Oxtellar XR

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Seek medical treatment if you have a serious drug reaction that can affect many parts of your body. Symptoms may include: skin rash, fever, swollen glands, flu-like symptoms, muscle aches, severe weakness, unusual bruising, or yellowing of your skin or eyes.

Oxcarbazepine can reduce the sodium in your body to dangerously low levels, which can cause a life-threatening electrolyte imbalance. Call your doctor right away if you have nausea, lack of energy, confusion, feeling tired or irritable, severe weakness, muscle pain, or increased seizures.

Report any new or worsening symptoms to your doctor, such as: mood or behavior changes, depression, anxiety, or if you feel agitated, hostile, restless, hyperactive (mentally or physically), or have thoughts about suicide or hurting yourself.

Common side effects may include:

• dizziness, drowsiness, tiredness;
• balance or coordination problems;
• nausea, vomiting;
• tremors or shaking;
• double vision; or
• rash.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Oxtellar XR (Oxcarbazepine Extended-Release Tablets)

 

Oxtellar XR Professional Information

SIDE EFFECTS

The following adverse reactions are described in other sections of the labeling:

• Hyponatremia [see WARNINGS AND PRECAUTIONS]
• Anaphylactic Reactions and Angioedema [see WARNINGS AND PRECAUTIONS]
• Hypersensitivity Reactions in Patients with Hypersensitivity to Carbamazepine [see WARNINGS AND PRECAUTIONS]
• Serious Dermatological Reactions [see WARNINGS AND PRECAUTIONS]
• Suicidal Behavior and Ideation [see WARNINGS AND PRECAUTIONS]
• Withdrawal of AEDs [see WARNINGS AND PRECAUTIONS]
• Multi-Organ Hypersensitivity [see WARNINGS AND PRECAUTIONS]
• Hematologic Reactions [see WARNINGS AND PRECAUTIONS]
• Risk of Seizures in the Pregnant Patient [see WARNINGS AND PRECAUTIONS]
• Laboratory Tests [see WARNINGS AND PRECAUTIONS]

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.

The safety data presented below are from 384 patients with partial epilepsy who received Oxtellar XR® (366 adults and 18 children) with concomitant AEDs.

In addition, safety data presented below are from a total of 2,288 patients with seizure disorders treated with immediate-release oxcarbazepine; 1,832 were adults and 456 were children.

Most Common Adverse Reactions Reported by Adult Patients Receiving Concomitant AEDs in Oxtellar XR® Clinical Studies

Table 3 lists adverse reactions that occurred in at least 2% of adult patients with epilepsy treated with Oxtellar XR® or placebo and concomitant AEDs and that were numerically more common in the patients treated with any dose of Oxtellar XR® than in patients receiving placebo.

The overall incidence of adverse reactions appeared to be dose related, particularly during the titration period. The most commonly observed ( ≥ 5%) adverse reactions seen in association with Oxtellar XR® and more frequent than in placebo-treated patients were: dizziness, somnolence, headache, balance disorder, tremor, vomiting, diplopia, and asthenia.

Table 3: Adverse Reaction Incidence in a Controlled Clinical Study of Oxtellar XR® with Concomitant AEDs in Adults*

	Oxtellar XR® 2400 mg/day N=123 %	Oxtellar XR® 1200 mg/day N=122 %	Placebo N=121 %
Any System / Any Term	69	57	55
Nervous System Disorders
Dizziness	41	20	15
Somnolence	14	12	9
Headache	15	8	7
Balance Disorder	7	5	5
Tremor	1	5	2
Nystagmus	3	3	1
Ataxia	1	3	1
Gastrointestinal Disorders
Vomiting	15	6	9
Abdominal Pain Upper	0	3	1
Dyspepsia	0	3	1
Gastritis	0	3	2
Eye Disorders
Diplopia	13	10	4
Vision Blurred	1	4	3
Visual Impairment	1	3	0
General Disorders And Administration Site Conditions
Asthenia	7	3	1
Fatigue	3	6	1
Gait Disturbance	0	3	1
Drug Intolerance	2	0	0
Infections And Infestations
Nasopharyngitis	0	3	0
Sinusitis	0	3	2
* Reported by ≥ 2% of Patients Treated with Oxtellar XR® and Numerically More Frequent than in the Placebo Group

