Patient

For What Conditions is SUBVENITE Indicated?

SUBVENITE (lamotrigine tablets, USP) are indicated for:

Epilepsy—adjunctive therapy in patients aged 2 years and older:

 

  • partial-onset seizures.
  • primary generalized tonic-clonic seizures.
  • generalized seizures of Lennox-Gastaut syndrome.

 

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.

 

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.

What are generic and branded generic products?

Generic products are just like brand-name products in that they are therapeutically equivalent but tend to have a lower price than the brand-name drug.

 

Branded generic products are generically priced, therapeutically equivalent medications that happen to have both a brand and generic name. Unlike other generics, branded generics have a brand name which allows patients and healthcare providers to request the specific generic product by brand name.

 

SUBVENITE Starter Kits are OWP Pharmaceuticals’ branded generic alternative to Lamictal® (lamotrigine) tablets Starter Kits. Your healthcare provider should always write DAW-1 (Dispense As Written — or appropriate language required by your state) to ensure that your prescription is not substituted for another Starter Kit. Writing SUBVENITE Starter Kit DAW-1 ensures you will receive OWP’s Starter Kit.

 

Discuss with your healthcare provider what options are best for you. Make sure your SUBVENITE Starter Kit matches the prescription you received from your healthcare provider.

At the Pharmacy…

If you and your healthcare provider decide that the SUBVENITE Starter Kit is right for you, go to any local pharmacy to fill your prescription. You may also call 800-273-6729 for assistance in finding a pharmacy to fill your prescription.

 

To ensure you receive the medication you and your healthcare provider discussed, make sure your prescription is marked “DAW-1” (Dispense as Written — or the appropriate language required by your state). This instructs the pharmacy to fill the exact Starter Kit on the prescription.

Subvenite Blue Starter Kit

Orange Starter Kit: Total 49 Tablets
(42 X 25mg) (7 X 100mg)
NDC 69102-300-01

Subvenite Blue Starter Kit

Blue Starter Kit: Total 35 Tablets
(35 X 25mg)
NDC 69102-306-01

Subvenite Blue Starter Kit

Green Starter Kit: Total 98 Tablets
(84 X 25mg) (14 X 100mg)
NDC 69102-312-01

Make sure when your prescription is filled:

The Starter Kit says SUBVENITE

If you have difficulties filling your SUBVENITE Starter Kit prescription, speak to the pharmacist about receiving the correct Starter Kit.

You can ask your pharmacist to note in your chart not to substitute your prescription without you and your healthcare provider’s consent. This helps ensure that you receive the drug you were prescribed, instead of receiving another substitute. If you have difficulties filling your SUBVENITE prescription at your local pharmacy, please contact your prescribing healthcare provider’s office or OWP Pharmaceuticals for assistance at 1-800-273-6729.

To find a pharmacy in your area that carries SUBVENITE Starter Kits please visit the “Pharmacy Locator” page on this website or visit: owppharma.com/pharmacy-locator

Consistent Treatment Plans Require Communication

Healthcare Provider Office

Make sure your healthcare provider writes DAW-1 on your initial prescription.

Pharmacist

If your pharmacist attempts to substitute your SUBVENITE Starter Kit prescription for a bottle of tablets, make sure they contact your healthcare provider’s office to explain why before filling your prescription.

You

Know that you have the right to choose either generic, branded generic, or brand name medications.

*Lamictal® is a registered trademark of GlaxoSmithKline, Inc.

For general questions or inquiries please contact us at: info@owppharma.com
For SUBVENITE Starter Kit questions please contact us at: medinfo@owppharma.com
To report-safety related concerns please contact us at: safety@owppharma.com

OWOS1062V3 12/20

SUBVENITE SAFETY INFORMATION

IMPORTANT SAFETY INFORMATION

 

WARNING: SERIOUS SKIN RASHES

Cases of lifethreatening serious rashes, including StevensJohnson syndrome and toxic epidermal necrolysis, and/or rashrelated death have been caused by lamotrigine. 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 of SUBVENITE.

Benign rashes are also caused by lamotrigine; 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.

 

Please refer to the full Prescribing Information for SUBVENITE (lamotrigine tablets, USP) for the complete boxed warning.

