Abilify Asimtufii

Abilify Asimtufii is an atypical antipsychotic used for schizophrenia and bipolar I disorder in adults. Abilify Asimtufii is an extended-release injection that is given once every two months; this helps compliance and means patients only need 6 injections per year.

Abilify Asimtufii is thought to work (mechanism of action) by balancing the levels of serotonin and dopamine in the brain, however, the exact mechanism of action for schizophrenia and bipolar I disorder is unknown.

Abilify (aripiprazole) is also available as:

• Abilify (oral tablets)
• Abilify MyCite (tablet embedded with an ingestible sensor)
• Abilify Maintena (extended-release injection for administration once every month).
• Abilify Asimtufii (longer-acting slow-release injection that is given every two months)

Abilify Asimtufii is an FDA-approved medicine used for the treatment of schizophrenia in adults and is used alone (monotherapy) as maintenance treatment of bipolar I disorder in adults.

Schizophrenia is a mental illness characterized by disruptions in thought processes, perceptions, emotional responsiveness, and social interactions.

Bipolar I disorder is a mental illness that characterized by unusual shifts in a person’s mood, energy, activity levels, and concentration.

Patients who have schizophrenia or bipolar I disorder require long-term treatment.

For patients who have never taken aripiprazole, you must first check their tolerability with oral aripiprazole before initiating treatment with this injection. Due to the half-life of oral aripiprazole, it may take up to 2 weeks to fully assess tolerability.

Abilify Asimtufii injection must be given into your buttock muscles by your healthcare provider. Do not administer by any other route.

Abilify Asimtufii is given once every 2 months.

Patients Receiving Oral Antipsychotics

There are two ways to initiate Abilify Asimtufii in patients taking oral antipsychotics:

1-day initiation:

• Administer one intramuscular injection of Abilify Asimtufii I 960 mg in the gluteal muscle, one injection of Abilify Maintena 400 mg in a separate gluteal or deltoid muscle, and one dose of oral aripiprazole 20 mg, on the first day of treatment withAbilify Asimtufii. Do not administer both injections into the same muscle.

14-day initiation:

• Administer one intramuscular injection of Abilify Asimtufii 960 mg in the gluteal muscle and continue treatment 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 one intramuscular injection of Abilify Asimtufii 960 mg in the gluteal muscle and continue treatment with the oral antipsychotic for 14 consecutive days.

Patients Receiving Abilify Maintena

For patients receiving Abilify Maintena 400mg (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 to 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.

Abilify Asimtufii is not approved for use in older adults with dementia-related psychoses.

People with depression or mental illness may have thoughts about suicide. Some young people may have increased suicidal thoughts when first starting medicine to treat depression. Tell your doctor right away if you have any sudden changes in mood or behavior or thoughts about suicide.

Do not stop using aripiprazole suddenly, or you could have unpleasant withdrawal symptoms.

Avoid driving and doing other tasks or actions that call for you to be alert or have clear eyesight until you see how aripiprazole affects you.

High blood sugar or diabetes, high cholesterol, and weight gain have happened with drugs like this one. These may raise the chance of heart and brain blood vessel disease.

Low white blood cell counts have happened with drugs like this one. This may lead to a higher chance of infection. Rarely, infections have been deadly. Tell your doctor if you have ever had a low white blood cell count. Call your doctor right away if you have signs of infection like fever, chills, or sore throat.

You should not take this medicine if you are allergic to the active ingredient aripiprazole or any of the inactive ingredients.This medicine may increase the risk of death in older adults with dementia-related psychosis and is not approved for this use.

To make sure Abilify Asimtufii is safe for you, tell your doctor if you have:

• heart problems or a stroke;
• high or low blood pressure;
• diabetes (in you or a family member);
• seizures; or
• low white blood cell (WBC) counts.

People with depression or mental illness may have thoughts about suicide. Some young people may have increased suicidal thoughts when first starting medicine to treat depression. Stay alert to changes in your mood or symptoms. Your family or caregivers should also watch for sudden changes in your behavior.

This medicine can cause high blood sugar (hyperglycemia). If you are diabetic, check your blood sugar levels carefully.

Pregnancy

Tell your healthcare provider if you are pregnant or plan to become pregnant. This medicine may harm your unborn baby. Receiving this medicine 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 this medicine during pregnancy. Do not stop the medicine without your doctor's advice.

Tell your healthcare provider right away if you become pregnant or think that you are pregnant during treatment. If you become pregnant during treatment, 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/.

Breastfeeding

Tell your healthcare provider if you are breastfeeding or plan to breastfeed. This medicine 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.

Common side effects of Abilify Asimtufii

Common Abilify Asimtufii side effects may include:

• Increased weight (17%)
• Akathisia movement disorder with difficulty sitting or remain still (11%)
• Constipation (10%)
• Injection site pain (5%)
• Sedation (5%)
• Decreased weight (4%)
• Dizziness (4%)
• Upper respiratory tract infection (4%)
• Dry mouth (4%)
• Joint pain (4%)
• Back pain (4%)
• Muscle pain (4%)
• Musculoskeletal pain (3%)
• Diarrhea (3%)
• Vomiting (3%)
• Tremor (3%)

These common side effects occurred in 3% or more of Abilify Maintena patients in a 12-week double-blind, placebo-controlled study.

