Patient Medication Information: uses, side effects, how to take - Agenerase (Glaxosmithkline, 50 mg, 150 mg)

ABOUT THIS MEDICATION

What the medication is used for:

The name of your medicine is AGENERASE™ (amprenavir). AGENERASE™ can only be obtained with a prescription from your doctor.

AGENERASE™ is used in combination with other antiretroviral agents to reduce the human immunodeficiency virus (HIV) in your blood.

What it does:

The human immunodeficiency virus (HIV) is a retrovirus. Infection with HIV damages the immune system and can lead to Acquired Immune Deficiency Syndrome (AIDS) and other related illnesses.

AGENERASE™ is an antiretroviral medication. It belongs to a group of medicines called protease inhibitors. AGENERASE™ in combination with other antiretroviral agents reduces HIV in your blood. Response to treatment with AGENERASE™ varies between patients. Your doctor will be monitoring the effectiveness of your treatment. AGENERASE™ does not cure AIDS or kill the virus, but may help to prevent further damage to the immune system by slowing the production of new viruses.

When it should not be used:

AGENERASE™ must not be taken if you are allergic to the active substance amprenavir, any of the other ingredients found in AGENERASE™, or sulfonamide containing drugs. If you are not sure please consult with your doctor.

AGENERASE™ capsules contain a large quantity of vitamin E. Avoid taking vitamin E supplements or any products containing vitamin E.

You should not use products containing St. John’s Wort (Hypericum perforatum) because co-administration may reduce the effectiveness of AGENERASE™.

What the medicinal ingredient is:

AGENERASE™ contains the active ingredient amprenavir.

What the important nonmedicinal ingredients are:

Each capsule contains the inactive ingredients vitamin E (d-alpha tocopheryl polyethylene glycol 1000 succinate (TPGS)), polyethylene glycol 400 (PEG 400), and propylene glycol. The capsule shell contains the inactive ingredients d-sorbitol and sorbitans solution, gelatin, glycerin, and titanium dioxide. The soft gelatin capsules are printed with edible red ink.

What dosage forms it comes in:

Each bottle of AGENERASE™ 50 mg capsules contains 480 capsules. Each bottle of AGENERASE™ 150 mg capsules contains 240 capsules.

WARNINGS AND PRECAUTIONS

Medications not to be taken while taking AGENERASE™

Protease inhibitors, including AGENERASE™, may interact with other drugs, including those you take without a prescription. Before you take AGENERASE™, tell your doctor about any drugs that you are taking or planning to take, including nonprescription drugs.

You should not take any of the following medications with AGENERASE™ capsules because serious or life-threatening problems could occur: astemizole, cisapride, diazepam, ergot medications, flurazepam, midazolam, pimozide, terfenadine, or triazolam.

You should also not take rifampin with AGENERASE™ capsules because this drug reduces the effectiveness of AGENERASE™.

Special Warnings

AGENERASE™ helps to control the amount of HIV found in your blood but is not a cure for HIV infection. You will need to take AGENERASE™ every day. Do not stop taking AGENERASE™ without first talking to your doctor.

Treatment with AGENERASE™ has not been shown to reduce the risk of passing HIV infection on to others by sexual conduct or by blood transfer. You should continue to use appropriate precautions to prevent this.

You may continue to develop other infections and other illnesses associated with HIV disease. You should therefore keep in regular contact with your doctor while taking AGENERASE™.

You should tell your doctor about any medical conditions that you have or have had. If you suffer from liver disease the dose of AGENERASE™ may need to be reduced. There have been reports of increased bleeding in patients with hemophilia taking protease inhibitors.

Use Of This Medicine During Pregnancy and Breast Feeding

If you are pregnant, or planning on becoming pregnant soon, or if you are breast feeding please inform your doctor before taking any medicines. The safe use of AGENERASE™ in human pregnancy has not been established. Your doctor will advise whether you should continue to take AGENERASE™.

The active substance amprenavir in AGENERASE™ is likely to be found in human breast milk. There are no safety data available following treatment with AGENERASE™ in babies. Mothers with HIV should not breast feed their infants because HIV in the breast milk can infect the infant.

Driving and Operating Machinery

There is no information currently available that suggests taking AGENERASE™ affects the ability to drive or operate machinery.

INTERACTIONS WITH THIS MEDICATION

Some drugs change the usefulness and safety of AGENERASE™. It is important that you tell your doctor about all the medicines you’re are taking or planning to take, including all those that you have bought yourself. This is very important, as using more than one medicine at the same time can strengthen or weaken the effect of the medicine, causing in some cases serious medical conditions.

