ZEPOSIA SIDE EFFECTS
- Generic Name: ozanimod capsules
- Brand Name: Zeposia
- Drug Class: Sphingosine 1-Phosphate Receptor Modulators
SIDE EFFECTS
The following serious adverse reactions are described elsewhere in the labeling:
- Infections
- Bradyarrhythmia and Atrioventricular Conduction Delays
- Liver Injury
- Fetal Risk
- Increased Blood Pressure
- Respiratory Effects
- Macular Edema
- Posterior Reversible Encephalopathy Syndrome
- Unintended Additive Immunosuppressive Effects from Prior Treatment with Immunosuppressive or Immune-Modulating Drugs
- Severe Increase in Multiple Sclerosis Disability after Stopping ZEPOSIA
- Immune System Effects after Stopping ZEPOSIA
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 clinical practice.
Common Adverse Reactions
Multiple Sclerosis
The safety of ZEPOSIA was evaluated in two randomized, double-blind, active comparator-controlled clinical studies in which 882 patients received ZEPOSIA 0.92 mg.
Table 1 lists adverse reactions that occurred in at least 2% of ZEPOSIA-treated patients and greater than comparator. The most common adverse reactions that occurred in at least 4% of ZEPOSIA-treated patients and greater than in patients who received IFN beta-1a were upper respiratory infection, hepatic transaminase elevation, orthostatic hypotension, urinary tract infection, back pain, and hypertension.
Table 1: Adverse Reactions with an Incidence of at Least 2% in ZEPOSIA-Treated Patients and at Least 1% Greater than IFN beta-1a in Patients with Multiple Sclerosis (Pooled MS Study 1 and Study 2)a
| Adverse Reactions | MS Studies 1 and 2 | |
| ZEPOSIA 0.92 mg Once Dailye (n=882) % |
IFN beta-1a 30 mcg Intramuscularly Once Weekly (n=885) % |
|
| Upper respiratory infectionb | 26 | 23 |
| Hepatic transaminase elevationc | 10 | 5 |
| Orthostatic hypotension | 4 | 3 |
| Urinary tract infection | 4 | 3 |
| Back pain | 4 | 3 |
| Hypertensiond | 4 | 2 |
| Upper abdominal pain | 2 | 1 |
| a PData are not an adequate basis for comparison of rates between ZEPOSIA and the active control. b PIncludes the following terms: nasopharyngitis, upper respiratory tract infection, pharyngitis, respiratory tract infection, bronchitis, rhinitis, viral respiratory tract infection, viral upper respiratory tract infection, rhinorrhea, tracheitis, and laryngitis. c Includes the following terms: alanine aminotransferase increased, gamma-glutamyl transferase increased, aspartate aminotransferase increased, hepatic enzyme increased, abnormal liver function test, and increased transaminases. d Includes hypertension, essential hypertension, and orthostatic hypertension. e PZEPOSIA was initiated with a 7-day titration |
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Ulcerative Colitis
The safety of ZEPOSIA was evaluated in two randomized, double-blind, placebo-controlled clinical studies [UC Study 1 (induction), n=429; and UC Study 2 (maintenance), n=230] in adult patients with moderately to severely active ulcerative colitis.Additional data from the induction period of a randomized, double-blind, placebo-controlled study (UC Study 3, NCT01647516) included 67 patients who received ZEPOSIA 0.92 mg once daily.
Common adverse reactions in UC Study 1 and Study 3 and in UC Study 2 are listed in Tables 2 and 3, respectively. The most common adverse reactions that occurred in at least 4% of ZEPOSIA-treated patients and greater than in patients who received placebo were liver test increased, upper respiratory infection, and headache.
Table 2: Adverse Reactions with an Incidence of at Least 2% in ZEPOSIA-Treated Patients and at Least 1% Greater than Placebo in Patients with Ulcerative Colitis (Pooled UC Study 1 and Study 3)
| Adverse Reactions | Induction Periods (UC Study 1 and Study 3) | |
| ZEPOSIA 0.92 mg Once Daily (n=496)cd % |
Placebo (n=281) %d |
|
| Upper respiratory infectiona | 5 | 4 |
| Liver test increasedb | 5 | 0 |
| Headache | 4 | 3 |
| Pyrexia | 3 | 2 |
| Nausea | 3 | 2 |
| Arthralgia | 3 | 1 |
| a PIncludes the following terms: streptococcal pharyngitis, pharyngotonsillitis, bacterial pharyngitis, nasopharyngitis, upper respiratory tract infection, pharyngitis, sinusitis, tonsillitis, viral upper respiratory tract infection, laryngitis, acute sinusitis, catarrh, chronic sinusitis, upper respiratory tract inflammation, chronic tonsillitis, viral pharyngitis, viral sinusitis, bacterial sinusitis, bacterial upper respiratory tract infection, viral labyrinthitis, laryngeal inflammation, and pharyngeal inflammation. b PIncludes the following terms: gamma-glutamyl transferase increased, alanine aminotransferase increased, aspartate aminotransferase increased, hepatic enzyme increased, hyperbilirubinemia, liver function test increased, blood alkaline phosphatase increased, and increased transaminases. c PZEPOSIA was initiated with a 7-day titration. d Percentages were calculated as the sum of each individual study percentage multiplied by its Cochran-Mantel-Haenszel weight. |
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Table 3: Adverse Reactions with an Incidence of at Least 4% in ZEPOSIA-Treated Patients and at Least 1% Greater than Placebo in Patients with Ulcerative Colitis (UC Study 2)
| Adverse Reactions | Maintenance Period (UC Study 2) | |
| ZEPOSIA 0.92 mg Once Daily (n=230)% |
Placebo (n=227) % |
|
| Liver test increaseda | 11 | 2 |
| Headache | 5 | <1 |
| a PIncludes the following terms: gamma-glutamyl transferase increased, alanine aminotransferase increased, aspartate aminotransferase increased, hepatic enzyme increased, hyperbilirubinemia, blood bilirubin increased, liver function test increased, and blood alkaline phosphatase increased. | ||
Other Adverse Reactions
Reduction In Heart Rate
Initiation of ZEPOSIA may result in transient decrease in heart rate in MS and UC patients.
Respiratory Effects
Dose-dependent reductions in absolute FEVR1R and FVC were observed in MS and UC patients treated with ZEPOSIA.
Malignancies
Malignancies, such as melanoma, basal cell carcinoma, breast cancer, seminoma, cervical carcinoma, and adenocarcinomas, including rectal adenocarcinoma, were reported with ZEPOSIA in controlled trials of MS and UC. An increased risk of cutaneous malignancies has been reported with another S1P receptor modulator.
Hypersensitivity
Hypersensitivity, including rash and urticaria, has been reported with ZEPOSIA in active-controlled MS clinical trials.
Peripheral Edema
Peripheral edema was observed in 3% of ZEPOSIA-treated patients and in 0.4% of patients who received placebo in UC Study 2.
SRC: NLM .