Zerit: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for

ZERIT (Pronounced ZER it) is a prescription medicine used in combination with other drugs to treat adults and children who are infected with HIV (the human immunodeficiency virus), the virus that causes AIDS.

What it does

ZERIT belongs to a class of drugs called nucleoside analogues. By reducing the growth of HIV, ZERIT helps your body maintain its supply of CD4 cells, which are important for fighting HIV and other infections.

ZERIT will not cure your HIV infection. At present there is no cure for HIV infection. Even while taking ZERIT, you may continue to have HIV-related illnesses, including infections caused by other disease-producing organisms. Continue to see your doctor regularly and report any medical problems that occur. Inform your doctor of all your medical conditions such as liver disease, diabetes, or if you are taking other medications. Do not take any medicine, vitamin, supplement, or other health preparation without first checking with your doctor.

ZERIT does not prevent a patient infected with HIV from passing the virus to other people. To protect others, you must continue to practice safe sex and take precautions to prevent others from coming in contact with your blood and other body fluids.

The long-term effects of ZERIT are unknown at this time.

When it should not be used

Do not take ZERIT if you are allergic to any of its ingredients, including its active ingredient, stavudine, and the inactive ingredients. (See “What the nonmedicinal ingredients are” in this leaflet). Tell your doctor if you think you have had an allergic reaction to any of these ingredients.

What the medicinal ingredient is:

Stavudine

What the nonmedicinal ingredients are:

ZERIT Capsules: lactose (milk sugar), magnesium stearate, microcrystalline cellulose, sodium starch glycolate. Capsule shell: gelatin, black iron oxide (20 mg only), printing ink, silicon dioxyde, sodium lauryl sulphate, titanium dioxide and yellow and red iron oxides.

ZERIT for Oral Solution: methylparaben, propylparaben, sodium carboxymethylcellulose, sucrose (table sugar) and antifoaming (simethicone, polyethylene glycol monostearate, glyceryl monostearate, sorbic acid, water) and flavoring agents.

What dosage forms it comes in:

Capsules: 5, 15, 20, 30 and 40 mg

Powder for Oral Solution: Fruit flavored powder that provides 1 mg of stavudine per mL of solution upon constitution with water.

WARNINGS AND PRECAUTIONS

Serious Warnings and Precautions Lactic acidosis and severe liver enlargement - Lactic acidosis (severe increase of lactic acid in the blood) and severe liver enlargement, including deaths, have been reported among patients taking ZERIT. Symptoms of lactic acidosis may include:

< nausea, vomiting, or unusual or unexpected stomach discomfort;

< feeling very weak and tired;

< shortness of breath;

< weakness in arms and legs.

If you notice these symptoms or if your medical condition has suddenly changed, stop taking ZERIT and call your doctor right away. Lactic acidosis is a medical emergency that must be treated in a hospital.

See “SIDE EFFECTS AND WHAT TO DO ABOUT THEM”.

Talk to your doctor before using ZERIT if:

• You are using other medications including those you can buy without a prescription, as they may interfere with ZERIT (See Interactions with this medication). • You are pregnant or planning on becoming

pregnant. It is not known if ZERIT can harm a human fetus. Also, pregnant women have experienced serious side effects when taking ZERIT in combination with didanosine and other HIV medicines. ZERIT should be used during pregnancy only after discussion with your doctor.

• You are breastfeeding. Studies have shown ZERIT is

  in the breast milk of animals receiving the drug, so it may be present in human breast milk. The Centers for Disease Control and Prevention (CDC) recommends that HIV-infected mothers not breast-feed to reduce the risk of passing HIV infection to their babies and the potential for serious adverse reactions in nursing infants. Therefore, do not nurse a baby while taking ZERIT.

• You have kidney, liver problems or history of heavy

  alcohol use.

• You have had pancreatitis, gallstones.
• You have had peripheral neuropathy.

