Support for Patients using Commercial or Private Insurance
Helping Patients Afford INVEGA HAFYERA™
Janssen CarePath can help you find out what affordability assistance may be available for your patients taking INVEGA HAFYERA™. You may download the Affordability Options for INVEGA HAFYERA™ resource for your patients to help them learn about cost support options.
Support for Patients using Commercial or Private Insurance
Janssen CarePath Savings Program for INVEGA HAFYERA™
Eligible patients using commercial insurance to pay for their medication can save on their out-of-pocket costs for INVEGA HAFYERA™. Depending on their health insurance plan, savings may apply toward co-pay, co-insurance, or deductible. Eligible patients pay $10 per dose with an $8,000 maximum program benefit per calendar year or 2 doses, whichever comes first. Not valid for patients using Medicare, Medicaid, or other government-funded programs to pay for their medications. Terms expire at the end of each calendar year and may change. There is no income requirement. Program does not cover the cost to give patients their injections. See full eligibility requirements.
We provide cost support directly to patients through the Janssen CarePath Savings Program. This benefit is intended to help eligible patients afford their out-of-pocket obligations as set by their health plans. The cost support is meant solely for patients—not health plans and/or their partners. If your patients are having any difficulty accessing cost support through the Janssen CarePath Savings Program, please have them contact us at 877-CarePath (877-227-3728).
Two ways to help get your patients started:
If you only want to check your patients' eligibility and enroll them in the Janssen CarePath Savings Program for INVEGA HAFYERA™, click here for the Express Enrollment Site. You may print and provide the patient with their savings card information. You will not be able to view patients' Savings Program benefits at this site.
In the Janssen CarePath Provider Portal, you can enroll your eligible patients in the Janssen CarePath Savings Program, print a Savings Program card, review your patients' available benefits, view patient transactions, and receive timely alerts and program updates.
Already registered? Log In
Patients and caregivers can enroll in the Janssen CarePath Savings Program at MyJanssenCarePath.com/express.
Patients can request that their doctor's office process their Janssen CarePath Savings Program card as secondary insurance.
If your patients' pharmacy is unable to process their Savings Program card, or if you choose to obtain INVEGA HAFYERA™ for your patients, your patient must complete, sign and return the rebate form, with the required proof of purchase, to receive a rebate check from the Janssen CarePath Savings Program. Click here to get the rebate form.
Support for Patients using Government-funded Healthcare Programs or Patients without Health Coverage
Our Medicare Resource Guide provides important information for your patients to consider as they select their health plan coverage.
Our Medicare Low-Income Subsidy Brochure provides extra help to low-income residents of the United States who are enrolled in Medicare Prescription Drug Plans.
Janssen CarePath can provide information about other resources that may be able to help your patients with their out-of-pocket medication costs:
- State-Sponsored Programs
- Medicare Savings Program
- Medicare Part D Extra Help—Low-Income Subsidy
- Independent Foundations*
Call Janssen CarePath at 877-CarePath (877-227-3728) or click here for more information on affordability programs that may be available.
*Independent co-pay assistance foundations have their own rules for eligibility. We have no control over these independent foundations and can only refer your patients to a foundation that supports their disease state. We do not endorse any particular foundation.
Johnson & Johnson Patient Assistance Foundation, Inc.
The Johnson & Johnson Patient Assistance Foundation, Inc. (JJPAF) is an independent, nonprofit organization. JJPAF gives eligible patients free prescription medicines donated by Johnson & Johnson companies. Patients may be eligible if they don't have insurance, if their medicine is not covered by insurance, or if they have Medicare coverage and can't pay for their medicine.
Do you have patients who may need help? They can see if they are eligible and get an application at JJPAF.org or call 800-652-6227 (Monday through Friday, 8:00 AM to 8:00 PM ET).
INVEGA HAFYERA™, an every-six-month injection, is an atypical antipsychotic indicated for the treatment of schizophrenia in adults after they have been adequately treated with:
- A once-a-month paliperidone palmitate extended release injectable suspension (e.g., INVEGA SUSTENNA®) for at least four months or
- An every-three-month paliperidone palmitate extended release injectable suspension (e.g., INVEGA TRINZA®) for at least one three-month cycle.
WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS.
See full prescribing information for complete Boxed Warning.
Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. INVEGA HAFYERA™ is not approved for use in patients with dementia-related psychosis.
Contraindications: INVEGA HAFYERA™ is contraindicated in patients with a known hypersensitivity to either paliperidone, risperidone, or to any excipients of their formulation.
Cerebrovascular Adverse Reactions: Cerebrovascular adverse reactions (e.g., stroke, transient ischemic attacks), including fatalities, were reported at a higher incidence in elderly patients with dementia-related psychosis taking risperidone, aripiprazole, and olanzapine compared to placebo. No studies have been conducted with oral paliperidone or INVEGA HAFYERA™ in elderly patients with dementia. These medications are not approved for the treatment of patients with dementia-related psychosis.
Neuroleptic Malignant Syndrome (NMS): NMS, a potentially fatal symptom complex, has been reported in association with antipsychotic drugs, including paliperidone.
Clinical manifestations of NMS are hyperpyrexia, muscle rigidity, altered mental status including delirium, and autonomic instability (irregular pulse of blood pressure, tachycardia, diaphoresis, and cardiac dysrhythmia). Additional signs may include elevated creatine phosphokinase, myoglobinuria (rhabdomyolysis), and acute renal failure.
If NMS is suspected, immediately discontinue INVEGA HAFYERA™ and provide symptomatic treatment and monitoring.
QT Prolongation: Paliperidone causes a modest increase in the corrected QT (QTc) interval. Avoid the use of drugs that also increase QTc interval and in patients with risk factors for prolonged QTc interval. Paliperidone should also be avoided in patients with congenital long QT syndrome and in patients with a history of cardiac arrhythmias. Certain circumstances may increase the risk of the occurrence of torsades de pointes and/or sudden death in association with the use of drugs that prolong the QTc interval.
Tardive Dyskinesia (TD): TD, a syndrome consisting of potentially irreversible, involuntary, dyskinetic movements, may develop in patients treated with antipsychotic drugs. Although the prevalence of the syndrome appears to be highest among the elderly, especially elderly women, it is impossible to predict which patients will develop the syndrome. Whether antipsychotic drug products differ in their potential to cause tardive dyskinesia is unknown.
The risk of developing TD and the likelihood that it will become irreversible appear to increase with the duration of treatment and the cumulative dose. The syndrome can develop after relatively brief treatment periods, even at low doses. It may also occur after discontinuation. TD may remit, partially or completely, if antipsychotic treatment is discontinued. Antipsychotic treatment itself, however, may suppress (or partially suppress) the signs and symptoms of the syndrome, possibly masking the underlying process. The effect that symptomatic suppression has upon the long-term course of the syndrome is unknown.
If signs and symptoms of TD appear in a patient on INVEGA HAFYERA™, drug discontinuation should be considered. However, some patients may require treatment with INVEGA HAFYERA™ despite the presence of the syndrome. In patients who do require chronic treatment, use the lowest dose and the shortest duration of treatment producing a satisfactory clinical response. Periodically reassess the need for continued treatment.
Metabolic Changes: Atypical antipsychotic drugs have been associated with metabolic changes that may increase cardiovascular/cerebrovascular risk. These metabolic changes include hyperglycemia, dyslipidemia, and body weight gain. While all of the drugs in the class have been shown to produce some metabolic changes, each drug has its own specific risk profile.
Hyperglycemia and Diabetes Mellitus: Hyperglycemia and diabetes mellitus, in some cases extreme and associated with ketoacidosis, hyperosmolar coma or death, have been reported in patients treated with all atypical antipsychotics (APS). Patients starting treatment with APS who have or are at risk for diabetes mellitus should undergo fasting blood glucose testing at the beginning of and during treatment. Patients who develop symptoms of hyperglycemia during treatment should also undergo fasting blood glucose testing. All patients treated with atypical antipsychotics should be monitored for symptoms of hyperglycemia. Some patients require continuation of antidiabetic treatment despite discontinuation of the suspect drug.
Dyslipidemia: Undesirable alterations have been observed in patients treated with atypical antipsychotics.
Weight Gain: Weight gain has been observed with atypical antipsychotic use. Clinical monitoring of weight is recommended.
