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Sustiva is a brand name for Efavirenz. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: SUSTIVA is indicated in antiviral combination treatment of human immunodeficiency virus-1 (HIV- 1) infected adults, adolescents and children 3 months of age and older and weighing at least 3.5 kg. SUSTIVA has not been adequately studied in patients with advanced HIV disease, namely in patients with CD4 counts < 50…
Verbatim from this product's EMA label. Tap a section to expand.
Therapy should be initiated by a physician experienced in the management of HIV infection. 5). 8). 5) is 600 mg orally, once daily. , to 300 mg once daily. 5). 5). Children and adolescents (3 months to 17 years) The recommended dose of efavirenz in combination with a PI and/or NRTIs for patients between 3 months and 17 years of age is described in Table 1.
Efavirenz intact hard capsules must only be administered to children who are able to reliably swallow hard capsules. 2. 4). Hepatic impairment Patients with mild liver disease may be treated with their normally recommended dose of efavirenz.
4). 5 kg have not been established. No data are available. Method of administration It is recommended that efavirenz be taken on an empty stomach. 4. 2). 6 for instructions). No additional food should be consumed for up to 2 hours after administration of efavirenz..
Summary of the safety profile Efavirenz has been studied in over 9,000 patients. 5%). The most Medicinal product no longer authorised 23 notable adverse reactions associated with efavirenz are rash and nervous system symptoms. Nervous system symptoms usually begin soon after therapy onset and generally resolve after the first 2 - 4 weeks.
Severe skin reactions such as Stevens-Johnson syndrome and erythema multiforme; psychiatric adverse reactions including severe depression, death by suicide, and psychosis like behaviour; and seizures have been reported in patients treated with efavirenz.
4). The long-term safety profile of efavirenz-containing regimens was evaluated in a controlled trial (006) in which patients received efavirenz + zidovudine + lamivudine (n = 412, median duration 180 weeks), efavirenz + indinavir (n = 415, median duration 102 weeks), or indinavir + zidovudine + lamivudine (n = 401, median duration 76 weeks).
Long-term use of efavirenz in this study was not associated with any new safety concerns. Tabulated list of adverse reactions Adverse reactions of moderate or greater severity with at least possible relationship to treatment regimen (based on investigator attribution) reported in clinical trials of efavirenz at the recommended dose in combination therapy (n = 1,008) are listed below.
Also listed in italics are adverse reactions observed post-marketing in association with efavirenz-containing antiretroviral treatment regimens. Frequency is defined using the following convention: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); or very rare (< 1/10,000).
6%)* common pruritus uncommon erythema multiforme, Stevens-Johnson syndrome* rare photoallergic dermatitis† Reproductive system and breast disorders uncommon gynaecomastia General disorders and administration site conditions common Fatigue *,†,‡ See section Description of selected adverse reactions for more details.
Efavirenz must not be used as a single agent to treat HIV or added on as a sole agent to a failing regimen. Resistant virus emerges rapidly when efavirenz is administered as monotherapy. 1). Co-administration of efavirenz with the fixed combination tablet containing efavirenz, emtricitabine, and tenofovir disoproxil is not recommended unless needed for dose adjustment (for example, with rifampicin).
5). 5). Co-administration of glecaprevir/pibrentasvir with efavirenz may significantly decrease plasma concentrations of glecaprevir and pibrentasvir, leading to reduced therapeutic effect. 5). 5). When prescribing medicinal products concomitantly with efavirenz, physicians should refer to the corresponding Summary of Product Characteristics.
If any antiretroviral medicinal product in a combination regimen is interrupted because of suspected intolerance, serious consideration should be given to simultaneous discontinuation of all antiretroviral medicinal products. The antiretroviral medicinal products should be restarted at the same time upon resolution of the intolerance symptoms.
Intermittent monotherapy and sequential reintroduction of antiretroviral agents is not advisable because of the increased potential for selection of resistant virus. Rash Mild-to-moderate rash has been reported in clinical studies with efavirenz and usually resolves with continued therapy.
Appropriate antihistamines and/or corticosteroids may improve the tolerability and hasten the resolution of rash. Severe rash associated with blistering, moist desquamation or ulceration has been reported in less than 1% of patients treated with efavirenz.
