Patient Medication Information: uses, side effects, how to take - Agenerase (Glaxosmithkline, 15 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™ oral solution contains 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:
Each millilitre of AGENERASE™ 15 mg/mL oral solution contains 15 mg of amprenavir.
What the important nonmedicinal ingredients are:
AGENERASE™ 15 mg/mL oral solution contains the non-medicinal ingredients acesulfame potassium, artificial grape/bubblegum flavour, citric acid (anhydrous), vitamin E (d-alpha tocopheryl polyethylene glycol 1000 succinate (TPGS)), menthol, natural peppermint flavour, polyethylene glycol 400 (PEG 400), propylene glycol, saccharin sodium, sodium chloride and sodium citrate (dihydrate).
AGENERASE™ capsules and AGENERASE™ oral solution are not interchangeable on a milligram per milligram basis.
What dosage forms it comes in:
Each bottle contains 240 mL of AGENERASE™ 15 mg/mL oral solution.
WARNINGS AND PRECAUTIONS
AGENERASE™ oral solution should not be used in infants and children below the age of 4 years, pregnant women, patients with liver or kidney failure, and patients receiving disulfiram or metronidazole.
AGENERASE™ oral solution contains a large amount of propylene glycol, a liquid needed to dissolve amprenavir.
Because of the possible side effects of the large amount of propylene glycol, AGENERASE™ oral solution should be used only when AGENERASE™ capsules or other protease inhibitor formulations are not options.
You should not switch from AGENERASE™ capsules to AGENERASE™ oral solution without talking to your doctor.
If you are a woman or a patient of Asian origin or Aboriginal, or if you have liver or kidney disease, you may be at increased risk of side effects from the large amount of propylene glycol in AGENERASE™ oral solution.
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™ oral solution because serious or life-threatening problems could occur: astemizole, cisapride, diazepam, ergot medications, flurazepam, midazolam, pimozide, terfenadine, or triazolam.
For the same reason you must not take disulfiram or other medicines that reduce alcohol metabolism (e.g. metronidazole) or preparations that contain alcohol (e.g. ritonavir oral solution) or additional propylene glycol while you are taking AGENERASE™ oral solution.
Drinking alcoholic beverages is not recommended while taking AGENERASE™ oral solution because it may increase side effects related to propylene glycol content.
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.
AGENERASE™ oral solution should be used with caution if you have limited liver enzyme activity, kidney impairment or a genetically lower ability to metabolize alcohol (e.g. of Asian origin) due to adverse reactions that may be related to the propylene glycol in the solution.
Use Of This Medicine During Pregnancy and Breast Feeding
AGENERASE™ oral solution should not be used by pregnant women. Talk to your doctor if you are pregnant or if you become pregnant while taking AGENERASE™ oral solution.
Mothers with HIV should not breastfeed their infants because HIV in the breast milk can infect the infant.
Driving and Operating Machinery
There is no information currently available that suggests that taking AGENERASE™ affects the ability to drive or operate machinery, however it is suggested that you do not drive or operate machinery until you know how you react to AGENERASE™ oral solution.
INTERACTIONS WITH THIS MEDICATION
Some drugs may change the usefulness and safety of AGENERASE™. It is important that you tell your doctor about all the medicines you 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, lidociane (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 also interact with the hormones in the contraceptive pill, injection or patch. If you are taking hormonal contraceptives, it is recommended that you use an alternative method to prevent pregnancy while you are taking AGENERASE™.
PROPER USE OF THIS MEDICATION
Usual dose:
Take AGENERASE™ oral solution exactly as your doctor prescribes it. AGENERASE™ oral solution 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™ oral solution. If you are unsure about how to take it, ask your doctor or pharmacist.
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, mood disorders, rash, tingling sensation around the mouth, fatigue, 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.
Possible side effects from the large amount of propylene glycol in AGENERASE™ oral solution include seizures, drowsiness, fast heart rate, and kidney and blood abnormalities.
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™ oral solution between 5° to 25°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://gsk.ca
or by contacting the sponsor, GlaxoSmithKline Inc., at: 7333 Mississauga Rd
Mississauga, Ontario
L5N 6L4
1-800-387-7374
Last revised: June 14, 2005
© 2005 GlaxoSmithKline Inc. All Rights Reserved
™ AGENERASE used under license by GlaxoSmithKline Inc.