Kaletra (lopinavir, ritonavir)

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.

- Disturbances of the gut such as diarrhoea, nausea, vomiting, indigestion, abdominal pain, flatulence or constipation.
- Headache.
- Difficulty in sleeping (insomnia).
- Weakness or loss of strength (asthenia).
- Increase in the level of cholesterol and triglycerides in the blood.
- High blood glucose level (hyperglycaemia).
- Redistribution of body fat, eg decreased fat under the skin, increased fat on the abdomen, 'buffalo humps' and breast enlargement.
- Skin reactions such as rash, itching, hair loss, acne, dry skin, sweating.
- Changes in appetite or weight.
- Abnormal dreams.
- Mood swings.
- Anxiety.
- Confusion.
- Dizziness.
- Memory loss.
- Muscle or nerve problems.
- Pain in the muscle or joints.
- Visual disturbances.
- Sensation of ringing, or other noise in the ears (tinnitus).
- Impotence and abnormal ejaculation.
- Shortness of breath (dyspnoea).
- Increased blood pressure.
- Palpitations.
- Inflammation of veins.
- Inflammation of the pancreas (pancreatitis).
- Liver disorders.
- Kidney stones.

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?

It is important to tell your doctor or pharmacist what medicines you are taking, including those bought without a prescription and herbal medicines, before you start treatment with this medicine. Likewise, always check with your doctor or pharmacist before taking any other medicines during treatment with this one so that they can ensure that the combination is safe.

Kaletra must not be taken in combination with any of the following medicines, because it could increase the blood levels of these medicines and result in serious side effects:

- amiodarone
- astemizole
- cisapride
- dihydroergotamine
- ergotamine
- midazolam
- pimozide
- terfenadine
- triazolam
- vardenafil.

Kaletra must also not be taken in combination with the following medicines, because these could decrease the blood level of lopinavir and so make Kaletra less effective at treating HIV infection:

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

As Kaletra oral solution contains alcohol, it should not be taken with the following medicines, as the alcohol content may cause reactions such as facial flushing, throbbing headache, palpitations, increased heart rate and nausea and vomiting:

- disulfiram
- metronidazole.

Your doctor may need to adjust the doses of other anti-HIV medicines you are already taking when Kaletra is added to your treatment.

If you are taking didanosine as part of your anti-HIV therapy, it is recommended that you take your didanosine at least one hour before or two hours after taking Kaletra with food. This is because didanosine must be taken on an empty stomach. If you are taking Kaletra tablets (which can be taken on an empty stomach) you can take them at the same time as didanosine.

Kaletra may increase the blood level of cholesterol-lowering medicines known as statins. Simvastatin and lovastatin are not recommended for use in combination with Kaletra, as the increased blood levels may lead to side effects on the muscles. If atorvastatin is used with Kaletra it should be at the lowest possible dose. If cholesterol-lowering treatment is needed, the recommended statins are fluvastatin or pravastatin, as the blood levels of these are not affected by Kaletra.

Kaletra increases the blood levels of sildenafil (Viagra) and tadalafil (Cialis) used for treating erectile dysfunction. This increases the risk of side effects such as dizziness, fainting, visual disturbances and prolonged erection caused by these medicines. These medicines should be used with extreme caution in people taking Kaletra.

Kaletra also increases the blood level of the corticosteroids fluticasone and 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 Kaletra is not recommended, unless the benefits are thought to outweigh the potential risks.

Kaletra may also increase the blood levels of the following medicines. Since this may increase the risk of their side effects, people taking any of these in combination with Kaletra may need extra monitoring by their doctor:

- bepridil
- calcium channel blockers such as felodipine, nifedipine and nicardipine
- ciclosporin
- clarithromycin
- digoxin
- itraconazole (high doses of more than 200mg per day are not recommended in combination with Kaletra)
- ketoconazole (high doses of more than 200mg per day are not recommended in combination with Kaletra)
- lidocaine
- quinidine
- rifabutin
- sirolimus
- tacrolimus
- trazodone
- vinblastine
- vincristine.

Kaletra may affect the blood level of the anti-blood-clotting (anticoagulant) medicine, warfarin. If you are taking warfarin with Kaletra, your blood-clotting time (INR) should be monitored.

Kaletra may lower the blood level of methadone. The manufacturer recommends that people taking methadone with this medicine should have their methadone blood levels monitored.

The ritonavir in Kaletra may lower the blood level of the antifungal medicine voriconazole, making it less effective at treating infection. As a result, voriconazole should be avoided where possible in people taking Kaletra.

The following medicines may decrease the blood level of lopinavir from Kaletra. If you are taking any of these, your doctor may need to prescribe you a larger dose of Kaletra:

- carbamazepine
- dexamethasone
- phenobarbital
- phenytoin (Kaletra may also decrease the blood level of phenytoin).

There may be an increased risk of abnormal heart rhythms (seen as a 'prolonged QT interval' on an ECG) if Kaletra is taken in combination with the following medicines:

- clarithromycin
- chlorphenamine
- erythromycin
- medicines to treat abnormal heartbeats (antiarrhythmics), eg quinidine, procainamide, sotalol.

Kaletra may reduce the effectiveness of hormonal contraceptives containing ethinylestradiol. For this reason, an additional or alternative method of contraception should be used to prevent pregnancy. A barrier method of contraception, such as condoms, will prevent pregnancy, as well as preventing transmission of the HIV virus. Discuss this with your doctor.

Other medicines containing the same active ingredients

There are currently no other medicines available in the UK that contain both lopinavir and ritonavir as the active ingredients.

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