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Fuzeon is a brand name for Enfuvirtide. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Fuzeon is indicated in combination with other antiretroviral medicinal products for the treatment of HIV-1 infected patients who have received treatment with and failed on regimens containing at least one medicinal product from each of the following antiretroviral classes: protease inhibitors, non- nucleoside reverse…
Verbatim from this product's EMA label. Tap a section to expand.
Fuzeon should be prescribed by physicians who are experienced in the treatment of HIV infection.
Posology Adults and adolescents ≥ 16 years:
The recommended dose of Fuzeon is 90 mg twice daily injected subcutaneously into the upper arm, anterior thigh or abdomen. In case a Fuzeon dose is missed, patients should be instructed to administer the dose as soon as possible. However, if it is less than 6 hours before the next regular dose, the missed dose should be skipped.
Elderly:
There is no experience in patients > 65 years old. 2). 2). 2). 2). Method of Administration Fuzeon is only to be administered by subcutaneous injection. 6.
a. 1). Safety results are expressed as the number of patients with an adverse reaction per 100 patient-years of exposure (except for injection site reactions). The most frequently reported events were injection site reactions, diarrhoea and nausea.
The addition of Fuzeon to background antiretroviral therapy generally did not increase the frequency or severity of most adverse reactions. b. Tabulated list of adverse reactions Table 2 presents events seen at a higher rate among patients receiving Fuzeon + OB regimen than among patients on the OB alone regimen with an exposure adjusted increase of at least 2 patients with event per 100 patient-years.
A statistically significant increase was seen for pneumonia and lymphadenopathy. Most adverse reactions were of mild or moderate intensity. Adverse reactions are listed according to MedDRA system organ class and frequency category. Frequency categories are 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); not known (cannot be estimated from the available data).
6 Table 2: Adverse reactions attributed to treatment with Fuzeon in studies TORO 1 and TORO 2 combined System organ class Frequency Adverse reaction Infections and infestations Common Sinusitis, skin papilloma, influenza, pneumonia, ear infection Blood and lymphatic system disorders Common Lymphadenopathy Metabolism and nutrition disorders Common Appetite decreased, anorexia, hypertriglyceridaemia, blood triglycerides increased, diabetes mellitus Psychiatric disorders Common Anxiety, nightmare, irritability Nervous system disorders Very common Common Peripheral neuropathy Hypoaesthesia, disturbance in attention, tremor Eye disorders Common Conjunctivitis Ear and labyrinth disorders Common Vertigo Respiratory, thoracic and mediastinal disorders Common Nasal congestion Gastrointestinal disorders Common Pancreatitis, gastro-oesophageal reflux disease Skin and subcutaneous tissue disorders Common Dry skin, eczema seborrhoeic, erythema, acne Musculoskeletal, connective tissue and bone disorders Common Myalgia Renal and Urinary Disorders Common Nephrolithiasis, haematuria General disorders and administration site conditions Very common Common Weight decreased Influenza like illness, asthenia c.
Fuzeon must be taken as part of a combination regimen. Please also refer to the respective summary of product characteristics of the other antiretroviral medicinal products used in the combination. 1). Patients should be informed that Fuzeon is not a cure for HIV-1 infection.
3). In clinical trials, an increased rate of some bacterial infections, most notably a higher rate of pneumonia, was seen in patients treated with Fuzeon; however, an increased risk of bacterial pneumonia related to the use of Fuzeon has not been confirmed by subsequent epidemiological data.
Hypersensitivity reactions have occasionally been associated with therapy with enfuvirtide and in rare cases hypersensitivity reactions have recurred on rechallenge. Events included rash, fever, nausea and vomiting, chills, rigors, low blood pressure and elevated serum liver transaminases in various combinations, and possibly primary immune complex reaction, respiratory distress and glomerulonephritis.
Patients developing signs/symptoms of a systemic hypersensitivity reaction should discontinue enfuvirtide treatment and should seek medical evaluation immediately. Therapy with 4 enfuvirtide should not be restarted following systemic signs and symptoms consistent with a hypersensitivity reaction considered related to enfuvirtide.
