Keppra XR

• UCB, Inc.

Before taking Keppra XR, tell your doctor about all of your medical conditions, including if you:

• have or have had depression, mood problems or suicidal thoughts or behavior
• have kidney problems
• are pregnant or planning to become pregnant. It is not known if Keppra XR will harm your unborn baby. 
• are breastfeeding. Keppra XR can pass into your milk and may harm your baby. 

Tell your doctor about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements. Do not start a new medicine without first talking with your doctor.

Know the medicines you take. Keep a list of them to show your doctor and pharmacist each time you get a new medicine.

• Seizure (Epilepsy)
• Seizures Symptoms and Types

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (Keppra XR® extended-release tablets):
  • For partial onset seizures:
    • Adults and children 16 years and older—At first, 1000 milligrams (mg) once per day. Your doctor may adjust your dose as needed. However, the dose is usually not more than 3000 mg per day.
    • Children younger than 16 years—Use and dose must be determined by your doctor.
• For oral dosage form (Keppra® solution or tablets):
  • For partial onset seizures:
    • Adults and children 16 years and older—At first, 500 milligrams (mg) 2 times a day. Your doctor may adjust your dose as needed. However, the dose is usually not more than 3000 mg per day.
    • Children 4 to 15 years—Dose is based on body weight and must be determined by your doctor. The usual starting dose is 10 milligrams (mg) per kilogram (kg) of body weight 2 times a day. Your doctor may adjust your dose as needed. However, the dose is usually not more than 60 mg per kg of body weight per day.
    • Children 6 months to 3 years—Dose is based on body weight and must be determined by your doctor. The usual starting dose is 10 mg per kg of body weight 2 times a day. Your doctor may adjust your dose as needed. However, the dose is usually not more than 50 mg per kg of body weight per day.
    • Children 1 to 5 months—Dose is based on body weight and must be determined by your doctor. The usual starting dose is 7 mg per kg of body weight 2 times a day. Your doctor may adjust your dose as needed. However, the dose is usually not more than 42 mg per kg of body weight per day.
    • Children younger than 1 month—Use and dose must be determined by your doctor.
  • For juvenile myoclonic seizures:
    • Children 12 years and older—At first, 500 milligrams (mg) 2 times a day. Your doctor may adjust your dose as needed. However, the dose is usually not more than 3000 mg per day.
    • Children younger than 12 years—Use and dose must be determined by your doctor.
  • For primary generalized tonic-clonic seizures:
    • Adults and children 16 years and older—At first, 500 milligrams (mg) 2 times a day. Your doctor may adjust your dose as needed. However, the dose is usually not more than 3000 mg per day.
    • Children 6 to 15 years—Dose is based on body weight and must be determined by your doctor. The usual starting dose is 10 milligrams (mg) per kilogram (kg) of body weight 2 times a day. Your doctor may adjust your dose as needed. However, the dose is usually not more than 60 mg per kg of body weight per day.
    • Children younger than 6 years—Use and dose must be determined by your doctor.
• For oral dosage forms (Spritam® tablets, Spritam® tablets for suspension):
  • For partial onset seizures:
    • Adults and children 4 years and older weighing over 40 kilograms (kg)—Dose is based on body weight and must be determined by your doctor. The usual starting dose is 500 milligrams (mg) 2 times a day. Your doctor may adjust your dose as needed. However, the dose is usually not more than 3000 mg per day.
    • Children 4 years and older weighing 20 to 40 kg—Dose is based on body weight and must be determined by your doctor. The usual starting dose is 250 mg 2 times a day. Your doctor may adjust your dose as needed. However, the dose is usually not more than 1500 mg per day.
    • Children younger than 4 years and weighing less than 20 kg—Use is not recommended.
  • For juvenile myoclonic seizures:
    • Children 12 years and older—At first, 500 milligrams (mg) 2 times a day. Your doctor may adjust your dose as needed. However, the dose is usually not more than 3000 mg per day.
    • Children younger than 12 years—Use and dose must be determined by your doctor.
  • For primary generalized tonic-clonic seizures:
    • Adults and children 6 years and older weighing over 40 kilograms (kg)—Dose is based on body weight and must be determined by your doctor. The usual starting dose is 500 milligrams (mg) 2 times a day. Your doctor may adjust your dose as needed. However, the dose is usually not more than 3000 mg per day.
    • Children 6 years and older weighing 20 to 40 kg—Dose is based on body weight and must be determined by your doctor. The usual starting dose is 250 mg 2 times a day. Your doctor may adjust your dose as needed. However, the dose is usually not more than 1500 mg per day.
    • Children younger than 6 years and weighing less than 20 kg—Use is not recommended.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

• Aggressive or angry
• anxiety
• change in personality
• chills
• cough or hoarseness
• crying
• depersonalization
• diarrhea
• dry mouth
• euphoria
• fever
• general feeling of discomfort or illness
• headache
• hyperventilation
• irregular heartbeats
• irritability
• joint pain
• loss of appetite
• lower back or side pain
• mental depression
• muscle aches and pains
• nausea
• painful or difficult urination
• paranoia
• quick to react or overreact emotionally
• rapidly changing moods
• restlessness
• shaking
• shivering
• shortness of breath
• sleepiness or unusual drowsiness
• sore throat
• stuffy or runny nose
• sweating
• trouble sleeping
• unusual tiredness or weakness
• vomiting

