Health Care Provider

Why Prescribe ROWEEPRA?

  • ROWEEPRA is OWP Pharmaceuticals’ branded generic alternative, AB rated to Keppra® (levetiracetam) tablets. ROWEEPRA can be prescribed DAW.
  • Writing ROWEEPRA™ DAW ensures the same manufacturer refill-to-refill.
  • ROWEEPRA pills are the same shape, size and color every time.
  • ROWEEPRA is available at a significant cost savings from brand name Keppra®.
  • Proceeds from each ROWEEPRA prescription helps treat people with epilepsy in under-resourced areas globally.

Generic Bioequivalency?

Generic products are considered bioequivalent to the brand (reference drug) if the confidence interval (90%) for AUC and Cmaxis within 80-125% of the brand (reference drug).1

The FDA has determined that generic drugs that are classified as therapeutically equivalent can be substituted with the full expectation that the substituted product will produce the same clinical effect and safety profile as the reference product.2

FDA Approved Range for Generic Bioequivalency

DAW – Ensuring your patient receives the medication you prescribe

DAW-Roweepra-RX

Always write DAW (Dispense As Written or appropriate language required by your state) to ensure that your patient’s prescription is not substituted for another generic.

Patient Education – Empowering your patient with information

  • Encourage your patient to ask for branded generic ROWEEPRA™ at the pharmacy.
  • Ask your patient to check these details upon receiving medication:
    • The medication name is ROWEEPRA™.
    • The dosage on their bottle matches the dosage on the original Rx.
    • The manufacturer is OWP Pharmaceuticals.
  • Inform your patient that an alternative to fulfillment at their local pharmacy is to mail order ROWEEPRA™ online.
  • Instruct your patient to contact your office if they have difficulty filling their prescription at the local pharmacy or if they have any questions regarding their ROWEEPRA™ prescription.
  • Encourage your patient to bring their ROWEEPRA™ medication to their follow-up visit.

ROWEEPRA™ INFORMATION FOR THE PHARMACIST

Available through the wholesalers: Amerisource, Cardinal, McKesson, HD Smith, Morris & Dickson, Mutual and others. If you have questions, please contact us at info@roweepra.com.

References

1. Center for Drug Evaluation and Research. Guidance for Industry: Statistical Approaches to Establishing Bioequivalence. Silver Spring, MD: Food and Drug Administration, US Department of Health and Human Services; 2001. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm070244.pdf. Accessed September 26, 2013.
2. Office of Generic Drugs, Center for Drug Evaluation and Research. Approved Drug Products With Therapeutic Equivalence Evaluations. 33rd ed. Silver Spring, MD: Food and Drug Administration, US Department of Health and Human Services; 2013. http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/ucm071436.pdf. Accessed September 26, 2013.

*Keppra® is a registered trademark of UCB Biopharma

ROWEEPRA SAFETY INFORMATION

INDICATIONS AND USAGE

ROWEEPRA is indicated for adjunctive therapy in the treatment of:

 

  • Partial onset seizures in patients one month of age and older with epilepsy
  • Myoclonic seizures in patients 12 years of age and older with juvenile myoclonic epilepsy
  • Primary generalized tonic-clonic seizures in patients 6 years of age and older with idiopathic generalized epilepsy

 

IMPORTANT SAFETY INFORMATION

WARNINGS AND PRECAUTIONS

 

  • Behavioral abnormalities including psychotic symptoms, suicidal ideation, irritability, and aggressive behavior have been observed; monitor patients for psychiatric signs and symptoms
  • Suicidal Behavior and Ideation: Monitor patients for new or worsening depression, suicidal thoughts/behavior, and/or unusual changes in mood or behavior
  • Monitor for somnolence and fatigue and advise patients not to drive or operate machinery until they have gained sufficient experience on ROWEEPRA
  • Withdrawal Seizures: ROWEEPRA must be gradually withdrawn
  • Serious Dermatological Reactions including Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis
  • Coordination Difficulties
  • Hematological abnormalities; cases of agranulocytosis have been reported in the post-marketing setting
  • Increase in blood pressure; patients 1 month to
  • Seizure control during pregnancy: ROWEEPRA plasma levels may gradually decrease throughout pregnancy; monitor carefully patients during pregnancy and through the postpartum period

 

ADVERSE REACTIONS

 

  • Psychiatric Symptoms
  • Suicidal Behavior and Ideation
  • Somnolence and Fatigue
  • Serious Dermatological Reactions
  • Coordination Difficulties
  • Hematologic Abnormalities
  • Increase in Blood Pressure

 

When used for partial onset seizures

In adult patients:

most common adverse reactions: asthenia, somnolence, headache, infection, dizziness

 

In pediatric patients:

most common adverse reactions: headache, nasopharyngitis, vomiting, somnolence, fatigue, aggression

 

In pediatric patients 1 month

most common adverse reactions: somnolence, irritability

When used for myoclonic seizures
Most common adverse reactions:

somnolence, neck pain, pharyngitis, depression

 

When used for primarily generalized tonic-clonic seizures
Most common adverse reactions: nasopharyngitis, fatigue, diarrhea

 

USE IN SPECIFIC POPULATIONS
Pregnancy
ROWEEPRA should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

 

To provide information regarding the effects of in utero exposure to ROWEEPRA , physicians are advised to recommend that pregnant patients taking ROWEEPRA enroll in the North American Antiepileptic Drug (NAAED) pregnancy registry. This can be done by calling the toll free number 1-888-233-2334, and must be done by the patients themselves. Information on the registry can also be found at the website http://www.aedpregnancyregistry.org/

 

Nursing mothers

ROWEEPRA is excreted in human milk. A decision whether discontinuing the drug or discontinuing nursing should be made.

 

Pediatric population
The safety and effectiveness of ROWEEPRA in the adjunctive treatment of partial onset seizures in pediatric patients age 1 month to 16 years old with epilepsy have been established.

 

The safety and effectiveness of ROWEEPRA as adjunctive treatment of myoclonic seizures in adolescents 12 years of age and older with juvenile myoclonic epilepsy have been established.

 

The safety and effectiveness of ROWEEPRA as adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in pediatric patients 6 years of age and older with idiopathic generalized epilepsy have been established.

 

Geriatric patients
No overall differences in safety were observed between these subjects and younger subjects.

 

Renal impairment
Clearance of ROWEEPRA is decreased in patients with renal impairment and is correlated with creatinine clearance.

 

RESOURCES

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