Abilify Asimtufii Injection

Abilify Asimtufii injection is a prescription medicine given by injection by a healthcare provider for the treatment of schizophrenia in adults and alone as maintenance monotherapy treatment for bipolar I disorder in adults. Abilify Asimtufii is an extended-release injectable suspension for intramuscular use.

It is not known if Abilify Asimtufii is safe and effective in children under 18 years of age.

Do not receive Abilify Asimtufii if you are allergic to aripiprazole or any of the ingredients in Abilify Asimtufii.

• Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death.
• Abilify Asimtufii is not approved for the treatment of patients with dementia-related psychosis
• Clinical studies showed an increased incidence of cerebrovascular adverse reactions (e.g., stroke, transient ischemic attack), including fatalities, in oral aripiprazole-treated patients with dementia-related psychosis (mean age: 84 years; range: 78 to 88 years).

• Neuroleptic Malignant Syndrome (NMS), a potentially fatal symptom complex has been reported with antipsychotic drugs, including aripiprazole. Rare cases of NMS have been reported during aripiprazole treatment in the global clinical database.

  • Symptoms of NMS are hyperpyrexia, muscle rigidity, altered mental status, and evidence of autonomic instability (irregular pulse or 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 Abilify Asimtufii and provide symptomatic treatment and monitoring.

Abilify Asimtufii may cause serious side effects, including:

• Increased risk of death in elderly people with dementia-related psychosis. Abilify Asimtufii increases the risk of death in elderly people who have lost touch with reality (psychosis) due to confusion and memory loss (dementia). Abilify Asimtufii is not for the treatment of people with dementia-related psychosis.

Abilify Asimtufii and other medicines may affect each other causing possible serious side effects. Abilify Asimtufii may affect the way other medicines work, and other medicines may affect how Abilify Asimtufii works.

Your healthcare provider can tell you if it is safe to receive Abilify Asimtufii with your other medicines. Do not start or stop any medicines during treatment with Abilify Asimtufii without first talking to your healthcare provider.

Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.

Other side effects of Abilify Asimtufii include:

• Stroke, (cerebrovascular problems) in elderly people with dementia-related psychosis that can lead to death.
• Neuroleptic malignant syndrome (NMS), a serious condition that can lead to death. Call your healthcare provider or go to the nearest emergency room right away if you have some or all of the following signs and symptoms of NMS:
  • high fever
  • confusion
  • changes in pulse, heart rate, and blood pressure
  • stiff muscles
  • increased sweating
• Uncontrolled body movements (tardive dyskinesia). Abilify Asimtufii may cause movements that you cannot control in your face, tongue, or other body parts. Tardive dyskinesia may not go away, even if you stop receiving Abilify Asimtufii. Tardive dyskinesia may also start after you stop receiving Abilify Asimtufii.
• Problems with your metabolism such as:
  • high blood sugar (hyperglycemia) and diabetes: Increases in blood sugar can happen in some people who are treated with Abilify Asimtufii. Extremely high blood sugar can lead to coma or death. If you have diabetes or risk factors for diabetes such as being overweight, or a family history of diabetes, your healthcare provider should check your blood sugar before you start treatment with Abilify Asimtufii, and during treatment with Abilify Asimtufii.

    Call your healthcare provider if you have any of these symptoms of high blood sugar during treatment with Abilify Asimtufii:

