FUZEON is an HIV-medicine
FUZEON is sold as an HIV-1 fusion inhibitor indicated for use in combination with
other antiretroviral agents for the treatment of HIV-1 infection in treatment experienced
patients with HIV-1 replication despite ongoing antiretroviral therapy.
FUZEON is manufactured by Roche
owns the patent for Fuzeon's active ingredient Enfuvirtide
Text: Carl Grinde Date: 16 March 2012
Text also shared from linked pages
Uppdated 22 Juli 2012
In reality FUZEON inhibits the important process called 'fusion' necessary for blood vessels creation.
Fuzeon is not a medicine. Fuzeon is poison.
There is nothing as an HIV virus.
AIDS and HIV is a big lie
created by the pharmaceutical industry.
It is the HIV medications that kills people and make them sick.
The package inserts to the medication all say that they might be lethal or cause damage to the heart, cause pneumonia, cysts etc.
(To find words quickly in a text or PDF, press CTRL F on a PC. Tip: copy text and paste into the text field in a PDF)
freefoto.com Spanish version French version
Fuzeon for the consumer -side effects and a convenience kit
Higlight of prescribing information
These highlights do not include all the information needed to use Fuzeon safely and effectively.
See full prescribing information for Fuzeon.
Based on this observational study, it is not possible to exclude
an increased risk of pneumonia in patients treated with FUZEON compared to non-FUZEON treated patients.
(Irrelevant statements follows here)
It is unclear if the increased incidence of pneumonia is related to FUZEON use.
However, because of these
findings, patients with HIV-1 infection should be carefully monitored for signs and symptoms of pneumonia,
especially if they have underlying conditions which may predispose them to pneumonia. Risk factors for
pneumonia included low initial CD4 cell count, high initial viral load, intravenous drug use, smoking, and a
prior history of lung disease.
5.5 Non-HIV Infected Individuals
There is a theoretical risk that FUZEON use may lead to the production of anti-enfuvirtide antibodies which
cross react with HIV gp41. This could result in a false positive HIV test with an ELISA assay; a confirmatory
western blot test would be expected to be negative. FUZEON has not been studied in non-HIV infected
5.6 Immune Reconstitution Syndrome
Immune reconstitution syndrome has been reported in patients treated with combination antiretroviral therapy,
including FUZEON. During the initial phase of combination antiretroviral treatment, patients whose immune
system responds may develop an inflammatory response to indolent or residual opportunistic infections (such as
Mycobacterium avium infection, cytomegalovirus, Pneumocystis jirovecii pneumonia [PCP] or tuberculosis),
which may necessitate further evaluation and treatment.
6.1 Clinical Trials Experience
...Assessment of treatment-emergent adverse events is based on the pooled data from the two randomized,
controlled, open-label, multicenter trials in treatment-experienced subjects, T20-301 (TORO 1) and T20-302
Local Injection Site Reactions
Local injection site reactions were the most frequent adverse events associated with the use of FUZEON. In
T20-301 and T20-302, 98% of subjects had at least one local injection site reaction (ISR). A total of 7% of
subjects discontinued treatment with FUZEON because of ISRs (4%) or difficulties with injecting FUZEON
(3%) such as injection fatigue and inconvenience. Eighty-five percent of subjects experienced their first ISR
during the initial week of treatment; ISRs continued to occur throughout treatment with FUZEON. For most
subjects the severity of signs and symptoms associated with ISRs did not change during the 48 weeks of
treatment. The majority of ISRs were associated with erythema, induration, the presence of nodules or
and mild to moderate pain at the injection site (Table 2). In addition, the average duration of individual ISRs
was between three and seven days in 41% of subjects and more than seven days in 24% of subjects. Also, the
numbers of ISRs per subject at any one time was between six to 14 ISRs in 26% of subjects and more than 14
ISRs in 1.3% of subjects. Infection at the injection site (including abscess and cellulitis) was reported in 1.7% of
Less Common Events
The following adverse events have been reported in 1 or more subjects; however, a causal relationship to
FUZEON has not been established.
