Lenacapavir

Lenacapavir
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

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.