Lenacapavir (subcutaneous)

Lenacapavir (subcutaneous)

Lenacapavir (subcutaneous)

Lenacapavir uses

This medicine does not cure HIV infection or AIDS. It lowers the amount of HIV in the blood and strengthens the immune system. This can help delay some of the illnesses that usually result from AIDS or HIV disease. It will not stop you from transmitting HIV to other people.

This medicine should only be administered by or under your doctor's direct supervision.

Before using lenacapavir

When deciding whether to use a medicine, the risks of taking the medicine must be weighed against the benefits it produces. This is a decision that you and your doctor will make. The following should be noted with this medicine:

Allergies

Tell your doctor if you have ever had an unusual or allergic reaction to this medicine or any other medicines. Also tell your doctor if you have other allergies, such as to foods, dyes, preservatives or animals. For over-the-counter products, read the label or package ingredients carefully.

Pediatrics

No appropriate studies have been conducted on the relationship between age and the effects of lenacapavir injection in children and adolescents. Safety and effectiveness have not been established.

geriatrics

Studies conducted to date have not shown any geriatric-specific problems that would limit the benefit of lenacapavir injection in the elderly.

Breastfeeding

There are insufficient studies in women to determine the risk to infants when using this drug while breast-feeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Drug interactions

Although certain medicines should not be used together at all, in other cases two different medicines can be used together, although interactions may occur. In these cases, your doctor may want to change the dose or other precautions may be necessary. If you are receiving this medicine, it is particularly important that your doctor knows whether you are taking any of the medicines listed below. The following interactions were selected for their potential significance and are not necessarily exhaustive.

The use of this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or to change some of the other medications you are taking.

• Apalutamid
• Carbamazepin
• Enzalutamid
• Fosphenytoin
• Lumacaftor
• Mitotan
• Phenytoin
• Rifampin
• Johanniskraut

Using this medicine with any of the following medicines is not usually recommended but may be necessary in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both medicines.

• Acalabrutinib
• Alfentanil
• Apixaban
• Aprepitant
• Atazanavir
• Avanafil
• Avapritinib
• Benzhydrocodon
• Bosentan
• Bosutinib
• Budesonid
• Buprenorphin
• Buspiron
• Cenobamat
• Clarithromycin
• Cobicistat
• Cobimetinib
• Kodein
• Conivaptan
• Kortison
• Cyclosporin
• Dabigatranetexilat
• Darifenacin
• Darunavir
• Dasatinib
• Dexamethason
• Digoxin
• Dihydroergotamin
• Dofetilid
• Dronedaron
• Edoxaban
• Efavirenz
• Eletriptan
• Entrectinib
• Eplerenon
• Ergotamin
• Etravirin
• Everolimus
• Felodipin
• Fentanyl
• Finerenon
• Flibanserin
• Fluticason
• Fosaprepitant
• Hydrocodon
• Hydrocortison
• Ibrexafungerp
• Ibrutinib
• Indinavir
• Itraconazol
• Ivabradin
• Ivacaftor
• Ketoconazol
• Lomitapid
• Lorlatinib
• Lovastatin
• Lurasidon
• Maraviroc
• Methadon
• Methylergonovin
• Midazolam
• Modafinil
• Nafcillin
• Naloxegol
• Nevirapin
• Oxcarbazepin
• Oxycodon
• Phenobarbital
• Pimavanserin
• Pimozid
• Primidon
• Quetiapin
• Chinidin
• Rifabutin
• Rifapentin
• Ritonavir
• Rivaroxaban
• Sildenafil
• Simvastatin
• Sirolimus
• Tacrolimus
• Tadalafil
• Telaprevir
• Temsirolimus
• Ticagrelor
• Tipranavir
• Tolvaptan
• Tramadol
• Triazolam
• Ubrogepant
• Vardenafil
• Venetoclax
• Voclosporin

Interactions with food/tobacco/alcohol

Certain medicines should not be taken during or near food or consumption of certain foods because interactions may occur. Consuming alcohol or tobacco with certain medications can also lead to interactions. Discuss using your medicine with food, alcohol or tobacco with your doctor.

Proper use of lenacapavir

A nurse or other trained health professional can give you this medicine. It is given as an injection under the skin, usually in the stomach.

This medicine comes with a package leaflet. Read and follow these instructions carefully. Ask your doctor if you have any questions.

