What is Lopinavir / Ritonavir Mylan and what is it used for?
Lopinavir / Ritonavir Mylan is used in combination with other medicines to treat patients over the age of two years who have contracted the human immunodeficiency virus type 1 (HIV-1), a virus that causes acquired immune deficiency syndrome ( AIDS). Lopinavir / Ritonavir Mylan contains the active substances lopinavir and ritonavir.
Lopinavir / Ritonavir Mylan is a "generic medicine". This means that it is similar to a 'reference medicine' already authorized in the European Union (EU) called Kaletra. For more information on generic medicines, see the questions and answers by clicking here.
How is Lopinavir / Ritonavir Mylan used?
Lopinavir / Ritonavir Mylan can only be obtained with a prescription and treatment should be started by a doctor who has experience in the treatment of HIV infection. It is available as tablets (100 mg of lopinavir and 25 mg of ritonavir; 200 mg of lopinavir and 50 mg of ritonavir).
In adults and adolescents (at least 12 years of age), the recommended dose of Lopinavir / Ritonavir Mylan is two 200/50 mg tablets twice a day. This dose is also suitable for children (aged between two and 12 years), provided they weigh more than 40 kg or with a body surface (calculated based on the height and weight of the child) greater than 1.4 m2 The dose for younger children depends on your body surface and the other medicines you are taking.
For adults (aged 18 or over) who have contracted an HIV that is likely to respond to medicines belonging to the same class as Lopinavir / Ritonavir Mylan (protease inhibitors), your doctor may prescribe you to take the full daily dose of 4 tablets of 200/50 mg in a single dose. When deciding whether to use the single daily dose, your doctor should take into account that it may not be as effective as twice-daily dosing for maintaining low levels of HIV over the long term and that it could increase the risk of diarrhea. For more information, see the package leaflet.
How does Lopinavir / Ritonavir Mylan work?
The active substances in this medicine, lopinavir and ritonavir, are protease inhibitors: they block an enzyme called protease that is involved in the replication of HIV. Once the enzyme is blocked, the virus ceases to reproduce normally and the spread of the infection slows down. In Lopinavir / Ritonavir Mylan, lopinavir guarantees activity while ritonavir is used as an "enhancer", to reduce the rate at which lopinavir is degraded by the liver. In this way, the concentration of lopinavir in the blood increases and it is possible to use a lower dose of lopinavir obtaining the same antiviral effect.
Lopinavir / Ritonavir Mylan, taken with other anti-HIV medicines, reduces the amount of HIV in the blood and keeps the level of the virus low. It does not cure HIV infection, but it can delay the onset of damage to the immune system and prevent the development of infections and diseases associated with AIDS.
How has Lopinavir / Ritonavir Mylan been studied?
Because Lopinavir / Ritonavir Mylan is a generic medicine, studies in patients have been limited to tests to determine its bioequivalence to the reference medicine, Kaletra. Two medicines are bioequivalent when they produce the same levels of active ingredient in the body.
What are the benefits and risks of Lopinavir / Ritonavir Mylan?
Because Lopinavir / Ritonavir Mylan is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are considered to be the same as those of the reference medicine.
Why has Lopinavir / Ritonavir Mylan been approved?
The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Lopinavir / Ritonavir Mylan has been shown to have comparable quality and to be bioequivalent to Kaletra. Therefore, the CHMP considered that, as in the case of Kaletra, the benefits outweigh the identified risks and recommended to approve the use of Lopinavir / Ritonavir Mylan in the EU.
What measures are being taken to ensure the safe and effective use of Lopinavir / Ritonavir Mylan?
A risk management plan has been developed to ensure that Lopinavir / Ritonavir Mylan is used as safely as possible. Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Lopinavir / Ritonavir Mylan, including the appropriate precautions to be followed by healthcare professionals and patients.
More information on Lopinavir / Ritonavir Mylan
For more information about treatment with Lopinavir / Ritonavir Mylan, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. The full EPAR for the reference medicine can also be found on the Agency's website.
