Soliris Side Effects

Generic Name: eculizumab

Please note - some side effects for Soliris may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Side Effects of Soliris - for the Consumer

Soliris

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Soliris:

Back pain; diarrhea; mild cough; mild headache; nausea; nose, throat, or sinus irritation; stomach pain; stuffy nose; tiredness; trouble sleeping; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur when using Soliris:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling mouth, face, lips, or tongue); difficult or painful urination; fast heartbeat; fever or chills; light-headedness; persistent cough or sore throat; severe or persistent headache or dizziness; swelling of the hands, ankles, or feet; unusual tiredness or weakness.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

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Soliris Side Effects - for the Professional

Soliris

Clinical Trial Experience

Meningococcal infections are the most important adverse reactions experienced by patients receiving Soliris. In PNH clinical studies, two patients experienced meningococcal sepsis. Both patients had previously received a meningococcal vaccine. In clinical studies among patients without PNH, meningococcal meningitis occurred in one unvaccinated patient. Meningococcal sepsis occurred in one previously vaccinated patient enrolled in the retrospective aHUS study during the post-study follow-up period [see Warnings and Precautions (5.1)].

PNH

The data described below reflect exposure to Soliris in 196 adult patients with PNH, age 18-85, of whom 55% were female. All had signs or symptoms of intravascular hemolysis. Soliris was studied in a placebo-controlled clinical study (in which 43 patients received Soliris and 44, placebo); a single arm clinical study and a long term extension study. 182 patients were exposed for greater than one year. All patients received the recommended Soliris dose regimen.

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. Table 4 summarizes the adverse reactions that occurred at a numerically higher rate in the Soliris group than the placebo group and at a rate of 5% or more among patients treated with Soliris.

Table 4: Adverse Reactions Reported In 5% Or More Of Soliris Treated Patients And Greater Than Placebo In The Controlled Clinical Study

Reaction	Soliris N = 43 N (%)	Placebo N = 44 N (%)
Headache	19 (44)	12 (27)
Nasopharyngitis	10 (23)	8 (18)
Back pain	8 (19)	4 (9)
Nausea	7 (16)	5 (11)
Fatigue	5 (12)	1 (2)
Cough	5 (12)	4 (9)
Herpes simplex infections	3 (7)	0
Sinusitis	3 (7)	0
Respiratory tract infection	3 (7)	1 (2)
Constipation	3 (7)	2 (5)
Myalgia	3 (7)	1 (2)
Pain in extremity	3 (7)	1 (2)
Influenza-like illness	2 (5)	1 (2)

In the placebo-controlled clinical study, serious adverse reactions occurred among 4 (9%) patients receiving Soliris and 9 (21%) patients receiving placebo. The serious reactions included infections and progression of PNH. No deaths occurred in the study and no patients receiving Soliris experienced a thrombotic event; one thrombotic event occurred in a patient receiving placebo.

Among 193 patients with PNH treated with Soliris in the single arm, clinical study or the follow-up study, the adverse reactions were similar to those reported in the placebo-controlled clinical study. Serious adverse reactions occurred among 16% of the patients in these studies. The most common serious adverse reactions were: viral infection (2%), headache (2%), anemia (2%), and pyrexia (2%).

aHUS

The safety of Soliris therapy in patients with aHUS was evaluated in two prospective, single-arm studies (aHUS Studies 1 and 2) and one retrospective study (aHUS Study 3). The data described below were derived from 37 adult and adolescent patients with aHUS enrolled in aHUS Study 1 and aHUS Study 2. All patients received the recommended dosage of Soliris. Median exposure was 38 weeks (range: 2-64 weeks).

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. Table 5 summarizes all adverse events reported in at least 10% of patients in aHUS Studies 1 and 2 combined.

Table 5: Per Patient Incidence of Adverse Events in Adult and Adolescent Patients Enrolled in aHUS Study 1 and aHUS Study 2 Separately and in Total

a. includes the preferred terms hypertension, accelerated hypertension, and malignant hypertension. b. includes the preferred terms upper respiratory tract infection and nasopharyngitis.
MedDRA ver. 11.0	Number (%) of Patients
	Study 1 (n=17)	Study 2 (n=20)	Total (n=37)
Vascular Disorders
Hypertensiona	8(47)	5 (25)	13 (35)
Infections and Infestations
Upper respiratory tract infectionb	5 (29)	8 (40)	13(35)
Urinary tract infection	4 (24)	2 (10)	6 (16)
Gastrointestinal Disorders
Diarrhea	6 (35)	6 (30)	12 (32)
Vomiting	5 (29)	3 (15)	8 (22)
Nausea	4 (24)	3 (15)	7 (19)
Abdominal pain	0	4 (20)	4 (11)
Nervous System Disorders
Headache	7 (41)	4 (20)	11 (30)
Blood and Lymphatic System Disorders
Anemia	6 (35)	3 (15)	9 (24)
Leukopenia	4 (24)	2 (10)	6 (16)
Psychiatric Disorders
Insomnia	4 (24)	1 (5)	5 (14)
Respiratory, Thoracic and Mediastinal Disorders
Cough	2 (12)	3 (15)	5 (14)
Pharyngolaryngeal pain	1 (6)	4 (20)	5 (14)
General Disorders and Administration Site Conditions
Fatigue	3 (18)	1 (5)	4 (11)
Peripheral edema	3 (18)	1 (5)	4 (11)
Pyrexia	3 (18)	1 (5)	4 (11)
Ear and Labyrinth Disorders
Vertigo	1 (6)	3 (15)	4 (11)
Musculoskeletal and Connective Tissue Disorders
Pain in extremity	1 (6)	3 (15)	4 (11)

In aHUS Studies 1 and 2 combined, 54% (20/37) of patients experienced a serious adverse event (SAE). The most commonly reported SAEs were hypertension (16%) and infections (14%). One patient discontinued Soliris due to adverse events deemed unrelated to Soliris.

