Consumer Information for: AURO-NEVIRAPINE

Consumer Information

Information about the product including what the product is used for, dosage, warnings, proper use and side effects. This summary will not tell you everything about the product. Contact your healthcare professional if you have any questions about the product.


What the medication is used for

AURO-NEVIRAPINE is a medicine used to treat Human Immunodeficiency Virus (HIV) infection, the virus that causes AIDS (Acquired Immune Deficiency Syndrome).

AURO-NEVIRAPINE does not cure HIV or AIDS, and it is not known if it will help you live longer with HIV. People taking AURO-NEVIRAPINE may still get infections common in people with HIV (opportunistic infections). Therefore, it is very important that you stay under the care of your doctor.

What it does

AURO-NEVIRAPINE is a type of anti-HIV medicine called a “Non-Nucleoside Reverse Transcriptase Inhibitor” (NNRTI). It works by lowering the amount of HIV in the blood (“viral load”). You must take AURO-NEVIRAPINE with other anti-HIV medicines. When taken with other anti-HIV medicines, AURONEVIRAPINE can reduce viral load and increase the number of CD4 cells (“T cells”). CD4 cells are a type of immune helper cell in the blood. AURONEVIRAPINE may not have these effects in every patient.

AURO-NEVIRAPINE is not a cure for HIV infection.

When it should not be used

  • If you are allergic (hypersensitive) to nevirapine or its components (see What the non-medicinal ingredients are).
  • If you have a severe liver problem.
  • If you have rare hereditary conditions of galactosemia, galactose intolerance, glucose/galactose malabsorption, Lapp lactase deficiency, as this product contains lactose.
  • If you are allergic (hypersensitive) to nevirapine or its components (See What the non-medicinal ingredients are ) or have used AURONEVIRAPINE and had a severe rash with associated symptoms such as malaise, fatigue, muscle/joint aches, blisters, facial edema (facial swelling), oral lesions, conjunctivitis, and/or hepatitis, eosinophilia(a lot of white blood cells called eosinophils in the blood), granulocytopenia (a decrease in white blood cells called granulocytes in the blood), lymphadenopathy (swelling of the lymph nodes), and renal dysfunction (kidneys not working properly), you must permanently discontinue AURO-NEVIRAPINE and seek medical evaluation immediately. (See WARNINGS AND PRECAUTIONS)
  • Do not take AURO-NEVIRAPINE with St. John’s wort (Hypericum perforatum) as it will reduce AURO-NEVIRAPINE blood levels.
What the medicinal ingredient is

AURO-NEVIRAPINE tablets contain the active ingredient Nevirapine.

What the non-medicinal ingredients are

Non-medicinal Ingredients (in alphabetical order): colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, and sodium starch glycolate.

What dosage form it comes in

AURO-NEVIRAPINE (nevirapine) comes as a white to off-white tablet containing 200 mg of Nevirapine.

Warnings and precautions

Serious Warnings and Precautions

Severe, life-threatening, and in some cases fatal liver toxicity, particularly in the first 18 weeks, has been reported in patients treated with AURONEVIRAPINE (nevirapine), including pregnant women receiving chronic AURO-NEVIRAPINE therapy in conjunction with other antiretroviral medication. Female gender and higher CD4 counts at the start of therapy may increase the risk of liver problems (see SIDE EFFECTS AND WHAT TO DO ABOUT THEM)

Severe skin and allergic reactions, including fatal cases have occurred with accompanying symptoms such as severe rash with fever, fatigue, muscle/joint pain, swelling of the face, hepatitis (liver inflammation), blood and kidney problems. If this occurs discontinue AURO-NEVIRAPINE and contact your doctor immediately.

