FDA approved three new drugs in March 2018: 1) Trogarzo (ibalizumab-uiyk), a CD4-directed HIV-1 inhibitor given via monthly IV infusion, for treatment-experienced patients with multidrug-resistant HIV. 2) Ilumya (tildrakizumab-asmn), an interleukin-23 antagonist injected subcutaneously every 12 weeks for moderate-to-severe plaque psoriasis. 3) Symfi, a new once-daily oral combination tablet of efavirenz, lamivudine, and tenofovir disoproxil fumarate for HIV treatment.

1. A MONTHLY
DOSE OF EDUCATION
Brian Pelletier, PharmD, BCGP, FASCP
CEO, A Dose of Education, LLC
March 2018

2. FDA Approval
• Trogarzo™ (ibalizumab-uiyk) – approved 3/6/2018
• A CD4-directed post-attachment HIV-1 inhibitor
• In combination with other antiretroviral(s), is indicated for the treatment
of human immunodeficiency virus type 1 (HIV-1) infection in heavily
treatment-experienced adults with multidrug resistant HIV-1 infection
failing their current antiretroviral regimen
• Formulation and Administration:
• Injection: 200 mg/1.33 mL (150 mg/mL) in a single-dose (2ml) vial
• Given intravenously (IV) as a single loading dose of 2,000 mg (10 vials)
followed by a maintenance dose of 800 mg (2 vials) every 2 weeks after
dilution in 250 mL of 0.9% Sodium Chloride Injection, USP.
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761065lbl.pdf

3. Trogarzo™ (ibalizumab-uiyk)
• Warning/Precautions:
• Immune Reconstitution Inflammatory Syndrome (IRIS) has been reported
• Lactation: Women infected with HIV should be instructed not to
breastfeed due to the potential for HIV transmission
• Adverse Reactions:
• Most common adverse reactions (incidence ≥ 5%) were diarrhea,
dizziness, nausea, and rash
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761065lbl.pdf

4. Trogarzo™ (ibalizumab-uiyk)
• Miscellaneous Drug Info:
• Once diluted, solution should be administered immediately.
• If not administered immediately, store the diluted TROGARZO solution at
room temperature (20°C to 25°C, 68°F to 77°F) for up to 4 hours, or
refrigerated (2°C to 8°C, 36°F to 46°F) for up to 24 hours.
• If refrigerated, allow the diluted TROGARZO solution to stand at room
temperature (20°C to 25°C, 68°F to 77°F) for at least 30 minutes but no
more than 4 hours prior to administration.
• The duration of the first infusion (loading dose) should be no less than 30
minutes. If no infusion-associated adverse reactions have occurred, the
duration of the subsequent infusions (maintenance doses) can be
decreased to no less than 15 minutes.
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761065lbl.pdf

5. FDA Approval
• ILUMYA™ (tildrakizumab-asmn) – approved 3/20/2018
• An interleukin-23 antagonist indicated for the treatment of adults with
moderate-to-severe plaque psoriasis who are candidates for systemic
therapy or phototherapy
• Formulation and Administration:
• Injection: 100 mg/mL solution in a single-dose prefilled syringe
• Administer by subcutaneous injection
• Recommended dose is 100 mg at Weeks 0, 4, and every twelve weeks
thereafter
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761067s000lbl.pdf

6. ILUMYA™ (tildrakizumab-asmn)
• Warnings/Precautions:
• Hypersensitivity: If a serious allergic reaction occurs, discontinue
immediately and initiate appropriate therapy.
• Infections: Mmay increase the risk of infection. Instruct patients to seek
medical advice if signs or symptoms of clinically important chronic or
acute infection occur. If a serious infection develops, consider
discontinuing until the infection resolves.
• Tuberculosis (TB): Evaluate for TB prior to initiating treatment.
• Avoid live vaccinations during treatment.
• Adverse Reactions:
• Most common (≥1%) adverse reactions are upper respiratory infections,
injection site reactions, and diarrhea.
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761067s000lbl.pdf

7. New Combination
• Symfi™ (efavirenz; lamivudine; tenofovir disoproxil fumurate)1:
• Tablets: 600 mg efavirenz, 300 mg lamivudine and 300 mg tenofovir
disoproxil fumarate (equivalent to 245 mg of tenofovir disoproxil)
• One tablet taken orally once daily on an empty stomach, preferably at
bedtime
• Remember: February approval for Symfi Lo™ 2
• Tablets: 400 mg efavirenz, 300 mg lamivudine and 300 mg tenofovir disoproxil
fumarate (equivalent to 245 mg of tenofovir disoproxil)
1. https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022142s000lbl.pdf
2. https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208255s000lbl.pdf

8. Thank you!