Immune System Disorders: worsening abacavir hypersensitivity reaction
Renal and Urinary Disorders: glomerulonephritis; tubular necrosis; renal insufficiency; renal failure (including
Blood and Lymphatic Disorders: thrombocytopenia; neutropenia; fever; lymphadenopathy
Endocrine and Metabolic: hyperglycemia
Infections: sepsis; herpes simplex
Nervous System Disorders: taste disturbance; Guillain-Barre syndrome (fatal); sixth nerve palsy; peripheral
Cardiac Disorders: unstable angina pectoris
Gastrointestinal Disorders: constipation; abdominal pain upper
Hepatobiliary Disorders: toxic hepatitis; hepatic steatosis
Investigations: increased amylase; increased lipase; increased AST; increased GGT; increased triglycerides
Psychiatric Disorders: insomnia; depression; anxiety; suicide attempt
Respiratory, Thoracic, and Mediastinal Disorders: pneumopathy; respiratory distress; cough
Skin and Subcutaneous Tissue Disorders: pruritus
Patients should be made aware that an increased rate of bacterial pneumonia was observed in subjects
treated with FUZEON in clinical trials. Patients should be advised to seek medical evaluation immediately if
they develop signs or symptoms suggestive of pneumonia (cough with fever, rapid breathing, shortness of
breath) [see Warnings and Precautions (5.3)].
Patients should be advised of the possibility of a systemic hypersensitivity reaction to FUZEON. Patients
should be advised to discontinue therapy and immediately seek medical evaluation if they develop
signs/symptoms of systemic hypersensitivity such as combinations of rash, fever, nausea and vomiting,
chills, rigors, and/or hypotension [see Warnings and Precautions (5.4)].
FUZEON is not a cure for HIV-1 infection and patients may continue to contract illnesses associated with
HIV-1 infection. The long-term effects of FUZEON are unknown at this time. FUZEON therapy has not
been shown to reduce the risk of transmitting HIV-1 to others through sexual contact or blood
FUZEON is a trademark of Hoffmann-La Roche Inc.
FUZEON has been jointly developed by Trimeris, Inc. and Hoffmann-La Roche Inc.
FUZEON is manufactured by Hoffmann-La Roche Inc.
An increased rate of pneumonia, primarily
bacterial, was observed in the enfuvirtide
group compared with the control group, in the
combined safety analysis of TORO 1 and 2,
both at 24 weeks (4.9 versus 0.6 per 100
patient-years)13,14 and 48 weeks (6.6 versus
0.6 per 100 patient-years).15 Bacterial pneumonia
was included as a precaution in the product
This module reflects the initial scientific discussion for the approval of Fuzeon.
(local PDF copy)
This scientific discussion has been updated until 1 November 2004. For information on changes after approval,
please refer to module 8b.
1. Chemical, pharmaceutical and biological aspects
Fuzeon is presented as a powder for solution for injection and a powder and solvent for solution for
injection containing 90 mg of enfuvirtide, as active substance. It is intended for single-dose
subcutaneous administration following reconstitution with water for injections.
The other ingredients include sodium carbonate anhydrous, mannitol, sodium hydroxide, hydrochloric
acid (and water for injections).
Enfuvirtide is a chemically synthesised 36-amino acid peptide. Its sequence is derived from the HIV-1
Single dose toxicity
Enfuvirtide was lethal after a single intravenous injection of 100 mg/kg in rats. The cause of death
appeared to be lung damage. Macroscopic and microscopic changes of the lungs were seen at doses
>? 20 mg/kg. Mild signs of possible intolerance were seen in female monkeys receiving 50 mg/kg.
Repeated dose toxicity
The repeated dose toxicity was evaluated in rats after intravenous injection (28 days) or subcutaneous
injection (6-months) and monkeys after intravenous injection (28-days) or subcutaneous (28-days and
Microscopic changes in the lung were also seen in rats after intravenous injection. These changes
(microgranuloma and inflammatory loci) were not considered treatment related by the pathologist.
However, the increased frequency in the high-dose group (10 mg/kg) and similar findings in the
single-dose toxicity study could suggest a relation. This applicant undertook to further investigate this
finding post-authorisation. There were slight decreases in leucocytes at the end of the treatment and
minor changes in red cells parameters at the end of the recovery period in males treated with
10 mg/kg. Small reversible increases in absolute and relative thyroid/parathyroid weights were seen in
both gender at 10 mg/kg.
