Abilify Asimtufii

Dosage Form: Extended-Release Injectable Suspension (Intramuscular Use)

Composition:

• Active Ingredient: Aripiprazole monohydrate
• Inactive components include sodium carboxymethylcellulose, PEG 400, povidone, sodium chloride, monobasic sodium phosphate monohydrate, sodium hydroxide, and sterile water for injection.

What is Abilify Asimtufii?

Abilify Asimtufii is an atypical antipsychotic designed for adults diagnosed with schizophrenia and bipolar I disorder. This medication is administered as an extended-release injection that is given once every two months.

Although the exact mechanism of action of Abilify Asimtufii is not entirely understood, it is believed to work by modulating dopamine and serotonin levels in the brain, which play a crucial role in mood regulation and cognitive function.

In addition to Abilify Asimtufii, aripiprazole is also available in different formulations, including:

• Abilify – Oral tablet
• Abilify MyCite – Tablet with an ingestible sensor for tracking medication adherence
• Abilify Maintena – Extended-release injection administered once a month

Since Abilify Asimtufii is a long-acting formulation, it requires only six injections per year, which can improve treatment adherence and reduce the risk of missed doses.

What Conditions Does Abilify Asimtufii Treat?

Abilify Asimtufii is FDA-approved for treating:

• Schizophrenia in adults
• Bipolar I disorder (as a maintenance treatment in adults, used alone)

Understanding These Conditions

• Schizophrenia is a chronic mental disorder characterized by disruptions in thinking, perception, emotional response, and social interactions.
• Bipolar I disorder is a mood disorder that causes extreme shifts in mood, energy, activity levels, and concentration, alternating between manic and depressive episodes.

Both schizophrenia and bipolar I disorder require long-term treatment to manage symptoms effectively.

Warnings and Precautions

Important Safety Information

• Not Approved for Dementia-Related Psychosis
  • Abilify Asimtufii should not be used in older adults with dementia-related psychosis, as it may increase the risk of death in this population.
• Suicidal Thoughts and Mood Changes
  • People with mental health conditions may experience suicidal thoughts.
  • Young individuals may have increased suicidal ideation when starting treatment.
  • Notify your doctor immediately if you or a loved one notices sudden mood changes or suicidal thoughts.
• Do Not Stop Suddenly
  • Abruptly discontinuing aripiprazole may cause withdrawal symptoms.
• Drowsiness and Impaired Alertness
  • Avoid driving or engaging in activities requiring clear focus until you understand how the medication affects you.
• Metabolic Risks
  • Aripiprazole may lead to high blood sugar (diabetes), weight gain, and increased cholesterol, which can elevate the risk of heart disease and stroke.
• Low White Blood Cell Count (WBCs)
  • This medication may reduce WBC levels, increasing the risk of serious infections.
  • Contact your doctor if you experience fever, chills, or a sore throat.

Before Using Abilify Asimtufii

Who Should Avoid This Medication?

Do not take Abilify Asimtufii if you are allergic to aripiprazole or any of its inactive ingredients.

This medication should not be used in elderly patients with dementia-related psychosis, as it may increase mortality risk in this group.

Before beginning treatment, let your healthcare provider know if you have any of the following conditions:

✔ Heart disease or a history of stroke
✔ High or low blood pressure
✔ Diabetes (personal or family history)
✔ Seizure disorder (epilepsy)
✔ Low white blood cell count (WBCs)

Mental Health Monitoring

Patients with depression or other psychiatric disorders should be closely monitored for worsening symptoms or suicidal thoughts, particularly in the early stages of treatment.

Family members and caregivers should also stay vigilant for sudden behavioral changes.

Blood Sugar and Diabetes Risk

Aripiprazole can cause high blood sugar (hyperglycemia). If you have diabetes, regularly monitor your blood glucose levels and report any significant changes to your doctor.