 

SUBVENITE (lamotrigine tablets, USP) are indicated for:

 

Epilepsy—adjunctive therapy in patients aged 2 years and older:

  • partial-onset seizures.
  • primary generalized tonic-clonic seizures.
  • generalized seizures of Lennox-Gastaut syndrome.

 

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.

 

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.

 

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.

 

CONTRAINDICATIONS

SUBVENITE is contraindicated in patients who have demonstrated hypersensitivity to the drug or its ingredients.

 

WARNINGS & PRECAUTIONS

  • Cases of life‐threatening serious rashes, including Stevens‐Johnson syndrome, toxic epidermal necrolysis, and/or rash‐related death, have been caused by SUBVENITE. The rate of serious rash is greater in pediatric patients than in adults. Refer to SUBVENITE – BOXED WARNING.
  • SUBVENITE should not be abruptly discontinued. In patients with epilepsy there is a possibility of increasing seizure frequency. Unless safety concerns require a more rapid withdrawal, the dose of SUBVENITE should be tapered over a period of at least 2 weeks. Refer to SUBVENITE – DOSAGE AND ADMINISTRATION.
  • Hemophagocytic lymphohistiocytosis (HLH) has occurred in adult and pediatric patients taking SUBVENITE. HLH is a life-threatening syndrome of pathologic immune activation characterized by clinical signs and symptoms of extreme systemic fibrosis. It is associated with high mortality rates if not recognized early and treated. HLH has presented with systemic inflammation (fever, rash, hepatosplenomegaly, and organ system dysfunction) and blood dyscrasias. Symptoms have been reported to occur within 8 to 24 days following the initiation of treatment. Patients who develop early manifestations of pathologic immune activation should be evaluated immediately, and a diagnosis of HLH should be considered.
  • Multiorgan hypersensitivity reactions, also known as Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), have occurred with SUBVENITE. Some have been fatal or life threatening. DRESS typically, although not exclusively, presents with fever, rash, and/or lymphadenopathy in association with other organ system involvement, such as hepatitis, nephritis, hematologic abnormalities, myocarditis, or myositis, sometimes resembling an acute viral infection. Eosinophilia is often present. This disorder is variable in its expression, and other organ systems not noted here may be involved. Fatalities associated with acute multiorgan failure and various degrees of hepatic failure have been reported. Prior to initiation of treatment with SUBVENITE, the patient should be instructed that a rash or other signs or symptoms of hypersensitivity (e.g., fever, lymphadenopathy) may herald a serious medical event and that the patient should report any such occurrence to a healthcare provider immediately.
  • In vitro testing showed that SUBVENITE exhibits Class IB antiarrhythmic activity at therapeutically relevant concentrations. Based on these in vitro findings, SUBVENITE could slow ventricular
    conduction (widen QRS) and induce proarrhythmia, which can lead to sudden death, in patients with clinically important structural or functional heart disease (i.e., patients with heart failure,
    valvular heart disease, congenital heart disease, conduction system disease, ventricular arrhythmias, cardiac channelopathies [e.g., Brugada syndrome], clinically important ischemic heart
    disease, or multiple risk factors for coronary artery disease). Any expected or observed benefit of SUBVENITE in an individual patient with clinically important structural or functional heart disease
    must be carefully weighed against the risks for serious arrythmias and/or death for that patient. Concomitant use of other sodium channel blockers may further increase the risk of proarrhythmia.
  • There have been reports of blood dyscrasias that may or may not be associated with multiorgan hypersensitivity (also known as DRESS). These have included neutropenia, leukopenia, anemia, thrombocytopenia, pancytopenia, and, rarely, aplastic anemia and pure red cell aplasia.
  • Antiepileptic drugs (AEDs), including SUBVENITE, increase the risk of suicidal thoughts or behavior in patients taking these drugs for any indication. Patients treated with any AED for any indication should be monitored for the emergence or worsening of depression, suicidal thoughts or behavior, and/or any unusual changes in mood or behavior. Anyone prescribing SUBVENITE must balance the risk of suicidal thoughts or behavior with the risk of untreated illness. Epilepsy and many other illnesses for which AEDs are prescribed are themselves associated with morbidity and mortality and an increased risk of suicidal thoughts and behavior. Should suicidal thoughts and behavior emerge during treatment with SUBVENITE, the prescriber needs to consider whether the emergence of these symptoms in any given patient may be related to the illness being treated. Patients, their caregivers, and families should be informed that AEDs increase the risk of suicidal thoughts and behavior and should be advised of the need to be alert for the emergence or worsening of the signs and symptoms of depression, any unusual changes in mood or behavior, the emergence of suicidal thoughts, behavior, or thoughts about self‐harm. Behaviors of concern should be reported immediately to healthcare providers.
  • Therapy with SUBVENITE increases the risk of developing aseptic meningitis. Because of the potential for serious outcomes of untreated meningitis due to other causes, patients should also be evaluated for other causes of meningitis and treated as appropriate.
  • Medication errors involving SUBVENITE have occurred. In particular, the name SUBVENITE or lamotrigine can be confused with the names of other commonly used medications. Medication errors may also occur between the different formulations of SUBVENITE.
  • Some estrogen‐containing oral contraceptives have been shown to decrease serum concentrations of lamotrigine. Dosage adjustments will be necessary in most patients who start or stop estrogen‐containing oral contraceptives while taking SUBVENITE.
  • Valid estimates of the incidence of treatment‐emergent status epilepticus among patients treated with SUBVENITE are difficult to obtain because reporters participating in clinical trials did not all employ identical rules for identifying cases. At a minimum, 7 of 2,343 adult patients had episodes that could unequivocally be described as status epilepticus. In addition, a number of reports of variably defined episodes of seizure exacerbation (e.g., seizure clusters, seizure flurries) were made.
  • During the premarketing development of SUBVENITE, 20 sudden and unexplained deaths were recorded among a cohort of 4,700 patients with epilepsy (5,747 patient‐years of exposure).
  • Because valproate reduces the clearance of lamotrigine, the dosage of SUBVENITE in the presence of valproate is less than half of that required in its absence.
  • Because lamotrigine binds to melanin, it could accumulate in melanin‐rich tissues over time. This raises the possibility that lamotrigine may cause toxicity in these tissues after extended use. Although there are no specific recommendations for periodic ophthalmological monitoring, prescribers should be aware of the possibility of long‐term ophthalmologic effects.
  • There have been reports of decreased lamotrigine concentrations during pregnancy and restoration of pre‐partum concentrations after delivery. As with other AEDs, physiological changes during pregnancy may affect lamotrigine concentrations and/or therapeutic effect. Dosage adjustments may be necessary to maintain clinical response.
  • Lamotrigine is present in milk from lactating women taking SUBVENITE. Caution should be exercised when SUBVENITE is administered to a nursing woman.
  • Safety and efficacy of SUBVENITE used as adjunctive treatment for partial-onset seizures in very young pediatric patients (aged 1 to 24 months) has not demonstrated.
  • Safety and efficacy of SUBVENITE for the maintenance treatment of bipolar disorder in pediatric patients has not been demonstrated.
  • Because lamotrigine is metabolized predominantly by glucuronic acid conjugation, drugs that are known to induce or inhibit glucuronidation may affect the apparent clearance of lamotrigine and doses of SUBVENITE may require adjustment based on clinical response.

