Lenacapavir
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Alen Antony Pathil, M.D.[2]
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Overview
Lenacapavir is a HIV 1 antiretroviral agent that is FDA approved for the treatment of Multidrug-resistant Human Immunodeficiency Virus type 1 (HIV-1) infection among adults.. Common adverse reactions include *Immune reconstitution syndrome
- Injection site reaction
- swelling
- erythema
- pruritis
- pain
- nodule
- induration.
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
SUNLENCA along with other antiretroviral drugs are used for treating HIV1 infection among adults with multidrug resistance to their current HIV treatment regimen due to resistance, intolerance, or safety considerations.
There are 2 options for treatment regimen: Option 1:
- Initiation doaage-
Day 1 - 927 mg by subcutaneous injection (2 × 1.5 mL injections)+ 600 mg orally (2 × 300 mg tablets) Day 2 - 600 mg orally (2 × 300 mg tablets)
- Maintenance dosage-
Every 6 months (26 weeks) +/-2 weeks - 927 mg by subcutaneous injection (2 × 1.5 mL injections)
Option 2:
- Initiation dosage:
Day 1 - 600 mg orally (2 × 300 mg tablets) Day 2 - 600 mg orally (2 × 300 mg tablets) Day 8 - 300 mg orally (1 × 300 mg tablet) Day 15 - 927 mg by subcutaneous injection (2 × 1.5 mL injections)
- Maintenance dosage-
Every 6 months (26 weeks) * +/-2 weeks 927 mg by subcutaneous injection (2 × 1.5 mL injections)
If a dose has been missed and the time elapsed has been more than 28 weeks from last injection during the maintenance phase, it is advised to restart the initiation dosage regimen from Day 1, using either Option 1 or Option 2.
Off-Label Use and Dosage (Adult)
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
There is limited information regarding Lenacapavir FDA-Labeled Indications and Dosage (Pediatric) in the drug label.
Off-Label Use and Dosage (Pediatric)
Contraindications
SUNLENCA should not be concomitantly administrated with other CYP3A drugs as it decreases the plasma concentration of SUNLENA and this can lead to loss of the therapeutic efficacy of SUNLENCA or the development of resistance to SUNLENCA.
Warnings
1.Immune Reconstitution Syndrome- During the initial phase in combination with other antiretrovirals, the patient's immune system may should inflammatory response to indolent opportunistic infections like Mycobacterium avium infection, cytomegalovirus, Pneumocystis jirovecii pneumonia (PCP), or tuberculosis, which would required further evaluation and treatment. Autoimmune dissorders like Graves' disease, polymyositis, Guillain-Barré syndrome, and autoimmune hepatitis has also been reported due to immune constitution syndrome.
2.Long-Acting Properties and Potential Associated Risks with SUNLENCA- The residual components of lenacapavir remain in the body for a very long period, such as more than 12 months from the last subcutaneous injection dose. lenacapavir being a CYP3A inhibitor, can lead to a decrease in the efficacy of other drugs metabolized by CYP3A, when taken within the 9 months of the last injection dose. Patients are also counseled on the importance of adherence to the treatment regimen, because missed doses or non-adherence can lead to loss of virologic response and development of resistance.
3.Injection Site Reactions Injection site reactions may manifets as swelling, pain, erythema, nodule, induration, pruritus, extravasation, or mass. Nodules and indurations at the injection site may take longer to resolve than other reactions.
Adverse Reactions
Clinical Trials Experience
- Injection site reactions
- swelling
- pain
- erythema
- nodule
- induration
- pruritis
- extravasation
- mass
- nausea
Postmarketing Experience
There is limited information regarding Lenacapavir Postmarketing Experience in the drug label.
Drug Interactions
There is limited information regarding Lenacapavir Drug Interactions in the drug label.
Use in Specific Populations
Pregnancy
Pregnancy Category (FDA):
There is no FDA guidance on usage of Lenacapavir in women who are pregnant.
Pregnancy Category (AUS):
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Lenacapavir in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of Lenacapavir during labor and delivery.
Nursing Mothers
There is no FDA guidance on the use of Lenacapavir in women who are nursing.
Pediatric Use
There is no FDA guidance on the use of Lenacapavir in pediatric settings.
Geriatic Use
There is no FDA guidance on the use of Lenacapavir in geriatric settings.
Gender
There is no FDA guidance on the use of Lenacapavir with respect to specific gender populations.
Race
There is no FDA guidance on the use of Lenacapavir with respect to specific racial populations.
Renal Impairment
There is no FDA guidance on the use of Lenacapavir in patients with renal impairment.
Hepatic Impairment
There is no FDA guidance on the use of Lenacapavir in patients with hepatic impairment.
Females of Reproductive Potential and Males
There is no FDA guidance on the use of Lenacapavir in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of Lenacapavir in patients who are immunocompromised.
Administration and Monitoring
Administration
There is limited information regarding Lenacapavir Administration in the drug label.
Monitoring
There is limited information regarding Lenacapavir Monitoring in the drug label.
IV Compatibility
There is limited information regarding the compatibility of Lenacapavir and IV administrations.
Overdosage
There is limited information regarding Lenacapavir overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.
Pharmacology
There is limited information regarding Lenacapavir Pharmacology in the drug label.
Mechanism of Action
There is limited information regarding Lenacapavir Mechanism of Action in the drug label.
Structure
There is limited information regarding Lenacapavir Structure in the drug label.
Pharmacodynamics
There is limited information regarding Lenacapavir Pharmacodynamics in the drug label.
Pharmacokinetics
There is limited information regarding Lenacapavir Pharmacokinetics in the drug label.
Nonclinical Toxicology
There is limited information regarding Lenacapavir Nonclinical Toxicology in the drug label.
Clinical Studies
There is limited information regarding Lenacapavir Clinical Studies in the drug label.
How Supplied
There is limited information regarding Lenacapavir How Supplied in the drug label.
Storage
There is limited information regarding Lenacapavir Storage in the drug label.
Images
Drug Images
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Package and Label Display Panel
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Patient Counseling Information
There is limited information regarding Lenacapavir Patient Counseling Information in the drug label.
Precautions with Alcohol
Alcohol-Lenacapavir interaction has not been established. Talk to your doctor regarding the effects of taking alcohol with this medication.
Brand Names
There is limited information regarding Lenacapavir Brand Names in the drug label.
Look-Alike Drug Names
There is limited information regarding Lenacapavir Look-Alike Drug Names in the drug label.
Drug Shortage Status
Price
References
The contents of this FDA label are provided by the National Library of Medicine.