FDA label cf67ff17-8593-420c-af10-384fc8034982

5 WARNINGS AND PRECAUTIONS Injection Site Reaction: 98% of subjects experienced at least one injection site reaction during FUZEON treatment in randomized, controlled, open-label, multicenter trials. Manifestations included pain and discomfort, erythema, nodules and cysts, and ecchymosis. ( 5.1 ) Biojector ® 2000: Administration of FUZEON with Biojector 2000 may result in neuralgia and/or paresthesia, bruising and hematomas. ( 5.2 ) Post-Injection Bleeding: Patients receiving anticoagulants or persons with hemophilia, or other coagulation disorders, may have a higher risk of post-injection bleeding. ( 5.3 ) Hypersensitivity: FUZEON should be discontinued immediately upon signs and symptoms of systemic hypersensitivity reactions. ( 5.4 ) Pneumonia: Monitor for signs and symptoms of pneumonia in HIV-infected patients, especially those predisposed to pneumonia (e.g., low initial CD4 cell count). ( 5.5 ) Immune Reconstitution: Patients treated with combination antiretroviral therapy, including FUZEON, may experience immune reconstitution syndrome requiring further evaluation and treatment. ( 5.7 ) 5.1 Local Injection Site Reactions (ISRs) The majority of subjects (98%) receiving FUZEON in randomized, controlled, open-label, multicenter clinical trials had at least one local injection site reaction; ISRs occurred throughout treatment with FUZEON. Manifestations may include pain and discomfort, induration, erythema, nodules and cysts, pruritus, and ecchymosis [see Adverse Reactions (6) ] . Reactions are often present at more than one injection site. Patients must be familiar with the FUZEON Injection Instructions in order to know how to inject FUZEON appropriately and how to monitor carefully for signs or symptoms of cellulitis or local infection. 5.2 Administration with Biojector ® 2000 Nerve pain (neuralgia and/or paresthesia) lasting up to 6 months associated with administration at anatomical sites where large nerves course close to the skin, bruising and hematomas have occurred with use of the Biojector 2000 needle-free device for administration of FUZEON. 5.3 Post-Injection Bleeding Patients receiving anticoagulants or persons with hemophilia, or other coagulation disorders, may have a higher risk of post-injection bleeding. 5.4 Hypersensitivity Reactions Systemic hypersensitivity reactions have been associated with FUZEON therapy and may recur on re-challenge. Hypersensitivity reactions have occurred in <1% of subjects studied and have included combinations of: rash, fever, nausea and vomiting, chills, rigors, hypotension, and/or elevated serum liver transaminases. Other adverse events that may be immune mediated and have been reported in subjects receiving FUZEON include primary immune complex reaction, respiratory distress, glomerulonephritis, and Guillain-Barre syndrome. Patients developing signs and symptoms suggestive of a systemic hypersensitivity reaction should discontinue FUZEON and should seek medical evaluation immediately. Therapy with FUZEON should not be restarted following systemic signs and symptoms consistent with a hypersensitivity reaction. Risk factors that may predict the occurrence or severity of hypersensitivity to FUZEON have not been identified. 5.5 Pneumonia An increased rate of bacterial pneumonia was observed in subjects treated with FUZEON in the Phase 3 clinical trials compared to the control arm. The incidence of pneumonia was 2.7% or 3.2 events/100 patient-years in subjects receiving FUZEON+background regimen. On analysis of all diagnoses of pneumonia (pneumonia, bacterial pneumonia, bronchopneumonia, and related terms) in T20-301 and T20-302, an increased rate of bacterial pneumonia was observed in subjects treated with FUZEON compared to the control arm (6.9%, 6.7 pneumonia events per 100 patient-years versus 0.6 events per 100 patient-years, respectively). Approximately half of the study subjects with pneumonia required hospitalization. Three subject deaths in the FUZEON arm were attributed to pneumonia; all three had serious concomitant AIDS-related illnesses that contributed to their deaths. Risk factors for pneumonia included low initial CD4 lymphocyte count, high initial viral load, intravenous drug use, smoking, and a prior history of lung disease. Because it was unclear whether the higher incidence rate of pneumonia was related to FUZEON use, an observational study in 1850 HIV-infected patients (740 FUZEON treated patients and 1110 non-FUZEON treated patients) was conducted to evaluate the risk of pneumonia in patients treated with FUZEON. A total of 123 patients had a confirmed or probable pneumonia event in this study (62 in the FUZEON treatment arm with 1962 patient-years of observation and 61 in the non-FUZEON treatment arm with 3378 patient-years of observation). The incidence of pneumonia was 3.2 events/100 patient-years in the FUZEON treatment arm and 1.8 events/100 patient-years in the non-FUZEON treatment arm. The hazard ratio, adjusting for other baseline risk factors, was 1.34 (95% C.I. = 0.90 – 2.00). 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. 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. 5.6 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 individuals. 5.7 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. Autoimmune disorders (such as Graves' disease, polymyositis, and Guillain-Barré syndrome) have also been reported to occur in the setting of immune reconstitution, however, the time to onset is more variable, and can occur many months after initiation of treatment.

