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APO-DARUNAVIR is a brand name for Darunavir, supplied as a tablet. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: APO-DARUNAVIR (darunavir), co-administered with 100 mg ritonavir, and with other antiretroviral agents, is indicated for the treatment of HIV-1 infection in patients ≥ 40 kg. For a description of the clinical data in support of this indication, refer to 14 CLINICAL TRIALS. 1.1 Pediatrics Pediatrics (≥ 40 kg):…
Verbatim from this product's HC label. Tap a section to expand.
and 7 WARNINGS AND PRECAUTIONS). 2 Geriatrics Geriatrics (> 65 years of age) Clinical studies of darunavir did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently from younger patients.
In general, caution should be exercised in the administration and monitoring of APO-DARUNAVIR in elderly patients, reflecting the greater frequency of decreased hepatic, renal or cardiac function and of concomitant disease or other drug therapy (see 4 DOSAGE AND ADMINISTRATION, 7 WARNINGS AND PRECAUTIONS, and 10 CLINICAL PHARMACOLOGY).
2 CONTRAINDICATIONS APO-DARUNAVIR is contraindicated in patients who are hypersensitive to this drug or to any ingredient in the formulation or component of the container. For a complete listing, refer to
). Rash was mostly mild-to-moderate, often occurring within the first four weeks of treatment and resolving with continued dosing. 5%. Darunavir contains a sulfonamide moiety. APO-DARUNAVIR should be used with caution in patients with a known sulfonamide allergy.
In clinical studies with darunavir/rtv, the incidence and severity of rash was similar in patients with or without a history of sulfonamide allergy. Rash occurred more commonly in treatment-experienced patients receiving regimens containing darunavir/rtv + raltegravir compared to subjects receiving darunavir/rtv without raltegravir or raltegravir without darunavir/rtv.
However, rash that was considered drug related occurred at similar rates for all three groups. These rashes were mild to moderate in severity and did not limit therapy; there were no discontinuations APO-DARUNAVIR (Darunavir Tablets) Page 14 of 106 due to rash.
1 Pregnant Women APO-DARUNAVIR should not be used during pregnancy unless the potential benefit justifies the potential risk. There are no adequate and well-controlled studies with darunavir in pregnant women. Darunavir/ritonavir (600/100 mg twice daily.
or 800/100 mg once daily) in combination with a background regimen was evaluated in a clinical trial of 36 pregnant women during the second and third trimesters, and postpartum. The pharmacokinetic data demonstrate that exposure to darunavir and ritonavir as part of an antiretroviral regimen was lower during pregnancy compared with postpartum (6 to 12 weeks).
Virologic response was preserved throughout the study period in both arms. No mother to child transmission occurred in the infants born to the 31 subjects who stayed on the antiretroviral treatment through delivery. Darunavir/ritonavir was well tolerated during pregnancy and postpartum.
3 Pharmacokinetics). Studies in animals have not shown evidence of developmental toxicity or effect on reproductive function and fertility. However, due to limited bioavailability and/or dosing limitations, animal exposures (based on AUC) were only 50% (mice and rats) and 5% (rabbit) of those obtained in humans at the recommended clinical dose boosted with ritonavir (see 16 NON-CLINICAL TOXICOLOGY, Reproductive and Developmental Toxicology).
). 2 Geriatrics Geriatrics (> 65 years of age) Clinical studies of darunavir did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently from younger patients. In general, caution should be exercised in the administration and monitoring of APO-DARUNAVIR in elderly patients, reflecting the greater frequency of decreased hepatic, renal or cardiac function and of concomitant disease or other drug therapy (see 4 DOSAGE AND ADMINISTRATION, 7 WARNINGS AND PRECAUTIONS, and 10 CLINICAL PHARMACOLOGY).
2 CONTRAINDICATIONS APO-DARUNAVIR is contraindicated in patients who are hypersensitive to this drug or to any ingredient in the formulation or component of the container. For a complete listing, refer to 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING.
APO-DARUNAVIR is contraindicated in patients with severe (Child-Pugh Class C) hepatic insufficiency. Co-administration of APO-DARUNAVIR/ritonavir (rtv) is contraindicated with drugs that are highly dependent on CYP3A4 for clearance and for which elevated plasma concentrations are associated with serious and/or life-threatening events (narrow therapeutic index).