• You have diabetes. Zerit for Oral Solution contains 50

  mg of sucrose (sugar) per mL.

INTERACTIONS WITH THIS MEDICATION

Other medicines, including those you can buy without a prescription, may interfere with the actions of ZERIT. You should not use ZERIT in combination with zidovudine (AZT). You should talk to your doctor if you are taking doxorubicin or ribavarin as these drugs may interfere with ZERIT. Do not take any medicine, vitamin, supplement, or other health preparation without first checking with your doctor. (Taking ZERIT with other drugs that also may cause peripheral neuropathy may increase your risk of getting this serious side effect.)

PROPER USE OF THIS MEDICATION

Usual dose

Your doctor will determine your dose (the amount in each capsule or spoonful) based on your body weight, kidney and liver function, and any side effects that you may have had with other medicines. Take ZERIT exactly as instructed. ZERIT may be taken with food or on an empty stomach.

Capsules: ZERIT capsules are usually taken twice a day (every 12 hours).

Oral solution (for children): ZERIT for Oral Solution is taken twice a day (every 12 hours). If your child will be taking ZERIT, the doctor should give you written instructions on how to give this medicine. Before measuring each dose, shake the bottle well.

If you have a kidney problem: If your kidneys are not working properly, your doctor may monitor your kidney function while you take ZERIT. Also, your dosage of ZERIT may be adjusted.

Overdose

Missed Dose

Try not to miss a dose, but if you do, take it as soon as possible. If it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not double doses.

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

Serious side effects of ZERIT may include:

• Lactic acidosis, severe increase of lactic acid in the blood, severe liver enlargement, including inflammation (pain and swelling) of the liver, and liver failure, which can cause death.
• Peripheral neuropathy, a nerve disorder of the hands and feet.

People who take ZERIT along with other medicines that may cause similar side effects may have a higher chance of developing these side effects than if they took ZERIT alone. For example, if you use ZERIT in combination with other drugs (including didanosine) that may be associated with liver enlargement, peripheral neuropathy, or pancreatitis, you may be at increased risk for these side effects. Children experience side effects that are similar to those experienced by adults.

Lactic acidosis and severe liver enlargement - Lactic acidosis and severe liver enlargement, including deaths, have been reported among patients taking ZERIT. Symptoms of lactic acidosis may include:

• nausea, vomiting, or unusual or unexpected stomach discomfort;

•

feeling very weak and tired;

• shortness of breath;
• weakness in arms and legs.

If you notice these symptoms or if your medical condition has suddenly changed, stop taking ZERIT and call your doctor right away. Lactic acidosis is a medical emergency that must be treated in a hospital. Women, overweight patients, and those who have had lengthy treatment with nucleoside medicines are more likely to develop lactic acidosis. Your doctor should check your liver function periodically while you are taking ZERIT, especially if you have a history of heavy alcohol use or a liver problem. The combination of ZERIT and didanosine may increase your risk for liver damage, which may be fatal. Your doctor should closely monitor your liver function if you are taking this combination.

Fat redistribution - Changes in body fat have been seen in some patients taking antiretroviral therapy. These changes may include increased amount of fat in the upper back and neck (“buffalo hump”), breasts, and around the trunk. Loss of fat from the legs, arms, and face may also happen. The cause and long-term health effects of these conditions are not known at this time.

Peripheral neuropathy - This nerve disorder is rare, but may be serious. Tell your doctor right away if you or a child taking ZERIT has continuing numbness, tingling, burning, or pain in the feet and/or hands. A child may not recognize these symptoms or know to tell you that his or her feet or hands are numb, burning, tingling, or painful. Ask your child's doctor for instructions on how to find out if your child develops peripheral neuropathy.

