lenacapavir (oral/injection)

What is the most important information I should know about lenacapavir?

Tell your doctor about all your other medicines. Some drugs should not be used with lenacapavir.

What is lenacapavir?

Lenacapavir is used in adults with other antiviral drugs to treat HIV, the virus that can cause acquired immunodeficiency syndrome (AIDS). Lenacapavir is not a cure for HIV or AIDS.

Lenacapavir is given after several other HIV medications did not work, have stopped working or could not be tolerated.

Lenacapavir may also be used for purposes not listed in this medication guide.

What should I discuss with my healthcare provider before using lenacapavir?

There may be other reasons you should not use lenacapavir in combination with certain medicines, such as efavirenz, nevirapine, rifabutin, rifampin, rifapentine, carbamazepine, oxcarbazepine, phenytoin, primidone, dexamethasone, prednisone, St. John's wort, phenobarbital or other barbiturate medicine.

Tell your doctor if you have ever had:

• an autoimmune disorder such as Graves' disease, polymyositis, or Guillain-Barré syndrome.

To prevent HIV in a newborn baby, use all medications to control your infection during pregnancy. Your name may be listed on an antiviral pregnancy registry.

It is not known if lenacapavir will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

How is lenacapavir given?

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

The starting dose of lenacapavir is usually given as tablets and injections, followed by maintenance injections every six months (26 weeks). Your doctor will determine the right treatment for you.

You may take lenacapavir with or without food.

A healthcare provider will give you this injection under the skin in the abdomen.

Lenacapavir may affect other medicines for up to 9 months after your last injection.

What happens if I miss a dose?

Call your doctor for instructions if you miss an appointment for your lenacapavir injection.

What happens if I overdose?

What should I avoid while using lenacapavir?

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

What are the possible side effects of lenacapavir?

Lenacapavir can affect your immune system (even weeks or months after you've used this medicine). Tell your doctor if you have:

• signs of a new infection --fever, night sweats, swollen glands, cold sores, cough, wheezing, diarrhea, weight loss;
• trouble speaking or swallowing, problems with balance or eye movement, weakness or prickly feeling; or
• swelling in your neck or throat (enlarged thyroid), menstrual changes, impotence.

Common side effects may include:

• bruising, swelling, warmth, redness, oozing, or bleeding where an injection was given; or
• nausea.

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 FDA at 1-800-FDA-1088.

What other drugs will affect lenacapavir?

Tell your doctor about all your current medicines. Many drugs can affect lenacapavir, especially:

• phenobarbital or other barbiturate medicine;
• St. John's wort;
• an antibiotic --rifabutin, rifampin, rifapentine;
• cancer medicine --apalutamide, enzalutamide, mitotane;
• HIV or AIDS medicine --efavirenz, nevirapine;
• seizure medicine --carbamazepine, oxcarbazepine, phenytoin, primidone; or
• steroid medicine --dexamethasone, prednisone.

This list is not complete and many other drugs may affect lenacapavir. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

Where can I get more information?

Your doctor or pharmacist can provide more information about lenacapavir.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2023 Cerner Multum, Inc. Version: 2.01. Revision date: 2/14/2023.