6 ADVERSE REACTIONS The following adverse reactions are discussed in greater detail in other sections: Administration with Biojector ® 2000 [see Warnings and Precautions (5.2) ] Hypersensitivity Reactions [see Warnings and Precautions (5.4) ] Pneumonia [see Warnings and Precautions (5.5) ] Most common adverse reactions are local injection site reactions, diarrhea, nausea, and fatigue. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Genentech at 1-888-835-2555 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience 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 practice. The overall safety profile of FUZEON is based on 2131 subjects who received at least 1 dose of FUZEON during various clinical trials. This includes 2051 adults, 658 of whom received the recommended dose for greater than 48 weeks, and 63 pediatric subjects. 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 (TORO 2). 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 cysts, 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 adult subjects. Table 2 Summary of Individual Signs/Symptoms Characterizing Local Injection Site Reactions to Enfuvirtide in Studies T20-301 and T20-302 Combined (% of Subjects) Through 48 Weeks N=663 Event Category Any Severity Grade % of Subjects with Grade 3 Reactions % of Subjects with Grade 4 Reactions Pain/Discomfort Grade 3 = severe pain requiring prescription non-topical analgesics or limiting usual activities. Grade 4 = severe pain requiring hospitalization or prolongation of hospitalization, resulting in death, or persistent or significant disability/incapacity, or life-threatening, or medically significant. 96% 11% 0% Induration 90% 39% >25 but <50 mm 18% ≥50 mm Erythema 91% 22% >50 but <85 mm 10% ≥85 mm Nodules and Cysts 80% 23% >3 cm average diameter 0.2% Draining Pruritus Grade 3 = refractory to topical treatment or requiring oral or parenteral treatment. Grade 4 = not applicable. 65% 3% NA Ecchymosis 52% 5% >3 but ≤5 cm 2% >5 cm Other Adverse Events In T20-301 and T20-302, after study week 8, subjects on background alone who met protocol defined criteria for virological failure were permitted to revise their background regimens and add FUZEON. Exposure on FUZEON+background was 557 patient-years, and to background alone 162 patient-years. Due to this difference in exposure, safety results are expressed as the number of patients with an adverse event per 100 patient-years of exposure. For FUZEON+background, adverse events are also displayed by percent of subjects. The events most frequently reported in subjects receiving FUZEON+background regimen, excluding ISRs, were diarrhea (38 per 100 patient-years or 31.7%), nausea (27 per 100 patient-years or 22.8%), and fatigue (24 per 100 patient-years or 20.2%). These events were also commonly observed in subjects that received background regimen alone: diarrhea (73 per 100 patient-years), nausea (50 per 100 patient-years), and fatigue (38 per 100 patient-years). Treatment-emergent adverse events, regardless of causality and excluding ISRs, from Phase 3 studies are summarized for adult subjects, in Table 3 . Any Grade 2 or above events occurring at ≥2 percent of subjects and at a higher rate in subjects treated with FUZEON are summarized in Table 3 ; events that occurred at a higher rate in the control arms are not displayed. Rates of adverse events for subjects who switched to FUZEON after virological failure were similar. Table 3 Rates of Treatment-Emergent Adverse Events Excludes Injection Site Reactions (≥Grade 2) Reported in ≥2% of Subjects Treated with FUZEON Events listed occurred more frequently in subjects treated with FUZEON (based on rates/100 patient-years). (Pooled Studies T20-301/T20-302 at 48 Weeks) Adverse Event (by System Organ Class) FUZEON+Background Regimen (N=663) FUZEON+Background Regimen (N=663) Background Regimen (N=334) 663 subjects total 557 total