Adverse Reactions Associated with Discontinuation of Oxtellar XR® Treatment

Approximately 23.3% of the 366 adult patients receiving Oxtellar XR® in clinical studies discontinued treatment because of an adverse reaction. The adverse reactions most commonly associated with discontinuation of Oxtellar XR® (reported by ≥ 2%) were: dizziness (9.8%), vomiting (5.3%), nausea (3.7%), diplopia (3.2%), and somnolence (2.4%).

Adjunctive Therapy with Oxtellar XR® in Pediatric Patients 4 to 16 Years Old Previously Treated with other AEDs

In a pharmacokinetic study in 18 children (age 4-16 years) with partial seizures treated with different doses of Oxtellar XR®, the observed adverse reactions seen in association with Oxtellar XR® were similar to those seen in adults.

Most Common Adverse Reactions in Immediate-Release Oxcarbazepine Controlled Clinical Studies

Controlled Clinical Studies of Adjunctive Therapy with Immediate-Release Oxcarbazepine in Adults Previously Treated with other AEDs: Table 4 lists adverse reactions that occurred in at least 2% of adult patients with epilepsy treated with immediate-release oxcarbazepine or placebo with concomitant AEDs and that were numerically more common in the patients treated with any dose of immediate-release oxcarbazepine than in placebo. As immediate-release oxcarbazepine and Oxtellar XR® were not examined in the same trial, adverse event frequencies cannot be directly compared between the two formulations.

Table 4: Adverse Reaction Incidence in a Controlled Clinical Study of Immediate Release Oxcarbazepine with Concomitant AEDs in Adults*

	Immediate-Release Oxcarbazepine Dosage (mg/day)			Placebo N = 166 %
	OXC 600 N = 163 %	OXC 1200 N = 171 %	OXC 2400 N = 126 %
Body as a Whole
Fatigue	15	12	15	7
Asthenia	6	3	6	5
Edema Legs	2	1	2	1
Weight Increase	1	2	2	1
Feeling Abnormal	0	1	2	0
Cardiovascular System
Hypotension	0	1	2	0
Digestive System
Nausea	15	25	29	10
Vomiting	13	25	36	5
Pain Abdominal	10	13	11	5
Diarrhea	5	6	7	6
Dyspepsia	5	5	6	2
Constipation	2	2	6	4
Gastritis	2	1	2	1
Metabolic and Nutritional Disorders
Hyponatremia	3	1	2	1
Musculoskeletal System
Muscle Weakness	1	2	2	0
Sprains and Strains	0	2	2	1
Nervous System
Headache	32	28	26	23
Dizziness	36	32	49	13
Somnolence	20	28	36	12
Ataxia	9	17	31	5
Nystagmus	7	20	26	5
Gait Abnormal	5	10	17	1
Insomnia	4	2	3	1
Tremor	3	8	16	5
Nervousness	2	4	2	1
Agitation	1	1	2	1
Coordination Abnormal	1	3	2	1
EEG Abnormal	0	0	2	0
Speech Disorder	1	1	3	0
Confusion	1	1	2	1
Cranial Injury NOS	1	0	2	1
Dysmetria	1	2	3	0
Thinking Abnormal	0	2	4	0
Respiratory System
Rhinitis	2	4	5	4
Skin and Appendages
Acne	1	2	2	0
Special Senses
Diplopia	14	30	40	5
Vertigo	6	12	15	2
Vision Abnormal	6	14	13	4
Accommodation Abnormal	0	0	2	0
* Events in at Least 2% of Patients Treated with 2400mg/day of Immediate-Release Oxcarbazepine and Numerically More Frequent than in the Placebo Group

Other Reactions Observed in Association with the Administration of Immediate-Release Oxcarbazepine

In the paragraphs that follow, the adverse reactions, other than those in the preceding tables or text, that occurred in a total of 565 children and 1,574 adults exposed to immediate-release oxcarbazepine and that are reasonably likely to be related to drug use are presented. Events common in the population, events reflecting chronic illness and events likely to reflect concomitant illness are omitted particularly if minor. They are listed in order of decreasing frequency. Because the reports cite reactions observed in open label and uncontrolled trials, the role of immediate-release oxcarbazepine in their causation cannot be reliably determined.