 

DOSING GUIDELINES & CONSIDERATIONS

  • Refer to the SUBVENITE ‐ DOSAGE AND ADMINISTRATION section of the full prescribing information for recommended dosing guidelines for SUBVENITE.
  • There are a number of significant drug interactions with SUBVENITE. Refer to the SUBVENITE ‐ DRUG INTERACTIONS section of the full prescribing information.

 

ADVERSE REACTIONS

  • See the ADVERSE REACTIONS section of the SUBVENITE full prescribing information for adverse reaction rates from clinical trials conducted under widely varying conditions.
  • The 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.
  • The most common adverse reactions (incidence >5%) in adults with bipolar disorder were nausea, insomnia, somnolence, back pain, fatigue, rash, rhinitis, abdominal pain, and xerostomia.
  • 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.

 

Please refer to the full Prescribing Information for SUBVENITE Tablets, including Medication Guide at www.subvenite.com.

05/2021

RESOURCES

Before you fill your prescription, make sure your pharmacy has the branded generic SUBVENITE Starter Kit in stock. If not, you can request it. The Savings Card can only be used for the branded generic SUBVENITE Starter Kit.

When calling please note the following NDC codes for each Starter Kit:

Orange: NDC 69102-300-01
Blue: NDC 69102-306-01
Green: NDC 69102-312-01