XARTEMIS XR SIDE EFFECTS
- Generic Name: oxycodone hydrochloride and acetaminophen extended-release
- Brand Name: Xartemis XR
SIDE EFFECTS
The following treatment-emergent adverse reactions are discussed in more detail in other sections of the labeling:
- Respiratory Depression
- Hepatotoxicity
- Use With Other Acetaminophen-containing Products
- Interactions with Other CNS Depressants
Clinical Studies Experience
Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in clinical practice.
In safety data from two Phase 3 (one placebo-controlled, one open-label) trials where multiple doses of XARTEMIS XR were administered for up to 42 days, the most common adverse reactions (reported by ≥ 10% in any XARTEMIS XR dose group) were: nausea, dizziness and vomiting. The most common reasons for discontinuation due to AEs in these 2 studies (reported by ≥ 1% in any XARTEMIS XR dose group) were vomiting (4.8%) and nausea (4.1%); there were no reports of these adverse reactions in the placebo-treated patients.
A total of 1028 subjects in 14 clinical studies were treated with XARTEMIS XR during the clinical development program, including 892 subjects treated with 15 mg oxycodone and 650 mg acetaminophen. This dosage regimen of XARTEMIS XR was administered to 607 patients in two Phase 3 studies (one placebo-controlled and one open-label).
In a placebo-controlled post-bunionectomy acute pain trial, 329 patients were dosed with 15 mg oxycodone and 650 mg acetaminophen XARTEMIS XR or placebo orally every 12 hours, for approximately 48 hours (blinded period). Table 1 lists the adverse reactions reported by ≥ 1% of XARTEMIS XR-treated patients and more frequently in XARTEMIS XRtreated patients compared with placebo.
Table 1: Treatment-Emergent Adverse Reactions* Reported by ≥ 1% of XARTEMIS XR-Treated Patients and More Frequently than Placebo in XARTEMIS XR-Treated Patients with Postoperative Bunionectomy Pain (blinded period)
| Preferred Term | XARTEMIS XR (N = 166)% |
Placebo (N = 163)% |
| Nausea | 31 | 6 |
| Dizziness | 13 | 1 |
| Headache | 10 | 5 |
| Vomiting | 9 | 0 |
| Constipation | 4 | 3 |
| Somnolence | 4 | < 1 |
| Rash | 2 | 1 |
| Blister | 1 | < 1 |
| Dysuria | 1 | 0 |
| Edema peripheral | 1 | 0 |
| Erythema | 1 | 0 |
| Excoriation | 1 | 0 |
| Hot flush | 1 | < 1 |
| Pruritus generalized | 1 | 0 |
| *A treatment-emergent adverse reaction refers to any untoward medical event associated with the use of the drug in humans, whether or not considered drug-related. | ||
Other Adverse Reactions Observed During The Premarketing Evaluation Of XARTEMIS XR
The following adverse drug reactions not listed above occurred in ≥ 1% of XARTEMIS XR-treated patients in the pooled safety data from two Phase 3 studies (including a placebo-controlled and an open-label non-controlled safety study) where multiple-doses of XARTEMIS XR were administered every 12 hours for up to 42 days:
Gastrointestinal disorders: dry mouth, dyspepsia, diarrhea
General disorders and administration site conditions: fatigue
Investigations: hepatic enzyme increased
Psychiatric disorders: insomnia
Respiratory, thoracic and mediastinal disorders: cough
The following adverse drug reactions occurred in < 1% of XARTEMIS XR-treated patients in the pooled safety data from the two Phase 3 studies described above:
Cardiac disorders: palpitations
Eye and ear disorders: tinnitus, vision blurred
Gastrointestinal disorders: abdominal discomfort, abdominal pain, esophageal spasm
General disorders and administration site conditions: asthenia, chest discomfort, chills, contusion, fall, feeling jittery, malaise, non-cardiac chest pain, thirst
Immune system disorders: hypersensitivity
Investigations: alanine aminotransferase increased, aspartate aminotransferase increased, blood lactate dehydrogenase increased, blood pressure increased, gamma-glutamyltransferase increased, liver functional test abnormal
Metabolic and nutritional: decreased appetite
Musculoskeletal and connective tissue disorders: arthralgia, musculoskeletal stiffness
Nervous system disorders: cognitive disorder, memory impairment, migraine, myoclonus, paraesthesia, sedation, tremor
Psychiatric disorders: anxiety, confusional state, disorientation, euphoric mood, mood altered, sleep disorder, withdrawal syndrome
Renal and urinary disorders: urine flow decreased
Respiratory, thoracic and mediastinal disorders: dyspnea, hiccups, hypopnea, oropharyngeal pain, throat irritation
Skin and subcutaneous tissue disorders: dermatitis, ecchymosis, hyperhidrosis, urticaria
Vascular disorders: flushing, hypertension
SRC: NLM .