Selzentry Side Effects
Generic Name: maraviroc
Please note - some side effects for Selzentry 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 Selzentry - for the Consumer
Selzentry
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 Selzentry:
Seek medical attention right away if any of these SEVERE side effects occur when using Selzentry:Constipation; cough; diarrhea; dizziness; muscle or joint pain; runny nose; sinus inflammation; stomach pain; trouble sleeping.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bloody diarrhea; burning, numbness, or tingling; chest, jaw, or left arm pain; confusion; depression; difficult or painful urination; fainting; fever, chills, or sore throat; flu-like symptoms; numbness of an arm or leg; one-sided weakness; red, swollen, blistered, or peeling skin; seizures; severe muscle pain; severe or persistent dizziness; severe or persistent stomach pain; shortness of breath; slurred speech; sores or white patches in the mouth; sudden, severe headache or vomiting; symptoms of liver problems (eg, yellowing of the eyes or skin, dark urine, pale stools, loss of appetite, nausea, unusual tiredness, vomiting); unusual lumps, skin growths, or skin changes; vision changes.
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.
TopSelzentry Side Effects - for the Professional
Selzentry
The following adverse reactions are discussed in other sections of the labeling:
- Hepatotoxicity [see Boxed Warning, Warnings and Precautions (5.1)]
- Cardiovascular events [see Warnings and Precautions (5.2)]
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 with rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Studies in Treatment-Experienced Subjects: The safety profile of Selzentry is primarily based on 840 HIV-infected subjects who received at least 1 dose of Selzentry during two Phase 3 trials. A total of 426 of these subjects received the indicated twice-daily dosing regimen.
Assessment of treatment-emergent adverse events is based on the pooled data from 2 studies in subjects with CCR5-tropic HIV-1 (A4001027 and A4001028). The median duration of therapy with Selzentry for subjects in these studies was 48 weeks, with the total exposure on Selzentry twice daily at 309 patient-years versus 111 patient-years on placebo + optimized background therapy (OBT). The population was 89% male and 84% white, with mean age of 46 years (range: 17 to 75 years). Subjects received dose equivalents of 300 mg maraviroc once or twice daily.
The most common adverse events reported with twice-daily therapy with Selzentry with frequency rates higher than placebo, regardless of causality, were upper respiratory tract infections, cough, pyrexia, rash, and dizziness. Additional adverse events that occurred with once-daily dosing at a higher rate than both placebo and twice-daily dosing were diarrhea, edema, influenza, esophageal candidiasis, sleep disorders, rhinitis, parasomnias, and urinary abnormalities. In these 2 studies, the rate of discontinuation due to adverse events was 5% for subjects who received Selzentry twice daily + OBT as well as those who received placebo + OBT. Most of the adverse events reported were judged to be mild to moderate in severity. The data described below occurred with twice-daily dosing of Selzentry.
The total number of subjects reporting infections were 233 (55%) and 84 (40%) in the group receiving Selzentry twice daily and the placebo group, respectively. Correcting for the longer duration of exposure on Selzentry compared with placebo, the exposure-adjusted frequency (rate per 100 subject-years) of these events was 133 for both Selzentry twice daily and placebo.
Dizziness or postural dizziness occurred in 8% of subjects on either Selzentry or placebo, with 2 subjects (0.5%) on Selzentry permanently discontinuing therapy (1 due to syncope, 1 due to orthostatic hypotension) versus 1 subject on placebo (0.5%) permanently discontinuing therapy due to dizziness.
Treatment-emergent adverse events, regardless of causality, from A4001027 and A4001028 are summarized in Table 3. Selected events occurring at ≥2% of subjects and at a numerically higher rate in subjects treated with Selzentry are included; events that occurred at the same or higher rate on placebo are not displayed.
