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Privacy Policy

Effective Date: September 21, 2026

OWP Pharmaceuticals, Inc. (“OWP,” “we,” “us,” or “our”) respects your privacy. This Privacy Policy explains how we collect, use, disclose, and protect information associated with subvenite.com (the “Website”).

This Website is intended for residents of the United States. It may nevertheless be accessible from other countries.

Information You Provide

If you register to receive SUBVENITE® oral suspension email updates, we may collect your email address, first and last name, ZIP code, institution or practice name, subscription selections, and related consent information.

We may also collect information you voluntarily provide when contacting us by email, telephone, or another available channel.

Please Do Not Send Medical Information Through General Channels

Do not submit medical records, diagnoses, prescription information, patient names, treatment details, adverse-event information, or other sensitive personal or health information through the general email address or email-update form.

The Website and its general communication channels are not intended for emergencies, medical advice, diagnosis, treatment, or the submission of patient-specific medical information.

For a medical emergency, call 911 or seek immediate medical care. Product safety concerns and suspected adverse reactions should be reported through the safety-reporting channels identified on the Website.

Information Collected Automatically

When you use the Website, we and our service providers may automatically collect information such as your IP address, approximate location, browser, device type, operating system, referring page, pages viewed, interactions, and approximate dates and times of access.

We use Google Analytics and related technologies strictly for aggregate Website measurement and administration, not intentionally for targeted advertising or remarketing.

How We Use Information

We may use information to:

  • operate, maintain, secure, and improve the Website;
  • provide requested email updates and other communications;
  • administer subscriptions and honor unsubscribe requests;
  • understand aggregate Website usage and performance;
  • respond to inquiries and requests;
  • detect spam, fraud, security incidents, or misuse;
  • comply with legal, regulatory, pharmacovigilance, recordkeeping, and reporting obligations; and
  • establish, exercise, or defend legal rights.

Email Communications

The healthcare-professional email-update form is serviced by Constant Contact. Information submitted through the form may be processed and stored by Constant Contact on our behalf. You may unsubscribe using the link included in applicable emails. Unsubscribing from promotional messages does not prevent necessary administrative, legal, or safety-related communications.

Cookies and Similar Technologies

We use cookies and similar technologies as described in our Cookie Policy. These may support analytics, Website operation, security, embedded content, and email-form functionality.

How We Disclose Information

We may disclose information:

  • to service providers supporting hosting, analytics, security, communications, or Website operations;
  • to professional advisers, regulators, law-enforcement agencies, or other parties when reasonably necessary or legally required;
  • in connection with a merger, financing, reorganization, sale, transfer, or similar business transaction; or
  • with your direction or consent.

OWP does not sell personal information for monetary compensation. OWP does not intentionally use Website information for targeted advertising or cross-context behavioral advertising.

Third-Party Websites and Services

The Website may link to prescribing information, savings-program materials, pharmacies, governmental resources, social platforms, video providers, and other independently operated services. Their privacy practices are governed by their own policies. A link does not make OWP responsible for a third party’s privacy, security, content, or operations.

Downloading or presenting a savings card may lead to processing by pharmacies, insurers, claims processors, or program administrators outside this Website. Their activities are governed by their own notices and applicable law.

Data Retention

We retain information for as long as reasonably necessary for the purposes described in this policy, including legal, regulatory, security, recordkeeping, dispute-resolution, and enforcement purposes. Retention periods vary according to the nature and context of the information.

Security

We use reasonable administrative, technical, and organizational safeguards designed to protect information. No website, transmission, or storage system can be guaranteed to be completely secure, and we cannot guarantee the security of information submitted to or processed through the Website.

Children’s Privacy

The Website is not directed to children under 13, and we do not knowingly collect personal information directly from children under 13 through the Website. If you believe a child has submitted personal information, contact us so we can review the matter.

Your Privacy Choices and Rights

You may unsubscribe from promotional emails through the link provided in the message. You may also control certain cookies through your browser.

Depending on your residence and applicable law, you may have rights concerning access, correction, deletion, portability, restriction, or appeal regarding certain personal information. These rights may be subject to exceptions, identity verification, record-retention obligations, and limitations under applicable law.

To submit a privacy request, email info@owppharma.com. Please do not include sensitive medical information. We will not unlawfully discriminate against you for exercising an applicable privacy right.

International Access

The Website is intended for the United States and is operated in accordance with applicable United States requirements. If you access it from another country, information may be processed in the United States, where privacy laws may differ.

Changes to This Policy

We may update this Privacy Policy periodically. Any revised policy will be posted with an updated effective date.

Contact Us

OWP Pharmaceuticals, Inc.
701 Warrenville Road, Suite 200
Lisle, IL 60532
Telephone: 1-800-273-6729
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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