    • feel very thirsty
    • feel very hungry
    • feel sick to your stomach
    • need to urinate more than usual
    • feel weak or tired
    • feel confused, or your breath smells fruity
  • Increased fat levels (cholesterol and triglycerides) in your blood.
  • Weight gain. You and your healthcare provider should check your weight regularly during treatment with Abilify Asimtufii.
• Unusual and uncontrollable (compulsive) urges. Some people receiving Abilify Asimtufii have had unusual strong urges to gamble and gambling that cannot be controlled (compulsive gambling). Other compulsive urges including sexual urges, shopping, and eating or binge eating. If you or your family members notice that you are having unusual urges or behaviors, talk to your healthcare provider.
• Decreased blood pressure (orthostatic hypotension). You may feel lightheaded or faint when you rise too quickly from a sitting or lying position.
• Falls. Abilify Asimtufii may make you sleepy or dizzy, may cause a decrease in your blood pressure when changing position (orthostatic hypotension), and can slow your thinking and motor skills which may lead to falls that can cause fractures or other injuries.
• Low white blood cell count. Your healthcare provider may do blood tests during your first few months of treatment with Abilify Asimtufii.
• Seizures (convulsions)
• Sleepiness, drowsiness, feeling tired, difficulty thinking and doing normal activities. 
• Problems controlling your body temperature so that you feel too warm. 
• Difficulty swallowing that can cause food or liquid to get into your lungs.

The most common side effects of Abilify Asimtufii include: weight gain, restlessness or feeling like you need to move (akathisia), injection site pain, or sleepiness (sedation).

These are not all the possible side effects of Abilify Asimtufii.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about Abilify Asimtufii that is written for healthcare professionals.

For patients who have never taken aripiprazole, establish tolerability with oral aripiprazole prior to initiating treatment with Abilify Asimtufii. Due to the half-life of oral aripiprazole, it may take up to 2 weeks to fully assess tolerability.

Abilify Asimtufii must be administered as an intramuscular gluteal injection by a healthcare professional. Do not administer by any other route.

Recommended Dosage For Abilify Asimtufii

The recommended dosage of Abilify Asimtufii is 960 mg, administered once every 2 months (56 days after previous injection).

Patients Receiving Oral Antipsychotics

When Abilify Asimtufii injection is initiated in patients receiving oral aripiprazole, administer the first dose of Abilify Asimtufii along with oral aripiprazole (10 mg to 20 mg) for 14 consecutive days.

For patients already stable on another oral antipsychotic (and known to tolerate aripiprazole), administer the first Abilify Asimtufii injection along with the oral antipsychotic for 14 consecutive days.

Patients Receiving Abilify Maintena

For patients receiving Abilify Maintena (once monthly dosing), administer Abilify Asimtufii 960 mg (once every 2 month dosing) in place of the next scheduled injection of the Abilify Maintena. The first Abilify Asimtufii injection may be administered in place of the second, or later injection of Abilify Maintena.

If there are adverse reactions with the Abilify Asimtufii 960 mg dosage, the dosage may be reduced to 720 mg once every 2 months.

Patients may be given the Abilify Asimtufii injection up to 2 weeks before or 2 weeks after the 2-month scheduled timepoint.

Missed Doses

If more than 8 weeks and less than 14 weeks have elapsed since the last injection, administer the next dose of Abilify Asimtufii as soon as possible. The once every 2 month schedule should be resumed.

If more than 14 weeks have elapsed since the last injection, restart concomitant oral aripiprazole for 14 days with the next administered injection of Abilify Asimtufii.

Dosage Recommendations For Cytochrome P450 Considerations

Dosage adjustments for patients who are CYP2D6 poor metabolizers and/or in patients taking concomitant CYP3A4 inhibitors or CYP2D6 inhibitors for more than 14 days are described in Table 1.

If the CYP3A4 inhibitor or CYP2D6 inhibitor is withdrawn, the dosage of Abilify Asimtufii may need to be increased to the previous dose.

Dosage adjustments are not recommended for patients with concomitant use of CYP3A4 inhibitors, CYP2D6 inhibitors or CYP3A4 inducers for less than 14 days.