|
Selzentry Twice Dailya |
Placebo | |||
|
N = 426 (%) |
Exposure-adjusted rate (per 100 pt-yrs) PYE = 309b |
N = 426 (%) |
Exposure-adjusted rate (per 100 pt-yrs) PYE = 111b |
|
| Eye Disorders | ||||
| Conjunctivitis | 2 | 3 | 1 | 3 |
| Ocular infections, inflammations, and associated manifestations | 2 | 3 | 1 | 2 |
| Gastrointestinal Disorders | ||||
| Constipation | 6 | 9 | 3 | 6 |
| General Disorders and Administration Site Conditions | ||||
| Pyrexia | 13 | 20 | 9 | 17 |
| Pain and discomfort | 4 | 5 | 3 | 5 |
| Infections and Infestations | ||||
| Upper respiratory tract infection | 23 | 37 | 13 | 27 |
| Herpes infection | 8 | 11 | 4 | 8 |
| Sinusitis | 7 | 10 | 3 | 6 |
| Bronchitis | 7 | 9 | 5 | 9 |
| Folliculitis | 4 | 5 | 2 | 4 |
| Pneumonia | 2 | 3 | 5 | 10 |
| Anogenital warts | 2 | 3 | 1 | 3 |
| Influenza | 2 | 3 | 0.5 | 1 |
| Otitis media | 2 | 3 | 0.5 | 1 |
| Metabolism and Nutrition Disorders | ||||
| Appetite disorders | 8 | 11 | 7 | 13 |
| Musculoskeletal and Connective Tissue Disorders | ||||
| Joint-related signs and symptoms | 7 | 10 | 3 | 5 |
| Muscle pains | 3 | 4 | 0.5 | 1 |
| Neoplasms Benign, Malignant, and Unspecified | ||||
| Skin neoplasms benign | 3 | 4 | 1 | 3 |
| Nervous System Disorders | ||||
| Dizziness/postural dizziness | 9 | 13 | 8 | 17 |
| Paresthesias and dysesthesias | 5 | 7 | 3 | 6 |
| Sensory abnormalities | 4 | 6 | 1 | 3 |
| Disturbances in consciousness | 4 | 5 | 3 | 6 |
| Peripheral neuropathies | 4 | 5 | 3 | 6 |
| Psychiatric Disorders | ||||
| Disturbances in initiating and maintaining sleep | 8 | 11 | 5 | 10 |
| Depressive disorders | 4 | 6 | 3 | 5 |
| Anxiety symptoms | 4 | 5 | 3 | 7 |
| Renal and Urinary Disorders | ||||
| Bladder and urethral symptoms | 5 | 7 | 1 | 3 |
| Urinary tract signs and symptoms | 3 | 4 | 1 | 3 |
| Respiratory, Thoracic, and Mediastinal Disorders | ||||
| Coughing and associated symptoms | 14 | 21 | 5 | 10 |
| Upper respiratory tract signs and symptoms | 6 | 9 | 3 | 6 |
| Nasal congestion and inflammations | 4 | 6 | 3 | 5 |
| Breathing abnormalities | 4 | 5 | 2 | 5 |
| Paranasal sinus disorders | 3 | 4 | 0.5 | 1 |
| Skin and Subcutaneous Tissue Disorders | ||||
| Rash | 11 | 16 | 5 | 11 |
| Apocrine and eccrine gland disorders | 5 | 7 | 4 | 7.5 |
| Pruritus | 4 | 5 | 2 | 4 |
| Lipodystrophies | 3 | 5 | 0.5 | 1 |
| Erythemas | 2 | 3 | 1 | 2 |
| Vascular Disorders | ||||
| Vascular hypertensive disorders | 3 | 4 | 2 | 4 |
a300-mg dose equivalent.
bPYE = Patient-years of exposure.
Laboratory Abnormalities: Table 4 shows the treatment-emergent Grade 3-4 laboratory abnormalities that occurred in >2% of subjects receiving Selzentry.
Table 4. Maximum Shift in Laboratory Test Values (Without Regard to Baseline)
Incidence ≥2% of Grade 3-4 Abnormalities (ACTG Criteria) Studies A4001027 and A4001028 (Pooled Analysis, 48 Weeks)
| Laboratory Parameter Preferred Term | Limit |
Selzentry Twice Daily + OBT (N = 421)a % |
Placebo + OBT (N = 207)a % |
| Aspartate aminotransferase | >5.0x ULN | 4.8 | 2.9 |
| Alanine aminotransferase | >5.0x ULN | 2.6 | 3.4 |
| Total bilirubin | >5.0x ULN | 5.5 | 5.3 |
| Amylase | >2.0x ULN | 5.7 | 5.8 |
| Lipase | >2.0x ULN | 4.9 | 6.3 |
| Absolute neutrophil count | <750/mm3 | 4.3 | 2.4 |
aPercentages based on total subjects evaluated for each laboratory parameter.