Body as a Whole: fever, malaise, pain chest precordial, rigors, weight decrease.

Cardiovascular System: bradycardia, cardiac failure, cerebral hemorrhage, hypertension, hypotension postural, palpitation, syncope, tachycardia.

Digestive System: appetite increased, blood in stool, cholelithiasis, colitis, duodenal ulcer, dysphagia, enteritis, eructation, esophagitis, flatulence, gastric ulcer, gingival bleeding, gum hyperplasia, hematemesis, hemorrhage rectum, hemorrhoids, hiccup, mouth dry, pain biliary, pain right hypochondrium, retching, sialoadenitis, stomatitis, stomatitis ulcerative.

Hematologic and Lymphatic System: thrombocytopenia.

Laboratory Abnormality: gamma-GT increased, hyperglycemia, hypocalcemia, hypoglycemia, hypokalemia, liver enzymes elevated, serum transaminase increased.

Musculoskeletal System: hypertonia muscle.

Nervous System: aggressive reaction, amnesia, anguish, anxiety, apathy, aphasia, aura, convulsions aggravated, delirium, delusion, depressed level of consciousness, dysphonia, dystonia, emotional lability, euphoria, extrapyramidal disorder, feeling drunk, hemiplegia, hyperkinesia, hyperreflexia, hypoesthesia, hypokinesia, hyporeflexia, hypotonia, hysteria, libido decreased, libido increased, manic reaction, migraine, muscle contractions involuntary, nervousness, neuralgia, oculogyric crisis, panic disorder, paralysis, paroniria, personality disorder, psychosis, ptosis, stupor, tetany.

Respiratory System: asthma, bronchitis, coughing, dyspnea, epistaxis, laryngismus, pleurisy.

Skin and Appendages: acne, alopecia, angioedema, bruising, dermatitis contact, eczema, facial rash, flushing, folliculitis, heat rash, hot flushes, photosensitivity reaction, pruritus genital, psoriasis, purpura, rash erythematous, rash maculopapular, vitiligo, urticaria.

Special Senses: accommodation abnormal, cataract, conjunctival hemorrhage, edema eye, hemianopia, mydriasis, otitis externa, photophobia, scotoma, taste perversion, tinnitus, xerophthalmia.

Urogenital and Reproductive System: dysuria, hematuria, intermenstrual bleeding, leukorrhea, menorrhagia, micturition frequency, pain renal, pain urinary tract, polyuria, priapism, renal calculus, urinary tract infection.

Other: Systemic lupus erythematosus.

Postmarketing And Other Experience

The following adverse reactions have been observed in named patient programs or post-marketing experience with immediate-release oxcarbazepine or Oxtellar XR®. 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.

Body as a Whole: multi-organ hypersensitivity disorders characterized by features such as rash, fever, lymphadenopathy, abnormal liver function tests, eosinophilia and arthralgia [see WARNINGS AND PRECAUTIONS]

Anaphylaxis: [see WARNINGS AND PRECAUTIONS]

Digestive System: pancreatitis and/or lipase and/or amylase increase

Hematologic and Lymphatic Systems: aplastic anemia [see WARNINGS AND PRECAUTIONS]

Metabolism: hypothyroidism

Skin and subcutaneous tissue disorders: erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis[see WARNINGS AND PRECAUTIONS], Acute Generalized Exanthematous Pustulosis (AGEP)

Musculoskeletal, connective tissue and bone disorders: There have been reports of decreased bone mineral density, osteoporosis and fractures in patients on long-term therapy with immediate-release oxcarbazepine.

Read the entire FDA prescribing information for Oxtellar XR (Oxcarbazepine Extended-Release Tablets)

&Copy; Oxtellar XR Patient Information is supplied by Cerner Multum, Inc. and Oxtellar XR Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.