Pronunciation:

zal-SYE-ta-been

Brand Names:

• Hivid

Dosage Forms:

• Tablet

Warnings:

The use of zalcitabine has been associated with significant clinical adverse reactions, some of which are potentially fatal. Zalcitabine can cause severe peripheral neuropathy, pancreatitis (rare), and hepatic failure (rare). Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have also been reported. Use with extreme caution in patients with preexisting neuropathy; suspend therapy immediately in any patient who develops any symptoms suggestive of pancreatitis .

Classifications:

Therapeutic

Antiretroviral Agent

Pharmacologic

Nucleoside Reverse Transcriptase Inhibitor

Uses of This Medicine:

Zalcitabine (also known as ddC) is used in the treatment of the infection caused by the human immunodeficiency virus (HIV). HIV is the virus that causes acquired immune deficiency syndrome (AIDS).

Zalcitabine (ddC) will not cure or prevent HIV infection or AIDS; however, it helps keep HIV from reproducing and appears to slow down the destruction of the immune system. This may help delay the development of problems usually related to AIDS or HIV disease. Zalcitabine will not keep you from spreading HIV to other people. People who receive this medicine may continue to have other problems usually related to AIDS or HIV disease.

Zalcitabine may cause some serious side effects, including peripheral neuropathy (a problem involving the nerves). Symptoms of peripheral neuropathy include tingling, burning, numbness, or pain in the hands or feet. Zalcitabine may also cause pancreatitis (inflammation of the pancreas). Symptoms of pancreatitis include stomach pain, and nausea and vomiting. Check with your doctor if any new health problems or symptoms occur while you are taking zalcitabine.

Zalcitabine was available only with your doctor's prescription.

HIVID® (zalcitabine) was discontinued by Roche Pharmaceuticals on December 31, 2006 due to the availability of newer HIV medicines.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children

Zalcitabine can cause serious side effects in any patient. Therefore, it is especially important that you discuss with your child's doctor the good that this medicine may do as well as the risks of using it. Your child must be seen frequently and your child's progress carefully followed by the doctor while the child is taking zalcitabine.

Older adults

Zalcitabine has not been studied specifically in older people. Therefore, it is not known whether it causes different side effects or problems in the elderly than it does in younger adults.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast-feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Cimetidine
• Didanosine
• Lamivudine
• Probenecid
• Ribavirin

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Aluminum Carbonate, Basic
• Aluminum Hydroxide
• Aluminum Phosphate
• Calcium
• Calcium Carbonate
• Dihydroxyaluminum Aminoacetate
• Dihydroxyaluminum Sodium Carbonate
• Magaldrate
• Magnesium Carbonate
• Magnesium Hydroxide
• Magnesium Oxide
• Magnesium Trisilicate
• Pentamidine

Other interactions

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Alcohol abuse or
• Increased amylase (or a history of ) or
• Increased blood triglycerides (or a history of) or
• Pancreatitis (or a history of, or at risk for) or
• Receiving nutrition in your veins Patients with these medical problems may be at increased risk of pancreatitis (inflammation of the pancreas).

• Abnormal liver function, or
• Alcohol abuse, history of, or
• At risk for liver disease, or
• Hepatitis, or
• Liver disease, or
• Obesity, or
• Taking medicines called nucleosides for a long time Zalcitabine may make liver disease worse in patients with liver disease or a history of alcohol abuse.

• Allergy to zalcitabine, or
• Allergy to any part of the medicine Serious allergic reactions can occur.

• Bone marrow disease Patients with this condition may develop severe blood problems when taking zalcitabine.

• Heart problems, or
• Congestive heart failure Zalcitabine may make these conditions worse.

• Kidney disease Patients with kidney disease may have an increased chance of side effects.

• Low CD4 cell count Zalcitabine may cause serious side effects in patients with very low CD4 cell counts.

• Peripheral neuropathy or at risk of developing peripheral neuropathy, or
• Diabetes, or
• Low CD4 cell count, or
• Weight loss Zalcitabine may increase your chance of developing neuropathy or worsening neuropathy.

Proper Use of This Medicine:

Take this medicine exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. Also, do not stop taking this medicine without checking with your doctor first.

Keep taking zalcitabine for the full time of treatment, even if you begin to feel better.

This medicine works best when there is a constant amount in the blood. To help keep the amount constant, do not miss any doses. If you need help in planning the best times to take your medicine, check with your health care professional.

Only take medicine that your doctor has prescribed specifically for you. Do not share your medicine with others.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (tablets):
  • For treatment of HIV infection:
    • Adults and children 12 years of age and older 0.75 milligrams (mg).
    • Children up to 12 years of age Use and dose must be determined by your doctor.

Missed dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Precautions While Using This Medicine:

It is very important that your doctor check your progress at regular visits.

Do not take any other medicines without checking with your doctor first. To do so may increase the chance of side effects from zalcitabine.

HIV may be acquired from or spread to other people through infected body fluids, including blood, vaginal fluid, or semen. If you are infected, it is best to avoid any sexual activity involving an exchange of body fluids with other people. If you do have sex, always wear (or have your partner wear) a condom (“rubber”). Only use condoms made of latex, and use them every time you have vaginal, anal, or oral sex. The use of a spermicide (such as nonoxynol-9) may also help prevent transmission of HIV if it is not irritating to the vagina, rectum, or mouth. Spermicides have been shown to kill HIV in lab tests. Do not use oil-based jelly, cold cream, baby oil, or shortening as a lubricant these products can cause the condom to break. Lubricants without oil, such as K-Y Jelly, are recommended. Women may wish to carry their own condoms. Birth control pills and diaphragms will help protect against pregnancy, but they will not prevent someone from giving or getting the AIDS virus. If you inject drugs, get help to stop. Do not share needles or equipment with anyone. In some cities, more than half of the drug users are infected, and sharing even 1 needle or syringe can spread the virus. If you have any questions about this, check with your health care professional.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

Lab results that show problems with liver

tingling, burning, numbness, or pain in the hands, arms, feet, or legs

Less common

Fever

joint pain

muscle pain

nausea and vomiting

seizures

skin rash

stomach pain (severe)

ulcers in the mouth and throat

Rare

Discouragement, feeling sad or empty, irritability, lack of appetite, loss of interest or pleasure, tiredness, trouble concentrating, trouble sleeping

fever and sore throat

yellow eyes or skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common

Constipation

diarrhea

headache

hives or welts

itching skin

swelling or inflammation of the mouth

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.