An Overview of Zerit (Stavudine, d4T)

STAV-yoo-deen

Brand Name:

Zerit
Other Name(s): BMY-27857, Estavudina, d4T

Drug Class: Nucleoside Reverse Transcriptase Inhibitors

Stavudine, also known as Zerit or d4T, is a type of medicine called a nucleoside reverse transcriptase inhibitor (NRTI). Stavudine works by disrupting one of the early steps in the HIV life cycle, called reverse transcription. During normal reverse transcription, HIV's reverse transcriptase enzyme (a type of protein) converts HIV's RNA -- a single strand of genetic information -- into DNA -- a double strand of genetic information. It does this by recoding the RNA building blocks into complimentary DNA building blocks. As the HIV life cycle proceeds, the newly formed DNA is used to make more copies of HIV virus.

When stavudine is present, however, it competes with one of the available DNA building blocks called deoxythymidine 5'-triphosphate. By replacing deoxythymidine 5'-triphosphate in the newly developing HIV DNA, stavudine is able to stop reverse transcriptase from completing its job. This prevents the HIV DNA strand from being formed and halts the HIV life cycle.

Indications and Usage

Stavudine was approved by the U.S. Food and Drug Administration (FDA) on June 24, 1994, for use in combination with other antiretroviral agents for the treatment of HIV infection in adults and children. Stavudine may also be used to prevent health care workers and others from getting HIV infection after they accidentally come into contact with the virus on the job; however, this practice does not have FDA approval.

Stavudine does not cure or prevent HIV infection or AIDS and does not reduce the risk of passing the virus to other people.

Dosage Form/Administration

Always take this medication as your doctor instructs. Stavudine is taken by mouth, without regard to food, and it is always used with other anti-HIV medications.

Dosage forms and strengths:

• Capsules: 15 mg, 20 mg, 30 mg, or 40 mg
• Oral Solution: 1 mg/mL

What storage conditions are needed for this medication?

• Store stavudine capsules between 59°F and 86°F (15°C to 30°C).
• Store stavudine oral solution (reconstituted) in a refrigerator between 36° F and 46° F (2° C to 8° C). Discard any unused portion after 30 days.

Keep this medication in the container it came in, tightly closed, and out of reach of children. Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.

In case of emergency/overdose:

In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.

What other information should I know?

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

Recommended Daily Dose

Recommended adult dosage (based on body weight) for the treatment of HIV infection:

• For patients weighing 132 lbs (60 kg) or greater: 40 mg taken twice daily (every 12 hours) by mouth, without regard to food
• For patients weighing less than 132 lbs (60 kg): 30 mg taken twice daily (every 12 hours) by mouth, without regard to food

Note: For patients with renal impairment or patients undergoing hemodialysis, dosing adjustments may be needed. See the drug label for detailed information.

Recommended pediatric dosage for the treatment of HIV infection:

• Newborns from birth to 13 days old: 0.5mg/kg/dose given twice daily (every 12 hours) by mouth, without regard to food
• Pediatric patients 14 days old or greater and weighing less than 66 lbs (30 kg): 1mg/kg/dose given twice daily (every 12 hours) by mouth, without regard to food
• Pediatric patients weighing 66 lbs (30 kg) or greater: Should receive the recommended adult dosage

Note: Before measuring and administering each dose of the oral solution, make sure to shake the bottle well.

What should I do if I forget a dose?

Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed dose.

Contraindications

Before taking stavudine,

• Tell your doctor and pharmacist if you are allergic to stavudine or any other medications.
• Tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Your doctor may need to change the doses of your medications or monitor you more carefully for side effects.
• Tell your doctor if you are pregnant or plan to become pregnant. If you become pregnant while taking stavudine, call your doctor. Tell your doctor if you are breast-feeding. You should not breast-feed if you are infected with HIV or if you are taking stavudine.

Possible Side Effects

Stavudine may cause side effects.

The following life-threatening side effects have been reported. Contact your doctor immediately if you experience:

• Lactic acidosis (buildup of an acid in the blood). This can be a medical emergency and may require treatment in the hospital. Call your healthcare provider right away if you experience any of the following signs of lactic acidosis:
  • Weak or tired
  • Unusual muscle pain
  • Trouble breathing
  • Unusual stomach pain or discomfort, nausea, vomiting
  • Cold sensation, especially in your arms and legs
  • Dizzy or lightheaded
  • Fast or irregular heartbeat
  • Unexplained weight loss
• Hepatoxicity (serious liver problem), with hepatomegaly (liver enlargement) and steatosis (fat in the liver). Call your healthcare provider right away if you experience the following signs of liver problems:
  • Skin or white part of the eyes turn yellow (jaundice)
  • Urine turns dark
  • Bowel movements turn light in color
  • Uninterested in eating food for several days or longer
  • Nauseous
  • Lower stomach area pain
• Pancreatitis (dangerous inflammation of the pancreas). Tell your doctor if you have ever had pancreatitis, regularly drink alcoholic beverages, or have gallstones, as pancreatitis occurs more often in patients with these conditions. Call your doctor immediately if you develop any of the following signs of pancreatitis:
  • Stomach pain
  • Nausea
  • Vomiting

Note: You may be more likely to experience lactic acidosis or liver problems if you are female, are very overweight (obese), or have been taking nucleoside analog medicines, like stavudine, for a long time. In addition, the combination of stavudine and didanosine may increase your risk for pancreatitis.

Some side effects can be serious. The following side effects have occurred:

• Numbness, tingling, burning, or pain in the feet and/or hands
• Headache
• Diarrhea
• Rash
• Trouble sleeping (insomnia)
• Loss of appetite
• Chills
• Fever
• Allergic reactions
• Blood disorders
• High blood sugar
• Changes in body fat

Stavudine may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the U.S. FDA's MedWatch Adverse Event Reporting program online at www.fda.gov/Safety/MedWatch or by phone at 1-800-332-1088.

Drug Interactions

What special dietary instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet. Stavudine may be taken without regard to food.

What other information should I know?

• Stavudine should not be given with zidovudine or any zidovudine-containing products (Combivir, Retrovir, Trizivir).
• The combined use of stavudine and hydroxyurea, with or without didanosine, should be avoided.
• The combined use of stavudine and didanosine should be used with caution.
• If you are taking ribavirin or interferon, your doctor may need to monitor or change your therapy.

Clinical Trials

Click here to search ClinicalTrials.gov for trials that use Stavudine.

Manufacturer Information

Stavudine
Bristol - Myers Squibb Co
PO Box 4500
Princeton, NJ 08543-4500
Phone: 800-321-1335

Zerit
Bristol - Myers Squibb Co
PO Box 4500
Princeton, NJ 08543-4500
Phone: 800-321-1335