The chronic 6-month repeated dose study in rats receiving twice daily subcutaneous injections (up to
34.5 mg/kg/day for the 1st month and up to 30 mg/kg/day for the following 5 months) resulted in an
exposure to enfuvirtide which was only 70% of the expected therapeutic exposure. The only reported
adverse effect was injection site reactions (subdermal haemorrhages, subdermal chronic
inflammation/fibrosis and degeneration of the cutaneous muscle on the injection sites in males). There
were very low amounts of anti-enfuvirtide antibodies. Later studies in the rat with higher doses
showed that higher exposures were attainable. A study on pregnant rats showed an exposure to
enfuvirtide 8.9-fold higher than the therapeutic exposure.
The chronic 9-month repeated dose study in cynomolgus monkeys (twice daily subcutaneous
injections with doses up to 10 mg/kg/dose) resulted in an exposure 2.8 times higher than therapeutic
exposure. The only reported adverse effect was injection site reactions (haemorrhage, oedema and
inflammatory infiltrate with plasma cells and eosinophile). Other changes were an increased
prominence of splenic follicular germinal centers in all animals treated with 20 mg/kg/day, and
depletion of cortical lymphocytes in the thymus. The spleen effect was considered related to an
ongoing immune response to enfuvirtide, whereas the thymus effect was considered related to
8/29 EMEA 2005
experimental stress. However, there was a higher frequency of thymic lymphocyte depletion in the
animals treated with enfuvirtide. The applicant undertook to further address this issue postauthorisation.
The exposure in rats is below the expected clinical exposure. The exposure in the monkey study is
above the expected clinical exposure but the safety margin is narrow. The applicant undertook to
further address this issue as part of the special obligation to be fulfilled post-authorisation.
Inflammatory reactions were seen at the injection site in the subcutaneous repeated dose studies as
already highlighted. Local reactions were commonly seen in control animals but tended to be more
severe in enfuvirtide treated animals. The reports did not clearly describe the kinetics of the reactions
and in most cases the analysis of the reaction site was performed after a long period of treatment. A
72-hr study was performed with subcutaneous infusion of enfuvirtide. An inflammatory response at
the infusion site was evident within this time period.
The injection site reaction was further characterised in 2 weeks study in mini-pigs receiving
subcutaneous injections of two different strengths (50 and 100 mg/ml). Subcutaneous masses were
9/29 EMEA 2005
evident from day 8 in one study and day 4 in a second study. Microscopic findings in the repeated
dose toxicity studies and the mini-pig studies were similar, although more severe in the latter. They
consisted of non-specific changes (haemorrhage, oedema, necrosis and fibrosis, cutaneous muscle
degeneration) and a mixed inflammatory infiltrate composed of macrophages, lymphocytes and other
cell types. In more severe cases, granulomas were found, characterised by a necrotic centre surrounded
by multinucleated giant cells and foamy macrophages with distended cytoplasm.
The mechanism for the local inflammation and granuloma formation has not been elucidated yet but
the applicant undertook to further explore this finding post-authorisation.
The guinea pig maximisation test showed a skin sensitisation response indicative of a potential for
causing delayed type hypersensitivity.
Injection site reactions
The overall most common adverse event was injection site reaction, affecting almost every patient on
enfuvirtide (98.3%) and seen mainly during the first treatment week (85.6%). There was no evidence
of an increase in severity over time for either overall pain and discomfort or any of the signs and
symptoms of a local injection site. The most frequent signs were erythema (91.7%), induration
and cysts (81.4%).
Overall, 96.1% of the patients experienced some pain or
discomfort and 11.5% had injection site reactions that required analgesics or limited usual activities.
Most patients had grade 1-2 (90.6%) injection site reactions. The remaining patients had grade 3
reactions and none had grade 4 reactions. Few patients (4.1%) discontinued treatment due to injection
These results were confirmed at week 48 – final data, submitted post-authorisation (Table 13).
conjuchem owns enfuvitride patent
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