Orthostatic Hypotension and Syncope: INVEGA HAFYERA™ may induce orthostatic hypotension in some patients due to its alpha-adrenergic blocking activity. INVEGA HAFYERA™ should be used with caution in patients with known cardiovascular disease, cerebrovascular disease or conditions that would predispose patients to hypotension (e.g., dehydration, hypovolemia, treatment with antihypertensive medications). Monitoring should be considered in patients for whom this may be of concern.
Falls: Somnolence, postural hypotension, motor and sensory instability have been reported with the use of antipsychotics, including INVEGA HAFYERA™, which may lead to falls and, consequently, fractures or other fall-related injuries. For patients, particularly the elderly, with diseases, conditions, or medications that could exacerbate these effects, assess the risk of falls when initiating antipsychotic treatment and recurrently for patients on long-term antipsychotic therapy.
Leukopenia, Neutropenia and Agranulocytosis have been reported with antipsychotics, including INVEGA HAFYERA™. In patients with a history of clinically significant low white blood cell count (WBC)/absolute neutrophil count (ANC) or drug-induced leukopenia/neutropenia, perform a complete blood count frequently during the first few months of therapy. Consider discontinuing INVEGA HAFYERA™ at the first sign of a clinically significant decline in WBC in the absence of other causative factors. Monitor patients with clinically significant neutropenia for fever or other symptoms or signs of infection and treat promptly if such symptoms or signs occur. Discontinue INVEGA HAFYERA™ in patients with severe neutropenia (absolute neutrophil count <1000/mm3) and follow their WBC until recovery.
Hyperprolactinemia: As with other drugs that antagonize dopamine D2 receptors, INVEGA HAFYERA™ elevate prolactin levels, and the elevation persists during chronic administration. Paliperidone has a prolactin-elevating effect similar to risperidone, which is associated with higher levels of prolactin elevation than other antipsychotic agents.
Potential for Cognitive and Motor Impairment: Somnolence, sedation, and dizziness were reported as adverse reactions in subjects treated with INVEGA HAFYERA™. INVEGA HAFYERA™ has the potential to impair judgment, thinking, or motor skills. Patients should be cautioned about performing activities that require mental alertness such as operating hazardous machinery, including motor vehicles, until they are reasonably certain that INVEGA HAFYERA™ does not adversely affect them.
Seizures: INVEGA HAFYERA™ should be used cautiously in patients with a history of seizures or with conditions that potentially lower seizure threshold. Conditions that lower seizure threshold may be more prevalent in patients 65 years or older.
Administration: For gluteal intramuscular injection only by a healthcare professional using only the needles provided in the INVEGA HAFYERA™ kits. Care should be taken to avoid inadvertent injection into a blood vessel.
Drug Interactions: Strong CYP3A4/P-glycoprotein (P-gp) inducers: Avoid using a strong inducer of CYP3A4 and/or P-gp (e.g., carbamazepine, rifampin, St John’s Wort) during a dosing interval for INVEGA HAFYERA™. If administering a strong inducer is necessary, consider managing the patient using paliperidone extended-release tablets.
Pregnancy/Nursing: INVEGA HAFYERA™ may cause extrapyramidal and/or withdrawal symptoms in neonates with third trimester exposure. Advise patients to notify their healthcare professional if they become pregnant or intend to become pregnant during treatment with INVEGA HAFYERA™. Patients should be advised that there is a pregnancy registry that monitors outcomes in women exposed to INVEGA HAFYERA™ during pregnancy. INVEGA HAFYERA™ can pass into human breast milk. The benefits of breastfeeding should be considered along with the mother’s clinical need for INVEGA HAFYERA™ and any potential adverse effect on the breastfed infant from INVEGA HAFYERA™ or the mother’s underlying condition.
Commonly Observed Adverse Reactions for INVEGA HAFYERA™: The most common adverse reactions (incidence at least 5% in the double-blind phase) in the INVEGA HAFYERA™ clinical trial were upper respiratory tract infection, injection site reaction, weight increased, headache and parkinsonism.
Please click here to read the full Prescribing Information, including Boxed WARNING, for INVEGA HAFYERA™.