Abilify Asimtufii provides a long-acting treatment option for schizophrenia and bipolar I disorder, allowing for better adherence and convenience. However, it is essential to consider potential risks and maintain close communication with your healthcare provider throughout the treatment process.

Pregnancy and Abilify Asimtufii

If you are pregnant or planning to become pregnant, inform your healthcare provider. Receiving Abilify Asimtufii during the third trimester of pregnancy may lead to abnormal muscle movements or withdrawal symptoms in the newborn. These symptoms can include tremors, stiffness, feeding difficulties, or breathing problems. Discuss the potential risks with your healthcare provider before continuing or stopping this medication during pregnancy. Do not discontinue use without medical guidance, as this could lead to worsening symptoms.

Breastfeeding Considerations

If you are breastfeeding or planning to do so, consult your doctor before using this medication. Aripiprazole, the active ingredient, can pass into breast milk, though it is unclear whether this affects a nursing infant. To ensure your baby’s safety, your doctor may discuss alternative feeding options or assess the potential risks and benefits of continuing treatment while breastfeeding.

How Abilify Asimtufii is Administered

Before starting Abilify Asimtufii, patients who have never taken aripiprazole should first try the oral form to determine tolerability. Since oral aripiprazole has a long half-life, it may take up to two weeks to fully evaluate any side effects.

This medication is administered as an intramuscular injection in the gluteal (buttock) muscle by a healthcare professional. It is not intended for administration by any other method.

Abilify Asimtufii is given once every two months.

Patients Transitioning from Oral Antipsychotics

For individuals currently taking oral aripiprazole, the first injection of Abilify Asimtufii should be accompanied by oral aripiprazole (10 mg to 20 mg) for the first 14 days.

Patients switching from a different oral antipsychotic should continue their previous medication alongside the first Abilify Asimtufii injection for 14 days to ensure a smooth transition.

Patients Transitioning from Abilify Maintena

For those receiving Abilify Maintena (a once-monthly aripiprazole injection), the first Abilify Asimtufii dose (960 mg every two months) should replace the next scheduled Abilify Maintena injection.

If side effects occur with the 960 mg dose, the healthcare provider may reduce the dose to 720 mg every two months.

The injection may be administered up to two weeks before or after the scheduled two-month interval if necessary.

Abilify Asimtufii Dosage Guidelines

Schizophrenia Treatment in Adults

• Standard Dose: 960 mg intramuscular injection every two months
• Alternative Dose (for those with side effects): 720 mg every two months
• Important Notes:
  • Patients new to aripiprazole should establish tolerability with oral aripiprazole before receiving an injection.
  • Only a trained healthcare provider should administer the injection in the gluteal muscle.

Bipolar I Disorder Maintenance in Adults

• Standard Dose: 960 mg intramuscular injection every two months
• Alternative Dose (if needed): 720 mg every two months
• Important Notes:
  • As with schizophrenia treatment, patients should first test their response to oral aripiprazole.
  • The injection must be administered only by a healthcare professional.

Missed Dose Instructions

• If 8 to 14 weeks have passed since the last dose, the next injection should be given as soon as possible, then continue with the regular two-month schedule.
• If more than 14 weeks have passed since the last injection, patients should restart oral aripiprazole for 14 days along with their next injection.

Precautions and Safety Measures

Activities to Avoid

• Standing up too quickly: This may cause dizziness or lightheadedness.
• Driving or operating machinery: Aripiprazole can impair reaction time, thinking, and coordination. Do not engage in dangerous activities until you understand how the medication affects you.
• Alcohol consumption: Drinking alcohol can increase the risk of side effects such as drowsiness, dizziness, and impaired judgment.
• Overheating or dehydration: This medication may reduce your ability to regulate body temperature. Stay hydrated, avoid excessive heat, and take precautions during exercise or warm weather.

Comprehensive List of Abilify Asimtufii Side Effects

Abilify Asimtufii (aripiprazole) can cause various side effects, ranging from mild to severe. If you notice any unexpected symptoms, contact your doctor right away.

