FDA Approves Invega Hafyera, a Twice-Yearly Medication Used to Treat Schizophrenia

A group of medications that’s typically prescribed for people with schizophrenia is antipsychotics. These medications come in various forms, including oral pills, oral liquids, and long-lasting injections. In September 2021, Invega Hafyera (paliperidone palmitate) became the longest-lasting antipsychotic injection approved by the FDA.

Here, we’ll discuss what Invega Hafyera is, how long its effects last, and what you can expect if your healthcare provider prescribes it for you.

What is Invega Hafyera?

Invega Hafyera is a twice-yearly antipsychotic injection made by pharmaceutical manufacturer Janssen. It is FDA-approved to treat adults with schizophrenia that have successfully received Invega Sustenna (once-monthly paliperidone palmitate) for at least 4 months, or Invega Trinza (once-every-3-months paliperidone palmitate) at least once.

How is Invega Hafyera different from Invega Sustenna?

Invega Hafyera and Invega Sustenna contain the same active ingredient — paliperidone palmitate. The difference is how long each injection lasts in the body. Each Invega Hafyera injection lasts for 6 months. Invega Sustenna only lasts for 1 month.

It’s important to note that neither injection should be started if you’ve never taken shorter-acting antipsychotics before. As mentioned above, you should only start Invega Hafyera after successfully receiving either Invega Sustenna or Invega Trinza for a set period of time. And you shouldn’t start Invega Sustenna unless you have already been taking oral Invega (paliperidone) or Risperdal (risperidone) without problems.

How does Invega Hafyera work for treating schizophrenia?

Invega Hafyera is an atypical antipsychotic, also called a second-generation antipsychotic. While the way it treats schizophrenia isn’t fully understood, experts believe it works by blocking the areas of the brain where the hormones serotonin and dopamine attach. Both of these hormones are believed to play a role in various schizophrenia symptoms.

How is Invega Hafyera administered?

Invega Hafyera is a gluteal injection, meaning it should be given in the muscle on your buttocks. It should only be given by a nurse or healthcare provider. Never attempt to give yourself the injection.

Invega Hafyera is given every 6 months and is available in two doses:

• 1,092 mg/3.5 mL

• 1,560 mg/5 mL

The dosage that you start with depends on the strength of Invega Sustenna or Invega Trinza you were previously taking.

Why was Invega Hafyera’s FDA approval important?

Invega Hafyera can help people with schizophrenia stick to their medication schedules better. It can also help people avoid missing doses of their antipsychotic.

Medication adherence — that is, taking your medication on time without missing doses — is difficult for many people. But people living with schizophrenia tend to have a very tough time sticking to a medication schedule. Some studies and literature reviews have noted that as many as 89% of people with the condition have issues with medication adherence.

Missing doses or stopping your medication can cause symptoms to worsen or raise your risk of a hospital stay. Long-acting injections, such as Invega Hafyera, help people to stay on track with their medications better, keeping their symptoms more controlled.

Invega Hafyera requires only two doses in a year. This is the only antipsychotic currently available that lasts this long after its administered. This dose schedule may be much easier than having to remember to take pills every day or visiting your healthcare provider’s office multiple times a year if it’s not necessary.

How effective is Invega Hafyera?

Invega Hafyera is very effective for treating schizophrenia. In the phase 3 clinical trial that earned the medication its FDA approval, Invega Hafyera prevented relapse — a reappearance or flare-up of symptoms — in over 92% of study participants after 1 year. The study authors determined that it was similarly effective to Invega Trinza, which prevented relapse in 95% of participants.

Relapses of schizophrenia can be serious in multiple ways. A sudden return of symptoms can lead to some or all of the following:

• Self-harm

• Accidentally hurting others

• Missed days of work

• Performing actions that could jeopardize a job

• Strained relationships with family and friends

Because of these possible outcomes, preventing relapse is essential when treating schizophrenia. Invega Hafyera’s ability to prevent relapse in over 92% of clinical trial participants makes it an effective choice for this condition.

