Usual Adult Dose for HIV Infection

Loading dose: 2000 mg IV once
Maintenance dose: 800 mg IV every 2 weeks

Use: In combination with other antiretroviral(s), for the treatment of HIV-1 infection in heavily therapy-experienced patients with multidrug-resistant HIV-1 infection failing their current antiretroviral regimen

Renal Dose Adjustments

Data not available

Liver Dose Adjustments

Data not available

Precautions

CONTRAINDICATIONS:
Prior hypersensitivity reaction to the active component or any of the ingredients

Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:

• A trained medical professional should administer the diluted solution.
• Administer as an IV infusion in the cephalic vein of the patient's right or left arm; if this vein is not accessible, use an appropriate vein located elsewhere. Do not administer as an IV push or bolus.
• Administer the first infusion (loading dose) over at least 30 minutes; if no infusion-related side effects occur, may administer subsequent infusions (maintenance dose) over at least 15 minutes
• After infusion is complete, flush with 30 mL of 0.9% Sodium Chloride Injection, USP.
• Observe all patients for 1 hour after completion of administration for at least the first infusion; if no infusion-related side effects occur, may reduce post-infusion observation to 15 minutes thereafter
• If a maintenance dose (800 mg) is missed by at least 3 days past the scheduled dosing day, administer a loading dose (2000 mg) as soon as possible; resume maintenance dosing (800 mg) every 14 days thereafter.

• Before dilution: Store vials under refrigeration at 2C to 8C (36F to 46F); do not freeze; protect from light.
• After dilution: If not administered immediately, store diluted solution at room temperature (20C to 25C [68F to 77F]) for up to 4 hours or refrigerated (2C to 8C [36F to 46F]) for up to 24 hours; if refrigerated, allow diluted solution to stand at room temperature for at least 30 minutes (but no more than 4 hours) before administration.

• This drug must be diluted before administration.
• The solution for infusion should be prepared by a trained medical professional; 10 vials are used to prepare the loading dose (2000 mg); 4 vials are used to prepare the maintenance dose (800 mg).
• The manufacturer product information should be consulted.

• Compatible diluent: 0.9% Sodium Chloride Injection, USP
• Other IV diluents must not be used to prepare this drug for infusion.

• Read the US FDA-approved patient labeling (Patient Information).
• Seek immediate medical attention if signs/symptoms of hypersensitivity occur/are suspected.
• Do not use this drug if you have had clinically significant hypersensitivity reactions to this drug.
• Notify health care provider at once of any symptoms of infection.
• It is important to receive these injections every 2 weeks as recommended by health care professional; do not change dosing schedule of this or any antiretroviral agent without consulting health care provider.
• Patients of childbearing potential: Notify health care provider of a known/suspected pregnancy.

Frequently asked questions

• How well does Trogarzo work to treat multidrug-resistant (MDR) HIV-1?
• How is Trogarzo used in the treatment of HIV?
• What are the side effects with HIV treatment Trogarzo?