Uses

This drug is used with other HIV medications to help control HIV infection. It helps to decrease the amount of HIV in your body so your immune system can work better. This lowers your chance of getting HIV complications (such as new infections, cancer) and improves your quality of life. Stavudine belongs to a class of drugs known as nucleoside reverse transcriptase inhibitors (NRTI).

Stavudine is not a cure for HIV infection. To decrease your risk of spreading HIV disease to others, continue to take all HIV medications exactly as prescribed by your doctor. Use an effective barrier method (latex or polyurethane condoms/dental dams) during sexual activity as directed by your doctor. Do not share personal items (such as needles/syringes, toothbrushes, and razors) that may have contacted blood or other body fluids. Consult your doctor or pharmacist for more details.

Other Uses

This section contains uses of this drug that are not listed in the approved professional labeling for the drug but that may be prescribed by your health care professional. Use this drug for a condition that is listed in this section only if it has been so prescribed by your health care professional.

This product may also be used to lessen the risk of HIV infection after contact with the virus (for example, due to a needle stick). Ask your doctor for more details.

How To Use

Read the Medication Guide and the Patient Information Leaflet provided by your pharmacist before you start using stavudine and each time you get a refill. If you have any questions, consult your doctor or pharmacist.

Take this medication by mouth with or without food, usually every 12 hours or as directed by your doctor.

The dosage is based on your weight, medical condition, and response to treatment.

For the best effect, take this medication at evenly spaced times. To help you remember, take this medication at the same times every day.

It is very important to continue taking this medication (and other HIV medications) exactly as prescribed by your doctor. Do not skip any doses. Refill your medication before you run out.

Do not take more or less of this drug than prescribed or stop taking it (or other HIV medicines) even for a short time unless directed to do so by your doctor. Skipping or changing your dose without approval from your doctor may cause the amount of virus to increase, make the infection more difficult to treat (resistant), or worsen side effects.

Side Effects

See also Warning section.

Headache or diarrhea may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

As your immune system gets stronger, it can begin to fight off infections you already had, possibly causing disease symptoms to come back. You could also have symptoms if your immune system becomes overactive. This reaction may happen at any time (soon after starting HIV treatment or many months later). Get medical help right away if you have any serious symptoms, including:

• unexplained weight loss
• severe tiredness
• muscle aches/weakness that doesn't go away
• headaches that are severe or don't go away
• joint pain
• numbness/tingling of the hands/feet/arms/legs
• vision changes
• signs of infection (such as fever, chills, swollen lymph nodes, trouble breathing, cough, non-healing skin sores)
• signs of an overactive thyroid (such as irritability, nervousness, heat intolerance, fast/pounding/irregular heartbeat, bulging eyes, unusual growth in the neck/thyroid known as a goiter)
• signs of a certain nerve problem known as Guillain-Barre syndrome (such as unsteadiness, loss of coordination, trouble swallowing/speaking/chewing, trouble moving your eyes)

This medication can cause severe nerve problems in the hands/feet/legs (peripheral neuropathy). Symptoms may include numbness/tingling/pain, muscle weakness, or decreased muscle control. If you experience any of these symptoms, contact your doctor right away so that you can be monitored closely. Your doctor may decide to reduce or stop your dose of stavudine.

Changes in body fat (such as increased fat in the upper back and stomach areas, decreased fat in the arms and legs) may occur while you are taking HIV medication. The cause and long-term effects of these changes are unknown. Discuss the risks and benefits of therapy with your doctor, as well as the possible role of exercise to reduce this side effect.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including:

• rash
• itching/swelling (especially of the face/tongue/throat)
• severe dizziness
• trouble breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Precautions

Before taking stavudine, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of:

• pancreatitis
• kidney problems
• liver problems (such as hepatitis, cirrhosis)
• nerve problems (such as peripheral neuropathy)
• alcohol use
• gall bladder problems (such as gall stones)

Avoid alcoholic beverages because they may increase your risk for liver problems and/or pancreatitis.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Kidney function declines as you grow older. This medication is removed by the kidneys. Caution is advised when using this drug in older adults because they may be more sensitive to the effects of the drug, especially the increased risk of nerve problems.

Tell your doctor if you are pregnant before using this medication. Treatment can lower the risk of passing HIV infection to your baby. Discuss the risks and benefits with your doctor.

This medication passes into breast milk. Because breast milk can transmit HIV, do not breast-feed.

Drug Interactions

See also Warning section.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Some products that may interact with this drug include:

• didanosine
• doxorubicin
• hydroxyurea
• orlistat
• zidovudine
• drugs that can cause nerve problems (such as isoniazid, vincristine)

Overdose

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 9-1-1. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

Notes

Do not share this medication with others.

Laboratory and/or medical tests (such as kidney tests, liver tests, viral load, T-cell counts) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.

Keep all medical and laboratory appointments.

Missed Dose

If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.

Storage

Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.