Trogarzo
The first dose takes 90 seconds if pushed, or at least 30 minutes if infused. If no infusion-related adverse events occur, subsequent doses can be given as an IV push over 30 seconds or as an IV infusion over 15 minutes. Doses may be administered every two weeks at an inpatient and/or outpatient setting, including at-home infusion, if desired. All patients should be observed for 1 hour after receiving their first dose. If no administration-associated adverse reaction is noted, the post-administration observation time can be reduced to 15 minutes for subsequent doses.
For the IV push: The undiluted solution should be administered immediately. Trogarzo should be administered in the cephalic vein of the patient's arm. For the IV infusion: Once diluted, the Trogarzo solution should be administered immediately. If not administered immediately, store at room temperature for up to 4 hours or refrigerated 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, prior to administration.
Trogarzo must be given with an optimized background regimen (OBR). An OBR consists of the best antiretroviral therapy that can be selected for a person based on the patterns of HIV drug resistance of their virus. Other considerations can include safety profile, tolerability and lack of adverse drug-drug interactions or cross-resistance. Dose modifications of Trogarzo are not required when administered with any other antiretroviral or any other treatments.
If a maintenance dose of Trogarzo is missed by 3 days or longer beyond the scheduled dosing day, a loading dose (2,000 mg) should be administered as soon as possible. Then maintenance dosing (800 mg) can be resumed every 14 days thereafter.
- See package insert for more complete information on potential side effects and interactions.
Distributed by
Theratechnologies Inc.
theratech.com; trogarzo.com
● CAP & PAP Information
Co-pay program: Thera Patient Support provides insurance verification and assists in applying any eligible co-pay assistance for which you may qualify. Call (833) 23-THERA (833-238-4372) or GO TO trogarzo.com.
PAP: Thera Patient Support provides insurance verification and assists in applying any eligible co-pay assistance for which you may qualify. Call (833) 23-THERA (833-238-4372) or GO TO trogarzo.com.
JO-ANN JOSE, MD, MPH:
As s a monoclonal antibody, Trogarzo is designed to perform a very specific function. We only use this drug in people whose virus has developed extensive drug resistance and there are very limited options for treatment. It requires IV infusions or an IV push every two weeks, and you have to come to your doctor’s office or clinic. Trogarzo does not have any known drug interactions. Care providers are not prescribing this drug unless we really, really need to. If it’s being offered to you, it’s because there are extensive viral mutations and drug resistance, and you have relatively few options, so this might be a good addition to your regimen. You’re also not going to use Trogarzo by itself; there’s almost always going to be other medications that you take, usually orally, to optimize your regimen. A patient assistance program helps individuals with the extremely high cost of this medication, however, that does not protect the provider from the price—it ends up being quite expensive to deliver from a clinic standpoint.
Based on Trogarzo’s mechanism of action and pharmacokinetic profile, drug-drug interactions are not expected. No formal drug interaction studies have been conducted with Trogarzo.
The most common adverse reactions observed in clinical studies were diarrhea (8%), dizziness (8%), nausea (5%) and rash (5%). Select lab abnormalities noted to occur in at least 5% of studied patients were increased bilirubin by greater than 2.6 times ULN (upper limit of normal), 5%; increased creatinine (greater than 1.8 times ULN or 1.5x baseline), 10%; increased lipase (greater than 3 times ULN), 5%; decreased leukocytes, 5% and decreased neutrophils, 5%. Most (90%) of the adverse reactions reported were mild or moderate in severity. No formal studies were conducted to examine the effects of either renal or hepatic impairment on the pharmacokinetics of Trogarzo. Renal impairment is not anticipated to affect the pharmacokinetics of Trogarzo. Based on animal data using higher doses of medication than would be used in humans, the FDA updated the drug label in 2021 to include the potential for transient immunosuppression in infants exposed to the drug inside the womb. See Section 8.1 (Pregnancy) in the prescribing information for more details.
The FDA approval is for heavily treatment-experienced (HTE) individuals with resistance to multiple HIV drug classes, in combination with an optimized background regimen (OBR), for people whose regimen is no longer effective. To watch a YouTube video of its mechanism of action, GO TO bit.ly/Trogarzo-mechanism-of-action. A key point is that people must still take other HIV medications that have some activity—there has to be at least one HIV drug to which their virus is sensitive that’s included in their OBR. Trogarzo is a relatively newer option that comes with some rules. Non-adherence is not an option—people won’t be able to just show up whenever they want or be late to appointments when going to a doctor’s office or an infusion center. Individuals must be on time.
Trogarzo is a biologic and a monoclonal antibody. Trogarzo can be administered at a provider’s office, clinics or IV centers and there may be an option for people to receive it at home. The undiluted IV push dosing requires less time and fewer supplies to administer.
Other long-acting HIV drugs are on the way and may be studied in combination with Trogarzo as well. Sunlenca (see that drug page) has been approved for heavily treatment-experienced people and can be combined with Trogarzo. Trogarzo is also the first HIV orphan drug—made for a relatively small population of people, fewer than 200,000. It was produced for people with multidrug-resistant HIV, estimated by the company to be fewer than 25,000. These are heavily treatment-experienced people who have multidrug resistance, and have, therefore, limited treatment options. Trogarzo has been shown to work against highly drug-resistant virus, when combined with an OBR. Data presented at ID Week 2020 showed evidence for long-term safety and efficacy as well as tolerability in people receiving Trogarzo for almost a decade. Trogarzo has also demonstrated CD4 improvements in clinical studies.
Trogarzo is neither metabolized in the liver nor eliminated by the kidneys. Monoclonal antibodies such as ibalizumab are transported across the placenta as pregnancy progresses; therefore, the developing fetus has the potential to be exposed to Trogarzo. Pregnant individuals can voluntarily enroll in the Antiretroviral Pregnancy Registry through their provider; GO TO apregistry.com.
Thera Patient Support can assist with private or government insurance coverage, including AIDS Drug Assistance Programs (ADAPs), and will also assist in applying any eligible co‑pay assistance. Commercially insured people may be eligible for co-pay assistance and may pay as little as $0. Call (833) 23-THERA (833-238-4372) or GO TO therapatientsupport.com.
JUAN MICHAEL PORTER II:
Trogarzo (ibalizumab) is a monoclonal antibody that stops HIV from entering CD4 cells. It was developed by a small biotech company. Although it works well for people who have almost no other treatment options, it hasn’t really taken off. In fact, it’s only really found in North America, possibly because it’s incredibly expensive, has to be taken in tandem with other drugs and it requires delivery by infusion through an IV line—a potentially laborious process—every two weeks.