patient-years 162 total patient-years % frequency rate/100 patient-years rate/100 patient-years Weight Decreased 6.6% 7.9 6.2 Sinusitis 6.0% 7.2 4.9 Abdominal Pain 3.9% 4.7 3.7 Cough 3.9% 4.7 2.5 Herpes Simplex 3.5% 4.1 3.7 Appetite Decreased 3.2% 3.8 2.5 Pancreatitis 3.0% 3.6 2.5 Pain in Limb 2.9% 3.4 3.1 Pneumonia (see text below) 2.7% 3.2 0.6 Myalgia 2.7% 3.2 1.2 Influenza-Like Illness 2.4% 2.9 1.9 Folliculitis 2.4% 2.9 2.5 Anorexia 2.3% 2.7 1.9 Dry Mouth 2.1% 2.5 1.9 Conjunctivitis 2.0% 2.3 1.9 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 fatal cases) 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 neuropathy Cardiac Disorders: unstable angina pectoris Gastrointestinal Disorders: constipation; abdominal pain upper General: asthenia 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 Laboratory Abnormalities Table 4 shows the treatment-emergent laboratory abnormalities that occurred in at least 2 subjects per 100 patient-years and more frequently in those receiving FUZEON+background regimen than background regimen alone from T20-301 and T20-302. Table 4 Treatment-Emergent Laboratory Abnormalities in ≥2% of Subjects Receiving FUZEON Events listed occurred more frequently in subjects treated with FUZEON (based on rates/100 patient-years). (Pooled Studies T20-301 and T20-302 at 48 Weeks) Laboratory Parameters Grading FUZEON+Background Regimen (N=663) FUZEON+Background Regimen (N=663) Background Regimen (N=334) 663 subjects total 557 total patient-years 162 total patient-years % frequency rate/100 patient-years rate/100 patient-years Eosinophilia 1-2 × ULN (0.7 × 10 9 /L) 0.7-1.4 × 10 9 /L 9.1% 10.8 3.7 >2 × ULN (0.7 × 10 9 /L) >1.4 × 10 9 /L 1.8% 2.2 1.8 ALT Grade 3 >5-10 × ULN 4.1% 4.8 4.3 Grade 4 >10 × ULN 1.2% 1.4 1.2 Creatine Phosphokinase (U/L) Grade 3 >5-10 × ULN 6.9% 8.3 8.0 Grade 4 >10 × ULN 2.6% 3.1 8.6 Adverse Events in Pediatric Patients FUZEON has been studied in 63 pediatric subjects 5 through 16 years of age with duration of FUZEON exposure ranging from 1 dose to 134 weeks. Adverse experiences seen during clinical trials were similar to those observed in adult subjects, although infections at site of injection (cellulitis or abscess) were more frequent in adolescents than in adults, with 4 events occurring in 3 of 28 (11%) subjects. 6.2 Postmarketing Experience The following adverse reaction has been identified during post approval use of FUZEON. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Skin and Subcutaneous Tissue Disorders Cutaneous amyloidosis at the injection site.

<table width="75%" ID="t2"><caption>Table 2 Summary of Individual Signs/Symptoms Characterizing Local Injection Site Reactions to Enfuvirtide in Studies T20-301 and T20-302 Combined (% of Subjects) Through 48 Weeks</caption><col width="30%" align="left" valign="top"/><col width="20%" align="center" valign="top"/><col width="25%" align="center" valign="top"/><col width="25%" align="center" valign="top"/><thead><tr styleCode="Botrule"><th styleCode="Lrule Rrule"/><th styleCode="Rrule" colspan="3">N=663</th></tr><tr><th styleCode="Lrule Rrule">Event Category</th><th styleCode="Rrule">Any Severity Grade</th><th styleCode="Rrule">% of Subjects with Grade 3 Reactions</th><th styleCode="Rrule">% of Subjects with Grade 4 Reactions</th></tr></thead><tbody><tr styleCode="Botrule"><td styleCode="Lrule Rrule">Pain/Discomfort <footnote>Grade 3 = severe pain requiring prescription non-topical analgesics or limiting usual activities. Grade 4 = severe pain requiring hospitalization or prolongation of hospitalization, resulting in death, or persistent or significant disability/incapacity, or life-threatening, or medically significant.