Durart

Durart Adverse Reactions

darunavir

Manufacturer:

Viatris

Distributor:

Atlanta Medicare

Marketer:

Atlanta Medicare
Full Prescribing Info
Adverse Reactions
Throughout this section, adverse reactions are presented. Adverse reactions are adverse events that were considered to be reasonably associated with the use of darunavir based on the comprehensive assessment of the available adverse event information. A causal relationship with darunavir cannot be reliably established in individual cases. Further, because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.
The overall safety profile of darunavir is based on all available clinical trial and post-marketing data, and is consistent with the data presented as follows.
Due to the need for co-administration of darunavir with ritonavir, please refer to ritonavir prescribing information for ritonavir-associated adverse reactions.
Adverse reactions to darunavir/rtv identified in clinical trials in adults: Adverse reactions to darunavir/rtv 800/100 mg q.d. identified in antiretroviral treatment-naïve adult patients: The safety assessment is based on all safety data up to 192 weeks of treatment from the Phase III ARTEMIS trial comparing darunavir/rtv 800/100 mg q.d. versus lopinavir/ritonavir 800/200 mg per day in antiretroviral naïve HIV-1 infected adult patients. The total patient years exposure in the darunavir/rtv arm and the lopinavir/rtv arm was 1072.0 and 1021.4, respectively.
The majority of the ARs reported during treatment with darunavir/rtv were mild in severity. The most frequent (≥ 5%) ARs of moderate to severe (grade 2-4) intensity were diarrhea, headache, and abdominal pain.
The most frequent (≥1%) ARs of severe (grade 3 or 4) intensity were related to laboratory abnormalities. All other grade 3 or 4 ARs were reported in less than 1% of the patients.
2.3% of the patients in the darunavir/rtv arm discontinued treatment due to ARs.
Adverse Reactions to darunavir/rtv 800/100 mg q.d. of at least moderate intensity (grade 2-4) in antiretroviral treatment naïve HIV-1 infected adult patients are presented in Table 4. (See Table 4.)

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Laboratory abnormalities, grade 2-4, considered ARs, in antiretroviral treatment naïve HIV-1 infected adult patients are shown in Table 5. (See Table 5.)

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Adverse reactions to darunavir/rtv 600/100 mg b.i.d. identified in antiretroviral 923 treatment-experienced adult patients: The safety assessment is based on all safety data from the Phase III trial TITAN comparing darunavir/rtv 600/100 mg b.i.d. versus lopinavir/ritonavir 400/100 mg b.i.d. in antiretroviral treatment-experienced HIV-1 infected adult patients. The total patient years of exposure in the darunavir/rtv arm and the lopinavir/rtv arm was 462.5 and 436.1, respectively.
The majority of the ARs reported during treatment with darunavir/rtv were mild in severity. The most frequent (≥ 5%) ARs of moderate to severe (grade 2-4) intensity were diarrhoea, hypertriglyceridaemia, hypercholesterolaemia, nausea, abdominal pain, vomiting, lipodystrophy, hepatic enzymes increased, and rash.
The most frequent (≥ 1%) severe (grade 3 or 4) ARs were lipodystrophy or related to laboratory abnormalities. All other grade 3 or 4 ARs were reported in less than 1% of the patients. 4.7% of the patients discontinued treatment due to ARs.
Adverse Reactions to darunavir/rtv 600/100 mg b.i.d. of at least moderate intensity (grade 2-4) in antiretroviral treatment-experienced HIV-1 infected adult patients in the TITAN trial are mentioned in Table 6. (See Table 6.)

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Laboratory abnormalities, grade 2-4, considered ARs, in antiretroviral treatment-experienced HIV-1 infected adult patients in the TITAN trial are shown in Table 7. (See Table 7.)

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Additional adverse reactions to darunavir/rtv identified in adult patients in other clinical trials: Not applicable.
Adverse reactions to darunavir/rtv identified in pediatric patients: The safety assessment in children and adolescents is based on the safety data from the week 48 analysis of three Phase II trials: DELPHI, in which 80 antiretroviral treatment-experienced HIV-1 infected pediatric patients aged from 6 to < 18 years and weighing at least 20 kg received darunavir tablets in combination with low dose ritonavir and other antiretroviral agents (see Pharmacology: Pharmacodynamics under Actions).
Frequency, type, and severity of adverse reactions in pediatric patients were comparable to those observed in adults.
Postmarketing data: In addition to the adverse reactions reported during clinical studies and listed previously, the following adverse reactions have been reported during postmarketing experience. The frequencies are provided according to the following convention: Very common: ≥ 1/10; Common: ≥ 1/100 and < 1/10; Uncommon: ≥ 1/ 1000 and < 1/100; Rare: ≥ 1/10000 and < 1/1000; Very rare: < 1/10000, including isolated reports.
In Table 8, adverse reactions identified during post-marketing experience are presented by frequency category based on spontaneous reporting rates. (See Table 8.)

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Effects of combination antiretroviral therapy: Combination antiretroviral therapy has been associated with redistribution of body fat (lipodystrophy) in HIV patients, including loss of peripheral and facial subcutaneous fat, increased intra-abdominal and visceral fat, breast hypertrophy, and dorsocervical fat accumulation (buffalo hump).
Combination antiretroviral therapy has also been associated with metabolic abnormalities such as as hypertriglyceridaemia, hypercholesterolaemia, insulin resistance, hyperglycaemia, and hyperlactataemia.
In HIV infected patients with severe immune deficiency at the time of initiation of combination antiretroviral therapy, an inflammatory reaction to asymptomatic or residual opportunistic infections may arise (immune reconstitution inflammatory syndrome). Autoimmune disorders such as Graves' disease have also been reported in the context of immune reconstitution inflammatory syndrome (see Precautions).
There have been reports of increased spontaneous bleeding in hemophilia patients receiving PIs.
Increased CPK, myalgia, myositis, and rarely, rhabdomyolysis have been reported with the use of HIV protease inhibitors, particularly in combination with NRTIs.
Special populations: Patients co-infected with hepatitis B and/or hepatitis C virus: In patients co-infected with hepatitis B or C virus receiving darunavir/rtv, the incidence of adverse events and clinical chemistry abnormalities was not higher than in patients receiving darunavir/rtv who were not co-infected, except for increased hepatic enzymes (see Precautions). The pharmacokinetic exposure in co-infected patients was comparable to that in patients without co-infection.
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