Study in Treatment-Naive Subjects:Treatment-Emergent Adverse Events: Treatment-emergent adverse events, regardless of causality, from Study A4001026, a double-blind, comparative, controlled study in which 721 treatment-naive subjects received Selzentry 300 mg twice daily (N = 360) or efavirenz (N = 361) in combination with zidovudine/lamivudine for 96 weeks, are summarized in Table 5. Selected events occurring at ≥2% of subjects and at a numerically higher rate in subjects treated with Selzentry are included; events that occurred at the same or higher rate on efavirenz are not displayed.
|
Selzentry 300 mg Twice Daily + Zidovudine/Lamivudine (N = 360) % |
Efavirenz 600 mg Once Daily + Zidovudine/Lamivudine (N = 361) % |
|
| Blood and Lymphatic System Disorders | ||
| Anemias NEC | 8 | 5 |
| Neutropenias | 4 | 3 |
| Ear and Labyrinth Disorders | ||
| Ear disorders NEC | 3 | 2 |
| Gastrointestinal Disorders | ||
| Flatulence, bloating, and distention | 10 | 7 |
| Gastrointestinal atonic and hypomotility disorders NEC | 9 | 5 |
| Gastrointestinal signs and symptoms NEC | 3 | 2 |
| General Disorders and Administration Site Conditions | ||
| Body temperature perception | 3 | 1 |
| Infections and Infestations | ||
| Bronchitis | 13 | 9 |
| Herpes infection | 7 | 6 |
| Upper respiratory tract infection | 32 | 30 |
| Bacterial infections NEC | 6 | 3 |
| Herpes zoster/varicella | 5 | 4 |
| Lower respiratory tract and lung infections | 3 | 2 |
| Neisseria infections | 3 | 0 |
| Tinea infections | 4 | 3 |
| Viral infections NEC | 3 | 2 |
| Musculoskeletal and Connective Tissue Disorders | ||
| Joint-related signs and symptoms | 6 | 5 |
| Nervous System Disorders | ||
| Memory loss (excluding dementia) | 3 | 1 |
| Paresthesias and dysesthesias | 4 | 3 |
| Renal and Urinary Disorders | ||
| Bladder and urethral symptoms | 4 | 3 |
| Reproductive System and Breast Disorders | ||
| Erection and ejaculation conditions and disorders | 3 | 2 |
| Respiratory, Thoracic, and Mediastinal Disorders | ||
| Upper respiratory tract signs and symptoms | 9 | 5 |
| Skin and Subcutaneous Disorders | ||
| Acnes | 3 | 2 |
| Alopecias | 2 | 1 |
| Lipodystrophies | 4 | 3 |
| Nail and nail bed conditions (excluding infections and infestations) | 6 | 2 |
Laboratory Abnormalities:
| Laboratory Parameter Preferred Term | Limit |
Selzentry 300 mg Twice Daily + Zidovudine/Lamivudine |
Efavirenz 600 mg Once Daily+ Zidovudine/Lamivudine |
| Aspartate aminotransferase | >5.0 x ULN | 4.0 | 4.0 |
| Alanine aminotransferase | >5.0 x ULN | 3.9 | 4.0 |
| Creatine kinase | 3.9 | 4.8 | |
| Amylase | >2.0 x ULN | 4.3 | 6.0 |
| Absolute neutrophil count | <750/mm3 | 5.7 | 4.9 |
| Hemoglobin | <7.0 g/dL | 2.9 | 2.3 |
a N = Total number of subjects evaluable for laboratory abnormalities.
Percentages based on total subjects evaluated for each laboratory parameter. If the same subject in a given treatment group had >1 occurrence of the same abnormality, only the most severe is counted.
Less Common Adverse Events in Clinical Trials: The following adverse events occurred in <2% of subjects treated with Selzentry. These events have been included because of their seriousness and either increased frequency on Selzentry or are potential risks due to the mechanism of action. Events attributed to the patient’s underlying HIV infection are not listed.
Blood and Lymphatic System: Marrow depression and hypoplastic anemia.
Cardiac Disorders: Unstable angina, acute cardiac failure, coronary artery disease, coronary artery occlusion, myocardial infarction, myocardial ischemia.
Hepatobiliary Disorders: Hepatic cirrhosis, hepatic failure, cholestatic jaundice, portal vein thrombosis, hypertransaminasemia, jaundice.
Infections and Infestations: Endocarditis, infective myositis, viral meningitis, pneumonia, treponema infections, septic shock, Clostridium difficile colitis, meningitis.
Musculoskeletal and Connective Tissue Disorders: Myositis, osteonecrosis, rhabdomyolysis, blood CK increased.