</footnote></td><td styleCode="Rrule">96%</td><td styleCode="Rrule">11%</td><td styleCode="Rrule">0%</td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule">Induration</td><td styleCode="Rrule">90%</td><td styleCode="Rrule">39% &gt;25 but &lt;50 mm</td><td styleCode="Rrule">18% &#x2265;50 mm</td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule">Erythema</td><td styleCode="Rrule">91%</td><td styleCode="Rrule">22% &gt;50 but &lt;85 mm</td><td styleCode="Rrule">10% &#x2265;85 mm</td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule">Nodules and Cysts</td><td styleCode="Rrule">80%</td><td styleCode="Rrule">23% &gt;3 cm average diameter</td><td styleCode="Rrule">0.2% Draining</td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule">Pruritus <footnote>Grade 3 = refractory to topical treatment or requiring oral or parenteral treatment. Grade 4 = not applicable.</footnote></td><td styleCode="Rrule">65%</td><td styleCode="Rrule">3%</td><td styleCode="Rrule">NA</td></tr><tr><td styleCode="Lrule Rrule">Ecchymosis</td><td styleCode="Rrule">52%</td><td styleCode="Rrule">5% &gt;3 but &#x2264;5 cm</td><td styleCode="Rrule">2% &gt;5 cm</td></tr></tbody></table>

<table width="75%" ID="t3"><caption>Table 3 Rates of Treatment-Emergent Adverse Events<footnote>Excludes Injection Site Reactions</footnote> (&#x2265;Grade 2) Reported in &#x2265;2% of Subjects Treated with FUZEON<footnote>Events listed occurred more frequently in subjects treated with FUZEON (based on rates/100 patient-years).</footnote> (Pooled Studies T20-301/T20-302 at 48 Weeks)</caption><col width="35%" align="left" valign="top"/><col width="23%" align="center" valign="top"/><col width="23%" align="center" valign="top"/><col width="19%" align="center" valign="top"/><thead><tr styleCode="Botrule"><th styleCode="Lrule Rrule">Adverse Event (by System Organ Class)</th><th styleCode="Rrule">FUZEON+Background Regimen (N=663)</th><th styleCode="Rrule">FUZEON+Background Regimen (N=663)</th><th styleCode="Rrule">Background Regimen (N=334)</th></tr><tr styleCode="Botrule"><th styleCode="Lrule Rrule"/><th styleCode="Rrule">663 subjects total</th><th styleCode="Rrule">557 total patient-years</th><th styleCode="Rrule">162 total patient-years</th></tr><tr><th styleCode="Lrule Rrule"/><th styleCode="Rrule">% frequency</th><th styleCode="Rrule">rate/100 patient-years</th><th styleCode="Rrule">rate/100 patient-years</th></tr></thead><tbody><tr styleCode="Botrule"><td styleCode="Lrule Rrule">Weight Decreased</td><td styleCode="Rrule">6.6%</td><td styleCode="Rrule">7.9</td><td styleCode="Rrule">6.2</td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule">Sinusitis</td><td styleCode="Rrule">6.0%</td><td styleCode="Rrule">7.2</td><td styleCode="Rrule">4.9</td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule">Abdominal Pain</td><td styleCode="Rrule">3.9%</td><td styleCode="Rrule">4.7</td><td styleCode="Rrule">3.7</td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule">Cough</td><td styleCode="Rrule">3.9%</td><td styleCode="Rrule">4.7</td><td styleCode="Rrule">2.5</td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule">Herpes Simplex</td><td styleCode="Rrule">3.5%</td><td styleCode="Rrule">4.1</td><td styleCode="Rrule">3.7</td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule">Appetite Decreased</td><td styleCode="Rrule">3.2%</td><td styleCode="Rrule">3.8</td><td styleCode="Rrule">2.5</td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule">Pancreatitis</td><td styleCode="Rrule">3.0%</td><td styleCode="Rrule">3.6</td><td styleCode="Rrule">2.5</td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule">Pain in Limb</td><td styleCode="Rrule">2.9%</td><td styleCode="Rrule">3.4</td><td styleCode="Rrule">3.1</td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule">Pneumonia (see text below)</td><td styleCode="Rrule">2.7%</td><td styleCode="Rrule">3.2</td><td styleCode="Rrule">0.6</td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule">Myalgia</td><td styleCode="Rrule">2.7%</td><td styleCode="Rrule">3.2</td><td styleCode="Rrule">1.2</td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule">Influenza-Like