AGENERASE™ may interact with other medicines you are being treated with. Some of the medicines that can interact with amprenavir include: amiodarone, phenobarbital, phenytoin, lidocaine (systemic), tricyclic antidepressants, warfarin, sildenafil, cholesterol-lowering drugs and quinidine.

If you are taking antacids (or didanosine) you should take AGENERASE™ at least 1 hour before or after antacid (or didanosine) use.

AGENERASE™ may interact with the hormones in the contraceptive pill, injection or patch. If you are taking oral hormonal contraceptives, it is recommended that you use an alternative method to prevent pregnancy while taking AGENERASE™.

PROPER USE OF THIS MEDICATION

Usual dose:

Take AGENERASE™ as your doctor has advised you.

AGENERASE™ capsules should be swallowed whole with water.

AGENERASE™can be taken with or without food. However, you should not take AGENERASE™ with a high-fat meal because this could reduce the effectiveness of AGENERASE™ capsules. If you are unsure about how to take it, ask your doctor or pharmacist.

The recommended oral dose in adults and adolescents greater than 12 years of age is 600 mg of AGENERASE™ (four 150 mg capsules) twice a day plus 100 mg of ritonavir twice a day in combination with other antiretroviral agents.

If AGENERASE™ is used with other antiretroviral agents, excluding ritonavir, 1200 mg (eight 150 mg capsules) of AGENERASE™ twice a day should be used.

The combined use of AGENERASE™ and ritonavir is not recommended in children.

An oral solution (15 mg/mL) is available for the treatment of patients unable to swallow capsules. Do not switch to oral solution without talking to your Doctor.

If you have a liver problem your dose may be reduced. In patients with more severe forms of liver disease, AGENERASE™ capsules should not be taken together with ritonavir.

Overdose:

You should immediately contact either your doctor, your hospital emergency department or the nearest poison control centre.

Missed Dose:

If you forget to take AGENERASE™, take it as soon as you remember. Then continue as before.

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

The following undesirable effects are thought to be related to treatment with AGENERASE™; nausea, diarrhea, rash, tingling sensation around the mouth, fatigue, mood disorders, headache, abdominal pain and vomiting.

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.

Your doctor will test your blood regularly to check for increases in liver enzymes and blood fats. These have been reported in patients taking AGENERASE™. Your blood will also be checked for increases in blood sugar levels, as occasionally protease inhibitors have been shown to cause this.

Always tell your doctor or pharmacist about any undesirable effect, even those not mentioned in this leaflet. If you feel ill in any other way that you do not understand, tell your doctor or pharmacist.

SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM

If you have a severe skin rash, check with your doctor and he may advise you to stop taking AGENERASE™.

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

HOW TO STORE IT

Store AGENERASE™ capsules between 15° and 30°C.

Do not take AGENERASE™ after the expiry date on the container.

As with all medications, keep AGENERASE™ out of reach of children.

REPORTING SUSPECTED SIDE EFFECTS

To monitor drug safety, Health Canada collects information on serious and unexpected effects of drugs. If you suspect you have had a serious or unexpected reaction to this drug you may notify Health Canada by:

toll-free telephone: 866-234-2345 toll-free fax 866-678-6789

By email: cadrmp@hc-sc.gc.ca

By regular mail:

National AR Centre

Marketed Health Products Safety and Effectiveness Information Division

Marketed Health Products Directorate

Tunney’s Pasture, AL 0701C

Ottawa ON K1A 0K9

NOTE: Before contacting Health Canada, you should contact your physician or pharmacist.

MORE INFORMATION

Remember: AGENERASE™ is for you. Never give it to someone else. It may harm them even if their symptoms are the same as yours.

This leaflet does not tell you everything about AGENERASE™. If you have any questions or are not sure about anything, then ask your doctor or pharmacist. You may need to read this leaflet again. Please do not throw this leaflet away until you are no longer taking AGENERASE™.

This document plus the full product monograph, prepared for health professionals can be found at:

http://www.gsk.ca or by contacting the sponsor, GlaxoSmithKline Inc., at:

7333 Mississauga Rd

Mississauga, Ontario

L5N 6L4

1-800-387-7374

Agenerase (Glaxosmithkline, 50 mg, 150 mg): Uses, Side Effects and Dosage