Ibalizumab

Ibalizumab is a prescription medication used in combination with other antiretroviral drugs for the treatment of HIV-1 infection in heavily treated adults with multidrug-resistant infection failing their current antiretroviral therapy (ART) regimen.

• Ibalizumab is available under the following different brand names: Ibalizumab-uiyk, Trogarzo

Common side effects of Ibalizumab include:

• diarrhea
• dizziness
• nausea
• rash

Serious side effects of Ibalizumab include:

• hives
• difficulty breathing
• swelling of the face, lips, tongue, or throat
• cough
• hot flush
• wheezing
• nausea
• chest pain
• vomiting
• chest tightness
• sudden vision loss
• blurred vision
• tunnel vision
• eye pain or swelling
• seeing halos around lights
• fast, irregular, or pounding heartbeats
• fluttering in the chest
• shortness of breath
• sudden dizziness
• lightheadedness
• fainting
• severe headache
• confusion
• slurred speech
• arm or leg weakness
• trouble walking
• loss of coordination
• feeling unsteady
• very stiff or rigid muscles
• high fever
• profuse sweating
• tremors

Rare side effects of Ibalizumab include:

• none

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, coordination loss, unsteady, very stiff muscles, high fever, profuse sweating, or tremors;
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult dosage

Solution for injection

• 150 mg/mL (200 mg/1.33 mL single-dose vial)
• Must dilute further

HIV Infection

Adult dosage

• First dose (single loading dose): 2000 mg IV infused over at least 30 min; begin maintenance doses 2 weeks after loading dose; if no infusion-associated adverse reactions occur, subsequent infusions (maintenance doses) can be decreased to 15 minutes or given IV push
• Maintenance doses: 800 mg IV every 2 weeks infused over 15–30 minutes or IV push over 30 seconds

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, healthcare provider, or pharmacist first.

• Ibalizumab has no noted severe interactions with any other drugs
• Ibalizumab has no noted serious interactions with any other drugs
• Ibalizumab has no noted moderate interactions with any other drugs
• Ibalizumab has no noted minor interactions with any other drugs

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all the products you use. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, health questions, or concerns.

Contraindications

• Prior hypersensitivity reaction to drug or product components

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Ibalizumab?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Ibalizumab?”

Cautions

• Immune reconstitution inflammatory syndrome was reported in 1 patient treated with Ibalizumab in combination with other ARTs
• During the initial phase of combination ARTs, patients whose immune systems respond may develop an inflammatory response to indolent or residual opportunistic infections, which may necessitate further evaluation and treatment
• Hypersensitivity reactions including infusion-related reactions and anaphylactic reactions reported following infusion during post-approval use; if signs and symptoms of anaphylactic or other clinically significant hypersensitivity reaction occur, immediately discontinue administration, and initiate appropriate treatment

Pregnancy and Lactation

• There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antiretrovirals during pregnancy; this registry does not include Trogarzo, but likely includes patients’ concomitant antiretroviral drugs
• Healthcare providers are encouraged to register patients by calling the Antiretroviral Pregnancy Registry (APR) at 1-800-258-4263
• Based on animal data, Ibalizumab-quick use during pregnancy may cause reversible immunosuppression (CD4+ T cell and B cell lymphocytopenia) in infants exposed to Ibalizumab-quick in utero; immunoglobulin G (IgG) antibodies, such as Ibalizumab-risk, are transported across the placenta in significant amounts, especially near term; therefore, Ibalizumab-uiyk has potential to be transferred from mother to developing fetus
• There are no available data on ibalizumab-uiyk use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes
• Immunoglobulin G (IgG) antibodies are increasingly transported across the placenta as pregnancy progresses, with the largest amount transferred during the third trimester; administration during pregnancy may affect immune responses in the utero-exposed infant; for infants with perinatal exposure to the drug, immune phenotyping of peripheral blood, including CD4+ T cell and B cell counts, recommended; expert consultation is also recommended to guide monitoring and management (e.g., need for antibiotic or immunoprophylaxis) of exposed infants based on the degree of immunosuppression observed; safety of administering live or live-attenuated vaccines in exposed infants is unknown
  • Lactation
  • Unknown if distributed into breast milk
  • The CDC recommend that HIV-1-infected mothers in the US should not breastfeed infants to avoid risking postnatal transmission of HIV-1 infection
  • Owing to the potential for HIV transmission (in HIV-negative infants), developing viral resistance (in HIV-positive infants), and adverse reactions in a breastfed infant, instruct mothers not to breastfeed