Neoplasms Benign, Malignant, and Unspecified (Including Cysts and Polyps): Abdominal neoplasm, anal cancer, basal cell carcinoma, Bowen’s disease, cholangiocarcinoma, diffuse large B-cell lymphoma, lymphoma, metastases to liver, esophageal carcinoma, nasopharyngeal carcinoma, squamous cell carcinoma, squamous cell carcinoma of skin, tongue neoplasm (malignant stage unspecified), anaplastic large cell lymphomas T- and null-cell types, bile duct neoplasms malignant, endocrine neoplasms malignant and unspecified.
Nervous System Disorders: Cerebrovascular accident, convulsions and epilepsy, tremor (excluding congenital), facial palsy, hemianopia, loss of consciousness, visual field defect.
Postmarketing Experience
The following events have been identified during post-approval use of Selzentry. Because these reactions are reported voluntarily from a population of unknown size, it is not possible to estimate their frequency or establish a causal relationship to exposure to Selzentry.
Skin and Subcutaneous Tissue Disorders: Stevens-Johnson syndrome.
TopSide Effects by Body System - for Healthcare Professionals
General
The safety report of maraviroc is principally based on 840 treatment-experienced HIV-infected patients receiving at least one dose of maraviroc during two Phase 3 trials. Of these patients, 426 received the indicated twice daily dosing regimen.
The most common side effects reported with maraviroc twice daily treatment, regardless of causality, were cough, pyrexia, upper respiratory tract infections, rash, musculoskeletal symptoms, abdominal pain, and dizziness. Additional side effects reported with once daily dosing were diarrhea, edema, influenza, esophageal candidiasis, sleep disorders, rhinitis, parasomnias, and urinary abnormalities. In the two studies, discontinuations due to side effects were 5% in patients receiving maraviroc twice daily plus optimized background therapy (OBT) compared to 5% in those receiving placebo plus OBT. Most of the side effects reported were considered mild to moderate in severity.
Treatment-emergent side effects, regardless of causality, from a controlled study of 721 treatment-naive subjects have also been included.
Cardiovascular
Cardiovascular side effects have included vascular hypertensive disorders (3%) and arrhythmia. Unstable angina, acute cardiac failure, coronary artery disease, coronary artery occlusion, endocarditis, myocardial infarction, and myocardial ischemia have been reported in less than 2% of patients. Postural hypotension has been reported.
Respiratory
Respiratory side effects have included coughing and associated symptoms (14%), upper respiratory tract signs and symptoms (6%), nasal congestion and inflammations (4%), breathing abnormalities (4%), bronchospasm and obstruction (2.1%), paranasal sinus disorders (3%), respiratory tract disorders (2.1%), and epistaxis. Upper respiratory tract signs and symptoms (9%) have been reported in treatment-naive patients.
Nervous system
Nervous system side effects have included dizziness/postural dizziness (9%), paresthesias and dysesthesias (5%), sensory abnormalities (4%), peripheral neuropathies (4%), and headache. Paresthesias and dysesthesias (4%), memory loss (excluding dementia; 3%), and ear disorders NEC (3%) have been reported in treatment-naive patients. Cerebrovascular accident, convulsions and epilepsy, tremor (excluding congenital), facial palsy, hemianopia, loss of consciousness, and visual field defect have been reported in less than 2% of patients.
Other
Other side effects have included pyrexia (13%), pain and discomfort (4%), edema, fatigue, asthenia, and hot flushes. Body temperature perception (3%) has been reported in treatment-naive patients.
Immunologic
Immunologic side effects have included upper respiratory tract infection (including upper respiratory tract infection, laryngitis, laryngopharyngitis, nasopharyngitis, pharyngitis, respiratory tract infection, rhinitis, viral respiratory tract infection; 23%), Herpes simplex infection (including Herpes simplex, Herpes virus, Herpes ophthalmic, proctitis Herpes; 8%), sinusitis (including sinusitis, acute sinusitis, chronic sinusitis, sinobronchitis; 7%), bronchitis (including bronchitis, acute bronchitis, bacterial bronchitis; 7%), folliculitis (4%), condyloma acuminatum (2%), pneumonia (including pneumonia, lobar pneumonia, bacterial pneumonia, bronchopneumonia; 2%), otitis media (2%), influenza (including influenza, influenza-like illness; 2%), and esophageal candidiasis. Upper respiratory tract infection (32%), bronchitis (13%), herpes infection (7%), bacterial infections NEC (6%), herpes zoster/varicella (5%), tinea infections (4%), lower respiratory tract and lung infections (3%), Neisseria infections (3%), and viral infections NEC (3%) have been reported in treatment-naive patients. Clostridium difficile colitis, infective myositis, viral meningitis, pneumonia, treponema infections, meningitis, and septic shock have been reported in less than 2% of patients.
