Kemeruvir, 400 mg 60 pcs

HIV infectionTreatment of HIV infection in adults and children aged 6 years or older with a body weight of 20 kg or more who have previously received antiretroviral therapy (in combination with low-dose ritonavir and other antiretroviral drugs).

Active ingredient

How to take, the dosage

Ingestion. Darunavir should always be administered in combination with low-dose ritonavir to improve its pharmacokinetic characteristics, as well as in combination with other antiretrovirals. The possibility of prescribing ritonavir should be considered before starting therapy with darunavir/ritonavir.

Patients should not change or discontinue therapy after starting therapy with darunavir without consulting their physician.

Dosages of 75 mg and 150 mg are designed for pediatric use. In adults to reach therapeutic doses these dosages require a large number of tablets which on the one hand make it difficult to swallow and on the other can cause allergic reactions due to the increased intake of excipients contained in the tablets, so they should only be used when other dosages are not available.

Adult patients

Patients who have not previously received protease inhibitors:
Patients who have previously received protease inhibitors:
No mutations causing resistance to darunavir*
Patients previously receiving protease inhibitors:
Having at least 1 mutation causing resistance to darunavir*
800 mg once daily in combination with 100 mg ritonavir, with meals
800 mg once daily in combination with 100 mg ritonavir, with meals.
600 mg 2 times daily in combination with 100 mg ritonavir, with meals
Mutations causing resistance to darunavir: V11I, V32I, L33F, I47V, I50V, I54M, I54L, T74P, L76V, I84V and L89V
For patients who received protease inhibitors previously it is recommended to perform genotypic analyses.
But if genotypic testing is not possible, patients who have not previously received protease inhibitors are recommended to take the combination darunavir/ritonavir once daily 800 mg/ 100 mg, and patients who have previously received protease inhibitors are recommended to take the combination darunavir/ritonavir twice daily 600 mg/ 100 mg.
Children
Patients 6 to 18 years of age who have previously received antiretroviral therapy
The recommended dose of darunavir/ritonavir for children 6 to 18 years of age and weighing at least 20 kg depends on body weight (see table below) and should not exceed the recommended dose for adult patients (600/100 mg 2 times daily). Kemeruvir tablets should be taken with ritonavir 2 times daily with meals.
Recommended dose of darunavir and ritonavir for patients 6 to 18 years old who have previously received antiretroviral therapy
Body weight (kg)
Dose

> 20 kg – < 30 kg

375 mg of darunavir with 50 mg of ritonavir twice daily
> 30 kg – < 40 kg

450 mg of darunavir with 60 mg of ritonavir 2 times daily

> 40 kg
600 mg of darunavir with 100 mg of ritonavir 2 times daily

The type of food does not affect the absorption of darunavir. Ritonavir (100 mg) is used as an enhancer of the pharmacokinetics of darunavir. If a dose of darunavir and/or ritonavir is missed within 6 hours of the usual dosing time, the prescribed dose of darunavir and/or ritonavir should be taken as soon as possible. If more than 6 hours have elapsed after the usual dosing time, it is recommended that the prescribed drug regimen be followed. These recommendations are based on a 15-hour half-life of darunavir in the presence of ritonavir and a prescribed regimen of taking the drug every 12 hours.

Special Instructions

* Mild to moderate hepatic impairment (Child-Pugh class A and B)
* Allergy to sulfonamides
* Age over 65
* Concomitant administration of drugs that are highly bound to alpha1-acid glycoprotein.
* In patients with chronic hepatitis (including chronic viral hepatitis B and C).
* In patients with hemophilia.

Contraindications

* Hypersensitivity to darunavir or to any drug components.
* Concomitant use with drugs that are metabolized primarily by cytochrome P450 3A4 isoenzymes and whose increased plasma concentrations are associated with serious and/or life-threatening side effects (narrow therapeutic range). These drugs include antihistamines (astemizole, terfenadine), alfuzosin, quetiapine, sildenafil (used to treat pulmonary arterial hypertension), rifampicin, sedatives/depressants (oral triazolam, midazolam), GI stimulants (cisapride), drugs drugs containing St. John’s Wort extract, ergot alkaloids (ergotamine, dihydroergotamine, ergometrine and methylergometrine), antiarrhythmic drugs (amiodarone, bepridil, quinidine, lidocaine for systemic use), HMG-CoA reductase inhibitors (simvastatin, lovastatin), neuroleptics (pimozide, sertindol). See also section “Interaction with other medicinal products”.
* Concomitant use with lopinavir/ritonavir combination.
* Severe hepatic impairment (Child-Pugh class C).
* Children under 6 years of age.