Analysis of retrospectively collected adverse event data from pediatric and adult patients enrolled in aHUS Study 3 (N=30) revealed a safety profile that was similar to that which was observed in the two prospective studies. aHUS Study 3 included 19 pediatric patients less than 18 years of age. Overall, the safety of Soliris in pediatric patients with aHUS enrolled in Study 3 appeared similar to that observed in adult patients. The most common (≥15%) adverse events occurring in pediatric patients are presented in Table 6.

Table 6: Adverse Reactions Occurring in at Least 15% of Patients Less than 18 Years of Age Enrolled in aHUS Study 3

a. includes the preferred terms upper respiratory tract infection and nasopharyngitis.
MedDRA ver. 11.0	Number (%) of Patients
	< 2 yrs (n=5)	2 to < 12 yrs (n=10)	12 to < 18 yrs (n=4)	Total (n=19)
General Disorders and Administration Site Conditions
Pyrexia	4 (80)	4 (60)	1 (25)	9 (47)
Gastrointestinal Disorders
Diarrhea	1 (20)	4 (40)	1 (25)	6 (32)
Vomiting	2 (40)	1 (10)	1 (25)	4 (21)
Infections and Infestations
Upper respiratory tract infectiona	2 (40)	3 (30)	1 (25)	6 (32)
Respiratory, Thoracic and Mediastinal Disorders
Cough	3 (60)	2 (20)	0 (0)	5 (26)
Nasal congestion	2 (40)	2 (20)	0 (0)	4 (21)
Cardiac Disorders
Tachycardia	2 (40)	2 (20)	0 (0)	4 (21)

Immunogenicity

As with all proteins there is a potential for immunogenicity. The immunogenicity of Soliris has been evaluated using two different immunoassays for the detection of anti-eculizumab antibodies: a direct enzyme-linked immunosorbent assay (ELISA) using the Fab fragment of eculizumab as target was used for the PNH indication; and an electro-chemiluminescence (ECL) bridging assay using the eculizumab whole molecular as target was used for the aHUS indication. Low titers of antibodies to Soliris were detected in 3/196 (2%) of all PNH patients treated with Soliris by the ELISA assay. In patients with aHUS treated with Soliris, antibodies to Soliris were detected in 1/37 (2.7%) by the ECL assay. An ECL based neutralizing HAHA assay with a low sensitivity of 2 mcg/mL was performed to detect neutralizing antibodies for the 37 patients with aHUS. No neutralizing activity to Soliris was detected in patients with aHUS treated with Soliris. No apparent correlation of antibody development to clinical response was observed in both indications. The immunogenicity data reflect the percentage of patients whose test results were considered positive for antibodies to Soliris in an ELISA based assay and/or an ECL based assay are highly dependent on the sensitivity and specificity of the assay used. Additionally, the observed incidence of antibody positivity in the assay may be influenced by several factors including sample handling, timing of sample collection, concomitant medications and underlying disease. For these reasons, comparison of the incidence of antibodies to Soliris with the incidence of antibodies to other products may be misleading.

Postmarketing Experience

Cases of serious or fatal meningococcal infections have been reported.

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Side Effects by Body System - for Healthcare Professionals

Immunologic

Immunologic side effects have included herpes simplex infections (up to 7%) and influenza-like illness (up to 5%). Postmarketing cases of serious or fatal meningococcal infections have also been reported.

Respiratory

Respiratory side effects have included upper respiratory tract infection (up to 35%), nasopharyngitis (up to 23%), cough ( up to 14%), pharyngolaryngeal pain (up to 14%), sinusitis (up to 7%), and low titers of antibodies to eculizumab (up to 3%).

Musculoskeletal

Musculoskeletal side effects have included back pain (up to 19%), pain in extremity (up to 11%), arthralgia (up to 7%), and myalgia (up to 7%).

Gastrointestinal

Gastrointestinal side effects have included diarrhea (up to 32%), vomiting (up to 22%), nausea (up to 19%), abdominal pain (up to 11%), and constipation (up to 7%).

Hematologic

Hematologic side effects have included anemia (up to 24%), and leukopenia (up to 16%).

Cardiovascular

Cardiovascular side effects have included hypertension (up to 35%).

Nervous system

Nervous system side effects have included headache (up to 44%), vertigo (up to 11%), and dizziness (up to 5%).

General

General side effects have included fatigue (up to 12%), peripheral edema (up to 11%), and pyrexia (up to 11%).

Psychiatric

Psychiatric side effects have included insomnia (up to 14%).

Genitourinary

Genitourinary side effects have included urinary tract infection (up to 16%).

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