Lenacapavir (len-a-KAP-a-vir)

Treats HIV infection. HIV causes AIDS. This medicine does not cure HIV or AIDS, but combinations of drugs may slow the progress of the disease.

Brand Name(s):

Sunlenca

When This Medicine Should Not Be Used:

How to Use This Medicine:

Injectable

• Your doctor will prescribe your exact dose and tell you how often it should be given. This medicine is given as a shot under your skin. It is usually given in the stomach area.
• A nurse or other health provider will give you this medicine.
• Treatment with this medicine contains injections and tablets. There are also 2 options in starting this treatment. Your doctor will decide which option is the best for you.
• Your doctor will ask you to stay under their care during your treatment with this medicine.
• This medicine is used with other medicines to treat HIV infection. Take all other medicines your doctor has prescribed as part of your combination treatment.
• Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.
• Missed dose: You must use this medicine on a fixed schedule. Call your doctor or pharmacist if you miss a dose.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Do not use this medicine together with carbamazepine, phenytoin, rifampin, or St John's wort.
• Some medicines can affect how lenacapavir works. Tell your doctor if you are using the following:
  • Dabigatran, digoxin, edoxaban, midazolam, naloxegol, rifabutin, rifapentine, rivaroxaban, sildenafil, tadalafil, triazolam, vardenafil
  • Ergot medicine (including dihydroergotamine, ergotamine, methylergonovine)
  • Medicine to lower cholesterol (including lovastatin, simvastatin)
  • Narcotic pain medicine (including buprenorphine, fentanyl, methadone, oxycodone, tramadol)
  • Other medicine to treat HIV infection (including atazanavir/cobicistat, atazanavir/ritonavir, efavirenz, nevirapine, tipranavir/ritonavir)
  • Seizure medicine (including oxcarbazepine, phenobarbital)
  • Steroid medicine (including dexamethasone, hydrocortisone)

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant, or if you have kidney disease or liver disease.
• Do not breastfeed. You can spread HIV or AIDS to your baby through your breast milk.
• This medicine may cause autoimmune problems (including Graves disease, polymyositis, Guillain-Barré syndrome, hepatitis).
• Your immune system may get stronger when you start taking HIV medicines. This could cause a hidden infection in your body to become active. Tell your doctor right away if you notice any changes in your health.
• Always practice safe sex, even if your partner also has HIV. If you stop taking this medicine or do not take it as prescribed, you may spread HIV to others. Do not reuse or share needles, or other items, that may have blood or body fluids on them.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Dark urine or pale stools, nausea, vomiting, loss of appetite, stomach pain, yellow skin or eyes
• Inability to move the arms and legs, numbness and weakness in the arms and legs
• Joint pain, muscle weakness, weight loss
• Pain, itching, burning, swelling, or a lump under your skin where the shot was given

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088