Treatment with this medicine includes injections and tablets. There are also two ways to start this treatment. Your doctor will decide which option is best for you.

Your doctor will ask you to remain under his or her care while you are being treated with this medicine.

dosage

The dose of this medicine is different for different patients. Follow your doctor's instructions or the label directions. The following information includes average doses of this medicine only. If your dose is different, do not change it unless your doctor tells you to.

The amount of medicine you take depends on the strength of the medicine. In addition, the number of doses you take each day, the time between doses, and how long you take the medicine depend on the medical problem for which you are using the medicine.

• Für Injektionsdosierungsformen (Lösung) und orale Dosierungsformen (Tabletten):
  • Zur Behandlung einer HIV-Infektion:
    • Option 1:
      • Erwachsene – zunächst 927 Milligramm (mg) (2 Durchstechflaschen) unter die Haut injiziert und 600 mg (2 Tabletten) einmal täglich am ersten Tag. Anschließend 600 mg (2 Tabletten) einmal täglich am zweiten Tag. Zur Erhaltung 927 mg (2 Durchstechflaschen), einmal täglich alle 6 Monate (26 Wochen) unter die Haut injiziert.
      • Kinder – Anwendung und Dosis müssen von Ihrem Arzt festgelegt werden.
    • Option 2:
      • Erwachsene – Zunächst 600 Milligramm (mg) (2 Tabletten) einmal täglich an den Tagen 1 und 2. Anschließend 300 mg (1 Tablette) einmal täglich am 8. Tag. Anschließend werden 927 mg (2 Durchstechflaschen) unter die Haut injiziert am 15. Tag. Zur Erhaltungstherapie werden alle 6 Monate (26 Wochen) einmal täglich 927 mg (2 Durchstechflaschen) unter die Haut injiziert.
      • Kinder – Anwendung und Dosis müssen von Ihrem Arzt festgelegt werden.

Missed dose

Call your doctor or pharmacist for instructions.

Precautions when using lenacapavir

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly. Blood tests may be needed to check for adverse effects.

Do not use this medicine with carbamazepine (Tegretol®), phenytoin (Dilantin®), rifampin (Rifadin®), or St. John's wort.

Your immune system can be strengthened when you start taking HIV medications. Tell your doctor immediately if you notice any changes in your health. Sometimes the immune system begins to fight infections that have been hidden in your body, including pneumonia, herpes, or tuberculosis. Autoimmune diseases (e.g. Graves' disease, polymyositis and Guillain-Barré syndrome) can also occur.

This medicine may cause reactions at the injection site. Consult your doctor immediately if you experience bleeding, blistering, burning, cold, discoloration of the skin, pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, pain, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site.

Do not take any other medicines unless you have discussed this with your doctor. This includes both prescription and nonprescription (over-the-counter [OTC]) medications and herbal or vitamin supplements.

Lenacapavir side effects

In addition to the necessary effects, a medicine may also have some undesirable effects. Although not all of these side effects may occur, medical attention may be required if they occur.

Contact your doctor or nurse immediately if any of the following side effects occur:

More common

• Blutungen, Blasenbildung, Brennen, Kälte, Verfärbung der Haut, Druckgefühl, Nesselsucht, Infektion, Entzündung, Juckreiz, Knoten, Taubheitsgefühl, Schmerzen, Hautausschlag, Rötung, Narbenbildung, Schmerzen, Stechen, Schwellung, Empfindlichkeit, Kribbeln, Geschwüre oder Wärme an der Injektionsstelle

Incident not known

• Dunkler Urin
• Fieber
• Unfähigkeit, Arme und Beine zu bewegen
• Gelenkschmerzen
• heller Stuhlgang
• Muskelempfindlichkeit, -schwäche oder -schmerzen
• Übelkeit und Erbrechen
• Hautausschlag
• Plötzliche Taubheit und Schwäche in Armen und Beinen
• ungewöhnliche Müdigkeit oder Schwäche
• Schmerzen im oberen rechten Bauch oder Magen
• Gewichtsverlust
• gelbe Augen und Haut

Some patients may also experience other side effects not listed. If you notice other side effects, contact your doctor.

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

Commonly used brand names

In the USA

• Sunlenca

Available dosage forms:

• Lösung

Therapeutic class: Antiretroviral agent

More information