In rare cases liver problems have led to liver failure and can lead to a liver transplant or death. Therefore, if you develop any of the following symptoms of liver problems stop taking AURONEVIRAPINE and call your doctor right away:

  • general ill feeling or “flu-like” symptoms
  • yellowing skin or whites of your eyes
  • tiredness
  • dark urine (tea colored)
  • nausea (feeling sick to your stomach)
  • pale stools (bowel movements)
  • lack of appetite
  • pain, ache, or sensitivity to touch on your right side below your ribs

Your doctor should check you and do blood tests often to check your liver function during the first 18 weeks of therapy. Checks for liver problems should continue regularly during treatment with AURO-NEVIRAPINE.

Skin Reactions

Skin rash is the most common side effect of AURONEVIRAPINE. Most rashes occur in the first 6 weeks of treatment. In a small number of patients, rash can be serious and result in death. Therefore, if you develop a rash with any of the following symptoms, stop using AURO-NEVIRAPINE and call your doctor right away:

  • general ill feeling or “flu-like” symptoms
  • blisters
  • fever
  • mouth sores
  • muscle or joint aches
  • swelling of your face
  • conjunctivitis (red or inflamed eyes, like “pinkeye”)
  • tiredness
  • any symptoms of liver problems discussed above

If your doctor tells you to stop treatment with AURO-NEVIRAPINE because you have experienced the serious liver or skin reactions described above, never take AURO-NEVIRAPINE again.
These are not all the side effects of AURONEVIRAPINE. See the section SIDE EFFECTS AND WHAT TO DO ABOUT THEM for more information. Tell your doctor if you have any side effects from AURO-NEVIRAPINE.

BEFORE you use AURO-NEVIRAPINE talk to your doctor or pharmacist:

  • If you have or have had any diseases of the liver particularly hepatitis B or C infection;
  • If you are pregnant or intend to become pregnant;
  • If you are a breast-feeding mother. It is recommended that HIV infected women not breast-feed, to avoid transmission of the virus to the infant;
  • If you are taking any medications, including prescription, non-prescription, herbal or homeopathic remedies;
  • If you have any allergies to foods or drugs;
  • If you are undergoing dialysis.

Interactions with this medication

Drugs that may interact with AURO-NEVIRAPINE include:

AURO-NEVIRAPINE may change the effect of other medicines, and other medicines can change the effect of AURO-NEVIRAPINE. Tell your doctors and pharmacists about all medicines you take, including non-prescription medicines, vitamins and herbal supplements.

Do not take ketoconazole, rifampin, efavirenz, delavirdine, etravirine, rilpivirine, elvitegravir (in combination with cobicistat), or boceprevir; with AURO-NEVIRAPINE.

Tell your doctor if you take clarithromycin, fluconazole, methadone, rifabutin, indinavir, lopinavir/ritonavir combination, saquinavir or itraconazole.

AURO-NEVIRAPINE may not be right for you, or you may need careful monitoring.

You should be aware that AURO-NEVIRAPINE may change the effectiveness of oral contraceptives. Therefore oral contraceptives and other hormonal methods of birth control should not be used as a method of contraception in women taking AURONEVIRAPINE; other methods (barrier) must be used.

Proper use of this medication

Usual Dose

Adult:

Follow the directions exactly as given to you by your doctor or pharmacist regarding the amount and frequency of dosing. The label will usually tell you this information as well. If you are not sure about dosing, ask your doctor or pharmacist.

As a general guide, swallow one tablet (200 mg) once a day for the first 14 days (this lead-in period should be used because it has been found to lessen the frequency of rash) followed by one 200 mg tablet twice daily as part of a multi-drug treatment program. AURONEVIRAPINE tablets can be taken with or without food.

It is important to strictly follow the once daily dose for the first 14 days. Do not start taking the 200 mg AURO-NEVIRAPINE twice daily if you have any symptoms of liver problems or skin rash (see SIDE EFFECTS AND WHAT TO DO ABOUT THEM). The manufacturer’s recommended dosage and monitoring for the other administered anti-retroviral drugs should be followed

Overdose

In case of drug over dosage, contact a healthcare practitioner (e.g. doctor), hospital emergency department or regional Poison Control Centre, even if there are no symptoms.