Co-administration of APO-DARUNAVIR/rtv is contraindicated with APO-DARUNAVIR (Darunavir Tablets) Page 5 of 106 rifampin and St. John’s Wort as it may reduce plasma concentrations of darunavir which may result in loss of therapeutic effect and development of resistance.
4 Drug-Drug Interactions, Table 13 and Table 14).
Table 1:
Drugs that are Contraindicated with APO-DARUNAVIR/ritonavir (rtv) Drug Class Drugs within Class that are Contraindicated with APO- DARUNAVIR/rtv Alpha 1- Adrenoreceptor Antagonist alfuzosin Antiarrhythmics/Antianginals amiodarone, dronedarone, ivabradine, lidocaine (systemic) Direct Oral Anti-coagulants (DOACs) apixaban, rivaroxaban Anti-gout colchicine (in patients with renal and/or hepatic impairment) Antimycobacterial rifampin Antivirals (Hepatitis C virus [HCV] direct-acting antivirals) elbasvir/grazoprevir Ergot Derivatives dihydroergotamine, ergonovine, ergotamine Herbal Products St.
APO-DARUNAVIR is contraindicated in patients who are hypersensitive to this drug or to any ingredient in the formulation or component of the container. For a complete listing, refer to 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING.
APO-DARUNAVIR is contraindicated in patients with severe (Child-Pugh Class C) hepatic insufficiency. Co-administration of APO-DARUNAVIR/ritonavir (rtv) is contraindicated with drugs that are highly dependent on CYP3A4 for clearance and for which elevated plasma concentrations are associated with serious and/or life-threatening events (narrow therapeutic index).
Co-administration of APO-DARUNAVIR/rtv is contraindicated with APO-DARUNAVIR (Darunavir Tablets) Page 5 of 106 rifampin and St. John’s Wort as it may reduce plasma concentrations of darunavir which may result in loss of therapeutic effect and development of resistance.
4 Drug-Drug Interactions, Table 13 and Table 14).
Table 1:
Drugs that are Contraindicated with APO-DARUNAVIR/ritonavir (rtv) Drug Class Drugs within Class that are Contraindicated with APO- DARUNAVIR/rtv Alpha 1- Adrenoreceptor Antagonist alfuzosin Antiarrhythmics/Antianginals amiodarone, dronedarone, ivabradine, lidocaine (systemic) Direct Oral Anti-coagulants (DOACs) apixaban, rivaroxaban Anti-gout colchicine (in patients with renal and/or hepatic impairment) Antimycobacterial rifampin Antivirals (Hepatitis C virus [HCV] direct-acting antivirals) elbasvir/grazoprevir Ergot Derivatives dihydroergotamine, ergonovine, ergotamine Herbal Products St.
John’s wort (Hypericum perforatum) HMG-CoA Reductase Inhibitors / Other lipid modifying agents lovastatin, simvastatin lomitapide Neuroleptics lurasidone, pimozide Opioid Antagonist naloxegol PDE-5 Inhibitor sildenafil (for treatment of pulmonary arterial hypertension) Sedatives/Hypnotics triazolam
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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The Antiretroviral Pregnancy Registry has received prospective reports of exposure to darunavir- containing regimens during pregnancies resulting in live births. The majority had first exposure in the first trimester. No safety concern relating to darunavir has been identified to date.
Antiretroviral Pregnancy Registry:
To monitor maternal-fetal outcomes of pregnant women exposed to APO-DARUNAVIR, an Antiretroviral Pregnancy Registry has been established. Physicians are encouraged to register patients by calling 1-800-258-4263. 2 Breast-feeding HIV-infected mothers should not breast-feed their infants to avoid risking postnatal transmission of HIV.
It is not known whether darunavir is excreted in human milk. Studies in rats have demonstrated that darunavir is excreted into the milk of lactating rats and at high levels (1,000 mg/kg/day) resulted in toxicity. Because of both the potential for HIV transmission and the potential for serious adverse events in nursing infants, mothers should be instructed APO-DARUNAVIR (Darunavir Tablets) Page 15 of 106 not to breast-feed if they are receiving APO-DARUNAVIR (see 16 NON-CLINICAL TOXICOLOGY, Reproductive and Developmental Toxicology).