Dermatologic
Dermatologic side effects have included rash (11%), apocrine and eccrine gland disorders (5%), pruritus (4%), dermatitis and eczema (3.1%), lipodystrophies (3%), and erythemas (2%). Nail and nail bed conditions (excluding infections and infestations; 6%), lipodystrophies (4%), acnes (3%), and alopecias (2%) have been reported in treatment-naive patients. Stevens-Johnson syndrome has been reported during postmarketing experience.
Musculoskeletal
Musculoskeletal side effects have included musculoskeletal and connective tissue signs and symptoms (8.7%), joint related signs and symptoms (7%), and muscle pains (3%). Joint related signs and symptoms (6%) have been reported in treatment-naive patients. Myositis, osteonecrosis, rhabdomyolysis, and increased blood creatine kinase have been reported in less than 2% of patients.
Gastrointestinal
Gastrointestinal side effects have included gastrointestinal and abdominal pains (8.2%), constipation (6%), dyspeptic signs/symptoms (2.8%), ulceration stomatitis (2.6%), diarrhea, nausea, gingivitis, dry mouth, flatulence, and vomiting. Flatulence, bloating, and distention (10%), gastrointestinal atonic and hypomotility disorders NEC (9%), and gastrointestinal signs and symptoms NEC (3%) have been reported in treatment-naive patients.
Hepatic
Hepatic side effects have included elevated aspartate transaminase (greater than 5 times ULN; 4.8%), alanine transaminase (greater than 5 times ULN; 2.6%), and total bilirubin (greater than 5 times ULN; 5.5%). Elevated aspartate transaminase (greater than 5 times ULN; 4%) and alanine transaminase (greater than 5 times ULN; 3.9%) have been reported in treatment-naive patients. Hepatic cirrhosis, hepatic failure, cholestatic jaundice, portal vein thrombosis, hypertransaminasemia, and jaundice have been reported in less than 2% of patients. Hepatotoxicity, sometimes associated with rash and eosinophilia, has been reported.
Psychiatric
Psychiatric side effects have included disturbances in initiating and maintaining sleep (8%), disturbances in consciousness (4%), depressive disorders (4%), anxiety symptoms (4%), parasomnias, and somnolence.
Metabolic
Metabolic side effects have included appetite disorders (8%), elevated amylase (greater than 2 times ULN; 5.7%), elevated lipase (greater than 2 times ULN; 4.9%), unintentional weight loss (wasting), and hyperlipidemia. Elevated amylase (greater than 2 times ULN: 4.3%) and creatine kinase (3.9%) have been reported in treatment-naive patients.
Oncologic
Oncologic side effects have included benign skin neoplasms (3%). Abdominal neoplasm, anal cancer, anaplastic large cell lymphomas (T- and null-cell types), malignant bile duct neoplasms, endocrine neoplasms (malignant and unspecified), basal cell carcinoma, Bowen's disease, cholangiocarcinoma, diffuse large B-cell lymphoma, lymphoma, metastases to liver, esophageal carcinoma, squamous cell carcinoma, squamous cell carcinoma of skin, and tongue neoplasm (unspecified malignant stage) have been reported in less than 2% of patients.
Hematologic
Hematologic side effects have included decreased absolute neutrophil count (less than 750/mm3; 4.3%). Anemias NEC (8%), decreased absolute neutrophil count (less than 750/mm3; 5.7%), decreased hemoglobin (less than 7 g/dL; 2.9%), and neutropenias (4%) have been reported in treatment-naive patients. Marrow depression and hypoplastic anemia have been reported in less than 2% of patients.
Genitourinary
Genitourinary side effects have included bladder and urethral symptoms (5%), urinary tract signs and symptoms (3%), and urinary abnormalities. Bladder and urethral symptoms (4%) and erection and ejaculation conditions and disorders (3%) have been reported in treatment-naive patients.
Ocular
Ocular side effects have included conjunctivitis (2%), ocular infections, inflammations, and associated manifestations (2%), abnormal vision, and eye pain.
TopMore Selzentry resources
- Selzentry Prescribing Information (FDA)
- Selzentry Monograph (AHFS DI)
- Selzentry Advanced Consumer (Micromedex) - Includes Dosage Information
- Selzentry Consumer Overview
- Selzentry MedFacts Consumer Leaflet (Wolters Kluwer)
- Maraviroc Professional Patient Advice (Wolters Kluwer)
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