Table 1: Dosage Recommendations for Abilify Asimtufii in Patients Who are Known CYP2D6 Poor Metabolizers, Patients Taking Concomitant CYP2D6 Inhibitors, 3A4 Inhibitors, or CYP3A4 Inducers for Greater than 14 days

Avoid the following while receiving Abilify Asimtufii:

• Do not drive a car, operate machinery, or do other dangerous activities until you know how Abilify Asimtufii affects you. Abilify Asimtufii may affect your judgment, thinking, or motor skills.
• Do not drink alcohol during treatment with Abilify Asimtufii.
• Do not become too hot or dehydrated during treatment with Abilify Asimtufii.
  • Do not exercise too much.
  • In hot weather, stay inside in a cool place if possible.
  • Stay out of the sun.
  • Do not wear too much clothing or heavy clothing.
  • Drink plenty of water.

Table 7 presents clinically significant drug interactions with Abilify Asimtufii.

Table 7: Clinically Important Drug Interactions with Abilify Asimtufii

Drugs Having No Clinically Important Interactions with Abilify Asimtufii

Based on pharmacokinetic studies with oral aripiprazole, no dosage adjustment of Abilify Asimtufii is required when administered concomitantly with famotidine, valproate, lithium, lorazepam.

In addition, no dosage adjustment is necessary for substrates of CYP2D6, CYP2C9, CYP2C19, or CYP3A4 when coadministered with Abilify Asimtufii. Additionally, no dosage adjustment is necessary for valproate, lithium, lamotrigine, lorazepam, or sertraline when coadministered with Abilify Asimtufii.

• Abilify Asimtufii may cause extrapyramidal and/or withdrawal symptoms in a neonate. Notify your healthcare provider if you are pregnant or suspect you may be pregnant.
• There is a pregnancy exposure registry that monitors pregnancy outcomes in patients exposed to Abilify Asimtufii during pregnancy. You can register by contacting the National Pregnancy Registry for Atypical Antipsychotics at 1-866-961-2388 or visit http://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/.
• Aripiprazole is present in human breast milk; however, there are insufficient data to assess the amount in human milk, the effects on the breastfed infant, or the effects on milk production. The development and health benefits of breastfeeding should be considered along with the mother’s clinical need for Abilify Asimtufii and any potential adverse effects on the breastfed infant from Abilify Asimtufii or from the underlying maternal condition.

Do not receive Abilify Asimtufii if you are allergic to aripiprazole or any of the ingredients in Abilify Asimtufii.

Before receiving Abilify Asimtufii, tell your healthcare provider about all of your medical conditions, including if you:

• have never taken aripiprazole before
• have or had diabetes or high blood sugar or a family history of diabetes or high blood sugar. Your healthcare provider should check your blood sugar before you start receiving Abilify Asimtufii and during your treatment with Abilify Asimtufii.
• have or had high levels of total cholesterol, LDL cholesterol, or trigylcerides, or low levels of HDL cholesterol
• have or had low or high blood pressure
• have or had heart problems or a stroke
• have or had a low white blood cell count
• have or had seizures (convulsions)
• have problems that may affect you receiving an injection in your buttocks
• are pregnant or plan to become pregnant. Abilify Asimtufii may harm your unborn baby. Receiving Abilify Asimtufii during your third trimester of pregnancy may cause your baby to have abnormal muscle movements or withdrawal symptoms after birth. Talk to your healthcare provider about the risk to your unborn baby if you receive Abilify Asimtufii during pregnancy.
  • Tell your healthcare provider right away if you become pregnant or think that you are pregnant during treatment with Abilify Asimtufii.
  • If you become pregnant during treatment with Abilify Asimtufii, talk to your healthcare provider about registering with the National Pregnancy Registry for Atypical Antipsychotics. You can register by calling 1-866-961-2388 or visit http://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/.
• are breastfeeding or plan to breastfeed. Abilify Asimtufii can pass into your breast milk and it is not known if it may harm your baby. Talk to your healthcare provider about the best way to feed your baby during treatment with Abilify Asimtufii.

Tell your healthcare provider about all the medicines you take, including prescription medicines and over-the-counter medicines, vitamins, and herbal supplements.