Agenerase (amprenavir)

Side effects

Medicines and their possible side effects can affect individual people in different ways. The following are some of the side effects that are known to be associated with this medicine. Just because a side effect is stated here does not mean that all people using this medicine will experience that or any side effect.

- Rash.
- Fatigue.
- Headache.
- Disturbances of the gut such as diarrhoea, flatulence, nausea, vomiting or abdominal pain.
- Loss of appetite.
- Changes in mood.
- Pins and needles sensation in or around the mouth.
- Tremor.
- Disturbed sleep.
- Redistribution of body fat, eg decreased fat under the skin, increased fat on the abdomen, 'buffalo humps' and breast enlargement.
- Increase in the level of fats eg cholesterol in the blood (hyperlipidaemia).
- High blood glucose level (hyperglycaemia).
- Pain in the muscles (myalgia).
- Severe blistering skin reaction affecting the tissues of the eyes, mouth, throat and genitals (Stevens-Johnson Syndrome).
- Muscle breakdown (rhabdomyolysis).

The side effects listed above may not include all of the side effects reported by the drug's manufacturer. For more information about any other possible risks associated with this medicine, please read the information provided with the medicine or consult your doctor or pharmacist.

How can this medicine affect other medicines?

You should tell your doctor or pharmacist what medicines you are using, particularly those listed below, before you start treatment with this medicine. This includes those bought without a prescription and herbal medicines. Likewise, check with your doctor or pharmacist before starting any new medicines while you are taking this medicine, so they can check that the combination is safe.

Amprenavir must not be taken with any of the following medicines because it may increase their blood levels and lead to a risk of serious or life threatening side effects:

- amiodarone
- astemizole
- cilostazol
- cisapride
- dihydroergotamine
- ergotamine
- flecainide
- midazolam taken by mouth
- pimozide
- propafenone
- quinidine
- terfenadine.

Amprenavir must not be taken with any of the following medicines because they may reduce the blood level of amprenavir, thus making it less effective against HIV:

- rifampicin
- the herbal remedy St John's wort (Hypericum perforatum).

Due to its propylene glycol content, Agenerase oral solution must not be taken with the following (this does not apply to Agenerase capsules):

- ritonavir oral solution
- other medicines that contain alcohol or propylene glycol
- disulfiram or metronidazole, which reduce the metabolism of alcohol.

Antacids for indigestion may reduce the absorption of amprenavir from the gut. If you need to take an antacid, or your HIV treatment includes Videx tablets (which contain an antacid), the doses of these should be separated from your amprenavir doses by at least one hour to minimise this.

Ritonavir increases, and efavirenz and nevirapine may reduce the blood levels of amprenavir. Dosage adjustments may be made by your doctor if ritonavir, nevirapine or efavirenz are added to your anti-HIV treatment.

Amprenavir may increase the blood level of rifabutin. If you need treatment with rifabutin a lower than normal dose may be prescribed.

Amprenavir may increase the blood levels of the following medicines, and you may need extra monitoring by your doctor if you are taking any of these with amprenavir:

- alprazolam
- ciclosporin
- cimetidine
- clarithromycin
- clozapine
- dapsone
- diazepam
- erythromycin
- halofantrine (not recommended for people taking Agenerase)
- itraconazole (high doses of more than 200mg per day are not recommended in combination with Agenerase)
- ketoconazole (high doses of more than 200mg per day are not recommended in combination with Agenerase)
- lidocaine by injection (not recommended for people taking Agenerase)
- loratadine
- midazolam given by injection
- sildenafil (Viagra)
- sirolimus
- tacrolimus
- tadalafil
- the calcium channel blockers diltiazem, nicardipine, nifedipine or nimodipine
- tricyclic antidepressants
- vardenafil
- warfarin (your blood clotting time, INR, should be monitored more frequently if you are taking warfarin with amprenavir).

Amprenavir may also increase the blood level of cholesterol-lowering medicines known as statins. Simvastatin and lovastatin are not recommended for use in combination with amprenavir, as the increased blood levels may lead to side effects on the muscles. If cholesterol-lowering treatment is needed, fluvastatin or pravastatin are recommended.

Amprenavir and ritonavir may increase the blood level of the corticosteroids fluticasone or budesonide taken by inhaler or nasal spray. This could increase the risk of systemic side effects of these steroids, such as Cushing's syndrome, or decreased production of natural steroids by the adrenal glands. For this reason, the use of these corticosteroids in combination with amprenavir and ritonavir is not recommended, unless the benefits are thought to outweigh the potential risks.

Amprenavir may reduce the effect of hormonal contraceptives and for this reason a barrier method of contraception, such as condoms, should be used to prevent pregnancy, as well as to prevent transmission of the HIV virus.

Amprenavir may reduce the blood level of opiate derivatives such as methadone.

The antiepileptics phenobarbitone, phenytoin or carbamazepine may affect the blood level of amprenavir, while amprenavir may affect their blood levels. These antiepileptic medicines should be used with caution in combination with amprenavir.

Agenerase capsules and oral solution also contain vitamin E. For this reason taking extra vitamin E supplements is not recommended while taking this medicine.

Other medicines containing the same active ingredient

There are currently no other medicines available in the UK that contain amprenavir as the active ingredient. Telzir contains fosamprenavir, which is a pro-drug of amprenavir.

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