What are the known side effects of Invega Hafyera?

In one clinical trial, side effects of Invega Hafyera were similar to those experienced with Invega Trinza. The most common side effects reported include:

• Upper respiratory infections (runny nose, sneezing, etc.)

• Redness, pain, or discomfort where the medication was injected

• Weight gain

• Headache

• Tremor

• Raised blood glucose (sugar)

• Raised cholesterol

Metabolic side effects — weight gain and raised cholesterol or blood glucose — can lead to long-term issues. Over time, these side effects can raise the risk of developing chronic conditions, such as Type 2 diabetes. Be sure to go for any blood tests and follow-up appointments your healthcare provider recommends, as they can help catch these problems early.

All antipsychotics, including Invega Hafyera, can cause uncontrollable tremors or muscle twitches called extrapyramidal symptoms (EPS). EPS are more common with typical antipsychotics, such as Haldol (haloperidol), than with atypical antipsychotics. But these side effects are possible with all medications in this class.

Serious Invega Hafyera side effects

In rare instances, EPS can also include facial muscles and the tongue. These occurrences can result in tardive dyskinesia (TD). TD can interfere with your ability to eat, drink, and talk. Less commonly, it can affect the trunk and limbs. Contact your healthcare provider if you notice any unusual body or facial movements.

Very rarely, antipsychotic medications can lead to a potentially life-threatening complication called neuroleptic malignant syndrome (NMS). Signs of NMS include fever, stiff muscles, and a high heart rate. Seek emergency medical care if you notice these symptoms at any point after starting Invega Hafyera.

Invega Hafyera shouldn’t be used to treat psychosis (hallucinations or delusions) for older adults with dementia. Using antipsychotics for this purpose raises the risk of these people dying. Be sure to discuss your medical history with your healthcare provider before starting this medication.

Does Invega Hafyera interact with other medications?

While uncommon, sleepiness and dizziness have been reported by study participants who received Invega Hafyera. Taking other medications that cause these side effects or drinking alcohol can make it more likely you will experience them. If you take medications that cause drowsiness, let your healthcare provider know before starting Invega Hafyera.

Certain medications can make Invega Hafyera less effective. Some of the most notable medications from these groups include Tegretol (carbamazepine), rifampin, and St. John’s wort. Double check with your healthcare provider or pharmacist to see if any other medications you take would make Invega Hafyera less effective.

Additionally, some medications used to treat Parkinson’s disease are less effective when taken at the same time as Invega Hafyera. If you take medications like Sinemet (carbidopa/levodopa), be sure to discuss this with your healthcare provider.

How to save on Invega Hafyera

There are ways to save on Invega Hafyera, which is only available as a brand-name medication. If you’re uninsured, you may be eligible for Invega Hafyera’s patient assistance program, which offers the medication free of cost.

Invega free trial program

The Invega free trial program is an option for people taking Invega Sustenna. It’s not available for Invega Hafyera. If you or your loved one is new to long-acting Invega injections, this option could help you save money.

As discussed earlier, a person needs to take either Invega Sustenna or Invega Trinza before starting Invega Hafyera. If eligible for the Invega Sustenna free trial program, you could receive up to two injections of Invega Sustenna free of cost in one calendar year. This can help you save on two of the Invega Sustenna injections you would need prior to starting Invega Hafyera.

The Invega free trial program is only available at certain hospitals and healthcare facilities. Ask your healthcare provider whether this savings program is available near you.

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Written by:

Christina Aungst, PharmD

Christina Aungst, PharmD, is a pharmacy editor for GoodRx. She began writing for GoodRx Health in 2019, transitioning from freelance writer to editor in 2021.

Reviewed by:

Joshua Murdock, PharmD, BCBBS

Joshua Murdock, PharmD, BCBBS, is a licensed pharmacist in Arizona, Colorado, and Rhode Island. He has worked in the pharmacy industry for more than 10 years and currently serves as a pharmacy editor for GoodRx.

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