Risk factors that may predict the occurrence or severity of hypersensitivity to enfuvirtide have not been identified.
Liver disease:
The safety and efficacy of enfuvirtide has not been specifically studied in patients with significant underlying liver disorders. Patients with chronic hepatitis B and C and treated with antiretroviral therapy are at an increased risk for severe and potentially fatal hepatic adverse events.
Few patients included in the phase III trials were co-infected with hepatitis B/C. In these the addition of Fuzeon did not increase the incidence of hepatic events. In case of concomitant antiviral therapy for hepatitis B or C, please refer also to the relevant product information for these medicinal products.
1.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Description of selected adverse reactions Injection site reactions Injection site reactions (ISRs) were the most frequently reported adverse reaction and occurred in 98% of the patients (Table 3). The vast majority of ISRs occurred within the first week of Fuzeon 7 administration and were associated with mild to moderate pain or discomfort at the injection site without limitation of usual activities.
The severity of the pain and discomfort did not increase with treatment duration. The signs and symptoms generally lasted equal to or less than 7 days. 5% of patients. 7%g aAny severity grade. bGrade 3= severe pain requiring analgesics (or narcotic analgesics for ≤ 72 hours) and/or limiting usual activities; Grade 4= severe pain requiring hospitalisation or prolongation of hospitalisation, resulting in death, or persistent or significant disability/incapacity, or life-threatening, or medically significant.
cGrade 3= ≥ 50 mm but < 85 mm average diameter; Grade 4= ≥ 85 mm average diameter. dGrade 3= ≥ 25 mm but < 50 mm average diameter; Grade 4= ≥ 50 mm average diameter. eGrade 3= ≥ 3 cm; Grade 4= If draining. fGrade 3= refractory to topical treatment or requiring oral or parenteral treatment; Grade 4= not defined.
gGrade 3= > 3 cm but ≤ 5 cm; Grade 4= > 5 cm. 4). Other adverse reactions In HIV-infected patients with severe immune deficiency at the time of initiation of combination antiretroviral therapy (CART), an inflammatory reaction to asymptomatic or residual opportunistic infections may arise.
4). Cases of osteonecrosis have been reported, particularly in patients with generally acknowledged risk factors, advanced HIV disease or long-term exposure to CART. 4). As a peptide, enfuvirtide can cause cutaneous amyloidosis at the injection site.
Laboratory abnormalities The majority of patients had no change in the toxicity grade of any laboratory parameter during the study except for those listed in Table 4. 6 patients with event per 100 patient-years). 8 patients with event per 100 patient- years).
8 Table 4: Exposure adjusted Grade 3 & 4 laboratory abnormalities among patients […]
Administration of Fuzeon to non-HIV-1 infected individuals may induce anti-enfuvirtide antibodies that cross-react with HIV gp41. This may result in a false positive HIV test with the anti-HIV ELISA test. There is no experience in patients with reduced hepatic function.
Data is limited in patients with moderate to severe renal impairment, and in patients maintained on dialysis. 2).
Immune Reactivation Syndrome:
In HIV-infected patients with severe immune deficiency at the time of institution of combination antiretroviral therapy (CART), an inflammatory reaction to asymptomatic or residual opportunistic pathogens may arise and cause serious clinical conditions, or aggravation of symptoms.
Typically, such reactions have been observed within the first few weeks or months of initiation of CART. Relevant examples are cytomegalovirus retinitis, generalised and/or focal mycobacterial infections, and Pneumocystis carinii pneumonia.
Any inflammatory symptoms should be evaluated and treatment instituted when necessary. Autoimmune disorders (such as Graves’ disease and autoimmune hepatitis) have also been reported to occur in the setting of immune reactivation; however, the reported time to onset is more variable and can occur many months after initiation of treatment.
Osteonecrosis:
Although the etiology is considered to be multifactorial (including corticosteroid use, alcohol consumption, severe immunosuppression, higher body mass index), cases of osteonecrosis have been reported particularly in patients with advanced HIV-disease and/or long-term exposure to CART.
Patients should be advised to seek medical advice if they experience joint aches and pain, joint stiffness or difficulty in movement.