Serious Abilify Asimtufii side effects

Get emergency medical help if you have signs of an allergic reaction to aripiprazole: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Tell your doctor right away if you have new or sudden changes in mood or behavior, including new or worse depression or anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, more active or talkative, or have thoughts about suicide or hurting yourself.

Call your doctor at once if you have:

• severe agitation, distress, or restless feeling;
• twitching or uncontrollable movements of your eyes, lips, tongue, face, arms, or legs;
• mask-like appearance of the face, trouble swallowing, problems with speech;
• seizure (convulsions);
• severe nervous system reaction - very stiff (rigid) muscles, high fever, sweating, confusion, fast or uneven heartbeats, tremors, feeling like you might pass out;
• low blood cell counts - fever, chills, sore throat, weakness, easy bruising, unusual bleeding, purple or red spots under your skin; or
• high blood sugar - increased thirst, increased urination, dry mouth, fruity breath odor.

You may have increased sexual urges, unusual urges to gamble, or other intense urges while taking this medicine. Talk with your doctor if this occurs.

This is not a complete list of side effects, and others may occur. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Usual Abilify Asimtufii Adult Dose for Schizophrenia

Dose: 960 mg administered once every 2 months as a single injection.

Use: for the treatment of schizophrenia in adults.

Usual Abilify Asimtufii Adult Dose for Bipolar I Disorder

Dose: 960 mg administered once every 2 months as a single injection.

Use: maintenance monotherapy treatment of bipolar I disorder in adults.

General dosing information:

• Dose can be reduced to 720 mg in patients with adverse reactions.
• For patients naïve to aripiprazole, establish tolerability with oral aripiprazole prior to initiating treatment.
• Administer by intramuscular injection in the gluteal muscle by a healthcare professional. Do not administer by any other route.

Injections are available as:

• Abilify Asimtufii 960 mg/3.2 mL
• Abilify Asimtufii 720 mg/2.4 mL

If more than 8 weeks and less than 14 weeks have elapsed since the last injection, administer the next dose 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.

Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Avoid driving or hazardous activity until you know how aripiprazole will affect you. Dizziness or drowsiness can cause falls, accidents, or severe injuries.

Do not drive a car, operate machinery, or do other dangerous activities until you know how this injection affects you. This medicine may affect your judgement, thinking or motor skills.

Avoid drinking alcohol. Dangerous side effects could occur.

While taking aripiprazole, you may be more sensitive to very hot conditions. Avoid becoming overheated or dehydrated. Drink plenty of fluids, especially in hot weather and during exercise.

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

Abilify Asimtufii and other medicines may affect each other causing possible serious side effects. This injection may affect the way other medicines work, and vice versa.

Your healthcare provider can tell you if it is safe to receive this injection with your other medicines. Do not start or stop any medicines during treatment 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.

Especially tell your healthcare provider if you take any of the following medicines:

• clarithromycin (Biaxin)
• antidepressants such as fluoxetine (Prozac), paroxetine (Paxil), and nefazodone
• antifungals such as fluconazole (Diflucan), ketoconazole (Nizoral), and itraconazole (Sporanox)
• quinidine
• HIV medicines such as indinavir (Crixivan), ritonavir (Norvir), saquinavir (Fortova, Invirase), and lopinavir/ritonavir (Kaletra)
• carbamazepine (Tegretol)
• rifampin (Rifadin).

Not all possible drug interactions are listed here.

HCPs and patients often use the Abilify Asimtufii Package Insert (PI) for more detailed information about this medicine. The Package Insert (prescribing information) contains more comprehensive information on Indications and Usage, Dosage and Administration, Clinical Pharmacology, Clinical Studies, Drug Interaction, and more. Discuss any medical questions you have with your HCP (health care professional). This is not all the information you need to know about this medicine for safe and effective use, and it does not take the place of talking to your doctor about your treatment.

The Package Insert is sometimes called the Abilify Asimtufii Prescribing Information (PI) or FDA label.

Abilify Asimtufii J-code is J3490 J codes are used for medicines that are not taken orally and include injections, inhalations, and chemotherapies. J codes are important for accurate and consistent coding for billing and reimbursement purposes.

Your physician will need the Abilify Asimtufii J-code when filling out forms for your treatment.

Store at 25°C (77°F), excursions permitted between 15° and 30°C (59° to 86°F)

Active ingredient: aripiprazole monohydrate.

Inactive ingredients: carboxymethylcellulose sodium, polyethylene glycol 400, povidone, sodium chloride, sodium phosphate monobasic monohydrate, sodium hydroxide and water for injection.

Distributed and marketed: by Otsuka America Pharmaceutical, Inc., Rockville, MD 20850.

Marketed by: Lundbeck, Deerfield, IL 60015 USA.