d4T

What is the most important information I should know about d4T?

· Lactic acidosis and severe liver problems, including fatal cases, have been reported with the use of reverse transcriptase inhibitors, such as d4T, alone or in combination. Contact your doctor immediately if you experience nausea, vomiting, or unusual or unexpected stomach discomfort; weakness and tiredness; shortness of breath; weakness in the arms and legs; yellowing of the skin or eyes; or pain in the upper stomach area. These may be early symptoms of lactic acidosis or liver problems.

· Serious cases of pancreatitis (inflammation of the pancreas) have been reported with the use of d4T. Notify your doctor immediately if you develop symptoms of pancreatitis including nausea, vomiting, diarrhea, abdominal pain.

· Avoid alcohol while taking d4T. Alcohol may increase the risk of damage to the pancreas and/or liver.

· The most common side effect from d4T therapy is peripheral neuropathy, which may cause loss of feeling, numbness, tingling, or pain in a part of the body. Approximately 20% of patients taking d4T will experience peripheral neuropathy. Contact your doctor if you experience any of these side effects.

· Follow your doctor's instructions with respect to high-risk activities such as unprotected sex and the sharing of needles. d4T is not a cure for HIV or AIDS, and you can still transmit the virus to others during therapy with this medication.

 

What is d4T?

· d4T is an antiviral medication. It is in a category of HIV medicines called reverse transcriptase inhibitors. d4T inhibits the reproduction of HIV in the body.

· d4T is used to treat the human immunodeficiency virus (HIV), which causes the acquired immunodeficiency syndrome (AIDS). d4T is not a cure for HIV or AIDS.

· d4T may also be used for purposes other than those listed in this medication guide.

 

What should I discuss with my healthcare provider before taking d4T?

· Before taking d4T, tell your doctor if you have:     ·kidney disease;     ·liver disease;     ·pancreatitis; or     ·a history of peripheral neuropathy (numbness or tingling). or

· You may not be able to take d4T, or you may require a dosage adjustment or special monitoring during treatment if you have any of the conditions listed above.

· The d4T oral solution contains 50 mg of sucrose per mL. Individuals with diabetes may need to monitor their intake of sucrose.

· d4T is in the FDA pregnancy category C. This means that it is not known whether it will harm an unborn baby. Fatal lactic acidosis has been reported in pregnant women treated with the combination of didanosine (Videx, Videx EC) and d4T with other antiretroviral medicines. It is very important to treat HIV/AIDS during pregnancy to reduce the risk of infecting the baby. Talk to your doctor about your treatment options.

· It is not known whether d4T passes into breast milk and what effect it may have on a nursing baby. To prevent transmission of the virus to uninfected babies, it is recommended that HIV-positive mothers not breast-feed. Talk to your doctor about breast-feeding if you are taking d4T.

 

How should I take d4T?

· Take d4T exactly as directed by your doctor. If you do not understand these directions, ask your pharmacist, nurse, or doctor to explain them to you.

· Take each dose with a full glass of water.

· d4T can be taken with or without food.

· Shake the suspension well before measuring a dose.

· To ensure that you get a correct dose, measure the liquid form of d4T with a special dose-measuring spoon or cup, not with a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.

· Swallow the extended-release capsules (Zerit XR) whole, without crushing or chewing. If swallowing the capsules is difficult, they can be carefully opened and the contents mixed with two tablespoons of applesauce or yogurt. The mixture should then be swallowed whole, without chewing or crushing the beads. Consume the mixture immediately, do not save it for later use.

· Treatment of HIV/AIDS almost always requires the use of two or more drugs. If you need to stop taking one of the medicines you are taking for HIV, you should stop all of them until you can talk to your doctor.

· It is important to take d4T regularly to get the most benefit.

· Your doctor may want you to have blood tests or other medical evaluations during treatment with d4T to monitor progress and side effects.

· Store d4T capsules at room temperature away from moisture and heat.

· Store the d4T suspension in the refrigerator between 2 and 8 degrees Celsius (36 to 46 degrees Fahrenheit). Throw away any unused suspension after 30 days.

 

What happens if I miss a dose?

· Take the missed dose as soon as you remember. However, if it is almost time for the next regularly scheduled dose, skip the missed dose and take the next one as directed. Do not take a double dose of this medication unless your doctor directs otherwise.

 

What happens if I overdose?

· Seek emergency medical attention.

· Symptoms of a d4T overdose include liver damage (yellowing of the skin or eyes, nausea, abdominal pain or discomfort, unusual bleeding or bruising, severe fatigue) and numbness, tingling, or pain in a part of the body.

 

What should I avoid while taking d4T?

· Follow your doctor's instructions with respect to high-risk activities such as unprotected sex and the sharing of needles. d4T is not a cure for HIV or AIDS, and you can still transmit the virus to others during therapy with this medication.

· Avoid alcohol while taking d4T. Alcohol may increase the risk of damage to the pancreas and/or liver.

 

What are the possible side effects of d4T?

· Stop taking d4T and seek emergency medical attention if you experience an allergic reaction (difficulty breathing; closing of your throat; swelling of your lips, tongue, or face; or hives).

· Lactic acidosis and severe liver problems, including fatal cases, have been reported with the use of reverse transcriptase inhibitors, such as d4T, alone or in combination. Contact your doctor immediately if you experience nausea, vomiting, or unusual or unexpected stomach discomfort; weakness and tiredness; shortness of breath; weakness in the arms and legs; yellowing of the skin or eyes; or pain in the upper stomach area. These may be early symptoms of lactic acidosis or liver problems.

· Serious cases of pancreatitis (inflammation of the pancreas) have been reported with the use of d4T. Notify your doctor immediately if you develop symptoms of pancreatitis including nausea, vomiting, diarrhea, abdominal pain.

· The most common side effect from d4T therapy is peripheral neuropathy, which may cause loss of feeling, numbness, tingling, or pain in a part of the body. Approximately 20% of patients taking d4T will experience peripheral neuropathy. Contact your doctor if you experience any of these side effects.

· Other, less serious side effects may be more likely to occur. Continue to take d4T and talk to your doctor if you experience any of the following side effects:     ·headache;     ·a fever or chills;     ·nausea, vomiting, or diarrhea;     ·insomnia;     ·decreased appetite;     ·a rash; or     ·redistribution of body fat (loss of fat from the arms, legs, and face and increased fat around the neck, breast, and trunk).

· Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

 

What other drugs will affect d4T?

· d4T may interact with other medications resulting in reduced effectiveness and/or side effects. Talk to your doctor and pharmacist before taking any other prescription or over-the-counter medications, including herbal products.

 

Where can I get more information?

· Your pharmacist has more information about d4T written for health professionals that you may read.