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EFAVIRENZ SANDOZ is a brand name for Efavirenz. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Efavirenz is indicated in antiviral combination treatment of human immunodeficiency virus-1 (HIV-1) infected adults, adolescents and children 3 years of age and older. Efavirenz has not been adequately studied in patients with advanced HIV disease, namely in patients with CD4 counts < 50 cells/mm3, or after failure of…
Verbatim from this product's MHRA 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. Efavirenz film-coated tablets are not suitable for children weighing less than 40 kg. Other efavirenz formulations are available for these patients.
Please refer to the accompanying summary of product characteristics of suitable formulations for the paediatric posology. , to 300 mg once daily. 5). 5). 4).
Hepatic impairment:
Patients with mild liver disease may be treated with their normally recommended dose of efavirenz. 4).
Paediatric population:
The safety and efficacy of efavirenz in children below the age of 3 years or weighing less than 13 kg have not yet been established. 2, but no recommendation on a posology can be made. Method of administration Tablets shall preferably be taken whole but may be divided in equal doses if dose adjustments are necessary or in case of difficulty swallowing.
It is recommended that efavirenz be taken on an empty stomach. 4. 2).
Summary of the safety profile Efavirenz has been studied in over 9,000 patients. 5%). The most 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); 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 fumarate is not recommended, unless needed for dose adjustment (for example with rifampicin).
Coadministration 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.
While effective viral suppression with antiretroviral therapy has been proven to substantially reduce the risk of sexual transmission, a residual risk cannot be excluded. Precautions to prevent transmission should be taken in accordance with national guidelines.
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. 2). 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. g. hypokalaemia or hypomagnesemia. Patients taking medicinal products that are known to prolong the QTc interval (proarrhythmic).
These medicinal products 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.
5). This effect is due to an induction of CYP3A4 or P-gp by efavirenz and is expected to result in the loss of virologic response of elbasvir/grazoprevir
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%. 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. 3% - non-fatal suicide attempts […]
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. 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 and 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. Late-onset neurotoxicity, including ataxia and encephalopathy (impaired consciousness, confusion, psychomotor slowing, psychosis, delirium), may occur months to years after beginning efavirenz therapy.
Some events of late- onset neurotoxicity have occurred in patients with CYP2B6 genetic polymorphisms, which are associated with increased efavirenz levels despite standard dosing of efavirenz. Patients presenting with signs and symptoms of serious neurologic adverse experiences should be evaluated promptly to assess the possibility that these events may be related to efavirenz use, and whether discontinuation of efavirenz is warranted.
Seizures:
Convulsions have been observed in 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). […]