Drug Notebook

FDA Alerts

  • Severe peripheral neuropathy reported. Caution in patients with neuropathy. (See Peripheral Neuropathy under Cautions.)

  • Pancreatitis reported rarely. If pancreatitis suspected, temporarily interrupt therapy until diagnosis is excluded. (See Pancreatitis under Cautions.)

  • Lactic acidosis and severe hepatomegaly with steatosis (including some fatalities) reported rarely in patients receiving nucleoside reverse transcriptase inhibitors (NRTIs) alone or in conjunction with other antiretrovirals. (See Lactic Acidosis and Severe Hepatomegaly with Steatosis under Cautions.)

  • Hepatic failure and death reported rarely; possibly related to underlying hepatitis B virus (HBV) infection and zalcitabine therapy.

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

Zalcitabine may cause lactic acidosis (the build up of lactic acid in the body). Lactic acidosis symptoms can start slowly and gradually get worse. Symptoms include unusual muscle pain and weakness, trouble breathing, fast or uneven heart rate, nausea, vomiting, stomach pain, and numbness or cold feeling in your arms or legs. Call your doctor at once if you have any of these symptoms, even if they are only mild. Early signs of lactic acidosis generally get worse over time and this condition can be fatal. Zalcitabine can also cause severe or life-threatening effects on your liver or pancreas. Call your doctor at once if you have any of these symptoms while taking zalcitabine: severe pain in your upper stomach spreading to your back, fast heart rate, nausea and vomiting, diarrhea, loss of appetite, low fever, dark urine, clay-colored stools, or jaundice (yellowing of the skin or eyes). Before taking this medication, tell your doctor if you have kidney disease, liver disease, a history of pancreatitis, or if you have used a medicine similar to zalcitabine in the past, such as abacavir (Ziagen), didanosine (Videx), lamivudine (Epivir), stavudine (Zerit), tenofovir (Viread), or zidovudine (Retrovir).

HIV/AIDS is usually treated with a combination of different drugs. To best treat your condition, use all of your medications as directed by your doctor. Be sure to read the medication guide or patient instructions provided with each of your medications. Do not change your doses or medication schedule without advice from your doctor. Every person with HIV or AIDS should remain under the care of a doctor.

Taking zalcitabine will not prevent you from passing HIV to other people through unprotected sex or sharing of needles. Talk with your doctor about safe methods of preventing HIV transmission during sex, such as using a condom and spermicide. Sharing drug or medicine needles is never safe, even for a healthy person.

What is zalcitabine?

Zalcitabine is an antiviral medication that prevents human immunodeficiency virus (HIV) cells from multiplying in your body.

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

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

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

Do not use this medication if you are allergic to zalcitabine. Before taking this medication, tell your doctor if you are allergic to any drugs, or if you have:
  • kidney disease;
  • liver disease (including hepatitis B);
  • a history of pancreatitis; or

  • if you have used a medicine similar to zalcitabine in the past, such as abacavir (Ziagen), didanosine (Videx), lamivudine (Epivir), stavudine (Zerit), tenofovir (Viread), or zidovudine (Retrovir).

If you have any of the conditions listed above, you may not be able to use zalcitabine or you may need a dosage adjustment or special tests during treatment.

Zalcitabine may cause lactic acidosis (the build up of lactic acid in the body). Lactic acidosis symptoms can start slowly and gradually get worse. Symptoms include unusual muscle pain and weakness, trouble breathing, fast or uneven heart rate, nausea, vomiting, stomach pain, and numbness or cold feeling in your arms or legs. Call your doctor at once if you have any of these symptoms, even if they are only mild. Early signs of lactic acidosis generally get worse over time and this condition can be fatal. Zalcitabine can also cause severe or life-threatening effects on your liver or pancreas. Call your doctor at once if you have any of these symptoms while taking zalcitabine: severe pain in your upper stomach spreading to your back, fast heart rate, nausea and vomiting, diarrhea, loss of appetite, low fever, dark urine, clay-colored stools, or jaundice (yellowing of the skin or eyes). FDA pregnancy category C. This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. 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 an antiviral pregnancy registry when you start using zalcitabine. The purpose of this registry is to track the outcome of the pregnancy and delivery to evaluate whether zalcitabine had any effect on the baby.

You should not breast-feed while you are using zalcitabine. Women with HIV or AIDS should not breast-feed at all. Even if your baby is born without HIV, you may still pass the virus to the baby in your breast milk.
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