Missed Dose

If you miss a dose: If you forget to take your medicine, take it as soon as you remember. Then continue as before; do not double your next dosage.

If it is almost time for your next dose, do not take the missed dose. Instead, follow your regular dosing schedule by taking the next dose at its regular time.

If you stop taking AURO-NEVIRAPINE for more than 7 days, ask your doctor how much to take before you start taking it again. You may need to start with once-aday 200 mg AURO-NEVIRAPINE tablet dosing.

Avoid doing things that can spread HIV infection, as AURO-NEVIRAPINE does not stop you from passing HIV infection to others. Do not share needles, other injection equipment or personal items that can have blood or body fluids on them, like toothbrushes and razor blades. Always practice safe sex by using a latex or polyurethane condom to lower the chance of sexual contact with semen, vaginal secretions, or blood.

This medicine is for you. Never give it to someone else, as it may harm them even if their symptoms are the same as yours.

Take your medications exactly as prescribed by your doctor. Do not change the dose without consulting your doctor.

Do not take any other medication including prescription, non prescription, herbal or homeopathic remedies without your doctor’s advice. Also, inform any other doctor, dentist or pharmacist you consult that you are taking this medication.

Keep out of reach of children.

If you have any other questions about AURONEVIRAPINE contact your doctor or pharmacist

Side effects and what to do about them

AURO-NEVIRAPINE can cause serious liver damage and skin reactions that can cause death. Any patients can experience such side effects, but some patients are more at risk than others. See WARNINGS AND PRECAUTIONS.

Other common side effects of AURO-NEVIRAPINE include nausea, fatigue, fever, headache, vomiting, diarrhea, abdominal pain, skin rash and itching, myalgia (muscle pain) and arthralgia (joint pain). This list of side effects is not complete. Ask your doctor or pharmacist for more information.

Abnormal liver function test results, decrease in red blood cells or white blood cells called granulocytes, decrease in blood phosphorus, increase in blood pressure and hypersensitivity including severe allergic reaction with facial swelling may also occur.

If you feel unwell in any other way or have any symptoms that you do not understand, you should contact your doctor immediately.

Sleepiness can occur. Do not drive or operate machinery if you become drowsy.

Always tell your doctor or pharmacist about any undesirable effects you experience after taking AURONEVIRAPINE, even those not mentioned above.

Changes in body fat have been seen in some patients taking anti-retroviral therapy. These changes may include increased amount of fat in the upper back and neck (“buffalo hump”), breast, 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.

Consult your doctor immediately if you experience any symptoms as listed above, or any symptoms that you do not understand.

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

Serious side effects and what to do about them
Symptom / effect Talk to your healthcare professional Only if severe Talk to your healthcare professional In all cases Stop taking drug and get immediate medical help
Uncommon
Severe liver disease with symptoms such as nausea, abdominal pain, aches, tiredness, lack of appetite, dark urine, pale stools (bowel movement) , yellowing of skin and eyes, and a general ill feeling or “flu-like” symptoms.     ✔
Severe skin reactions such as rash, blistering accompanied by symptoms such as fever, muscle/joint pain, tiredness, mouth sores, swelling of the face, conjunctivitis, and a general ill feeling or “flu-like” symptoms.     ✔

How to store

Store AURO-NEVIRAPINE tablets at room temperature (15oC to 30oC). As with all medicines, keep AURO-NEVIRAPINE tightly closed and out of the reach of children. Do not take your medicine after the expiry date shown on the bottle.

Reporting side effects

You can report any suspected side effects associated with the use of health products to Health Canada by:

NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.

More information

If you want more information about AURONEVIRAPINE:

This leaflet was prepared by
Auro Pharma Inc.
3700 Steeles Avenue West, Suite # 402
Woodbridge, Ontario, L4L 8K8,
Canada.

Date of Preparation: November 16, 2020.

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