3 Pediatrics Pediatrics (<40 kg) The pharmacokinetics, safety, tolerability and efficacy of APO- DARUNAVIR in pediatric patients < 40 kg have not been established. Treatment-Naïve Pediatric Patients The pharmacokinetics, safety, tolerability and efficacy of darunavir in antiretroviral treatment-naïve pediatric patients have not been established.
4 Geriatrics Geriatrics (> 65 years of age) Clinical studies of darunavir did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently from younger patients. In general, caution should be exercised in the administration and monitoring of APO-DARUNAVIR in elderly patients, reflecting the greater frequency of decreased hepatic, renal or cardiac function and of concomitant disease or other drug therapy.
9% of patients experienced at least one adverse drug reaction (ADR). 5 weeks. 3%). The majority of ADRs were mild or moderate in severity. 1%. 4%). 5%). 3%). 2 Clinical Trial Adverse Reactions Clinical trials are conducted under very specific conditions.
The adverse reaction rates observed in the clinical trials; therefore, may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug. Adverse reaction APO-DARUNAVIR (Darunavir Tablets) Page 16 of 106 information from clinical trials may be useful in identifying and approximating rates of adverse drug reactions in real-world use.
Antiretroviral Treatment-Naïve Adult Patients The safety assessment is based on all safety data from the randomized, […]
1 Dosing Considerations APO-DARUNAVIR (darunavir) must always be given with ritonavir as a pharmacokinetic enhancer, and in combination with other antiretroviral medicinal products. The prescribing information of ritonavir must, therefore, be consulted prior to initiation of therapy with APO- DARUNAVIR/rtv.
2 Recommended Dose and Dosage Adjustment, Adults). 2 Recommended Dose and Dosage Adjustment APO-DARUNAVIR (Darunavir Tablets) Page 6 of 106 Patients who have difficulty swallowing APO-DARUNAVIR tablets should contact their physician as soon as possible regarding potential therapeutic alternatives, such as an oral suspension.
Adults The recommended oral dosing regimens for adult patients are APO-DARUNAVIR 800 mg in combination with ritonavir (100 mg) once daily and with food, or 600 mg in combination with ritonavir (100 mg) twice daily and with food. 5 Drug-Food Interactions).
The dosing schedule for APO-DARUNAVIR/rtv is presented in Table 2.
Table 2:
Recommended Dose for Adult Patients for APO-DARUNAVIR Tablets with ritonavir (100 mg) Treatment-Naïve Adult Patients Treatment-Experienced Adult Patients With no darunavir resistance- associated mutations (DRV- RAMs)a With at least one darunavir resistance- associated mutation (DRV-RAM)a 800 mg APO-DARUNAVIR in combination with ritonavir 100 mg once daily and with food 800 mg APO-DARUNAVIR in combination with ritonavir 100 mg once daily and with food 600 mg APO-DARUNAVIR in combination with 100 mg ritonavir twice daily and with food a DRV-RAMs: V11I, V321, L33F, I47V, I50V, I54M, I54L, T74P, L76V, I84V and L89V For antiretroviral treatment-experienced patients HIV genotypic testing is recommended.
However, when HIV genotypic testing is not feasible, the APO-DARUNAVIR/rtv once-daily dosing regimen is recommended in protease inhibitor-naive patients and the twice daily dosing regimen is recommended in protease inhibitor-experienced patients.
The type of food does not affect exposure to darunavir. 3 Pharmacokinetics ). A further increase in the dose of darunavir or ritonavir is not likely to result in any clinically relevant increase in antiviral activity. Geriatric Patients In general, caution should be exercised in the administration and monitoring of APO- DARUNAVIR in elderly patients, reflecting the greater frequency of decreased hepatic, renal or cardiac function, and of concomitant disease or other drug therapy (see 1 INDICATIONS, 7 WARNINGS AND PRECAUTIONS and 10 CLINICAL PHARMACOLOGY).
APO-DARUNAVIR (Darunavir Tablets) Page 7 of 106 Pediatric Patients APO-DARUNAVIR/rtv should not be used in pediatric patients < 40 kg (see7 WARNINGS AND PRECAUTIONS and 16 NON-CLINICAL TOXICOLOGY). ) (see 14 CLINICAL TRIALS). APO-DARUNAVIR should be taken with ritonavir twice daily and with food.
5 Drug- Food Interactions Effects of Food on Oral Absorption , ). Before prescribing APO-DARUNAVIR […]