Pifeltro

The active ingredient in Pifeltro is doravirine. It is a non-nucleoside reverse transcriptase inhibitor (NNRTI) that works by stopping an enzyme called reverse transcriptase. This prevents HIV from making copies of itself and spreading.

Pifeltro is used as part of HIV combination therapy. Standard regimens may include either an NNRTI like Pifeltro or a protease inhibitor (PI) with a pharmacokinetic enhancer (booster) such as cobicistat or ritonavir. Pifeltro is also given with other medications like efavirenz (EFV), emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), and abacavir/lamivudine (ABC/3TC).

Follow all directions given to you by your doctor and read all documents provided, including the full Prescribing Information, FDA-Approved Product Labeling, Instructions for Use, and Medication Guide before using Pifeltro. However, the following is a synopsis of the general guidelines for the use of Pifeltro:

• You and your healthcare provider should consider your CD4 cell count, your viral load, any symptoms you are having, and your preferences when deciding which HIV medications to take.
• Take Pifeltro at the same time every day, with or without food.
• Pifeltro is typically taken once a day. If you also take rifabutin, you may need to take doravirine twice a day. Follow your doctor's dosing recommendations carefully.
• Use all HIV drugs exactly as prescribed, and read all medication guidelines you receive. Do not change your dose or dosing schedule without consulting your doctor first. Every individual with HIV should be under the supervision of a doctor.

In clinical trials, Pifeltro was given along with other HIV AVRs, so these side effects may not all be caused by Pifeltro. Some mild and most common side effects from these trials include:

• Dizziness.
• Fatigue and extreme tiredness.
• Sleepiness.
• Strange dreams.
• Stomach pain.
• Trouble sleeping.

Some individuals may experience serious side effects while using Pifeltro. These side effects may require immediate medical attention. If you experience any of the following, contact your healthcare provider or seek emergency medical help:

• Allergic reactions include skin rashes, itching, hives, and swelling of the face, lips, tongue, or throat.
• Changes in your immune system (Immune Reconstitution Syndrome) can happen when you start taking HIV-1 medicines. This can cause aches and pains, fever, extreme fatigue, and rash.

These are not all of the possible side effects of Pifeltro. You should always seek medical advice from your healthcare provider for any questions or concerns about your medical condition or treatment. Read all patient information, medication guides, or drug information sheets that come with this medication. You can also report adverse effects to the Food and Drug Administration at www.fda.gov/medwatch or 1-800-FDA-1088.

Before starting Pifeltro, it is crucial to discuss any existing health conditions with your healthcare provider. You should be sure that your healthcare provider is aware of all your medical conditions, including:

• Tell your doctor about all your current medicines and any you start or stop using. Many drugs can interact with Pifeltro, and some drugs should not be used together.

Cannot be taken concurrently with medications that inhibit Pifeltro’s metabolism. This includes the herbal supplement St. John's wort and some antiseizure and TB treatments.

Pifeltro begins acting immediately after the first dose to diminish the amount of virus in the body. However, the improvements in viral load are monitored over weeks to months using blood testing. Many patients have a considerable reduction in viral load within 2-4 weeks, with undetectable levels being achieved after a few months of persistent daily treatment.

When Pifeltro is taken with other prescription drugs, over-the-counter medications, vitamins, and supplements, it may change how they work or increase the frequency or severity of side effects. Make sure that you tell your healthcare professional about anything that you are taking to avoid any negative drug interactions, including:

• Rifabutin (or if you have taken it in the past 4 weeks).
• Darunavir (DRV).
• Ritonavir.
• Rilpivirine.
• Etravirine.
• Nevirapine.
• Lamivudine.
• Enzalutamide.
• Mitotane.
• Rifampin.
• Rifapentine.
• St. John’s wort.
• Seizure medications include carbamazepine, phenobarbital, phenytoin, and oxcarbazepine.

The average oral dose is 100 mg per day, with or without food.

If you miss a dose, take the next dose as soon as possible, but omit it if it's almost time for the following dose. Do not take two doses at the same time.

Store at room temperature and keep out of reach of children.

Merck & Co. Inc. is the company that manufactures Pifeltro.

There are no lower-cost generic versions available of Pifeltro.

You should not discontinue Pifeltro (doravirine) without your doctor's clearance. Because it is part of HIV treatment, discontinuing abruptly might cause the virus to grow rapidly, increasing your viral load and increasing the risk of drug resistance.

Inform your doctor if you are pregnant, and use your drugs correctly to control your infection. If HIV is not treated during pregnancy, it can be passed on to your baby. Your name may be entered into a register to track the effects of antiviral medication on the baby.

Women who are HIV or AIDS positive should not breastfeed their babies. Even if your kid is born HIV-free, the virus may be transmitted to the newborn through your breast milk or lactation.