Apretude

In order to ensure the medication is well tolerated, the usual starting dose of cabotegravir is one 30 mg tablet taken by mouth once a day for at least 1 month. It may be taken with or without food.

Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.

It is important to take this medication exactly as prescribed by your doctor. If you miss a dose, and it is less than 12 hours since the missed dose, take it as soon as possible and continue with your regular schedule. If it less than 12 hours until your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.

After one month of taking the tablets, dosing changes to 600 mg injected intramuscularly (into a muscle). The first 600 mg injection is given on the last day or up to 3 days after the last dose of the tablets. A second 600 mg injection is given one month after the first injection. After the second dose, the ongoing dose of cabotegravir is 600 mg injected intramuscularly, every 2 months.

It is important this medication be given exactly as recommended by your doctor. If you miss an appointment to receive cabotegravir, contact your doctor as soon as possible to reschedule your appointment.

Store this medication at room temperature, protect it from light and moisture, and keep it out of the reach of children.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

Tablet

Each white, film-coated, oval tablet, debossed with "SV CTV" on one side contains, 31.62 mg of cabotegravir sodium (equivalent to 30 mg of cabotegravir). Nonmedicinal ingredients: hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium starch glycolate, and titanium dioxide.

Injectable Suspension

Each mL of white-to-light-pink, free-flowing, extended-release injectable suspension, contains 200 mg of cabotegravir. Nonmedicinal ingredients: mannitol, polysorbate 20, polyethylene glycol (PEG) 3350, and water for injection.

Do not take this medication if you:

• are allergic to cabotegravir or any ingredients of the medication

• are or may be HIV-1 positive

• are taking any of the following medications:

  • carbamazepine

  • oxcarbazepine

  • phenobarbital

  • phenytoin

  • rifampin

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

• abdominal (stomach) pain

• abnormal dreams

• diarrhea

• dizziness

• fatigue

• feeling hot

• gas

• general feeling of being unwell

• headache

• injection site reactions (e.g., pain, swelling, redness, itching)

• muscle pain

• nausea

• rash

• trouble sleeping

• vomiting

• weight gain

Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

• anxiety

• signs of depression (e.g., poor concentration, changes in weight, changes in sleep, decreased interest in activities, thoughts of suicide)

• signs of liver problems (e.g., nausea, vomiting, diarrhea, loss of appetite, weight loss, yellowing of the skin or whites of the eyes, dark urine, pale stools)

Stop taking the medication and seek immediate medical attention if any of the following occur:

• signs of a serious allergic reaction (e.g., abdominal cramps, difficulty breathing, nausea and vomiting, or swelling of the face and throat)

• symptoms of a hypersensitivity reaction (e.g., chills, fever, muscle aches or pains or other flu-like symptoms shortly before or at the same time as a skin rash)

• thoughts of suicide or self-harm

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.

Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.

Depression: Anti-retroviral medications have been known to cause mood swings and symptoms of depression. If you have depression or a history of depression, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed. If you experience symptoms of depression such as poor concentration, changes in weight, changes in sleep, decreased interest in activities, or notice them in a family member who is taking this medication contact your doctor as soon as possible.

HIV-1 infection: Taking cabotegravir without other antiviral medications when you have HIV-1 infection can cause the human immunovirus to become resistant to treatment with the medication. Your doctor will test your blood before prescribing this medication, to make sure you are not HIV-1 positive.

Hypersensitivity reactions: Severe allergic reactions involving multiple organs in the body have been reported with other medications that are similar to cabotegravir. These reactions can be fatal if they are not quickly treated. Get immediate medical attention if you have symptoms of a severe allergic reaction, including fever, swollen glands, yellowing of the skin or eyes, or flu-like symptom with skin rash or blistering.

Liver function: People taking cabotegravir may have changes in liver function that produce abnormal liver test results. Your doctor will recommend regular liver tests while you are taking this medication. If you have severe changes in liver function, your doctor may recommend that you take a lower dose of this medication or stop taking it altogether.

People with hepatitis B or C may be more likely to experience decreased liver function. If you have decreased liver function or other liver problems, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect dosing and effectiveness of this medication, and whether any special monitoring is needed.

Preventing HIV infection: Cabotegravir is not always effective in preventing infection with the human immunodeficiency virus. The time from when you start taking the medication to when it is effective is not fully known. It is important to protect yourself from contact with HIV by using condoms during sexual contact and avoid sharing needles to reduce the risk of contact with contaminated blood.

Pregnancy: This medication should not be used during pregnancy unless the benefits outweigh the risks. It is not known if this medication will cause harm to an unborn baby if it is used during pregnancy. If you plan to become pregnant or become pregnant while taking this medication, contact your doctor immediately.

Breast-feeding: It is not known if cabotegravir passes into breast milk. If you are breast-feeding and taking this medication, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: The safety and effectiveness of using this medication have not been established for children or adolescents younger than 12 years of age or those who weigh less than 35 kg.

**For a full list of interactions, use the Drug Interaction Checker **available on the Drugs.com website.

If you are taking other medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,

• change one of the medications to another,

• change how you are taking one or both of the medications, or

• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

All material copyright MediResource Inc. 1996 – 2024. Terms and conditions of use. The contents herein are for informational purposes only. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. Source: www.medbroadcast.com/drug/getdrug/Apretude