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Terms of Use

Effective Date: September 21, 2026

These Terms of Use govern your access to and use of subvenite.com (the “Website”), operated by OWP Pharmaceuticals, Inc. (“OWP,” “we,” “us,” or “our”). By accessing or using the Website, you agree to these Terms. If you do not agree, do not use the Website.

United States Audience

The Website is intended for residents of the United States. Product information may not be appropriate, approved, or legally available outside the United States. Access from another jurisdiction does not mean OWP markets or offers its products there.

Informational Purpose Only

The Website provides general educational and product information. It does not provide medical advice, diagnosis, treatment, prescribing guidance for a particular patient, or a substitute for professional judgment.

Always consult a qualified healthcare professional regarding medical conditions, treatment decisions, medication use, or suspected adverse reactions. Never disregard or delay professional medical advice because of Website content.

For a medical emergency, call 911 or seek immediate medical care.

Prescribing Information Controls

Healthcare professionals must rely on their independent clinical judgment and the current FDA-approved Full Prescribing Information when making treatment decisions. If Website content differs from the current FDA-approved labeling, the FDA-approved labeling controls.

Dosing Calculator and Healthcare-Professional Resources

Any dosing calculator or healthcare-professional tool is provided only as a supplemental informational resource. It does not replace the Full Prescribing Information, independent verification, professional judgment, or individualized patient assessment.

Users are responsible for confirming all inputs, calculations, dosing schedules, contraindications, warnings, interactions, and patient-specific considerations. OWP does not warrant that a calculator or tool is error-free, complete, appropriate for a particular patient, or continuously available.

No Physician-Patient Relationship

Use of the Website does not create a physician-patient, pharmacist-patient, advisory, fiduciary, or other professional relationship between you and OWP or its representatives.

Product Availability and Savings Information

Product availability, coverage, reimbursement, savings, eligibility, pharmacy participation, and program terms may vary and may change or end without notice. Website content does not constitute a guarantee of availability, coverage, reimbursement, savings, or eligibility.

No purchase, prescription fulfillment, payment, or healthcare transaction is completed directly through the Website.

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You may use the Website for lawful, personal, informational, or legitimate professional purposes. You may not:

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Governing Law and Venue

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Severability and Entire Agreement

If any provision is found unenforceable, it will be limited or removed to the minimum extent necessary, and the remaining provisions will continue in effect. These Terms and the policies referenced herein constitute the entire agreement concerning use of the Website.

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Email: info@owppharma.com

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Important Safety Information & Resources

WARNING: SERIOUS SKIN RASHES

See full prescribing information for complete boxed warning.

Cases of life-threatening serious rashes, including Stevens-Johnson syndrome and toxic epidermal necrolysis, and/or rash-related death have been caused by lamotrigine, the active ingredient in SUBVENITE. The rate of serious rash is greater in pediatric patients than in adults. Additional factors that may increase the risk of rash include:

  • coadministration with valproate.
  • exceeding recommended initial dose of SUBVENITE.
  • exceeding recommended dose escalation for SUBVENITE.
  • presence of the HLA-B*1502 allele. (5.1)

Benign rashes are also caused by lamotrigine, the active ingredient in SUBVENITE; however, it is not possible to predict which rashes will prove to be serious or life threatening. SUBVENITE should be discontinued at the first sign of rash, unless the rash is clearly not drug related. (5.1)
 

SUBVENITE is indicated for:
Epilepsy—adjunctive therapy in patients aged 2 years and older:

  • partial-onset seizures
  • primary generalized tonic-clonic (PGTC) seizures
  • generalized seizures of Lennox-Gastaut syndrome. (1.1)
 

Epilepsy—monotherapy in patients aged 16 years and older: Conversion to monotherapy in patients with partial-onset seizures who are receiving treatment with carbamazepine, phenytoin, phenobarbital, primidone, or valproate as the single antiepileptic drug. (1.1)

Bipolar disorder: Maintenance treatment of bipolar I disorder to delay the time to occurrence of mood episodes in patients treated for acute mood episodes with standard therapy. (1.2)

Limitations of Use: Treatment of acute manic or mixed episodes is not recommended. Effectiveness of SUBVENITE in the acute treatment of mood episodes has not been established.