1%. Efavirenz must be discontinued in patients developing severe rash associated with blistering, desquamation, mucosal involvement or fever. 8). 8). , Stevens-Johnson syndrome) while taking another NNRTI. Psychiatric symptoms Psychiatric adverse reactions have been reported in patients treated with efavirenz.
1. 2). 5). 5). Herbal preparations containing St. 5). Patients with: - a family history of sudden death or of congenital prolongation of the QTc interval on electrocardiograms, or with any other clinical condition known to prolong the QTc interval.
- a history of symptomatic cardiac arrhythmias or with clinically relevant bradycardia or with congestive cardiac failure accompanied by reduced left ventricle ejection fraction. , hypokalaemia or hypomagnesaemia. Medicinal product no longer authorised 5 Patients taking drugs that are known to prolong the QTc interval (proarrhythmic).
These drugs include: - antiarrhythmics of classes IA and III, - neuroleptics, antidepressive agents, - certain antibiotics including some agents of the following classes: macrolides, fluoroquinolones, imidazole and triazole antifungal agents, - certain non-sedating antihistamines (terfenadine, astemizole), - cisapride, - flecainide, - certain antimalarials, - methadone.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Description of selected adverse reactions Information regarding post-marketing surveillance †These adverse reactions were identified through post-marketing surveillance; however, the frequencies were determined using data from 16 clinical trials (n=3,969).
‡These adverse reactions were identified through post-marketing surveillance but not reported as drug- related events for efavirenz-treated patients in 16 clinical trials. The frequency category of "rare" was defined per A Guideline on Summary of Product Characteristics (SmPC) (rev.
2, Sept 2009) on the basis of an estimated upper bound of the 95% confidence interval for 0 events given the number of patients treated with efavirenz in these clinical trials (n=3,969). Rash In clinical studies, 26% of patients treated with 600 mg of efavirenz experienced skin rash compared with 17% of patients treated in control groups.
Skin rash was considered treatment related in 18% of patients treated with efavirenz. 7% discontinued therapy because of rash. 1%. Medicinal product no longer authorised 25 Rashes are usually mild-to-moderate maculopapular skin eruptions that occur within the first two weeks of initiating therapy with efavirenz.
In most patients rash resolves with continuing therapy with efavirenz within one month. Efavirenz can be reinitiated in patients interrupting therapy because of rash. Use of appropriate antihistamines and/or corticosteroids is recommended when efavirenz is restarted.
Experience with efavirenz in patients who discontinued other antiretroviral agents of the NNRTI class is limited. Reported rates of recurrent rash following a switch from nevirapine to efavirenz therapy, primarily based on retrospective cohort data from published literature, range from 13 to 18%, comparable to the rate observed in patients treated with efavirenz in clinical studies.
) Psychiatric symptoms Serious psychiatric adverse reactions have been reported in patients treated with efavirenz.
In controlled trials, the frequency of specific serious psychiatric events were:
Efavirenz regimen (n=1,008) Control […]
Patients with a prior history of psychiatric disorders appear to be at greater risk of these serious psychiatric adverse reactions. In particular, severe depression was more common in those with a history of depression. There have also been post-marketing reports of severe depression, death by suicide, delusions, psychosis-like behaviour and catatonia.
8). 8). Nervous system symptoms usually begin during the first one or two days of therapy and generally resolve after the first 2 - 4 weeks. Patients should be informed that if they do occur, these common symptoms are likely to improve with continued therapy and are not predictive of subsequent onset of any of the less frequent psychiatric symptoms.
Seizures Convulsions have been observed in adult and paediatric patients receiving efavirenz, generally in the presence of known medical history of seizures. Patients who are receiving concomitant anticonvulsant medicinal products primarily metabolised by the liver, such as phenytoin, carbamazepine and phenobarbital, may require periodic monitoring of plasma levels.
5). Caution must be taken in any patient with a history of seizures. 8). Liver enzyme monitoring should be considered for patients without pre-existing hepatic dysfunction or other risk factors. 1). Consider alternatives to efavirenz for co-administration with a drug with a known risk of Torsade de Pointes or when to be administered to patients at higher risk of Torsade de Pointes.
8). It is recommended that efavirenz be taken on an empty stomach, preferably at bedtime. Immune Reactivation Syndrome In HIV infected patients with severe immune deficiency at the time of institution of combination antiretroviral therapy (CART), an inflammatory […]