Severe Side Effects – Seek Emergency Medical Help

• Allergic reactions – Symptoms include:
  • Hives
  • Difficulty breathing
  • Swelling of the face, lips, tongue, or throat
• Neurological and Movement Disorders
  • Severe agitation, distress, or restlessness
  • Extrapyramidal symptoms (EPS) – Uncontrollable movements, including:
    • Twitching or tremors
    • Involuntary muscle movements in the eyes, lips, tongue, face, arms, or legs
    • Mask-like facial expressions
    • Difficulty swallowing
    • Slurred or slow speech
  • Tardive dyskinesia (TD) – Repetitive, involuntary movements that may become permanent
  • Dystonia – Painful muscle stiffness, spasms, or prolonged contractions, particularly in the neck, tongue, or jaw
  • Seizures (convulsions)
• Neuroleptic Malignant Syndrome (NMS) – A life-threatening reaction to antipsychotics, characterized by:
  • High fever
  • Rigid muscles
  • Confusion
  • Sweating
  • Rapid or irregular heartbeat
  • Tremors
  • Risk of coma or death if untreated
• Cardiovascular and Blood Pressure Issues
  • Irregular heartbeat (arrhythmia)
  • Fast or slow heart rate
  • Sudden drop in blood pressure when standing (orthostatic hypotension), causing dizziness or fainting
  • Chest pain
  • Increased risk of stroke (especially in elderly patients with dementia-related psychosis)
• Metabolic and Endocrine Effects
  • High blood sugar (hyperglycemia) – Symptoms include:
    • Increased thirst
    • Frequent urination
    • Dry mouth
    • Fruity-smelling breath
  • Ketoacidosis (a severe form of hyperglycemia)
  • Diabetes exacerbation or new-onset diabetes
  • Weight gain
  • Increased cholesterol or triglyceride levels
• Psychiatric and Behavioral Changes
  • Worsening depression or anxiety
  • Panic attacks
  • Aggression or hostility
  • Impulsivity
  • Suicidal thoughts or behaviors
  • Hallucinations or delusions (in rare cases)
  • Confusion or memory problems
• Blood and Immune System Disorders
  • Low white blood cell count (leukopenia, neutropenia, agranulocytosis) – Symptoms include:
    • Fever
    • Frequent infections
    • Sore throat
    • Weakness
  • Low platelet count (thrombocytopenia) – Increased risk of bleeding or bruising
  • Anemia (low red blood cells) – Symptoms include fatigue and dizziness
• Gastrointestinal Issues
  • Severe nausea, vomiting, or diarrhea
  • Constipation (can become severe or chronic)
  • Difficulty swallowing (dysphagia), increasing the risk of choking
  • Abdominal pain or bloating
• Urinary and Kidney Problems
  • Difficulty urinating or pain during urination
  • Kidney dysfunction in rare cases
  • Increased or decreased urination
• Hormonal and Sexual Side Effects
  • Increased or decreased libido (sex drive)
  • Increased sexual urges (hypersexuality)
  • Erectile dysfunction in men
  • Menstrual irregularities in women
  • Breast swelling or tenderness in both men and women
  • Galactorrhea (unexpected breast milk production)
• Skin and Allergic Reactions
  • Rash or itching
  • Hives
  • Skin discoloration
  • Severe skin reactions such as Stevens-Johnson syndrome (a rare but life-threatening condition with painful blisters and peeling skin)
• Respiratory Issues
  • Shortness of breath
  • Wheezing or difficulty breathing
  • Respiratory infections, including pneumonia (more common in elderly patients)
• Sleep-Related and Fatigue Symptoms
  • Insomnia (difficulty sleeping)
  • Excessive daytime drowsiness
  • Unusual dreams or nightmares
  • Sleepwalking or other abnormal sleep behaviors
• Temperature Regulation Issues
  • Inability to control body temperature – Risk of heatstroke in hot weather
  • Sweating excessively or not at all

Common Side Effects (Less Severe but Still Notable)

• Drowsiness or fatigue
• Dizziness or lightheadedness
• Blurred vision
• Increased saliva or drooling
• Muscle stiffness or mild tremors
• Anxiety or nervousness
• Headaches
• Mild nausea or stomach discomfort
• Cold or flu-like symptoms (stuffy nose, sneezing, sore throat, cough)
• Appetite changes (increased or decreased)

Rare but Serious Side Effects

• Rhabdomyolysis (severe muscle breakdown that can lead to kidney damage) – Symptoms include muscle pain, weakness, and dark-colored urine
• Liver damage or hepatitis – Symptoms include yellowing of the skin (jaundice), dark urine, and persistent nausea
• Severe hypersensitivity reactions – Anaphylaxis, severe swelling, or shock

What to Do If You Experience Side Effects

• Mild side effects – If manageable, inform your doctor at your next visit.
• Severe or worsening side effects – Seek immediate medical attention.
• Allergic reactions, seizures, or signs of NMS – Call emergency services immediately.

This list is comprehensive but not exhaustive. Always consult your doctor for medical guidance.

If you experience any side effects, you can also report them to the FDA at 1-800-FDA-1088.

Medications That May Interact with Abilify Asimtufii

Before starting Abilify Asimtufii, inform your healthcare provider about all the medications you take, including prescription drugs, over-the-counter medicines, vitamins, and herbal supplements.

This injection can interact with other medications, potentially leading to serious side effects. It may alter how other drugs work, and in turn, other medications may influence its effects.

Your healthcare provider will assess whether it is safe to use Abilify Asimtufii alongside your current medications. Always consult your doctor before beginning or discontinuing any medication.

Medications That Require Special Precaution

Be sure to inform your healthcare provider if you are using any of the following:

• Certain antibiotics – e.g., clarithromycin (Biaxin)
• Antidepressants – such as fluoxetine (Prozac), paroxetine (Paxil), and nefazodone
• Antifungal medications – including fluconazole (Diflucan), ketoconazole (Nizoral), and itraconazole (Sporanox)
• Antiarrhythmic drug – quinidine
• HIV treatments – such as indinavir (Crixivan), ritonavir (Norvir), saquinavir (Fortovase, Invirase), and lopinavir/ritonavir (Kaletra)
• Seizure medications – e.g., carbamazepine (Tegretol)
• Tuberculosis medication – rifampin (Rifadin)

Storage Guidelines

Store at 25°C (77°F), with allowable temperature fluctuations between 15°C and 30°C (59°F to 86°F).

Questions and Answers about Abilify Asimtufii

What is the difference between ABILIFY MAINTENA and Asimtufii?

The main difference is the dosing frequency. Abilify Maintena is administered once monthly, while Abilify Asimtufii is administered once every two months. Both contain the same active ingredient (aripiprazole) and are used to treat similar conditions.

How long does Abilify Asimtufii last?

Abilify Asimtufii lasts for two months. It is a long-acting injectable formulation designed to be administered once every two months.

What should you avoid while taking Abilify?

Avoid alcohol, as it may increase drowsiness. Also, avoid driving or operating machinery until you know how Abilify affects you, as it can cause dizziness and drowsiness.

How to know if Abilify is working?

You may notice improvements in symptoms over time, such as decreased anxiety, improved sleep quality, or reduced compulsive behaviors. Regular check-ups with your doctor will help monitor progress.

Why is Abilify so expensive?

Abilify can be expensive due to factors like pharmacy pricing, insurance coverage, and location. Generic versions are generally less expensive, with costs ranging from $20 to $150 for a month’s supply.

Is aripiprazole the best antipsychotic?

There’s no definitive answer as the effectiveness of antipsychotics varies among individuals. Aripiprazole (Abilify) has shown efficacy in treating various conditions, but the best antipsychotic depends on individual patient factors and response to treatment.

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