• Bloody nose
• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
• clumsiness or unsteadiness
• discouragement
• dizziness or lightheadedness
• double vision
• earache
• feeling of constant movement of self or surroundings
• feeling sad or empty
• increase in body movements
• loss of bladder control
• loss of memory
• mood or mental changes
• outburst of anger
• pain or tenderness around the eyes and cheekbones
• problems with memory
• redness or swelling in the ear
• seizures
• sensation of spinning
• shakiness and unsteady walk
• shakiness in the legs, arms, hands, or feet
• tightness of the chest
• tiredness
• trembling or shaking of the hands or feet
• trouble concentrating
• unsteadiness, trembling, or other problems with muscle control or coordination

• Attempts at killing oneself
• being forgetful
• bleeding gums
• blistering, peeling, or loosening of the skin
• bloating
• blood in the urine or stools
• bloody, black, or tarry stools
• blurred vision
• changes in vision
• chest pain
• constipation
• dark urine
• difficulty with moving
• fast heartbeat
• fever with or without chills
• general feeling of tiredness or weakness
• high fever
• increase in body movements
• indigestion
• itching
• light-colored stools
• muscle pains or stiffness
• painful or difficult urination
• pains in the stomach, side, or abdomen, possibly radiating to the back
• pale skin
• pinpoint red spots on the skin
• red skin lesions, often with a purple center
• red, irritated eyes
• sores, ulcers, or white spots on the lips or in the mouth
• stomach pain, continuing
• swollen glands
• swollen joints
• thoughts or attempts at killing oneself
• trouble with balance
• twitching, twisting, or uncontrolled repetitive movements of the tongue, lips, face, arms, or legs
• uncontrolled jerking or twisting movements of the hands, arms, or legs
• uncontrolled movements of the lips, tongue, or cheeks
• unexplained bleeding or bruising
• unusual bleeding or bruising
• upper right abdominal or stomach pain
• weight loss
• yellow eyes or skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Loss of strength or energy
• muscle pain or weakness
• pain
• tender, swollen glands in the neck
• trouble swallowing
• unusual weak feeling
• voice changes

• Body aches or pain
• burning, dry, or itching eyes
• change in the color of the skin
• congestion
• cough increased
• rash
• sneezing

• Hair loss or thinning of the hair
• skin rash, encrusted, scaly, and oozing

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

• It is used to treat seizures.
• It may be given to you for other reasons. Talk with the doctor.

Advise the patient to read the FDA-approved patient labeling (Medication Guide).

Psychiatric Reactions and Changes in Behavior

Advise patients that KEPPRA XR may cause changes in behavior (e.g. irritability and aggression). In addition, patients should be advised that they may experience changes in behavior that have been seen with other formulations of KEPPRA, which include agitation, anger, anxiety, apathy, depression, hostility, and psychotic symptoms [see Warnings and Precautions (5.1)].

Suicidal Behavior and Ideation

Counsel patients, their caregivers, and/or families that antiepileptic drugs (AEDs), including KEPPRA XR, may increase the risk of suicidal thoughts and behavior and advise patients to be alert for the emergence or worsening of symptoms of depression; unusual changes in mood or behavior; or suicidal thoughts, behavior, or thoughts about self-harm. Advise patients, their caregivers, and/or families to immediately report behaviors of concern to a healthcare provider [see Warnings and Precautions (5.2)].

Effects on Driving or Operating Machinery

Inform patients that KEPPRA XR may cause dizziness and somnolence. Inform patients not to drive or operate machinery until they have gained sufficient experience on KEPPRA XR to gauge whether it adversely affects their ability to drive or operate machinery [see Warnings and Precautions (5.3)].

Anaphylaxis and Angioedema

Advise patients to discontinue KEPPRA XR and seek medical care if they develop signs and symptoms of anaphylaxis or angioedema [see Warnings and Precautions (5.4)].

Dermatological Adverse Reactions

Advise patients that serious dermatological adverse reactions have occurred in patients treated with levetiracetam and instruct them to call their physician immediately if a rash develops [see Warnings and Precautions (5.5)].

Dosing and Administration

Patients should be instructed to only take KEPPRA XR once daily and to swallow the tablets whole. They should not be chewed, broken, or crushed.

Inform patients that they should not be concerned if they occasionally notice something that looks like swollen pieces of the original tablet in their stool.

Pregnancy

Advise patients to notify their healthcare provider if they become pregnant or intend to become pregnant during KEPPRA XR therapy. Encourage patients to enroll in the North American Antiepileptic Drug (NAAED) pregnancy registry if they become pregnant. This registry is collecting information about the safety of antiepileptic drugs during pregnancy. To enroll, patients can call the toll free number 1-888-233-2334 [see Use in Specific Populations (8.1)].

KEPPRA XR manufactured for
UCB, Inc.
Smyrna, GA 30080

KEPPRA XR is a registered trademark of the UCB Group of companies
© 2017, UCB, Inc., Smyrna, GA 30080
All rights reserved.

Common side effects of Keppra XR include: infection, asthenia, drowsiness, aggressive behavior, agitation, anxiety, apathy, depersonalization, depression, hostility, mental disorders, nervousness, outbursts of anger, emotional lability, and irritability. Other side effects include: dizziness, abnormal behavior, influenza, and nasopharyngitis. See below for a comprehensive list of adverse effects.