Let your doctor know if you or a child taking ZERIT has ever had peripheral neuropathy, because this condition occurs more often in patients who have had it previously. Peripheral neuropathy is also more likely to occur in patients taking drugs that affect the nerves and in patients with advanced HIV disease, but it can occur at any disease stage. If you develop peripheral neuropathy, your doctor may tell you to stop taking ZERIT. In some cases the symptoms worsen for a short time before getting better. Once symptoms of peripheral neuropathy go away completely, your doctor may decide to start ZERIT again at a lower dose.

Pancreatitis - Pancreatitis is a dangerous inflammation of the pancreas. It may cause death. Tell your doctor right away if you develop stomach pain, nausea, or vomiting. These can be signs of pancreatitis. Let your doctor know if you have ever had pancreatitis, regularly drink alcoholic beverages, or have gallstones. Pancreatitis occurs more often in patients with these conditions. It is also more likely in people with advanced HIV disease, but can occur at any disease stage. The combination of ZERIT and didanosine,

with or without hydroxyurea, may increase your risk for pancreatitis.

Immune reconstitution syndrome - Your immune system may get stronger when you start taking HIV medecines. It may begin to fight infections that have been hidden in your body for a long time or your immune system could react against your own body (autoimmune disease). Examples are Grave’s disease (which affects your thyroid gland), Guillain-Barre Syndrome (which affects the nervous system) or polymyositis (which affects the muscles). Autoimmune disease may develop at any time, sometimes months after the start of the HIV therapy. Sometimes symptoms can be severe, so if you develop high temperature (fever), joint or muscle pain, redness, rash, swelling or fatigue or any new symptoms contact your doctor straight away.

Other side effects - In addition to peripheral neuropathy, the most frequent side effects observed in studies of adults taking the recommended dose of ZERIT were headache, diarrhea, rash, and nausea and vomiting. Other side effects may include abdominal pain, muscle pain, insomnia, loss of appetite, chills or fever, allergic reactions, blood disorders.

This is not a complete list of side effects. For any unexpected effects while taking ZERIT, contact your doctor or pharmacist.

HOW TO STORE IT

ZERIT capsules should be stored at room temperature (15^o to 30^oC) and protected from excessive moisture. Do NOT store this medicine in a damp place such as a bathroom medicine cabinet or near the kitchen sink. Keep bottles tightly closed and out of the reach of children and pets.

ZERIT for Oral Solution should be protected from excessive moisture and stored in tightly closed containers at room temperature (15° - 30°C). After constitution, store tightly closed containers of ZERIT for Oral Solution in a refrigerator (2° -8°C)and throw away any unused portion after 30 days. The solution may also be stored at room temperature for up to 3 days.

This medicine was prescribed for your particular condition. Do not use ZERIT for another condition or give it to others. Keep ZERIT and all other medicines out of the reach of children. Please return all unused medication to the pharmacist for proper disposal.

This summary does not include everything there is to know about ZERIT. Medicines are sometimes prescribed for purposes other than those listed in a Patient Information Leaflet. If you have questions or concerns, or want more information about ZERIT, your physician and pharmacist have the complete prescribing information upon which this leaflet was based. You may want to read it and discuss it with your doctor or other healthcare professional. Remember, no written summary can replace careful discussion with your doctor.

MORE INFORMATION

For more information or for the full Product Monograph on ZERIT, contact the sponsor, Bristol-Myers Squibb, at: 1-866-463-6267.

Last revised: September 24, 2013

REPORTING SUSPECTED SIDE EFFECTS

You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following 3 ways:

• Report online at www.healthcanada.gc.ca/medeffect • Call toll-free at 1-866-234-2345

• Complete a Canada Vigilance Reporting Form and:

  • Fax toll-free to 1-866-678-6789, or

  • Mail to: Canada Vigilance Program

    Health Canada

    Postal Locator 0701C

    Ottawa, ON K1A 0K9

Postage paid labels, Canada Vigilance Reporting Form and the adverse reactions reporting guidelines are available on the MedEffect^tm Canada Web site at www.healthcanada.gc.ca/medeffect.

Note: Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice.