen has caused a severe allergic reaction resulting in death. This reaction usually occurs during the first 6 weeks of taking Ziagen but can occur at any time. Individuals taking Ziagen should stop taking it and tell a doctor right away if they have a skin rash or any two or more of the following symptoms: sudden fever; severe tiredness or achiness; diarrhea, nausea, vomiting, or stomach pain; sore throat, shortness of breath, or cough; or a general ill feeling. These symptoms are listed on a warning card included with the prescription; individuals should carry the warning card with them at all times.
If a doctor suspects these symptoms are caused by an allergic reaction, the individual should never take Ziagen or an Ziagen-containing medicine again, because death could occur within hours. If Ziagentreatment is stopped for a period of time, it is important that a doctor be notified before the individual starts to take it again. Some of the most common side effects of Ziagenare also signs and symptoms of severe allergic reaction, such as nausea, vomiting, diarrhea, fever, chills, achiness, extreme tiredness, and skin rash. More than half of all individuals who take Ziagen have one or more of these side effects, but only about 8% of individuals who take Ziagen have a severe allergic reaction.
Even though this is a very small percentage, individuals who think they may be having a severe allergic reaction should stop taking Ziagen and see a doctor right away.Ziagen sulfate, like other NRTIs, can cause serious, sometimes fatal, liver disease. This has occurred both in individuals who had liver disease and in those with no known history of liver disease. Individuals who have liver disease should tell a doctor before taking this medicine. Problems with digestion have also been reported. Individuals should tell a doctor if they have any of these side effects.
Stop using Ziagen and call your doctor at once if you have symptoms of an allergic reaction from two or more of these specific side effect groups:
- Group 1 – fever;
- Group 2 – rash;
- Group 3 – nausea, vomiting, diarrhea, stomach pain;
- Group 4 – general tiredness, body aches;
- Group 5 – shortness of breath, cough, sore throat.
Once you have had an allergic reaction to Ziagen, you must never use it again. If you stop taking Ziagen for any reason, talk to your doctor before you start taking the medication again.
Ziagen can cause other serious side effects that may not be signs of an allergic reaction. Call your doctor at once if you have:
- lactic acidosis – muscle pain or weakness, numb or cold feeling in your arms and legs, trouble breathing, stomach pain, nausea with vomiting, slow or uneven heart rate, dizziness, or feeling very weak or tired;
- liver damage – nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
- severe skin symptoms – fever, sore throat, and headache with a severe blistering, peeling, and red skin rash;
- pancreatitis – severe pain in your upper stomach spreading to your back, nausea and vomiting, fast heart rate;
- wheezing, trouble breathing;
- vision changes or increased sensitivity to light;
- urinating less than usual or not at all;
- fever, chills, body aches, flu symptoms; or
- any other signs of new infection.
Less serious side effects may include:
- sleep problems or strange dreams;
- headache, mood changes; or
- changes in the shape or location of body fat (especially in your arms, legs, face, neck, breasts, and trunk).