Illness</td><td styleCode="Rrule">2.4%</td><td styleCode="Rrule">2.9</td><td styleCode="Rrule">1.9</td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule">Folliculitis</td><td styleCode="Rrule">2.4%</td><td styleCode="Rrule">2.9</td><td styleCode="Rrule">2.5</td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule">Anorexia</td><td styleCode="Rrule">2.3%</td><td styleCode="Rrule">2.7</td><td styleCode="Rrule">1.9</td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule">Dry Mouth</td><td styleCode="Rrule">2.1%</td><td styleCode="Rrule">2.5</td><td styleCode="Rrule">1.9</td></tr><tr><td styleCode="Lrule Rrule">Conjunctivitis</td><td styleCode="Rrule">2.0%</td><td styleCode="Rrule">2.3</td><td styleCode="Rrule">1.9</td></tr></tbody></table>

<table width="90%" ID="t4"><caption>Table 4 Treatment-Emergent Laboratory Abnormalities in &#x2265;2% of Subjects Receiving FUZEON<footnote>Events listed occurred more frequently in subjects treated with FUZEON (based on rates/100 patient-years).</footnote> (Pooled Studies T20-301 and T20-302 at 48 Weeks)</caption><col width="32%" align="left" valign="top"/><col width="14%" align="center" valign="top"/><col width="18%" align="center" valign="top"/><col width="18%" align="center" valign="top"/><col width="18%" align="center" valign="top"/><thead><tr><th styleCode="Lrule Rrule">Laboratory Parameters</th><th styleCode="Botrule Rrule">Grading</th><th styleCode="Botrule Rrule">FUZEON+Background Regimen (N=663)</th><th styleCode="Botrule Rrule">FUZEON+Background Regimen (N=663)</th><th styleCode="Botrule Rrule">Background Regimen (N=334)</th></tr><tr styleCode="Botrule"><th styleCode="Lrule Rrule"/><th styleCode="Rrule"/><th styleCode="Rrule">663 subjects total</th><th styleCode="Rrule">557 total patient-years</th><th styleCode="Rrule">162 total patient-years</th></tr><tr><th styleCode="Lrule Rrule"/><th styleCode="Rrule"/><th styleCode="Rrule">% frequency</th><th styleCode="Rrule">rate/100 patient-years</th><th styleCode="Rrule">rate/100 patient-years</th></tr></thead><tbody><tr><td styleCode="Lrule Rrule Botrule">Eosinophilia</td><td styleCode="Rrule Botrule"/><td styleCode="Rrule Botrule"/><td styleCode="Rrule Botrule"/><td styleCode="Rrule"/></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule"> 1-2 &#xD7; ULN (0.7 &#xD7; 10⁹/L)</td><td styleCode="Rrule">0.7-1.4 &#xD7; 10⁹/L</td><td styleCode="Rrule">9.1%</td><td styleCode="Rrule">10.8</td><td styleCode="Rrule Toprule">3.7</td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule"> &gt;2 &#xD7; ULN (0.7 &#xD7; 10⁹/L)</td><td styleCode="Rrule">&gt;1.4 &#xD7; 10⁹/L</td><td styleCode="Rrule">1.8%</td><td styleCode="Rrule">2.2</td><td styleCode="Rrule">1.8</td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule">ALT</td><td styleCode="Rrule"/><td styleCode="Rrule"/><td styleCode="Rrule"/><td styleCode="Rrule"/></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule"> Grade 3</td><td styleCode="Rrule">&gt;5-10 &#xD7; ULN</td><td styleCode="Rrule">4.1%</td><td styleCode="Rrule">4.8</td><td styleCode="Rrule">4.3</td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule"> Grade 4</td><td styleCode="Rrule">&gt;10 &#xD7; ULN</td><td styleCode="Rrule">1.2%</td><td styleCode="Rrule">1.4</td><td styleCode="Rrule">1.2</td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule">Creatine Phosphokinase (U/L)</td><td styleCode="Rrule"/><td styleCode="Rrule"/><td styleCode="Rrule"/><td styleCode="Rrule"/></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule"> Grade 3</td><td styleCode="Rrule">&gt;5-10 &#xD7; ULN</td><td styleCode="Rrule">6.9%</td><td styleCode="Rrule">8.3</td><td styleCode="Rrule">8.0</td></tr><tr><td styleCode="Lrule Rrule"> Grade 4</td><td styleCode="Rrule">&gt;10 &#xD7; ULN</td><td styleCode="Rrule">2.6%</td><td styleCode="Rrule">3.1</td><td styleCode="Rrule">8.6</td></tr></tbody></table>