DOSAGE AND ADMINISTRATION

  • Dosing is based on concomitant medications, indication, and patient age. (2.1, 2.2, 2.3, 2.4)
  • To avoid an increased risk of rash, the recommended initial dose and subsequent dose escalations should not be exceeded. (2.1, 16)
  • Do not restart SUBVENITE in patients who discontinued due to rash unless the potential benefits clearly outweigh the risks. (2.1, 5.1)
  • Adjustments to maintenance doses will be necessary in most patients starting or stopping estrogen-containing products, including oral contraceptives. (2.1, 5.9)
  • Discontinuation: Taper over a period of at least 2 weeks (approximately 50% dose reduction per week). (2.1, 5.10)
 

Epilepsy:
Adjunctive therapy—See Table 1 for patients older than 12 years and Tables 2 and 3 for patients aged 2 to 12 years. (2.2)
Conversion to monotherapy—See Table 4. (2.3)
Bipolar disorder: See Tables 5 and 6. (2.4)

DOSAGE FORMS AND STRENGTHS

  • Oral Suspension: 10 mg/mL (3)
 

CONTRAINDICATIONS

Hypersensitivity to the drug or its ingredients. (Boxed Warning, 4)

WARNINGS & PRECAUTIONS

  • Life-threatening serious rash and/or rash-related death: Discontinue at the first sign of rash, unless the rash is clearly not drug related. (Boxed Warning, 5.1).
  • Hemophagocytic lymphohistiocytosis: Consider this diagnosis and evaluate patients immediately if they develop signs or symptoms of systemic inflammation. Discontinue lamotrigine if an alternative etiology is not established. (5.2)
  • Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)/Multiorgan Hypersensitivity: Discontinue if no alternate etiology. (5.3)
  • Cardiac rhythm and conduction abnormalities: Can cause cardiac rhythm and conduction abnormalities, particularly in patients with underlying cardiac disorders or arrhythmias. (5.4)
  • Blood dyscrasias (e.g., neutropenia, thrombocytopenia, pancytopenia): May occur, either with or without an associated hypersensitivity syndrome. Monitor for signs of anemia, unexpected infection, or bleeding. (5.5)
  • Suicidal behavior and ideation: Monitor for suicidal thoughts or behaviors. (5.6)
  • Aseptic meningitis: Monitor for signs of meningitis. (5.7)
  • Medication errors due to product name confusion: Strongly advise patients to visually inspect the product to verify the received drug is correct. (5.8, 16, 17)
 

ADVERSE REACTIONS

Epilepsy: Most common adverse reactions (incidence ≥10%) in adults were dizziness, headache, diplopia, ataxia, nausea, blurred vision, somnolence, rhinitis, pharyngitis, and rash. Additional adverse reactions (incidence ≥10%) reported in children included vomiting, infection, fever, accidental injury, diarrhea, abdominal pain, and tremor. (6.1)

Bipolar Disorder: Most common adverse reactions (incidence >5%) in adults were nausea, insomnia, somnolence, back pain, fatigue, rash, rhinitis, abdominal pain, and xerostomia. (6.1)

To report SUSPECTED ADVERSE REACTIONS, contact OWP Pharmaceuticals Inc. at 1-800-273-6729 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

DRUG INTERACTIONS

  • Valproate increases lamotrigine concentrations more than 2-fold. (7, 12.3)
  • Carbamazepine, phenytoin, phenobarbital, primidone, and rifampin decrease lamotrigine concentrations by approximately 40%. (7, 12.3)
  • Estrogen-containing oral contraceptives decrease lamotrigine concentrations by approximately 50%. (7, 12.3)
  • Protease inhibitors lopinavir/ritonavir and atazanavir/lopinavir decrease lamotrigine exposure by approximately 50% and 32%, respectively. (7, 12.3)
  • Coadministration with organic cationic transporter 2 substrates with narrow therapeutic index is not recommended (7, 12.3)
 

USE IN SPECIFIC POPULATIONS

  • Pregnancy: Based on animal data may cause fetal harm. (8.1)
  • Hepatic impairment: Dosage adjustments required in patients with moderate and severe liver impairment. (2.1, 8.6)
  • Renal impairment: Reduced maintenance doses may be effective for patients with significant renal impairment. (2.1, 8.7)
 

See 17 for PATIENT COUNSELING INFORMATION and Medication Guide.

Please refer to the full Prescribing Information for SUBVENITE at www.subvenite.com.

08/2026
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